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Reporter: Gail S. Thornton, M.A.

LPBI Update

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Newsletter #1 – February 2020

Welcome to the premier issue of LPBI Group News, where readers can find relevant news and updates about science, business and medical innovation. This newsletter is distributed as a service for our readers.

The Conference Forum Highlights Immuno-Oncology 360° in New York

The Conference Forum is hosting Immuno-Oncology 360°, which reports on current data and developments of immuno-oncology in the science and business communities. The summit takes place on February 26-28 at the Crowne Plaza Times Square in New York.

Please visit www.io360summit.com to register and use code LPBI20 for a 20% discount. 

Ahead of the conference, Immuno-Oncology 360° has created a series celebrating their women speakers in the work they are doing to fight cancer. To read the series, visit: https://theconferenceforum.org/conferences/immuno-oncology-360/io360%cb%9a-leadership-interviews/

This information is published in conjunction with the Immuno-Oncology 360° Summit.

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Venture Summit Attracts Top Innovators in Silicon Valley

Leaders in Pharmaceutical Business Intelligence (LPBI) Group is one of the sponsors of Venture Summit | West, “Where Innovation Meets Capital.”

The meeting will be held on March 23-24 at the Santa Clara Convention Center, Silicon Valley.

 

Special offer:  Register Now & Save $450 off (Use discount code “LPBI-VIP”)

For more information, please visit: https://pharmaceuticalintelligence.com/2019/12/17/venture-summit-west-where-innovation-meets-capital-march-23rd-24th-2020-santa-clara-convention-center-silicon-valley/

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e-Proceedings of 15th Annual Personalized Medicine Conference at Harvard Medical School

The 15th Annual Personalized Medicine Conference at Harvard Medical School, Boston last year [November 13-14, 2019], entitled  The Paradigm Evolves, explored the science, business and policy issues facing personalized medicine. In today’s world, scientists need to understand how molecular diagnostics augmented by artificial intelligence, data analytics and digital health empowers physicians and patients in their health care decisions.

Please visit for LPBI Group coverage of the meeting, including social media activities at the conference:

https://pharmaceuticalintelligence.com/2019/07/19/15th-annual-personalized-medicine-conference-at-harvard-medical-school-the-paradigm-evolves-november-13-14-2019-%e2%80%a2-harvard-medical-school-boston-ma/

https://pharmaceuticalintelligence.com/2019/11/15/tweets-and-retweets-by-aviva1950-and-by-pharma_bi-for-15th-annual-personalized-medicine-conference-at-harvard-medical-school-the-paradigm-evolves-november-13-14-2019-%e2%80%a2/

  •   3D Medical BioPrinting Technology Featured in Podcast

LPBI Group leaders, Aviva Lev-Ari, Ph.D., R.N., Stephen Williams, Ph.D., and Irina Robu, Ph.D., spoke with Partners in Health and Biz, a half-hour audio podcast that reaches 40,000 listeners, about the topic of 3D Medical BioPrinting Technology: A Revolution in Medicine.

Please click on this link to hear the podcast. https://www.youtube.com/watch?v=laozyrfi29c.

The topic is also the title of a recently offered e-book by the LPBI Group on 3D BioPrinting, available on Amazon/Kindle Direct [https://www.amazon.com/Medical-BioPrinting-Technologies-Patient-centered-Patient-Centered-ebook/dp/B078QVDV2W]. 

The 3D BioPrinting technology is being used to develop advanced medical practices that will help with previously difficult processes, such as delivering drugs via micro-robots, targeting specific cancer cells and even assisting in difficult eye operations.

The table of contents in this book includes: Chapter 1: 3D Bioprinting: Latest Innovations in a Forty year-old Technology. Chapter 2: LPBI Initiative on 3D BioPrinting, Chapter 3: Cardiovascular BioPrinting, Chapter 4: Medical and Surgical Repairs – Advances in R&D Research, Chapter 5: Organ on a Chip, Chapter 6: FDA Regulatory Technology Issues, Chapter 7: DNA Origami, Chapter 8: Aptamers and 3D Scaffold Binding, Chapter 9: Advances and Future Prospects, Chapter 10: BioInks and MEMS, Chapter 11: BioMedical MEMS, Chapter 12: 3D Solid Organ Printing and Chapter 13: Medical 3D Printing: Sources and Trade Groups – List of Secondary Material. 

