HP&M’s James Valentine & Ellis Unger @ DIA 2022: FDA Rare Disease Town Hall with CDER & CBER Center Directors, Optimizing Benefit-Risk Assessments, Reflecting on 10 Years of PFDD

June 3, 2022

Hyman, Phelps & McNamara, P.C.’s James Valentine and Ellis Unger will be presenting at the DIA 2022 Global Annual Meeting held this June 19-23 in Chicago, IL.  This meeting brings together industry, regulators, academics, and patients to discuss global and local challenges in the life sciences industry.  James and Ellis will be participating in sessions covering key topic areas that our firm’s drug development client face on a daily basis:

FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences? (June 20, 4-5pm Central)

Ellis Unger will be joining an expert panel to review the EMA and FDA benefit-risk frameworks and how to optimize these processes.  Topics will include the addition of sponsor input to highlight critical considerations in the submission and suggestions for effective public communications.  As the former Director of the Office of Drug Evaluation-I and the Office of Cardiology, Hematology, Endocrinology, and Nephrology in CDER’s Office of New Drugs, Ellis brings important insights into implementing benefit-risk assessments. More information can be found here.

Patient-Focused Drug Development: Reflecting on a Decade of Insights (June 21, 11am-12pm Central)

It’s been 10 years since the FDA’s Patient-Focused Drug Development initiative was launched, and James Valentine joins a panel to share his lessons learned and future opportunities for engaging FDA.  His experience dates back to his involvement in helping develop and launch the program when at the Agency and has continued, having worked with dozens of patient advocacy organizations, including having helped plan and moderate three-fourths of the 55+ externally-led PFDD meetings held to date.  More information can be found here.

FDA Rare Disease Town Hall with CDER & CBER Center Directors (June 22, 2-3pm Central)

A recurring annual session not to be missed, James Valentine will be moderating a discussion with FDA officials on trends in the development and review of medical products for rare disease, including new regulatory tools and strategies to support this area of development and review.  This year James will be joined by CDER and CBER’s Center Directors, Drs. Patrizia Cavazzoni and Peter Marks, as well as a rare patient community perspective provided by Annie Kennedy from the EveryLife Foundation for Rare Diseases.  More information can be found here.

Information about the meeting and registration can be found here.