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Archive for the ‘Pharmaceutical Industry Competitive Intelligence’ Category

AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025

Curator: Aviva Lev-Ari, PhD, RN

We had researched the topic of AI Initiatives in Big Pharma in the following article:

  • Authentic Relevance of LPBI Group’s Portfolio of IP as Proprietary Training Data Corpus for AI Initiatives at Big Pharma

https://pharmaceuticalintelligence.com/2025/11/15/authentic-relevance-of-lpbi-groups-portfolio-of-ip-as-proprietary-training-data-corpus-for-ai-initiatives-at-big-pharma/

 

We are publishing a Series of Five articles that demonstrate the Authentic Relevance of Five of the Ten Digital IP Asset Classes in LPBI Group’s Portfolio of IP for AI Initiatives at Big Pharma.

  • For the Ten IP Asset Classes in LPBI Group’s Portfolio, See

https://pharmaceuticalintelligence.com/portfolio-of-ip-assets/

The following Five Digital IP Asset classes are positioned as Proprietary Training Data and Inference for Foundation Models in Health care.
This Corpus comprises of Live Repository of Domain Knowledge Expert-Written Clinical Interpretations of Scientific Findings codified in the following five Digital IP ASSETS CLASSES:
 IP Asset Class I: Journal: PharmaceuticalIntelligence.com
6,250 scientific articles (70% curations, creative expert opinions.  30% scientific reports).
2.4MM Views, equivalent of $50MM if downloading an article is paid market rate of $30.

https://pharmaceuticalintelligence.com/vision/pharmaceuticalintelligence-com-journal-projecting-the-annual-rate-of-article-views/

 

• IP Asset Class II: 48 e-Books: English Edition & Spanish Edition.
152,000 pages downloaded under pay-per-view. The largest number of downloads for one e-Publisher (LPBI)
• IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025
Article Summary by @Grok
Conclusions and Implications
LPBI Group’s IP Asset Class III assets are “rare, defensible” for Big Pharma AI, powering from R&D acceleration to equitable care. Technical Implications: Enables theme-specific models (e.g., oncology conferences) for diagnostics/trials. Business Implications: Boosts ROI on $500M investments; licensing for symposia/webinars. Unique Insight: As the sole record of speaker insights, these outpace public data for “frontier” inference—key in series for holistic pharma AI moats.Promotional with resource links (e.g., IP portfolio, biotech conference lists). Complements prior pieces by adding temporal/event depth.

• IP Asset Class V: 7,500 Biological Images in our Digital Art Media Gallery, as prior art. The Media Gallery resides in WordPress.com Cloud of LPBI Group’s Web site

• IP Asset Class X: +300 Audio Podcasts: Interviews with Scientific Leaders
BECAUSE THE ABOVE ASSETS ARE DIGITAL ASSETS they are ready for use as Proprietary TRAINING DATA and INFERENCE for AI Foundation Models in HealthCare.
Expert‑curated healthcare corpus mapped to a living ontology, already packaged for immediate model ingestion and suitable for safe pre-training, evals, fine‑tuning and inference. If healthcare domain data is on your roadmap, this is a rare, defensible asset.
The article TITLE of each of the five Digital IP Asset Classes matched to AI Initiatives in Big Pharma, an article per IP Asset Class are:
  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class I: PharmaceuticalIntelligence.com Journal, 2.5MM Views, 6,250 Scientific articles and Live Ontology

https://pharmaceuticalintelligence.com/2025/11/22/ai-initiatives-in-big-pharma-grog-prompt-proprietary-data-training-and-inference-by-lpbi-groups-ip-asset-class-i-pharmaceuticalintelligence-com-journal-2-5mm-views-6250-scientific-article/

 

  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class II: 48 e-Books: English Edition & Spanish Edition. 152,000 pages downloaded under pay-per-view

https://pharmaceuticalintelligence.com/2025/11/22/ai-initiatives-in-big-pharma-grog-prompt-proprietary-training-data-and-inference-by-lpbi-groups-ip-asset-class-ii-48-e-books-english-edition-spanish-edition-152000/

 

  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025

https://pharmaceuticalintelligence.com/2025/11/22/ai-initiatives-in-big-pharma-grog-prompt-proprietary-training-data-and-inference-by-lpbi-groups-ip-asset-class-iii-100-e-proceedings-and-50-tweet-collections-of-top-biotech/

 

  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class V: 7,500 Biological Images in LPBI Group’s Digital Art Media Gallery, as Prior Art

https://pharmaceuticalintelligence.com/2025/11/22/ai-initiatives-in-big-pharma-grog-prompt-proprietary-training-data-and-inference-by-lpbi-groups-ip-asset-class-v-7500-biological-images-in-lpbi-groups-digital-art/

 

  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class X: +300 Audio Podcasts Library: Interviews with Scientific Leaders

https://pharmaceuticalintelligence.com/2025/11/22/ai-initiatives-in-big-pharma-grog-prompt-proprietary-training-data-and-inference-by-lpbi-groups-ip-asset-class-x-300-audio-podcasts-library-interviews-with-scientific-leaders/

 

In the series of five articles, as above, we are presenting the key AI Initiatives in Big Pharma as it was created by our prompt to @Grok on 11/18/2025:

  • What are PFIZER’s AI INITIATIVES?

@Grok Response:

x.com/i/grok/share/0ol5VOJsEYs11baXq4xkzNb0h

Generative AI tools that save scientists up to 16,000 hours annually in literature searches and data analysis.
Drug Discovery and Development Acceleration Pfizer uses AI, supercomputing, and ML to streamline R&D timelines
Clinical Trials and Regulatory Efficiency AI:

-Predictive Regulatory Tools

-Decentralize Trials

-inventory management

Disease Detection and Diagnostics:

–       ATTR-CM Initiative

–       Rare diseases

Generative AI and Operational Tools:

–       Charlie Platform

–       Scientific Data Cloud AWS powered ML on centralized data

–       Amazon’s SageMaker /Bedrock for Manufacturing efficiency

–       Global Health Grants:

Pfizer Foundation’s AI Learning Lab for equitable access to care and tools for community care

Partnerships and Education

–       Collaborations: IMI Big Picture for 3M – sample disease database

–       AI in Pharma AIPM Symposium: Drug discovery and Precision Medicine

–       Webinars of AI for biomedical data integration

–       Webinar on AI in Manufacturing

Strategic Focus:

–       $500M R&D reinvestment by 2026 targets AI for Productivity

–       Part of $7.7B cost savings

–       Ethical AI, diverse DBs

–       Global biotech advances: China’s AI in CRISPR

  • AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025

The Left Column was written @Grok

The Right Column was written by Aviva Lev-Ari, PhD, RN

 

AI Initiative at Big Pharma

i.e., Pfizer

e-Proceedings: N = +100

and

Tweet Collections: N = +50

Generative AI tools that save scientists up to 16,000 hours annually in literature searches and data analysis.
Drug Discovery and Development Acceleration Pfizer uses AI, supercomputing, and ML to streamline R&D timelines e-Proceeding of +100 TOP Conferences in Biotech, in Medicine, in Genomics, in Precision Medicine

https://pharmaceuticalintelligence.com/press-coverage/part-two-list-of-biotech-conferences-2013-to-present/

In these conferences the Frontier of Science was presented. These Proceedings are the ONLY written record of the events.

The tweet Collection are QUOTES of speakers on record. NOT ELSEWHERE available by name of speaker and affiliation

Clinical Trials and Regulatory Efficiency AI:

-Predictive Regulatory Tools

-Decentralize Trials

-inventory management

Disease Detection and Diagnostics:

–       ATTR-CM Initiative

–       Rare diseases

Generative AI and Operational Tools:

–       Charlie Platform

–       Scientific Data Cloud AWS powered ML on centralized data

–       Amazon’s SageMaker/Bedrock for Manufacturing efficiency

–       Global Health Grants:

Pfizer Foundation’s AI Learning Lab for equitable  access to care and tools for community care

Ingest to Charlie Platform ALL e-Proceedings of ALL Conferences

 

Apply GPT:

Training Data:

–       One conference at a time

–       All Conference on ONE subject matter, i.e., Immunotherapy, Oncolytic Virus Immunotherapy, Immune Oncology

Partnerships and Education

–       Collaborations: IMI Big Picture for 3M – sample disease database

–       AI in Pharma AIPM Symposium: Drug discovery and Precision Medicine

–       Webinars of AI for biomedical data integration

–       Webinar on Ai in Manufacturing

Use Past agendas to build Future Conference Agendas

Use Speakers Lists

Use topics covered in Employee training & and in Leadership development

Strategic Focus:

–       $500M R&D reinvestment by 2026 targets AI for Productivity

–       Part of $7.7B cost savings

–       Ethical AI, diverse DBs

–       Global biotech advances: China’s AI in CRISPR

Having access to +100 e-Proceedings vs Not having access to this resource is a make or break in Branding

 

CONCLUSIONS: The Voice of Dr. Stephen J. Williams PhD

PENDING

Article Summary of the ArticleTitle:

AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025

Publication Date: November 22, 2025

Author/Curator: Aviva Lev-Ari, PhD, RN
(Curator; Posted by 2012pharmaceutical)
@Grok SOURCE:


Overview: Third in LPBI Group’s five-article series on AI-ready digital IP assets for Pharma companies. This installment highlights IP Asset Class III—100 e-proceedings and 50 tweet collections from top global biotech/medical conferences (2013-2025)—as a proprietary, expert-curated corpus of frontier science insights. Using a November 18, 2025, Grok prompt on Pfizer’s AI efforts, it maps these assets to pharma applications, stressing their role in training/inference for foundation models. Unlike prior classes (journal articles, e-books), this focuses on real-time event captures (e.g., speaker quotes, agendas) as unique, non-replicable data for efficiency, education, and branding in AI-driven R&D.

Main Thesis and Key Arguments

  • Core Idea: LPBI’s IP Asset Class III assets provide the “only written record” of +100 top conferences, with tweet collections as verbatim speaker quotes/affiliations—ideal for ingesting into AI platforms to amplify human expertise in combinatorial predictions. This supports Pfizer’s goals like 16,000-hour savings via generative AI, enabling subject-specific training (e.g., immunotherapy) and future agenda building.
  • Value Proposition: 150 total assets (100 e-proceedings + 50 tweet collections) form a live repository of domain knowledge, mapped to ontology for immediate AI use. Equivalent to $50MM value (aligned with series benchmarks); unique for branding (“make or break”) as no other source offers such curated event intel. Part of five AI-ready classes (I, II, III, V, X) for healthcare models.
  • Broader Context: Builds on series by emphasizing event-based data for partnerships/education; contrasts generic datasets with defensible, ethical expert interpretations for global equity (e.g., Pfizer’s AI Learning Lab).

AI Initiatives in Big Pharma (Focus on Pfizer)Reuses Grok prompt highlights, presented in a verbatim table:

Initiative Category
Description
Generative AI Tools
Save scientists up to 16,000 hours annually in literature searches and data analysis.
Drug Discovery Acceleration
Uses AI, supercomputing, and ML to streamline R&D timelines.
Clinical Trials & Regulatory Efficiency
Predictive Regulatory Tools; Decentralize Trials; Inventory management.
Disease Detection & Diagnostics
ATTR-CM Initiative; Rare diseases.
Generative AI & Operational Tools
Charlie Platform; Scientific Data Cloud (AWS-powered ML on centralized data); Amazon’s SageMaker/Bedrock for Manufacturing efficiency; Pfizer Foundation’s AI Learning Lab for equitable access to care and community tools.
Partnerships & Education
IMI Big Picture (3M-sample disease database); AI in Pharma AIPM Symposium (Drug discovery and Precision Medicine); Webinars on AI for biomedical data integration; Webinar on AI in Manufacturing.
Strategic Focus
$500M R&D reinvestment by 2026 for AI productivity; Part of $7.7B cost savings; Ethical AI with diverse DBs; Global biotech advances (e.g., China’s AI in CRISPR).
Mapping to LPBI’s Proprietary DataCore alignment table (verbatim extraction, linking Pfizer initiatives to Class III assets):
Pfizer AI Initiative
Class III Alignment (100 e-Proceedings + 50 Tweet Collections)
Generative AI Tools (16,000 hours saved)
(No specific mapping.)
Drug Discovery Acceleration
e-Proceedings of +100 TOP Conferences in Biotech, Medicine, Genomics, Precision Medicine (2013-2025). Frontier of Science presented; ONLY written record of events. Tweet Collections: Speaker QUOTES on record (not elsewhere available by name/affiliation).
Clinical Trials & Regulatory Efficiency
(No specific mapping.)
Disease Detection & Diagnostics (ATTR-CM, rare diseases)
(No specific mapping.)
Generative AI & Operational Tools (Charlie, AWS, etc.)
Ingest ALL e-Proceedings into Charlie Platform. Apply GPT: Training Data—one conference at a time; OR All Conferences on ONE subject (e.g., Immunotherapy, Oncolytic Virus Immunotherapy, Immune Oncology).
Partnerships & Education (IMI, AIPM, webinars)
Use Past Agendas/Speakers Lists/Topics for: Employee Training & Leadership Development; Build Future Conference Agendas.
Strategic Focus ($500M reinvestment, ethics)
Access to +100 e-Proceedings vs. None = Make or Break in Branding.

Examples: Subject clusters like Immunotherapy; resources include conference lists (2013-present) and e-proceedings deliverables.Methodologies and Frameworks

  • AI Training Pipeline: Ingest proceedings/tweets into Charlie/AWS (e.g., SageMaker); GPT processing per conference or theme for pre-training/fine-tuning/inference. Use ontology for semantic mapping; tweets for quote-based evals.
  • Productivity Model: Enhances Pfizer’s savings ($7.7B total) via event intel for education/partnerships; ethical diverse data for global grants (e.g., CRISPR AI).
  • Insights: Quote from Dr. Stephen J. Williams, PhD: Emphasizes strategic branding via access. Predicts revolution in AI education/leadership from historical agendas.

Conclusions and Implications

LPBI Group’s IP Asset Class III assets are “rare, defensible” for Big Pharma AI, powering from R&D acceleration to equitable care. Technical Implications: Enables theme-specific models (e.g., oncology conferences) for diagnostics/trials. Business Implications: Boosts ROI on $500M investments; licensing for symposia/webinars. Unique Insight: As the sole record of speaker insights, these outpace public data for “frontier” inference—key in series for holistic pharma AI moats.Promotional with resource links (e.g., IP portfolio, biotech conference lists). Complements prior pieces by adding temporal/event depth.
Let me know if you want series comparisons or dives into specific conferences!

Read Full Post »

China is Making Large Inroads into Biotech: Is Investment Money Following? Is US Investment Money Following the China Biotech Boom?

Curator: Stephen J. Williams, Ph.D.

 

A common route for raising capital or exit strategy for many US biotechs has been strategic transfer or sale of intellectual property (IP) or strategic partnership with large pharmaceutical companies looking to acquire new biotechnologies or expand their own pipelines. Most US based biotechs had enjoyed a favorable (although not fully exclusive) deal-making environment with US pharmaceutical companies with some competition from international biotech companies.  US government agencies such as FINRA, CFIUS, and the SEC closely monitored such international deals and the regulatory environment for such international deal making in the biotechnology space was tight.

 

Smaller Chinese biotechs have operated in the United States (at various biotech hubs around the country) and have usually set up as either service entities to the biotech industry as contract research organizations (Wuxi AppTech), developing research reagents for biotech (Sino Biological) or conducting research for purposes of transferring IP to a parent company in China.  Most likely Chinese biotechs set up research operations because of the overabundance of biotech hubs in the United States, with a dearth of these innovation hubs in the China mainland.

 

However, as highlighted in the Next in Health Podcast Series from PriceWaterHouseCoopers (PwC), China has been rapidly been developing innovation hubs as well as biotech hubs.  And Chinese biotech companies are staying home in mainly China and exporting their IP to major US pharmaceutical companies.  As PwC notes this deal making between Chinese biotech in China and US pharmaceutical companies have rapidly expanded recently.

 

The following are notes from PriceWaterHouseCoopers (PwC) podcast entitled: Strategic Shifts: Navigating China’s Biotech Boom and Its Impact on US Pharma:

 

You can hear this podcast on YouTube at https://music.youtube.com/podcast/iguywci6oG0 

 

Tune in as Glenn Hunzinger, PwC’s Health Industries Leader and Roel van den Akker, PwC’s Pharma and Life Sciences Deals Leader discuss the rapid rise of China’s biotech industry and what it means for U.S. pharmaceutical companies. They discuss the evolving role of Chinese biotech in the global innovation landscape and share perspectives on how U.S. pharmaceutical companies can thoughtfully assess opportunities, manage cross-border complexities, and build effective partnering and diligence strategies.