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New e-Book: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology

LPBI Group’s latest e-book entitled, Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology, offers the reader content curation with embedded videos and audio podcasts, real-time conference e-Proceedings by LPBI’s scientists and professors and archived tweets of quotes from speakers at leading biotechnology conferences.

Please click on this link on Amazon/Kindle Direct: https://www.amazon.com/dp/B08385KF87

 

The book integrates in a single volume four distinct perspectives: basic science, technologies and methodologies, clinical aspects and business and legal aspects of genomics research. “The materials in this book represents the scientific frontier in Biological Sciences and Medicine related to the genomics aspects of disease onset,” said Aviva Lev-Ari, Ph.D., R.N., and founder of LPBI Group.

The book addresses:

  • aspects of life: the Cell, the Organ, the Human Body and Human Populations;
  • methodologies of genomic data analysis: Next Generation Sequencing, Gene Editing, AI, Single Cell Genomics, Evolution Biology Genomics, Simulation Modeling in Genomics, Genotypes and Phenotypes Modeling, measurement of Epigenomics effects on disease, and developments in Pharmaco-Genomics.

Additionally, artificial Intelligence in medicine is covered in Part 3 of the e-Book, which represents the frontier in this emerging field, with topics, such as the science, technologies and methodologies, clinical aspects, business and legal implications as well as the latest machine learning algorithms harnessed for medical diagnosis.

This e-book is significant because it:

  • contains 326 articles on topics, such as gene editing, bioinformatics and genome ontology;
  • incorporates 74 e-Proceedings created in real time by the Book’s authors and editors
  • includes four collections of Tweets representing quotes from speakers at global leading conferences on Genomics
  • has 13 locations of Videos and Audio Podcasts that serve to enrich the e-Reader’s experience.

We welcome your comments and suggestions. Please send them to Aviva Lev-Ari at avivalev-ari@alum.berkeley.edu.

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Real Time Coverage @BIOConvention #BIO2019: Dealmakers’ Intentions: 2019 Market Outlook June 5 Philadelphia PA

Reporter: Stephen J Williams, PhD @StephenJWillia2

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

 

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A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding

Reported from source: http://funginstitute.berkeley.edu/directors-blog/message-faculty-director-lee-fleming-latest-issue-crowdfunding/

I would like to announce our special issue in the California Management Review on CrowdFunding (thank you to Olav Sorenson for co-editing and the Kauffman Foundation for support).  We have a broad and practical set of articles that should appeal to practitioners and academics alike (please see this linkfor the special issue introduction by Olav and myself).

The landscape of CF can be quite confusing; Peter Younkin and Keyvan Kashkooli give us a mapping of the landscape by asking a simple question, namely, what problems does CF solve?  Gary Dushnitsky and his co-authors provide a rich description of CF in Europe; they identify the surprising strength of national boundaries.  Ethan Mollick and Alicia Robb provide us an easily understood synopsis of their research on the importance of CF for under-served entrepreneurs.  Carina Thurridl and Bernadette Kamleitner help aspiring entrepreneurs understand how to bundle the optimal set of rewards to attract backers.  Ajay Agrawal and co-authors describe a recent trend in CF, namely, the emergence of lead investors and syndicates.  Finally, Valentina Assenova and Olav lead a round table discussion of industry leaders, including Jason Best, Mike Cagney, Douglas Ellenoff, Kate Karas, Jay Moon, Sherwood Neiss, and Ron Suber.  Happy reading!

Here is a short video based on our article:

 

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Bad News this Week for Biotech Deals?

 

Curator: Stephen J. Williams, Ph.D

 

Last week in biotech ( 3/7-3/11/2016) had a plethora of disappointing stories related to biotech drug development and hits to biotech investing and VC.  Since October of 2016 the biotech index has lost 35% to today (see Biotech ETFs Hit 52-Week Lows: Time to Buy?) however were the hit back in October a signal of some of the listed events below (as shown on Biospace News) and includes:

  •  an long-time biotech startup with failure of mesothelioma trial who has struggled in the past
  • multiple clinical trial failures forces the de-listing of a NASDAQ company (other biotechs this year had similar problems)
  • more problems with drug development for Duchenne’s Muscular Dystrophy

