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Key Sessions

Opening Keynote Address: Partnering Opportunities with Industry to Solve Market Challenges

8:00am 8:45am (45 mins)

Main agenda

Morning Coffee & Registration

8:30am 8:45am (15 mins)

Main agenda

Chairman’s Opening Remarks

  • Nielsen Hobbs - Editor, The Pink Sheet

8:45am 9:30am (45 mins)

Main agenda

Opening Keynote Address: Partnering Opportunities with Industry to Solve Market Challenges

9:25am 10:10am (45 mins)

Main agenda

Pricing, Value and Leverage: Addressing the Ever Growing Cost of Drugs Through New Channels

Continuing the ongoing discussion around pricing, hear industry perspectives on the driving forces behind the continual increase in drug prices, the role of value in controlling cost as well as what, if any, tools and leverage federal agencies like FDA and CMS have in addressing the issue.

  • Panelist Hervé Hoppenot - Chairman, President, and Chief Executive Officer, Incyte

10:00am 10:30am (30 mins)

Main agenda

Networking & Refreshment Break

10:30am 11:10am (40 mins)

Main agenda

CMS Update: Medicaid and Prescription Drug Coverage

11:10am 12:10pm (60 mins)

Main agenda

Obstacles to Success for Biosimilars in the US Market

This presentation will explore why biosimilars for chronic diseases, the largest category of biological therapies, are unlikely to yield cost savings and look at examples of biosimilar adoption has impacted healthcare economics in emerging countries and abroad. 

  • Moderator Nicholas Florko - Associate Editor, Inside Health Policy
  • Panelist Aaron Hakim - Researcher, Yale School of Medicine
  • Panelist Sarfaraz Niazi, PhD - Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

12:10pm 1:10pm (60 mins)

Main agenda

Networking Luncheon

1:10pm 1:55pm (45 mins)

Main agenda

Fast Track vs Breakthrough Therapy Designation - Small Business Perspective

Hear perspective from a a small biotech company that has been granted fast track designation and breakthrough therapy designation in some of its programs on the differences, challenges, and opportunities presented by these two designations.

  • Presenter Catherine Melfi PhD - Chief Regulatory Officer, Omeros Corporation

2:40pm 3:40pm (60 mins)

Main agenda

The Impact and Implications of the "right to try" Movement

“Right to Try” initiatives have become the flag bearer of a growing public demand for better pre-approval treatment options for patients with serious unmet medical need.  But the prospect of Federal “Right to Try” legislation raises questions about the practical benefit and the ethical hazards of sidestepping existing FDA-authorized channels for access.  This session focuses on whether this populist movement helps or harms the ongoing efforts to improve pre-approval access for patients and their doctors.

  • Moderator Meg Tirrell - Biotech and Pharma Reporter, CNBC
  • Panelist Jess Rabourn - Managing Director, Wide Trial
  • Panelist Allison Bateman-House PhD - Division of Medical Ethics, NYU Langone Health

3:40pm 3:40pm (0 mins)

Main agenda

Conference Concludes