Master of Regulatory Affairs

Regulatory Affairs Leadership

Program Staff

Erika Callaghan, MS, MA, CAPM

Associate Director, ITMAT Education
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Erika Callaghan, MS, MA, CAPM

Erika Callaghan oversees the operational and student-affairs aspects of regulatory education programs and contributing to the strategic development of online courses and programs. She has extensive experience in instructional design and managing programs in higher education, with specific expertise in digital learning and accessibility.
Layah Bogen

Instructional Design Coordinator
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Layah Bogen

Leadership

Emma Meagher, MD

Director, ITMAT Ed; Co-Program Director, MSTR, Co-Program Director, K12; Co-Program Director, MSRS
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Emma Meagher, MD

Emma A. Meagher, MD, serves as Professor of Medicine and Pharmacology at the Perelman School of Medicine (PSOM) at the University of Pennsylvania in Philadelphia. Dr. Meagher graduated cum laude with her medical doctorate degree from the Royal College of Surgeons in Dublin, Ireland, and completed postgraduate training in Internal Medicine, Cardiology, and Pharmacology.

Dr. Meagher's educational interests are in the fields of translational research methodology and career development for graduate and pre- and postdoctoral students; and novel modalities for education in pharmacology for undergraduate medical students. Dr. Meagher's research interest is in the development of novel therapeutics in dyslipidemia. Her clinical practice focused on cardiovascular risk modification, with an emphasis on dyslipidemia management, hypertension, and women's cardiovascular health.

In her roles as Vice Dean and Chief Clinical Research Officer, and as Senior Associate Vice Provost for Human Research, Dr. Meagher oversees the institution’s clinical research infrastructure and its portfolio, and sets the strategy for Penn Medicine’s clinical research enterprise. In her roles as Associate Dean for PSOM Master’s and Certificate Programs, and as Director of Translational Research Education, Dr. Meagher is responsible for the rapidly growing portfolio of professional education opportunities provided by the Perelman School of Medicine.

Dr. Meagher is certified as a Master Trainer via the NIH-funded National Research Mentoring Network (NRMN). At Penn, she has implemented a Research Mentor and Mentee Training program for investigators conducting clinical and translational science. Dr. Meagher has received recognition for her efforts in education through numerous teaching awards, including the university's highest teaching honor, the Lindback Award for Medical Education (2005), and the Alpha Omega Alpha Robert J. Glaser Distinguished Teacher Award from the Association of American Medical Colleges (2014).
Rachel McGarrigle, MSEd

Director of Education, ITMAT Education
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Rachel McGarrigle, MSEd
Andrew Fesnak, MD, MHCI

Program Director, MRA, Co-Program Director, MSRS
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Andrew Fesnak, MD, MHCI

Andrew Fesnak holds a BA in molecular biology from Princeton, an MD from the University of Medicine and Dentistry of New Jersey, and a Masters in Health Care Innovation from the University of Pennsylvania. He is an Assistant Professor of Clinical Pathology and Laboratory Medicine, Director of Cell Manufacturing and Development in the Clinical Cell and Vaccine Production Facility, and a recipient of multiple education and teaching awards.

Course Directors

Jeff Barrett, PhD

Course Director, REG 6180: Introduction to Vaccine Development

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Jeff Barrett, PhD

Dr. Jeff Barrett is the Chief Science Officer at Aridhia Bioinformatics. Previously, he as Senior Vice-President at the Critical Path Institute serving as a critical liaison between C-Path and the pharmaceutical industry, foundations, and other key stakeholders, and help grow C-Path’s portfolio in drug development solutions, with a focus, but not limited to model-informed drug development (MIDD). Jeff was the former Head of Quantitative Sciences at the Bill & Melinda Gates Medical Research Institute (MRI). In this role he was responsible for implementing model-based drug development and employing PK/PD modeling, statistics, and clinical trial simulations to advance the discovery and development of new medicines and vaccines to treat malaria, tuberculosis (TB) and enteric diarrheal disease (EDD). In this role, he engaged and led the Global Health ecosystem in the promotion of Open Science policies to create a collaborative environment for data and model sharing. Prior to MRI, he was Vice President, Global Head of Translational Informatics at Sanofi Pharmaceuticals. He led various aspects of model-based decision-making spanning from drug discovery through commercialization and provided leadership for Sanofi’s cloud-based, high-performance computing and “big data” initiatives.