GlaxoSmithKline dumps Five Prime’s cancer drug in the midst of Phase I

March 11, 2016 | By Damian Garde

GSK gave Five Prime a 180-day notice that it’s nixing its license to the company’s FP-1039, which is designed to block the spread of cancer by interrupting protein signaling. The decision follows GSK’s January move to stop developing FP-1039 in squamous non-small cell lung cancer due to the rise of immuno-oncology therapies from Merck ($MRK), Bristol-Myers Squibb ($BMY) and others, citing a “change in treatment paradigms.”GlaxoSmithKline ($GSK) is cutting ties with Five Prime Therapeutics’ ($FPRX) in-development cancer therapy, backing out in the middle of a mesothelioma trial.

Now GSK is set to abandon a drug it inherited through its $3 billion acquisition of Human Genome Sciences in 2012, leaving Five Prime to go it alone in an ongoing Phase Ib study testing FP-1039 against mesothelioma. Five Prime said it plans to work with GSK to complete enrollment in the study, adding that it “continues to be encouraged” by the drug’s potential in mesothelioma.

Embattled Bay Area XOMA  (XOMA) Terminates Gevokizumab Trials, Slashes Headcount by 50%

3/11/2016 6:39:17 AM

March 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BERKELY, Calif. – Troubled XOMA Corp. (XOMA) is terminating half of its workforce after a late-stage failure of its experimental drug gevokizumab for treatment of pyoderma gangrenosum, the San Francisco Business Times reported this morning.

Following the announcement, Xoma’s stock is down this morning about 5 percent, trading at 91 cents per share as of this writing.

Xoma said it is interested in divesting itself of gevokizumab. In a statement, the company said several companies have approached Xoma about acquiring the drug. Gevokizumab binds to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine. Xoma said it will make all information about the drug and study information available to potential buyers. Gevokizumab has had a troubled history with Xoma. The company has halted several trials with the drug for various diseases, including diabetes and a blinding eye disease, the Times reported. In 2014, Xoma was forced to stop testing gevokizumab as an arthritis treatment after the drug did not show significant benefit against placebo after a six-month period.

Struggling Eleven Biotherapeutics (EBIO) Gets Delisting Notice from Nasdaq After Back-to-Back Clinical Trial Failures

3/10/2016 6:07:38 AM

March 10, 2016
By Mark Terry, BioSpace.com Breaking News Staff

With one piece of bad news after another, Cambridge, Mass.-based Eleven Biotherapeutics Inc. (EBIO) filed a Form 8-Kwith the U.S. Securities and Exchange Commission, addressed a delisting notification it received from the Nasdaq on Mar. 3.

The Nasdaq informed the company that its stock dropped below $1 a share, and that the stockholder equity didn’t comply with the $5,000,000 minimum stockholders’ equity requirement. As a result, it has 180 days to comply with Nasdaq rules.

On Jan. 10, the company announced that its Phase III clinical trial of EBI-005 (isunakinra) for severe allergic conjunctivitis did not meet its primary endpoint.

In May 2015, the company reported that its drug, EBI-005, for moderate to severe dry eye disease, failed to prevent damage to the cornea or reduce eye pain in comparison to the control group.

In a January statement, Abbie Celniker, president and chief executive officer of Eleven Biotherapeutics, said, “We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis. Our efforts will be focused on submitting an investigational new drug application (IND) for EBI-031 in diabetic macular edema in the first half of 2016.”

EBI-031 was designed for intravitreal delivery using the company’s AMP-Rx platform. The drug blocks both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). The compound is being developed to treat diabetic macular edema (DME) and uveitis.

DMD Setback Prompts Sarepta (SRPT) to Shutter West Coast Location and Consolidate to Massachusetts, 30 Jobs Gone

3/9/2016 6:13:13 AM

March 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Cambridge, Mass.-based Sarepta Therapeutics (SRPTannounced yesterday that it was shuttering its research-and-development manufacturing facility in Corvalis, Ore. Most of the employees there are expected to move to Sarepta’s facilities in Andover and Cambridge, Mass. About 30 people are expected to be laid off.

On Jan. 21, Sarepta announced that, with an impending snowstorm on the east coast, the U.S. Food and Drug Administration (FDA)’s meeting to review the company’s New Drug Application (NDA) for eteplirsen to treat Duchenne Muscular Dystrophy (DMD) was postponed.

