billy dunn, fda biography

Billy Dunn, a top Food and Drug Administration official who played a key role in recent approvals of new therapies for Alzheimer's and ALS, is leaving the agency. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters. Billy Dunn, FDA official in charge of neuroscience drug reviews, to Here's why we approved the first new Alzheimer's drug in two decades Sign uphereto receive it in your inbox. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. If the client is making the choice not to use that particular tool, we would not make a policy-based objection to that, Scott said That is the governments call.. Get the free daily newsletter read by industry experts. The FDA ended up clearing the drug in another controversial decision a few days later. Traynor voted against Amylyx's drug at the committee's previous meeting in March, but voted in favor on Wednesday. Office of Neuroscience The records add to the mystery of why Dunn whose close collaboration with Biogen is now being reviewed as part of multiple federal investigations would risk his unimpeachable reputation to push for the approval of the unproven drug. Diagnosis, STATs weekly newsletter about the politics and policy of health and medicine. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. Reporter, Commercial Determinants of Health. While Dunn had gained a reputation as a tough overseer of drug standards, he became a more controversial figure after the FDAs 2021 approval of Biogens Alzheimers drug Aduhelm a decision he was closely involved in. As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. Last week, it outlined steps to strengthen its tobacco program. Before sharing sensitive information, make sure you're on a federal government site. The next big target for ALS advocates ire. Topics covered: Drug commercialization, pharma salesforces, generic and biosimilar competition, drug advertising and much more. A growing field of RNA-targeting therapies is advancing alongside them. Lawmakers could still further delay or repeal the policy in a, Banning spread pricing practices by drug middlemen (more on those two below), Extending Medicare sequestration pay cuts for health care providers, Letting HHS force drug makers to pay back the government for wasted drugs that were sold in large packages. Hospitals and drugmakers have both activated their lobbying armies to defend their territory (and their money). A growing field of RNA-targeting therapies is advancing alongside them. All quotes delayed a minimum of 15 minutes. Dunn had become a controversial figure after his role in the FDAs review and contentious approval of Biogens Alzheimers drug Aduhelm. Your California Privacy Rights | Do Not Sell My Personal Information How a top FDA official's words helped push a closely watched ALS drug Most recently, she served as the Acting Center Deputy Director for Operations, directing center and agency-level priority and initiative programs and leading GDUFA III reauthorization negotiations. M. Khair ElZarrad, Ph.D., M.P.H., is the Director of the Office of Medical Policy (OMP) in FDAs Center for Drug Evaluation and Research (CDER). OPQ combines non-enforcement-related drug quality work into one super-office. Providers havent been able to apply to recoup their losses anytime after June 2020, which includes much of last summers surge, a surge last winter, and recent hospitalizations related to Delta. Our Standards: The Thomson Reuters Trust Principles. February 24, 2016 Dear Dr. Dunn, We write collectively as an interested and highly vested group of experts in Duchenne muscular dystrophy (DMD) in order to provide commentary on the upcoming FDA decision regarding approval of eteplirsen. Dr. Rosemary Roberts is the Director for the newly realigned Staff, renamed Counter-Terrorism and Emergency Coordination Staff (CTECS) in the Office of the Center Director, as of September 2014. Billy Dunn, who presided over the polarizing approval of the Alzheimer's disease treatment Aduhelm, is leaving the FDA after more than 15 years at the agency. LCDR Amy Ramanadham, Pharm.D., M.S., serves as CDERs Acting Associate Director for Drug Safety Operations. Why Billy Dunns support of Aduhelm is so shocking. Topics covered: Gene replacement therapy, gene editing, engineered cell therapy, manufacturing, pricing, reimbursement and much more. Beltsville, MD 20705-1266. Billy Dunn, head of the FDA's neuroscience office, has been with the agency for around 18 years, during which he was involved in several high-profile drug approvals. He also serves as the CDER Executive Officer and