Regulatory Affairs Leadership
Leadership
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Emma Meagher, MD
Director, ITMAT Education
More information about Emma Meagher, MD
Emma Meagher, MD Profile PageEmma 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).
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Rachel McGarrigle, MSEd
Director of Education, ITMAT Education
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Andrew Fesnak, MD, MHCI
Program Director, Regulatory Education, ITMAT Education
More information about Andrew Fesnak, MD, MHCI
Andrew Fesnak, MD, MHCI Profile PageAndrew 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.
Program Staff
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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.
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Course Directors
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Andrew Fesnak, MD, MHCI
Program Director, Regulatory Education, ITMAT Education
More information about Andrew Fesnak, MD, MHCI
Andrew Fesnak, MD, MHCI Profile PageAndrew 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.
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Amanda Brock, MSN, MBE, RN
Program Director, Certificate in Clinical Research Nursing
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Gary Dubin, MD
Course Director, New Trends in Medicine and Vaccine Discovery
More information about Gary Dubin, MD
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.
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Narendra Chirmule, PhD
Course Director, 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.
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Eileen Doyle, PharmD
Course Director, 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.
