What's New in Regulatory Science

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 Video Series providing insight on CDER regulatory science CDER has launched a new series of videos in which Center Director Janet Woodcock, M.D., describes major challenges in drug evaluation and development and how FDA and its collaborators are addressing them. The following videos are now available:

Improving Drug Review with Data Standards. Learn how data standards can support the integration of real world evidence into the drug development process and patient-centric decisions.

• Patient-Focused Drug Development. Explore how the voice of the patient critically impacts drug development.
• Real World Evidence.  Learn how FDA is collaborating with external stakeholders to identify and evaluate previously unreported adverse reactions and support early detection of safety signals.
• The Importance of Partnerships and Consortia. Explore how partnerships and consortia can enable us to address challenging regulatory science questions.

CDER has also added new videos and podcasts to its collection of interviews with some of its leading investigators. In “CDER Scientists – In Their Own Words,” these investigators describe their roles in FDA’s regulatory science program, and how their research advances drug development and the public health.  Click the investigator’s name below to view their video: 

• Kathryn Aikin, Ph.D., describes how social scientists at CDER evaluate prescription drug advertisements and analyze how they are interpreted by patients to ensure they convey information that is truthful, balanced, and not misleading. 
• Celia Cruz, Ph.D., provides an update on how the Office of Pharmaceutical Quality is investigating innovative approaches to drug manufacturing like 3D printing, and developing advanced analytic approaches to ensure the quality of a new generation of drug products. 
• Lisa LaVange, Ph.D., provides an overview of how CDER’s statisticians assess evidence in pre- and post-market settings to ensure that drugs are safe and effective while helping to improve the design of the clinical trials used to evaluate new personalized treatments for cancer.
• Raj Madabushi, Ph.D.,  explains how computational approaches like Model-Informed Drug Development are being used to improve drug dosing in children and other populations and help to provide better guidance to developers.
• Karen Mahoney, M.D., describes a logical drug label language approach developed and championed by her division to facilitate the over-the-counter availability of Naloxone, an opioid blocking drug. 
• Michael Nguyen, M.D.,  provides a brief introduction to Sentinel, FDA’s active surveillance program, and describes how it engages with multiple data partners to help monitor medical products and provides epidemiologists with new opportunities to address urgent questions of drug safety and efficacy.
• Ashutosh Rao, Ph.D., describes how research on protein oxidation provides critical information on the stability of protein therapeutics and supports development of safer and more effective versions of these products.
• Amy Rosenberg, M.D.,  discusses cutting edge research examining alterations in protein therapeutics and treatment modalities that may improve patient outcomes.  
• Connie Ruzicka, Ph.D., gives an overview on how new kinds of portable instrumentation can be used to screen dietary supplements for harmful additives.
• David Strauss, M.D., Ph.D., uses several examples of multi-disciplinary projects from CDER’s Division of Applied Regulatory Science to illustrate how clinical, laboratory, and computational approaches are being used to predict how a patient may respond to a new drug.
• Daniela Verthelyi, M.D., Ph.D., describes development of methods to evaluate biologic products submitted via the abbreviated licensure pathway (biosimilars), and CDER’s efforts to develop new treatments for a parasitic disease that affects millions of individuals worldwide.
• Kimberly Witzmann, M.D. , explores the challenges of evaluating equivalence of generic and brand name drugs, describing how the Office of Generic Drugs is developing new ways to evaluate complex products such as drugs delivered with inhalers.
• Lynne Yao, M.D., highlights the need to develop safe and effective drugs for children and pregnant women, and describes how CDER is helping to ensure that specific labeling is available to guide prescribing for these patients.