Prior to Sanofi, Jeff spent 10+ years at the University of Pennsylvania where he was Professor, Pediatrics and Director, Laboratory for Applied PK/PD at the Children’s Hospital of Pennsylvania. Jeff received his B.S. in Chemical Engineering from Drexel University and Ph.D. in Pharmacokinetics from University of Michigan. He has co-authored over 175 manuscripts and has given over 140 invited lectures on PK/PD, clinical pharmacology and pharmacometrics. He is a fellow of ACCP and AAPS and the recipient of numerous honors including ACCP awards for Young Investigator (2002) and Mentorship in Clinical Pharmacology (2007) and the AAPS Award in Clinical Pharmacology and Translational Research (2011). Dr. Barrett was awarded for Exceptional Innovation and Advancing the Discipline of Pharmacometrics at the International Society for Pharmacometrics (2013) and elected ISOP Fellow (2017). He served on the Editorial Boards of the Journal of Pharmacokinetics and Pharmacodynamics and the ASCPT Pharmacometrics & Systems Pharmacology Journal and is currently the co-Specialty Chief Editor of Frontiers in Obstetric and Pediatric Pharmacology Journal. He is currently an active member of the Child Health and Human Development Pediatrics Subcommittee and is a study section reviewer for this committee. He was a past acting chair of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology and was a voting member of the committee for 8 years.
Joanna Brougher, MPH, Esq.

Course Director, REG 6260: Patent Law for Drug Development

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Joanna Brougher, MPH, Esq.

Joanna is a patent attorney whose experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Joanna also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.

Joanna has extensive experience counseling clients on domestic and international legal and contractual matters, including issues related to U.S. and global clinical trials, intellectual property, technology licensing, laboratory services, joint development, research and development, manufacturing, consulting, confidential disclosure, material transfer and other related agreements.

Joanna is also a former Adjunct Lecturer at the Harvard School of Public Health and the current Editor-in-Chief of the Journal of Commercial Biotechnology. She regularly speaks on intellectual property-related topics and is a frequent author of articles related to patent law and healthcare. In 2013, Joanna published a book called "Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health" which examines the relationship between patents and public health in the context of medical technologies.

In 2014, Joanna was selected to the National Law Journal’s list of Boston’s Rising Stars.

Joanna graduated from the University of Rochester with a B.S. in Microbiology, a B.A. in German, and a Masters in Public Health. Joanna received her J.D. degree from Boston College Law School. She is admitted to the Massachusetts and New York State Bars as well as the USPTO.
Melissa Byrne, MS, MBE

Course Director, REG 6190: Research Ethics in Regulatory Affairs

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Melissa Byrne, MS, MBE

Melissa Byrn is the Assistant Dean for Clinical Research at the University of Chicago Biological Sciences Division. In this role she leads the development and implementation of strategic initiatives to support faculty research goals and grow the clinical research enterprise. She partners with the Dean for Clinical Research and stakeholders including the UChicago Comprehensive Cancer Center, Institute for Translational Medicine, UChicago Medicine, and University Research Administration to identify opportunities for enhancing integration between clinical research and patient care across our health care system. Melissa oversees the Office of Clinical Research, a divisional office established in 2004 to support research infrastructure focusing on human subject protection, data integrity and site performance to help faculty and research staff advance medical discovery and innovation.

Prior to joining the BSD, Melissa served as Director of Innovation Programs at the Polsky Center for Entrepreneurship and Innovation at the University of Chicago where she developed the science and technology entrepreneurship strategy and managed a broad portfolio of programs designed to spinout deep technology startups from research labs across the University. Melissa has held leadership roles in clinical trial operations and regulatory compliance at the University of Chicago and the University of Pennsylvania and has expertise in FDA regulations, operations, and informatics. Melissa is passionate about mentoring and training the next generation of STEM innovators. Melissa holds a Master of Science in Biomedical Informatics from the University of Chicago and a Master of Biomedical Ethics from the University of Pennsylvania.
Narendra Chirmule, PhD

Course Director, REG 6240: Applied Regulatory Processes of Vaccines and Biologics

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Narendra Chirmule, PhD

Narendra Chirmule is co-founder and CEO of SymphonyTech Biologics, a data analytics company focused on engineering solutions to biology. Former Head, R&D, Biocon (Bangalore), leadership positions in Amgen and Merck.

Narendra Chirmule has contributed to the development of vaccines and biopharmaceuticals over the past three decades. The drug development experiences include vaccines for cervical cancer [HPV], shingles [Varicella zoster], childhood diarrhea [Rotavirus]), and biopharmaceuticals for osteoporosis (Prolia), rheumatoid arthritis (Enbrel), platelet loss (NPlate), breast cancer (Ogrivi), biosimilar insulins among many others. He has worked on gene therapy using viral vectors at UPenn in the late 1990s. He has published extensively and presented seminars on subjects of immunology, biologics, and vaccines.