DMD is a muscle wasting disease caused by mutations in the dystrophin gene. The disease is progressive and generally causes death in early adulthood. Complications include serious heart or respiratory-related problems. It mostly affects boys, about 1 in every 3,500 to 5,000 male children.

On Jan. 15, an FDA advisory committee decided to reschedule the meeting, at which point a recommendation or approval decision will be made. That meeting of the Peripheral and Central Nervous System Advisory Committee has not been rescheduled yet, but Sarepta believes it will be prior to May 26, which is the PDUFA date. The Prescription Drug User Fee Act (PDUFA) is a law that allows the FDA to collect an application fee from drug companies when an NDA or Biologics License Application (BLA) is submitted.

The DMD drug arena has been fraught with failures and bad news this year. San Rafael, Calif.-based BioMarin Pharmaceutical Inc. (BMRN)’s application for its DMD drug Kyndrisa (drisapersen) was turned down by the FDA on Jan. 15. The FDA argued that Kyndrisa didn’t show enough benefit.

On Jan. 25, Cambridge, Mass.-based Akashi Therapeuticsannounced that it had halted its DMD trial for HT-100 after one of its patients developed serious, life-threatening health problems. In that DMD is a serious, life-threatening health problem in itself, it’s not clear if the patient’s problems are directly related to the drug. The patient was receiving the highest dose in the HALO trial, while others in the trial with lower doses were not showing adverse side effects.

 

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GSK Partners With SG3 Ventures to Add $100 Million to the Pittsburgh Biotech Scene

From Biospace News: Backed by GlaxoSmithKline (GSK), New VC Firm SG3 Ventures Has $100 Million to Bet on Pittsburg Startups

Reporter: Stephen J. Williams, Ph.D.

Source: http://www.biospace.com/News/backed-by-glaxosmithkline-new-vc-firm-sg3-ventures/412039/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

 

Pittsburgh-area entrepreneurs will soon have another funding option for growing early phase startup companies.

Pharmaceutical giant GlaxoSmithKline has thrown its support behind the creation of a $100 million venture capital fund, which will help meet a need for early stage business startup capital in the Pittsburgh area. Philadelphia-based SG3 Ventures anticipates awarding its first round of funding in about a year, according to Brian McVeigh, vice president of worldwide business development transactions and investment management at GSK.

From Pittsburgh Post Gazette: http://www.post-gazette.com/business/healthcare-business/2016/03/11/New-early-stage-venture-fund-forming-with-eye-on-Pittsburgh-startups/stories/201603090016

New early-stage venture fund forming with eye on Pittsburgh startups

Pittsburgh-area entrepreneurs will soon have another funding option for growing early phase startup companies.

Pharmaceutical giant GlaxoSmithKline has thrown its support behind the creation of a $100 million venture capital fund, which will help meet a need for early stage business startup capital in the Pittsburgh area. Philadelphia-based SG3 Ventures anticipates awarding its first round of funding in about a year, according to Brian McVeigh, vice president of worldwide business development transactions and investment management at GSK.

“There is a huge untapped opportunity,” Mr. McVeigh said. “Let’s bring the money here.”

New prescription drug treatments will be a priority for fund investments, but a balanced portfolio including life science technologies is planned.

In the venture ecosystem, insurers, pension funds and other institutions use such funds to invest in promising startup companies — both to balance their portfolios and to get a shot at investment returns that would not otherwise be possible. The venture funds oversee allotting capital to a portfolio of startup companies.

The investment money enables startups to mature and eventually bring in other investors through a public offering or acquisition by a larger company, generating money to repay the initial investors.

GSK and other big pharmaceutical companies are making similar investments to maximize returns and keep their product pipelines full, but GSK has been focusing on earlier stage companies, shifting its focus to pre-clinical technologies about five years ago, Mr. McVeigh said.

In addition, Big Pharma is increasingly relying on outsourced research and development operations, often in collaboration with universities, to fill industry product pipelines. GSK has funded a number of these initiatives, including a cancer collaboration with the University of California, San Diego School of Medicine and Moores Cancer Center.

SG3 Managing Director Keith Marmer said the new venture fund will be committed to technologies developed outside the better known tech hubs of Silicon Valley and Boston-Cambridge.

