NEW YORK – The precision oncology community is hoping it could soon see a new landscape of drug trials using circulating tumor DNA as an early or surrogate endpoint for adjuvant therapies and other treatments in early-stage disease. In a recent draft guidance, the US Food and Drug Administration said that while the evidence isn’t there yet…
The Senate Health, Education, Labor, and Pensions Committee in June approved legislation that would fill critical oversight gaps regarding two widely used health products: diagnostic tests and dietary supplements. The move represented an important step toward greater safety and peace of mind for American consumers. The Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of…
As real-world evidence becomes ever more essential, a cancer health technology company that played a key role in modernizing 21st-century health data is capitalizing on its accomplishments in the U.S.—and moving into international markets to meet the growing demand for actionable data. Founded in 2012, Flatiron Health, now in its 10th year, is entering the…
Patients with incurable cancers should have an easier time getting into clinical trials under new FDA guidance on developing criteria for trial eligibility. The final guidance marks the latest effort by the Food and Drug Administration to expand the criteria for who can participate in cancer studies. Enrollment has remained an ongoing challenge in oncology research and…
Friends of Cancer Research (FOCR) has issued an evidentiary roadmap for validating circulatory tumor DNA (ctDNA) as an early endpoint for accelerated drug approval in solid tumors, spelling out a strategy for generating the data needed to support the use of ctDNA levels as a drug development tool in regulatory decision making. The roadmap builds on earlier…
The Biden administration has selected a Dana-Farber Brigham Cancer Center surgeon and professor at Harvard Medical School as the next director of the National Cancer Institute, according to published reports. Dr. Monica Bertagnolli will become the first woman to run NCI, according to Stat News, which first reported the appointment citing “two sources familiar with the decision.” The…
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…
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…
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…
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,…