 

 Discussion highlights:

 

  • China’s biotech industry is growing fast and becoming a global player, with U.S. companies increasingly looking to partner with Chinese firms on cutting-edge science
  • U.S. pharma leaders are encouraged to move beyond skepticism and stay curious by building relationships, learning from local innovation, and exploring new partnership opportunities
  • Successfully partnering with Chinese biotech firms requires a careful and well-structured approach that accounts for global complexity, protects data and IP, and uses creative deal structures like new company formations to manage risk and stay flexible
  • U.S. companies need to be proactive in order to stay competitive by actively exploring global innovation, understanding the risks, and having a clear strategy to bring high-potential science to U.S. patients

 

Speakers:

 

Roel Van den Akker, Pharmaceutical and Life Sciences Deals Leader 

 

Glenn Hunzinger, Partner, Health Industries Leader, PwC

 

Linked materials:

 

https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast/strategic-shifts-navigating-chinas-biotech-boom-and-its-impact-on-us-pharma.html 

 

China’s rise as a biotech innovation hub: 4 key strategic questions for US biopharma executives 

 

For more information, please visit us at: https://www.pwc.com/us/en/industries/..

 

In 2019 there were zero in licensing deals from China to US pharma…. Today one in five come from China.  

  1. China evolved into a expanding economy because China invested in biotech companies
  2. Lots of skilled people
  3. Built centers that rivaled biotech innovation centers in places like  Boston, California Bay  Area, and Philadelphia

China has gone from low cost manufacturing country to an innovative economy with great science coming out of it. US pharma boardrooms need to understand this

 

The analysts at PWC suggest to look at Data integrity, IP protection and risks before bringing China biotech IP  in US.  It is imperative that companies do ample due  diligence.

 

China’s rise as a biotech innovation hub: 4 key strategic questions for US biopharma executives

May 08, 2025

Roel van den Akker; Partner, Pharmaceutical & Life Science Deals Leader, PwC

China’s biotech sector is evolving at breakneck speed — and the implications for US pharma are too significant to ignore. Over the past five years, China has transitioned from being a nice to watch market to a central pillar of global biopharma innovation. Today, one-third of in-licensed molecules at US pharma multinationals originate from China, up from virtually zero in 2019.

China’s biotech sector, however, is not monolithic or uniform. The ecosystem spans high-quality, globally competitive biotech hubs in cities like Hangzhou and Suzhou — home to companies producing first-in-class and novel innovations in ophthalmology, cardiovascular, and immunology — as well as a long tail of undercapitalized players where execution and capability gaps remain profound.

And now, Washington is paying attention, too. A recent report from the US National Security Commission on Emerging Biotechnology (NSCEB) highlighted China’s ambitions to dominate biotech as a “strategic priority” with dual-use implications across health and security. The report urges the US government and private sector to reassess dependencies and increase scrutiny of biotechnology partnerships abroad. For the US biopharma industry, this isn’t just a supply chain concern — it is a boardroom issue.

With the licensing market still skewed toward buyers, venture funding remaining depressed in China and IPO windows in Hong Kong slowly reopening, there is a compelling window for US companies to secure differentiated assets at relatively attractive terms. Speedy deal execution is increasingly important as the highest quality assets are being quickly scooped up. But navigating this terrain can require more than opportunism. It calls for deliberate strategy, structured governance and a nuanced geopolitical risk framework.

Here are four questions every US biopharma executive should be asking:

1. What is our posture toward preclinical and clinical science from China?

Are we approaching Chinese innovation with a default posture of skepticism or strategic curiosity? Many top-tier Chinese biotechs are now generating US-caliber data at the speed of light, particularly in therapeutic modalities such as mAbs, ADCs and T-cell engagers, but plenty still have execution gaps. Those that elect to lean in will likely need a deliberate eco-system approach geared towards being the partner of choice and local brand building.

2. What does our China diligence playbook look like?

In light of national security concerns, companies need a China-specific diligence framework — one that goes beyond the science. This includes scrutiny around data integrity, IP protection, export controls, and cross border data sharing.

3. What is our plan post-licensing or acquisition?

Ownership is just the start. US companies need a clear strategy for globalizing China-origin assets — from IND transfers to FDA filing to commercial launch. In some cases, that may require reworking the preclinical package or rebuilding the CMC infrastructure entirely. Increasingly, US (or Europe)-based “Newcos” may serve as geopolitical firewalls.

4. How can we preserve agility amid regulatory and political volatility?

With rising US-China tensions and new export control proposals under review, companies must future-proof deal structures. This could include regional carveouts, US-only development rights, or milestone-gated commitments. The NSCEB report makes clear: passive engagement is no longer tenable.

Innovation strategy meets national interest

The trendlines are clear: China is not just a manufacturing hub — it is an increasingly important source of global biotech innovation. But sourcing innovation from China now sits at the intersection of science, strategy and security. US pharma and biopharma companies can no longer afford to treat China engagement as tactical. Those who adopt a deliberate, resilient and agile China strategy — grounded in scientific rigor and geopolitical realism — likely lead in tomorrow’s innovation race.

 

Source: https://www.pwc.com/us/en/industries/health-industries/library/china-biotech-sector.html 

 

US pharma bets big on China to snap up potential blockbuster drugs

By Sriparna Roy and Sneha S K

June 16, 202511:26 AM EDTUpdated June 16, 2025

A researcher prepares medicine at a laboratory in Nanjing University in Nanjing, Jiangsu province, April 29, 2011. REUTERS/Aly Song/File Photo Purchase Licensing Rights

, opens new tab

  • U.S. drugmakers turn to Chinese companies as they face patent expirations
  • Licensing deals accelerate while traditional mergers decline
  • Chinese biotechs are challenging Western peers, analysts say

June 16 (Reuters) – U.S. drugmakers are licensing molecules from China for potential new medicines at an accelerating pace, according to new data, betting they can turn upfront payments of as little as $80 million into multibillion-dollar treatments.

Through June, U.S. drugmakers have signed 14 deals potentially worth $18.3 billion to license drugs from China-based companies. That compares with just two such deals in the year-earlier period, according to data from GlobalData provided exclusively to Reuters.

 

How to stop the shift of drug discovery from the U.S. to China. The FDA must make it easier to do such work in the U.S.

Scott GottliebMay 6, 2025

 

Five years ago, U.S. pharmaceutical companies didn’t license any new drugs from China. By 2024, one-third of their new compounds were coming from Chinese biotechnology firms.

Why are U.S. drugmakers sending their business to China? As in many other industries, it’s so much cheaper to synthesize new compounds inside Chinese biotechnology firms once a novel biological target has been discovered in American laboratories.

Yet the costs of developing new drugs in the U.S. needn’t be so high. They are driven up, in part, by increasing regulatory requirements that burden early-stage drug discovery in America. That’s especially true for Phase I clinical trials, in which drugs are tested in people for the first time.

Newsletter

The smartest thinkers in life sciences on what’s happening — and what’s to come

This shift of discovery work to China is going to accelerate if we don’t take deliberate steps to make it easier to do such work here in America. Yet the imperative to modernize early-stage drug development — to ensure that groundbreaking drug discovery remains in the U.S. rather than migrating to China — is colliding head-on with an impulse to slash the very government workforce capable of spearheading these reforms. These conflicting impulses have created a paradoxical tension: on one hand, the desire to stay competitive with China in biotechnology innovation, and on the other, a parallel campaign to reduce and in some cases dismantle the investments and institutions essential to achieving that goal.

In most cases, Chinese firms are not discovering new biological targets, nor are they crafting genuinely novel compounds to engage these targets through homegrown Chinese research. Instead, they piggyback on Western innovations by scouring U.S. patents, zeroing in on biological targets that are initially uncovered in American labs, and then developing “me too” drugs that replicate American-made compounds with only superficial tweaks, or producing “fast follower” drugs that capitalize on the original breakthroughs while refining key features to try to surpass U.S. innovation. Facing fewer regulations, the Chinese drugmakers can move more quickly than U.S. biotechnology companies — synthesizing copy-cat drugs based on our biological advances and then promptly moving these Chinese-made compounds into early-stage clinical trials, outpacing their American counterparts.

According to the investment bank Jefferies, large American drug companies spent more than $4.2 billion over the past year licensing or acquiring new compounds originally synthesized by Chinese firms. Many comprised advanced compounds such as antibody drugs and cell therapies — underscoring Chinese companies’ growing sophistication in adopting the latest American technologies. The cost of licensing these compounds from China, rather than synthesizing them in American labs, can be significantly lower. At a time when research funding in the U.S. is being cut, and research budgets are becoming painfully stretched, companies are looking to lower the cost of building their pipelines. In a fast-moving field such as oncology, this shift toward Chinese-synthesized compounds is particularly striking: I am told by someone inside the FDA process that nearly three-quarters of new small molecule cancer drugs submitted to the Food and Drug Administration for permission to begin U.S.-based clinical trials are initially made in China.

Usually, only a few months elapse between the moment a U.S. research team publishes a patent identifying a new biological target and when a biotechnology firm in China creates the corresponding drug that capitalizes on these findings. Because Chinese firms can synthesize new molecules at a fraction of the cost incurred by U.S. biotechnology companies — owing to a large and skilled but much cheaper workforce — they find the most intriguing biological targets pursued by Western researchers, rapidly churning out potent yet less expensive copycat molecules that they then market to Western companies.

A major challenge for U.S. firms is the long and costly process of obtaining FDA approval for Phase I studies, in which drugmakers test a new drug’s safety and tolerability in a small group of human volunteers. In China, launching this initial phase of clinical trials is far simpler, giving Chinese biotechnology companies a competitive advantage: By swiftly advancing their molecules into early-stage patient testing, Chinese firms can more readily determine which compounds hit their biological targets and show the greatest therapeutic promise. This allows the Chinese firms to quickly refine their molecules and then leapfrog their American counterparts, who are slowed by more cautious regulatory processes. While China’s regulatory process doesn’t uphold the patient safeguards that Americans rightly insist upon, the U.S. FDA could still streamline its path into early-stage drug development, bolstering America’s competitive edge without compromising patient safety.

In the U.S., one of the costliest early hurdles is the exhaustive animal testing that the FDA requires before a drug can be advanced into Phase I studies. These “pre-clinical” studies help safeguard patients, but the agency also uses this testing to weed out potential failures before a drug requires more intensive FDA scrutiny in later trials.

Over time, this regulatory framework has frontloaded a significant share of costs to the earliest phases of drug development, when biotechnology startups are often running on shoestring budgets, lack clinical data to attract investors, and can least afford delays. One measure of the increasing difficulty in securing the FDA’s permission for Phase I trials is the growing number of U.S. drugmakers who take compounds discovered on American soil and conduct these clinical trials in other Western markets, where they can obtain data more quickly and inexpensively before bringing it back to the FDA. One popular locale is Australia, where costs run about 60% lower than U.S.-based clinical trials, largely because the Australian government offers tax incentives to attract this kind of biomedical investment.

Many animal studies address esoteric questions about a drug’s long-term effects on parameters that may not be relevant to its eventual use — for example, at doses and durations of use that may be far beyond how patients will ultimately use the drug. The FDA’s preclinical testing protocols sometimes require American researchers to administer new compounds to animals at levels up to 500 times higher than any intended dose for patients, aiming for maximum animal exposure before human trials can begin. Where the FDA needs to screen for certain remote risks, many animal studies could be safely deferred until human trials confirm that a drug may benefit patients. At that point, it becomes easier for biotechnology companies to raise capital to fund these pro forma testing efforts.

To modernize the process, the FDA could tap into the wealth of data from existing drugs to establish a more phased approach to these requirements, where the amount of initial animal testing is more closely matched to a drug’s novelty and a better estimation of its perceived risks. It’s a prime opportunity to employ artificial intelligence — mining current data and extrapolating known information to newly discovered molecules. For new molecules that share structural similarities with established drugs, where a robust body of safety information already exists (and the likelihood of uncovering novel risks is judged to be minimal), some animal studies might simply be unnecessary. To establish a graduated approach to the scope of pre-clinical toxicology studies that the FDA requires for new molecules, Congress could revise the agency’s statutory framework, explicitly empowering it to adopt such flexible standards. It would also require targeted investments, enabling the FDA to craft the necessary tools and protocols to implement these refined methodologies.

Mice and even primates are often poor proxies for many of the remote toxicities the FDA is trying to test for, anyway. The agency can also make a more concerted effort to adopt advanced technologies, like pieces of human organs embedded in chips that can be used to test for remote dangers a drug may pose to specific organs like the heart and liver. These tools can reliably screen for risks at a fraction of the time and cost. FDA Commissioner Marty Makary recently announced his intention to pursue a plan that would phase out animal studies in the preclinical evaluation of antibody drugs, shifting instead toward innovative technologies that assess toxicology without relying on live animals. This positive step requires the FDA to invest in new capabilities, and scientific staff that possess expertise in these novel domains.

But right now, that investment seems unlikely. The size and scientific scope of the FDA staff responsible for reviewing early-stage drug development — and evaluating data collected from animal studies — has failed to keep up with the increasing complexity and sheer volume of applications flooding into the agency to launch Phase I clinical trials. Now, the FDA has made deep staffing cuts, prompted by DOGE, that have specifically targeted scientific teams that would lead these essential reforms.

Adding to these woes, morale at the FDA has declined so markedly that many foresee a wave of voluntary resignations among clinical reviewers. By thinning the ranks of experts who tackle novel scientific questions and resolve issues that span across different drug development programs — especially the elimination of the policy office within the FDA’s Office of New Drugs, which adjudicated these kinds of cross-cutting scientific questions — the government has impeded the early dialogue with drug developers that often results in streamlining requirements for Phase I studies. Even more challenging, it weakens the staff’s ability to develop new guidance documents and put better review practices into place — reforms essential for lasting improvements to the preclinical review process.

Instead of strengthening America’s biotechnology ecosystem, such measures risk accelerating the migration of discovery activities to China, undermining innovation at home. When U.S. drugmakers license compounds from China, they divert funds that might otherwise bolster innovation hubs such as Boston’s Kendall Square or North Carolina’s Research Triangle. The U.S. biotechnology industry was the world’s envy, but if we’re not careful, every drug could be made in China.

Scott Gottlieb, M.D., is a senior fellow at the American Enterprise Institute and served as commissioner of the Food and Drug Administration from 2017 to 2019. He is a partner at the venture capital firm New Enterprise Associates and serves on the boards of directors of Pfizer Inc. and Illumina.

From FierceBiotech: US Biotech Companies are finding that foreign investments may put them in a precarious position for government funding

Source: https://www.fiercebiotech.com/biotech/us-appears-be-terminating-grants-biotechs-investors-certain-countries 

 

By Gabrielle Masson  Jun 18, 2025 11:50am

 

By Gabrielle Masson  Jun 18, 2025

The Department of Health and Human Services is allegedly denying clinical trial funding for biotechs based on their ties to certain foreign investors, Fierce Biotech has learned.

At the BIO conference in Boston this week, Fierce spoke with a biotech executive who had their grant pulled, as well as an industry thought leader who backed up the claims about a change in the HHS’ funding approach.

“We’re in a situation where some of the companies are confused about their ability to take foreign investment,” said John Stanford, founder and executive director of Incubate, a nonprofit organization of biotech venture capital firms and patient advocacy groups designed to educate policymakers on life science investment and innovation.

“We’ve been hearing about SBIR grants canceled,” Stanford told Fierce in a separate interview at BIO. “Anecdotally, we’ve also heard it’s a lot more than China and it’s countries—Canada, Norway, the EU—that traditionally we think of as allies.”

“Again, that’s anecdotal,” he stressed. “But we would be very concerned [about] the idea that we won’t take Canadian investments or Japanese investments or EU-based investments.”

“We want foreign investors coming to U.S.-based companies to develop drugs for the world,” Stanford said. “That is a win-win-win.”

Back in February, President Donald Trump issued a memorandum titled the “America First Investment Policy” that aims to restrict both inbound and outbound investments related to “foreign adversaries” in certain strategic industries. The document lacks specifics but puts China front and center while mentioning both healthcare and biotech among the sectors it will regulate.

And the investment analysis firm Jeffries noted that

 

Looking at financial data from FactSet, Jefferies analysts found biotech funding in May 2025 was down 57%, to just over $2.7 billion, compared to the same time last year. That sum was only slightly better than the nearly $2.6 billion raised in April — the worst haul in three years — and was also 44% lower than the average seen across the past 12 months.

 

Source: https://www.biopharmadive.com/news/biotech-funding-trump-policy-ipo-venture-pipe/749784/ 

 

But according to other Jeffries analysis biotech investment is not diminishing but realigning and maybe going international:

 

From Health Tech World: https://www.htworld.co.uk/insight/opinion/biotech-investment-isnt-shrinking-its-smarter-fn25/ 

Today, total capital remains relatively steady, but it’s flowing differently.

