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Posts Tagged ‘Global Partnering & Biotech Investment’


Real Time Coverage @BIOConvention #BIO2019: Keynote Address Jamie Dimon CEO @jpmorgan June 5 Philadelphia

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

  • Dr Janet Woodcock from FDA was given the BIO Heritage award for leading the FDA from safety focus of 90s to the Voice of the Patient. She became a champion for advocacy groups
  • Governor Phil Murphy, Governor of New Jersey, received the Governor of the Year Award.  New Jersey known as medicine chest of the world, have first 3D printed drug on market and number two in biotech and number one on drug approvals.  We must do more to foster stem education.  It will take private and public capital investment.  New Jersey matches federal dollars and had doubled the angel investor tax credit.
  • Dr. Kakkis CEO of Ultragenix wins the Genzyme Henri Termeer Award for visionary work.  Dr. Termeer recently passed.  Dr. Kakkis is awarded for work with patients of rare diseases and help formulating legislation to help patients with rare disease have access to investigational drugs quickly.
  • Dr. Jeremy Levin from OVID named new chair of BIO

Interview with Jamie Dimon, CEO of JPMorgan

  • Mr Dimon had recently survived throat cancer and now has a renewed dedication to improving people’s lives.  With Amazon had embarked on a nonprofit experimental model to streamline healthcare for their employees.  He said the hardest part of going through cancer was telling his parents and children.
  • On the bailout he said it was a lie all banks needed TARP but could not just give to some and not all.  He says the financial system in US is very solid so next downturn will not come from financial sector and never is from geopolitical but trade issues could be a catalyst. Policy usually always does the opposite of what is intended.  He announced no intention of running for President of US.
  • We need to keep a growth agenda which includes education and infrastructure, without these competitive business tax relief does no account for much.  We need a better conversation of how government handles finances
  • Immigration, education very important.  Higher education needs to reduce costs and incentivize the people they bring in to stay here.
  • on healthcare:  JPM had reduced the deductables to zero for workers making $60,000 or less

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

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

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#BIO2019 (official meeting hashtag)

Other Article on this Open Access Journal on Global Partnerships, Global Investing and JPMorgan Include:

 

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Real Time Coverage @BIOConvention #BIO2019: June 4 Morning Sessions; Global Biotech Investment & Public-Private Partnerships

Reporter: Stephen J Williams PhD @StephenJWillia2

Each country have their own needs and most important drug cost structure. Must involve patients and providers.
BCI survey: countries output different, who improved who didnt
Is industry having collaboration with government? hardly ten percent by survey and worse vice versa
Transparancy and holistic view important for collaboration
Korea: lack of communication need input from government on pricing; wants global open innovation and enhance RD investments
Tawain: price, price but based on efficacy; pharma needs to talk with doctors hospital patients, find balance
Pitts: we need trust; staff that country offices with people who know that country. Price not defining value
Columbia:  need to attract investors

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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Real Time Coverage of BIO 2019 International Convention, June 3-6, 2019 Philadelphia Convention Center, 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)

Please check daily on this OPEN ACCESS JOURNAL for updates on one of the most important BIO Conferences of the year for meeting notes, posts, as well as occasional PODCASTS.

 

The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry. The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities.  The Convention also features the BIO Business Forum (One-on-One Partnering), hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition – the BIO Exhibition.

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

 

Keynote Speakers INCLUDE:

Fireside Chat with Margaret (Peggy) Hamburg, MD, Foreign Secretary, National Academy of Medicine; Chairman of the Board, American Association for the Advancement of Science

Tuesday Keynote: Siddhartha Mukherjee (Author of the bestsellers Emperor of All Maladies: A Biography of Cancer and  The Gene: An Intimate History)

Fireside Chat with Jeffrey Solomon, Chief Executive Officer, COWEN

Fireside Chat with Christi Shaw, Senior Vice President and President, Lilly BIO-Medicines, Eli Lilly and Company

Wednesday Keynote: Jamie Dimon (Chairman JP Morgan Chase)

Fireside Chat with Kenneth C. Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co., Inc.

Fireside Chat: Understanding the Voices of Patients: Unique Perspectives on Healthcare

Fireside Chat: FDA Town Hall

 

ALSO SUPERSESSIONS including:

Super Session: What’s Next: The Landscape of Innovation in 2019 and Beyond

Super Session: Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Digital Health in Practice: A Conversation with Ameet Nathawani, Chief Digital Officer, Chief Medical Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Realizing the Promise of Gene Therapies for Patients Around the World

Super Session: Biotech’s Contribution to Innovation: Current and Future Drivers of Success

Super Session: The Art & Science of R&D Innovation and Productivity

Super Session: Dealmaker’s Intentions: 2019 Market Outlook

Super Session: The State of the Vaccine Industry: Stimulating Sustainable Growth

 

See here for full AGENDA

Link for Registration: https://convention.bio.org/register/

The BIO International Convention is literally where hundreds of deals and partnerships have been made over the years.

