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Category: In the News

Stat News – Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief

WASHINGTON — The Biden administration has selected Monica Bertagnolli, a renowned surgical oncologist, as the next director of the National Cancer Institute, according to two sources familiar with the decision. Bertagnolli, currently a surgeon at Dana-Farber Cancer Center and a professor at Harvard Medical School, will take the reins of the country’s largest biomedical research…

Bloomberg Law – Biden to Name First Woman to Lead National Cancer Institute

Harvard cancer surgeon Monica M. Bertagnolli is on tap to serve as the next director of the National Cancer Institute, indicating the White House plans to install a well-known cancer physician-scientist as it shores up the next phase of the Cancer Moonshot. President Joe Biden’s appointment would make Bertagnolli the 16th director of the NCI and the…

Science – Biden to tap prominent Harvard cancer surgeon to head National Cancer Institute

President Joe Biden is expected to pick cancer surgeon Monica Bertagnolli as the next director of the National Cancer Institute (NCI). Bertagnolli, a physician-scientist at Brigham and Women’s Hospital, the Dana-Farber Cancer Center, and Harvard Medical School, specializes in gastrointestinal cancers and is well known for her expertise in clinical trials. She will replace Ned…

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,…

AJMC – Pierce Looks to the Future of Trial Diversity, Reflecting on Current and Historical Barriers

Lori J. Pierce, MD, FASTRO, FASCO, started her session with “the obvious.” The chair of the American Society of Clinical Oncology (ASCO) Board of Directors said, “We know the participation of adult cancer patients on clinical trials in this country is woefully low. “We also know the rate of participation of patients [of racial and…

AJMC – ASCO Spotlight With Randall A. Oyer, MD: Clinical Trials Must Be Accessible to Everyone

Randall A. Oyer, MD, medical director of the Ann B. Barshinger Cancer Institute, medical director of oncology, and medical director of the Cancer Risk Evaluation Program, Lancaster General Health, discusses recommendations to improve diversity in clinical trials. The theme of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting was “Advancing Equitable Cancer Care…

Pink Sheet – Accelerated Approval: Mid-Review Decisions ‘Not The Norm’ But Will Continue, FDA’s Cavazzoni says

Without directly referencing Biogen, Inc.’s Alzheimer’s drug Aduhelm (aducanumab-avwa), the leader of the US Food and Drug Administration’s drugs center defended the agency’s ability to make “rare” decisions about the use of accelerated approval during the course of an application review. Speaking at a 20 July Friends of Cancer Research meeting on use of circulating tumor…

Precision Oncology News – Synthetic Control Arms Finding Stronger Footing in Precision Oncology Trials, Regulatory Submissions

NEW YORK – Drugmakers, academic oncologists, and even regulators are becoming more accepting of clinical trials using synthetic, or external, control arms when evaluating the benefit of precision oncology drugs, recognizing that gold-standard randomized-controlled trials aren’t often feasible. In interventional medicine, it is widely accepted that the most unbiased way of proving a treatment’s benefit…

Pink Sheet – Biomarker Work Needs To Start Early In Drug Development Programs, US FDA Says

When it comes to biomarker and surrogate endpoint development, the US Food and Drug Administration has a plea for industry: “think early.” Work on establishing biomarkers and surrogate endpoints needs to start early in a drug development program and requires planning and a substantial resource investment. However, companies often do not focus on biomarker development…

MedPage Today – Bone Marrow Biopsy Value Limited in Follicular Lymphoma Response Assessment

Bone marrow biopsy (BMB) provided little information for response assessment in clinical trials of follicular lymphoma (FL) and should be eliminated from clinical trial requirements and diagnostic guidelines, authors of a large retrospective analysis concluded. Fewer than 1% of 580 patients had a positive baseline BMB, complete radiologic response, and subsequent positive biopsy after treatment.…