Panel Discussion: Establishing Multistakeholder-Relevant Clinical Endpoints

Time: 11:30 am
day: Clinical - AM

Details:

• How can we ensure clinical trial endpoints are meaningful to patients, agreeable to regulators, and measurable to payers
• Considerations for internal team structuring to ensure endpoints are relevant to all stakeholders
• Understanding EMA and FDA differences in deeming an outcome ‘clinically meaningful’

Speakers:

Mitra Tavakkoli Executive physician scientist with extensive rare disease gene therapy drug development experience

Carrie Edwards Wolkoff Successful Market Access Gene Therapy Launch experience in Rare Disease: alternative pricing contracts, value-based contracts, securing reasonable medical policy and payer specific PA processes to Read more

Terry Pirovolakis Elpida Therapeutics SPC: A social purpose corporation registered in California, was established by Mr. Pirovolakis in response to this significant unmet need, with the intention Read more

Doreen Morgan Doreen V. Morgan, Pharm.D., M.S., RPh. has extensive career experience in drug development and global regulatory strategy expertise in small and large molecules, cell and Read more