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The Cancer Letter – Monica Bertagnolli, first woman and first clinical trials group chair to direct the National Cancer Institute

The Cancer Letter – Monica Bertagnolli, first woman and first clinical trials group chair to direct the National Cancer Institute

President Joe Biden is expected to name Bertagnolli, who is now chief of the Division of Surgical Oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute, to the position of institute director.

The rollout of Bertagnolli’s appointment didn’t go smoothly, as news leaked out on Twitter and in the press, first appearing in STAT, in the morning of July 21, shortly after the White House announced that the president had contracted COVID-19.

Bertagnolli, 63, will be the 16th NCI director since the institute’s founding in 1937 and the tenth since the National Cancer Act elevated the job to the status of a presidential appointment. The NCI director is presidentially appointed but is not subject to approval by the Senate.

Bertagnolli, a past president of the American Society of Clinical Oncology, has decades of clinical expertise and executive leadership in oncology and cancer policy. Her expertise in clinical trials, along with her presidential theme at ASCO in 2018-2019—“Caring for every patient, learning from every patient”—can be taken as clues that her agenda for NCI will include an emphasis on translational science, observers say.

Bertagnolli serves as chair of Alliance for Clinical Trials in Oncology, a clinical trials cooperative group funded through NCI’s National Clinical Trials Network.

At NCI, Bertagnolli replaces Ned Sharpless, who stepped down April 29 (The Cancer LetterApril 9, 2022).

“I believe Monica is a terrific choice to lead the super-charged Cancer Moonshot and be director of the National Cancer Institute,” Sharpless said to The Cancer Letter. “She is an outstanding researcher in surgical oncology, and will understand the challenges of basic scientists, health services researchers, and clinical trialists.

“She has a long-standing commitment to excellence in patient care, training, and addressing health care disparities; all key issues for the NCI today.”

Karen E. Knudsen, CEO of the American Cancer Society, said Bertagnolli is an exceptional choice for leading NCI.

“Her strong track record as a surgical oncologist, scientist, innovator, and leader provide an unparalleled foundation for guiding the next phase of the NCI,” Knudsen said to The Cancer Letter. “At the American Cancer Society, wherein Dr. Bertagnolli serves on the board of directors, we have benefitted from her wisdom, creativity, and dedication to our goal of improving the lives of cancer patients and their families.

“We look forward to continuing to work closely with the NCI to end cancer as we know it—and with Dr. Bertagnolli in this new role.”

Clifford A. Hudis, CEO of the American Society of Clinical Oncology, described Bertagnolli as “an accomplished cancer surgeon and researcher with deep expertise in community-based cancer research.”

Said Hudis:

“During her presidential year, she continually highlighted the need for oncologists to learn from every single patient with cancer, including through clinical research and the application of real-world data and real-world evidence, so that we can accelerate progress and every patient can have the best possible outcome for their disease.

She also spearheaded efforts to increase access to equitable cancer care in rural areas, challenging the status quo and working to remove barriers to patient participation in clinical research, like geographic distance and lack of coverage for routine care costs associated with participating in trials.

Additionally, as group chair of the Alliance for Clinical Trials in Oncology, Dr. Bertagnolli has a strong understanding of the NCI’s mission and how it works to improve the lives of cancer patients. This expertise will be critically important as the NCI continues to address priorities like improving overall access, eligibility, and diversity in clinical trials, increasing investigator-initiated research funding, and advancing the Cancer Moonshot to improve outcomes for patients with cancer.”

Margaret Foti, CEO of the American Association for Cancer Research, said Bertagnolli’s expertise as a translational scientist makes her an excellent choice for NCI.

“Dr. Bertagnolli brings impressive qualifications to this vital position, including her background as a top-tier physician-scientist and much admired professor,” Foti said. “Her appreciation for the value and importance of basic research to advancing translational discoveries, as well as her commitment to ensuring that such treatment innovations reach patients in all populations across the United States, will ensure that the NCI continues to lead the way in programs aimed at improving health, preventing cancer, and reducing the incidence and mortality from this devastating disease.”

