Run it by FDA first, FDA’s newly retired Office of Medical Policy Director Rachel Sherman said, of major drug development decisions.

Sherman has joined consultancy Greenleaf Health as a principal focusing on drugs and biologics with a mission to help biopharmaceutical companies avoid common mistakes by emphasizing often-forgotten agency resources.

Sherman will bring a quarter century of regulatory experience, including crafting key policies related to breakthrough drugs, biosimilars and safety surveillance to Greenleaf, where she will join many former senior FDA officials including company President Patrick Ronan, former FDA chief of staff.

The agency is not just a regulator, but a resource for industry, Sherman said in an interview. But while working on the review side, she found that companies “didn’t avail themselves of the resource as often as they could. I think that is something I would like to help foster.”

Simple Mistakes Doom Applications

“More is better,” Sherman said of industry-FDA interaction.

In addition she said she hopes to be able to help “bridge” different drug development stakeholders through partnerships like the many government, industry, academic and non-profit endeavors she worked on at FDA.

Sherman said she “really became a huge believer in the power of partnership and the power of bringing all the factors together,” but each party needs to understand the perspective of others involved because each organization will come to a collaborative venture with certain necessities that they cannot part with or break.

Sherman said she often sees companies make mistakes in their development programs that could have been avoided if they simply ran the choice by the FDA first.

She pointed to a January Journal of the American Medical Association paper authored by FDA employees that found that many drug applications are rejected by the agency not due to lack of efficacy or safety but because the information supplied with the application was unsatisfactory to make an adequate efficacy and safety determination.

For instance, many companies selected the wrong drug dose or suboptimal patient population or endpoint for Phase III Also see "Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows" - Pink Sheet, 21 January, 2014..

“If you look at that paper, applications often are not approved for example, because of missing data, which everyone fears,” she said. “Some of the frequent reasons for non-approval, at least first cycle, were things that probably should have been and could have been discussed early on, what is the endpoint, what is the right population. Things like that. Those conversations should happen early and often.”

At times of big decisions, there should be a discussion, Sherman said. This includes decisions during the pre-IND phase to end-of-Phase II meetings and even during the application review process.

Sherman acknowledged that FDA can be “somewhat of a black box or it’s hard to get people on the phone. … It cuts both ways.”

The oncology and antiviral offices are terrific examples of parts of the agency that have worked to make access for industry as efficient and fast as possible and companies have taken notice, she said.

“It’s very easy to point a finger at the agency and say ‘gee they are not responsive,’” she said because FDA isn’t in a position where it is always permitted to say “look at all the applications where we have done, x, y, and z.”

Sherman said she isn’t advocating for any formal changes in FDA/company interaction. Instead, she said firms should take advantage of both informal and formal opportunities for interaction.

She wants to make sure the interactions happen and “that they are as transparent as possible.”

Another problem Sherman found was that companies would make mistakes because they weren’t reading all of the available guidance and regulation on a topic. “Anything that is out there really should be thought about and looked at.” She found this could be a problem of both large and small companies alike.

“Certain people or certain companies had it down to a science and ran a really tight ship and others didn’t.”

Life-Cycle Expertise, Life-Cycle Influence

Sherman influenced all phases of drug development in her time at FDA from pre- to post-market. Towards the end of her tenure, she made her mark on antibiotic policy, helped influence the designation of “breakthrough” products, engaged in clinical trial design issues and programs such as the Critical Path Institute and was key to the development of new biosimilar policy.

She also had her hands in advertising, as OMP oversaw the Office of Prescription Drug Promotion and she spearheaded the post-market surveillance Sentinel Initiative Also see "FDA Policy In Biosimilars, “Breakthrough” And Social Media Under New Management" - Pink Sheet, 19 December, 2013..

She began her career with FDA in the Division of Antiviral Drug Products at the Center for Drug Evaluation and Research in 1989, eventually rising to clinical team leader. In 1998, she became Deputy Office Director for the Office of Drug Evaluation I and a year later she became deputy office director for CDER’s newly established Office of Medical Policy.

Sherman hopes to be able to continue to make waves in all areas of drug regulation, though she will be prohibited from direct agency interaction for a year. At Greenleaf, she will expand the drug capacity, which prior to her arrival was composed largely of one ex-FDAer – Linda Carter, formerly associate director of CDER’s Office of Drug Evaluation I.

“I’d like to keep doing all of it,” Sherman said. “I’d like to do product-specific development work. I’d like to remain active in the policy arena with some of the colleagues that I worked with at the agency.”

Among the policy areas where Sherman wants to be particularly active are promotion and labeling. “Communication of medical product information is crucial,” she said.

But she also cautions that she joined Greenleaf because she wants to use her experience to advise clients, and not her connections to senior FDA leadership to wield influence.

Former FDA Medical Policy Head Joins Greenleaf, Will Highlight FDA As “Resource”

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