“We’re here, we’re from here, and we want to be here,” he told a group of entrepreneurs at a recent breakfast meeting in Oakland. “Sustaining technology through research funding isn’t happening anywhere.”

Parsippany N.J.-based GSK closed its consumer health care operations in Moon in 2015, eliminating 274 jobs a year after the company’s merger with Swiss vaccine maker Novartis. Mr. McVeigh works at the company’s offices in King of Prussia, Pa.

With federal research dollars flat in recent years, universities nationwide have been turning to commercialization of intellectual property as a new source of revenue.

At the same time, Pittsburgh’s startup community is showing signs of new life.

Among the signs: Patrick Gallagher’s commitment to the commercialization of faculty research since becoming University of Pittsburgh chancellor 18 months ago, awakening a sleeping giant of economic development and innovation and hospital system UPMC’s creation of a commercial enterprises arm to fund promising technologies.

The timing couldn’t be better for venture capital funds like SG3.

Nationwide, early stage funding has been chasing fewer deals, according to a report by Money Tree, which was compiled by PricewaterhouseCoopers and the National Venture Capital Association based on data provided by Thomson Reuters.

Early stage investments nationally last year totaled $19.8 billion, a 23 percent increase from $16.1 billion in 2014. But the number of deals were essentially flat from the previous year, suggesting that some companies were left out in the cold.

What’s more, the amount of money available to Pittsburgh-area entrepreneurs after the earliest rounds of investment isn’t keeping pace with the innovations coming out of the city’s universities, said Dietrich Stephan, a serial entrepreneur who also chairs the human genetics department at Pitt.

“There’s real substance here,” he said. “Without money, we can’t build.”

Seed investment funding — the earliest level of funding — is not a problem in Pittsburgh, said Buchanan Ingersoll Rooney PC lawyer Jeremy Garvey, who also chairs the Bridgeville-based Pittsburgh Venture Capital Association.

“The predominance of funding in this market comes in the earliest stages,” he said. “Institutional funding is much harder to get in this market.”

Early stage venture funding began drying up with the stock market crash of 2008, which also chilled the financial markets for initial public offerings for biotech companies, Mr. McVeigh said. Eventually, conditions thawed for IPOs, but the lower valuations for new companies than before 2008 made that less attractive than before.

“We’re really energized by the energy there” in Pittsburgh, Mr. McVeigh said. “We’re looking to bring venture capital to the region.”

Kris B. Mamula: kmamula@post-gazette.com

About SG3 Ventures

SG3 Ventures is an early stage life science venture capital firm. Our primary focus in on therapeutics and digital health; however, we will invest opportunistically when presented with a potential vehicle to drive superior returns for our limited partners. We are active in company formation, deploying financial and human resources to help deliver value. In addition, we access deep industry networks to ensure a path to market with strong commercial partnerships built into our companies from the beginning. SG3 prefers to invest in the greater Philadelphia Region (Princeton to the north, Baltimore to the south and Pittsburgh to the west). We prefer to make initial investments at the formation or seed stage with a focus on providing financing through mature rounds of investment.

  • Website

    http://sg3ventures.com

  • Industry

    Financial Services

  • Type

    Partnership

  • Headquarters

    3711 Market Street Suite 800Philadelphia, PA 19104 United States

  • Company Size

    1-10 employees

More articles on the Open Access Journal on Biotech Investing Include

J.P. Morgan 34th Annual Healthcare Conference & Biotech Showcase™ January 11 – 15, 2016 in San Francisco

New Values for Capital Investment in Technology Disruption: Life Sciences Group @Google and the Future of the Rest of the Biotech Industry

Bristol-Myers Squibb: A global BioPharma leader – Tracing the innovative biotech core of $3.7 billion R&D Investment and $16.4 billion in Net Sales

 

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Starting a Biotech the European Way

Author:  Stephen J. Williams, Ph.D.

A wonderful post by Tony Marcel in Nature Biotechnology highlights some of the structural differences in the way biotech startups are formed in Europe contrasted with bio-entrepreneurship as conducted in the United States.  Tony Marcel is currently the CEO of FGene S.A. and gives a personal experience  of the European biotech startup scene and highlights the differences, as he sees it, in the unique business development models occurring in Europe versus the US.  This post will highlight features from the article.