Bertagnolli is a member of the AACR’s Tumor Microenvironment Working Group and Women in Cancer Research membership group.

“I offer my heartfelt congratulations to Dr. Bertagnolli on her appointment as the next NCI Director,” said AACR President Lisa M. Coussens. “The AACR looks forward to collaborating with her in support of the NCI’s many initiatives, including increasing diversity in cancer research, furthering education and training of the cancer research workforce, improving funding across the cancer continuum, and working together with NCI-designated cancer centers to solve the biggest problems in cancer.”

“They don’t get any more expert than Dr. Bertagnolli”

Chairs of clinical trials groups were delighted to see their peer appointed to lead the institute.

Charles D. Blanke, chair of SWOG Cancer Research Network and Professor of Medicine at Oregon Health and Science University’s Knight Cancer Institute, said Bertagnolli’s expertise will allow NCI to rapidly test emerging scientific leads.

“This is the perfect time, given the amazing recent breakthroughs achieved in translational oncology research, to have a National Clinical Trials Network expert head up the NCI. And they don’t get any more expert than Dr. Bertagnolli,” Blanke said to The Cancer Letter. “SWOG could not be happier with this choice. It’s wonderful news for the country and for everyone involved in cancer research.”

“Dr. Bertagnolli is a high-profile leader in cancer research and an early and visionary proponent of collaborative interactions across basic and clinical research,” Peter J. O’Dwyer, group co-chair of the ECOG-ACRIN Cancer Research Group and professor of medicine at the Hospital of the University of Pennsylvania and the Presbyterian Medical Center of Philadelphia, said to The Cancer Letter.

“She brings the insights of her highly successful leadership of the Alliance for Clinical Trials in Oncology to the potential for clinical trials to be amplified through engagement of diverse populations, so as to bring advances in cancer care to all.”

“I am happy to see a giant in cancer care and clinical research appointed as the next director of the NCI,” said Mitchell D. Schnall, group co-chair ECOG-ACRIN and the Eugene P. Pendergrass of Radiology, and the Chair of the Radiology Department at the Perelman School of Medicine at UPenn, said to The Cancer Letter.

“Dr. Bertagnolli brings many strengths to this national leadership role, especially an innovative approach to collaboration, advancement of women to leadership positions, and her understanding of cancer as a practitioner. I look forward to seeing what she will bring to the future of the institute’s programs,” Schnall said.

“The right person at the right time”

“I am thrilled. This is fantastic news for cancer, cancer patients, and cancer science,” Ellen V. Sigal, founder and chair of Friends of Cancer Research, said to The Cancer Letter. “It’s a fantastic choice. She is the right person at the right time. I am thrilled that she is a woman leader and that she is a physician treating patients. The fact that she has clinical trials experience is incredible.”

Otis W. Brawley, the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University, said the depth of Bertagnolli’s understanding of clinical trials and health equity makes her an excellent choice.

“I have known Monica for three decades. She is a wonderful human being. She is the consummate physician scientist and a superb clinical trialist,” Brawley said to The Cancer Letter. “She understands all the issues, she appreciates the need to focus on prevention/risk reduction as well as equity in care, efficiency of treatment and survivorship.”

Bertagnolli’s emphasis on health disparities and the need for strengthening clinical research shaped her ASCO presidency.

Many cancer patients are not realizing the benefits of progress against cancer “either because we lack acceptable treatments for their cancer or because of the widening gaps in socio-economic status across the United States that put available treatments out of reach for some,” Bertagnolli wrote in a guest editorial in this publication (The Cancer LetterJan. 18, 2019).

As ASCO president, she held a series of meetings with patients and care providers.

Wrote Bertagnolli:

“These visits are heart-warming and heart-breaking. At every meeting is a story of dedication, resourcefulness, and community support to meet the needs of cancer patients. This illustrates a central dilemma that we face: how to structure our healthcare system so that each unique community has what it needs to support the patients and providers of cancer care.

