Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
The following remembrances of American Association of Cancer Research (AACR) prominent member who have recently passed in 2026 is given below. Each have contributed seminal research and discovery in the field of cancer biology and cancer risk. In many cases, their discoveries transformed the way we understand and treat cancer. A separate In Memoriam for Nobel Leaureatte Dr. J. Michael Bishop will be given in a separate post.
Joseph F. Fraumeni, Jr., MD, FAACR, a renowned cancer epidemiologist, a Fellow of the AACR Academy, and a former member of the AACR Board of Directors, died June 22, 2026, at the age of 93. A career researcher and leader at the National Cancer Institute, Fraumeni was a co-discoverer of the genetic condition now known as the Li-Fraumeni syndrome and launched the U.S. Atlas of Cancer Mortality, which mapped geographic variations in cancer.Born April 1, 1933, in Boston, Fraumeni earned a bachelor’s degree from Harvard College, a medical degree from Duke University School of Medicine, and a master of science in epidemiology from the Harvard University School of Public Health. He completed medical residencies at Johns Hopkins Hospital and the Memorial Sloan-Kettering Cancer Center. A member of the AACR since 1968, Fraumeni served on the AACR’s Board of Directors from 1983 to 1986. He also served the AACR as an assistant editor, senior editor, and editorial board member for Cancer Epidemiology, Biomarkers & Prevention and an assistant editor for Cancer Research. The AACR recognized him with the AACR-American Cancer Society Award for Research Excellence in Epidemiology and Prevention in 1993 and the AACR Award for Lifetime Achievement in Cancer Research in 2009. He was inducted as a member of the inaugural class of Fellows of the AACR Academy in 2013. Fraumeni was a fellow of the American College of Physicians, the American Association for the Advancement of Science, and the American Academy of Arts and Sciences, and a member of the Institute of Medicine, the Association of American Physicians, and the National Academy of Sciences.
In 1962, Fraumeni joined the Epidemiology Branch of the National Cancer Institute (NCI) as a commissioned officer in the U.S. Public Health Service (USPHS). He went on to hold several leadership positions at the NCI, including posts as head of the Ecology Studies Section, chief of the Environmental Epidemiology Branch, director of the Epidemiology and Biostatistics Program, and founding director of the Division of Cancer Epidemiology and GeneticsHe retired from the USPHS in 1999 with the rank of rear admiral and assistant surgeon general. When he retired from NCI in 2017, he was named Scientist Emeritus. He authored or co-authored more than 900 scientific publications.
His research focused the epidemiology of high cancer risk populations and, in 1969, led him to discover a familial syndrome of early-onset cancers of the breast, brain, and other malignancies known as Li-Fraumeni Syndrome. Li-Fraumeni Sydrome is characterized by inherited mutations in the p53 tumor suppressor gene.
Li-Fraumeni Syndrome
from Cleveland Clinic: Li-Fraumeni syndrome is a rare genetic disorder that increases the risk you and your family members will develop cancer. Everyone with this condition has a 90% chance of developing one or more types of cancer by age 60. About half develop cancer before they turn 40. Females with Li-Fraumeni syndrome almost always develop breast cancer.
Below is the original reference published with his colleague the late Dr, Federick Li. Thier work together over the years helped develop the discovery of cancer susceptiblitiy genes and the importance of mutations of these genes linked to increased risk of developing cancer.
Li FP, Fraumeni JF Jr. 1969. Soft-tissue sarcomas, breast cancer, and other neoplasms. A familial syndrome? Ann Intern Med 71: 747–752.
Four families were identified in which a pair of children had soft-tissue sarcomas: three sets of sibs and one set of cousins. One parent of each affected child developed cancer; carcinoma of the breast occurred in three mothers under 30 years of age. Other young adults in these families had a high frequency of cancer, with no evidence of underlying genetic disorders known to carry a high risk of neoplasia. The increased familial susceptibility to cancer was manifested not only by the large number of members affected but by a seeming excess of multiple primary neoplasms.
It wasn’t until the 1990’s that Malkin et al. that germline mutations in TP53 were associated with this disease
Malkin D, Li FP, Strong LC, Fraumeni JF Jr, Nelson CE, Kim DH, Kassel J, Gryka MA, Bischoff FZ, Tainsky MA, et al. 1990. Germ line p53 mutations in a familial syndrome of breast cancer, sarcomas, and other neoplasms. Science 250: 1233–1238.
A similar syndrome named Lynch syndrome also gave rise to early increased risk of multiple cancers but due to germline mutations in mismatch repair genes like MLH1, MSH2, MSH6, or PMS2.
Lynch HT, Mulcahy GM, Harris RE, Guirgis HA, Lynch JF. 1978. Genetic and pathologic findings in a kindred with hereditary sarcoma, breast cancer, brain tumors, leukemia, lung, laryngeal, and adrenal cortical carcinoma. Cancer 41: 2055–2064.
Pierre Chambon, MD, FAACR, a Fellow of the AACR Academy who was a pioneer in the structure and expression of genes, died May 5, 2026, at the age of 95. Chambon’s early work contributed to the discovery of PolyADPribose, the discovery of multiple RNA polymerases, major contributions to the elucidation of chromatin structure, and the discovery of animal split genes. Later work included the discovery of multiple promoter elements and their cognate factors. His research on nuclear receptors has had a marked influence on the understanding of signal transduction and endocrinology in vertebrates.
Born February 7, 1931, in Mulhouse, France, Chambon received his medical degree from the University of Strasbourg in 1958. He joined the university as a research associate, becoming an associate professor in 1962 and professor of biochemistry in 1968. He founded the Institute for Genetics and Cellular and Molecular Biology in 1994 and served as its director until 2002. He then founded the Mouse Clinical Institute and served as director until 2006. He held the chair of molecular genetics at the Collège de France from 1993 to 2003 and served as chair of molecular genetics and biology at the University of Strasbourg Institute for Advanced Study from 2012 to 2021. Chambon was elected to the French Academy of Sciences in1985, the same year in which he was elected a foreign member of both the U.S. National Academy of Sciences and the American Academy of Arts and Sciences.
Juliet M. Daniel, PhD
Juliet M. Daniel, PhD, a cell biologist who was a distinguished university professor at McMaster University in Hamilton, Ontario, and member of AACR since 2002, died April 28, 2026. She was 61 years of age. Noted for her work on genetic risk factors for breast cancer, Daniel discovered and gave the name “Kaiso” to a gene associated with triple negative breast cancer in women of African descent. Born in Barbados in 1964, Daniel obtained a bachelor’s degree in life sciences from Queen’s University in Kingston, Ontario, in 1987 and a doctorate in microbiology from University of British Columbia in Vancouver in 1993. She conducted postdoctoral research at St. Jude Children’s Research Hospital in Memphis and Vanderbilt University in Nashville. She joined McMaster as an assistant professor in 1999, the first black woman to become a member of the Faculty of Science. She was promoted to associate professor in 2005 and professor in 2012. Daniel was appointed associate dean of research and external relations for the Faculty of Science on an acting basis in 2020 and permanently in 2021. She was named strategic advisor to the university president for the Canada-Caribbean Institute (CCI) at McMaster in 2024. She was named a distinguished university professor, the highest faculty honor, in 2025. Among many other honors, she was elected a fellow of the Canadian Academy of Health Sciences in 2025, received the inaugural Canadian Cancer Society Inclusive Excellence Prize in Cancer Research in 2020, and was awarded an honorary doctorate in science by the University of the West Indies in 2021.
