FasterCures to present at HHS' "Accelerate Clinical Innovation Initiative" public hearing June 20-21 | What more powerful patients mean to pharma | Potentially dodgy stem cell trials threaten valid studies
The Oncology Clinical Trial Information Commons is a clinical trials information platform for data mining and patient matching being planned by the Biden Cancer Initiative, in collaboration with up to nine health care companies. The platform will be available to health institutions, clinical trial sponsors and investigators, patient advocacy organizations, government registries and technology developers.
In case you missed it: The Department of Health and Human Services (HHS) is holding a Public Hearing on the ReImagine HHS "Accelerate Clinical Innovation Initiative" on June 20-21. This meeting, with presenters from FasterCures, will help HHS develop programs and procedures for accelerating the pace of the clinical innovation throughout the US. HHS will hear from patients, physicians, researchers, medical product developers, commercial health insurance plan sponsors and carriers, private investors and the community at large. Please view the Federal Register Notice for more information on how to register or live-stream the event.
Pharma must acknowledge that the health care ecosystem has shifted to give more power to patients and decide where it fits in before it can leverage new technologies, said Dr. Ameet Nathwani, Sanofi's chief medical and digital officer. Nathwani told the BIO 2019 conference that companies should try to predict how people will treat their disease and expect to be managed several years after their product becomes available, and make sure that matches how the drug is being developed.
The FDA has been cracking down on companies and clinics that market unapproved, unproven stem cell therapies, but some of the organizations' trials remain listed on clinicaltrials.gov, which critics say gives the firms undeserved credibility. Critics also say that charging participants, as some stem cell studies do, is unethical, and trials run by unapproved sellers threaten participation in valid studies that comply with federal regulations.
A study in the journal JAMA described how researchers are trying to create a treatment to potentially replace antiretroviral therapy. "Because we've been so successful [with ART], there is a substantial proportion of people who are doing well who feel they want to take it to the next step. They don't want to have to take an antiretroviral drug every day, for a number of reasons," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Eli Lilly and Atomwise agreed to work together to develop up to 10 drug targets using the latter's artificial intelligence technology. Under the terms of the deal, Atomwise will get up to $1 million in milestones for each drug discovery and up to $550 million for milestones tied to development and sales for all targets.
Biotechnology Innovation Organization Chairman Jeremy Levin vowed to expel member companies that increase drug prices dramatically. "We are obliged to confront this transparently, openly, acknowledge past efforts that were incorrect, acknowledge past mistakes, and now engage incredibly constructively with everybody to ensure that we get the right policies put in place," Levin said.
The Bill & Melinda Gates Foundation has awarded a $180 million grant to Emory University for research into curbing the mortality rates of children in some of the poorest countries in the world through the Child Health and Mortality Prevention Surveillance network. The award is part of the foundation's investment of $271 million in CHAMPS over 10 years.
The NIH has awarded a $20 million grant to expand the Rhode Island IDeA Network of Biomedical Research Excellence. The program, based at the University of Rhode Island, focuses on developing early-career scientists in the fields of cancer, neuroscience and environmental health sciences research.
The Mark Foundation for Cancer Research has awarded a $12 million grant to Penn Medicine, a division of the University of Pennsylvania, to establish the Mark Foundation Center for Immunotherapy, Immune Signaling, and Radiation. "Understanding important and potentially targetable mechanisms of immunotherapy resistance and how to use novel radiation therapies to enhance immunotherapies carries enormous benefits for patients," says Andy Minn, the center's director.
The Department of Health and Human Services announced plans to discontinue funding for NIH research that involves tissue from aborted fetuses, along with a project funded by HHS at the University of California at San Francisco. Medical and scientific groups asserted in a letter last December to HHS Secretary Alex Azar, "Claims that other cells can be used to replace fetal tissue in biomedical research are patently incorrect."
FasterCures, a center of the Milken Institute, is driven by a singular goal: to save lives by speeding up and improving the medical research system. The Milken Institute is a nonprofit, non-partisan think tank determined to increase global prosperity by advancing collaborative solutions that widen access to capital, create jobs, and improve health.
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