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, May 9, 2019, 12:00 p.m.‒1:00 p.m. EST - Dr. Lee, a General Health Scientist, will be presenting Gaining Insight into the Patient's Experience by Harnessing the Power of Social Listening and FDA Archival Data. This presentation explores how to consistently and comprehensively capture the patient’s voice by using multiple data sources, including unstructured FDA archival data and social media. Registration is required FDA GRAND ROUNDS - Thursday, April 11, 2019, 12:00 p.m.‒1:00 p.m. EST - Dr. Richard Forshee leads the Analytics and Benefit-Risk Assessment Team for CBER's Office of Biostatistics and Epidemiology at FDA, and will be presenting Uncertainty is the only certainty there is: Potential approaches for making public health decisions. This presentation explores how significant public health decisions face such uncertainty and yet the decisions still must be made. Registration is required Scientific Engagement Report at FDA - The FDA Science Board conducted a study examining on how the Agency can improve its interface with the outside scientific community. Clinical Investigator Training Course - November 13-15, 2018, Tommy Douglas Conference Center, Silver Spring, MD - This collaborative training course is hosted by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research’s (CDER’s) Office of Medical Policy (OMP), Small Business and Industry Assistance (SBIA) and University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI). This course takes a deep dive into the scientific background and practical methodology needed when conducting clinical trials. Attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review. Registration is required NEWS 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. FDA Voice - 2019 Spring Unified Agenda Reflects FDA's Continuity and Consistency - May 24, 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. Earlier this week, the federal government published the 2019 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda). This semiannual compilation of information about regulations under development by federal agencies across the government provides the public with a concise accounting of our government’s recent regulatory actions and future priorities that can have a profound impact on the lives of all Americans. FDA Voice - FDA's Strengthened Global Inspection Program helps Ensure Generic Drug Safety - May 17, 2019, Melinda K. Plaisier, MSW, Associate Commissioner for Regulatory Affairs. Through Program Alignment, FDA’s Office of Regulatory Affairs (ORA) has modernized its workforce and approach to improve public health in a way that keeps pace with the acceleration of scientific innovation, global expansion of markets, and new programmatic mandates. In the two years since implementing Program Alignment, FDA has achieved many of the original goals, providing greater focused expertise for our investigators across all products that fall under FDA’s purview, and the FDA’s regulation of generic drugs has never been stronger, more strategic, more risk-based, or more efficient than it is today. FDA Voice - Safety, Efficacy, and Qulatiy Remain Top Priorities as we Continue our Work to Expand Access to Cost-Saving Generic Drugs for the American Public- May 13, 2019, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research. The success of the FDA’s generic drug program — bolstered by recent efforts such as our Drug Competition Action Plan — has often been described in terms of our ability to efficiently determine the safety and efficacy of generic drugs under review for approval and how many new generics we subsequently approve as a result. FDA Voice - Shedding new Light on Suncreen Absorption - May 6, 2019, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER), and Theresa M. Michele, M.D., Director, CDER’s Division of Nonprescription Drug Products, Office of New Drugs. Skin cancer incidence rates continue to rise, making risk from excess sun exposure an important public health priority.1 Yet despite what we know about prevention, skin cancer remains the most commonly diagnosed cancer in the United States. Used with other sun protective measures, broad spectrum sunscreens with SPF values of at least 15 are critical elements for preventing skin cancer and protecting the skin from sunburn and other UV damage. With sunscreens now being used with greater frequency, in larger amounts, and by broader populations, it is more important than ever to ensure that sunscreens are safe and effective for daily, life-long use. FDA Voice - Implement a Team-Based Approach to Medical Device and Radiological Product Evaluation and Quality- May 1, 2019, William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, and Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health. Last month, CDRH announced one of the key steps in this transformation is a transition to a more holistic, team-based approach to premarket review, postmarket surveillance, and compliance that strengthens its focus on safety and effectiveness throughout the entire lifecycle of medical devices. And it makes it easier for CDRH customers to get the answers and support they need by having one team address all issues rather than having to navigate multiple officesy. FDA Voice - FDA Addresses Health Disparities Through Communication, Research, and Collaboration - April 30, 2019, CAPT Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health, Office of Minority Health and Health Equity; Ann T. Farrell, M.D., Director of the Division of Hematology Products within the Center for Drug Evaluation and Research; and Jovonni Spinner, M.P.H., CHES, Senior Public Health Advisor, Office of Minority Health and Health Equity. The FDA, including the Office of Minority Health and Health Equity (OMHHE), promotes and protects the health of diverse populations and strives for health equity for all, including those who experience disparities related to race and ethnicity. FDA Voice - Rapid Response Teams mark 10 Years of Collaboration on Public Health Emergencies- April 25, 2019, Barbara Cassens, Director, Office of Partnerships, Office of Regulatory Affairs. In 2008, to enable faster, more efficient responses to emergencies, the FDA launched a network of state-based Rapid Response Teams (RRT), comprised of multi-agency, multi-disciplinary teams that operate by the principles of the Incident Command System/National Incident Management System to respond to human and animal food emergencies. FDA Voice - FDA's Efforts to Advance the Development of Biologics - April 17, 2019, Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research. The safety and efficacy of the biological products regulated by the FDA are inextricably linked to the quality and consistency of their manufacturing. This is as true now as it was when the Biologics Control Act of 1902 was enacted. Over a century of experience has informed our development of a holistic approach to the development and regulation of these products, from facilitating preclinical development to clinical development and on to post-market surveillance. FDA Voice - FDA Protecting the Nation Through Medical Countermeasures - April 9, 2019, Anna Abram, Deputy Commissioner for Policy, Legislation and International Affairs, and RADM Denise Hinton, Chief Scientist. The FDA’s Medical Countermeasures Initiative (MCMi) furthers the development of medical countermeasures by establishing clear regulatory pathways and effective regulatory policies and mechanisms to facilitate timely access to available medical countermeasures. FDA Voice - Understanding the Health Impact and Dangers of Smoke and Vapor- April 3, 2019, Scott Gottlieb, M.D., Commissioner, and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner . Did you know that tobacco smoke harbors more than 7,000 chemicals, at least 70 of which are directly linked to cancer? FDA Voice - FDA's Advancing beneficial Animal Biotechnology Product Development - April 2, 2019, Scott Gottlieb, M.D., Commissioner, and Anna Abram, Deputy Commissioner for Policy, Legislation and International Affairs. This framework will help secure confidence in the safety and performance of plant and animal-based innovative products for consumers, patients, and America’s global trading partners. 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 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 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.