News Archives

All items herein are chronologically organized within the following categories:  FDA Grand Rounds, FDA Voice, FDA Cersi Lecture Series and Cersi Webinars, Certificate Programs, Conferences & Competitions, and Committees & Reports.

FDA GRAND ROUNDS:

• 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.  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.
• FDA GRAND ROUNDS - Thursday, August 9, 2018, 12:00 - 1:00 pm EST - Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics, FDA's Center for Drug Evaluation and Research, will discuss how the "FDA is transforming regulatory pathways with simulation", and give an overview of those methodologies, highlight success stories with simulation, and discuss the potential for in silico clinical trials for advancing medical products. - 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.
• 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.
• FDA GRAND ROUNDS - Thursday, March 8, 2018, 12:00-1:00 pm EST - Steven R. Bauer, PhD presented, "Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine".  Dr. Bauer, is the Chief of the Cellular and Tissue Therapy Branch (CTTB), in FDA’s Center for Biologics Evaluation and Research, where he supervises scientific staff engaged in review of cell-based biological therapies, policy development in emerging areas of cellular therapies, and research relevant to their use in clinical trials.  Stem cell-based cellular therapies are being actively developed and hold tremendous promise for treating a wide variety of medical conditions, from diabetes to heart disease and joint repair.  He addresses the regulatory question of "whether or not the characteristics that are measured in product testing are predictive of clinical outcomes".  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.
• 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.
• FDA GRAND ROUNDS - Thursday, September 14, 2017, 12:00-1:00 pm EST. - The webcast is entitled "Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs" and will be presented by: David Strauss, MD, PhD, Director, Division of Applied Regulatory Science, FDA's Center for Drug Evaluation and Research Research Microbiologist, FDA's Center for Food Safety and Nutrition.  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.

FDA VOICE:

• 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 Voice - On Farm Readiness Reviews Support Farmers as They Safeguard produce - September 11, 2018 - Scott Gottlieb, MD, and Stephen Ostroff, MD.  On-Farm Readiness Reviews provide farmers real-time feedback on their current operations and facilities. These reviews can help farmers address any areas in need of improvement before a regulatory inspection takes place in the future. Working together, the aim is to improve the safety of the food supply while still maintaining a vibrant agriculture sector.
• 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 i
• 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, MDFDA-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 MedicineFDA 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 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.  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 Voice - More Collaboration, Research Needed to Develop Cures - July 16, 2015 by Robert Califf, MD New report compares diseases where there is a robust pipeline of new therapies with diseases that have few known treatments or cures.
• FDA Voice - FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health  December 7, 2017 - Peter Stein, MD - 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 - FDA's efforts to ease the application process for expanded access - 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 Voice - China recently joining ICH in the pursuit of global harmonization of drug development standards.  August 9, 2017 - Theresa M. Mullin, PhD - Dr. Theresa Mullin discusses the mission to help increase patient access to safe, effective, and high quality pharmaceuticals and to ensure that pharmaceuticals are developed and registered efficiently.
• 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 CERSI LECTURE SERIES AND CERSI WEBINARS:

