Introduction to Regulatory Science

PHAR620: Introduction to Regulatory Science

 

Course Directors
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
Georgetown University

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.

INTERACTIVE SYLLABUS


SESSION 1: INTRODUCTION TO THE COURSE

Webinar: Background on FDA Patient-Focused Drug Development

Lecture module 1 (12:33 min)
Lecture module 2 (9:51 min)
Lecture module 3 (8:48 min)
Lecture module 4 (9:39 min)

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

Lecture module 1 (16:07 min)
Lecture module 2 (17:58 min)
Lecture module 3 (6:14 min)
Lecture module 4 (5:32 min)

Lecturer: Carolyn Wilson, Ph.D.

Lecture module 1 (10:03 min)
Lecture module 2 (17:17 min)
Lecture module 3 (15:43 min)

Readings 
 

 

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.

Lecture module 1 (12:50 min)
Lecture module 2 (10:08 min)
Lecture module 3 (15:09 min)

Lecturer: Nancy M. Ostreve, Ph.D 

Lecture module 1 (24:02 min)
Lecture module 2 (24:12 min)
Lecture module 3 (39:45 min)

Readings

EpiPen Advertisement
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

Lecture module 1 (7:46 min)
Lecture module 2 (5:29 min)
Lecture module 3 (16:48 min)
Lecture module 4 (17:25 min)
Lecture module 5 (2:35 min)

Lecturer: Rikin Mehta, JD, LL.M.

Lecture module 1 (24:19 min)
Lecture module 2 (26:28 min)

Readings

IOM. 2010. Ethical Issues in Studying the Safety of Approved Drugs
Forbidden and Permitted Statements about Mediations--Loosening the Rules
Embracing 21st Century Information Sharing

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.

Lecture module 1 (11:58 min)
Lecture module 2 (16:16 min)

Lecturer: Robert "Skip" Nelson, M.D., Ph.D.

Lecture module 1 (11:17 min)
Lecture module 2 (11:46 min)
Lecture module 3 (13:07 min)
Lecture module 4 (17:32 min)

Readings 

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
Ethical Methodologies
Ethical Reasoning
Havasupai DNA article
ICH E10
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. 

Lecture module 1 (16:18 min)
Lecture module 2 (20:00 min)
Lecture module 3 (11:11 min)
Lecture module 4 (17:02 min)

Lecturer: Rob Califf, M.D., MACC

Lecture module 1 (8:43 min)
Lecture module 2 (14:07 min)
Lecture module 3 (10:15 min)
Lecture module 4 (14:13 min)

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.

Lecture module 1 (6:53 min)
Lecture module 2 (7:27 min)
Lecture module 3 (6:01 min)
Lecture module 4 (11:59 min)

Lecturer: Alan Liss, Ph.D.

Lecture module 1 (5:57 min)
Lecture module 2 (7:48 min)
Lecture module 3 (8:59 min)
Lecture module 4 (8:43 min)

Readings

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.

Lecture module 1
Lecture module 2
Lecture module 3
Lecture module 4
Lecture module 5

Lecturer: Palmer Orlandi, Ph.D.

Lecture module 1
Lecture module 2
Lecture module 3

Readings

International Regulatory Impacts and FDA
Global Food Safety Regulation Course Readings
Globalization and Food Safey in Global Agri-Food Industries
Socio-Economic Foundations
Multilateral Governance

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.

Lecture module 1
Lecture module 2

Lecturer: Subha Madhavan, Ph.D.

Lecture module 1
Lecture module 2
Lecture module 3

Readings

Cheadle Immunol Rev 2013
Proposed Approach to Regulation of Cellular and Tissue-Based Products

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.

Lecture module 1
Lecture module 2
Lecture module 3

Lecturer: Li Zhang, M.D., Ph.D.

Lecture module 1
Lecture module 2

Lecturer: Frank Sasinowski, M.S., M.P.H., J.D.

Lecture module 1
Lecture module 2
Lecture module 3

Readings

PCAST Full Report
PCAST Thank You Letter from President
PCAST FDA Release
Subpart H Final
Quantum of Effectiveness-Update
Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs

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. 

Lecture module 1
Lecture module 2
Lecture module 3
Lecture module 4

Lecturer: Donna Mendrick, Ph.D. 

Lecture module 1
Lecture module 2
Lecture module 3

Readings

Beger et al_translation APAP Biomarkers_2015
Fabre et al_microphysiological Review_2014
Mangipudy et al_Animal Use_2014

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.

Lecture module 1
Lecture module 2
Lecture module 3
Lecture module 4

Lecturer: Corinne Husten, M.D., M.P.H.

Lecture module 1

Readings

Neuronal Nicotinic Receptors: 100 Years of Progress

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.

Lecture module 1
Lecture module 2
Lecture module 3

Lecturer: Marc Walton, M.D., Ph.D.

Lecture module 1
Lecture module 2
Lecture module 3

Lecturer: Janet Woodcock, M.D.

Lecture module 1

Lecturer: Chris Ausin, M.D. 

Lecture module 1
Lecture module 2
Lecture module 3
Lecture module 4