Philip S. Low, PhD
Philip S. Low, PhD, the Ralph C. Corley distinguished professor of chemistry at Purdue University, an inventor and entrepreneur with more than 100 patents to his credit, and an emeritus member of AACR, died March 4, 2026, at the age of 78. He also served as Purdue’s Presidential Scholar for Drug Discovery and was for a time as director of the university’s Center for Drug Discovery. Low held more than 100 U.S.-issued patents through Purdue Innovates and is listed on 600 U.S. and international patents and 145 invention disclosures. He founded seven companies based on based on work conducted at Purdue, one of which, Endocyte Inc., was sold to Novartis in 2018. Born in Ames, Iowa, in 1947, Low earned a bachelor’s degree in chemistry from Brigham Young University in 1971 and a doctorate in biochemistry from the University of California, San Diego, in 1975. He joined the Purdue University faculty in 1976. An AACR member since 2005, Low received the AACR Award for Outstanding Achievement in Chemistry in Cancer Research in 2015 in recognition of his research on low molecular weight ligand-targeted therapeutic and imaging agents. In the same year, he also received the American Chemical Society (ACS) George & Christine Sosnovsky Award for Cancer Research and was elected to the National Academy of Inventors. In August 2025, Low was named the recipient of the ACS Alfred Burger Award in Medicinal Chemistry for 2026. He also received the Order of the Griffin and the Morrill Award from Purdue.
In Memoriam: Professor Yitzhak Apeloig, President and Distinguised Professor of the Technion
Reporters: Aviva Lev-Ari, PhD, RN and Stephen J. Williams, Ph.D.
From the Technion:
The Technion community mourns the passing of Distinguished Professor Yitzhak Apeloig (1944–2026), president of the Technion from 2001 to 2009 and one of Israel’s most distinguished chemists.
A pioneer in computational chemistry and organosilicon compounds, Prof. Apeloig made groundbreaking scientific contributions while mentoring generations of researchers and helping position the Technion as a global leader in science and technology.
During his presidency, he expanded interdisciplinary research, strengthened international partnerships, increased investment in research infrastructure and scholarships, and advanced collaboration between engineering, medicine, and the humanities.“Prof. Apeloig led the Technion with quiet confidence and steadfast leadership,” said Technion President Prof. Uri Sivan. “His years in office were marked by exceptional academic development and a profound impact on the State of Israel and beyond.”
The Technion was his home and family. He will be deeply missed. May his memory be a blessing.
Distinguished Professor Yitzhak Apeloig (1944–2026), president of the Technion from 2001 to 2009 and one of Israel’s most distinguished chemists
A brief synopsis of Dr. Apeloig’s scientific achievements and contributions toward the field of chemistry:
1. Pioneering Computational Quantum Chemistry
In the 1970s, Apeloig was one of the first experimental chemists in the world to recognize the immense potential of using quantum theory and computational models to predict molecular characteristics.
The “First Calculate, Then Synthesize” Philosophy: He pioneered a paradigm shift in organic chemistry by using quantum-mechanical calculations to predict whether a novel molecule could exist and what its lifespan would be before attempting physical synthesis in the laboratory.
He was unique for his time in requiring his students to master both computational modeling and physical laboratory experimentation rather than separating the disciplines.
2. Breakthroughs in Organosilicon Chemistry
Before Apeloig’s work, much of the scientific community believed that silicon could not easily form stable multiple bonds (such as $Si=Si$ or $Si=C$ double bonds) in the way carbon does. Apeloig revolutionized the field of organosilicon chemistry:
Low-Coordination Silicon Compounds: He successfully used computational tools combined with experimental testing to predict, isolate, and understand highly reactive, low-coordination silicon species. This included landmark research into multiply-bonded silicon compounds, silyl radicals, silyl anions, silylenes, and metallosilane reagents.
Silicone and Materials Science: His structural insights fundamentally advanced the molecular understanding of silicon polymers and siloxanes, which heavily influenced the development of advanced moulding materials, rubbers, and photosensitive materials used in lithography.
3. Discovery of Reactive Intermediates
During his early career and PhD research, he focused heavily on physical organic chemistry and organic reaction mechanisms:
He was the first to experimentally demonstrate that a vinyl cation holds a linear geometry around its carbocationic center.
His extensive work mapping out short-lived, highly reactive intermediates (like carbenium ions and strained molecules) provided the foundational mechanics for how complex organic reactions occur.
Major Recognitions
For these definitive contributions to computational and silicon chemistry, Apeloig was awarded some of the highest honors in the discipline:
The Schrödinger Medal (2021): Awarded by the World Association of Theoretical and Computational Chemists (WATOC) for his seminal contributions to theoretical chemistry.
The ACS Frederic Stanley Kipping Award in Silicon Chemistry (2010): The premier international award recognizing advancements in the study of silicon.
The Wacker Silicone Award (2007) and the Israel Chemical Society Gold Medal (2017).
The seminal publications that define his academic footprint include:
1. Foundational Computational and Structural Chemistry
During the mid-1970s and 1980s, Apeloig co-authored several massive, highly cited studies establishing the rules of computational molecular architecture, specifically challenging traditional rules of carbon and silicon bonding.
“Stabilization of planar tetracoordinate carbon”
Journal of the American Chemical Society (1976)
Co-authors: J. B. Collins, J. D. Dill, E. D. Jemmis, P. v. R. Schleyer, R. Seeger, J. A. Pople
Impact: A true milestone in structural chemistry that theoretically demonstrated how specific substitution patterns could stabilize a planar geometry around a carbon atom, defying the standard tetrahedral configuration.
“A theoretical survey of unsaturated or multiply bonded and divalent silicon compounds. Comparison with carbon analogs”
Journal of the American Chemical Society (1986)
Co-authors: B. T. Luke, J. A. Pople, M. B. Krogh-Jespersen, M. Karni, J. Chandrasekhar, P. v. R. Schleyer
Impact: A definitive ab initio survey that comprehensively mapped out the differences between carbon and silicon multiple bonds, predicting the stability and reaction behaviors of transient silicon chemical species.
2. High-Impact Silicon and Stable Carbene Analogs
In the 1990s and 2000s, Apeloig focused on predicting and identifying highly sought-after reactive intermediates—particularly “impossible” double bonds and carbenes.
“On the Question of Stability, Conjugation, and ‘Aromaticity’ in Imidazol-2-ylidenes and Their Silicon Analogs”
Journal of the American Chemical Society (1996)
Co-authors: C. Heinemann, T. Müller, H. Schwarz
Impact: Heavily cited paper evaluating the electronic properties, structural stability, and aromaticity of N-heterocyclic carbenes (NHCs) versus their heavier silicon counterparts (silylenes).
“Substituent effects on the geometries and energies of the silicon-silicon double bond”
Journal of the American Chemical Society (1990)
Co-author: M. Karni
Impact: This study mapped how changing the attached chemical groups altered the trans-bending and bond lengths of $Si=Si$ double bonds, establishing a predictive guide for experimentalists trying to isolate stable disilenes.
3. Definitive Academic Reviews and Reference Books
Beyond standalone journal entries, Apeloig is globally recognized for editing the foundational texts that summarized the state of organosilicon chemistry for generations of scientists.
“The Chemistry of Organic Silicon Compounds” (Volumes 1, 2, and 3)
Co-edited with: Zvi Rappoport (Published by John Wiley & Sons, beginning in 1989)
Impact: Apeloig authored critical chapters, such as “Theoretical Aspects of Organosilicon Compounds,” within these volumes. This multi-book compendium serves as the literal “bible” for researchers studying silicon polymers, reactive silicon intermediates, and silicon-based material sciences.
