HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought Leader

HP&M’s James E. Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected

Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Law360 has recognized one of our firm’s Directors, James E. Valentine, as a 2023 Rising Star.  The honor was bestowed on only 183 attorneys, which is awarded to “top attorneys under 40 whose legal accomplishments belie their age.”  James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., Duchenne, Friederichs’s Ataxia, Sickle Cell Disease, Chagas, ALS).  This includes both forging the application of the FDAMA 115 “single study plus confirmatory evidence” standard as well as expanding the use of accelerated approval for products in conditions outside of cancer.

James’s status as a 15-year champion for bringing patient voices to the table with FDA and industry decision-makers was also considered.  James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development.  He is proud to have helped establish the Patient-Focused Drug Development initiative while working at FDA and has since gone on to help organize nearly three-quarters of the 76 externally-led PFDD meetings to date.

We are proud as a firm of this honor and would also like to extend congratulations to all of this year’s Law360 Rising Stars!

HP&M’s Kurt R. Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader

HP&M Director Kurt R. Karst was named by Who’s Who Legal: Life Sciences 2023 as one of only 14 “Global Elite Thought Leaders.”  This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.  Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

In addition to Mr. Karst, ten other HP&M Directors were tagged as “Recommended” by WWL: Life Sciences 2023:

• Ricardo Carvajal
• Robert A. Dormer
• Jeffrey N. Gibbs
• Paul M. Hyman
• Alan M. Kirschenbaum
• Allyson B. Mullen
• Frank J. Sasinowski
• Jeffrey K. Shapiro
• Anne K. Walsh
• Jeffrey N. Wasserstein

Congratulations to all of the WWL: Life Sciences 2023 awardees!