The subject of his Ph.D. was on the development of a leprosy vaccine, from Cancer Research Institute, Mumbai; post-doctoral studies on the pathogenesis of AIDS from Cornell University Medical College-North Shore Hospital, New York; teaching and research as an assistant professor in gene therapy at the University of Pennsylvania, Philadelphia.
Gary Dubin, MD

Course Director, REG 6220: New Trends in Medicine and Vaccine Discovery

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Gary Dubin, MD

Dr. Dubin has more than 35 years of experience in vaccine research, development and commercialization. Prior to retiring in Feb 2025, he spent 9 years at Takeda Pharmaceuticals where he last served as Vaccine Business Unit President. In this role, Dr Dubin led a vertically integrated vaccine organization with ~2000 global staff responsible for the research, development, manufacture, commercialization and distribution of new vaccines. Under his leadership Takeda introduced Qdenga, a novel vaccine against dengue fever in 2022 which is now licensed in many countries around the world. Prior to joining Takeda, he spent 20 years at GlaxoSmithKline Vaccines where he held the role of Vice President and Head, Global Late Clinical Development. During his career at GSK, Dr Dubin led global teams responsible for the clinical development and licensure of a broad range of vaccines addressing important unmet medical needs, including seasonal influenza (Fluarix Quadravalent and FluLaval Quadravalent), pandemic influenza (Pandemrix and Aprepandrix), meningococcal meningitis (Menhibrix and Nimenrix); human papillomavirus (Cervarix), rotavirus (Rotarix), strep pneumonia (Synflorix), malaria (Mosquirix) and herpes zoster (Shingrix). He also led the development activities of several ongoing vaccine programs (eg TB).

Dr. Dubin holds a Medical degree from the University of Pennsylvania and completed his Adult Internal Medicine residency training at the University of Colorado. He also completed a fellowship in Clinical Infectious Diseases and a postdoctoral research fellowship in Molecular Virology at the University of Pennsylvania. He served as Adjunct Associate Professor of Medicine at the University of Pennsylvania through 2019. He holds numerous patents in the vaccine field and has co-authored more than 90 scientific publications.
Eileen Doyle, PharmD

Course Director, REG 6120: Introduction to Drug Development

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Eileen Doyle, PharmD

Eileen Doyle, PharmD is a drug development scientist who integrates clinical development, clinical pharmacology and pharmacometrics to support program strategy and regulatory filings. She is currently the Director of Clinical Pharmacology Modeling and Simulation for Infectious Diseases at GlaxoSmithKline and formerly held senior positions in clinical pharmacology and pharmacometrics/pharmacokinetcs at Certara and Sanofi.
Andrew Fesnak, MD, MHCI

Program Director, MRA, Co-Program Director, MSRS
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Andrew Fesnak, MD, MHCI

Andrew Fesnak holds a BA in molecular biology from Princeton, an MD from the University of Medicine and Dentistry of New Jersey, and a Masters in Health Care Innovation from the University of Pennsylvania. He is an Assistant Professor of Clinical Pathology and Laboratory Medicine, Director of Cell Manufacturing and Development in the Clinical Cell and Vaccine Production Facility, and a recipient of multiple education and teaching awards.
Christine Lee

Course Director, REG 6100: Fundamentals of FDA Regulation

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Christine Lee

Christine Lee is a Regulatory executive who has worked with medical device companies across a broad spectrum of products with both starts-ups and large multinational corporations. She has experience with all regulatory processes related to development, submission, market clearance, and post-approval requirements. She specializes in commercialization of Class III PMA devices in the US. Education includes BS in Biomedical Engineering with Research option from Georgia Institute of Technology.
Dawn Lundin, MS

Course Director, REG 6160: Quality Assurance

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Dawn Lundin, MS

Dawn Lundin has over 25 years of quality assurance and compliance experience from the pharmaceutical industry, academia, and non-profit affiliations. As a subject matter expert in quality across GxPs, Dawn supported regulatory inspections and conducted due diligence visits for many acquisitions and licensing agreements. In 2018, and in attempt to gain more exposure to the patient experience, Dawn left a 20-year career at Merck and accepted a position heading the compliance unit for the Office of Clinical Research at the University of Pennsylvania managing the compliance program for the Perelman School of Medicine. She is now Head of Global Quality Management Systems at MAPS PBC.

Dawn has a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, a Bachelor of Science in Biology from Delaware Valley University, and a Certificate in Management Engagement from the Wharton School.