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.
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.
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.
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.
Cortellis Competitive Intelligence: maximize ROI and improve patient outcomes
Cortellis Deals Intelligence: Portfolio Strategy and Business Development (find best deal)
Cortellis Clinical Intelligence: Clinical Trial Support and Regulatory
Cortellis Digital Health Intelligence: understand digital health ecosystem
Cortellis Drug Discovery: improve drug development speed and efficiency
MetaBase and MetaCore: integrated omics knowledge bases for drug discovery
Cortellis Regulatory: help with filings
Cortellis HTA: health tech compliance (HIPAA)
CMC Intelligence: new drug marketing
Generics Intelligence
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
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:
Live Notes from JP Morgan Healthcare Conference Virtual Endpoints Preview: January 8-9 2024
Reporter: Stephen J. Williams, Ph.D.
Endpoints at #JPM24 | Primed to unlock biopharma’s next dealmaking wave
Endpoints at JP Morgan Healthcare Conference
January 8-9 | San Francisco, CA80 Mission St, San Francisco, CA
An oasis has emerged in the biopharma money desert as backers look to replenish capital — still, uncertainty remains on whether it’s a mirage or the much needed dealmaking bump the industry needs. Yet spirits run high as JPM24 marks the triumphant return of inking strategic alliances and peering into the industry crystal ball — while keeping an eye out for some major M&A.
We’re back live from San Francisco for JPM Monday and Tuesday — our calendar of can’t-miss panels and fireside chats will feature prominent biopharma leaders to watch. The Endpoints Hub provides the ultimate coworking space with everything you need — 1:1 and group meeting spots plus guest pass capabilities and more. Join us in-person at the Endpoints Hub or watch online to stay plugged into all the action.
8 JAN
Welcome remarks
8:05 AM – 8:25 AM PST
Pfizer vet Mikael Dolsten has some thoughts on Big Pharma R&D
Endpoints News founding editor John Carroll will sit down with longtime Pfizer CSO Mikael Dolsten to talk about Pfizer’s pipeline, what he’s learned on the job about preclinical research and development and what’s ahead for the pharma giant in drug development and deals.
Mikael Dolsten
Chief Scientific Officer, President, Pfizer Research & Development
Pfizer
Pfizer Mikael Dolsten: Pfizer produced a series of AI generated molecules with new properties. Sees rapid adoption of AI in the area of drug discovery and molecular design.
8:25 AM – 9:05 AM PST
What pharma wants: The industry’s dealmakers look ahead at 2024
The drug industry’s appetite for new assets hasn’t slowed down. Top business development execs will give their outlook on the year, what they’re looking for and how they see the market.
Glenn Hunzinger
Pharmaceutical & Life Sciences Consulting Solutions Leader
PwC US
Rachna Khosla
SVP, Head of Business Development
Amgen
James Sabry
Global Head of Pharma Partnering
Roche
Devang Bhuva
SVP, Corporate Development
Gilead Sciences, Inc.
Endpoints News
Dealmaking panel
Glenn Hunzinger: if you do not have a GLP1 will have a tough time getting a good market price for your company; capital markets are not where they want to be; sees a tough deal making climate like last year. The problem with many biotech companies are they are coming earlier to the venture capital because of greater funding needs and so it is imperative that they articulate the potential of their company in scientific detail
Rachna Khosla: Make sure your investors are not just CAPITAL PARTNERS but use their expertise and involve them in development issues you may have, especially ones that a young firm will face. The problem is most investments assume what the future looks like (for example how antibody drug conjugates, once a field left for dead, has been rejuvenated because of advances in chemistry).
James Sabry: noted that cardiac and metabolic drugs are now at the focus of many investors, especially with the new anti-obesity drugs on market
Devang Bhuva: Most deals we see start as collaborations or partnerships. You want to involve an alliance management team early in the deal making process. This process could take years.
9:05 AM – 9:20 AM PST
The IPO: How Apogee Therapeutics went public in the most challenging market in years
Not many biotechs went public in 2023. And of those that did, not many have had a great time of it. Apogee is the exception and our panel will offer a behind-the-scenes look at their decision to enter the market and what life is like as a young public company.
Michael Henderson
CEO
Apogee Therapeutics
Kyle LaHucik
MODERATOR
Senior Reporter
Endpoints News
Michael Henderson: Not many biotech IPOs deals happened in 2023. Michael feels it is because too many biotechs focused on building platforms, which was a hard sell in 2023. He felt not many biotechs had clear milestones and investors wanted a clear primary validated target. He said many biotech startups are in a funding crunch and most need at least $440M on their balance sheet to get to 2026.
9:50 AM – 10:10 AM PST
Top predictions for biotech in 2024
Catalent CEO Alessandro Maselli will be back at the big JPM healthcare confab to talk with Endpoints News founder John Carroll about their top predictions of what’s coming up for the biotech industry in 2024. The stakes couldn’t be higher as the industry grapples with headwinds and new opportunities in a gale of market forces. Two top observers share their thoughts on the year ahead.
Alessandro Maselli
President & CEO
Catalent
10:15 AM – 10:35 AM PST
Innovation at a crossroads: Keys to unlocking the value of science and technology
The industry has long discussed the promise of technology and the acceleration it provides in scientific advancement and across the industry value chain. However, the promise of its impact has yet to fully be realized. This discussion will outline the keys to unleashing this promise and the implications and actions to be taken by the biopharmaceutical companies across the industry.
Ray Pressburger
North America Life Sciences Industry Lead & Global Life Sciences Strategy Lead
Accenture
SPONSORED BY
10:35 AM – 11:05 AM PST
Activism and Investing: In conversation with Elliott Investment Management’s Marc Steinberg
Elliott has been behind many of 2023’s highest-profile healthcare investments, including multiple activist engagements and taking Syneos Health private. What has made large healthcare companies such interesting investment opportunities for firms like Elliott? What’s Elliott’s investing strategy in healthcare? And what should companies expect when an activist calls?
Marc Steinberg
Senior Portfolio Manager
Elliott Investment Management
Andrew Dunn
MODERATOR
Biopharma Correspondent
Endpoints News
11:05 AM – 11:35 AM PST
Creating ROI from AI
AI is predicted to transform the way drugs are made, from discovery to clinical trials to market. But beyond the initial hype and early adoption, where has AI made meaningful contributions to R&D? How does it help drug developers advance science? Endpoints publisher Arsalan Arif is convening a panel of leading experts to discuss the state of AI in the pharmaceutical landscape and the outlook for 2024. How does AI impact the drug pipeline, from the early steps of discovery to reducing trial failure rate?
Thomas Clozel
Co-Founder & CEO
Owkin
Venkat Sethuraman
SVP, Global Biometrics & Data Sciences
Bristol Myers Squibb
Frank O. Nestle
Global Head of Research & Chief Scientific Officer
Sanofi
Matthias Evers
Chief Business Officer
Evotec
Arsalan Arif
MODERATOR
Founder & Publisher
Endpoints News
SPONSORED BY
11:35 AM – 12:00 PM PST
Biopharma’s dealmaker: Behind the scenes with Centerview Partners co-president Eric Tokat
Almost every major biopharma deal in 2023 had Centerview’s name attached to it. And much of the time, Eric Tokat was the banker making those deals happen. Hear his outlook for 2024, how transactions are getting done and what’s placed his firm at the center of so much action.
