Sorell Schwartz, PhD
Professor Emeritus of Pharmacology
Georgetown University Medical Center
Erin Wilhelm, MPH
Instructor, Department of Pharmacology & Physiology
Executive Director, Program for Regulatory Science & Medicine
Course Overview: Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products. This survey course will examine the myriad issues that arise in the field of regulatory science, and will introduce students to fundamental principles of regulatory science, describe the differences between regulatory science and regulatory affairs, and provide an overview of the innovative clinical research tools of regulatory science. Building upon the Food and Drug Administration’s (FDA) Strategic Plan: Advancing Regulatory Science at FDA (September 2014), individual classes will focus on the eight priority areas defined by the FDA as necessary for advancing regulatory science. Expert lecturers from Georgetown University (GU) and the FDA will present case studies and best practices, and guide discussion of key issues.
Instruction Methods and Approaches: This course is structured around the FDA’s eight strategic priority areas to advance regulatory science. Classes will include recorded lecture sessions focused on the topic of the week, delivered by experts from Georgetown, FDA, and other stakeholder organizations. Students and lecturers meet in person weekly for discussion sessions. Students will submit a scholarly paper focused on one of the FDA priority areas.
Required Text: Session lecturers will assign readings throughout the semester.
Pre- or Co-Requisites: None
For more information, please contact Erin Wilhelm.
SESSION 1: INTRODUCTION TO THE COURSE
Webinar: Background on FDA Patient-Focused Drug Development
Webinar: FDA's Impact on Pharmaceutical Innovation (48 min)
SESSION 2: FUNDAMENTALS OF REGULATORY SCIENCE
Objective: Describe course purpose, structure, and requirements; introduce concepts and history of Regulatory Science.
Lecturer: Ira Shoulson, MD
Lecturer: Carolyn Wilson, Ph.D.
SESSION 3: REGULATORY SCIENCE AND SOCIAL BEHAVIORAL SCIENCES
Objective: Introduce ways regulatory science will enable health professionals and the public to make more informed decisions about medical and food products.
Lecturer: Nancy M. Ostreve, Ph.D
FDA's Strategic Plan for Risk Communication
Guidance for Industry: Presenting Risk Information in Drug and Medical Device Promotion
Communicating Risks and Benefits: an Evidence-Based User's Guide
SECTION 4: REGULATORY AFFAIRS AND THE LAW
Objective: Examine the legal issues that arise in the field of regulatory science; introduce key food and drug legislation and related legal issues; explain life cyle science and clinical research.
Lecturer: Sarah Spurgeon, PhRMA
Lecturer: Rikin Mehta, JD, LL.M.
SECTION 5. REGULATORY SCIENCE AND BIOETHICS
Objective: Describe reasoning skills required to explain and justify decisions regarding ethical questions and dilemmas; review the nine key training areas identified by NIH for the responsible conduct of research.
Lecturer: Kevin FitzGerald, S.J.
Lecturer: Robert "Skip" Nelson, M.D., Ph.D.
Nelson and Roth-Cline - Ethical Considerations in Design of Pediatric Trials in LMIC 2015
Roth-Cline et al Peds Pharm Chapter 2011
Roth-Cline & Nelson. Parental Permission and Child Assent in Research on Children
ANPRM change table
Biobank opt it or opt out
Emanuel E - What Makes Clinical Research Ethical JAMA 2000
Havasupai DNA article
Is teh Havasupai Indian Case a Fairy Tale
SECTION 6. CLINICAL RESEARCH TOOLS OF REGULATORY SCIENCE
Objective: Review the basic principles of clinical trials, emphasizing scientific rationale, organization and planning, and methodology; introduce trial designs, research monitoring, and statistical analysis tools.
Lecturer: Ira Shoulson, M.D.
Lecturer: Rob Califf, M.D., MACC
SECTION 7A. BIOSURVEILLANCE, MEDICAL COUNTERMEASURES, AND GLOBAL HEALTH
Objective: Provide an overview of regulatory science-informed medical countermeasures to protect the public from threats to national and global health and security.
Lecturer: Irene Jillson, Ph.D.
Lecturer: Alan Liss, Ph.D.
Buckley et al. 2013. What To Do About Unsafe Medicines
Lurie et al. 2014. Research as a Part of Public Health Emergency Response
Middle East Respiratory Syndrome
On Being a Scientist: A Guide to Responsible Conduct in Research
Emerging and Readily Available Technologies
Ethical Issues in Sythetic Biology: An Overview on the Debates
SECTION 7B. REGULATORY SCIENCE AND FOOD SAFETY
Objective: Introduce concepts of toxicology applied in food science; review the assessment of nutritional value; examine regulatory review practices that enable a prevention-focused food safety system.
Lecturer: Reba Carruth, Ph.D.
Lecturer: Palmer Orlandi, Ph.D.
SECTION 8: NOVEL TECHNOLOGIES FOR MEDICAL PRODUCT DEVELOPMENT; AND DATA SCIENCE FOR REGULATORY SCIENCE
Objective: Review ongoing efforts of regulators to evolve regulatory review practices to enable evaluation of innovative emerging technologies; introduce the application of information sciences to biology; review basics of molecular biology and genetics, and tools to analyze protein sequences; describe how diverse data can improve outcomes.
Lecturer: Peter Marks, M.D., Ph.D.
Lecturer: Subha Madhavan, Ph.D.
SECTION 9: CLINICAL RESEARCH, PERSONALIZED MEDICINE AND IMPROVED PATIENT OUTCOMES
Objective:Present innovative trial design and evaluation techniques to improve medical product development and patient outcomes.
Lecturer: Robert Temple, M.D.
Lecturer: Li Zhang, M.D., Ph.D.
Lecturer: Frank Sasinowski, M.S., M.P.H., J.D.
SECTION 10: TOXICOLOGY AND PRODUCT SAFETY
Objective: Introduce modern toxicology tools and methods to analyze pre-clinical and clinical data that informs regulators about the safety of medical products, including pharmaceuticals, biologics, and devices.
Lecturer: Sorell Schwartz, Ph.D.
Lecturer: Donna Mendrick, Ph.D.
SECTION 11: REGULATORY SCIENCE AND TOBACCO PRODUCTS
Objective: Develop knowledge, skills, and understanding of FDA’s broad regulatory authorities over tobacco products and its impact on population health.
Lecturer: Ken Kellar, Ph.D.
Lecturer: Corinne Husten, M.D., M.P.H.
SECTION 12: CLINICAL AND TRANSLATIONAL MEDICINE AND REGULATORY SCIENCE--FUTURE OF DRUG DEVELOPMENT AND REGULATION
Objective: Learn how regulatory science relates to clinical and translational medicine, and how applications of research from these disciplines lead to safe and effective medical products; review of current challenges facing medical product development; discuss FDA and NIH initiatives to overcome these challenges; learn how current advances in science and medicine may both help and hinder public health.
Lecturer: Jesse Goodman, M.D., M.P.H.
Lecturer: Marc Walton, M.D., Ph.D.
Lecturer: Janet Woodcock, M.D.
Lecturer: Chris Ausin, M.D.