In her spare time, Dawn enjoys time with family, watching her daughter outwit her husband, and snuggle time with her dog Phoebe and rescue cat Gizmo.
Carlo Russo, MD

Course Director, REG 6220: New Trends in Medicine and Vaccine Discovery

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Carlo Russo, MD

Senior Executive in pharmaceutical and biotech industry with extensive expertise in drug development including cardiovascular and metabolic diseases, biologics, vaccine, oncology, gene therapy and Rare Diseases with a proven track record of bringing products through stage 1-3 testing, approval, launch and life cycle management of marketed products, experience building a new company from start-up to product development.

Leadership position in major pharmaceutical companies including Merck and GlaxoSmithkline with responsibility in licensing and technology acquisition,
clinical research (metabolic, oncology, infectious disease, vaccines, rare diseases), discovery research, product development, quality assurance, and regulatory affairs. Biotech experience includes raising equity for startup, design and completion of state of the art manufacturing facility, recruitment of outstanding management and scientific staff, establishment of functions associated with Research and Development activities including breakthrough research in development of new products and mechanisms to enhance effectiveness, regulatory affairs, clinical trials, business development, manufacturing and operations. Successfully developed and implemented unique biotech model within a large pharmaceutical company that resulted in taking a large asset, TANZEUM® a GLP-1 agonist for Type 2 Diabetes, from first time in human to approval in US and EU and launch in the US.

Other industry achievements include filing original INDs for approved and launched products such as HPV vaccine Gardasil®, rotavirus vaccine Rotateq® both Merck products; in collaboration with Human Genomic Sciences, obtaining approval and launch Belimumab®, the 1st product for Lupus approved in 40 years; filing and obtaining approval in the US and EU for Arzerra® for refractory chronic lymphocytic leukaemia; developing and launching what was as April 2016 the only 2nd gene therapy product ever approved at that time in the EU, Strimvelis® for ADASCID.

Academic career at Scripps Clinic, Columbia University and Cornell Medical School included teaching and researching in clinical and basic immunology and interfaces with oncology, infectious diseases, transplantation, and aging. Actively involved with national and international immunological research and review programs and founding member of the Geriatric and Rehabilitation Medicine Study Section of the National Institute of Health.
Michele Roy, BSN, MS

Course Director, REG 6150: Post-Approval Maintenance of Drugs, Biologics and Devices

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Michele Roy, BSN, MS

Michele Roy is VP of Regulatory Affairs at Harmony Biosciences. She completed a MS in Regulatory Affairs and Quality Assurance at Temple University and a BSN at the University of Wisconsin-Milwaukee.
Megan Kasimatis Singleton, JD, MBE, CIP

Course Director, REG 6110: Clinical Study Management

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Megan Kasimatis Singleton, JD, MBE, CIP

Megan Kasimatis Singleton, JD, MBE, CIP is Associate Dean for Human Research Protection and Director of the Human Research Protection Program at Johns Hopkins University School of Medicine. In this role she is responsible for oversight and direction of JHM's 8 IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. Prior to assuming her role at Johns Hopkins, Ms. Singleton worked for 14 years in clinical research at the University of Pennsylvania, with 8 years at the University of Pennsylvania IRB. In addition to her current role in leading the Johns Hopkins Medicine HRPP, she serves as the director of central IRB (CIRB) activities for the Johns Hopkins/Tufts Trial Innovation Center (TIC), leading the charge for innovations in operationalizing single IRB (sIRB) review. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, member and Board Secretary for the PRIM&R Board of Directors and Co-Chair of PRIM&R’s Certification Committee. Ms. Singleton is also an AAHRPP, Inc. site visitor and member of AAHRPP council and is a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research.

Ms. Singleton teaches Clinical Study Management for the Master of Regulatory Affairs Program at University of Pennsylvania and Research Ethics and Integrity within the Department of Health Policy & Management at the Johns Hopkins University Bloomberg School of Public Health. She has developed research ethics curriculum and practical training in IRB administration tailored for national and international audiences. She loves teaching about research ethics issues and helping students and researchers navigate complex challenges in clinical research.

Regulatory Affairs Leadership

Program Staff

Erika Callaghan, MS, MA, CAPM

Layah Bogen

Leadership

Emma Meagher, MD

Rachel McGarrigle, MSEd

Andrew Fesnak, MD, MHCI

Course Directors

Jeff Barrett, PhD

Joanna Brougher, MPH, Esq.

Melissa Byrne, MS, MBE

Narendra Chirmule, PhD

Gary Dubin, MD

Eileen Doyle, PharmD

Andrew Fesnak, MD, MHCI

Christine Lee

Dawn Lundin, MS

Carlo Russo, MD

Michele Roy, BSN, MS

Megan Kasimatis Singleton, JD, MBE, CIP