HP&M’s James E. Valentine Named Prime Lawyer Below 40; Solely Meals and Drug Lawyer Chosen
Hyman, Phelps & McNamara, P.C. (HP&M) is happy to announce that Law360 has acknowledged certainly one of our agency’s Administrators, James E. Valentine, as a 2023 Rising Star. The dignity was bestowed on solely 183 attorneys, which is awarded to “prime attorneys below 40 whose authorized accomplishments belie their age.” James was solely certainly one of 5 life sciences attorneys chosen and the one meals and drug lawyer to make the record.
Amongst his accomplishments, Law360 thought-about the function James has performed in leveraging little-used pathways to FDA approval for sometimes first-ever medicine to deal with uncommon ailments (e.g., Duchenne, Friederichs’s Ataxia, Sickle Cell Illness, Chagas, ALS). This contains each forging the applying of the FDAMA 115 “single research plus confirmatory proof” normal in addition to increasing using accelerated approval for merchandise in situations exterior of most cancers.
James’s standing as a 15-year champion for bringing affected person voices to the desk with FDA and trade decision-makers was additionally thought-about. James is acknowledged as serving to essentially shift the tradition to contemplate the affected person voice as an integral a part of drug improvement. He’s proud to have helped set up the Affected person-Centered Drug Growth initiative whereas working at FDA and has since gone on to assist arrange almost three-quarters of the 76 externally-led PFDD conferences so far.
We’re proud as a agency of this honor and would additionally like to increase congratulations to all of this 12 months’s Law360 Rising Stars!
HP&M’s Kurt R. Karst Awarded WWL: Life Sciences 2023 World Elite Thought Chief
HP&M Director Kurt R. Karst was named by Who’s Who Legal: Life Sciences 2023 as certainly one of solely 14 “World Elite Thought Leaders.” That is an achievement that solely round 5% of WWL-listed practitioners had been accorded in 2023. Mr. Karst, a co-author of the FDA Regulation Weblog, offers regulatory counsel to pharmaceutical producers on Hatch-Waxman patent and exclusivity, drug improvement, pediatric testing, and orphan medicine. He helps purchasers develop methods for product lifecycle administration, acquiring approval, managing post-marketing points, and defining durations of exclusivity.
Along with Mr. Karst, ten different HP&M Administrators had been tagged as “Really useful” by WWL: Life Sciences 2023:
Congratulations to the entire WWL: Life Sciences 2023 awardees!