  • US model of biotech is not easily transferable to how Europe does business
  • US model involves developing a specific technology platform then selling that tool, service or platform to pharma for R&D $ and royalties
  • European perspective is to build networks instead of platforms which can deliver capabilities or one product to pharma
  • The article discusses three weaknesses identified in the biotech world with respect to Europe and the US

Three ” weaknesses” identified which may affect decision to start a biotech in Europe include:

  1. European academic scientists have trepidation making deals with big pharma
  2. European scientists are not as eager as US counterparts to start a biotech
  3. biotechs still are not as good as pharma in drug development so even their pipeline of “hits” are failing in clinical trials

The article aims to use these weaknesses to define a European way involving

  • defining management players and market niche early on
  • reducing the barriers to entry (i.e. legal)
  • establishing the relationships to increase viability

 

The full article can be found at the following link:

http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

 

An emerging European model for bioentrepreneurship

Tony Marcel

Tony Marcel is CEO of FGene S.A., 91, Avenue Kléber, 75116 Paris, France

e-mail:  tonymftmcgene@compuserve.com.

The US model for biotechnology is not easily exportable to Europe, but an alternative European business model may be adaptable everywhere.

There is a widespread opinion that biotechnology companies worldwide need to follow business models initiated in the US. These models, generally speaking, are based on development of a specific technology platform. The prevailing wisdom suggests this technology can be sold as a tool or service to pharmaceutical companies or can be used to develop a lead compound that can then be sold to big pharma for R&D dollars and single-digit downstream royalties.

But my experience as a former academic medical researcher who has helped discover, develop, and market drugs for Hoechst, Laboratoires Roussel, Roussel-Uclaf, Rhône-Poulenc Sante, and Amgen has taught me that there is an appealing alternative to this model that may be more practical from the European perspective. Rather than building technologies, one can build networks that have the capability of delivering to big pharma the one product they cannot refuse: validated lead compounds for unmet medical needs.

Identifying a market niche

My background has taught me that an effective way to find solutions is to look at weaknesses perceived by the status quo, and then to develop a strategy to turn them into strengths. Biotechnology’s biggest weakness was its lack of products, in traditional pharmaceutical terms. Relatively few lead compounds have made their way through clinical trials and onto the market. So to separate your company from the crowd, my first conclusion is that it needs to be product-based. It should develop lead compounds that can be sold to big pharma, or take those compounds through clinical trials and to the market.

How do you accomplish this in Europe? I identified three weaknesses from a traditional biotechnology or pharmaceutical perspective that I felt could be developed into strengths. The first was that European scientists are much more risk averse than their American counterparts when it comes to setting up their own business. The legal, financial, and cultural infrastructure to take such a step is far more developed in the US than elsewhere.

The second was that European academic scientists tended to be mistrustful of big pharma’s intentions in licensing discussions. Taking the fruits of their research and developing it into a business is an uncharted area for most, and their unfamiliarity with this process made them cautious.

Finally, biotechnology startups everywhere, not just in Europe, are usually not very efficient in conducting pharmaceutical development. In general, they are discovery-focused companies that lack both the expertise and the contacts in these areas to efficiently manage this process.

These three weaknesses provide the basis for my product-based business plan. The fact that European scientists are not as ready to start companies as in the US makes Europe a source of world-class research not already tied up commercially. In addition, my experience in the pharmaceutical world has demonstrated that a commitment to building a relationship based on trust with scientists and their university licensing departments tremendously enhances the quality of these exchanges and, over time, provides remarkable access to a pipeline of innovative lead compounds.

Finally, the pharmaceutical industry’s move to outsource much of the development and clinical trials process has created a remarkable infrastructure for moving lead compounds through development. One only needed to know when this was appropriate and to have the money to commit to that project to realize a major portion of the development process.

The business model that results from uniting these strengths is a company dedicated not to a specific technology platform, but rather to the development of innovative compounds discovered and patented by academia. The company’s niche is to license in molecules at an early stage and demonstrate proof of principle, and take them through regulatory preclinicals, as well as phase I/II clinicals. At that point, the company licenses its products to big pharma. Profit is generated by the substantial risk-to-reward ratio between the cost of licensing in molecules and the outlicensing price to big pharma.

