A decade before he became the US Surgeon General, Vivek Murthy, MD, published a 2004 study in JAMA about participants in cancer clinical trials. Among other findings, Murthy and his coauthors concluded that from 2000 to 2002, people aged 65 years or older were “strikingly underrepresented” in a set of National Cancer Institute–funded drug trials.…
Theresa LaVallee joined the Parker Institute for Cancer Immunotherapy in 2017 and is currently VP of translational medicine and regulatory affairs. As part of the institute’s efforts to bring precise and powerful immunotherapies to cancer patients, LaVallee and colleagues are on the front lines of both drug and biomarker development for a new class of…
Executive Summary Centers for Medicare & Medicaid Innovation could enable outcomes-based contracting for novel, ‘curative’ therapies follow something like the FDA’s Accelerated Approval model, former top HHS official suggests. One option for the US Medicare program to enable outcomes-based pricing agreements would be to create a demonstration project that applies something similar to the…
Executive Summary Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions. The US Food and Drug Administration’s Division of Psychiatry Products has one of the first review teams currently testing out the agency’s proposed new integrated review document as part of…
Executive Summary US FDA is encouraging common mechanisms of drug testing to enable pharma industry collaboration and avoid redundancy; Pazdur notes that there are many similar PD-1 drugs. Richard Pazdur, the director of US Food and Drug Administration’s Oncology Center of Excellence, has one plea for industry: work together to develop new cancer drugs.…
The growth of personalized medicine in oncology continues to fuel a shift from traditional chemotherapies to immunotherapy. Currently, there are more than 30 immunotherapies approved for use in the United States, with more than 2,300 immunotherapy clinical trials listed on ClinicalTrials.gov. However, significant disparities exist in randomized clinical trial participation with clinical trial populations…
Perhaps one of the biggest opportunities for AI (Artificial Intelligence) is the healthcare industry. According to ReportLinker, spending on this category is forecasted to jump from $2.1 billion to $36.1 billion by 2025. This is a hefty 50.2% compound annual growth rate (CAGR). So then what are some of the trends that look most…
The White House sees an opening for a drug pricing deal with House Democrats before the end of President Donald Trump’s first term—provided impeachment doesn’t derail the entire process. The White House Domestic Policy Council is working through technical aspects of a Medicare negotiation bill backed by House Speaker Nancy Pelosi (H.R. 3), Joe…
The Trump administration is apparently down to three final candidates for the top FDA job as a deadline for nomination looms. Acting commissioner Ned Sharpless is contending with Stephen Hahn, chief of radiation oncology at MD Anderson, and Harvard dermatology professor Alexa Boer Kimball, according to reports. Conspicuously absent from the group is Brett Giroir,…
It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him. That is likely to change soon: under federal law governing vacancies for Senate confirmed positions, an agency can only be led…