E. Eric Tokat
Co-President, Investment Banking
Centerview Partners
CenterView Partners Eric Tokat feels dealmaking will improve in 2024, given the recent flurry of dealmaking at end of last year and right before main JPM Healthcare Conference. He says Centerview wants to help the biotechs they invest in on their strategic path. This may translate into buyers more actively involved (more than startups want) and buyers now are in the drivers seat as far as the timeline of deals and development.
Is the megamerger dead for this year? He says it is very hard to see two major mergers happening but there will be many smaller and mid size biotech deals happening, but these deals will be more speculative in nature.. The focus for large pharma is top line growth. Most of the buyers have an infrastructure and value is more of buying and dropping it in their business so there is now a huge emphasis on due diligence on whether synergies exist or not
12:00 PM – 12:30 PM PST
Founder, legend, leader: In conversation with Nobel laureate Carolyn Bertozzi
Carolyn Bertozzi’s discoveries around bioorthogonal chemistry won the Nobel Prize in Chemistry in 2022 and are at the heart of new therapies being tested in patients. Join us as we discuss what inspires her and where she sees the next big advances.
Carolyn Bertozzi
Prof. of Chemistry, Stanford University and Baker Family Director of Sarafan ChEM-H
Stanford University
Nicole DeFeudis
MODERATOR
Editor
Endpoints News
Bioorthogonal chemistry: class of high yielding chemical reactions that proceed rapidly and selectively in biological environments without side reactions toward endogenous functions. This is also a type of ‘click chemistry’ in biological system where only specifically alter the biomolecule of interest.
Orthogonal: two chemicals not interacting with each other
Dr. Bertozzi noted she has started a new Antibody-Drug-Conjugate (ADC) company which involves designing with biorthogonal chemistry to make new functional molecules with varying properties
She noted hardly any biologists knew anything about glycobiology when she first started. However now she feels pharma and academia are working very well with each other
Bioorthogonal and Click Chemistry Curated by Prof. Carolyn R. Bertozzi, 2022 winner of the Nobel Prize in Chemistry
The 2022 Nobel Prize in Chemistry has been awarded jointly to ACS Central Science Editor-in-Chief, Carolyn R. Bertozzi of Stanford University, Morten Meldal of the University of Copenhagen, and K. Barry Sharpless of Scripps Research, for the development of click chemistry and bioorthogonal chemistry.
To celebrate this remarkable achievement, 2022 Nobel Prize winner Professor Carolyn R. Bertozzi has curated this Bioorthogonal and Click Chemistry Virtual Issue, highlighting papers published across ACS journals that have built upon the foundational work in this exciting area of chemistry.
Bioorthogonal reactions are chemical reactions that neither interact with nor interfere with a biological system. The participating functional groups must be inert to biological moieties, must selectively reactive with each other under biocompatible conditions, and, for in vivo applications, must be nontoxic to cells and organisms. Additionally, it is helpful if one reactive group is small and therefore minimally perturbing of a biomolecule into which it has been introduced either chemically or biosynthetically. Examples from the past decade suggest that a promising strategy for bioorthogonal reaction development begins with an analysis of functional group and reactivity space outside those defined by nature. Issues such as stability of reactants and products (particularly in water), kinetics, and unwanted side reactivity with biofunctionalities must be addressed, ideally guided by detailed mechanistic studies. Finally, the reaction must be tested in a variety of environments, escalating from aqueous media to biomolecule solutions to cultured cells and, for the most optimized transformations, to live organisms.
9 JAN
9:40 AM – 10:10 AM PST
Biotech downturn survival school
Our panelists have seen the worst, and made it through to the other side. Join us for downturn survival school as our panelists talk about what sets apart the ones who make it through tough times.
These panalists think it will be specialist capital year to shine while the general capital is still sitting on the sidelines
JJ Kang
CEO
Appia Bio
“2023 was a tough year while 2020 was a boon year to start a company. We will continue to see these cycles; many of these new CEOs have never seen a biotech downturn yet and may not know how to preserve capital for the downturn”.
“Doing a partnership with Kite Pharmaceuticals early in our startp allowed us to get work done without risking a lot of capital, even if it means equity and asset dilution. That makes sense. However even if you are small insist on being an equal partner.”
“There are many investors we talk to who do not want to invest in cell therapy. Too risky now”
Carl Gordon
Managing Partner
OrbiMed Advisors
There are many macroeconomic factors affecting investment and capital today which will carry on through 2024. Not raising money when you do not need money is a bad philosophy. Always bbe raising captial. This is especially true when you have to rely on hedge funds. Parnerships howeve are sometimes the only way for small biotechs to leverage their strengths.
Joshua Boger
Executive Chair
Alkeus Pharmaceuticals, Inc.
Boger: Expect volatility for 2024. This environment feels very different than past downturns.
Even in downturns there is still lots of capital; remember access to human capital is better in a downturn and is easier to access; however it has become harder to get drug approvals
The panelists agree that access to capital and funding will be as tricky in 2024 than 2023. They did
suggest that a new funding avenue, private credit, may be a source of capital. This is discussed below:
When thinking about a private alternative investment asset class, the first thing that springs to mind is private equity. But there’s one more asset class with the word private in its name that has recently gained much attention. We’re talking about private credit.
Indeed, this once little-known investment strategy is now growing rapidly in popularity, offering private investors worldwide an exciting opportunity to diversify their portfolio with, in theory, less risky investments that yield significant returns.
Private credit investments refer to investors lending money to companies who then repay the loan at a given interest rate within the predetermined period.
The private credit market has grown significantly over the past years, rising from $875 million in 2020 to $1.4 trillion at the beginning of 2023.
Please WATCH VIDEO BY GOLDMAN SACHS ON PRIVATE CREDIT
The New Molecule: How breakthrough technologies are actually changing pharma R&D
Join us for a look at how AI, machine learning and generative technologies are actually being applied inside drugmakers’ labs. We’ll explore how new technologies are being used, their implications, how they intersect with regulatory and IP issues and how this fast-changing field is likely to evolve.
Kailash Swarna
Managing Director & Global Life Sciences Clinical Development Lead
Accenture
Artificial Intelligence is making impact in a grand way on biology in three aspects:
Speeding up target validation: now we can get through 300 molecules a day
Predicition like AlphaFold is doing; molecular simulations
Document submission especially with regulatory and IND submissions
Pamela Carroll
COO
Isomorphic Labs formerly of AlphaFold
We were first with Novartis at last year JPM and was one year old but parnering with them in that initial year was very important for sealing the deal.
They are looking now at neurologic diseases like ALS. She wondered whether ALS is actually multiple diseases and we need to stratify patients like we do in oncology trials. Their main competion is the whole tech world like Amazon, Google and other Machine Learning companies so being a tech player in the biotech world means you are not just competing with other biotechs but large tech companies as well.
Jorge Conde
General Partner
Andreessen Horowitz
Need is still great for drug discovery; early adopters show AI tools can be used in big pharma. There are lots of applications of AI in managing care; a lot of back office applications including patient triaging. He does not see big AI mergers with pharma companies – this will be mainly partnerships not M&A deals
Alicyn Campbell
Chief Scientific Officer
Evinova, a Healthtech Subsidiary of the AstraZeneca Group
There is a need to turn AI for real world example. For example AI tools were used in clinical trials to determine patient cohorts with pneumonitis. At Evinova they are determining how AI can hel[p show clinical benefit with respect to efficacy and safety
Joshua Boger at #JPM24 (Brian Benton Photography)
January 12, 2024 09:06 AM ESTUpdated 10:00 AM PeopleStartups
Vertex founder Joshua Boger on surviving downturns, ‘painful’ partnerships, and the importance of culture: #JPM24
While the JP Morgan Healthcare Conference was full of voices of measured optimism, rooting for the market to bounce back in 2024, one longtime biotech leader warned against setting any firm expectations.
