Accelerating BioPharma Development

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FountainBlue’s August 17 Life Science Entrepreneurs’ Forum was on the topic of Accelerating BioPharma Development and featured:

• Facilitator Peter Berger II, CEO, Alitora
• Panelist Ian Irwin, Director of Drug Discovery, Parkinson’s Institute
• Panelist Michael O’Donnell, Partner, Wilson Sonsini
• Panelist Ted Spack, Managing Director, Fast Forward LLC
• Panelist Craig Taylor, Co-Founder and General Partner, Alloy Ventures
• Presenting Entrepreneur: Yadon Arad, Tiara Pharmaceuticals
• Presenting Entrepreneur: Julia O’Connor, CEO, Accelalox Inc.
• Presenting Entrepreneur: David Zarling, CEO, Colby Pharmaceuticals

Below are notes from the conversation. These notes are copyrighted by FountainBlue in 2006-09 and all rights are reserved. You have our permission to forward the notes on to others, to help support further discussion and connections, but please ensure that the notes are INTACT, and that there is proper acknowledgement for our speakers and to FountainBlue.

Major Changes and Challenges in Drug Development
The panelists represented decades of experience in the life science industry and remarked on the accelerated rate of technology development and science advancement. However, policies, regulations, and cultural hurdles have collectively raised the standards for drug approval, making it difficult to develop and manufacture drugs and bring them to market, despite the rapid advancements in technology. Expanding concerns about drug safety represent both a barrier (to developing new drugs) and an opportunity (safer versions of existing drugs) to drug development.

Indeed, companies have had an increasingly higher standard to meet prior to approvals for each phase of development. Requirements for animal and human trials and innumerable requirements for proving drug efficacy have made it almost impossible for entrepreneurs, intrapreneurs and investors to bring drugs to market cost-effectively. Policy and regulation changes and poor management of the approval process have also posed imposing obstacles for companies.

The Role of New Government Funding
With the dramatic and rapid changes in policy and administration and outlook toward the life science industry overall, new interest has been placed on how to identify the key players in the biopharma market, and facilitate forward progress for people and organizations in this industry. As big pharma companies have become more conservative in this constricted market, entrepreneurs are looking more toward government fundings and partnerships with academia.

Advice for Accelerating Drug Development
Start-up entrepreneurs are generally thinking and acting at a more rapid pace than their corporate, academic or government counterparts. Time is of the essence for companies with few resources and small windows of opportunity. Below are some suggestions entrepreneurs can do to continue moving forward while awaiting partnerships:

• Start building relationships with key partners early, and make every effort to maintain strong partnerships and relationships.
• Project-manage effectively as a team to drive deliverables and ensure smooth transition between groups, phases, organizations, countries.
• Manage your resources tightly to make a good impression.
• Keep making the case that safety needs to be balanced with efficacy, and encouraging forward momentum.
• Manage risks. Raise safety concerns in a timely manner.
• Move your concept and organization as far as you can with as few resources as possible. Make a convincing case that additional partnership and support would build measurable and specific traction toward pre-defined milestones.
• Be flexible and creative in securing funding, utilize all sources of funding to move forward with early development, including private foundation, angel investment, SBIR/STTR. Government and foundation grants might be good resource during early development phases, They require forming solid partnerships, AND can be time-consuming AND they can’t provide the kind of investment dollars necessary to grow the company beyond early development, but are still worth investigating.
• Accept where your sphere of influence is with your partners in corporate, government, investment, etc. and leverage where you will have the best payoff, while also growing your influence.
• Leverage outsourcing where practical, but manage the outsourcing projects closely.
• Enlist the support of entrepreneurial industry experts with complementary skills.

Game Changers in the Near Future
There is hope for the hopeful, industrious and resilient life science entrepreneur! The following opportunities were highlighted by the panelists:

• India and China will play an increasingly important role in accelerating drug development, not only as CRO/CMO service providers, but also drive for technology innovation and represent great market. As such, there will be more opportunities and larger markets as countries such as India and China become active in this space.
• Changes to reimbursement policies will make it more practical for existing and new solutions to go to market.
• There are many early-stage concepts which could not navigate all the hurdles of the development process, yet the thousands and millions of dollars already expended has produced science and technologies, even prototypes and studies which may be cost-effectively leveraged into new solutions, if the hurdles can be overcome.
• Advancements in personalized medicine will not only provide custom solutions for patients, but it may also explain why some drugs did not pass regulations. These drugs might then be brought to market, targeting a more specific, more responsive patient population.
• In general, with the advancements in technologies, there is more likely to be knowledge-driven understanding about what went wrong with drugs that could not complete the approval process and how to bring them to market cost-effectively.
• There are opportunities in diagnostic tools, in genomics, imaging, informatics and other scientific areas which could lead to new drugs.

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