URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities Events, News, and Funding Opportunities Translational Science 2019 - SAVE THE DATE - March 6-8, 2019, at the Washington Marriott Wardman Park. 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. Clinical Investigator Training Course - SAVE THE DATE 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 FDA GRAND ROUNDS - Thursday, September 13, 2018, 12:00 - 1:00 pm EST K. Barry Delclos, PhD, Research Pharmacologist, Division of Biochemical Toxicology, of FDA's National Center for Toxicological Research will discuss Bisphenol A (BPA) Toxicology and Pharmacokinetic Data to Inform On-going Safety Assessments - Bisphenol A (BPA) is a high-production-volume industrial chemical used in producing polycarbonate plastics and epoxy resins used in consumer products, such as storage containers for foods and beverages, medical devices, and thermal paper. The predominant human exposure is from food containers. Low levels of monomer can migrate from these products and there has been much controversy as to the potential toxicity of this BPA exposure. 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 - New Program with Payors Aims to Accelerate Patient Access to Medical Devices - September 5, 2018 - Scott Gottlieb, MD, announced patients may not have access to an FDA approved or cleared device in the absence of adequate coverage. So, the FDA recognizes the importance of working collaboratively with the payor community to streamline the path from FDA market authorization to payor coverage and reimbursement. Over the past few years, we’ve sought creative solutions to decreasing the gap between the FDA’s decision to advance a product to the market and the time it takes both public (e.g., Medicare, Medicaid) and private payors to determine whether and how they will provide coverage. FDA Voice - FDA's Comprehensive Effort Advance New Innovations Initiatives to Modernize for Innovation - August 29, 2018 - Scott Gottlieb, MD, announced the FDA's longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are becoming available. Many of these opportunities are enabled by new technology platforms such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies. FDA Voice - FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials- August 14, 2018 - Richard Pazdur, MD, announced advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early trials, or both. FDA Voice - Advancing Tobacco Regulation to Protect Children and Families - Updates and new Initiatives from FDA on the Anniversary of the Tobacco Control Act and FDA's Comprehensive Plan for Nicotine - August 2, 2018 - Scott Gottlieb, MD and Mitch Zeller, JD announced that this comprehensive plan places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The multi-year roadmap provides a framework for regulating nicotine and tobacco and is designed to reframe the conversation around nicotine and harm reduction. FDA Voice - FDA Announces Two Initiatives to Modernize Drug Quality Programs - July 26, 2018 - Janet Woodcock, MD and Michael Kopcha, PhD, RPH - Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination. To satisfy these important expectations, the FDA strives to make sure that FDA-approved drugs are manufactured to meet quality standards to ensure that every dose is safe, effective, and capable of providing its intended benefit. FDA Voice - Protecting and Promoting Public Health: Advancing the FDA's medical Countermeasures Mission - July 16, 2018 - Anna Abram, announced The U.S. Food and Drug Administration’s wide-ranging public health responsibilities include the vital role we play on the front lines of national security by facilitating the development and availability of safe and effective medical countermeasures. These are the vaccines, diagnostics and therapeutics that are needed to protect our nation from chemical, biological, and radiological and nuclear threats, whether naturally occurring, accidental, or deliberate. FDA Voice - FDA Budget matters: Investing in Advanced Domestic Manufacturing - July 13, 2018 - Scott Gottlieb, MD, announced there's new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. The FDA is focused on propelling these innovations. FDA Voice - FDA Budget Matters: Infrastructure to Support Robust Generic Drug Competition - June 18, 2018 - Scott Gottlieb, MD announced that the FDA launched its Drug Competition Action Plan more than a year ago, with the aim of advancing policies that would promote robust generic drug entry as a way to foster competition and lower drug prices. Access to drugs is a matter of public health. And among the best ways to help consumers get broader access to medicines is through policies that help ensure branded drugs are subject to timely generic competition. FDA Voice - FDA's New Efforts to Advance Biotechnology Innovation - June 6, 2018 - Scott Gottlieb, MD and Anna Abram - announced that scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researches and companies based in the United States helped pioneer these technologies. FDA Voice - FDA Proposes Process Modernization to Support New Drug Development - June 4, 2018 - Janet Woodcock, MD, The staff of the FDA's Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global "gold standard" in drug regulation. FDA Voice - Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis - May 14, 2018 - Scott Gottlieb, MD, announced that the biggest public health crisis facing FDA is opioid addiction. FDA is committed to making every possible effort to stem the tide of this crisis. A little over a year ago, the formation of the Opioid Policy Steering Committee (OPSC) was formed to double these efforts. This group, comprised of the agency’s most senior leaders, was tasked with developing new approaches to impacting this crisis. One overarching goal of the committee was to develop new policy solutions to reduce overall exposure to opioids, prevent new addictions, and support the development and use of better FDA-approved medications to treat those with opioid use disorder. FDA Voice - Spring Unified Agenda: FDA's Anticipated Upcoming Regulatory Work - May 9, 2018 - 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. 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. 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. 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.