Instead of predicting when the downturn may end, Vertex Pharmaceuticals founder Joshua Boger said he advises biotech leaders to expect — and plan for — volatility. Speaking Tuesday on an Endpoints News panel alongside OrbiMed’s Carl Gordon and Appia Bio CEO JJ Kang, Boger shared lessons learned on surviving downturns, striking pharma deals, and the importance of keeping a company’s culture based on his two decades of founding and leading Vertex as CEO from 1989 to 2009. The 72-year-old is now serving as executive chairman of Alkeus Pharmaceuticals, a startup developing a rare disease drug.
“I never experienced a straight line up,” Boger said. “Everything had its cycles, and it was how you respond to the cycle, not by predicting when the end is going to be, but just by responding to the present situation.”
At Boger’s first appearance at the JP Morgan conference in 1991, he said the conference’s theme was the end of biotech financing. Just a few months later, Regeneron successfully went public, rapidly changing the outlook for the whole field.
“We had no idea we were ever going to take public money,” he said. “When Regeneron did their IPO, we went, ‘Whoa, there’s something happening here,’ and we pivoted quickly.”
Vertex went public later that year. Throughout his 20-year tenure, Boger said no pharma company ever made an acquisition offer for Vertex, which now commands a market value of $110 billion and recently won the first FDA approval for a CRISPR gene editing therapy.
“We had an uber corporate policy to always make ourselves more expensive than anyone would stomach,” Boger said.
However, Vertex did strike a range of partnerships with Big Pharmas, which Boger described as a painful but necessary part of running a biotech startup.
“It’s impossible for a partnership not to slow you down,” he said. “You can and should try as hard as you can not to do that, but just count on it. They’ll slow you down.”
Boger said startups should insist on being equal partners in pharma deals, at least making sure they have a seat at a partner’s development meetings.
“Realize they’re going to be painful, it’s going to be horrible, and you need to do it,” Boger said.
While Vertex suffered through layoffs, stock price plunges, and trial failures, Boger credited a focus on culture as key to its long-term success.
“It’s the most important ingredient for a successful company,” he said. “Technology is acquirable. Culture is not acquirable. There are 10 companies that will fail because of culture for every one that succeeds, and the successful companies in retrospect will almost always have special cultural aspects that kept them through those downtimes.”
JPM24 opens with ADCs the hottest ticket in San Francisco
The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.
And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.
J.P. Morgan’s annual 2023 Biopharma Licensing and Venture Report arrived on the eve of the firm’s famous conference, which is set to welcome thousands of attendees in San Francisco today—East Coast weather permitting.
2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.
Follow the Fierce team’s coverage of the 2024 J.P. Morgan Healthcare Conference here.
Biopharma licensing partnerships accounted for $63 billion in total value during the fourth quarter from 108 deals. Just one deal—Merck’s ADC partnership with Daiichi Sankyo—accounted for $22 billion of that. Another huge one was another ADC bet, with Bristol Myers Squibb signing on to work with SystImmune for a total value of $8.4 billion. If you exclude the Merck deal, the total value of these partnerships is still higher than the previous quarter, which ended with $32.1 billion.
The total number of licensing deals compares to 149 in the same quarter a year earlier, 195 for Q4 2021 and 223 for Q4 2022.
As for venture investments, the year closed out with $17 billion total across 250 rounds, thanks to $3.5 billion earned through 79 rounds in the last quarter. Aiolos Bio snagged the title of largest venture round of the quarter with $245 million, which also proved to be the largest series A, too.
There was just one IPO in all of the fourth quarter—Cargo Therapeutics making the plunge for $300 million—and 13 overall for the year. It’s a far cry from the heyday of 2021 and experts are still unsure what 2024 will hold. J.P. Morgan reported $2.5 billion raised from 12 completed biopharma IPOs for the year on Nasdaq and NYSE. Nine out of the 12 companies had clinical programs when they took the leap to the public markets. As of December 13, five of the companies were trading above their IPO price.
As for M&A, December saw a rush of Big Pharmas snapping up companies around Christmas. J.P. Morgan tallied the fourth quarter at $37.6 billion and $128.8 billion across 112 total acquisitions for all of 2023.
AbbVie was the top buyer of the quarter with the two largest acquisitions thanks to the $10 billion outlay for ImmunoGen and $8.7 billion buy of Cerevel Therapeutics.
All of this adds up to 270 total deals in the fourth quarter total, which is lower than the third quarter which exceeded 300.
J.P. Morgan sees some big potential for smaller biopharmas looking for licensing partners, as Big Pharmas have been handing out larger upfront payments for the deals they really want.
Cancer was once again the most in-demand therapeutic areas, reaching a new height of $86.1 billion in 2023. Followed by $21.1 billion for neurological disorders.
For More Articles on Real Time Conference Coverage in this Open Access Scientific Journal see:
Eight Subcellular Pathologies driving Chronic Metabolic Diseases – Methods for Mapping Bioelectronic Adjustable Measurements as potential new Therapeutics: Impact on Pharmaceuticals in Use
In this curation we wish to present two breaking through goals:
Goal 1:
Exposition of a new direction of research leading to a more comprehensive understanding of Metabolic Dysfunctional Diseases that are implicated in effecting the emergence of the two leading causes of human mortality in the World in 2023: (a) Cardiovascular Diseases, and (b) Cancer
Goal 2:
Development of Methods for Mapping Bioelectronic Adjustable Measurements as potential new Therapeutics for these eight subcellular causes of chronic metabolic diseases. It is anticipated that it will have a potential impact on the future of Pharmaceuticals to be used, a change from the present time current treatment protocols for Metabolic Dysfunctional Diseases.
According to Dr. Robert Lustig, M.D, an American pediatric endocrinologist. He is Professor emeritus of Pediatrics in the Division of Endocrinology at the University of California, San Francisco, where he specialized in neuroendocrinology and childhood obesity, there are eight subcellular pathologies that drive chronic metabolic diseases.
These eight subcellular pathologies can’t be measured at present time.
In this curation we will attempt to explore methods of measurement for each of these eight pathologies by harnessing the promise of the emerging field known as Bioelectronics.
Unmeasurable eight subcellular pathologies that drive chronic metabolic diseases
Glycation
Oxidative Stress
Mitochondrial dysfunction [beta-oxidation Ac CoA malonyl fatty acid]
Insulin resistance/sensitive [more important than BMI], known as a driver to cancer development
Membrane instability
Inflammation in the gut [mucin layer and tight junctions]
Epigenetics/Methylation
Autophagy [AMPKbeta1 improvement in health span]
Diseases that are not Diseases: no drugs for them, only diet modification will help
Image source
Robert Lustig, M.D. on the Subcellular Processes That Belie Chronic Disease
These eight Subcellular Pathologies driving Chronic Metabolic Diseases are becoming our focus for exploration of the promise of Bioelectronics for two pursuits:
Will Bioelectronics be deemed helpful in measurement of each of the eight pathological processes that underlie and that drive the chronic metabolic syndrome(s) and disease(s)?
