URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities Events, News, and Funding Opportunities EVENTS The 2019 FDA Science Forum - SAVE THE DATE - September 11-12, 2019, on FDA's White Oak campus. The Forum will highlight the breadth and depth of cutting-edge science FDA conducts and showcase how FDA's scientific research informs our regulatory decision-making. Details on the Forum are forthcoming. FDA GRAND ROUNDS - Thursday, October 10, 2019, 12:00 p.m. - 1:00 pm EST - will be announced shortly. FDA GRAND ROUNDS - Thursday, July 11, 2019, 12:00 p.m.‒1:00 p.m. EST - Dr. Amy Inselman is a staff fellow in NCTR’s Division of Systems Biology, Biomarkers and Alternative Models Branch, will be presenting Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems. FDA has recognized the need for coordinated research to address public health needs during the perinatal period. These include the health of the mother, premature infants, and newborns as well as development throughout childhood. To that end, FDA’s National Center for Toxicological Research (NCTR) established FDA’s virtual Perinatal Health Center of Excellence (PHCE) to address the special public health needs of these important and understudied populations. Registration is required NEWS FDA Voice - FDA's Comprehensive Response to HIV - Part II- September 19, 2019, Ned Sharpless, M.D., Acting Commissioner, the FDA is engaged on many fronts in the effort to combat HIV, applying its focus on the best available science, combined with important collaboration with many different stakeholders, industry, and patients. Yesterday I looked at some of the issues we are dealing with on the domestic front; today, I will examine some of the work we are doing globally.. FDA Voice - FDA's Comprehensive Response to HIV - Part I - September 18, 2019, Ned Sharpless, M.D., Acting Commissioner, For those engaged in the field of public health, the AIDS crisis is a particularly instructive example of some of the ways such crises and responses to them evolve, particularly because this response coincides with our own medical training, development, and professional experience. FDA Voice - Delivering Promising New Medicines Without Sacrificing Safety and Efficacy - August 27, 2019, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research. The FDA walks a fine line. We must balance timely patient access to important new medicines with assuring they meet key standards. These standards exist to make sure that approved drugs have a high chance of helping those who use them. Medicines ultimately must lead to overall improvements in how patients feel, function or survive. FDA Voice - Preventing Medical device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing - July 15, 2019, Suzanne B. Schwartz, M.D., M.B.A., Deputy Director of the Office of Strategic Partnerships and Technology Innovation and Acting Office Director, Center for Devices and Radiological Health (CDRH), and CAPT Elizabeth F. Claverie-Williams, M.S., Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH. Read how the FDA began monitoring the shortages of devices after the closure of a large device sterilization facility—which sterilized 594 types of medical devices—because of concerns about the level of ethylene oxide emissions. Today, the FDA continues to work with manufacturers on site changes and engage with manufacturers about potential solutions to shortage concerns. The FDA also continues to collaborate with the EPA and provide the EPA with updates on FDA activities in this area.MDDT program streamlines the medical device development and review process. FDA Voice - How the FDA Uses Science to Speed Medical Device Innovation - July 11, 2019, Ed Margerrison, Ph.D., Director, Office of Science and Engineering Laboratories, and CAPT Hilda Scharen, Director, Medical Device Development Tools Program, Center for Devices and Radiological Health. Read how The MDDT program streamlines the medical device development and review process. FDA Voice - Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators - July 11, 2019, Anna K. Abram, Deputy Commissioner for Policy, Legislation and International Affairs, and Mark Abdoo, Associate Commissioner for Global Policy and Strategy. At the end of FY2018 there were 4,676 drug manufacturing sites subject to surveillance inspection. Of those, 61% are foreign, For FY2018, the FDA conducted 1,346 drug quality inspections - 53% at foreign sites. FDA Voice - How FDA is Regulating E-Cigarettes - July 10, 2019, Ned Sharpless, M.D., Acting Commissioner. More oversight, restricting youth access to ENDS products, and the FDA is conducting regular inspections of ENDS manufacturing facilities. FDA Voice - FDA, CDC Develop Robust Strategy to Prevent Illnesses Caused by Cyclospora- July 2, 2019, By Frank Yiannas, Deputy Commissioner for Food Policy and Response, U.S. Food and Drug Administration and Monica Parise, M.D., Director, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention. FDA, CDC join forces during Cyclospora season to prepare for the potential need to rapidly address intestinal illnesses and prevent a cyclosporiasis outbreak. FDA Voice - Forward Into