URMC / Research Alliances / Regulatory Science / News, Events, and Funding Opportunities Events, News, and Funding Opportunities 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: - Assessing Flavorant Toxicity - Characterizing Flavors and Their Impact on Behavior - Determining Respiratory health Effects of Flavors - Evaluating the Effects of Product Marketing 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, November 8, 2018, 12:00 - 1:00 pm EST. Randy Self is a research chemist with FDA’s Applied Technology Center in the Pacific Northwest Laboratory, where he conducts research on method development for food safety applications. He will discuss Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling. The presentation will include sensory analysis is performed in FDA testing laboratories to determine the decomposition status of seafood samples. Current methodology to complement this testing with chemical analysis (e.g., histamine) is not always directly comparable to sensory testing. FDA GRAND ROUNDS - Thursday, October 11, 2018, 12:00 - 1:00 pm EST. Lynnd Hull, Phd, Lead Pharmacologist within FDA’s Center for Tobacco Products, joined the Center in 2014 from NIH’s National Cancer Institute. The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes. This presentation will give an overview of the systematic literature review that FDA’s Center for Tobacco Products has done on the likely effects of reducing nicotine in combusted tobacco, as well as on consumer knowledge, attitudes, perceptions, beliefs, and planned behavior on reduced nicotine tobacco products 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 - FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products - November 30, 2018, Jeff Shuren, MD, JD and Jonathan Jaro, MD. As part of the FDA’s ongoing commitment to address the opioid crisis, the FDA’s Center for Devices and Radiological Health (CDRH) launched an Innovation Challenge in May 2018. The challenge was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain. The goal was to provide additional incentives for medical device developers to invest in products that can address the addiction crisis and advance the development of innovative, safe and effective technologies. We received more than 250 applications from medical device developers. FDA Voice - FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products - November 29, 2018, Anna Abram and Mark Abdoo. Even in this modern era, when so much can be done remotely, there are many tangible benefits to having “boots on the ground” when doing business overseas. That’s the thinking behind the FDA’s foreign offices, which play a vital role in inspecting foreign manufacturing facilities, gathering market and industry information, and building closer relationships with local regulatory bodies, all in the interests of protecting the public health of Americans. FDA Voice - FDA is Advancing New Efforts to Address Drug Shortages - November 19, 2018, Scott Gottlieb, MD and Janet Woodcock, MD. A key component of our public health mission is to help ensure Americans have access to safe and effective medicines. That’s why, as drug shortages arise, we take immediate action within our authorities, working across the FDA and with other government agencies, industry, and other stakeholders, to minimize the impact of these shortages and maintain or restore availability of critical medicines for the patients who need them. FDA Voice - The Medical Device Ecosystem and Cyber-security - Building Capabilities and Advancing Contributions - November 1, 2018, Suzanne B. Schwartz, MD, MBA. As medical devices become more digitally interconnected and interoperable, they can improve the care patients receive and create efficiencies in the health care system. However, medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. FDA Voice - Advancing Toward the Goal of Global Approval for Generic Drugs: FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs - October 18, 2018, Scott Gottlieb, MD. Too many Americans struggle with the high cost of drugs. In some cases, patients go without needed medicines. This is why drug pricing is a matter of public health. And it’s why FDA launched a Drug Competition Action Plan that focuses on three key areas designed to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines. FDA Voice - Fall 2018 Unified Agenda: FDA's New Regulatory Work to Advance Health and Safety - October 17, 2018, Scott Gottlieb, MD. Today, the federal government published the Fall 2018 Unified Agenda, which provides federal agencies the opportunity to share the government’s top regulatory priorities with the American public. For the U.S. Food and Drug Administration (FDA), the Agenda reflects our ongoing commitment to protecting and promoting the public health through science-based decision-making that informs new regulations that advance the public health and promote innovative, efficient oversight of our key areas of influence. FDA Voice - CDRH FY 2019 Proposed Guidance Document and Retrospective Review - October 3, 2018 - Jeff Shuren, MD, JD, FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff, to address areas including design, manufacturing, and testing of regulated products, scientific issues, content and evaluation of applications for product approvals, postmarked surveillance, and inspection and enforcement policies. 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.