IF we will be able to suggest new measurements to currently unmeasurable health harming processes THEN we will attempt to conceptualize new therapeutic targets and new modalities for therapeutics delivery – WE ARE HOPEFUL
In the Bioelecronics domain we are inspired by the work of the following three research sources:
Michael Levin is an American developmental and synthetic biologist at Tufts University, where he is the Vannevar Bush Distinguished Professor. Levin is a director of the Allen Discovery Center at Tufts University and Tufts Center for Regenerative and Developmental Biology. Wikipedia
THE VOICE of Dr. Justin D. Pearlman, MD, PhD, FACC
PENDING
THE VOICE of Stephen J. Williams, PhD
Ten TakeAway Points of Dr. Lustig’s talk on role of diet on the incidence of Type II Diabetes
25% of US children have fatty liver
Type II diabetes can be manifested from fatty live with 151 million people worldwide affected moving up to 568 million in 7 years
A common myth is diabetes due to overweight condition driving the metabolic disease
There is a trend of ‘lean’ diabetes or diabetes in lean people, therefore body mass index not a reliable biomarker for risk for diabetes
Thirty percent of ‘obese’ people just have high subcutaneous fat. the visceral fat is more problematic
there are people who are ‘fat’ but insulin sensitive while have growth hormone receptor defects. Points to other issues related to metabolic state other than insulin and potentially the insulin like growth factors
At any BMI some patients are insulin sensitive while some resistant
Visceral fat accumulation may be more due to chronic stress condition
Fructose can decrease liver mitochondrial function
A methionine and choline deficient diet can lead to rapid NASH development
Acinetobacter baumannii bacteria that are resistant to important antibiotics called carbapenems. Acinetobacter baumannii are highly-drug resistant bacteria that can cause a range of infections for hospitalized patients, including pneumonia, wound, or blood infections.
Pseudomonas aeruginosa, which are resistant to carbapenems. Pseudomonas aeruginosa can cause skin rashes and ear infectious in healthy people but also severe blood infections and pneumonia when contracted by sick people in the hospital.
Enterobacteriaceae — a family of bacteria that live in the human gut — that are resistant to both carbepenems and another class of antibiotics, cephalosporins.
It has been designated critical need for development of antibiotics to these pathogens. Now researchers at Mcmaster University and others in the US had used artificial intelligence (AI) to screen libraries of over 7,000 chemicals to find a drug that could be repurposed to kill off the pathogen.
Liu et. Al. (1) published their results of an AI screen to narrow down potential chemicals that could work against Acinetobacter baumanii in Nature Chemical Biology recently.
Abstract
Acinetobacter baumannii is a nosocomial Gram-negative pathogen that often displays multidrug resistance. Discovering new antibiotics against A. baumannii has proven challenging through conventional screening approaches. Fortunately, machine learning methods allow for the rapid exploration of chemical space, increasing the probability of discovering new antibacterial molecules. Here we screened ~7,500 molecules for those that inhibited the growth of A. baumannii in vitro. We trained a neural network with this growth inhibition dataset and performed in silico predictions for structurally new molecules with activity against A. baumannii. Through this approach, we discovered abaucin, an antibacterial compound with narrow-spectrum activity against A. baumannii. Further investigations revealed that abaucin perturbs lipoprotein trafficking through a mechanism involving LolE. Moreover, abaucin could control an A. baumannii infection in a mouse wound model. This work highlights the utility of machine learning in antibiotic discovery and describes a promising lead with targeted activity against a challenging Gram-negative pathogen.
Schematic workflow for incorporation of AI for antibiotic drug discovery for A. baumannii from 1. Liu, G., Catacutan, D.B., Rathod, K. et al. Deep learning-guided discovery of an antibiotic targeting Acinetobacter baumannii. Nat Chem Biol (2023). https://doi.org/10.1038/s41589-023-01349-8
Antibiotics kill bacteria. However, there has been a lack of new drugs for decades and bacteria are becoming harder to treat, as they evolve resistance to the ones we have.
More than a million people a year are estimated to die from infections that resist treatment with antibiotics.The researchers focused on one of the most problematic species of bacteria – Acinetobacter baumannii, which can infect wounds and cause pneumonia.
You may not have heard of it, but it is one of the three superbugs the World Health Organization has identified as a “critical” threat.
It is often able to shrug off multiple antibiotics and is a problem in hospitals and care homes, where it can survive on surfaces and medical equipment.
Dr Jonathan Stokes, from McMaster University, describes the bug as “public enemy number one” as it’s “really common” to find cases where it is “resistant to nearly every antibiotic”.
Artificial intelligence
To find a new antibiotic, the researchers first had to train the AI. They took thousands of drugs where the precise chemical structure was known, and manually tested them on Acinetobacter baumannii to see which could slow it down or kill it.
This information was fed into the AI so it could learn the chemical features of drugs that could attack the problematic bacterium.
The AI was then unleashed on a list of 6,680 compounds whose effectiveness was unknown. The results – published in Nature Chemical Biology – showed it took the AI an hour and a half to produce a shortlist.
The researchers tested 240 in the laboratory, and found nine potential antibiotics. One of them was the incredibly potent antibiotic abaucin.
Laboratory experiments showed it could treat infected wounds in mice and was able to kill A. baumannii samples from patients.
However, Dr Stokes told me: “This is when the work starts.”
The next step is to perfect the drug in the laboratory and then perform clinical trials. He expects the first AI antibiotics could take until 2030 until they are available to be prescribed.
Curiously, this experimental antibiotic had no effect on other species of bacteria, and works only on A. baumannii.
Many antibiotics kill bacteria indiscriminately. The researchers believe the precision of abaucin will make it harder for drug-resistance to emerge, and could lead to fewer side-effects.
In principle, the AI could screen tens of millions of potential compounds – something that would be impractical to do manually.
“AI enhances the rate, and in a perfect world decreases the cost, with which we can discover these new classes of antibiotic that we desperately need,” Dr Stokes told me.
The researchers tested the principles of AI-aided antibiotic discovery in E. coli in 2020, but have now used that knowledge to focus on the big nasties. They plan to look at Staphylococcus aureus and Pseudomonas aeruginosa next.
“This finding further supports the premise that AI can significantly accelerate and expand our search for novel antibiotics,” said Prof James Collins, from the Massachusetts Institute of Technology.
He added: “I’m excited that this work shows that we can use AI to help combat problematic pathogens such as A. baumannii.”
Prof Dame Sally Davies, the former chief medical officer for England and government envoy on anti-microbial resistance, told Radio 4’s The World Tonight: “We’re onto a winner.”
She said the idea of using AI was “a big game-changer, I’m thrilled to see the work he (Dr Stokes) is doing, it will save lives”.
Other related articles and books published in this Online Scientific Journal include the following:
Series D: e-Books on BioMedicine – Metabolomics, Immunology, Infectious Diseases, Reproductive Genomic Endocrinology
The Vibrant Philly Biotech Scene: Recent Happenings & Deals
Curator: Stephen J. Williams, Ph.D.
UPDATED: 07/06/2026
This update is a review on the current biotech funding situation as of Q1 of 2026. The situation in Philadelphia biotech has turned a bit dire, as CRE that went on massive construction projects are finding vacancy rates up in certain neighborhoods and hubs in the Philadelphia area. Presented here are some of the observations from CRE, the investment community, and some recent issues in biotech buildouts that have reshaped the Philly landscape.
The following is a post form Technical.ly in Philadelphia on the issues in finding Venture Capital to stay and grow in the Philadelphia Area. As noted, the dearth of venture capitalist firms in the city or commited to the cities’ biotech initiative is a major reason for some of the recent setbacks to Philly Biotech.
Philly’s life sciences scene saw wins this year, but there’s still a big problem: Money
Partnerships with giants like Eli Lilly and Thermo Fisher Scientific put biotech in the spotlight again, though founders still struggle to find investments in their hometown.
