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Explanation from DeAunne Denmark, MD, PhD : And just to clarify for all, since all of the testing jargon and landscape can be *extremely* confusing, especially now: The FDA has currently relaxed regulations for COVID diagnostics under "Emergency Use" (EUA). This authorizes, not approves, test kits, machines and devices to run those kits, and all other aspects involved in diagnostic testing. Authorize vs approve are very different animals under FDA. And you will see this repeatedly emphasized on the FDA site. But most often neglected, skipped over, mistaken in the wider press. Many articles and press releases use "approve" which is technically wrong - they mean authorize, or "grant use", or "use will not be objected to by FDA." If you have the stamina, I highly recommended reading as much of this as you can: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2 "Validation" is yet an additional aspect that is probably the grayest zone of all, since it is left to each company/testing entity how exactly this is done. Validation can range from excellent to pretty cruddy science and still meet FDA "standards". These will be the devilish details we need to sort out re: collaborating with partners. And will unfortunately likely be a big mess for many outpatient Drs trying to figure out which test to order.

Recommended by Tyler: "Project Patient Voice has been initiated by the Oncology Center of Excellence to give patients and health care professionals unique information on symptomatic side effects to better inform their treatment choices," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development. Where patient-reported symptom information is collected rigorously, this information should be readily available to patients." "I'm sure this will be useful - and help cancer patients better evaluate treatment options, based on other patients' experience, especially around side effects. I think this is also worth curating." Thanks! Tyler

DeAunne Denmark, MD, PhD: "To date, the FDA has granted EUA for only these 4 companies: Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems and the Mount Sinai Laboratory. Really looking forward to the validation and head-to-head comparison data promised here from the FDA, Chan Zuckerberg (supposedly this week?), and others. That should be telling... "

"You've probably heard a lot about coronavirus testing recently. If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your health care provider, local pharmacy, or local health departmentExternal Link Disclaimer immediately. The FDA has been working around the clock to increase the availability of critical medical products, including tests for the coronavirus, to fight the COVID-19 pandemic. Learn more about the different types of tests and the steps involved."

The video on this page seems to be solid information for raising health information literacy. What does the group think?

"Remarks by Scott Gottlieb, M.D. Commissioner of Food and Drugs Friends of Cancer Research 7th Annual Blueprint for Breakthrough Forum Sept. 13, 2018 Washingon, DC "Blueprint for Breakthroughs - Charting the Course for Precision Medicin"

"An FDA advisory panel recommended emergency use authorization (EUA) of a booster dose of Moderna's COVID-19 vaccine for adults ages 65 and older, as well as for younger adults with high-risk medical conditions or at high risk of occupational or institutional exposure."

Recommended by vicky newman

"Sitting in freezer at Boston Children's Hospital is a drug you won't find anywhere else. It's called milasen, and the 18 g that the hospital custom-ordered nearly 2 years ago should last for decades. That's because milasen was designed to treat a single patient-a now 8-year-old girl named Mila Makovec. Milasen was built on decades of work on a class of drugs called antisense oligonucleotides. But after Boston Children's Hospital scientist Timothy Yu diagnosed Mila with a never-before-seen genetic mutation, he took only 10 months to go from idea to injection. It's a record-shattering sprint in the typical drug-development marathon, and an unprecedented degree of personalization for a chemical drug."

Janice O'Connor will be testing this device at VIP Nuero-Rehab on 10/10/19 "It's not just walking - it's More Than Walking: ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury (SCI) to stand upright, walk, turn, and climb and descend stairs*. ReWalk is the first exoskeleton to receive FDA clearance for personal and rehabilitation use in the United States."

From LinkedIn: As a society, we have not learned from past outbreaks. It's critical that we identify and build on recent progress in biomedical research and innovation. Explore the 20 lessons learned during #COVID19 that can be preserved and enhanced to help speed cures to multiple diseases: #research https://lnkd.in/dztPFiA Among those interviewed for the report were: Francis Collins of National Institutes of Health, Anthony Fauci of National Institute of Allergy and Infectious Diseases (NIAID), Scott Gottlieb of American Enterprise Institute, Margaret Hamburg of National Academy of Medicine, Annalisa Jenkins of London School of Hygiene and Tropical Medicine, U. of London, Peter Mark of Center for Biologics Evaluation and Research, FDA; and Janet Woodcock of FDA. #biomedicalresearch #biotech #preparedness

"Follow this page to share information that can benefit someone you know. The U.S. Department of Health and Human Services (HHS) touches the lives of nearly all Americans from research to food safety, health care, aging and much more."

"The company, which received about $30 million from the National Institutes of Health to ramp up production capacity, will be able to produce about 100,000 tests a day by January, Parsons says. By March, production should increase to about 250,000 tests a day. By June, productions should hit 1 million a day."

"Patient-Focused Drug Development (PFDD) is a process that provides patients and caregivers impacted by a rare disease the opportunity to share their experience with those directly involved in the drug development process. The Rare Disease Cures Accelerator, a Data Analysis Platform (RDCA-DAP®), a collaboration between the National Organization for Rare Disorders (NORD®), Critical Path Institute (C-Path), and the US Food and Drug Administration (FDA), can strengthen PFDD efforts to support life-saving and life-changing outcomes. This webinar is intended for patients, caregivers, advocates, students, and those who are interested in learning more about PFDD as well as efforts to accelerate research and drug development in rare diseases, such as the RDCA-DAP. For more information on RDCA-DAP, visit: www.rarediseases.org/rdca-dap. SHOW LESS "

The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®) is an integrated database and analytics hub that is designed to be used in building novel tools to accelerate drug development across rare diseases. It is being developed by the Critical Path Institute (C-Path) and NORD through a collaborative grant from the FDA [Critical Path Public-Private Partnerships Grant Number U18 FD005320 from the US Food and Drug Administration].

"There are 7,000 rare diseases but less than 10% have an FDA approved treatment There are 30 million rare disease patients in the US but 95% of physicians feel unprepared to treat them There are 6,093 US hospitals, but rare disease patients travel an average of 563 miles just to get a diagnosis ​ It's Time to Listen to the Rare Disease Community."

VLA15 is currently the only active vaccine program in clinical development against Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common pathogenic strains found in the United States and Europe. Valneva has completed recruitment and reported initial results for two Phase 2 clinical trials [5,6] of VLA15 in over 800 healthy adults and in which Valneva observed high levels of antibodies against all six serotypes. Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 [7]. As part of its collaboration with Pfizer, Valneva accelerated the pediatric development of VLA15 with an additional Phase 2 clinical trial initiated in March 2021. In July 2021, Pfizer and Valneva announced recruitment completion for VLA15-221 with a total of 625 participants, 5 to 65 years of age [8]. The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 [9].