CBI’s FDA/CMS Summit draws the highest leadership at the FDA to update the industry on current developments, initiatives, changes and the year ahead as it pertains to major stakeholders in the drug development process. CMS brings updates on changes to pharmaceutical coverage and other key areas of policy under its oversight. This is the only event that convenes both groups together to meet with senior and executive leadership and regulatory leaders within the industry and continues to deliver 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. The 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.

Key Topics Include:

• Update on the Office of New Drug reorganization
• Address key shifts in the political landscape impacting
  pharma and bio regulations
• RWE and PRO in the drug approval process
• Evaluate access and affordability challenges for
  advanced therapeutics and gene therapies
• Economics, Impact, Challenges and advancements of biosimilars
• Valuation approaches for gene therapies and rare disease
• Advancing the use of innovative evidence to support
  evolving payment policies
• Update on the FDA’s incorporation of the science of
  patient input into regulatory decision making
• Examine the path forward for drugs, device and
  combination products
• Consider how to reconcile facilitated regulatory pathways
  with evidentiary requirements for payer coverage
• Update on value-based payment models —
  Examine strategies to better align data needed for regulatory
  approval with data needed for payment reimbursement models