Opening Plenary Lunch: A High-Speed Option at the FDA: Lessons from Veterans of the Breakthrough Therapy Designation Process
Tuesday, October 7, 2014 | 12:00 p.m. - 1:25 p.m. | Twin Peaks North/South
The Breakthrough Therapy Designation (BTD) program instituted under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 has produced its first set of accelerated approvals under this program, dramatically cutting time to market for some cancer, cystic fibrosis, and hepatitis C therapies. The FDA so far has granted BTD status to more than 50 applications; however, that amounts to only about 30% of requests. Research suggests that the advantages vary significantly across therapeutic areas. Our panelists will discuss the characteristics of successful applicants, what lessons they learned from their BTD program experience, and what advice they would give companies seeking to apply.
- Edward Dougherty, Principal, Dentons
- Cartier Esham, PhD, EVP Emerging Companies Section, Biotechnology Industry Organization (BIO)
- William Lis, CEO, Portola Pharmaceuticals
- Patrick J. McEnany, CEO, Catalyst Pharmaceutical Partners
- Robert Ryan, MD, President and CEO, Scioderm
Wednesday, October 8, 2014 | 12:30 p.m. - 1:25 p.m. | Sunset Court
Always a source for great debate, the 22nd annual “Back to School” report from BioCentury will be released in September, bringing a spotlight to an important issue affecting the industry deserving additional attention. At this session, all corners of biotech will be asked to weigh in and help develop consensus on where progress is most achievable and efforts should be directed. Details and panelists will follow after the report’s publication.
- David Flores, Co-Founder, President and CEO, BioCentury
- Erin McCallister, Senior Editor, BioCentury
- Susan Schaeffer, Editor, BioCentury
Wednesday, October 8, 2014 | 3:30 p.m. - 4:25 p.m. | Sunset Court
The past year has seen more biotech IPOs than the past five years combined and companies are going public earlier in their drug development than ever before. Public officials’ comments questioning whether there is a biotech “bubble” have created temporary market shocks before investor confidence returned. New classes of blockbuster therapies are breaking revenue records—and attracting new attention to trends in healthcare costs. Drug approval processes are accelerating while M&A activity suggests the potential for major employment shifts. Are the innovative researchers and experienced investment community that brought the industry to its current peak communicating well enough to sustain this growth? What external threats deserve watching most closely?
- Todd Foley, Managing Director, MPM Capital
- Douglas Fambrough, PhD, CEO, Dicerna Pharmaceuticals
- Rachel King, CEO, GlycoMimetics
- Ellen Lubman, VP Strategy and Innovation, Forest Laboratories
- Michael A. Margolis, RPh, Managing Director, Roth Capital
- Vijay Murthy, PhD, Director, Venture Investments & Early Stage Collaborations, AbbVie