Alum headed for ‘once-in-a-lifetime job’ at FDA

stenzel_interview.jpgDr. Tim Stenzel’s new post is culmination of successful career in academic medicine and industry

It has been a busy summer for Tim Stenzel, MD, PhD. In early July, the former Duke Pathology trainee and faculty member was back in North Carolina for his daughter’s wedding. Amid the celebration, he and his wife were putting an offer on a new house in Maryland and preparing to move from San Diego to the East Coast. It all had to happen fast: On July 23rd, Dr. Stenzel began his first day at the U.S. Food & Drug Administration as director of the Office of In Vitro Diagnostics and Radiological Health (OIR).

“It’s a once-in-a-lifetime job, and one you don’t turn down!” Dr. Stenzel says of the post and the craziness that he and his family went through to get there.

Dr. Stenzel first came to Duke in 1983 to begin the Medical Scientist Training Program, earning his medical degree and a doctoral degree in microbiology and immunology. Sal Pizzo, MD, PhD, who was on the MD/PhD admissions committee and later became chair of the Department of Pathology, took notice of the bright young physician-scientist. After Dr. Stenzel’s residency and an NIH fellowship in a human genetics research lab, Dr. Pizzo—who remained a key mentor throughout Dr. Stenzel’s training and career—asked him to join the faculty and challenged him to create and direct the Duke Clinical Molecular Diagnostics Laboratory. (That lab, which opened in 1997, is still in existence, and is run by one of Stenzel’s former post-docs, Siby Sebastian, PhD, now a professor.)

In 2003, Dr. Stenzel left academia for industry, although he remained adjunct faculty until joining the FDA. An FDA connection led him to make the jump—perhaps foreshadowing recent career developments.

“In the 1990s, the FDA changed some of its regulations, and unfortunately companies hadn’t yet developed FDA-approved tests for us to use in the Clinical Molecular Diagnostics Lab, so it fell to us to develop our own tests that we could rely on to manage patients,” he explains. “It was very challenging, but we did it.”

As time went on, few companies jumped in to fill this need, so when Dr. Stenzel was approached by a company called Vysis (now Abbott Molecular) to become their first medical director and guide research and development of new molecular products, he felt it was worth the unknowns of moving from academia to industry.

“I knew I could make a difference by going into industry and developing products that could be approved by the FDA—by going and doing what I’d been asking all of these companies to do for our lab. It was a chance to put my money where my mouth was.”

500px-Stenzel w autoradiograph 11-1996.jpgIn the ensuing years, Dr. Stenzel has also served as chief scientific officer and founder of the molecular diagnostics franchise at Quidel, and chief medical officer and vice president of R&D at Asuragen. He has played important roles in the development, FDA-approval, and launch of more than 30 in vitro diagnostic products, as well as numerous unique laboratory-developed tests, including the FDA-approved companion diagnostic for Novartis’ drug Rydapt and the world’s first clinical microRNA assay (for pancreatic cancer detection). 

Since 2014, he has been chief operating officer at Invivoscribe, where he has focused on developing dozens of next-generation sequencing assays. “That’s the new, exciting technology in our field right now, and it offers really challenging opportunities to innovate from a regulatory perspective.”

That makes this the perfect time for Dr. Stenzel to make the jump to our nation’s top regulatory agency. As OIR director, he will oversee a team that reviews diagnostic testing, radiological medical devices, and radiation-emitting products and will advise FDA leaders on issues that impact regulatory decisions, policy development, and programs.

The position will require Dr. Stenzel to draw on his prior experience in academia, industry, companion diagnostics, clinical lab management, and more. “It’s really important for us to figure out how to regulate these emerging technologies without slowing progress, so we don’t limit or slow down the ability to help patients,” he notes.

In fall 2019, Dr. Stenzel will return to Duke Pathology as the keynote speaker for the department’s annual Science Retreat. He looks forward to being back where his career began.

“I feel a deep connection to Duke Pathology,” he says. “I had a fabulous time, in training and on the faculty. I enjoyed the faculty and my co-residents. The quality of everybody is just so high, that it made a wonderful professional and learning experience.”

As he embraces this once-in-a-lifetime opportunity at the FDA, Dr. Stenzel recalls a similarly singular and life-changing opportunity he was given at Duke. “The chance to create and run a world-class molecular diagnostics lab at a top institution like Duke, that served not only the Pathology Department but all the other departments at the Medical Center, was incredible. That experience really set me up for success in industry and for this role at the FDA. It allowed me to understand the challenges, the opportunities, the impact on patients, the benefits and the risks of testing, the safety concerns, the regulatory process…. I’m excited to begin this new challenge, and I know that I’m building on a really strong foundation that was established at Duke.”

Photo: Dr. Stenzel at Duke in 1996 with an autoradiograph, developing the future Clinical Molecular Diagnostics Laboratory