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The Cancer Letter – After 7 months at NCI, Bertagnolli is about to be named NIH director

The Cancer Letter – After 7 months at NCI, Bertagnolli is about to be named NIH director

Multiple sources have confirmed that President Joe Biden intends to nominate Bertagnolli to the post of NIH director. Bertagnolli has served as head of NCI for not-quite seven months (The Cancer LetterOct. 7, 2022).

At AACR, Bertagnolli was rolling out her National Cancer Plan, which updates the thinking behind the cancer program (The Cancer LetterApril 14,  April 7,  March 24, 2023). The plan, published April 3, is organized around eight goals that span the spectrum of cancer prevention, treatment, and survivorship—aimed at achieving the objective of the White House Moonshot to cut the cancer mortality rate by half within 25 years (The Cancer LetterApril 7, 2023).

Further development of the plan is being spearheaded by the President’s Cancer Panel, chaired by Elizabeth Jaffee, professor of oncology and deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

We need more treatments, and we need more ability to do clinical research that broadly reaches every human being. Then, finally, we need much more to cover the last mile to make sure that anything we do truly does get to everyone who needs it.

Monica M. Bertagnolli

Another Bertagnolli initiative, the newly-created Clinical Trials Innovation Unit, brings together cooperative group chairs, leaders of other clinical trials networks, as well as FDA and the industry, will be fully described at the upcoming annual meeting of the American Society of Clinical Oncology.

The unit is co-directed by Sheila Prindiville, director of the NCI Coordinating Center for Clinical Trials, and Michael J. Morris, head of the Prostate Cancer Section, GU Oncology, at Memorial Sloan Kettering Cancer Center. Morris has been detailed to spend half of his time on this project at NCI.

In February, Bertagnolli created the CTIU, which was involved in launching Pragmatica-Lung, a phase III trial to evaluate the efficacy of ramucirumab plus pembrolizumab in non-small cell lung cancer, in less than a year (The Cancer LetterFeb. 10, 2023). Pragmatica-Lung opened for enrollment April 12 in 126 sites (The Cancer LetterDec. 2, 2022; April 14, 2023).

“We need to do better, and we need to change and innovate—always. And clinical trials are enormously complex,” Bertagnolli said in a recent conversation with The Cancer Letter. “And the National Clinical Trials Network is doing really important work right now with our existing structures.

“In order to really innovate and break the mold and frankly take some risks, we decided the best way to do it was to provide a dedicated team at NCI in collaboration with FDA and the leaders of the clinical trials groups to innovate,” Bertagnolli said. “The Clinical Trials Innovation Unit is about really new, different, break-the-mold ideas.”

The top job at NIH has been held by Interim Director Lawrence Tabak since December 2021.

The NIH job would allow Bertagnolli to pursue her oft-stated objectives of data integration and data-sharing.

This would include deriving data from clinical care environment and using it to inform research. Also, from the NIH position, Bertagnolli would be able to focus on increasing capacity in clinical trials across medicine.

Several cancer groups expressed support for Biden’s likely decision:

Clifford A. Hudis 
CEO, the American Society of Clinical Oncology

Dr. Bertagnolli would be an excellent choice if she were nominated to lead the National Institutes of Health. She has the ideal combination of scientific background, medical experience and dynamic leadership required for the role and would be an authentic, bold force for patients and for science.

Karen Knudsen
CEO of the American Cancer Society and the ACS Cancer Action Network

In her seven-month tenure as NCI director, Dr. Bertagnolli quickly demonstrated her strategic and comprehensive approach to accelerating progress in cancer prevention, detection and treatment. Among her accomplishments in the last half-year, Dr. Bertagnolli released a robust National Cancer Plan, laying out an inspired roadmap to advance the Cancer Moonshot Initiative, to end cancer as we know it.

We anxiously await the formal announcement from President Biden for this outstanding choice and look forward to working with Dr. Bertagnolli toward our shared vision to end cancer as we know it, for everyone. We urge swift confirmation by the Senate as ACS and ACS CAN look forward to working with Dr. Bertagnolli to continue the essential research necessary to ensure everyone has a fair and just opportunity to prevent, detect, treat, and survive cancer.

Ellen Sigal
Chair & founder of Friends of Cancer Research

If nominated, this will be a truly inspired choice. As a physician scientist and a patient herself, Dr. Bertagnolli understands the intricacies and personal impact of biomedical research. In a short period of time, she has show her incredible leadership at the NCI, and I have no doubt she will do the same at the NIH.

Rachel Pollock
Vice president of ACT for NIH

ACT for NIH is thrilled by the President’s nomination of Dr. Monica Bertagnolli for Director of the National Institutes of Health. Dr. Bertagnolli is a revered cancer researcher and a proven leader with the bold vision and skills to meet the challenges and opportunities at the greatest time in history for scientific discovery. NIH funding is vital to the health and wealth of our nation, and Dr. Bertagnolli will persuasively articulate with Congress how NIH-funded research drives our economy, reins-in sky-rocketing healthcare costs, and spares millions from the ravages of disease.