CBI’s FDA/CMS Summit 2019 draws the highest leadership at the FDA and CMS and delivers best available information on FDA and CMS priorities, policy changes, evidence-based practice, federal review processes on various areas of biopharma like CDER, CBER, CDRH and the most cutting-edge advances in healthcare and technology. This event is geared to the information needs of C-Suite biopharmaceutical executives, Directors/VPs of Regulatory/Government Affairs, FDA regulators, consultants, law firms, PhRMA and big pharmaceutical companies.

OPENING KEYNOTE ADDRESS Featuring FDA Director, Amy P. Abernethy

Amy P. Abernethy, MD, PhD
Principal Deputy Commissioner
U.S. Food and Drug Administration (FDA)

GARNER THE LATEST REGULATORY UPDATES AND PRIORITIES AND DISCUSS:

• Examine the strategic plans and priorities for CDER and
  the Office of New Drugs for 2019 and the year ahead
• Understand the evolving role of RWE and PROs in
  regulatory decision-making and drug development
• Explore shifts in the regulatory landscape for cell and
  gene therapies and next steps in removing barriers to
  access and reimbursement challenges
• Review the current state of streamlining the rare disease
  drug review pathway
• Consider the impact of the drug pricing debate on
  drug development pipeline decision-making
• Analyze how to further advance the science of patient input
  and the impact on regulatory decision-making and
  reimbursement models
• Assess evolving value-based payment models to address
  reimbursement challenges for rare disease drugs and
  advanced therapeutics
• Identify next steps to advance biosimilars adoption in the U.S.