Doreen Morgan

Company: Formerly of PTC Therapeutics

Job title: Vice President, Head of Global Regulatory Strategy

Bio:

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 gene therapies, including contributions leading to FDA approvals in multiple therapeutic fields. Her career highlights include strong global leadership and key stakeholder engagement working in small biotech and mid to large pharma. Doreen previously held the position of VP, Head of Global Regulatory Strategy at PTC Therapeutics.

Seminars:

Panel Discussion: Establishing Multistakeholder-Relevant Clinical Endpoints 11:30 am

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’Read more

day: Clinical - AM

Panel Discussion: Reaching, Enrolling, and Retaining Participants in Rare Disease Gene Therapy Trials 2:00 pm

Multi-stakeholder discussion of friction points in the development lifecycle and how to overcome them: what have we tried, what has been successful and under what circumstances Dissection of real-world examples over time and across different patient communities Analysis of recent trends and impacts of continuing advancesRead more

day: Clinical - PM