Fewer companies are commanding a greater share of investment, and a new global map of biotech leadership is emerging—one where Israel, Italy, Korea, Saudi Arabia, and NAME are not just participants but strategic innovators and investors in the space.

While some correction was inevitable after the pandemic’s urgency subsided, the sector’s foundation had already changed.

CROs didn’t scale down; they doubled down, offering sponsors the flexibility to develop therapies without taking on the full weight of manufacturing and trials in-house.

This shift underpinned a new era of capital efficiency and strategic outsourcing, which is strongly influenced by new smart technologies that generate code and content at a blink of an eye and refine research protocols.

Selective but Strong: The New Capital Math

After the surge of 2020–2021, a funding correction began in late 2022.

According to Jefferies, biotech funding in May 2025 was down 57 per cent year-over-year, dropping to roughly $2.7 billion.

Public markets also cooled. In 2023, biotech IPOs hit their lowest numbers in a decade, and follow-on offerings became increasingly rare.

This deceleration prompted talk of a “biotech winter.” Yet key indicators suggest a market in transition rather than decline. Private equity and venture capital remain active but are more selective.

While early-stage companies face greater hurdles, late-stage biotechs and those with de-risked clinical programs continue to attract significant funding.

Follow the Late-Stage Money

A recent GlobalData report underscores this trend: late-stage biotech companies now receive nearly double the capital of their earlier-stage counterparts.

Median venture rounds for Phase III companies have climbed to $62.5 million, as investors increasingly prioritise assets with regulatory clarity and near-term commercialisation potential.

The post-COVID period has revealed an important funding shift: fewer biotech companies are securing a larger percentage of available capital.

In an environment of macroeconomic uncertainty, geopolitical risk, and rising interest rates, investors are retreating from speculative bets and doubling down on known quantities.

From Gemini: Is US biotech investment going overseas in 2025? Plot in a bar graph the US biotech investment versus worldwide biotech investment by country

Is US biotech investment going overseas in 2025? Plot in a bar graph the US biotech investment versus worldwide biotech investment by country

Yes the US has many more venture capital  firms focused on Biotech investment but it is appearing that investment is not staying in the US.

The global biotech funding landscape in 2023: U.S. leads while Europe and China make strides

Earth planet inside DNA molecule. Elements of this image are furnished by NASA

[Image courtesy of Sergey Nivens/Adobe Stock]

In 2023, the U.S. continued to demonstrate its position as the biotech funding leader, commanding over one-third, 35%, of the global investment in the sector. Overall, U.S. biotech firms attracted $56.79 billion in funding, according to a survey of Crunchbase data. Next in line was China, which contributed about 12.7% to the global funding pool, or $20.61 billion. Up next was Europe, which secured more than $11.46 billion and representing more than 7% of the worldwide funding. 

While U.S. leads in total biotech funding, Chinese biotech companies, on average, saw larger funding rounds than either Europe or the U.S. The average funding size per company in China was roughly three times larger than that in the U.S. and six times larger than the average in Europe.

But while China-based companies had larger hauls, they were comparatively few. Chinese biotech secured in cumulative $20.61 billion among just 69 firms, with roughly $299 million in funding per company on average. Meanwhile, the 229 European biotech firms that won funding in the past year attracted $11.46 billion in funding, averaging $50 million each. In comparison, the 583 U.S. biotech companies with recent funding attracted $56.79 billion, averaging $97 million per company.

The map below represents the total biotech funding amount in USD across the globe. Funding amounts are shaded based on companies’ cumulative funding totals and density. Darker shades indicate higher funding amounts and density, with the U.S. hubs on the East and West Coasts showing the darkest shade, reflecting the combination of total funding and density.

The Chinese Biotech Market is expected to grow to over 800 million in 2025. This is on the heels of phenomenal growth from 2013, where almost a ten fold increase in market size growth has been seen from 2013 to 2025. Source: https://www.franklintempleton.co.uk/articles/2025/clearbridge-investments/china-emerging-as-a-global-biotechnology-player

 

Size of the US Biotech Market is expected to grow from half a billion in 2023 to 1.7 trillion in 2033. Source novaoneadvisor.com

 

Biotech investment trends in the US for 2025 present a complex picture. While some reports indicate a general slowdown in venture funding for biotech startups and concerns about tariff impacts, other sources suggest resilience within the sector, with strong revenue growth for public biotech companies in both the US and Europe in 2024, expected to continue into 2025. Additionally, there are calls for significant investment within the US to maintain its leadership in biotechnology. Therefore, it is not definitively clear that US biotech investment is predominantly going overseas in 2025, but rather navigating a challenging and evolving landscape.

Regarding US biotech investment versus worldwide biotech investment by country, here is a bar graph of key biotech investment moves in 2025 based on available data. Please note that this data reflects “key moves” in biotech funding for 2025 as reported by Labiotech, and a comprehensive worldwide investment breakdown for all countries was not available.

From Franklin Templeton: China is Emerging as a Global Biotechnology Player

See Source for more: https://www.franklintempleton.co.uk/articles/2025/clearbridge-investments/china-emerging-as-a-global-biotechnology-player 

The combined value of China’s outside licensing deals reached around US$46 billion in 2024, up from US$38 billion in 2023 and US$28 billion in 2022, according to data provider NextPharma. Meanwhile, the number of global companies licensing into China has decreased across the same period. These tailwinds have helped China expand its share of global drug development to nearly 30% compared to 48% for the United States, according to data provider Citeline. Strong IP protection has positioned China to receive global investment, with a 2024 policy encouraging more IP collaboration between global and Chinese companies. US investment bank Stifel projects that molecules licensed by large pharmaceutical firms from China will increase to 37% in 2025. This shift has been largely driven by US companies seeking cheaper drug development alternatives and has led to R&D spending in China outpacing that of the United States.

A Closer Look at the Financials and Comparison between China and US Biotech Investment Trends

This rapid growth of Chinese biopharma was predictable back in 2018 as this article from an investment newsletter suggests:

China’s Biopharma Industry: Market Prospects, Investment Paths

Source: https://www.china-briefing.com/news/china-booming-biopharmaceuticals-market-innovation-investment-opportunities/ 

November 10, 2022Posted by China BriefingWritten by Yi WuReading Time:  5 minutes

Biopharma, short for biopharmaceuticals, are medical products produced using biotechnology (or biotech). Typical biopharma products include pharmaceuticals generated from living organisms, vaccines, gene therapy, etc.

An important subsector of biotech, China’s biopharma industry has much attention home and abroad, especially after Chinese companies developed multiple COVID-19 vaccines now in wide circulation. Market capitalization of Chinese biopharma companies grew to over US$200 billion in 2020 from US$1 billion in 2016.

With China’s rapidly aging population and a growing affluent middle-class, the country’s biopharma industry presents challenging but compelling opportunities to investors.

In this article, we discuss the market size, growth drivers, and global competition facing China’s biopharma industry and suggest potential investment paths.

How big is China’s biopharma market?

Biopharmaceuticals in China is a lucrative business, with significant domestic demand due to an aging population and expanding household budgets for quality products and services as people’s living standards improve.

China’s healthcare market is predicted to expand from around US$900 billion (RMB 6.47 trillion) in 2019 to US$2.3 trillion (RMB 16.53 trillion) in 2030, and its market size is second to only the US. China’s total expenditure on healthcare as a component of its GDP increased to 5.35 percent in 2019 from 4.23 percent in 2010.

Specifically to the biopharma industry, the market size will likely grow from RMB 345.7 billion (US$47.60 billion) in 2020 to RMB 811.6 billion (US$111.76 billion) in 2025, an 135 percent increase in five years. Similarly, market capitalization of Chinese biopharma companies grew from US$1 billion in 2016 to over US$200 billion in 2020. From 2010 to 2020, 141 new drug and biotech companies were launched in China, doubling from the previous decade.

What are the growth drivers for China’s biopharma industry?

The broader biotech sector is a main focus of the Chinese government’s “Made in China 2025” strategy. The country needs a steady biopharmaceutical industry to address its healthcare needs and to build an internationally competitive and innovative pharmaceutical industry as part of wider economic restructuring. Under the same momentum, on January 30, 2022, nine agencies jointly issued the “14th Five-year Plan for the Development of the Pharmaceuticals Industry” as a guiding document that clarifies the goals and directions for China’s pharmaceutical industry development in the next five years.

Now let’s compare the size of the US biotech market: You can see the US biotech valuation is now similar to the estimated market capitalization of the China market.

 

The U.S. biotechnology market size was valued at USD 621.55 billion in 2024 and is projected to reach USD 1,794.11 billion by 2033, registering a CAGR of 12.5% from 2024 to 2033. Ongoing government initiatives are the key factors driving the growth of the market. Also, improving approval processes coupled with the favorable reimbursement policies can fuel market growth further.

Key Takeaways:

  •         DNA sequencing dominated this market and held the highest revenue market share of 18% in 2023
  •         The others’ segment is anticipated to grow at the fastest CAGR of 28.1% during the forecast period.
  •         The health segment dominated the market and accounted for the largest revenue market share of 44.13% in 2023.
  •         Bioinformatics is expected to witness the fastest growth, with a CAGR of 17.2% during the forecast period.

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The U.S. biotechnology market is witnessing major growth contributed by the increasing adoption and applications of biotechnology in many industries like pharmaceuticals, agriculture, food production, environmental conservation, and energy. In addition, market players in the industry are increasingly focusing on innovations across many fields such as energy, medicine, and materials science using biological processes to overcome challenges and fuel technological advancements. Also, in recent years there has been a notable surge in the utilization of biotechnological methods including DNA fingerprinting, stem cell technology, and genetic engineering propelling the market expansion soon.

 

From BioPharmaDive

Source: https://www.biopharmadive.com/news/biotech-us-china-competition-drug-deals/737543/ 

‘The bar has risen’: China’s biotech gains push US companies to adapt

A fast-improving pipeline of drugs invented in China is attracting pharma dealmakers, putting pressure on U.S. biotechs and the VC firms that back them.

Published Jan. 16, 2025

Ben Fidler

Senior Editor

Soon after starting a new biotechnology company, David Li realized he needed to rethink his strategy. 

Li had been conducting the competitive research biotech entrepreneurs typically undertake before soliciting investment. He drew up a list of drug targets that his startup, Meliora Therapeutics, could pursue and checked them against the potential competition. 

Li quickly found that biotechs in China were already working on many of the targets he had on his list. Curious, he visited Shanghai and Suzhou and witnessed a buzzing scene of startups set frenetically to task. 

The latest developments in oncology research

“They’re not really thinking about the U.S. at all. They’re just trying to create more value and stay alive to differentiate themselves from the next guy in China,” he said. “They’re moving quick. There are a lot of them and they’re just quite competitive.”

Li’s experience is illustrative of a trend that could pressure biotech companies in the U.S. and alter their drug development strategies. More and more, large pharmaceutical companies are licensing experimental drugs from China. Venture companies are testing similar tactics by launching new U.S. startups around compounds sourced from China’s laboratories. This shift has been sudden, with licensing deals ramping rapidly over the past two years. And it is occurring even as the shadow of U.S.-China competition within biotech grows longer. 

Executives and investors interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference this week share Li’s outlook. They expect such deals will accelerate and, in the process, force U.S. biotechs to work harder to stand out. 

“We’ve been warning people for a while, we’re losing our edge,” said Paul Hastings, CEO of cell therapy maker Nkarta and former chair of the U.S. lobbying group the Biotechnology Innovation Organization. “Innovation is now showing up on our doorstep.”

There’s perhaps no clearer example of this than ivonescimab, a drug developed by China-based Akeso Therapeutics and licensed by U.S.-based Summit Therapeutics. Recent results from a lung cancer study run in China showed ivonescimab outperformed Keytruda, Merck’s dominant immunotherapy and currently the pharmaceutical industry’s most lucrative single product. 

The finding “put a huge focus on what’s happening in China,” said Boris Zaïtra, head of business development at Roche, which sells a rival to Keytruda. 

Fast-moving research

Today’s deal boom has roots in efforts by the Chinese government to upgrade the country’s biotech capabilities by upping investment in technological innovation. In the life sciences, the initiative provided funding, discounted or even free laboratory space and grants to support what Li described as a “robust ecosystem” of biotechs. 

The results are clear. Places like Shanghai and Suzhou are home to a skilled workforce of scientists and hundreds of homegrown companies that employ them. Science parks akin to the U.S. biotech hubs of Cambridge, Massachusetts and San Francisco have sprouted up. 

Chinese companies generally can move faster, and at a lower cost, than their U.S. counterparts. Startups can go from launch to clinical trials in 18 months or less, compared to a few years in the U.S., Li estimated. Clinical trial enrollment is speedy, while staffing and supply chain costs are lower, helping companies move drugs along more cost effectively. 

“If you’re a national company within China running a trial, just by virtue of the networks that you work within, you pay a fraction of what we pay, and the access to patients is enough that you can go really fast,” said Andy Plump, head of research at Takeda Pharmaceutical. “All of those are enablers.” 

And what they’ve enabled is a large and growing stockpile of drug prospects, many of which are designed as “me too better” versions of existing medicines, analysts at the investment bank Jefferies wrote in a December report. Initially focused in oncology, China-based companies are now churning out high-quality compounds across multiple therapeutic areas, including autoimmune conditions and obesity

“There was a huge boom of investment in China, cost of capital was very low, and all these companies blew out huge pipelines,” said Alexis Borisy, a biotech investor and founder of venture capital firm Curie.Bio. ”Anything that anybody was doing in the biotech and pharmaceutical industry, you could probably find 10 to 50 versions of it across the China ecosystem.”

Me-toos become me-betters

For years now, Western biopharma executives have scouted the pipelines of China’s biotech laboratories — exploration that yielded a smattering of licensing deals and research collaborations. Borisy was among them, starting in 2020 a company called EQRx that sought to bring Chinese versions of already-approved drugs to the U.S. and sell them for less. EQRx’s plan backfired amid scrutiny by the U.S. Food and Drug Administration of medicines tested only in people from a single country.

Now, however, the pace of deals has accelerated rapidly. There are a few reasons for this. According to Plump, one is the improving quality of the drug compounds being developed. The “me toos” are becoming “me betters” that could surpass available therapies and earn significant revenue for companies — like BeiGene’s blood cancer drug Brukinsa, which, in new prescriptions for the treatment of leukemia, overtook two established medicines of the same type last year. 

Another reason, Plump said, is that China-based companies are becoming more innovative, studying drug targets that might not have yet yielded marketed medicines, or for which the most advanced competition is in early testing. Li notes how Chinese companies are going after harder “engineering problems,” like making complex, multifunctional antibody drugs, or antibody-drug conjugates. 

“There are so many [companies] that the new assets are going to keep coming,” Li said. 

Inside the market strategies of today’s drugmakers

Much as in the U.S., China-based biotechs are also fighting for funding, pushing them to consider licensing deals with multinational pharma companies. At the same time, these pharmas are hunting for cheap medicines they can plug into their pipelines ahead of looming patent cliffs. The two trends are “colliding,” said Kristina Burow, a managing director with Arch Venture Partners. “I don’t see an end to that.”

The statistics bear Burow’s view out. According to Jefferies, the number and average value of deals for China-developed drugs reached record levels last year. Another report, from Stifel’s Tim Opler, showed that pharma companies now source about one-third of their in-licensed molecules from China, up from around 10% to 12% between 2020 and 2022. 

“I see huge opportunities for us to partner and work together with Chinese companies,” said Plump, of Takeda. 

Several venture-backed startups have been built around China-originated drugs, too, among them Kailera Therapeutics, Verdiva Bio, Candid Therapeutics and Ouro Medicines, all of which launched with nine-figure funding rounds. 

“There’s been a lot of really good, high quality molecules and data that have emerged from China over the last couple of years,” said Robert Plenge, the head of research at Bristol Myers Squibb. “It’s also no longer just simply repeating what’s been done with the exact same type of molecule.”

Geopolitical risks

These deals are happening against an uncertain backdrop. The U.S. Congress has spent the last year or so kicking around iterations of the Biosecure Act, a bill that would restrict U.S. biotechs from working with certain China-based drug contractors. A committee in the House of Representatives is calling for new limits on clinical trials that involve Chinese military hospitals. And the incoming Trump administration has threatened tariffs that could ripple across industrial sectors. 

“We don’t know what this new administration is going to do,” said Jon Norris, a managing director at HSBC Innovation Banking.

The Biosecure Act “keeps going sideways,” added Hastings, who believes that any impact from the legislation, if passed, would be minimal. Instead, Hastings wonders if future tariffs may be more problematic. “There will be tariffs on other goods coming from China. Does that include raw materials and innovation? It’s hard to imagine that it won’t,” he said. 

But executives and investors expect deals to continue, meaning U.S. biotechs will have to do more to compete. 

“U.S. companies will need to figure out what it is they’re able to bring to the table that others can’t,” said Burow, of Arch. 