We cannot solve complex problems without understanding them, and understanding requires information: data from the clinical setting. It is time to give every patient the opportunity to participate in research and contribute to progress. ASCO is working toward this mission in a number of areas, including expanding eligibility criteria for clinical trials and removing financial barriers to broaden clinical trial participation.

I once heard someone say the only participants in cancer clinical trials are marathon runners who have cancer and happen to live in cities with large cancer centers. Notwithstanding the hyperbole, the fact remains that clinical trial participants differ significantly from the greater population of cancer patients, especially as it relates to race, ethnicity, and age.

This potentially makes the results of our research less applicable to treating more diverse patient populations seen in clinical practice. We know from many studies involving cancer patients that the greatest determinant of whether a patient participates in a clinical trial is whether their physician discusses participation. While there are many reasons that trial participation by both clinicians and patients is low, we need to do what we can to encourage clinicians to enroll patients and make it easier to participate in research.

A major barrier to clinical trials access is stringent eligibility criteria, leading to fewer patients qualifying to participate. Cancer researchers and sponsors have a responsibility to broaden eligibility criteria for clinical trials participation in order to rectify this issue. ASCO, Friends of Cancer Research, FDA, NCI, the NCI Cooperative Groups, and many other stakeholders are working to increase the diversity of clinical trial participants by broadening eligibility criteria…

Considerable work remains to give every patient the opportunity to participate in, and benefit from, cancer clinical trials, but it is a task that all oncologists must embrace. We owe it to our patients and our field to give everyone a chance to contribute to research that increases our understanding of and leads to better treatments for cancer.”

As president of ASCO, Bertagnolli set out to create a lingua franca for electronic health records and deployed an initiative, dubbed mCODE, to introduce common standards for cancer data elements (The Cancer LetterJune 7, 2019).

“Through her work as chair of the mCODE Executive Committee, Dr. Bertagnolli successfully spearheaded development of mCODE—short for Minimal Common Oncology Data Elements—a health data standard now approved by Health Level Seven International (HL7) designed to facilitate digital cancer data interoperability and improve patient care and research,” ASCO’s Hudis said to The Cancer Letter.

Bertagnolli’s research is focused on the APC (Adenomatous Polyposis Coli) gene, an important factor in colorectal carcinogenesis and in the development of desmoid tumors, according to the Dana-Farber/Harvard Cancer Center research consortium.

Using animal tumor models of the human disease, Familial Adenomatous Polyposis, Bertagnolli’s laboratory investigates the mechanisms of tumor transformation initiated by APC mutation or loss. Her laboratory also studies modulation of APC gene activity and tumor formation by chemopreventive drugs. This work includes animal model studies, and also human clinical trials in colorectal adenoma prevention and risk assessment.

Bertagnolli credits her grit as a physician and surgeon to her formative years on her family’s cattle ranch in Wyoming. “Back then surgery was a fairly hostile environment for women: the hours were brutally demanding, and it took many years to finish,” Bertagnolli said in 2018 to The ASCO Post. “I came from a ranching background, so I wasn’t about to let a male culture intimidate me.

“When I was a kid, we raised sheep, but it later became a working cattle ranch and remains one to this day. It was a wonderful way to grow up; the state itself is simply gorgeous,” Bertagnolli said. “We were 60 miles away from the nearest town, so we had to be independent and resourceful. If something broke you needed to fix it yourself, and when it came time to make dinner, you had to make do with whatever was available. I have two brothers and a sister, and we’re all pretty good at preparing and planning ahead, largely due to growing up on an isolated ranch.”

Bertagnolli attended Princeton University as an undergraduate, received her medical degree from the University of Utah College of Medicine, and completed her residency at Brigham and Women’s Hospital. She was elected to the National Academy of Medicine in October 2021.

Douglas Lowy will continue to serve as the NCI acting director while Bertagnolli’s appointment is finalized.

Lowy has stepped up in the acting director role three times in recent years: following Harold Varmus’s departure in 2015, during Sharpless’s stint at the helm of FDA, and following Sharpless’s resignation.