URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities Events, News, and Funding Opportunities EVENTS FDA GRAND ROUNDS - Thursday, June 11, 2020, 12:00 p.m. - 1:00 pm EST - Co-presented by Bernadette Dunham, D.V.M., Ph.D. Professorial Lecturer, Milken Institute School of Public Health, George Washington University, Advisor to the FDA One Health Initiative, Center for Veterinary Medicine, FDA; and CAPT Brianna Skinner, D.V.M., M.P.H., DACLAM CAPT, USPHS, Senior Regulatory Veterinarian, Office of the Commissioner, Office of Counterterrorism and Emerging Threats, FDA on A pandemic and a Call to Action for One Health: The FDA One Health Initiative. One Health is a concept that embraces a multisectoral and transdisciplinary approach to solving health problems by recognizing the interconnection between humans, animals, and their shared environment. Many global changes and activities associated with increased human-animal interactions are enabling disease transmission that become epidemics or pandemics that adversely impact public health. This presentation will explain the One Health Concept and the FDA One Health Initiative. It will also highlight the benefits of One Health and how FDA is operationalizing One Health actions Agency-wide. Registration is required. FDA GRAND ROUNDS - Thursday, May 14, 2020, 12:00 p.m. - 1:00 pm EST - Weida Tong, PhD, Division Director, NCTR, National Center for Toxicological Research (NCTR), FDA is presenting on Artificial Intelligence for Regulatory Science Research. Artificial Intelligence (AI) is a broad concept of training machines to think and behave like humans.An FDA Animal Scientist will explain the basic principles and methodologies of AI, describe different AI methods, and describe ways in which AI methods can be applied for drug and food safety, biomarker development and text mining Registration is required. FDA GRAND ROUNDS - Thursday, April 9, 2020, 12:00 p.m. - 1:00 pm EST - Lowri de Jager, PhD, Branch Chief, Methods Development Branch, Office of Regulatory Science, CFSAN is presenting on Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes. In order to assess exposure to PFAS from foods, analytical methodology for the determination of these compounds at part per trillion concentrations is needed. FDA’s recent surveys of foods that are part of the general food supply did not detect PFAS in the vast majority of the foods tested. These results and the continued analysis of TDS samples will inform the Agency’s continued work to understand the occurrence of PFAS in the general food supply. Presentation Recording. FDA GRAND ROUNDS - Thursday, March 12, 2020, 12:00 p.m. - 1:00 pm EST - Thomas O'Connor, Senior Chemical Engineer, Offices of Testing Research and Pharamceutical Quality CDER, is presenting on Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology. This presentation will provide an overview of these advanced manufacturing technologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs Registration is required. NEWS FDA Voice - FDA, CDC Develop Robust Strategy to Prevent Illnesses Caused by Cyclospora - July 2, 2020, Anna 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, shares that the FDA and CDC are collaborating to protect consumers from Cyclospora cayetanensis, a parasite that has caused multistate outbreaks of foodborne illness in recent years. FDA Voice - Partnering with the European Union and Global Regulators on COVID-19 - June 25, 2020, Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs and Mark Abdoo, Associate Commissioner for Global Policy and Strategy, share that this collaboration includes the 30 technical expert groups, or “clusters” that the FDA and the EMA have established since 2003. These clusters meet regularly for regulatory discussions held under confidentiality commitments and were well positioned to pivot to focus on COVID-19 because of their ongoing work together. FDA Voice - FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic - June 23, 2020, Stephen M. Hahn, M.D., Commissioner of Food and Drugs, announced that the FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years. FDA Voice - Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19 - June 11, 2020, Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research announced that as the FDA continues to prioritize development of new therapies for rare diseases, they are also working to minimize COVID-19 impact on the progress we’re making. Below are some examples FDA Voice - Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety - June 2, 2020, Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response shares that over the past few months we have revised the blueprint in light of the lessons learned during the pandemic. It is clear that COVID-19 has accelerated the need for these measures. Some elements of the blueprint are particularly meaningful now, and we’d like to touch on these, starting with tech-enabled traceability, then on to Food Safety Culture on the Farms, in Food Facilities and at Home. FDA Voice - Bringing a Cancer Doctor's Perspective to FDA's Response to the COVID-19 Pandemic - May 29, 2020, Stephen M. Hahn, M.D., Commissioner of Food and Drugs shares that in hospitals all across this country, doctors continue to deal with the influx of COVID-19 cases. As a doctor, my heart breaks for the patients and their families. I also want to express admiration for my peers in the medical community who are doing everything they can to treat patients ill with this novel disease that we continue to learn about every day. At the FDA, our public health concern is for the American people, and much like the health care professionals on the front lines, our team of 18,000 strong are using their years of expertise to make decisions based on the best science and data at hand during this unparalleled public health emergency. FDA Voice - COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products - May 18, 2020, Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs shares that Many of the medical products our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of Regulatory Affairs (ORA) work imperative to ensure