Substantive Updates Part Four: Key Regulatory and Pricing Developments Affecting How Life Sciences Companies Bring Products to Market

July 29, 2016 9:45am

Gail L. Daubert
Partner
Reed Smith LLP

Kendra A. Martello
Deputy Vice President, Strategic Operations
Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC)

  • Understanding what the new patient-centric drug and device development process means to manufacturers
  • The year of diversity in clinical trials: updates on key initiatives to ensure the women, racial and ethnic minorities, and the elderly are not underrepresented in trials
  • Delving into recent changes to key approval pathways: biosimilars, drug-device combination products, 3D products and more
  • Building a strategy for pricing and reimbursement of products in light of recent controversies including Turing and Valeant