Borisy said startups working on first-of-their-kind drugs need to be more secretive than ever. “Do not publish. Do not present at a scientific meeting. Do not put out a poster. Try to make your initial patent filing as obtuse as possible,” he cautioned. 

“The second that paper comes out, or poster at any scientific meeting, or talk or patent, assume it has launched a thousand ships.”

Those that are further along should assume companies in China will be quick on their heels with potentially superior drugs. “The day when you could come out with a bad molecule and open up a field is over,” he said. 

Greater competition isn’t necessarily a bad thing, according to Neil Kumar, CEO of BridgeBio Pharma. Drug development could become more efficient as pharmas acquire medicines from a “cheaper” starting point and advance them more quickly. 

Venture dollars could be directed towards newer ideas, rather than standing up a host of similar companies.“If all of a sudden this makes us less ‘lemming-like,’” Kumar said, “I have no problem with that.”

Li similarly argues that, going forward, U.S. companies need to focus on “novelty and innovation.” At his own company, Li is now working on things “we felt others were not able to access.”

“The game has always been the same. Bring something super differentiated to market,” he said. But “the bar has risen.” 

 Gwendolyn Wu and Jacob Bell contributed reporting. 

Is Chinese Biotechs just Producing Me-Too Drugs or are they Innovating New Molecular Entities?

The following articles explain the areas in which Chinese Biotech is expanding and focused on.

However the sort answer and summary to the aforementioned question is: Definately Chinese Biotechs are innovating at a rapid pace, and new molecular entities and new classes of drugs are outpacing any copycat or mee-too generic drug development.

This article  by Joe Renny on LinkedIn focuses on the degree of innovation in Chinese biotech companies. I put the article in mostly its entirety because Joe did an excellent analysis of China’s biotech industry.

You can see the full article here: https://www.linkedin.com/pulse/copy-chinas-biotech-boom-can-really-solve-pharmas-roi-joe-renny-rerge/ 

China’s Biotech Boom: Can It Really Solve Pharma’s ROI Problem?

Joe Renny

Joe Renny: Strategic Growth Leader | Driving M&A, Pharma Partnerships & Innovation | Unlocking the Commercial Potential of Science | Biotech & Pharmaceuticals

China’s biotech sector is in the midst of a stunning surge – its stocks have skyrocketed over 60% this year (outpacing even China’s high-flying tech sector), and the country now has over 1,250 innovative drugs in development, nearly catching up with the U.S. pipeline of ~1,440. Once known mainly for generic manufacturing, China is rapidly emerging as a source of differentiated innovation. Global pharma giants have taken notice: major licensing deals are proliferating as Western drugmakers snap up Chinese-born therapies in fields like oncology, metabolic diseases (obesity/diabetes), and immunology. The excitement is palpable – but a critical question looms beneath the optimism: Can this wave of innovation meaningfully improve the pharmaceutical industry’s return on investment (ROI)? In other words, will China’s biotech boom fix the underlying economics of drug development, or are the same old ROI challenges here to stay?

From Copycats to Cutting-Edge: China’s Rapid Ascent in Biotech

In the past decade, China’s pharma landscape has transformed from copycat chemistry to cutting-edge biotech. The sheer scale of innovation is unprecedented. A recent analysis found China had over 1,250 novel drug candidates enter development in 2024, far surpassing the EU and nearly reaching U.S. levels. This is a remarkable jump from just a few years ago – back in 2015, China contributed only ~160 compounds globally. Reforms to streamline drug approvals and massive R&D investments (spurred by initiatives like Made in China 2025) have unleashed a boom led by returnee scientists and ambitious startups.

Importantly, the quality of Chinese innovation has leapt upward alongside quantity. Drugs originating in China are increasingly clearing high bars of efficacy and safety. The world’s strictest regulators, including the U.S. FDA and European EMA, have begun fast-tracking more Chinese-developed drugs with priority reviews and “breakthrough” designations. For example, a cell therapy for blood cancer developed by China’s Legend Biotech won FDA approval (marketed by Johnson & Johnson) and is considered superior to a rival U.S. therapy. Another China-origin drug – Akeso Inc.’s novel cancer antibody that outperformed Merck’s Keytruda in trials – triggered a global wave of interest and a $500 million licensing deal in 2022. In short, China is no longer just a low-cost manufacturing base; it’s producing world-class treatments that Big Pharma is eager to get its hands on.

This trend is also evident in the stock markets. After a four-year slump, Chinese biotech stocks have roared back, becoming one of Asia’s best-performing sectors in 2025. The Hang Seng Biotech Index in Hong Kong is up over 60% since January, vastly outperforming broader tech indices. Investors are excited by signals that China is becoming a true global hub for biopharma innovation. According to one analyst, “China biotech is now a disruptive force reshaping global drug innovation… The science is real, the economics are compelling, and the pipeline is starting to deliver”. All of this represents a fundamental shift in the industry’s centre of gravity – and perhaps a new source of competitive pressure on Western incumbents.

Western Pharma’s Response: Licensing Deals and Partnerships Accelerate

Global pharmaceutical companies aren’t standing on the sidelines – they’re rushing to collaborate with and invest in Chinese biotechs. In fact, U.S. and European drugmakers have dramatically stepped up licensing deals to tap China’s innovations. Through the first half of 2025 alone, U.S. companies signed 14 licensing agreements worth up to $18.3 billion for Chinese-origin drugs, a huge jump from just 2 such deals in the same period a year earlier. Many of these partnerships involve potential blockbusters in cancer, metabolic disorders, and other areas where Chinese R&D is making leaps.

  • Oncology: China has become a hotbed for cancer drug innovation, especially with advanced biologics like bispecific antibodies. In May 2025, Pfizer paid a record $1.25 billion upfront to license a PD-1/VEGF bispecific antibody from China’s 3SBio (a deal worth up to $6 billion with milestones). Weeks later, Bristol Myers Squibb struck an $11.5 billion alliance for a similar immunotherapy developed in China. Virtually every active clinical trial for certain cutting-edge cancer combos (like PD-1/VEGF drugs) now originates in China, making it a goldmine for Western firms seeking the next breakthrough. AstraZeneca, Merck, Novartis, and others have all scooped up Chinese cancer therapies in recent years as they cast their nets wider for innovation.
  • Metabolic & Obesity Drugs: Western pharma is also eyeing China’s contributions in metabolic diseases. Notably, Merck licensed a Chinese-developed GLP-1 oral drug (for diabetes/obesity) from Hansoh Pharma in late 2022 for up to $1.7 billion. And in 2025, Regeneron paid $80 million upfront (in a deal worth up to $2 billion) for rights to an experimental obesity drug from Hansoh. These deals underscore that Chinese labs are producing competitive candidates in the red-hot obesity/diabetes arena – an area of huge global market potential.
  • Autoimmune & Other Areas: While oncology leads, Chinese biotechs are also advancing novel therapies in immunology and autoimmune diseases. For example, multiple deals in 2024–25 have focused on inflammatory conditions and neurology, indicating breadth in China’s pipeline. As one industry banker observed, roughly one-third of all new assets licensed by large pharmas in 2024 originated from China, and this could rise to 40–50% in coming years. In other words, nearly half of Big Pharma’s in-licensed pipeline may soon be sourced from China – a radical change from a decade ago.

Underpinning this deal frenzy is a stark reversal of roles: China has shifted from mostly importing therapies to now exporting its homegrown innovations. Back in 2015, Chinese companies mainly signed “license-in” deals to bring foreign drugs to China. But by 2024, nearly half of China’s transactions were license-out deals, with Chinese firms granting global rights to their own drugs. In 2024 alone, Chinese biotechs out-licensed 94 novel projects to overseas partners, often at early clinical stages. This boom in outbound deals – especially for high-value cancer therapies (like ADCs and bispecific antibodies) – highlights China’s maturation as an innovation engine.

In a scientific paper published by Yan et al, the authors provided a comparative analysis between the US, EU, and China of new approved drugs from the years 2019- 2023.

Yan Y, Guo X, Li Z, Shi W, Long M, Yue X, Kong F, Zhao Z. New Drug Approvals in China: An International Comparative Analysis, 2019-2023. Drug Des Devel Ther. 2025 Apr 3;19:2629-2639. doi: 10.2147/DDDT.S514132.

In the paper, the authors retrieved approval data from from the National Medical Products Administration (NMPA), Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA), including information on the generic name, trade name, applicants, target, approval date, drug type, approved indications, therapeutic area, the highest R&D status in China, and special approval status. The approval time gaps between China and other regions were calculated.

Results: Interestingly, China led with 256 new drug approvals, followed by the US (243 approvals), the EU (191 approvals), and Japan (187 approvals). Oncology, hematology, and infectiology were identified as the leading therapeutic areas globally and in China. Notably, PD-1 and EGFR inhibitors saw substantial approval, with 8 drugs each approved by the NMPA. China significantly reduced the approval timeline gap with the US and the EU since 2021, approving 15 first-in-class drugs during the study period.

The authors concluded, that despite the COVID-19 years, Chinese biotech has rapidly innovated in the biotech space and made up for the time gaps with increased research productivity.

Number of drug approvals by regulatory agency. Source: Yan Y, Guo X, Li Z, Shi W, Long M, Yue X, Kong F, Zhao Z. New Drug Approvals in China: An International Comparative Analysis, 2019-2023. Drug Des Devel Ther. 2025 Apr 3;19:2629-2639. doi: 10.2147/DDDT.S514132.

A comparison of drug approvals in US and China, as percentage of clinical use in various disease states. Source: Yan Y, Guo X, Li Z, Shi W, Long M, Yue X, Kong F, Zhao Z. New Drug Approvals in China: An International Comparative Analysis, 2019-2023. Drug Des Devel Ther. 2025 Apr 3;19:2629-2639. doi: 10.2147/DDDT.S514132.

China Biotech Innovation Hubs

The following was generated by Google AI

China has several prominent biotech innovation hubs, with the Yangtze River Delta region (including Shanghai, Suzhou, and Hangzhou) and Beijing being particularly strong. These regions leverage strong academic and research institutions, high R&D expenditures, and significant investment to foster a vibrant biotech ecosystem. 

Here’s a closer look at some key hubs:

Yangtze River Delta:

  • Shanghai:
    A major hub with a focus on oncology, cell and gene therapy, and a strong track record of biotech IPOs. It’s home to the Zhangjiang Biotech and Pharmaceutical Base, known as China’s “Medicine Valley”. 
  • Suzhou:
    Known for the BioBay industrial park, which houses numerous biotechnology and technology companies. 
  • Hangzhou:
    Features a growing biotech sector, with companies like Hangzhou DAC Biotech

Other Notable Hubs:

Key Factors Driving Growth:

  • Strong government support and investment:
    China has been actively promoting the growth of its biotech sector through various initiatives and funding programs. 
  • High R&D expenditures:
    China is investing heavily in research and development, particularly in the tech, manufacturing, and biotech sectors. 
  • Increasingly strong talent pool:
    China is producing a growing number of STEM graduates and globally recognized researchers. 
  • AI and technology integration:
    AI is being applied to drug design and discovery, accelerating innovation. 
  • Focus on specific areas:
    Different hubs are specializing in areas like oncology, regenerative medicine, and medical devices. 

Overall, China’s biotech sector is experiencing rapid growth and is becoming a significant player in the global landscape, with these hubs leading the way. 

 

Articles of Interest on International Biotech Venture Investment on the Open Access Scientific Journal Include:

10th annual World Medical Innovation Forum (WMIF) Monday, Sept. 23–Wednesday, Sept. 25 at the Encore Boston Harbor in Boston

CAR T-Cell Therapy Market: 2020 – 2027 – Global Market Analysis and Industry Forecast

2021 Virtual World Medical Innovation Forum, Mass General Brigham, Gene and Cell Therapy, VIRTUAL May 19–21, 2021

Real Time Coverage @BIOConvention #BIO2019: What’s Next: The Landscape of Innovation in 2019 and Beyond. 3-4 PM June 3 Philadelphia PA

 

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Some Recent Challenging News from Gene Therapy Companies: Sarepta’s Gene Therapy Halted by FDA, Spark Therapeutics Program Gets a Realignment and  Review from Roche

 

Curator: Stephen J.Williams,  Ph.D.

 

Sarepta Therapeutics has received a order from the FDA to halt clinical trials on its Duchenne Muscular Dystrophy gene therapy Elevidys on July 18, 2025 following three deaths.

 

From FDA: https://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold 

 

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths

 

For Immediate Release:

July 18, 2025

The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold following three deaths potentially related to these products and new safety concerns that the study participants are or would be exposed to an unreasonable and significant risk of illness or injury. The FDA has also revoked Sarepta’s platform technology designation.

The FDA leadership also met with Sarepta Therapeutics and requested it voluntarily stop all shipments of Elevidys today. The company refused to do so.  

“Today, we’ve shown that this FDA takes swift action when patient safety is at risk.” said FDA Commissioner Marty Makary, M.D., M.P.H. “We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges.”

The three deaths appear to have been a result of acute liver failure in individuals treated with Elevidys or investigational gene therapy using the same AAVrh74 serotype that is used in Elevidys. One of the fatalities occurred during a clinical trial conducted under an investigational new drug application for the treatment of Limb Girdle Muscular Dystrophy.

“Protecting patient safety is our highest priority, and the FDA will not allow products whose harms are greater than benefits. The FDA will halt any clinical trial of an investigational product if clinical trial participants would be exposed to an unreasonable and significant risk of illness or injury,” said Director of the FDA’s Center for Biologics Evaluation and Research Vinay Prasad, M.D., M.P.H.

Elevidys is an adeno-associated virus vector-based gene therapy using Sarepta Therapeutics, Inc.’s AAVrh74 Platform Technology for the treatment of Duchenne muscular dystrophy (DMD). It is designed to deliver into the body a gene that leads to production of Elevidys micro-dystrophin, a shortened protein (138 kDa, compared to the 427 kDa dystrophin protein of normal muscle cells) that contains selected domains of the dystrophin protein present in normal muscle cells. The product is administered as a single intravenous dose.

Duchenne muscular dystrophy is a rare and serious genetic condition which worsens over time, leading to weakness and wasting away of the body’s muscles. The disease occurs due to a defective gene that results in abnormalities in, or absence of, dystrophin, a protein that helps keep the body’s muscle cells intact.

Further, today, the FDA revoked the platform technology designation for Sarepta’s AAVrh74 Platform Technology because, among other things, given the new safety information, the preliminary evidence is insufficient to demonstrate that AAVrh74 Platform Technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on safety.

Elevidys received traditional approval for use in ambulatory DMD patients 4 years of age and older with a confirmed mutation in the DMD gene on June 20, 2024. It was approved for non-ambulatory patients on June 22, 2023 under the accelerated approval pathway. This pathway can allow earlier approval based on an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, while the company conducts confirmatory studies to verify the predicted clinical benefit. Continued approval for non-ambulatory patients is contingent upon verification and description of clinical benefit in a confirmatory trial. Given the new safety information, The FDA has notified the company that the indication should be restricted to use in ambulatory patients. The FDA is committed to further investigating the safety of the product in ambulatory patients and will take additional steps to protect patients as needed.

 

On July 18 Sarepta appeared to be disregarding the FDA release (according to the New York Times)

 

Source: https://www.nytimes.com/2025/07/18/health/fda-sarepta-elevidys-duchenne.html 

 

Published July 18, 2025 

 

In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.

In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Elevidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.

In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.

Dr. Marty Makary, the F.D.A. commissioner, said in the agency’s statement that its request to Sarepta demonstrated that the F.D.A. “takes swift action when patient safety is at risk.”

“We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges,” he said.

In the past, the F.D.A. has sometimes asked companies to pause distribution of a drug until a new problem is better understood and mitigated. However, it can also press its case, and begin a process to revoke the drug’s license, which would begin with a formal notification and opportunity to respond and participate in a public hearing.

 

On July 21, 2025 Sarepta announces on their website in press release

 

Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.

07/21/25 7:40 PM EDT

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jul. 21, 2025– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

Today, Sarepta Therapeutics notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily and temporarily pause all shipments of ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the United States, effective close of business Tuesday, July 22, 2025.

This proactive step will allow Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the ELEVIDYS safety labeling supplement process. The Company looks forward to a collaborative, science-driven review process and dialogue with the FDA.

“As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,” said Doug Ingram, chief executive officer, Sarepta. “It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the ELEVIDYS label supplement process.”

Sarepta remains committed to transparency and patient safety and will continue to provide timely updates to patients, families, healthcare providers, and the broader Duchenne community as additional information becomes available.

About ELEVIDYS (delandistrogene moxeparvovec-rokl)
ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.

ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age.

  • For patients who are ambulatory and have a confirmed mutation in the DMD gene
  • For patients who are non-ambulatory and have a confirmed mutation in the DMD gene.

