URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities Events, News, and Funding Opportunities EVENTS PERSONALIZED MEDICINE CONFERENCE - SAVE THE DATE November 14-15, 2018, 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 2017 Conference Program here. FDA GRAND ROUNDS - Thursday, May 10, 2018, 12:00-1:00 pm EST Suzanne Fitzpatrick, PhD, DABT, ERT, Senior Advisor for Toxicology, FDA's Center for Food Safety and Applied Nutrition (CFSAN), will discuss "FDA's Predictive Toxicology Roadmap", a six part framework for integrating new predictive toxicology methods into safety and risk assessments of FDA products. She'll detail FDA's collaborative efforts to advance toxicology toward a more predictive science with NIH, EPA and other federal agencies through programs Like Tox21 and ICCVAM. FDA's unprecedented role in the development and evaluation of the organs-on-a-chip technology with sister federal agencies and industry will be described and offered as an example of how FDA is enabling innovation in this exciting field. Learn how diverse stakeholders can work with FDA to share ideas, discuss new technologies, and highlight collaborations that are developing and testing new methods. - 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. 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 - Spring Unified Agenda: FDA's Anticipated Upcoming Regulatory Work - May 9, 2018 - Dr. Scott Gottlieb, MD, announced that the federal government published the "Spring 2018 "Unified Agenda of Federal Regulatory and Deregulatory Actions" (Unified Agenda), which provides federal agencies with the opportunity to update the American public on our government's regulatory priorities. FDA Voice - The FDA is Asking for More Information on Application Forms - Here's Why That's Good for Innovation and Improving Health - May 4, 2018 - Dr. Christopher Leptak, MD, PhD, announced that to be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT. By clearly identifying the intended uses or indications for a potential new drug, SNOMED CT enabled metrics will better inform review activities and aid in consistency in the FDA advice for applications with similar indications. Newly systematized indication information will allow the FDA to better identify areas of unmet medical need for future drug development. This information will also help inform policy development, and with it, allow FDA to become more proactive about developing guidances and gathering public feedback. Additionally, using SNOMED CT will make it possible for the FDA to link its internal data with other data sources coded to SNOMED CT (e.g., EHRs). FDA - Finalizes Guidances for Next Generation Sequencing Tests - April 12, 2018 - FDA finalized two guidances designed to enhance collaboration among researchers, and drive the efficient development of novel next generation sequencing (NGS) based tests. The first guidance, "Use of Public Human Genetic Variance Databases to Support Clinical Validity for Genetic and Genomic-based in Vitro Diagnostics", and the second, "Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing(NGS) Based in Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases." On Thursday, May 24, from 2:00 - 3:00pm ET, the FDA will host a webinar for product developers, database administrators, and others interested in learning more about these final guidances. More information about the webinar is available at http://www.fda.gov/CDRHwebinar. FDA Statement - March 20, 2018 - Scott Gottlieb, MD: "To reduce tobacco use, in Youths, the FDA is taking a look at the role "Flavors" play. The FDA announced a plan in the summer of 2017 to better regulate tobacco and nicotine in an effort to protect youth, as well as future generations, from the diseases and death caused by tobacco use. The FDA is seeking more information about both the positives and negatives of flavors in youth initiation and getting adult smokers to quit or transition to potentially less harmful products. FDA Statement - March 15, 2018 - Scott Gottlieb, MD: "To dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to non-addictive levels". The FDA recently issued an ANPRM to explore a product standard to LOWER nicotine in cigarettes to minimally or non-addictive levels - a pivotal step in a comprehensive plan that could help avoid millions of tobacco-related deaths across the country. 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. 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. PhRMA Foundation Grants and Fellowships The PhRMA Foundation’s 2018 award types of value assessment initiative, pre-doctoral fellowships, sabbatical fellowships, research starter grants, post-doctoral fellowship and other awards, support and reward innovative researchers in pharmaceutical science, across a variety of disciplines, including: health outcomes, informatics, pharmaceutics, pharmacology/toxicology, translational medicine and therapeutics, and regulatory science fellowship. 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: 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 investigators developing new methodologies or innovative approaches in regulatory science. The next award cycle will be announced in late 2018. 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.