• 11/12-14/2019 7:30 am - 5:00 pm ET - Regulatory Education for Industry (REdI): Clinical Investigator Training Course - This course provides a study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products. Registration is required.
• 10/2/19 - Dr. Leslie Wilson Professor, Departments of Medicine and Clinical Pharmacy, University of California, San Francisco School of Pharmancy is pleased to present "We're Good at Evaluating Risk:  how patients' Views Can make You Better" The inclusion of the patient’s voice in shared health care decision making has progressed from the physician’s office to the regulatory decisions made by the FDA. In 2013, the FDA launched the “Patient Preference Initiative” to incorporate patients’ views as scientific, empirical evidence, when appropriate. This led to CDRH and CBERs’ collaboration with the Medical Device and Innovation Consortium (MDIC) on a report cataloguing assessment methods published in 2015. This report was the basis for FDA’s CDRH and CBER draft guidance defining patient preference information for medical devices and outlining approaches to its measurement and use. Since then, the FDA has initiated multiple collaborations to advance the science and define the usability of patient preference information across different stakeholders at a rapid rate.
• 10/2/2019 8:00 am - 5:00 pm ET - The Divisions of Pulmonary, Allergy, and Rheumatology Products and Pediatric and Maternal Health, in collaboration with the University of Maryland CERSI, is announcing a 1-day public workshop, “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)” The purpose of the workshop is to discuss current barriers to expeditious pJIA drug development and steps to overcome them.  Specific topics will include extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA.  Registration is required.
• 9/23-25/19 8:30 am - 6:00 pm ET- The FDA's Division of Biopharmaceuticals, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER), CDER Small Business and Industry Assistance (SBIA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) are pleased to present Regulatory Education for Industry (REdI) and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls.  The purpose of this workshop is to identify and begin to fill the gaps in knowledge on the use of PBBM for drug product quality (e.g., to study in vivo impact of formulation and manufacturing changes). Registration is required.
• 11/6/19 - Christopher Chute, MD, DrPh, Bloomberg Distinguished Professor of Health Informatics is pleased to present "The Role of Ontology and controlled Terminology in Precision Medicine:  Implications for Post-Market Survelillance".  Biomedicine and healthcare, including post-market surveillance of adverse events, have become data-intensive activities. The importance of data is in part because much more is available, and in part because of our ability to analyze it with modern data science tools. However, integrating data from real-world sources remains a serious challenge. The data must be comparable, more or less by definition. It is beneficial if the data is also consistent and reliable. In this talk, Dr. Chute emphasized maturing methods and techniques to frame clinical data for downstream analyses and discovery.
• 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. 
• Clinical Investigator Training Course - 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
• 10/3-4/18 - Predictive Immunogenicity: Improved Medicines and Better Clinical Outcomes - FDA, Johns Hopkins University and University of Maryland CERSIs. This timely public workshop will present advances in the development of technological tools for predictions of immunogenicity and discussions on how to engage relevant stakeholders in application of these tools during drug development. There will be no registration fee to attend in-person or access the workshop via the webcast, but registration is required for DAY 1 - and - DAY 2.
• 9/28/18 - Translational Pathways for Optical Drugs and Devices for Cancer Imaging (FDA CDER and CDRH, NIH National Cancer Institute and University of Maryland CERSI Collaborative Workshop. This workshop will discuss regulatory expectations for the development of optical imaging drugs and devices, identify efficient translational pathways forward and you will hear perspectives from industry, academia, investigators and other stakeholders on how to enhance the clinical development on optical imaging drugs and devices.  Registration for both on-site and remote participation is now open.
• 9/26/18 - What Can Data Tell us About the Opioid Crisis? Presented by William C. Becker, MD, Associate Professor of Medicine Yale School of Medicine. Dr. Becker will explore the roots of the crisis, and will highlight and interpret observational and experimental data on both harms and benefits of long-term opioid therapy for pain. He will briefly review the clinical and research challenges in de-implementing risky opioid therapy. Finally, he will present emerging strategies – and their evidence – for a multi-pronged approach to mitigating the crisis.
• 9/12/18 - Patient Engagement in Real World Evidence - Presented by the Program Chairs: Fadia T. Shaya, PhD, MPH and Francis B. Palumbo, PhD, JD of Center on Drugs and Public Policy, along with Gregory Pappas, MD, PhD, and Lisa Miller, PhD of Center for Devices and Radiological Health. The workshop will provide a discussion forum for patients and patient groups on how they are engaged with real-world evidence generation for medical device or device and drug combination evaluation. To register for the public workshop and view the agenda, visit the following website: M-CERSI Events
• June 5, 2018: Non-invasive quantification of drug-target engagement at the tumor: Lessons from small molecules and biologics, Johns Hopkins University
• Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness - March 24, 2016, 8:30am-4:30pm, University of Maryland School of Pharmacy, 20 N. Pine Street, Room N103, Baltimore, MD 21201 - This workshop provides clinicians, researchers and others from the medical device industry, professional societies, health care delivery systems, patient advocacy groups, and the FDA the opportunity to discuss this important topic. Presenters discuss the scientific progress in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness.

CERTIFICATE PROGRAMS:

• UR 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.

CONFERENCES & COMPETITIONS: 

• 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.
• 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!
• PhRMA Foundation Grants and FellowshipsThe 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.
• 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.
• Clinical Research Forum at the American College of Cardiology - Monday, September 25, 2017, 1:00 pm - 5:00 pm, Washington, DC - This event plans to bring together researchers to discuss and advance issues relating to drug and device development, effectiveness in research, and dissemination of knowledge about clinical research findings.  To register, or find out more visit here.
• Global Summit on Regulatory Science - September 18-20, 2017, ANVISA Brasilia, DF BRAZIL - This is an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context.  This year's theme is "Emerging Technologies for Drug and Food Safety".  Register here.
• FDA's 2015 Office of Regulatory Science and Innovation Science Symposium, April 27, 2015 - Corey Hoffman, winner of the 2nd annual "America's Got Regulatory Science Talent" competition presented his project to the FDA's 2015 Office of Regulatory Science and Innovation Science Symposium in Maryland. Read more about his project here.
• 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 UR CTSI Stories Blog.

COMMITTEES & REPORTS:

• CERSI Science Board Report  An evaluation of the CERSI programs from the CERSI program Evaluation Subcommittee.
• FDA First-ever Patient Engagement Advisory Committee- Posted on 9/18/15 by Nina L. Hunter, PhD and Robert M. Califf, MD - Patients and their care partners participate in decision-making and priority-setting in all aspects of health care.

• FDA's Commissioner's Fellowship Program: 2015 Science Board Report to the FDA available now.

OTHER EVENTS

AGRST FILES:

Sarah Hackley

Cindy Wang