"From Innovation to Market: Navigating the Mine Fields"
Dr. Joseph Gulfo, Executive Director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University famously battled the FDA and won over a device in the late 2000s and early 2010s. His product was a melanoma detection device that would better identify melanoma in patients and effectively save more lives. This specific case is famous for the press it got and Dr. Gulfo was here today to explain to the PCT audience his battle plan and how he won the war.
· Build up of arms - peace through strength
o FDA decisions involve more than your product factors you don't know about
o Regulatory counsel
o BPA; Binding Protocol Agreement (with the FDA)
o Money ( He raised nearly 160 million because of the BPA that eliminated regulatory risk for investors)
· Strategy - sweating every detail
o AdComm Panel briefing document –
· Executive summary
o Best, most knowledgeable doctors and statisticians in the field (mock panel)
o Adaptable - change according to conditions on the ground
· Realizing you are in a fight
o Passion, dedication, determination
· Define yourself by the outcome
o Take it to Madison Square Garden (as much PR as possible, the FDA will win in a street fight - the media is your friend)
o Unconventional tactics - media and regulatory strategies (citizen petition)
o Be a leader, a powerful leader
Thank you for following along with PCT 2015 & stay tuned for more updates and recaps from Partnerships in Clinical Trials.
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