Executive Summary

US FDA oncology chief celebrates his 20th year at the agency with a frank and wide-ranging podcast interview in which he addresses the next (two) phases of the Oncology Center of Excellence, his ‘think it/do it’ mentality, and whether advisory committees still give good advice.

Richard Pazdur is clearly having a lot of fun.

After 20 years at the US Food and Drug Administration – and 40 years as a practicing oncologist – the agency’s cancer chief has carved out the perfect place at FDA to both make a major impact on cancer research and development while also doing what he loves most: driving innovation.

Rather than FDA’s oncology CEO, Pazdur likes to think of himself as the oncology CIO: the Chief Innovation Officer. In that role, he can both be at the forefront of new developments in oncology R&D – like tissue-agnostic approvals and the development of neoadjuvant therapies – while also thinking up new ways to make the drug development and review process more efficient.

Pazdur’s dual role as director of the Oncology Center of Excellence and acting director of the Center for Drug Evaluation & Research’s Office of Oncologic Diseases (known inside FDA as “double-O-D”) means he can create innovative regulatory programs and drive their implementation in the review divisions. “If I want something done … I say ‘let’s do it, and they are more than willing,’” he said during a podcast interview. (For the audio of the interview, see link at the bottom of the story.)

“Project Orbis” is a perfect example of Pazdur’s “think it/do it” mentality. Aware that patients in other countries often do not have access to oncology breakthroughs as soon as those in the U.S., Pazdur created a parallel review pilot program with regulatory authorities in Canada and Australia, using the approval Eisai Inc.’s Lenvima (lenvatinib) in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab) in advanced endometrial carcinoma.  (Also see “US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer” – Pink Sheet, 17 Sep, 2019.)

In speaking about the genesis of Project Orbis at the Friends of Cancer Research annual meeting in November 2019, Pazdur said he called up then-acting Commissioner Ned Sharpless and Principal Deputy Commissioner Amy Abernethy, explained the program and received their blessing.

In short, OCE’s multinational parallel drug review program got off the ground, Pazdur said, because “I just decided to do it.”  (Also see “Importation, Pricing Policies Raised Concerns For US FDA’s Project Orbis” – Pink Sheet, 13 Nov, 2019.)

That anecdote got a big laugh at the Friends annual meeting, but Pazdur’s dual role as chief of both OCE and OOD, he says, is what makes scenarios like that possible. “The success of the oncology program is because of this unified feature,” he said during the podcast. In planning for OCE, the center of excellence was initially to be segregated from the review division. “I put my foot down. I said this would not happen. And obviously, I won that.”

“I will warn people that if [separation] does occur, you will see a dramatic change in oncology and how drugs are approved here,” he said. “You can’t have two leaders of oncology.”

OCE “Not A Completed Picture”

Pazdur loves labeling his OCE innovations as one “Project” or another (see: “Project Facilitate,” “Project Point/CounterPoint,” “Project Orbis”), and his most recent is no different. “Project Avatar” (which Pazdur thought up at the gym; he is a spin class enthusiast) is a simple idea to make regulatory discussions more effective by hosting internal meetings via the web rather than staff calling in and not be able to hear and easily participate in the discussion.

“It’s just a spontaneous thing, but you need that interaction,” he said. “My management style, as many people know, I’m very direct with people. I also love to talk to people and get to know them. I’m very involved with walking around the office. My doors are never closed. I want people to come and tell me what their problems are. I don’t want them to fester and have things blow up.”

OCE is his innovation hub for the review divisions, and three years after being stood up, the center is still in “version one,” Pazdur said. There will be “version two, version three throughout the years. So this is not a completed picture.”

The original game plan – at least under then-Commissioner Scott Gottlieb – was to expand the center of excellence concept to other therapeutic areas.  (Also see “Cures Bill Authorizes ‘Intercenter Institutes,’ But Will US FDA Create Them?” – Pink Sheet, 28 Nov, 2016.) Given that, “we have to get it right. It is not 100% right at this time,” he said. “We have to work on the optimal structure.”

When asked what the next versions of OCE might look like, Pazdur demurred. “I know exactly what I want to do,” he said, but “I’m not telling you.” He did provide a somewhat vague tidbit: “centralization of the clinical staff within one organization,” and then using a “matrix activity” of the disciplines, such as manufacturing.

An “Inherent Tension” With CDER

Despite his dual roles, Pazdur acknowledges an “inherent tension” between OCE and CDER. While the two reside on the same line on the FDA org chart, they are charged with very different mandates. The idea behind the reorg of CDER’s Office of New Drugs is to provide uniformity and consistency between review divisions. The charge of the OCE, by contrast, is innovation. “You have this dichotomy here. This is one of the things that I have to navigate.”

Above all else, perhaps, Pazdur detests agency bureaucracy. “The FDA does not need more bureaucracy. It does not need more structure. It does not need more offices. It does not need more committees. It needs more leadership,” he said.

“Bureaucracy will never, ever compensate for ineffective leadership,” Pazdur said, pounding the table for emphasis. “Bureaucracy will never compensate for poor quality review staff.”

Despite those anti-bureaucracy feelings, Pazdur does not feel any pressure from the top in terms of making regulatory decisions. “Some people from the outside think the FDA commissioner is calling me up and asking me what we’re going to be do with a specific application.” That, he said, has never happened.

“In 20 years, I have never had a conversation … with the commissioners” about whether or not to approve an application. “They have been very hands-off as far as the running of the day-to-day applications – or even regulatory policy.”

Every job has its headaches – for Pazdur, it’s FDA bureaucracy (he used that term at least a dozen times in our hour-long podcast). But while he could be making triple his salary elsewhere, Pazdur enjoys the freedom afforded to him after 20 years in oncology regulation. And he sees the work as important: “There are many Earth-shattering things that are happening in oncology,” he said. “We have to be part of them.”

https://pink.pharmaintelligence.informa.com/PS141498/Richard-Pazdur-20t…