FDA's Pazdur Won't Become Oncology Bureaucrat: 'My Presence Will Be Felt'

Richard Pazdur is stepping aside from FDA's Office of Hematology and Oncology Products to head the agency's newly created Oncology Center of Excellence, but he expects to still run twice-weekly group meetings at OHOP.

Richard Pazdur has been named acting director of FDA's new Oncology Center of Excellence as part of the White House's Moonshot initiative, but he anticipates his presence will continue to be keenly felt at FDA's Office of Hematology and Oncology Products, which he's led since it was established more than a decade ago.

"My presence will be felt" at the Office of Hematology and Oncology Products (OHOP), Pazdur told a handful of reporters at Vice President Joe Biden's June 29 moonshot summit at Howard University in Washington, where the Oncology Center of Excellence (OCE) was officially announced (Also see "FDA's Pazdur Jumps Over To New 'Moonshot' Role" - Pink Sheet, 29 Jun, 2016.).

Pazdur emphasized that he didn't want his transition to OCE – which FDA describes as a "program" where the combined skills of regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics and devices will come together to support an integrated approach to the advancement of cancer treatment – to be a disruptive process.

"There have been agreements with companies and evaluation of drugs and certain principles I've established" at OHOP, he said. "I really enjoy what I do, so it's not like I just want to move to become a bureaucrat or administrator," Pazdur declared.

In his new job at OCE, Pazdur said he anticipated "working with the same group of people" he's been interacting with for many years at OHOP, whom he referred to as "personal friends and professional acquaintances."

'Believe Me, I Will Be There'

"So it's not that I'm going to be stepping away in a sense," Pazdur explained. "I am going to be there. Believe me, I will be there."

In fact, he said he likely will continue "running" and attending OHOP's Monday and Friday group meetings, where oncology regulators go over product applications under review.

Pazdur said his yet-to-be-named replacement at OHOP – an office he's brought from 12 medical oncologists to 70 during his tenure – "will not be the same role as I have now, obviously, because I am there and the center is there."

So that person won't be completely filling Pazdur's shoes at OHOP.

But he said he's excited to take on the challenge of setting up the OCE because it's "uncharted territory."

"I always like to do things that are unique and new," Pazdur said. "When I came to FDA in 1999, I had a vision for what oncology should be and that was a more interactive agency and a really academic focus. And this is really keeping in line with this and an expansion of a vision I had in 1999."

Indeed, Pazdur credits the culture of OHOP with helping employee retention (Also see "FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?" - Pink Sheet, 30 Nov, 2015.).

Forward Looking, Not Problem Solving

Pazdur emphasized the OCE currently is evolving and in fact, he is taking on the role of acting director to establish its structure and determine its direction, although Pazdur said he's not simply been given carte blanche.

"Obviously, I'm responsible to other people," Pazdur said, noting he now will be reporting directly to FDA commissioner Robert Califf rather than running an office within the Center for Drug Evaluation and Research (CDER).

CDER Director Janet Woodcock and the directors of the FDA's Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) will also have opportunities to weigh in on OCE's path forward, he said.

Pazdur said he's not under any specific deadline to set up the OCE. "What I'm more interested in doing is making sure everybody's voice is heard," he said. "One of the first things I want to do at this point is to sit down with the review staff."

Pazdur said the number of employees who will make up the OCE will depend on its structure and budgeting.

President Barack Obama requested $75m in his fiscal year 2017 budget for OCE – dollars that must still be approved by Congress – but Pazdur said the FDA has the necessary funds to get the program off the ground, although he noted it has yet to be defined how much will be "borrowed" from the agency's drug, biologics and device centers to set it up (Also see "FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders" - Pink Sheet, 15 Feb, 2016.).

"The structure has to come first and our understanding of how we are going to integrate and how people are going to move and who is going to move, etc., is an important issue," he said.

"At this point, this is a work in progress," Pazdur said. But he said the "whole purpose" of the OCE "is to look forward."

"It's really not to solve a problem," Pazdur explained. "It's really cognizant of the fact the agency has to look forward of how the agency wants to position itself with these new products that are coming out and how they are going to be used."

'The Only Person Who Loves Change Is A Baby With A Wet Diaper'

While there's currently communication among OHOP reviewers and those at CBER and CDRH when examining applications for combination products, Pazdur said the OCE aims to ensure there's a better understanding among the agency's scientists of each of the centers' respective regulatory processes.

As a center of "excellence," Pazdur said the OCE will examine the best practices within the FDA's drug and device centers and determine which ones are appropriate to be exported to the others.

While the idea to set up the OCE was a patient-driven concept, Pazdur noted the FDA has been seeking input from numerous stakeholders, including industry, at various listening sessions over the past few months – pointing out that communicating with people outside the agency has been key.

But Pazdur said he expects there to be some uneasiness in moving the new program forward.

"No one likes change," he said, quoting his late wife in saying "the only person who loves change is a baby with a wet diaper."

"So you really have to bring people together," he said. "Unless you have everybody on board with this, it can't work in an optimal fashion."