URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities News, Events, and Funding Opportunities EVENTS FDA GRAND ROUNDS - Thursday, January 11, 2018, 12:00-1:00 pm EST Sherry Ferguson, PhD and Vijayalakshmi Varma, PhD, will present "Ethnicity- and Gender-related Differences in Alzheimer's Disease". Dr. Ferguson is a research psychologist from the Division of Neurotoxicology of the FDA's National Center for Toxicological Research (NCTR). Dr. Varma is a research biologist at the NCTR. They will discuss research into protein levels in post-modern African American and Caucasian brain tissue from both genders to explore ethnicity and gender differences. FDA Grand Rounds is presented every other month and features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. Registration is required. PERSONALIZED MEDICINE CONFERENCE - REGISTER TODAY! November 14-16, 2017, Harvard Medical School, Boston, MA Representatives from every sector of the health system will define the landscape and outlook for personalized medicine in science, business and policy. See the Conference Program and register here. Association for Clinical and Translational Science (ACTS) Meeting SAVE THE DATE! April 19-21, 2018, Washington Marriott Wardman Park, Washington, DC Explore the latest research, collaborate with scientific peers, educate yourself on key issues presented by plenary speakers, and innovate your research by submitting a poster abstract and gain visibility among peers and colleagues! 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. NEWS FDA Voice: December 7, 2017 - Peter Stein, MD FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health - Dr. Stein discusses post-approval studies to address safety or better characterization of risk factors of drugs. These studies are referred to as post-marketing requirements (PMRs) and are monitored by the FDA to make sure they are conducted in a timely manner. Read more of the article, here. FDA Voice: October 3, 2017 - Scott Gottlieb, MD Dr. Gottlieb discusses the FDA's efforts to ease the application process for expanded access. To simplify the process for physicians seeking access to an investigational product to treat their patients, one IRB member can now approve the treatment. More simplifications are in the pipeline. FDA: Big leap into Precision Medicine FDA approved the cancer drug, Keytruda, for the treatment of tumors that express one of two biomarkers regardless of where it is in the body. This is the first time the FDA approved a cancer drug for treatment based on specific biomarkers rather than the tumors location. 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. 4th Annual “America’s Got Regulatory Science Talent”Competition The top two teams from the University of Rochester Regulatory Science competition visited the FDA on April 12, 2017 to present their ideas and meet with several FDA scientists and engineers. Dr. Steve Ostroff kicked off the event. For more information and to see the finalists' presentations visit the CTSI Stories Blog. CTSI OFFERS ADVANCED CERTIFICATE IN REGULATORY SCIENCE This is a NYS-approved certificate covering experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy. Fall registration is open. For more information, visit here. CERSI Science Board Report An evaluation of the CERSI programs from the CERSI program Evaluation Subcommittee. Archives FUNDING OPPORTUNITIES FDA Commissioner's Fellowship Program Request for applications is now closed. Program start is November 2017. Please visit the FDA's Commissioner's Fellowship Program webpage for program details. PhRMA Foundation Grants and Fellowships Supporting and rewarding innovative researchers in pharmaceutical science. Program links and deadline dates are available 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. Fellowship Term to begin July 1, 2017. 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. 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 investigators developing new methodologies or innovative approaches in regulatory science. 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.