Management

Contrary to the way many US biotechnology companies are run, the management structure of such a company is not a one-person show. This strategy relies heavily on a supervisory board made up of representatives from European ministries and major European banks. It is also dependent on a scientific advisory board (SAB) with members from key European states. Unlike the boards of some biotechnology companies, the individuals selected are not merely figureheads. They must be committed to an operational role in which they are regularly consulted about the company’s plans.

The key to making this work is to maintain permanent links with academia, the source of new molecules, through publications, meetings, and also through SAB members. One also needs to develop comparable relationships in the pharmaceutical industry in order to keep abreast of licensing-in needs. Using this dual approach, a company will be able to identify discoveries relevant to a major pharmaceutical market before they are published. The company can then select candidates for licensing based on demonstrations of their potentially useful activity, the proof of pilot synthesis and purification capability, and sufficient intellectual property protection.

Given the academic scientist’s aversion to starting a business, where will this network of managers come from? In Europe, the merger and acquisition fever that has hit both the pharmaceutical and banking industries has created a large pool of experienced professionals, acquainted with science, marketing, and business. Some of these individuals will be at a point in their lives where setting up companies is an exciting alternative career.

The challenge for this new generation of European bioentrepreneurs will be to develop their ability to create a new level of cross-talk between inventors and developers. Their core responsibility will be much in keeping with their training: Build and nurture a portfolio of molecules at various stages of development.

Barriers to entry

If this model is so straightforward, why do pharmaceutical companies not eliminate the biotechnology middleman and reap the rewards directly? One of the three premises of this model is that a small biotech company is more able to concentrate on an academic alliance than a large pharmaceutical company. Biotechnology’s close identification with academia through the training of both its management and staff gives it a cultural advantage in assuming this role.

Historically, the model in which big pharma establishes a direct relationship with academia has never proven successful. For example, SmithKline and French invested much of its Tagamet earnings into developing academic alliances to fill its pipelines. Nonetheless, investing a substantial amount of money in these relationships over a significant period of time did not prevent this group from having to merge with Beecham. Nearly every working pharmaceutical executive today has a similar war story.

The reason it has failed for the past 20 years, and is likely to continue to fail for the next 20, is that it concentrates efforts in the hands of the most powerful pharmaceutical companies and key research institutions. The resulting bureaucracy is so overwhelming it not only alienates the scientific innovators, but creates a stifling atmosphere in which decisions simply cannot be made.

But old habits die hard, and this model has long been a tradition in Europe—particularly in France. Therefore, it is likely, if for no other reason than to reap the potential financial returns of such a model, that pharmaceutical companies will continue to make this model work.

However, the important role that biotechnology can play in this process is being recognized by some individuals now in positions of responsibility in pharmaceutical companies, academic institutions, and government offices. These individuals are doing their best to support biotechnology’s role in the development of innovative new medicines.

Viability

If you have read this far, you are probably persuaded by the arguments, but may wonder, “If it is such a great business model, why hasn’t anyone done it before?” Well, they have. In 1995, FGene was founded in France as a company devoted to the development of biopharmaceutical products. The company was initiated by the willingness of the Paris-based Institut Pasteur, a major European academic institution, to license molecules to it. This relationship allowed the beginning of the process I have just described.

The resolve of the French government, key players in academia, the investment community, and the pharmaceutical industry to enhance the growth of biotechnology in France is an opportunity we have seized. We have tried to duplicate in Europe the remarkable links developed between biotechnology startups and academia in the US, and hope to create a viable business serving the needs of the world’s largest pharmaceutical companies that are literally in our backyard.

In three years of existence, FGene already boasts five products in its active development portfolio: a recombinant protein for the treatment of traumatic spinal section; a peptide for the prevention and therapy of cardiovascular and cerebrovascular ischemia, such as coronary diseases; a selective IL2 receptor agonist for the treatment of cancer; a peptide active on kidney and bone for the treatment of bone and mineral balance disorders, such as osteoporosis; and a peptide for improving male pattern sexual arousal.

We are encouraged that we have made this much progress in such a short time. While this model is still not proven in terms of financial success, it provides a much stronger foundation for growing a biotechnology company than most biotechnology business plans currently in use because costs are directly related to the development of marketable products.

Conclusions

For budding European bioentrepreneurs, this model recommends itself for three reasons: First, it uses unexploited resources that are difficult to access through traditional biotechnology or pharmaceutical models. Second, it is based on pharmaceutical customers’ high-priority needs. And third, it provides a company with a burn rate that is in direct proportion to the realization of a marketable product.