CDERs Associate Director for Management. They are: acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER Office of Neuroscience (ON) Director Billy Dunn. Ms. Jungman serves as the Center's primary representative for broad policy matters and issues related to human drugs. Exclusive analysis of biotech, pharma, and the life sciences. Billy Dunn, head of the FDA's neuroscience office, has been with the agency for around 18 years, during which he was involved in several high-profile drug approvals. Center for Drug Evaluation and Research | CDER, Recalls, Market Withdrawals and Safety Alerts, Center for Drug Evaluation and Research | CDER, CDER Manual of Policies & Procedures | MAPP. Office of Neuroscience - Division of Neurology I | FDA Billy Dunn. She oversees areas of strategic interest to external stakeholders. Given his experience and knowledge in the space, we dont think Dunn would choose to help guide a company with low probability, weak data or inadequate strategies and poor relations with the FDA, he wrote. STAT+ for less than $2/day, Unlimited access to essential biotech, medicine, and life sciences journalism, Subscribe to STAT+ for less than $2 per day, Unlimited access to the health care news and insights you need, Your go-to source for the latest news and insights on biopharma and the life sciences, Why the aspartame in Diet Coke and Coke Zero, Why the aspartame in Diet Coke and Coke Zero probably isnt worth worrying about, Human reproductive cloning: The curious incident of the dog, Human reproductive cloning: The curious incident of the dog in the night-time, Why fentanyl is deadlier than heroin, in a single, Why fentanyl is deadlier than heroin, in a single photo, House panel passes public health bills following contentious debate, How a key Senate committee is planning to regulate, How a key Senate committee is planning to regulate pharmacy benefit managers, Listen: Wegovy in the brain, pivotal Alzheimers data, &, Listen: Wegovy in the brain, pivotal Alzheimers data, & pulling Threads, most pivotal FDA player inside the Aduhelm saga, explains why the Delta variant is such a big deal, FDA budget battles, prisons sobering Covid response & BIOs CEO search is on, After nine months, an update on NIHs long Covid research, Delaying a Trump-era policy that would eliminate the drug rebates that pharmacy middlemen and insurers use to negotiate down the price of certain drugs. Peter Stein, M.D., is the Director of CDERs Office of New Drugs (OND). FDA Neurosciences Chief Billy Dunn to Leave Immediately, Analysts Raise Approval of Aducanumab for Alzheimer Disease-The FDA's Perspective The biggest PBMs are handling more and more of the countrys drug price negotiations. Liana Apostolova, a panelist and professor at the Indiana University School of Medicine, noted she was "reassured" by the possibility of a market withdrawal in that event. Biotech M&A is picking back up. These potential medicines include an Alzheimers disease pipeline with next-generation anti-amyloid beta and tau-targeted antibodies, and a vaccine that could be used in prevention paradigms.. Comments by Billy Dunn, head of the FDAs neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine. Now, advocates are so confident that the FDA will approve the drug, which is developed by Amylyx Pharmaceuticals, that theyre not even planning for the opposite scenario. New FDA documents show internal dissent on Aduhelm approval Eighteendeals were announced in the first six months of 2023, matching last years pace. Diagnosis, STATs weekly newsletter about the politics and policy of health and medicine. The departure comes as the FDA is working to recover from various scandals and missteps, including the dire national formula shortage and bungled oversight of vaping products. ET, Presented by studioID and Thermo Fisher Scientific, Webinar Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. And if youre curious about the science behind the drug, my colleague Adam Feuerstein has you covered here. That role, former colleagues told STAT, is at odds with the regulator they have come to know. Billy Dunn, a top Food and Drug Administration official who played a key role in recent approvals of new therapies for Alzheimers and ALS, is leaving the agency. Fax . John Carroll Editor & Founder. His departure was announced in an email to FDA staff sent by Peter Stein, head of the regulators Office of New Drugs. Youre reading the web edition of D.C. Reporter, Commercial Determinants of Health. My colleagues Adam Feuerstein, Damian Garde, and I spoke to more than 20 sources with connections