What's New in Regulatory Science - Summer/Fall 2018

About the Center for Drug Evaluation and Research > Office of Translational Sciences

Brought to you by the Office of Translational Sciences (OTS) in collaboration with the Office of Communications (OCOMM) in the Center for Drug Evaluation and Research (CDER).   What’s New in Regulatory Science is a quarterly newsletter from the Food and Drug Administration’s Center for Drug Evaluation and Research. It includes new developments, opportunities, and initiatives in regulatory science, with the goal of advancing medical product development.   Please share this message and the sign-up link with colleagues, and if you have comments or questions, contact us at OTSCommunications@fda.hhs.gov.

HIGHLIGHT

CDER’s Modernization of the New Drugs Regulatory Program Janet Woodcock, M.D., CDER Director, has posted a blog about proposed changes to CDER’s new drug regulatory program. This proposal focuses on the following areas: Recruiting the best and brightest individuals from many disciplines Enhancing our focus on multidisciplinary teams Prioritizing operational excellence Improving knowledge management Emphasizing the importance of safety across a drug’s lifecycle Incoporating the patient voice

To learn more, visit the FDA Proposes Process Modernization to Support New Drug Development blog. Also available is the statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office.   In support of this modernization initiative, the CDER Research Governance Council (RGC) was established to set research goals, objectives and cross-cutting priorities, enhance systems for tracking research investments and spend, develop research outcome metrics, develop a process for reviewing CDER’s research programs, and expand communication about CDER science program to stakeholders. More information on the RGC’s efforts will be included in future newsletters.

Recent CDER Impact Stories  CDER is continuing to highlight its regulatory science research in a series of regulatory science impact stories. Three recent posts include: How CDER statisticians have helped to develop clinical trial designs with adaptive and statistical features suitable for a disease outbreak setting (click here to read story), How deep learning approaches are being developed to help drug reviewers to better understand patient experience (click here to read story), and How CDER researchers are learning which commonly prescribed sedative drugs may exacerbate the side effect of prescription opioids (click here to read story).

Recent Spotlight on CDER Science

CDER continues with its Spotlight on CDER Science series, featuring the center’s noteworthy scientific and research-oriented activities. The latest spotlight, “New Class of Drugs Fulfills Promise of RNA-based Medicine” is now available. The approval of a small interfering RNA (siRNA) product to treat polyneuropathy caused by a rare and frequently fatal disease called hereditary transthyretin-mediated amyloidosis marks the arrival of a potentially game-changing class of therapeutics.

Table of Surrogate Endpoints Now Available Online A table of surrogate endpoints that were the basis of drug approval or licensure is now available on FDA’s website. This table is intended to provide valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.  For more information, visit the surrogate endpoints webpage. To download the table, click here (XLS-38KB)

Recent CDER Conversations

Mitra Ahadpour, MD, DABAM, is the deputy director of CDER’s Office of Translational Sciences (OTS) and an addiction medicine specialist. Dr. Ahadpour discusses how medication assisted treatment works and its importance in the fight against the opioid crisis that is currently affecting communities across the nation. To read more about this CDER Conversation, click here.

Raj Madabushi, Ph.D., is a team leader for the Guidance and Policy Team within OTS, Office of Clinical Pharmacology.  Dr. Madabushi discusses the current status and promise of model-informed drug development approaches to help inform drug development and decision-making.  To read more about this CDER Conversation, click here.   To see other past CDER Conversations, click here.

ONLINE RESOURCES

CDER Collaboration with NCATS We are working with the Clinical and Translational Science Awards (CTSA) Program team at National Center for Advancing Translational Sciences (NCATS) to enhance scientific interactions, including collaborations, sabbaticals and educational resources. The CTSA Program at NCATS supports a national network of medical research institutions called hubs, that work together to improve the translational research process to get more treatments to more patients more quickly.  Through the OTS-NCATS collaborative efforts, educational resources at FDA, including publicly available trainings, course modules, case studies, and video lectures, have been added to two CTSA sites:  1. The University of Rochester Regulatory Science webpage, and 2. Eagle-I, a resource discovery tool built to facilitate translational science research, that uses a Search engine named N-lighten, to query shared educational resources at NIH, FDA, Harvard Catalyst and Ohio State University. FDA’s Scientific Publications Online Database Are you looking for journal articles from FDA authors?  Check out the Scientific Publications by FDA Staffonline database which allows users to search for specific publication information by center and by date range.

UPCOMING EVENTS

September   Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments. FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, Rm. 1503, Section A, Silver Spring, MD 20993. September 10, 2018. Meeting Information Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices (FDA CDRH and University of Maryland CERSI Collaborative Workshop). University of Maryland, School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201. September 12, 2018. Meeting information. 2018 PDA/FDA Joint Regulatory Conference, Putting Patients First: Ensuring Innovation, Quality, Compliance, and Supply in an Evolving Environment.   Renaissance Hotel, 999 9th Street, NW, Washington, D.C. 20001. September 24 – 26, 2018.  Meeting Information October Predictive Immunogenicity for Better Clinical Outcomes. FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, Rm. 1503, Silver Spring, MD 20993-0002. October 3-4, 2018. Meeting Information Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments, FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Rm. 1503, Silver Spring, MD 20993, October 15-16, 2018. Meeting Information  November Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities.  FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Room 1503 (Great Room), Silver Spring, MD 20993. November 28, 2018.  Meeting information

CAREER OPPORTUNITIES

FDA has a new campaign to advance ongoing efforts to recruit and retain a world-class workforce dedicated to protecting and promoting the public health. Information on job vacancies, employment events, and hiring programs are available by following @FDAJobs on Twitter, by visiting the FDA’s LinkedIn pageand the Jobs at FDA webpage. Help us spread the news through your social media networks!   For more information, please visit FDA In Brief webpage