However this is not the first time Sarepta has been in the hot seat… 

 

Read this interesting article from Derrick  Lowe of Science.  I will put it in its entirety as Derick Lowe really writes some great articles in his blog.

 

Source: https://www.science.org/content/blog-post/sarepta-why 

 

Sarepta. Why? 21 Jun 2024

 

I really, really wish that I were not writing about Sarepta again. But here we are. Perhaps a quick review will explain my reluctance.

Back in 2013, the company was trying to get approval for an unusual “exon skipping” molecule (eteplirsen) as a therapy for Duchenne muscular dystropy. Nothing wrong with that – in fact, there’s a lot that’s right with that, since Duchenne is a perfect “unmet medical need” situation, and the exon-skipping idea was an innovative approach ten years ago (and it’s still not exactly a standard-issue therapy). Attacking very hard-to-treat diseases with new mechanisms of action is just what we’re supposed to be doing in this business.

The approval, though, was having trouble for some very good reasons. Sarepta’s trial was very, very small and the FDA later found that their trial design was very, very flawed. But in 2016 eteplirsen was suddenly approved, to the surprise of many observers (including me). A few years later, a follow-up drug (golodirsen) from the company (golodirsen) was also rejected by the FDA (with a Complete Response Letter) but then was later suddenly approved, although no new data had been presented. That was particularly mystifying since the eventually-published CRL detailed a number of real problems with eteplirsen since its approval, problems that looked to be possibly even greater with the follow-up drug. To the best of my knowledge, the confirmatory Phase III trial that was required at the time of golodirsen’s approval is still going on and is expected to read out next year. In 2021, another Sarepta exon-skipping drug (different exon this time) was approved (casimirsen) on the basis of biomarker levels that were expected to show eventual clinical benefit, and I believe that its confirmatory trial is part of the golodirsen one. That one at least did not go through the first-rejected-then-approved pathway.

More recently the company has been working on an outright gene therapy (elevidys) for Duchenne, and the initial results were quite promising. The company got accelerated FDA approval for that one last June for 4- and 5-year-old patients, even though actual clinical benefit had not yet been established. But gene therapy is a winding road, and last October the Phase III results for Elevidys were a complete miss in the primary endpoint. Arguing commenced, with the company saying that the results in the secondary endpoints showed that the drug was “modifying the trajectory” of the disease, and the CEO called the results a “massive win” and said that the company would use them to ask for a much wider label approval from the FDA. Apparently during the conference call, when he was asked about why he was so confident, he said that the FDA’s CBER head Peter Marks was “very supportive”. (It should be noted that since then another Duchenne gene therapy effort, this one from Pfizer, also failed its Phase III, so it’s not like this is a straightforward area).

Boy, was that the truth. The agency has just granted that use expansion, and it turns out that it was all due to Peter Marks, who completely overruled three review teams and two of his highest-level staffers (all of whom said that Sarepta had not proven its case). Honestly, I’m starting to wonder why any of us go to all this trouble. It appears that all you need is a friend high up in the agency and your clinical failures just aren’t an issue any more. Review committees aren’t convinced? Statisticians don’t buy your arguments? Who cares! Peter Marks is here to deliver hot, steaming takeout containers full of Hope.

Back in 2016, when eteplirsen first came up for its advisory committee vote, I wrote that there was a matrix of possible votes and interpretations, which I summed up this way:

(1) A negative vote, which is a rejection of the potential of the drug, the suffering of DMD patients, and their right to try a therapy which apparently does no harm, for a disease that has no other options.

(2) A negative vote, which is the only possible one, considering that the company’s trial data are far too sparse and unconvincing to allow a recommendation to approve the drug. If this gets recommended, what doesn’t? Why do we require new drugs to show efficacy at all?

 

(3) A positive vote, which is a victory for patient advocates everywhere, and in particular for the extremely ill boys who suffer from this disease, or. . .

 

(4) A positive vote, which marks an undeserved and potentially hazardous victory of emotional rhetoric and relentless patient advocacy over the scientific and medical evidence.

As I’ve said many times since, including just a few days ago, I believe that the FDA is tilting very, very noticeably towards #4 while proclaiming the wonderful new world of #3. And while I realize that this may make me sound like a heartless SOB, I think this is a huge mistake that we will be paying for for a long time.

 

Note that there has been reported deaths in 2024.

 

The following was from some data published in Nature in 2025 from Clinical Trial ClinicalTrials.gov: NCT05096221.

Mendell JR, Muntoni F, McDonald CM, Mercuri EM, Ciafaloni E, Komaki H, Leon-Astudillo C, Nascimento A, Proud C, Schara-Schmidt U, Veerapandiyan A, Zaidman CM, Guridi M, Murphy AP, Reid C, Wandel C, Asher DR, Darton E, Mason S, Potter RA, Singh T, Zhang W, Fontoura P, Elkins JS, Rodino-Klapac LR. AAV gene therapy for Duchenne muscular dystrophy: the EMBARK phase 3 randomized trial. Nat Med. 2025 Jan;31(1):332-341. doi: 10.1038/s41591-024-03304-z

 

Abstract

Duchenne muscular dystrophy (DMD) is a rare, X-linked neuromuscular disease caused by pathogenic variants in the DMD gene that result in the absence of functional dystrophin, beginning at birth and leading to progressive impaired motor function, loss of ambulation and life-threatening cardiorespiratory complications. Delandistrogene moxeparvovec, an adeno-associated rh74-viral vector-based gene therapy, addresses absent functional dystrophin in DMD. Here the phase 3 EMBARK study aimed to assess the efficacy and safety of delandistrogene moxeparvovec in patients with DMD. Ambulatory males with DMD, ≥4 years to <8 years of age, were randomized and stratified by age group and North Star Ambulatory Assessment (NSAA) score to single-administration intravenous delandistrogene moxeparvovec (1.33 × 1014 vector genomes per kilogram; n = 63) or placebo (n = 62). At week 52, the primary endpoint, change from baseline in NSAA score, was not met (least squares mean 2.57 (delandistrogene moxeparvovec) versus 1.92 (placebo) points; between-group difference, 0.65; 95% confidence interval (CI), -0.45, 1.74; P = 0.2441). Secondary efficacy endpoints included mean micro-dystrophin expression at week 12: 34.29% (treated) versus 0.00% (placebo). Other secondary efficacy endpoints at week 52 (between-group differences (95% CI)) included: Time to Rise (-0.64 (-1.06, -0.23)), 10-meter Walk/Run (-0.42 (-0.71, -0.13)), stride velocity 95th centile (0.10 (0.00, 0.19)), 100-meter Walk/Run (-3.29 (-8.28, 1.70)), time to ascend 4 steps (-0.36 (-0.71, -0.01)), PROMIS Mobility and Upper Extremity (0.05 (-0.08, 0.19); -0.04 (-0.24, 0.17)) and number of NSAA skills gained/improved (0.19 (-0.67, 1.06)). In total, 674 adverse events were recorded with delandistrogene moxeparvovec and 514 with placebo. There were no deaths, discontinuations or clinically significant complement-mediated adverse events; 7 patients (11.1%) experienced 10 treatment-related serious adverse events. Delandistrogene moxeparvovec did not lead to a significant improvement in NSAA score at week 52. Some of the secondary endpoints numerically favored treatment, although no statistical significance can be claimed. Safety was manageable and consistent with previous delandistrogene moxeparvovec trials.

As noted in the adobe abstract everything seemed to fine as reported in  this trial.

However there was a report of an immunoloically related death in 2023:

 

For the first time, in June 2023, delandistrogene moxeparvovec (SRP-9001), a gene replacement therapy based on an adeno-associated virus (AAV) vector, was approved in the USA for children aged 4-5 years with DMD. Other promising gene therapies are in preclinical development or clinical trials, including CRISPR/Cas9-mediated strategies to restore dystrophin expression. Two deaths following DMD gene therapy with high-dose AAV vectors were attributed to AAV-mediated immune responses. The pre-existing disease underlying the therapy is most likely involved in the fatal AAV toxicity.

 

Now this may have been dose related as the patient was given a high dose.

 

DMD gene therapy death exposes risks of treating older patients

By Nick Paul Taylor  May 19, 2023 9:35am

Duchenne muscular dystrophy (DMD) Cell & Gene Therapy gene therapy viral vectors

Cure Rare Disease plans to continue its programs with alternative vectors. (iStock / Getty Images Plus)

Cure Rare Disease has shared a deep dive into the death of the only participant in a gene therapy trial. The nonprofit and its collaborators tied the death of a patient with Duchenne muscular dystrophy (DMD) to an immune reaction to the viral vector, raising concerns about dosing older, more advanced people. 

Commercial development of DMD gene therapies has focused on younger patients, with Sarepta Therapeutics limiting enrollment in its phase 3 trial to children aged 4 to 8 years old. The restrictive recruitment criteria have stopped many DMD patients from accessing gene therapies in clinical trials run by Sarepta and its rivals. The patient dosed in the Cure Rare Disease clinical trial was 27 years of age, and the therapy had been designed for him. 

Last year, the nonprofit reported that the patient, who was the brother of its CEO, died after receiving the therapy. The death led to an investigation into what happened after the patient received the therapy, which was designed to use CRISPR transactivation to upregulate an alternate form of a key DMD protein.

Writing in preprint journal medRxiv (PDF), Cure Rare Disease described the findings of the investigation. A post-mortem showed injuries to the patient’s lungs, likely caused by a strong immune reaction to the high dose of the adeno-associated virus (AAV) vector that was given to try to ensure sufficient expression to achieve a therapeutic effect. There was minimal expression of the transgene in the liver. 

At 1×1014 vg/kg, the studied dose was similar to that tested in other clinical trials but resulted in a higher vector genome load, a finding the researchers attributed to the patient’s lower lean muscle mass, 45%. The analysis suggests the patient had “a more severe innate immune reaction than others receiving similar or slightly higher doses of rAAV in microdystrophin gene therapy trials.” 

Based on the finding, the researchers identified a need for more data on the characteristics that may predispose people to severe innate immune reactions and concluded “dose determination will remain a challenge for custom-designed AAV-mediated therapies, as by definition the precise therapeutic dose will not have been established.”

As for the application of CRISPR, the researchers said the toxicity and eventual death of the patient meant that an assessment of the safety and efficacy of the treatment was not possible.  

AAV related clinical trials have been  halted for drug-induced liver injury, predominantly due to severe immune reaction.  In many cases it appears when high dose AAV therapy is used.

 

Duan D. Lethal immunotoxicity in high-dose systemic AAV therapy. Mol Ther. 2023 Nov 1;31(11):3123-3126. Doi: 10.1016/j.ymthe.2023.10.015

.10.015. Epub 2023 Oct 10. PMID: 37822079; PMCID: PMC10638066.

Abstract

High-dose systemic gene therapy with adeno-associated virus (AAV) is in clinical trials to treat various inherited diseases. Despite remarkable success in spinal muscular atrophy and promising results in other diseases, fatality has been observed due to liver, kidney, heart, or lung failure. Innate and adaptive immune responses to the vector play a critical role in the toxicity. Host factors also contribute to patient death. This mini-review summarizes clinical findings and calls for concerted efforts from all stakeholders to better understand the mechanisms underlying lethality in AAV gene therapy and to develop effective strategies to prevent/treat high-dose systemic AAV-gene-therapy-induced immunotoxicity.

Table 1.

Fatality cases following high-dose systemic AAV delivery

Drug name AAV Clinical profile Reference
Serotype Dose (vg/kg) Promoter Transgene Disease Patient age Time of death Cause of death Immunotoxicity Clinical trial ID
Acute death PF-06939926 AAV9 2 × 1014 miniMCK μDys gene DMD 16 years 6 days post-dosing heart failure innate response NCT03362502 Lek et al.,8 Philippidis9, and Lek et al.10
CRD-TMH-001 AAV9 1 × 1014 CK8e dCas9-VP64 and gRNA DMD 27 years 8 days post-dosing lung failure innate response (cytokine-mediated) NCT05514249 Lek et al.10
Subacute death Zolgensma AAV9 1.1 × 1014 CBA SMN gene SMA ≤2 years (4 patients) 5–6 weeks post-dosing liver failure adaptive response post-marketing Philippidis, Whiteley, and Kishimoto and Samulski6,19,20
Zolgensma AAV9 1.1 × 1014 CBA SMN gene SMA 6 months 8 weeks post-dosing kidney failure innate response (complement mediated) post-marketing Guillou et al.7
AT132 AAV8 1.3–3 × 1014 DES MTM1 gene XLMTM ≤5 years (4 patients) 20–40 weeks post-dosing liver fa

 

Table from Duan D. Lethal immunotoxicity in high-dose systemic AAV therapy. Mol Ther. 2023 Nov 1;31(11):3123-3126. source: https://pmc.ncbi.nlm.nih.gov/articles/PMC10638066/ 

 

Roche Decides to Stop backing Sparks Therapeutics Hemophilia A Gene Therapy Program

 

     In 2019, Roche acquired Children’s Hospital of Pennsylvania (CHOP) spinout Spark Therapeutics for $4.8 billion, one of the largest pharma acquisitions up to that time.  It was reported on this site here

 

Spark Therapeutics’ $4.8Billion deal Confirmed as Biggest VC-backed Exit in Philadelphia

 

https://pharmaceuticalintelligence.com/2019/03/01/spark-therapeutics-4-8billion-deal-confirmed-as-biggest-vc-backed-exit-in-philadelphia/ 

However as reported by Fierce Biotech (and updated above link) at https://www.fiercepharma.com/pharma/roche-overhauls-spark-gene-therapy-unit-recording-24b-full-impairment  Roche will reorganize the company and deal, bringing in Spark into the corporate fold.  However this meant massive layoffs and possibly either end of the gene therapy program in order to integrate it with Roche’s current programs.  The Spark gene therapy has met with success so it will be interesting to see how Roche continues this program in the future.

However it has been a rough year for many gene therapies.

Other Articles in this Open Access Scientific Journol of Gene Therapy 

Tailored Hope: Personalized Gene Therapy Makes History

Lessons on the Frontier of Gene & Cell Therapy – The Disruptive Dozen 12 #GCT Breakthroughs that are revolutionizing Healthcare

Novartis uses a ‘dimmer switch’ medication to fine-tune gene therapy candidates

Top Industrialization Challenges of Gene Therapy Manufacturing

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Bridging the Gender Gap in Healthcare: Unlocking Biopharma’s Potential in Women’s Health

Curator: Dr. Sudipta Saha, Ph.D.

Nearly half of the global population—and 80 percent of patients in therapeutic areas such as immunology—are women. Yet, treatments are frequently developed without tailored insights for female patients, often ignoring critical biological differences such as hormonal impacts, genetic factors, and cellular sex. Historically, women’s health has been narrowly defined through the lens of reproductive organs, while for non-reproductive conditions, women were treated as “small men.” This lack of focus on sex-specific biology has contributed to significant gaps in healthcare.

A recent analysis found that women spend 25 percent more of their lives in poor health compared with men due to the absence of sex-based treatments. Addressing this disparity could not only improve women’s quality of life but also unlock over $1 trillion in annual global GDP by 2040.

Four key factors contribute to the women’s health gap: limited understanding of sex-based biological differences, healthcare systems designed around male physiology, incomplete data that underestimates women’s disease burden, and chronic underfunding of female-focused research. For instance, despite women representing 78 percent of U.S. rheumatoid arthritis patients, only 7 percent of related NIH funding in 2019 targeted female-specific studies.

However, change is happening. Companies have demonstrated how targeted R&D can drive better outcomes for women. These therapies achieved expanded FDA approvals after clinical trials revealed their unique benefits for female patients. Similarly, addressing sex-based treatment gaps in asthma, atrial fibrillation, and tuberculosis could prevent millions of disability-adjusted life years.

By closing the women’s health gap, biopharma companies can drive innovation, improve therapeutic outcomes, and build high-growth markets while addressing long-standing inequities. This untapped opportunity holds the potential to transform global health outcomes for women and create a more equitable future.

References

https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-womens-health-gap-biopharmas-untapped-opportunity?stcr=97136BA6BDD64C2396A57E9487438CC6

https://www.weforum.org

https://www.nih.gov

https://www.fda.gov

https://www.who.int

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The Health Care Dossier on Clarivate PLC: How Cortellis Is Changing the Life Sciences Industry

Curator: Stephen J. Williams, Ph.D.

Source: https://en.wikipedia.org/wiki/Clarivate 

Clarivate Plc is a British-American publicly traded analytics company that operates a collection of subscription-based services, in the areas of bibliometrics and scientometricsbusiness / market intelligence, and competitive profiling for pharmacy and biotechpatents, and regulatory compliancetrademark protection, and domain and brand protection. In the academy and the scientific community, Clarivate is known for being the company that calculates the impact factor,[4] using data from its Web of Science product family, that also includes services/applications such as PublonsEndNoteEndNote Click, and ScholarOne. Its other product families are Cortellis, DRG, CPA Global, Derwent, MarkMonitor, CompuMark, and Darts-ip, [3] and also the various ProQuest products and services.