to Dunn for a deep new profile for STAT. In the companys statement, Dunn highlighted Prothenas pioneering therapies focused on misfolded proteins in the body. HHS top budget official Norris Cochran said in a rare press availability Friday that the uninsured reimbursement program had to close down despite the significant funds remaining, because it was burning through money so quickly, and officials didnt want to accept claims the fund couldnt pay for. More about ShaAvhree Buckman-Garner MD, Ph.D., FAAP. Published Sept. 9, 2022 Ned Pagliarulo Lead Editor and Peter Stein. And surprise surprise, the FDA is about to face its next big test. Bryan Traynor, a committee member and senior investigator at the National Institute on Aging, said he was "struck by the public statements" from Amylyx committing to withdraw the drug if that confirmatory study turns out negative. Advancing the Development of Treatments for Neurological Disorders | FDA Reporting from the frontiers of health and medicine, You've been selected! BioCentury - FDA veteran Dunn to join Prothena's board Billy Dunn, the regulator at the center of the FDAs decision to greenlight the controversial Alzheimers drug Aduhelm, was a shining star at the FDA before the Aduhelm saga, according to new records obtained by STAT. Its been a politically tumultuous two years for the FDA which is supposed to review drugs and devices independent of political pressure. Reporter, Commercial Determinants of Health. What stood out to us besides his grades in undergraduate biochemistry and basic musical skills was the glowing performance reviews he got from his superiors at the FDA. More about M. Khair ElZarrad, Ph.D., M.P.H. The Health Resources and Services Administration said the difference was due to a semantic discrepancy about whether funds were unallocated or unobligated, and that the larger number includes money providers returned to the government and unclaimed money from some prior tranches of relief funds. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. He is the first director of the Office of Neuroscience, a group he helped design and stand up, according to Steins email. You can check my new story laying out the political stakes for the FDA here. After a long and highly productive career in public service, Billy has decided to retire from FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases.. Danita Hunter, who took over the division of HRSA responsible for distributing more than $180 billion in pandemic relief to hospitals and health clinics in Nov. 2020, has been removed from the departments website and directory, my colleague Rachel Cohrs reports. The FDA isnt the only group feeling the pressure from ALS advocates. Buckle up: Its time for the FDA to face another major political test. FDA budget battles, prisons sobering Covid response & BIOs CEO search is on, After nine months, an update on NIHs long Covid research. Subscribe to STAT+ for less than $2 per day, You've been selected! | 11 a.m. The retirement of Billy Dunn, MD, director of the Center for Drug Evaluation and Research's Office of Neuroscience, was reportedly announced in an internal memo to FDA staff. Marta Sokolowska, Ph.D., is the Deputy Center Director for Substance Use and Behavioral Health in FDAs Center for Drug Evaluation and Research (CDER). from the F. Edward Hbert School of Medicine in Bethesda, Maryland. ET, Presented by studioID and Thermo Fisher Scientific, Webinar Alzheimer's drug Aduhelm: What one ex-FDA adviser called - CNN Webinar PDF CENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug Administration But their roughly $78billion total value triples what was seen by this time in 2022. The Food and Drug Administration official who allegedly had an inappropriately cozy relationship with the maker of the controversial Alzheimer's drug Aduhelm is stepping down from his role, effective immediately, according to numerous media reports. ALS drug development How a top FDA official's words helped push a closely watched ALS drug toward approval Comments by Billy Dunn, head of the FDA's neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine. Need another reason to watch the hearing? Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in FDAs Center for Drug Evaluation and Research (CDER). 