 

BIO performs many services for members, but none of them are more visible than the BIO International Convention. The BIO International Convention helps BIO fulfill its mission to help grow the global biotech industry. Profits from the BIO International Convention are returned to the biotechnology industry by supporting BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.

The key benefits of attending the BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry though-leaders with over 1,500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 74 countries.

In addition, we produce BIOtechNOW, an online blog chronicling ‘innovations transforming our world’ and the BIO Newsletter, the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

 

Membership with the Biotechnology Innovation Organization (BIO)

BIO has a diverse membership that is comprised of  companies from all facets of biotechnology. Corporate R&D members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. The majority of our members are small companies – 90 percent have annual revenues of $25 million or less, reflecting the broader biotechnology industry. Learn more about how you can save with BIO Membership.

BIO also represents academic centers, state and regional biotech associations and service providers to the industry, including financial and consulting firms.

  • 66% R&D-Intensive Companies *Of those: 89% have annual revenues under $25 million,  4% have annual revenues between $25 million and $1 billion, 7% have annual revenues over $1 billion.
  • 16% Nonprofit/Academic
  • 11% Service Providers
  • 7% State/International Affiliate Organizations

Other posts on LIVE CONFERENCE COVERAGE using Social Media on this OPEN ACCESS JOURNAL and OTHER Conferences Covered please see the following link at https://pharmaceuticalintelligence.com/press-coverage/

 

Notable Conferences Covered THIS YEAR INCLUDE: (see full list from 2013 at this link)

  • Koch Institute 2019 Immune Engineering Symposium, January 28-29, 2019, Kresge Auditorium, MIT

https://calendar.mit.edu/event/immune_engineering_symposium_2019#.XBrIDc9Kgcg

http://kochinstituteevents.cvent.com/events/koch-institute-2019-immune-engineering-symposium/event-summary-8d2098bb601a4654991060d59e92d7fe.aspx?dvce=1

 

  • 2019 MassBio’s Annual Meeting, State of Possible Conference ​, March 27 – 28, 2019, Royal Sonesta, Cambridge

http://files.massbio.org/file/MassBio-State-Of-Possible-Conference-Agenda-Feb-22-2019.pdf

 

  • World Medical Innovation Forum, Partners Innovations, ARTIFICIAL INTELLIGENCE | APRIL 8–10, 2019 | Westin, BOSTON

https://worldmedicalinnovation.org/agenda-list/

https://worldmedicalinnovation.org/

 

  • 18th Annual 2019 BioIT, Conference & Expo, April 16-18, 2019, Boston, Seaport World Trade Center, Track 5 Next-Gen Sequencing Informatics – Advances in Large-Scale Computing

http://www.giiconference.com/chi653337/

https://pharmaceuticalintelligence.com/2019/04/22/18th-annual-2019-bioit-conference-expo-april-16-18-2019-boston-seaport-world-trade-center-track-5-next-gen-sequencing-informatics-advances-in-large-scale-computing/

 

  • Translating Genetics into Medicine, April 25, 2019, 8:30 AM – 6:00 PM, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York

https://pharmaceuticalintelligence.com/2019/04/25/translating-genetics-into-medicine-april-25-2019-830-am-600-pm-the-new-york-academy-of-sciences-7-world-trade-center-250-greenwich-st-fl-40-new-york/

 

  • 13th Annual US-India BioPharma & Healthcare Summit, May 9, 2019, Marriott, Cambridge

https://pharmaceuticalintelligence.com/2019/04/30/13th-annual-biopharma-healthcare-summit-thursday-may-9-2019/

 

  • 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, May 17, 2019, Harvard Law School

http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

https://pharmaceuticalintelligence.com/2019/01/11/2019-petrie-flom-center-annual-conference-consuming-genetics-ethical-and-legal-considerations-of-new-technologies/

 

  • 2019 Koch Institute Symposium – Machine Learning and Cancer, June 14, 2019, 8:00 AM-5:00 PM  ET MIT Kresge Auditorium, 48 Massachusetts Ave, Cambridge, MA

https://pharmaceuticalintelligence.com/2019/03/12/2019-koch-institute-symposium-machine-learning-and-cancer-june-14-2019-800-am-500-pmet-mit-kresge-auditorium-48-massachusetts-ave-cambridge-ma/

 

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37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 10, 2019: Deals and Announcements

Reporter: Stephen J. Williams, Ph.D.

From Biospace.com

 

JP Morgan Healthcare Conference Update: Sage, Mersana, Shutdown Woes and Babies

Speaker presenting to audience at a conference

With the J.P. Morgan Healthcare Conference winding down, companies remain busy striking deals and informing investors about pipeline advances. BioSpace snagged some of the interesting news bits to come out of the conference from Wednesday.

