Amy McKee, one of Richard Pazdur’s close allies in building out the Oncology Center of Excellence at the FDA, has left the agency to help companies navigate a regulatory landscape she helped shape.
As VP of regulatory consulting services at Parexel, she joins a nascent oncology initiative dedicated to connecting different business units to work up development plans — not unlike how she created a communications structure for different offices across the FDA’s centers for drug, biologics and devices.
“It was time to look at this entire drug development process from a different angle,” McKee tells me. At her new job, she says, “I’m helping companies prioritize which products to develop in which patients through which targets for the best response we can get. and so that’s how I view what I will be doing here. I don’t view it as different from my role at the FDA, I just view it as one of the different partners who is involved in this entire drug development process.”
During McKee’s 11-year career at the FDA, she’s held a frontrow seat to multiple breakthroughs from reviewing olaparib — the pioneering PARP inhibitor now known as Lynparza — to stamping the final seal of approval for Loxo’s tissue agnostic cancer drug.
The past five to eight years have seen research on pathways and immunology that goes back two or three decades come to fruition, leading to the “explosion of highly effective products” and corresponding regulatory innovations, McKee notes.
“That is why in oncology we are able to look at targeted products and say, yes, we know this is targeted and in this population we know that these response rates are real,” she says, “or in immuno-oncology agents we understand that they may take a little bit longer to work, but then you have these sustained responses because the immune system has kicked in.”
Now on her third day at the CRO, news of McKee’s appointment comes a few days after another top regulator — Leah Christl — officially left her position at the FDA’s biosimilar division.
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