609-664-7308, michael.bachner@prothena.com. FDA Official Who Oversaw Aducanumab Approval Retiring - Medscape | 11 a.m. More about LCDR Amy Ramanadham, Pharm. ET, gained a reputation as a tough overseer of drug standards, approval of Eisai and Biogens Alzheimers drug Leqembi, played a notable role in securing the support of FDA advisers, How a top FDA officials words helped push a closely watched ALS drug toward approval, How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimers drug. Beltsville, MD 20705-1266 For nearly two decades, Dr. Dunn has dedicated his career as a public servant to bringing new and innovative products to patients suffering from neurodegenerative diseases through his leadership role at the FDA. More about Jacqueline Corrigan-Curay, J.D., M.D. Dunns participation in approvals became so important that the stock of Reata Pharmaceuticals, which had a pending application for an inherited nerve disease treatment, sank on Feb. 27 on news of his departure. Billy Dunn, FDA's top neuroscience official to depart agency He leads the centers administrative management operations, which includes more than 5,000 employees and an annual budget of more than $1 billion, comprised of a mix of congressional appropriations and multiple user fee programs. Prothena, which is looking to transition its pipeline from experimental medicines to marketed products. Youre reading the web edition of D.C. Novo Nordisk bought the rights to the ATTR drug and Bristol Myers Squibb acquired rights to one of the Alzheimers medicines. Surprisingly, Amylyx's founders did. The Office of Neuroscience (ON) consists of five review divisions: The Division of Neurology I, the Division of Neurology II, the Division of Psychiatry, the Division of Anesthesiology, Addiction Medicine, Pain Medicine, and the Division of Pharm/Tox for Neuroscience (DPT-N). OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. FDA Approves New Treatment Option for Patients with ALS June 23, 2021 at 11:37 a.m. EDT . In Wake of Stunning New Revelations of Unprecedented FDA-Biogen Dr. Dunn is the founding and former Director of the Office of Neuroscience, Center for Drug Evaluation and Research (CDER), at the U.S. Food and Drug Administration (FDA). Theres some good and some bad for middlemen on the policy list above: they love the idea of repealing the Trump-era policy that eliminated rebates (though they dont think Congress is going far enough, since its only talking about delaying the policy from taking effect.) ON Director Billy Dunn, M.D., supervised the FDA team conducting this review and likely played a key role in the close FDA-Biogen collaboration. Biogen finally published the results of its Aduhelm trial in a journal edited by one of its biggest backers. Michael (Mike) Kopcha, Ph.D., R.Ph., serves as Director of the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research. Shares fell by more than a third on the news as analysts on Wall Street have viewed Dunns oversight of the review as supporting a potential approval. FDA neurosciences chief Billy Dunn to leave immediately - Reuters Center for Drug Evaluation and Research | CDER, Recalls, Market Withdrawals and Safety Alerts, Center for Drug Evaluation and Research | CDER, CDER Manual of Policies & Procedures | MAPP, Division of Anesthesiology, Addiction Medicine, Pain Medicine, OND Office and Division Contact Information. Theresa Mullin, Ph.D., serves as CDERs Associate Director for Strategic Initiatives. "Our underlying legal authority is clear in not only allowing, but also endorsing and encouraging the application of regulatory flexibility in the setting of serious and life threatening diseases," Dunn said at the meeting. During his tenure at FDA, Dr. Dunn had a significant impact on how drugs are developed for a range of serious neurological diseases, including many that previously had only limited treatment options. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. The FDA is digging into whether pharma reps at conferences are telling the truth. There was an error saving your display name. 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More here. | 11 a.m. Prothena Announces Appointment of Billy Dunn, M.D., to its Board of PDF Billy Dunn, MD Director Division of Neurology Products Office of Drug Among the many troubling revelations described in the STAT expos was an 'off-the-books' May 2019 meeting between Dr. Billy Dunn, the director of the FDA office responsible for the review of Alzheimer's disease drugs, and Biogen Chief Scientist, Al Sandrock. Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Dunn's comments also carried weight more broadly. Billy Dunn joined Prothena's board of directors less than three months after leaving the FDA. But, as I write in a new story for STAT, this panel is shaping up to be about much more than just a new drug.
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