Legal Challenges of International Drug Development

Many thanks to Clint Hermes, JD, for speaking with me about his work with biomedical research regulatory matters on The Art of Medicine with Dr. Andrew Wilner. We talked about his legal training at Harvard Law and how he became interested in this field. He’s worked at two academic medical centers, including St. Jude in Memphis, Tennessee. He is currently an attorney with Bass, Berry, and Sims. Clint works with different entities that require legal assistance with regulatory matters when conducting clinical trials such as academic centers, pharmaceutical companies, and even private physician groups. He discussed the importance of IRBs to protect human subjects as well as new statutes that mandate a single central IRB rather than multiple IRBs for federally funded studies. Clint observed that human subject protection had improved dramatically in the US since the Tuskegee syphilis study. However, questionable research practices are still a significant problem, especially in certain countries. Clint has done a lot of international travel and worked on behalf of clients in Africa, the Middle East, and Southeast Asia. He discussed the problem of research fraud and the role of the US Office of Research Integrity in preventing scientific misconduct in federally funded studies. Clint also touched on the regulatory process necessary to get FDA approval of a new vaccine. You can watch the program here: https://www.youtube.com/watch?v=oMDURUnxozM&t=109s Or listen: http://andrewwilner.buzzsprout.com. Your feedback is welcome!

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