Clarivate was formed in 2016, following the acquisition of Thomson Reuters‘ Intellectual Property and Science business by Onex Corporation and Baring Private Equity Asia. Clarivate has acquired various companies since then, including, notably, ProQuest in 2021.

Further information: Thomson Scientific

Clarivate (formerly CPA Global) was formerly the Intellectual Property and Science division of Thomson Reuters. Before 2008, it was known as Thomson Scientific. In 2016, Thomson Reuters struck a $3.55 billion deal in which they spun it off as an independent company, and sold it to private-equity firms Onex Corporation and Baring Private Equity Asia.

In May 2019, Clarivate merged with the Churchill Capital Corp SPAC to obtain a public listing on the New York Stock Exchange (NYSE) It currently trades with symbol NYSE:CLVT.

Acquisitions

  • June 1, 2017: Publons, a platform for researchers to share recognition for peer review.
  • April 10, 2018: Kopernio, AI-tech startup providing ability to search for full-text versions of selected scientific journal articles.
  • October 30, 2018: TrademarkVision, provider of Artificial Intelligence (AI) trademark research applications.
  • September 9, 2019: SequenceBase, provider of patent sequence information and search technology to the biotech, pharmaceutical and chemical industries.
  • December 2, 2019: Darts-ip, provider of case law data and analytics for intellectual property (IP) professionals.
  • January 17, 2020: Decision Resources Group (DRG), a leading healthcare research and consulting company, providing high-value healthcare industry analysis and insights.
  • June 22, 2020: CustomersFirst Now, in intellectual property (“IP”) software and tech-enabled services.
  • October 1, 2020: CPA Global, intellectual property (“IP”) software and tech-enabled services.
  • December 1, 2021: ProQuest, software, data and analytics provider to academic, research and national institutions.[27]It was acquired for $5.3 billion from Cambridge Information Group in what was described as a “huge deal in the library and information publishing world”. The company said that the operational concept behind the acquisition was integrating ProQuest’s products and applications with Web of Science. Chairman of ProQuest Andy Snyder became the vice chairman of Clarivate. The Scholarly Publishing and Academic Resources Coalition, an advocacy group for open access to scholarship, voiced antitrust concerns. The acquisition had been delayed mid-year due to a Federal Trade Commission antitrust probe.

Divestments

How Clarivate Has Changed Since 2019

2019 Strategy

From 2019 Manager Discussion Yearly Report

We are a leading global information services and analytics company serving the scientific research, intellectual property and life sciences end-markets. We provide structured information and analytics to facilitate the discovery, protection and commercialization of scientific research, innovations and brands.  Our product porfolio includes well-established market-leading brands such as Web of Science, Derwent Innovation, Life Sciences, CompuMark and MarkMonitor (which they later divested).  We believe that the stron balue proposition of our content, user interfaces, visualization and analytical tools, combined with the integration of our products and services into customers’ daily workflows, leads to our substantial customer loyalty as evidenced by their willingness to renew subscriptions with us.

Our structure, enabling a sharp focus on cross-selling opportunities within markets, is comprised of two product groups:

  • Science Group: consists of Web of Science and Life Science Product Lines
  • Intellectual Property Group: consists of Derwent, CompuMark and MarkMonitor

Corporations, government agencies, universities, law firms depend on our high-value curated content, analytics and services.  Unstructured data has grown exponentially over the last decade.  The trend has resulted in a critical need for unstructured data to be meaningfully filtered, analyzed and curated into relvent information that facilitates key operational and strategic decision making.  Our highly curated, proprietary information created through our sourcing, aggregation, verification, translation, and categorization (ONTOLOGY) of data has resulted in our solutions being embedded in our customers’ workflow and decision-making processes.

Overview of Clarivate PLC five year strategy in 2019. Note that in 2019 the Science Group accounted for 56.2% of revenue! This was driven by their product Cortellis!

Figure.  Overview of Clarivate PLC five year strategy in 2019. Note that in 2019 the Science Group accounted for 56.2% of revenue! This was driven by their product Cortellis!

Also Note nowhere in the M&A Discussion in years before 2023 was anything mentioned concerning AI or Large Language Models.

The Clarivate of Today:  Built for Life Sciences with Cortellis

Clarivate PLC has integrated multiple platforms into their offering Cortellis, which integrated AI and LLM into the structured knowledge bases (see more at https://clarivate.com/products/cortellis-family/)

“Life sciences organizations are tasked, now more than ever, to discover and develop treatments that challenge the status quo, increase ROI, and improve patient lives. However, its become increasingly difficult to find, integrate and analyze the key data your teams need to make critical decisions and get your Cortellis products to patients faster.

The Cortellis solutions help research and developmentportfolio strategy and business development, and regulatory and compliance professionals gather and assess the information you need to discover innovative drugs, differentiate your treatments, and increase chances of successful regulatory approval.

Some of Cortellis solutions include:

  1. Cortellis Competitive Intelligence: maximize ROI and improve patient outcomes
  2. Cortellis Deals Intelligence: Portfolio Strategy and Business Development (find best deal)
  3. Cortellis Clinical Intelligence: Clinical Trial Support and Regulatory
  4. Cortellis Digital Health Intelligence: understand digital health ecosystem
  5. Cortellis Drug Discovery: improve drug development speed and efficiency
  6. MetaBase and MetaCore: integrated omics knowledge bases for drug discovery
  7. Cortellis Regulatory: help with filings
  8. Cortellis HTA: health tech compliance (HIPAA)
  9. CMC Intelligence: new drug marketing
  10. Generics Intelligence
  11. Drug Safety Intelligence: both preclinical safety and post marketing pharmacovigilence

Watch Videos on Cortellis for Drug Discovery

Watch Video on Qiagen Site to see how Cortellis Integrates with Qiagen Omics Platform IPA with Clarivate Meta Core to gain more insights into genomic and proteomic data

https://digitalinsights.qiagen.com/products-overview/discovery-insights-portfolio/analysis-and-visualization/qiagen-ipa/?cmpid=QDI_GA_Comp&gad_source=2&gclid=EAIaIQobChMIwu6HtvHGhQMVnZ9aBR1iCgHTEAEYASAAEgJiWPD_BwE

From the Qiagen website on Ingenuity Pathway Analysis: https://digitalinsights.qiagen.com/products-overview/discovery-insights-portfolio/analysis-and-visualization/qiagen-ipa/ 

Understand complex ‘omics data to accelerate your research

Discover why QIAGEN Ingenuity Pathway Analysis (IPA) is the leading pathway analysis application among the life science research community and is cited in tens of thousands of articles for the analysis, integration and interpretation of data derived from ‘omics experiments. Such experiments include:

  • RNA-seq
  • Small RNA-seq
  • Metabolomics
  • Proteomics
  • Microarrays including miRNA and SNP
  • Small-scale experiments

With QIAGEN IPA you can predict downstream effects and identify new targets or candidate biomarkers. QIAGEN Ingenuity Pathway Analysis helps you perform insightful data analysis and interpretation to understand your experimental results within the context of various biological systems.

Articles Relevant to Drug Development, Natural Language Processing in Drug Development, and Clarivate on this Open Access Scientific Journal Include:

The Use of ChatGPT in the World of BioInformatics and Cancer Research and Development of BioGPT by MIT

From High-Throughput Assay to Systems Biology: New Tools for Drug Discovery

Medical Startups – Artificial Intelligence (AI) Startups in Healthcare

New York Academy of Sciences Symposium: The New Wave of AI in Healthcare 2024. May 1-2, 2024 New York City, NY

Clarivate Analytics – a Powerhouse in IP assets and in Pharmaceuticals Informercials

Read Full Post »

How to Create a Twitter Space for @pharma_BI for Live Broadcasts

Right now, Twitter Spaces are available on Android and iOS operating systems ONLY.  For use on a PC desktop you must install an ANDROID EMULATOR.  This means best to set up the Twitter Space using your PHONE APP not on the desktop or laptop computer.  Right now, even though there is the ability to record a Twitter Space, that recording is not easily able to be embedded in WordPress as a tweet is (or chain of tweets).  However you can download the recording (takes a day or two) and convert to mpeg using a program like Audacity to convert into an audio format conducible to WordPress.

A while ago I had put a post where I link to a Twitter Space I created for a class on Dissemination of Scientific Discoveries.  The post

“Will Web 3.0 Do Away With Science 2.0? Is Science Falling Behind?”

can be seen at

Will Web 3.0 Do Away With Science 2.0? Is Science Falling Behind?

 

This online discussion was tweeted out and got a fair amount of impressions (60) as well as interactors (50).

 

 

About Twitter Spaces

 

Spaces is a way to have live audio conversations on Twitter. Anyone can join, listen, and speak in a Space on Twitter for iOS and Android. Currently you can listen in a Space on web.

Quick links

How to use Spaces
Spaces FAQ
Spaces Feedback Community
Community Spaces

 

 

 

 

 

 

 

 

 

 

 

How to use Spaces

Instructions for:

How do you start a Space?

 

 

 

Step 1

The creator of a Space is the host. As a host on iOS, you can start a Space by long pressing on the Tweet Composer  from your Home timeline and and then selecting the Spaces  icon.

You can also start a Space by selecting the Spaces tab on the bottom of your timeline.

Step 2

Spaces are public, so anyone can join as a listener, including people who don’t follow you. Listeners can be directly invited into a Space by DMing them a link to the Space, Tweeting out a link, or sharing a link elsewhere.

Step 3

Up to 13 people (including the host and 2 co-hosts) can speak in a Space at any given time. When creating a new Space, you will see options to Name your Space and Start your Space.

Step 4

To schedule a Space, select Schedule for later. Choose the date and time you’d like your Space to go live.

Step 5

Once the Space has started, the host can send requests to listeners to become co-hosts or speakers by selecting the people icon  and adding co-hosts or speakers, or selecting a person’s profile picture within a Space and adding them as a co-host or speaker. Listeners can request permission to speak from the host by selecting the Request icon below the microphone.

Step 6

When creating a Space, the host will join with their mic off and be the only speaker in the Space. When ready, select Start your Space.

Step 7

Allow mic access (speaking ability) to speakers by toggling Allow mic access to on.

Step 8

Get started chatting in your Space.

Step 9

As a host, make sure to Tweet out the link to your Space so other people can join. Select the  icon to Share via a Tweet.

 

Spaces FAQ

Where is Spaces available?

Anyone can join, listen, and speak in a Space on Twitter for iOS and Android. Currently, starting a Space on web is not possible, but anyone can join and listen in a Space.

Who can start a Space?

People on Twitter for iOS and Android can start a Space.

Who can see my Space?

For now, all Spaces are public like Tweets, which means they can be accessed by anyone. They will automatically appear at the top of your Home timeline, and each Space has a link that can be shared publicly. Since Spaces are publicly accessible by anyone, it may be possible for people to listen to a Space without being listed as a guest in the Space.

We make certain information about Spaces available through the Twitter Developer Platform, such as the title of a Space, the hosts and speakers, and whether it is scheduled, in progress, or complete. For a more detailed list of the information about Spaces we make available via the Twitter API, check out our Spaces endpoints documentation.

Can other people see my presence while I am listening or speaking in a Space?

Since all Spaces are public, your presence and activity in a Space is also public. If you are logged into your Twitter account when you are in a Space, you will be visible to everyone in the Space as well as to others, including people who follow you, people who peek into the Space without entering, and developers accessing information about the Space using the Twitter API.

If you are listening in a Space, your profile icon will appear with a purple pill at the top of your followers’ Home timelines. You have the option to change this in your settings.

Instructions for:

Manage who can see your Spaces listening activity

Step 1

On the left nav menu, select the more  icon and go to Settings and privacy.

Step 2

Under Settings, navigate to Privacy and safety.

Step 3

Under Your Twitter activity, go to Spaces.

Step 4

Choose if you want to Allow followers to see which Spaces you’re listening to by toggling this on or off.

Your followers will always see at the top of their Home timelines what Spaces you’re speaking in.

What does it mean that Spaces are public? Can anyone listen in a Space?

Spaces can be listened to by anyone on the Internet. This is part of a broader feature of Spaces that lets anyone listen to Spaces regardless of whether or not they are logged in to a Twitter account (or even have a Twitter account). Because of this, listener counts may not match the actual number of listeners, nor will the profile photos of all listeners necessarily be displayed in a Space.

How do I invite people to join a Space?

Invite people to join a Space by sending an invite via DM, Tweeting the link out to your Home timeline, or copying the invite link to send it out.

Who can join my Space?

For now, all Spaces are public and anyone can join any Space as a listener. If the listener has a user account, you can block their account. If you create a Space or are a speaker in a Space, your followers will see it at the top of their timeline.

Who can speak in my Space?

By default, your Space will always be set to Only people you invite to speak. You can also modify the Speaker permissions once your Space has been created. Select the  icon, then select Adjust settings to see the options for speaker permissions, which include EveryonePeople you follow, and the default Only people you invite to speak. These permissions are only saved for this particular Space, so any Space you create in the future will use the default setting.

Once your Space has started, you can send requests to listeners to become speakers or co-hosts by selecting the  icon and adding speakers or selecting a person’s profile picture within a Space and adding them as a co-host or speaker. Listeners can request to speak from the host.

Hosts can also invite other people outside of the Space to speak via DM.

How does co-hosting work?

Up to 2 people can become co-hosts and speak in a Space in addition to the 11 speakers (including the primary host) at one time. Co-host status can be lost if the co-host leaves the Space. A co-host can remove their own co-host status to become a Listener again.

Hosts can transfer primary admin rights to another co-host. If the original host drops from Space, the first co-host added will become the primary admin. The admin is responsible for promoting and facilitating a healthy conversation in the Space in line with the Twitter Rules.

Once a co-host is added to a Space, any accounts they’ve blocked on Twitter who are in the Space will be removed from the Space.

Can I schedule a Space?

Hosts can schedule a Space up to 30 days in advance and up to 10 scheduled Spaces. Hosts can still create impromptu Spaces in the meantime, and those won’t count toward the maximum 10 scheduled Spaces.

Before you create your Space, select the scheduler  icon and pick the date and time you’d like to schedule your Space to go live. As your scheduled start time approaches, you will receive push and in-app notifications reminding you to start your Space on time. If you don’t have notifications turned on, follow the in-app steps on About notifications on mobile devices to enable them for Spaces. Scheduled Spaces are public and people can set reminders to be notified when your scheduled Space begins.

How do I edit my scheduled Space(s)?

Follow the steps below to edit any of your scheduled Spaces.

Instructions for:

Manage your scheduled Spaces

Step 1

From your timeline, navigate to and long press on the . Or, navigate to the Spaces Tab  at the bottom of your timeline.

Step 2

Select the Spaces  icon.

Step 3

To manage your scheduled Spaces, select the scheduler  icon at the top.

Step 4

You’ll see the Spaces that you have scheduled.

Step 5

Navigate to the more  icon of the Space you want to manage. You can edit, share, or cancel the Space.

If you are editing your Space, make sure to select “Save changes” after making edits.

How do I get notified about a scheduled Space?

Guests can sign up for reminder notifications from a scheduled Space card in a Tweet. When the host starts the scheduled Space, the interested guests get notified via push and in-app notifications.

Can I record a Space?

Hosts can record Spaces they create for replay. When creating a Space, toggle on Record Space.

While recording, a recording symbol will appear at the top to indicate that the Space is being recorded by the host. Once the Space ends, you will see how many people attended the Space along with a link to share out via a Tweet. Under Notifications, you can also View details to Tweet the recording. Under host settings, you will have the option to choose where to start your recording with Edit start time. This allows you to cut out any dead air time that might occur at the beginning of a Space.

If you choose to record your Space, once the live Space ends, your recording will be immediately and publicly available for anyone to listen to whenever they want. You can always end a recording to make it no longer publicly available on Twitter by deleting your recording via the more  icon on the recording itself. Unless you delete your recording, it will remain available for replay after the live Space has ended.* As with live Spaces, Twitter will retain audio copies for 30 after they end to review for violations of the Twitter Rules. If a violation is found, Twitter may retain audio copies for up to 120 days in total. For more information on downloading Spaces, please see below FAQ, “What happens after a Space ends and is the data retained anywhere?

Co-hosts and speakers who enter a Space that is being recorded will see a recording symbol (REC). Listeners will also see the recording symbol, but they will not be visible in the recording.

Recordings will show the host, co-host(s), and speakers from the live Space.

*Note: Hosts on iOS 9.15+ and Android 9.46+ will be able to record Spaces that last indefinitely. For hosts on older app versions, recording will only be available for 30 days. For Spaces that are recorded indefinitely, Twitter will retain a copy for as long as the Space is replayable on Twitter, but for no less than 30 days after the live Space ended.

 

What is clipping?