This model has first taken hold in France because of a unique set of circumstances, but its applicability seems uthe commitment of a network of individuals to build a new kind of biotechnology company.

My vision is that companies formed will reinvigorate the European pharmaceutical industry. In the end, everyone wins. Academic science has a new route to receive fair payment for their innovations, biotechnology companies show a rapid timeline to profitability, making investors happy, and pharmaceutical companies fill their pipelines with truly innovative medicines. But the real winner in the end will be the consumer—the rapid translation of genomic products will lead to medicines that improve healthcare at an affordable price, in a much shorter time frame than previously possible.

 

source: http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

More articles on BioEntrepreneurship in this Online Open Access Journal Include:

11:00AM – 10/1/2014: Scientific Collaborations @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

9:00AM 10/1/2014: Partnering I @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

BioTech Partnerships and the National Model in Israel

Four Startups After One Year: BioDesign Entrepreneurship Program @ Hebrew University-Hadassah Medical Center

Biotech Chinese and Israeli Strategic Collaboration: Pontifax and WuXi PharmaTech (Cayman) Inc. (NYSE: WX)

Top 10 Israeli medical advances to watch in 2014 @ ISRAEL21c

Israel’s Innovation System: A Triple Helix with Four Sub-helices

Helix Model of Innovation in Israel: The Global Scheme and its Local Application

i-CORE Participation In Israel: Hebrew University faculty leads and holds Scientific Management Positions in Five I-CORE Centers

Stem Cell Research — The Frontier is at the Technion in Israel

Next-generation Universal Cell Immunotherapy startup Adicet Bio, Menlo Park, CA is launched with $51M Funding by OrbiMed

Recent Breakthroughs in Cancer Research at the Technion-Israel Institute of Technology- 2015

BEYOND THE “MALE MODEL”: AN ALTERNATIVE FEMALE MODEL OF SCIENCE, TECHNOLOGY AND INNOVATION

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AGTC (AGTC) , An adenoviral gene therapy startup, expands in Florida with help from $1 billion deal with Biogen

Reporter: Stephen J. Williams, Ph.D.

from Biospace News

AGTC Sets Up Shop in Florida, New Facility to House 75 Employees
February 17, 2016
By Alex Keown, BioSpace.com Breaking News Staff

GAINESVILLE, Fla. — Applied Genetic Technologies Corporation (AGTC), a biotechnology company researching adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, is expanding into the rapidly growing north central Florida biotech corridor.

The company, which was founded on technology developed at the University of Florida, is opening a combined use corporate office and laboratory facility in Alachua, Fla. AGTC’s portion of the new multi-tenant facility is expected to accommodate up to about 75 people and consists of approximately 20,000 square feet including state-of-the-art lab and office space as well as space for future expansion, the company announced this morning.

“The new facility will help us to accelerate our research and development efforts for novel AAV-based gene therapies for rare diseases and house critical corporate functions including finance, quality assurance and project management, while providing ample space as we continue to bring new talent to our team,” Sue Washer, president and chief executive officer of AGTC said in a statement.

AGTC’s lead product candidates focus on X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which are inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. Retinoschisis is a condition in which an area of the retina has separated into two layers. The part of the retina that is affected by retinoschisis will have suboptimal vision, according to the University of Michigan’s Kellogg Eye Center. Achromatopsia is a condition of the eye that is characterized by an absence (partial or total) of color vision. People with the complete form of achromatopsia are unable to perceive any colors and can only see black, white and shades of gray.

AGTC is also pursuing pre-clinical development of treatments for wet AMD using the company’s experience in ophthalmology to expand into disease indications with larger markets.

In August, AGTC’s research was bolstered by a $1 billion deal withBiogen (BIIB) to support the company’s gene-based therapies. As part of the deal, Biogen holds a license to AGTC’s XLRS and XLRP programs and an additional three licenses, BioSpace (DHX) reported in August.

David Day, assistant vice president & director of the Office of Technology Licensing at the University of Florida, touted the growth of the biotech sector in north central Florida.

“AGTC’s progress in developing novel treatments for rare diseases without adequate therapeutic options is a particularly good model for the entire biotechnology sector,” Day said in a statement.

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