products are moving as quickly as possible through the ports of entry. The FDA is facilitating the entry of imported personal protective equipment (PPE) and COVID-19 test kits as well as drugs and medical devices, that are needed to provide supportive care for sick and hospitalized patients. Many of these products are also critical for essential workers, such as grocery store employees, food manufacturers and caregivers, who also need PPE to safely perform their essential duties. We are making sure that products move quickly to their destinations so frontline health care workers and essential workers have the tools they need to protect themselves and so that patients receive necessary care. FDA Voice - FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution, While Preserving Access - May 13, 2020, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research shares Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, but they can also pose unique risks. They are not approved by the FDA and, therefore, have not been evaluated for safety, effectiveness, or quality prior to marketing. The FDA’s compounding program is a priority for the agency and aims to develop policies that ensure appropriate access to lawfully-marketed compounded drugs for patients who have a medical need for them, while also protecting public health. Over the past several years, one of the most crucial aspects of our work in this area has been to identify opportunities to partner with the states to address these important public health goals. FDA Voice - Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy - May 4, 2020, Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health shares that the FDA issued an update to a policy from March 16, 2020 on antibody tests for COVID-19. High-quality antibody tests (a type of serological test) can help us understand a person’s and population’s exposure to COVID-19. A person who has been exposed to, and recovered from, COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood. These tests may be important for guiding our next steps in the fight against this pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease FDA Voice - A decade of FDA Advancing Health Equity - April 22, 2020, Stephen RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health shares that the FDA is committed to reducing the health inequities minorities face that often contribute to reduced quality of life and premature death (watch the OMHHE video to learn more). In our effort to provide the most current and accurate COVID-19 information, we have increased outreach by developing and disseminating COVID-19 health education materials for consumers in multiple languages, such as How You Can Make a Difference During the Coronavirus Pandemic (available in English, Spanish, and Chinese) and Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions (available in English and Spanish), that provide answers to questions consumers may have about COVID-19. These educational materials include general information and details on pertinent COVID-19 topics such as social distancing, diagnostic testing, vaccine development, fraudulent medical products, blood and plasma donation, and food safety. FDA Voice - FDA Provides Flexibility to the Food Industry During COVID-19 - April 21, 2020, Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition share that as restaurants may be closed or limited to take-out or delivery only, schools and hotels are closed, and many of us are cooking more at home. This has resulted in an imbalance in the food supply chain with excess quantities of food typically supplied to restaurants and other food service establishments and increased demand for food supplied to supermarkets There is temporary flexibility regarding packaging and labeling. FDA Voice - The Path Forward: Coronavirus Treatment Acceleration Program - April 20, 2020, Stephen M. Hahn, M.D., Commissioner of Food and Drugs, Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research and Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research share that the FDA launched a new program called the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as soon as possible. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. For example, studies include 1) direct-acting antivirals, 2) tamping down the body’s own immune reaction to the virus, and 3) using antibodies in the blood plasma to help others fight the infection. The FDA launched a new webpage to help guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. One donation has the potential to help up to four patients. FDA Voice - A Perspective on the FDA's COVID-19 Response - April 10, 2020, Mitch Zeller, Director, FDA Center for Tobacco Products shares that the FDA's leaders are working around the clock on addressing every aspect of the crisis, from diagnostics to therapeutics to food safety and everything in between. The recent establishment of the Coronavirus Treatment Acceleration Program and its many features provide just one example of how the agency is employing rapid, interactive response efforts. 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. 2020 PhRMA Foundation Awards The 2020 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 Translational 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 Monday, February 3, 2020. For more information or to apply, visit the PhRMA Foundation website, www.phrmafoundation.org. You may also call 202-572-7756. Beginning with the 2021 award cycle, the PhRMA Foundation is no longer providing funding in Pharmacology/Toxicology, Pharmaceutics and Informatics. The PhRMA Foundation is providing funding in new programs for young researchers with innovative projects in Drug Delivery and Drug Discovery, along with Health Outcomes Research, Translational Medicine and Value Assessment. The PhRMA Foundation is using a new application portal, proposalCENTRAL. This system requires registration. https://proposalcentral.com/. All applicants must attend a U.S. university or research institution based in the United States. Brochures can be found here. 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.