Clipping is a new feature we’re currently testing and gradually rolling out that lets a limited group of hosts, speakers, and listeners capture 30 seconds of audio from any live or recorded Space and share it through a Tweet if the host has not disabled the clipping function. To start clipping a Space, follow the instructions below to capture the prior 30 seconds of audio from that Space. There is no limit to the number of clips that participants in a Space can create.

When you enter the Space as a co-host or speaker, you will be informed that the Space is clippable through a tool tip notification above the clipping  icon.

Note: Currently, creating a clip is available only on iOS and Android, while playing a clip is available on all platforms to everyone.

Instructions for:

Host instructions: How to turn off clipping

 

When you start your Space, you’ll receive a notification about what a clip is and how to turn it off, as clipping is on by default. You can turn off clipping at any time. To turn it off, follow the instructions below.

Step 1

Navigate to the more  icon.

Step 2

Select Adjust settings .

Step 3

Under Clips, toggle Allow clips off.

Instructions for:

Host and speaker instructions: How to create a clipping

Step 1

In a recorded or live Space that is recorded, navigate to the clipping  icon. Please note that, for live Spaces, unless the clipping function is disabled, clips will be publicly available on your Twitter profile after your live Space has ended even though the Space itself will no longer be available.

Step 2

On the Create clip pop-up, go to Next.

Step 3

Preview the Tweet and add a comment if you’d like, similarly to a Quote Tweet.

Step 4

Select Tweet to post it to your timeline.

Why is my clip not displaying captions?

What controls do hosts have over existing clips?

What controls do clip creators have over clips they’ve created?

Other controls over clips: how to report, block, or mute

What controls do I have over my Space?

The host and co-host(s) of a Space have control over who can speak. They can mute any Speaker, but it is up to the individual to unmute themselves if they receive speaking privileges. Hosts and co-hosts can also remove,  report, and block others in the Space.

Speakers and listeners can report and block others in the Space, or can report the Space. If you block a participant in the Space, you will also block that person’s account on Twitter. If the person you blocked joins as a listener, they will appear in the participant list with a Blocked label under their account name. If the person you blocked joins as a speaker, they will also appear in the participant list with a Blocked label under their account name and you will see an in-app notification stating, “An account you blocked has joined as a speaker.” If you are entering a Space that already has a blocked account as a speaker, you will also see a warning before joining the Space stating, “You have blocked 1 person who is speaking.”

If you are hosting or co-hosting a Space, people you’ve blocked can’t join and, if you’re added as a co-host during a Space, anyone in the Space who you blocked will be removed from the Space.

What are my responsibilities as a Host or Co-Host of a Space?

As a Host, you are responsible for promoting and supporting a healthy conversation in your Space and to use your tools to ensure that the Twitter Rules are followed. The following tools are available for you to use if a participant in the Space is being offensive or disruptive:

  • Revoke speaking privileges of other users if they are being offensive or disruptive to you or others
  • Block, remove or report the user.

Here are some guidelines to follow as a Host or Co-Host:

  • Always follow the Twitter Rulesin the Space you host or co-host. This also applies to the title of your Space which should not include abusive slurs, threats, or any other rule-violating content.
  • Do not encourage behavior or content that violates the Twitter Rules.
  • Do not abuse or misuse your hosting tools, such as arbitrarily revoking speaking privileges or removing users, or use Spaces to carry out activities that break our rules such as following schemes.

How can I block someone in a Space?

How can I mute a speaker in a Space?

How can I see people in my Space?

Hosts, speakers, and listeners can select the  icon to see people in a Space. Since Spaces are publicly accessible by anyone, it may also be possible for an unknown number of logged-out people to listen to a Space’s audio without being listed as a guest in the Space.

How can I report a Space?

How can I report a person in a Space?

Can Twitter suspend my Space while it’s live?

How many people can speak in a Space?

How many people can listen in a Space?

 

What happens after a Space ends and is the data retained anywhere?

Hosts can choose to record a Space prior to starting it. Hosts may download copies of their recorded Spaces for as long as we have them by using the Your Twitter Data download tool.

For unrecorded Spaces, Twitter retains copies of audio from recorded Spaces for 30 days after a Space ends to review for violations of the Twitter Rules. If a Space is found to contain a violation, we extend the time we maintain a copy for an additional 90 days (a total of 120 days after a Space ends) to allow people to appeal if they believe there was a mistake. Twitter also uses Spaces content and data for analytics and research to improve the service.

Links to Spaces that are shared out (e.g., via Tweet or DM) also contain some information about the Space, including the description, the identity of the hosts and others in the Space, as well as the Space’s current state (e.g., scheduled, live, or ended). We make this and other information about Spaces available through the Twitter Developer Platform. For a detailed list of the information about Spaces we make available, check out our Spaces endpoints documentation.

For full details on what data we retain, visit our Privacy Policy.

Who can end a Space?

Does Spaces work for accounts with protected Tweets?

Following the Twitter Rules in Spaces

 

Spaces Feedback Community

We’re opening up the conversation and turning it over to the people who are participating in Spaces. This Community is a dedicated place for us to connect with you on all things Spaces, whether it’s feedback around features, ideas for improvement, or any general thoughts.

Who can join?

Anyone on Spaces can join, whether you are a host, speaker, or listener.

How do I join the Community?

You can request to join the Twitter Spaces Feedback Community here. By requesting to join, you are agreeing to our Community rules.

Learn more about Communities on Twitter.

 

Community Spaces

As a Community admin or moderator, you can create and host a Space for your Community members to join.

Note:

Currently, creating Community Spaces is only available to some admins and moderators using the Twitter for iOS and Twitter for Android apps.

Instructions for:

Admins & moderators: How to create a Space

Step 1

Navigate to the Community landing page.

Step 2

Long press on the Tweet Composer  and select the Spaces  icon.

Step 3

Select Spaces and begin creating your Space by adding in a title, toggling on record Space (optional), and adding relevant topics.

Step 4

Invite admins, moderators, and other people to be a part of your Space.

Members: How to find a Community Space

If a Community Space is live, you will see the Spacebar populate at the top of your Home timeline. To enter the Space and begin listening, select the live Space in the Spacebar.

Community Spaces FAQ

What are Community Spaces?

 

 

 

 

 

 

 

 

 

Spaces Social Narrative


A social narrative is a simple story that describes social situations and social behaviors for accessibility.

Twitter Spaces allows me to join or host live audio-only conversations with anyone.

Joining a Space

  1. When I join a Twitter Space, that means I’ll be a listener. I can join any Space on Twitter, even those hosted by people I don’t know or follow.
  2. I can join a Space by selecting a profile photo with a purple, pulsing outline at the top of my timeline, selecting a link from someone’s Tweet, or a link in a Direct Message (DM).
  3. Once I’m in a Space, I can seethe profile photos and names of some people in the Space, including myself.
  4. I can hearone or multiple people talking at the same time. If it’s too loud or overwhelming, I can turn down my volume.
  5. As a listener, I am not able to speak. If I want to say something, I can send a request to the host. The host might not approve my request though.
  6. If the host accepts my request, I will become a speaker. It may take a few seconds to connect my microphone, so I’ll have to wait.
  7. Now I can unmute myself and speak. Everyone in the Space will be able to hear me.
  8. When someone says something I want to react to, I can choosean emoji to show everyone how I feel. I will be able to see when other people react as well.
  9. I can leave the Space at any time. After I leave, or when the host ends the Space, I’ll go back to my timeline.

Hosting a Space

  1. When I start a Space, that means I’ll be the host. Anyone can join my Space, even people I don’t know and people I don’t follow.
  2. Once I start my space, it may take a few seconds to be connected, so I’ll have to wait.
  3. Now I’m in my Space and I can seemy profile photo. If other logged-in, people have joined, I will be able to see their profile photos, too.
  4. I will start out muted, which is what the microphone with a slash through it means. I can mute and unmute myself, and anyone in my Space, at any time.
  5. I can invitepeople to join my Space by sending them a Direct Message (DM), sharing the link in a Tweet, and by copying the link and sharing it somewhere else like in an email.
  6. Up to 10 other people can have speaking privileges in my Space at the same time, and I can choosewho speaks and who doesn’t. People can also request to speak, and I can choose to approve their request or not.

 

Read Full Post »

 

The Vibrant Philly Biotech Scene: Recent Happenings & Deals

Curator: Stephen J. Williams, Ph.D.

 

As the office and retail commercial real estate market has been drying up since the COVID pandemic, commercial real estate developers in the Philadelphia area have been turning to the health science industry to suit their lab space needs.  This includes refurbishing old office space as well as new construction.

Gattuso secures $290M construction loan for life sciences building on Drexel campus

Source: https://www.bizjournals.com/philadelphia/news/2022/12/19/construction-loan-gattuso-drexel-life-sciences.html?utm_source=st&utm_medium=en&utm_campaign=BN&utm_content=pl&ana=e_pl_BN&j=30034971&senddate=2022-12-20

 

By Ryan Mulligan  –  Reporter, Philadelphia Business Journal

Dec 19, 2022

Gattuso Development Partners and Vigilant Holdings of New York have secured a $290 million construction loan for a major life sciences building set to be developed on Drexel University’s campus.

The funding comes from Houston-based Corebridge Financial, with an additional equity commitment from Boston-based Baupost Group, which is also a partner on the project. JLL’s Capital Markets group arranged the loan.

Plans for the University City project at 3201 Cuthbert St. carry a price tag of $400 million. The 11-story building will total some 520,000 square feet, making it the largest life sciences research and lab space in the city when it comes online.

The building at 3201 Cuthbert will rise on what had served as a recreation field used by Drexel and is located next to the Armory. Gattuso Development, which will lease the parcel from Drexel, expects to to complete the project by fall 2024. Robert A.M. Stern Architects designed the building.

 

A rendering of a $400 million lab and research facility Drexel University and Gattuso Development Partners plan to build at 3201 Cuthbert St. in Philadelphia.

Enlarge

A rendering of a $400 million lab and research facility Drexel University and Gattuso Development Partners plan to build at 3201 Cuthbert St. in Philadelphia.

The building is 45% leased by Drexel and SmartLabs, an operator of life sciences labs. Drexel plans to occupy about 60,000 square feet, while SmartLabs will lease two floors totaling 117,000 square feet.

“We believe the project validates Philadelphia’s emergence as a global hub for life sciences research, and we are excited to begin construction,” said John Gattuso, the co-founder and president of Philadelphia-based Gattuso Development.

Ryan Ade, Brett Segal and Christopher Peck of JLL arranged the financing.

The project is another play in what amounts to an arms race for life sciences space and tenants in University City. Spark Therapeutics plans to build a $575 million, 500,000-square-foot gene therapy manufacturing plant on Drexel’s campus. One uCity Square, a $280 million, 400,000-square-foot life sciences building, was recently completed at 38th and Market streets. At 3151 Market St., a $307 million, 417,000-square-foot life sciences building is proposed as part of the Schuylkill Yards development.

Tmunity CEO Usman Azam departing to lead ‘stealth’ NYC biotech firm

 

By John George  –  Senior Reporter, Philadelphia Business Journal

Feb 7, 2022

The CEO of one of Philadelphia’s oldest cell therapy companies is departing to take a new job in the New York City area.

Usman “Oz” Azam, who has been CEO of Tmunity Therapeutics since 2016, will lead an unnamed biotechnology company currently operating in stealth mode.

In a posting on his LinkedIn page, Azam said, “After a decade immersed in cell therapies and immuno-oncology, I am now turning my attention to a new opportunity, and will be going back to where I started my life sciences career in neurosciences.”

Tmunity, a University of Pennsylvania spinout, is looking to apply CAR T-cell therapy, which has proved to be successful in treating liquid cancers, for the treatment of solid tumors.

Last summer, Tmunity suspended clinical testing of its lead cell therapy candidate targeting prostate cancer after two patients in the study died. Azam, in an interview with the Business Journal in June, said the company, which had grown to about 50 employees since its launch in 2015, laid off an undisclosed number of employees as a result of the setback.

Azam said on LinkedIn he is still a big believer in CAR T-cell therapy, noting Tmunity co-founder Dr. Carl June and his colleagues at Penn just published in Nature the 10-year landmark clinical outcomes study with the first CD19 CAR-T patients and programs.

“It’s just the beginning,” he stated. “I’m excited about the prospect of so many new cell- and gene-based therapies emerging in the next five to 10 years to tackle many solid and liquid tumors, and I hope we all continue to see the remarkable impact this makes on patients and families around the world.”

Azam could not be reached for comment Monday. Tmunity has engaged a search firm to identify his successor.

Tmunity, which is based in Philadelphia, has its own manufacturing operations in East Norriton. Tmunity’s founders include June and fellow Penn cell therapy pioneer Bruce Levine, who led the development of a CAR T-cell therapy now marketed by Novartis as Kymriah, a treatment for certain types of blood cancers.

In therapy using CAR-T cells, a patient’s T cells — part of their immune system — are removed and genetically modified in the laboratory. After they are re-injected into a patient, the T cells are better able to attack and destroy tumors. CAR is an acronym for chimeric antigen receptor. Chimeric antigen receptors are receptor proteins that have been engineered to give T cells their improved ability to target tumors.

Source: https://www.bizjournals.com/philadelphia/news/2022/02/07/tmunity-therapeutics-philadelphia-cell-azam-oz.html?utm_source=st&utm_medium=en&utm_campaign=BN&utm_content=pl&ana=e_pl_BN&j=30034971&senddate=2022-12-20

 

PIDC names U.S. Department of Treasury veteran, Philadelphia native as next president

 
By   –  Reporter, Philadelphia Business Journal

 

The Philadelphia Industrial Development Corp. has tapped U.S. Department of Treasury veteran Jodie Harris to be its next president.

Harris succeeds Anne Bovaird Nevins, who spent 15 years in the organization and took over as president in January 2020 before stepping down at the end of last year. Executive Vice President Sam Rhoads has been interim president.

Harris, a Philadelphia native who currently serves as director of the Community Development Financial Institutions Fund for the Department of Treasury, was picked after a regional and national search and will begin her tenure as president on June 1. She becomes the 12th head of PIDC and the first African-American woman to lead the organization.

PIDC is a public-private economic development corporation founded by the city and the Chamber of Commerce for Greater Philadelphia in 1958. It mainly uses industrial and commercial real estate projects to attract jobs, foster business opportunities and spur overall community growth. The organization has spurred over $18.5 billion in financing across its 65 years.

PIDC has its hand in development projects spanning the city, including master planning roles in expansive campuses like the Philadelphia Navy Yard and the Lower Schuylkill Biotech Campus in Southwest Philadelphia.

In a statement, Harris said that it is “a critical time for Philadelphia’s economy.”

“I’m especially excited for the opportunity to lead such an important and impactful organization in my hometown of Philadelphia,” Harris said. “As head of the CDFI Fund, I know first-hand what it takes to drive meaningful, sustainable, and equitable economic growth, especially in historically underserved communities.”

Harris is a graduate of the University of Maryland and received an MBA and master of public administration from New York University. In the Treasury Department, Harris’ most recent work aligns with PIDC’s economic development mission. At the Community Development Financial Institutions Fund, she oversaw a $331 million budget, mainly comprised of grant and administrative funding for various economic programs. Under Harris’ watch, the fund distributed over $3 billion in pandemic recovery funding, its highest level of appropriated grants ever.

Harris has been a part of the Treasury Department for 15 years, including as director of community and economic development policy.

In addition to government work, Harris has previously spent time in the private, academia and nonprofit sectors. In the beginning of her career, Harris worked at Meridian Bank and Accenture before turning to become a social and education policy researcher at New York University. She also spent two years as president of the Urban Business Assistance Corporation in New York.

Mayor Jim Kenney said that Philadelphia is “poised for long-term growth” and Harris will help drive it.

Source: https://www.bizjournals.com/philadelphia/news/2023/02/23/pidc-names-next-president-treasury.html 

$250M life sciences conversion planned for Philadelphia’s historic Quartermaster site

 
By   –  Reporter, Philadelphia Business Journal

Listen to this article     3 min

Real estate company SkyREM plans to spend $250 million converting the historic Quartermaster site in South Philadelphia to a life sciences campus with restaurants and a hotel.

The redevelopment would feature wet and dry lab space for research, development and bio-manufacturing.

The renamed Quartermaster Science + Technology Park is near the southwest corner of Oregon Avenue and South 20th Street in the city’s Girard Estates neighborhood. It’s east of the Quartermaster Plaza retail center, which sold last year for $100 million.

The 24-acre campus is planned to have six acres of green space, an Aldi grocery store opening by March and already is the headquarters for Indego, the bicycle share program in Philadelphia.

Six buildings totaling 1 million square feet of space would be used for research and development labs. There’s 500,000 square feet of vacant space available for life sciences and high technology companies with availabilities as small as 1,000 square feet up to 250,000 square feet contiguous. There’s also 150,000 square feet of retail space available.

