Benjamin Holt Email & Phone Number

I am an attorney with significant public service experience who has practiced in various areas of law advocating on behalf of clients and recently serving as a hearing officer making and writing agency decisions. I also recently earned a certificate in regulatory affairs where I was trained on FDA and global submission requirements (eCTD, NDA, BLA, 501K, PMA); clinical research requirements (IND, IRB); and post-market requirements (adverse incident reporting, ad/promo).As a lawyer, I have learned how to research, read, and understand “The Rules.” However, I also understand that, like the frame of a building, there is room to be creative as you design and flesh out the floors if you respect the basic structural requirements. For example, I negotiated a deal that greatly reduced my client’s liability by letting my client voluntarily comply with corrective action to the satisfaction of the State. Ordinarily, such corrective action would have been ordered and monitored by the Court as part of more restrictive measures, but the deal I negotiated granted my client greater freedom.This kind of creative problem solving and critical thinking within the rules didn’t just come from nowhere. I’m a strategy gamer. I’ve been reading and using the rules to my advantage my whole life. As a young child, my father taught me games that required me to understand the rules of the game, analyze the state of the board, do a cost-benefit analysis, plan out a strategy to win, and the execute that strategy while adapting on the fly to changes as the game progressed. I have honed those skills and learned how to apply them to life in general.If you think my skills in problem solving and strategic thinking can help your organization thrive, please feel free to reach out to me at benjamin.holt @ alumni.duke .edu.