HiveBio Accelerator 2025 cohort at its Investor Showcase (Courtesy HiveBio)
2025 pulled into focus the cracks in Philly’s life sciences ecosystem.
Philly has the talent, research institutions and collaboration to build a strong life sciences community. That’s helped the region build a reputation in the sector, but stakeholders say there’s not enough local funding to keep companies growing here.
With exciting partnerships started this year and more opportunities coming in 2026, capital is needed if Philadelphia wants the sector to reach its full potential.
“The fact that we’ve got excellent research capabilities and spin-off capabilities in Philadelphia speaks to the intellectual horsepower,” Ira Spector, CEO of SFA Therapeutics, told Technical.ly, “but Philadelphia does not have a very well-developed venture capital infrastructure.”
This year, Philly attracted major outside interest. Most recently, global pharmaceutical company Eli Lilly announced plans to open a new Lilly Gateway Labs in Center City, an incubator for early-stage biotech companies.
“Access to capital is a critical factor in moving forward, and that’s been a frustrating thing for us.”
New local resources sprouted, catering directly to startups’ VC needs. The HiveBio accelerator, which supports minority founders in the life sciences space, launched this year. After wrapping up its pilot this month, the program reported successful fundraising efforts for most of its cohort companies.
For life sciences — and the entire startup ecosystem — venture capital has also become harder to come by as the market fluctuated throughout 2025.
Developing a drug or therapy and bringing it to market is extremely expensive work. Oftentimes, investors don’t want to give money to companies that are still high risk, but it takes money to support development to derisk the product, Spector said.
“Philly is finally starting to step on the map,” Rakesh Shah, founder of Newtown-based medical device company DRS.LINQ, said. “We have so much talent in the biomedical engineering and med tech space. It’s just we need to harness that energy, bring it all together.”
A well-connected community, but few investors to maintain it
Founders are already looking for major investments outside of Philly, as it’s often their only option, according to Jean Cho, CEO of Trevarx Biomedical.
Jenkintown-based biotech company SFA Therapeutics is experiencing this firsthand. As it raises its next funding round, the majority of the money is coming from investors outside the region, CEO Spector said.
The company is tied to Philly because of its affiliation with Temple University and investments from Ben Franklin Technology Partners. It’s also integrated with Pennsylvania’s life sciences ecosystem, attending programming hosted by orgs like Life Sciences PA, although there aren’t usually a ton of investors at those events, Spector said.
The lack of local funding has caused Spector to consider what the company’s future would look like in other parts of the country. In Boston, for example, the VC ecosystem is very well developed, he said, and the company has raised money from investors there.
A bright spot: Millions raised by just one accelerator
Despite the lack of a strong local investor network, Philly isn’t alone in having a VC slowdown.
In general, the life sciences sector has been struggling this year, especially for early-stage companies. Since the IPO market for biotech companies has slowed down, investors aren’t making their money back and are focusing instead on existing later-stage firms.
But there are some programs in the city helping founders to secure much-needed investments.
The HiveBio accelerator exceeded its first-year goal, helping eight out of 10 companies raise a total of $3.6 million during the nine-month program, Tia Lyles-Williams, founder and CIO of HiveBio, told Technical.ly. Plus, a lot of that money came from local investors like Ben Franklin Technology Partners and Robin Hood Ventures, she said.
The key, she said, was giving founders as many opportunities as possible to have face time with investors.
“They had the opportunity, behind closed doors, with these mentors to be totally transparent about what they know, what they didn’t know, and what they needed,” she said. “These mentors and these experts in our local investment community delivered on that, they received it, implemented it, and that’s how these checks got written.”
“This is an industry that runs on capital,” Spector said. “It requires capital to prove that a drug or a therapeutic or a diagnostic or device works, and that means that access to capital is a critical factor in moving forward, and that’s been a frustrating thing for us.”
This story is made possible thanks to support from Ben Franklin Technology Partners of Southeastern Pennsylvania, a nonprofit that leads the Philadelphia region’s equitable economic growth by nurturing and investing in innovative, early-stage companies, and through purposeful involvement in regional and national initiatives. All stories are independently reported, with no partner review.
This is an analysis of the risk associated to bond tranches in the Philly Biotech niche
When looking at the riskiest secured bond tranches for the biotechnology sector in the Greater Philadelphia area, the risk is completely split between two totally different financial assets: commercial real estate debt backing empty lab spaces and corporate first-lien loans issued by struggling drug-development firms.
While “secured” bonds are theoretically lower risk because they are backed by physical or intellectual property collateral, specific sub-sectors in Philadelphia are facing unprecedented headwinds. [1, 2, 3, 4]
1. The Real Estate Angle: Speculative Lab Building Bonds
The absolute highest concentration of risk for secured debt sits with senior secured credit facilities, CMBS tranches, and construction bank bonds backing recently completed, unleased life sciences real estate. From 2019 to 2021, developers rushed to build or retrofit lab spaces, creating a massive oversupply just as venture capital funding slowed down. [1, 5, 6]
University City Speculative Developments: University City is the epicenter of Philly’s biotech boom, but the submarket currently faces a staggering 39.1% to 40% vacancy rate. Secured bonds or construction debt tranches tied directly to newly built, unleased towers in this zone (such as Brandywine’s mostly empty 3151 Market St. lab facility) are highly vulnerable. Without tenant cash flows to service the debt, these properties face imminent refinancing or modification risks. [1, 5, 7, 8, 9]
Suburban “Mega-Lab” Tranches: Out in the suburbs, massive suburban lab conversions are driving negative absorption. A prime example is the The Discover Labs in King of Prussia, where huge blocks of lab space became vacant. Tranches of commercial mortgage-backed securities (CMBS) or private credit heavily exposed to these massive suburban footprints carry elevated risk as local tenants shrink their physical boundaries. [10, 11]
2. The Corporate Angle: Asset-Backed Pre-Revenue Biotech Debt
For actual biotechnology companies (as opposed to their landlords), public bond issuance is rare. Instead, their secured debt takes the form of First-Lien Term Loans or Senior Secured Notes. [12]
Because biotech venture capital funding in Philadelphia dropped sharply—falling from $1.2 billion in 2021 to roughly $600 million—companies are facing a severe cash crunch. The riskiest secured corporate debt tranches share distinct characteristics: [13, 14, 15]
Maturity Term Loans: The riskiest tranches are senior secured facility loans facing upcoming refinancing walls. Lenders hold first-lien rights over the company’s patent portfolio, drug pipelines, and lab equipment. If a clinical trial fails, the “secured” collateral (intellectual property) loses almost all market value overnight. [16]
Sidecar & PIK (Payment-in-Kind) Tranches: To avoid outright defaults, distressed Philly biotechs are increasingly utilizing structured “sidecar facilities” or paying interest using more debt (PIK). These specific tranches are highly speculative because they delay the cash crunch rather than fixing the underlying capital structure. [8, 17]
Summary of Risk Profile
Tranche Type [1, 5, 10, 11, 13, 18, 19]
Location/Focus
Current Risk Driver
Collateral Value
University City Lab CMBS/Construction Bonds
Downtown Hub
~40% vacancy; tenants pivoting back to office use.
High (Prime real estate).
Suburban Life Science Mortgages
King of Prussia
Heavy negative absorption and tenant consolidation.
Medium (Harder to repurpose).
First-Lien Corporate Biotech Loans
Regional Startups
50% drop in local VC funding over recent years.
Low/Binary (Dependent on FDA approval).
