Soon after Scott Gottlieb announced he was stepping down, he released a statement (Scott Gottlieb’s March 14th, 2019 Statement) that talked about the clinical research landscape and we, at Kineticos, were quite shocked by some of the things that he said. Specifically, former FDA Commissioner Gottlieb stated, “Efforts to streamline medical product development based on advancing science can be frustrated by legacy business models that discourage collaboration and data sharing”. He then goes on to say, “Without a more agile clinical research enterprise capable of testing more therapies or combinations of therapies against an expanding array of targets more efficiently and at lower total cost, important therapeutic opportunities may be delayed or discarded…”

Moderator:

  • Shailesh Maingi, Founder & CEO, Kineticos

Panel Members:

  • Peter Benton, President & COO, Worldwide Clinical Trials
  • Rich Shea, CEO, Eldec Pharmaceuticals
  • Trey Putnam, Professor, Division of Clinical Translational Sciences, School of Pharmacy, Texas Tech University Health Sciences Center

Kineticos: “I was quite taken back by this but before we address his strong comments, let’s first think about the job the FDA has done to modernize our drug development system. When Scott Gottlieb was chosen for this position, the consensus within the industry was that he was a good choice. He is a physician, a cancer survivor, an investor, so he understands the space really well. Peter, starting with you, let’s grade the FDA over the past few years. Were we right about Gottlieb?”

PB: “Our view at Worldwide Clinical Trials is that the FDA has turned from gate keeper to enabler. Traditionally, the agency was envisioned as an organization with a mandate to assure compliance with regulations, under the umbrella of protecting patient welfare, while ensuring that trial conduct fell within precedent compared to other approved therapies. Today, the FDA is an enabler.”

To download the full discussion, click here:  The FDA’s Shift from Gate Keeper to Enabler


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