HP&M Promotes James Valentine to Director

Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that James E. Valentine will become the firm’s newest Director beginning on January 1, 2023.  James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure.  James has been involved with the approval of many new molecular entities, often for serious and rare diseases, several which utilized the accelerated approval pathway (see examples discussed here and here).  A unique aspect of his practice has been to ensure that patient stakeholders have a voice in drug development and approval decision-making, having helped to organize nearly 75% of the over 65 externally-led Patient-Focused Drug Development meetings held since the initiation of the program in 2015.  James’s work to advocate for the needs of rare disease patients was recognized by Global Genes, when in 2019 the organization named him a RARE Champion of Hope.

“James’s commitment to tackling the most challenging drug development scenarios, bringing a depth of technical expertise and a breadth of experiences that stem from nearly weekly meetings with FDA, offer our clients paths forward to develop important new drugs that may help to relieve the suffering of our brothers and sisters living with a wide range of devastating conditions,” said Frank Sasinowski, HP&M Director. “He brings compassion and hope to those very patients and their caregivers, ensuring they have a seat at the table with FDA officials and industry executives, a model of drug development that James has helped to pioneer.”

James joined the firm from the FDA, where he facilitated patient input into regulatory decision-making and, among other things, helped develop and launch the Patient-Focused Drug Development program.

His full bio can be found here.