Are you looking to evaluate specific real estate debt instruments (like CMBS or commercial mortgages) tied to Philly’s University City developments, or are you assessing the corporate high-yield loan market for localized clinical-stage drug developers? Let me know how you would like to filter the data. [5, 19, 20]
It has been surprising how fast the landscape in Philadelphia has changed. A few years ago, Philadelphia was being touted as “Cellicon Valley” due to the development of the CAR-T therapies and immuno and cell based therapy startups being spun-out from local universities. I have posted on this tranformation on this journal HERE.
In fact a huge campus in the Philadelphia suburbs including the Discovery Labs site (a former GSK site) was being buildout to be a major cGMP biomanufacturing facility which would handle University of Pennsylvania’s cell and gene therapy manufacturing needs as well as a contract manufacturing facility for pharma and biotech for cell and gene therapies.
A summary of the issues and refinancing problems of Discovery Labs can be seen below:
Current site issues and problems at the former pharmaceutical property include:
Contractor Payment Delays: The site, owned by MLP Ventures (CEO Brian O’Neill), was hit with roughly $100 million in mechanics’ liens for unpaid contracting work. [1]
Legal Battles with Key Tenants: In late 2025, MLP Ventures filed a civil lawsuit against its largest tenant, the Center for Breakthrough Medicines (CBM), and its majority stakeholder, South Korea’s SK Inc.. This involved a landlord/tenant dispute seeking more than $50,000 in damages. [1]
Massive Data Center Pivot & Protests: To offset debts, MLP Ventures proposed a sprawling 4.6 million-square-foot data center project across the Swedeland and Conshohocken areas. This has triggered massive pushback from local Upper Merion Township residents, who have cited heavy concerns over noise, pollution, and health risks. [1]
Financial Restructuring: The owner has sought extensive refinancing to manage the site’s debts and attempt to compensate the unpaid contractors, though progress has been slow. [1, 2]
Original Article
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
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.
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.
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.
Jodie Harris is a Philadelphia native who has spent the last 15 years in the U.S. Department of Treasury.
By Ryan Mulligan – 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.
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.
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.
A rendering shows part of the Quartermaster Science + Technology Park as a redeveloped mixed-use life science campus.
QUARTERMASTER / PROVIDED BY FIFTEEN
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.
SkyREM announced the redevelopment of the Quartermaster campus in South Philadelphia into a life sciences campus with restaurants and a hotel. This rendering looks across Oregon Avenue toward the southwest corner of Oregon and 21st Street.
QUARTERMASTER / PROVIDED BY FIFTEEN
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.
A rendering shows part of the future Quartermaster Science and Technology Park in South Philadelphia. The 24-acre campus is planned to have six buildings with 1 million square feet of life science space.
QUARTERMASTER / PROVIDED BY FIFTEEN
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 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.
Bacterial multidrug resistance problem solved by a broad-spectrum synthetic antibiotic
Reporter and Curator: Dr. Sudipta Saha, Ph.D.
There is an increasing demand for new antibiotics that effectively treat patients with refractory bacteremia, do not evoke bacterial resistance, and can be readily modified to address current and anticipated patient needs. Recently scientists described a promising compound of COE (conjugated oligo electrolytes) family, COE2-2hexyl, that exhibited broad-spectrum antibacterial activity. COE2-2hexyl effectively-treated mice infected with bacteria derived from sepsis patients with refractory bacteremia, including a CRE K. pneumoniae strain resistant to nearly all clinical antibiotics tested. Notably, this lead compound did not evoke drug resistance in several pathogens tested. COE2-2hexyl has specific effects on multiple membrane-associated functions (e.g., septation, motility, ATP synthesis, respiration, membrane permeability to small molecules) that may act together to abrogate bacterial cell viability and the evolution of drug-resistance. Impeding these bacterial properties may occur through alteration of vital protein–protein or protein-lipid membrane interfaces – a mechanism of action distinct from many membrane disrupting antimicrobials or detergents that destabilize membranes to induce bacterial cell lysis. The diversity and ease of COE design and chemical synthesis have the potential to establish a new standard for drug design and personalized antibiotic treatment.
Recent studies have shown that small molecules can preferentially target bacterial membranes due to significant differences in lipid composition, presence of a cell wall, and the absence of cholesterol. The inner membranes of Gram-negative bacteria are generally more negatively charged at their surface because they contain more anionic lipids such as cardiolipin and phosphatidylglycerol within their outer leaflet compared to mammalian membranes. In contrast, membranes of mammalian cells are largely composed of more-neutral phospholipids, sphingomyelins, as well as cholesterol, which affords membrane rigidity and ability to withstand mechanical stresses; and may stabilize the membrane against structural damage to membrane-disrupting agents such as COEs. Consistent with these studies, COE2-2hexyl was well tolerated in mice, suggesting that COEs are not intrinsically toxic in vivo, which is often a primary concern with membrane-targeting antibiotics. The COE refinement workflow potentially accelerates lead compound optimization by more rapid screening of novel compounds for the iterative directed-design process. It also reduces the time and cost of subsequent biophysical characterization, medicinal chemistry and bioassays, ultimately facilitating the discovery of novel compounds with improved pharmacological properties.
Additionally, COEs provide an approach to gain new insights into microbial physiology, including membrane structure/function and mechanism of drug action/resistance, while also generating a suite of tools that enable the modulation of bacterial and mammalian membranes for scientific or manufacturing uses. Notably, further COE safety and efficacy studies are required to be conducted on a larger scale to ensure adequate understanding of the clinical benefits and risks to assure clinical efficacy and toxicity before COEs can be added to the therapeutic armamentarium. Despite these limitations, the ease of molecular design, synthesis and modular nature of COEs offer many advantages over conventional antimicrobials, making synthesis simple, scalable and affordable. It enables the construction of a spectrum of compounds with the potential for development as a new versatile therapy for the emergence and rapid global spread of pathogens that are resistant to all, or nearly all, existing antimicrobial medicines.
2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products
Reporter: Aviva Lev-Ari, PhD, RN
SOURCE
Tal Bahar’s post on LinkedIn on 1/17/2023
Novel Drug Approvals for 2022
FDA’s Center for Drug Evaluation and Research (CDER)
New Molecular Entities (“NMEs”)
Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022.
Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations Press Release
To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.
Biologics License Applications and Supplements
New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded indications, new routes of administration, new dosage formulations and improved safety).
Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER)
Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.
There are five FDA-approved CAR-T treatments for blood cancers and two gene therapies to treat rare diseases now on the market in the U.S. The late-stage pipeline could produce several more cancer CAR-Ts and gene therapies to treat a range of diseases.
One of the biggest races to watch in the cell therapy space will be that between Gilead Sciences’ Yescarta and Bristol Myers Squibb’s Breyanzi, both of which are gunning to move their CAR-Ts into earlier lines of treatment in large B-cell lymphoma (LBCL). At ASH, both companies rolled out impressive data from their trials in the second-line setting, but Gilead could have the upper hand by virtue of its three-year head start in the market, analysts said. Gilead expects to hear from the FDA on a label expansion in the second-line setting in April.
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A pioneer in computational chemistry and organosilicon compounds, Prof. Apeloig made groundbreaking scientific contributions while mentoring generations of researchers and helping position the Technion as a global leader in science and technology.
During his presidency, he expanded interdisciplinary research, strengthened international partnerships, increased investment in research infrastructure and scholarships, and advanced collaboration between engineering, medicine, and the humanities.“Prof. Apeloig led the Technion with quiet confidence and steadfast leadership,” said Technion President Prof. Uri Sivan. “His years in office were marked by exceptional academic development and a profound impact on the State of Israel and beyond.”
The Technion was his home and family. He will be deeply missed. May his memory be a blessing.