The office park has 200,000 square feet already occupied by tenants. The Philadelphia Job Corps Center and Delaware Valley Intelligence Center are tenants at the site.

The campus was previously used by the military as a place to produce clothing, footwear and personal equipment during World War I and II. The clothing factory closed in 1994. The Philadelphia Quartermaster Depot was listed on the National Register of Historic Places in 2010.

“We had a vision to preserve the legacy of this built-to-last historic Philadelphia landmark and transform it to create a vibrant space where the best and brightest want to innovate, collaborate, and work,” SkyREM CEO and Founder Alex Dembitzer said in a statement.

SkyREM, a real estate investor and developer, has corporate offices in New York and Philadelphia. The company acquired the site in 2001.

Vered Nohi, SkyREM’s regional executive director of new business development, called the redevelopment “transformational” for Philadelphia.

 
 

Quartermaster would join a wave of new life sciences projects being developed in the surrounding area and across the region.

The site is near both interstates 76 and 95 and is about 2 miles north of the Philadelphia Navy Yard, which has undergone a similar transformation from a military hub to a major life sciences and mixed-use redevelopment project. The Philadelphia Industrial Development Corp. is also in the process of selecting a developer to create a massive cell and gene therapy manufacturing complex across two sites totaling about 40 acres on Southwest Philadelphia’s Lower Schuylkill riverfront.

At 34th Street and Grays Ferry Avenue, the University of Pennsylvania is teaming with Longfellow Real Estate Partners on proposed a $365 million, 455,000-square-foot life sciences and biomanufacturing building at Pennovation Works.

 

SkyREM is working with Maryland real estate firm Scheer Partners to lease the science and technology space. Philadelphia’s MPN Realty will handle leasing of the retail space. Architecture firm Fifteen is working on the project’s design.

Scheer Partners Senior Vice President Tim Conrey said the Quartermaster conversion will help companies solve for “speed to market” as demand for life science space in the region has been strong.

Brandywine pauses new spec office development, continues to bet big on life sciences

By   –  Reporter, Philadelphia Business Journal

 

Brandywine Realty Trust originally planned to redevelop a Radnor medical office into lab and office space, split 50-50 between the two uses.

After changes in demand for lab and office space, Brandywine (NYSE: BDN) recently completed the 168,000-square-foot, four-story building at 250 King of Prussia Road in Radnor fully for life sciences.

“The pipeline is now 100% life sciences, which, while requiring more capital, is also generating longer term leases at a higher return on cost,” Brandywine CEO Jerry Sweeney of the project said during the company’s fourth-quarter earnings call on Thursday.

At the same time, Brandywine is holding off on developing new office buildings unless it has a tenant lined up in advance.

The shift reflects how Philadelphia-based Brandywine continues to lean into — and bet big — on life sciences.

Brandywine is the city’s largest owner of trophy office buildings and has several major development projects in the works. The company is planning to eventually develop 3 million square feet of life sciences space. For now, 800,000 square feet of life sciences space is under development, including a 12-story, 417,000-square-foot life sciences building at 3151 Market St. and a 29-story building with 200,000 square feet of life sciences space at 3025 John F. Kennedy Blvd. Both are part of the multi-phase Schuylkill Yards project underway near 30th Street Station in University City.

Once its existing projects are completed, Brandywine would have 800,000 square feet of life sciences space, making up 8% of its portfolio.Sweeney said the company wants to grow that figure to 21%.

Brandywine is developing a 145,000-square-foot, build-to-suit office building at 155 King of Prussia Road in Radnor for Arkema, a France-based global supplier of specialty materials. The building will be Arkema’s North American headquarters. Construction began in January and is scheduled to be completed in late 2024.

Brandywine reported that since November it raised over $705 million through fourth-quarter asset sales, an unsecured bond transaction and a secured loan. The company has “complete availability” on its $600 million unsecured line of credit, Sweeney said.

Brandywine sold a 95% leased, 86,000-square-foot office building at 200 Barr Harbor Drive in West Conshohocken for $30.5 million. The company also sold its 50% ownership interest in the 1919 Market joint venture for $83.2 million to an undisclosed buyer. 1919 Market St. is a 29-story building with apartments, office and commercial space. Brandywine co-developed the property with LCOR and the California State Teacher’s Retirement System.

Brandywine declined to comment and LCOR could not be reached.

Brandywine’s core portfolio is 91% leased.

The project at 250 King of Prussia Road cost $103.7 million and was recently completed. The renovation included 12-foot high floor-to-ceiling glass on the second floor, a new roof, lobby, elevator core, common area with a skylight and an added structured parking deck.

Located in the Radnor Life Science Center, a new campus with nearly 1 million square feet of lab, research and office space, Sweeney said it’s a “magnet” for biotech companies. Avantor, a global manufacturer and distributor of life sciences products, is headquartered in the complex.

 

Sweeney said Brandywine is “very confident” demand will stay strong for life sciences in Radnor. The building at 250 King of Prussia Road is projected to be fully leased by early 2024.

“Larger users we’re talking to, they just tend to take a little bit more time than we would like as they go through technical requirements and space planning requirements,” Sweeney said.

While Brandywine is aiming to increase its life sciences footprint, the company is being selective about what it builds next. The company may steer away from developments other than life sciences. The Schuylkill Yards project, for example, features a significant life sciences portion in University City.

“Other than fully leased build-to-suit opportunities, our future development starts are on hold,” Sweeney said, “pending more leasing on the existing joint venture pipeline and more clarity on the cost of debt capital and cap rates.”

 

Brandywine said about 70% to 75%of suburban tenants have returned to offices while that number has been around 50% in Philadelphia. At this point, though, it hasn’t yet affected demand when leasing space. Some tenants, for example, have moved out of the city while others have moved in.

In the fourth quarter, Brandywine had $55.7 million funds from operations, or 32 cents per share. That’s down from $60.4 million, or 35 cents per share, in the fourth quarter of 2021. Brandywine generated $129 million in revenue in the fourth quarter, up slightly from $125.5 in the year-ago period.

Brandywine stock is up 6.4% since the start of the year to $6.70 per share on Monday afternoon.

Many of Brandywine’s properties are in desirable locations, which have seen demand remain strong despite challenges facing offices, on par with industry trends.

Brandywine’s 12-story, 417,000-square-foot building at 3151 Market St. is on budget for $308 million and on schedule to be completed in the second quarter of 2024. Sweeney said Brandywine anticipates entering a construction loan in the second half of 2023, which would help complete the project. The building, being developed along with a global institutional investor,would be used for life sciences, innovation and office space as part of the larger Schuylkill Yards development in University City.

The company’s 29-story building at 3025 John F. Kennedy Blvd. with 200,000 square feet of life sciences space and 326 luxury apartments, is also on budget, costing $287.3 million, and on time, eyeing completion in the third quarter of this year.

Source: https://www.bizjournals.com/philadelphia/news/2023/02/06/brandywine-realty-life-sciences-development.html

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AI enabled Drug Discovery and Development: The Challenges and the Promise

Reporter: Aviva Lev-Ari, PhD, RN

 

Early Development

Caroline Kovac (the first IBM GM of Life Sciences) is the one who started in silico development of drugs in 2000 using a big db of substances and computer power. She transformed an idea into $2b business. Most of the money was from big pharma. She was asking what is are the new drugs they are planning to develop and provided the four most probable combinations of substances, based on in Silicon work. 

Carol Kovac

General Manager, Healthcare and Life Sciences, IBM

from speaker at conference on 2005

Carol Kovac is General Manager of IBM Healthcare and Life Sciences responsible for the strategic direction of IBM′s global healthcare and life sciences business. Kovac leads her team in developing the latest information technology solutions and services, establishing partnerships and overseeing IBM investment within the healthcare, pharmaceutical and life sciences markets. Starting with only two employees as an emerging business unit in the year 2000, Kovac has successfully grown the life sciences business unit into a multi-billion dollar business and one of IBM′s most successful ventures to date with more than 1500 employees worldwide. Kovac′s prior positions include general manager of IBM Life Sciences, vice president of Technical Strategy and Division Operations, and vice president of Services and Solutions. In the latter role, she was instrumental in launching the Computational Biology Center at IBM Research. Kovac sits on the Board of Directors of Research!America and Africa Harvest. She was inducted into the Women in Technology International Hall of Fame in 2002, and in 2004, Fortune magazine named her one of the 50 most powerful women in business. Kovac earned her Ph.D. in chemistry at the University of Southern California.

SOURCE

https://www.milkeninstitute.org/events/conferences/global-conference/2005/speaker-detail/1536

 

In 2022

The use of artificial intelligence in drug discovery, when coupled with new genetic insights and the increase of patient medical data of the last decade, has the potential to bring novel medicines to patients more efficiently and more predictably.

WATCH VIDEO

https://www.youtube.com/watch?v=b7N3ijnv6lk

SOURCE

https://engineering.stanford.edu/magazine/promise-and-challenges-relying-ai-drug-development?utm_source=Stanford+ALL

Conversation among three experts:

Jack Fuchs, MBA ’91, an adjunct lecturer who teaches “Principled Entrepreneurial Decisions” at Stanford School of Engineering, moderated and explored how clearly articulated principles can guide the direction of technological advancements like AI-enabled drug discovery.

Kim Branson, Global head of AI and machine learning at GSK.

Russ Altman, the Kenneth Fong Professor of Bioengineering, of genetics, of medicine (general medical discipline), of biomedical data science and, by courtesy, of computer science.

 

Synthetic Biology Software applied to development of Galectins Inhibitors at LPBI Group

 

The Map of human proteins drawn by artificial intelligence and PROTAC (proteolysis targeting chimeras) Technology for Drug Discovery

Curators: Dr. Stephen J. Williams and Aviva Lev-Ari, PhD, RN

Using Structural Computation Models to Predict Productive PROTAC Ternary Complexes

Ternary complex formation is necessary but not sufficient for target protein degradation. In this research, Bai et al. have addressed questions to better understand the rate-limiting steps between ternary complex formation and target protein degradation. They have developed a structure-based computer model approach to predict the efficiency and sites of target protein ubiquitination by CRNB-binding PROTACs. Such models will allow a more complete understanding of PROTAC-directed degradation and allow crafting of increasingly effective and specific PROTACs for therapeutic applications.

Another major feature of this research is that it a result of collaboration between research groups at Amgen, Inc. and Promega Corporation. In the past commercial research laboratories have shied away from collaboration, but the last several years have found researchers more open to collaborative work. This increased collaboration allows scientists to bring their different expertise to a problem or question and speed up discovery. According to Dr. Kristin Riching, Senior Research Scientist at Promega Corporation, “Targeted protein degraders have broken many of the rules that have guided traditional drug development, but it is exciting to see how the collective learnings we gain from their study can aid the advancement of this new class of molecules to the clinic as effective therapeutics.”

Literature Reviewed

Bai, N. , Riching K.M. et al. (2022) Modeling the CRLRA ligase complex to predict target protein ubiquitination induced by cereblon-recruiting PROTACsJ. Biol. Chem.

The researchers NanoBRET assays as part of their model validation. Learn more about NanoBRET technology at the Promega.com website.

SOURCE

https://www.promegaconnections.com/protac-ternary-complex/?utm_campaign=ms-2022-pharma_tpd&utm_source=linkedin&utm_medium=Khoros&utm_term=sf254230485&utm_content=030822ct-blogsf254230485&sf254230485=1

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A laboratory for the use of AI for drug development has been launched in collaboration with Pfizer, Teva, AstraZeneca, Mark and Amazon

Reporter: Aviva Lev-Ari, PhD, RN

AION Labs unites pharma, technology and funds companies including IBF to invest in startups to integrate developments in cloud computing and artificial intelligence to improve drug development capabilities. An alliance of four leading pharmaceutical companies –  
AION Labs
 , the first innovation lab of its kind in the world and a pioneer in the process of adopting cloud technologies, artificial intelligence and computer science to solve the R&D challenges of the pharma industry, today announces its launch.
AstraZeneca ,  
Mark ,  
Pfizer  and 
Teva  – and two leading companies in the field of high-tech and biotech investments, respectively – AWS ( 
Amazon Web Services Inc ) and the Israeli investment fund IBF ( 
Israel Biotech Fund ) – which joined together to establish groundbreaking ventures Through artificial intelligence and computer science to change the way new therapies are discovered and developed.  “We are excited to launch the new innovation lab in favor of discoveries of drugs and medical devices using groundbreaking computational tools,” said Matti Gil, CEO of AION Labs. We are prepared and ready to make a difference in the process of therapeutic discoveries and their development. 
With a strong pool of talent from Israel and the world, cloud technology and artificial intelligence at the heart of our activities and a significant commitment by the State of Israel, we are ready to contribute to the health and well-being of the human race and promote industry in Israel. 
I thank the partners for the trust, and it is an honor for me to lead such a significant initiative. ” 
In addition, AION Labs has announced a strategic partnership with X  
BioMed  , an independent biomedical research institute operating in Heidelberg, Germany. 
BioMed X has a proven track record in advancing research innovations in the field of biomedicine at the interface between academic research and the pharmaceutical industry. 
BioMed X’s innovation model, based on global mass sourcing and incubators to cultivate the most brilliant talent and ideas, will serve as the R & D engine to drive AION Labs’ enterprise model.

SOURCE

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NCCN Shares Latest Expert Recommendations for Prostate Cancer in Spanish and Portuguese

Reporter: Stephen J. Williams, Ph.D.

Currently many biomedical texts and US government agency guidelines are only offered in English or only offered in different languages upon request. However Spanish is spoken in a majority of countries worldwide and medical text in that language would serve as an under-served need. In addition, Portuguese is the main language in the largest country in South America, Brazil.

The LPBI Group and others have noticed this need for medical translation to other languages. Currently LPBI Group is translating their medical e-book offerings into Spanish (for more details see https://pharmaceuticalintelligence.com/vision/)

Below is an article on The National Comprehensive Cancer Network’s decision to offer their cancer treatment guidelines in Spanish and Portuguese.

Source: https://www.nccn.org/home/news/newsdetails?NewsId=2871

PLYMOUTH MEETING, PA [8 September, 2021] — The National Comprehensive Cancer Network® (NCCN®)—a nonprofit alliance of leading cancer centers in the United States—announces recently-updated versions of evidence- and expert consensus-based guidelines for treating prostate cancer, translated into Spanish and Portuguese. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) feature frequently updated cancer treatment recommendations from multidisciplinary panels of experts across NCCN Member Institutions. Independent studies have repeatedly found that following these recommendations correlates with better outcomes and longer survival.

“Everyone with prostate cancer should have access to care that is based on current and reliable evidence,” said Robert W. Carlson, MD, Chief Executive Officer, NCCN. “These updated translations—along with all of our other translated and adapted resources—help us to define and advance high-quality, high-value, patient-centered cancer care globally, so patients everywhere can live better lives.”

Prostate cancer is the second most commonly occurring cancer in men, impacting more than a million people worldwide every year.[1] In 2020, the NCCN Guidelines® for Prostate Cancer were downloaded more than 200,000 times by people outside of the United States. Approximately 47 percent of registered users for NCCN.org are located outside the U.S., with Brazil, Spain, and Mexico among the top ten countries represented.

“NCCN Guidelines are incredibly helpful resources in the work we do to ensure cancer care across Latin America meets the highest standards,” said Diogo Bastos, MD, and Andrey Soares, MD, Chair and Scientific Director of the Genitourinary Group of The Latin American Cooperative Oncology Group (LACOG). The organization has worked with NCCN in the past to develop Latin American editions of the NCCN Guidelines for Breast Cancer, Colon Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Multiple Myeloma, and Rectal Cancer, and co-hosted a webinar on “Management of Prostate Cancer for Latin America” earlier this year. “We appreciate all of NCCN’s efforts to make sure these gold-standard recommendations are accessible to non-English speakers and applicable for varying circumstances.”

NCCN also publishes NCCN Guidelines for Patients®, containing the same treatment information in non-medical terms, intended for patients and caregivers. The NCCN Guidelines for Patients: Prostate Cancer were found to be among the most trustworthy sources of information online according to a recent international study. These patient guidelines have been divided into two books, covering early and advanced prostate cancer; both have been translated into Spanish and Portuguese as well.

NCCN collaborates with organizations across the globe on resources based on the NCCN Guidelines that account for local accessibility, consideration of metabolic differences in populations, and regional regulatory variation. They can be downloaded free-of-charge for non-commercial use at NCCN.org/global or via the Virtual Library of NCCN Guidelines App. Learn more and join the conversation with the hashtag #NCCNGlobal.


[1] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, in press. The online GLOBOCAN 2018 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing educationglobal initiativespolicy, and research collaboration and publication in oncology. Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and Twitter @NCCN.

Please see LPBI Group’s efforts in medical text translation and Natural Language Processing of Medical Text at

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