Plenary Sessions

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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.

Moderator

  • Dentons—Edward Dougherty, Principal

Panelists

  • BIO—Cartier Esham, PhD, EVP Emerging Companies Section
  • Catalyst Pharmaceutical Partners—Patrick J. McEnany, CEO
  • Portola Pharmaceuticals—William Lis, CEO
  • Scioderm—Robert Ryan, MD, President and CEO

Plenary Lunch Session: BioCentury Presents: 22nd Annual “Back to School” Report

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.

Closing Plenary: Up, Up, and Away: How Fragile is the Biotech Rally After Five Positive Years?

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?

Panelists

  • AbbVie Biotech Ventures, Inc.—David Donabedian, PhD, Vice President
  • Alnylam Pharmaceuticals—John Maraganore, PhD, CEO
  • Forest Laboratories—Ellen Lubman, SVP Strategy and Innovation
  • GlycoMimetics—Rachel King, CEO (BIO, Chair)
  • MPM Capital—Todd Foley, Managing Director
  • ROTH Capital—Michael Margolis, RPh, Managing Director