the Past With FDA's New History Exhibit - June 25, 2019, Ned Sharpless, M.D., Acting Commissioner. Understanding our history helps inform our future. FDA Voice - Ensuring Innovation and Competition for Biologics Leads to More Timely Products for Patients - June 13, 2019, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., Ph.D., Director, Center for Biologics, Evaluation and Research. Understanding our history helps inform our future. Roswell Park and URMC to Create $19 Million Research Program Focused on Flavored Tobacco. Prestigious federal grant funds effort to understand fast-growing but under-explored trend in tobacco use. The WNY Center for Research on Flavored Tobacco Products, or CRoFT, will unite teams from Roswell Park Comprehensive Cancer Center and the University of Rochester Medical Center in an effort to better document and understand one of the fastest-growing trends in tobacco use. This CRoFT team will pursue projects in four main areas: 1) Assessing Flavorant Toxicity; 2) Characterizing Flavors and Their Impact on Behavior; 3) Determining Respiratory health Effects of Flavors; 4) Evaluating the Effects of Product Marketing. FDA Expert Commentary and Interview Series A series of interviews and commentaries are available to communicate safety information to clinicians as part of a collaboration between the FDA and Medscape. Scott Steele selected to serve on FDA's Science Board Scott Steele, PhD, has been selected to serve on the Food and Drug Administration's Science Board. Dr. Steele is director of the Regulatory Science Core at the UR CTSI, director of the Rochester Center of Excellence in Data Science at the Goergen Institute for Data Science, and an associate professor of Public Health Sciences at the UR. He is one of the 21 voting members of the Science Board. 5th Annual “America’s Got Regulatory Science Talent” Competition The winners of the annual “America’s Got Regulatory Science Talent Competition” from the University of Maryland CERSI and University of Rochester presented their winning idea at FDA on April 26, 2018. For more information and to see the finalists' presentations visit the UR CTSI Stories Blog. Archives FUNDING OPPORTUNITIES FDA Commissioner's Fellowship Program Each class of fellows in the FDA Commissioner's Fellowship Program consists of outstanding health care professionals, scientists, and engineers who receive regulatory science training and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of FDA senior scientists. Please visit the FDA Student, Fellowship and Senior Scientist Programs website for available programs. 2019 PhRMA Foundation Awards The 2019 PhRMA Foundation Awards include three award programs and they are currently requesting applications: Health outcomes program offers pre- and post-doctoral fellowships and research starter grants. Translational Medicine and Therapeutics program offers post-doctoral fellowships and research starter grants. Paul Calabresi Medical Student Fellowship in Clinical and Translationa Pharmacology enables medical or dental students who have substantial interests in research and teaching careers in pharmacology/clinical pharmacology to pursue a specific research effort within a pharmacology or clinical pharmacology unit. Submissions are due by Friday, February 1, 2019. For more information or to apply, visit the PhRMA Foundation website, www.phrmafoundation.org. You may also call 202-572-7756. Fellowship in Parkinson's Regulatory Science The Michael J. Fox Foundation for Parkinson's Research and Georgetown University Fellowship in Parkinson's Regulatory Science are offering a fellowship in regulatory science that will promote postgraduate training in the Parkinson's research field to optimize clinical design and support approval of novel therapies. Request for applications is closed for this year: 2018. Fellowship in Regulatory Science – Georgetown University Program for Regulatory Science & Medicine and the Pharmaceutical Research and Manufacturers of America (PhRMA) is offering a Fellowship in Regulatory Science. Request for applications is closed for this year. Please refer to the website for additional information. UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) offers a Postdoctoral Fellowship in Regulatory Science. Request for applications is closed for this year. Please visit the website for more information and application deadlines. Regulatory Science Initiatives at the Burroughs Wellcome Fund – BWF's Innovation in Regulatory Science Awards provide up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform regulatory decisions. Submit application by Wednesday, February 6. More information can be found on the BWF's Innovation in Regulatory Science webpage. FDA Tobacco Regulatory Science Fellowship This fellowship is for mid-career professionals to gain expertise in the field of regulatory science as it relates to the regulation of tobacco products and FDA's authorities under the Family Smoking Prevention and Tobacco Control Act. Applications are taken from January - March every year. This is a 12-month, multidisciplinary residential program in Maryland which begins in September each year.