December 9 - 10, 2020
Your Window into Emerging FDA and CMS Regulatory Policies Affecting Life Sciences
The Original Forum for Life Sciences Providing Exclusive Access to FDA/CMS Regulators to Examine Shifting Regulatory and Reimbursement Policy.
What to Expect
Garner the Latest Regulatory Updates and Priorities
- Hear directly from CDER on goals, trends, new drug development and approvals, & other CDER, FDA initiatives and developments for 2020 and beyond
- Discuss the current status of streamlining the Rare Disease Drug Review Process and the impact of RWE in speeding access to new medicines for rare diseases
- Explore the shifting regulatory policy landscape for cell and gene therapies
- Evaluate the future of RWE and PRO in the drug approval process
Examine the Latest Updates to Reimbursement Policies
- Review CMS updates on changes to policy and new policies regarding the biopharma industry and big pharma
- Review reimbursement challenges associated with the rapid growth of novel drugs and high-cost therapies
- Understand the current state of value- based reimbursement models and value-based outcomes
Changes in the Political and Landscape and Market Trends that Impact Drug Development
- Drug pricing and affordability and access issues
- Key entries into the specialty and rare disease pipeline
- The impact of AI and machine learning on the identification and development of new breakthrough treatments
Connect and Network with Key Decision-Makers at FDA/CMS Summit 2020
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