SAGE Therapeutics – Following a positive Phase III report that its postpartum depression treatment candidate SAGE-217 hit the mark in its late-stage clinical trial, Sage Therapeutics is eying the potential to have multiple treatment options available for patients. At the start of J.P. Morgan, Sage said that patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression, compared to 13.6 for placebo. The company plans to seek approval for SAGE-2017, but before that, the FDA is expected to make a decision on Zulresso in March. Zulresso already passed muster from advisory committees in November, and if approved, would be the first drug specifically for postpartum depression. In an interview with the Business Journal, Chief Business Officer Mike Cloonan said the company believes there is room in the market for both medications, particularly since the medications address different patient populations.

 

Mersana Therapeutics – After a breakup with Takeda Pharmaceutical and the shelving of its lead product, Cambridge, Mass.-based Mersana is making a new path. Even though a partial clinical hold was lifted following the death of a patient the company opted to shelve development of XMT-1522. During a presentation at JPM, CEO Anna Protopapas noted that many other companies are developing therapies that target the HER2 protein, which led to the decision, according to the Boston Business Journal. Protopapas said the HER2 space is highly competitive and now the company will focus on its other asset, XMT-1536, an ADC targeting NaPi2b, an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is currently in Phase 1 clinical trials for NaPi2b-expressing cancers, including ovarian cancer, non-small cell lung cancer and other cancers. Data on XMT-1536 is expected in the first half of 2019.

Novavax – During a JPM presentation, Stan Erck, CEO of Novavax, pointed to the company’s RSV vaccine, which is in late-stage development. The vaccine is being developed for the mother, in order to protect an infant. The mother transfers the antibodies to the infant, which will provide the baby with protection from RSV in its first six months. Erck called the program historic. He said the Phase III program is in its fourth year and the company has vaccinated 4,636 women. He said they are tracking the women and the babies. Researchers call the mothers every week through the first six months of the baby’s life to acquire data. Erck said the company anticipates announcing trial data this quarter. If approved, Erck said the market for the vaccine could be a significant revenue driver.

“You have 3.9 million birth cohorts and we expect 80 percent to 90 percent of those mothers to be vaccinated as a pediatric vaccine and in the U.S. the market rate is somewhere between $750 million and a $1 billion and then double that for worldwide market. So it’s a large market and we will be first to market in this,” Erck said, according to a transcript of the presentation.

Denali Therapeutics – Denali forged a collaboration with Germany-based SIRION Biotech to develop gene therapies for central nervous disorders. The two companies plan to develop adeno-associated virus (AAV) vectors to enable therapeutics to cross the blood-brain barrier for clinical applications in neurodegenerative diseases including Parkinson’s, Alzheimer’s disease, ALS and certain other diseases of the CNS.

AstraZeneca – Pharma giant AstraZeneca reported that in 2019 net prices on average across the portfolio will decrease versus 2018. With a backdrop of intense public and government scrutiny over pricing, Market Access head Rick Suarez said the company is increasing its pricing transparency. Additionally, he said the company is looking at new ways to price drugs, such as value-based reimbursement agreements with payers, Pink Sheet reported.

Amarin Corporation – As the company eyes a potential label expansion approval for its cardiovascular disease treatment Vascepa, Amarin Corporation has been proactively hiring hundreds of sales reps. In the fourth quarter, the company hired 265 new sales reps, giving the company a sales team of more than 400, CEO John Thero said. Thero noted that is a label expansion is granted by the FDA, “revenues will increase at least 50 percent over what we did in the prior year, which would give us revenues of approximate $350 million in 2019.”

Government Woes – As the partial government shutdown in the United States continues into its third week, biotech leaders at JPM raised concern as the FDA’s carryover funds are dwindling. With no new funding coming in, reviews of New Drug Applications won’t be able to continue past February, Pink Sheet said. While reviews are currently ongoing, no New Drug Applications are being accepted by the FDA at this time. With the halt of NDA applications, that has also caused some companies to delay plans for an initial public offering. It’s hard to raise potential investor excitement without the regulatory support of a potential drug approval. During a panel discussion, Jonathan Leff, a partner at Deerfield Management, noted that the ongoing government shutdown is a reminder of how “overwhelmingly dependent the whole industry of biotech and drug development is on government,” Pink Sheet said.

Other posts on the JP Morgan 2019 Healthcare Conference on this Open Access Journal include:

#JPM19 Conference: Lilly Announces Agreement To Acquire Loxo Oncology

36th Annual J.P. Morgan HEALTHCARE CONFERENCE January 8 – 11, 2018

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: #JPM2019 for Jan. 8, 2019; Opening Videos, Novartis expands Cell Therapies, January 7 – 10, 2019, Westin St. Francis Hotel | San Francisco, California

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 8, 2019: Deals and Announcements

 

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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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