Regulatory Affairs Leadership
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Program Staff
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Erika Callaghan, MS, MA, CAPM
Associate Director
More information about Erika Callaghan, MS, MA, CAPM
Email
Erika Callaghan, MS, MA, CAPM
Associate Director
Erika.Callaghan@Pennmedicine.upenn.edu
Direct program questions to Nik.
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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Esther Martin
Instructional Designer, ITMAT Education
Esther.Martin-Ullrich@pennmedicine.upenn.edu
Leadership
Course Directors
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Emma Meagher, MD
REG/MTR 5100, Intro to Clinical and Translational Research
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Emma Meagher, MD
REG/MTR 5100, Intro to Clinical and Translational Research
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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Andrew Fesnak, MD, MHCI
REG 6250 Biomanufacturing Novel Therapies and Imaging Agents; REG 6400 Capstone I; REG 6410 Capstone II
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Andrew Fesnak, MD, MHCI
REG 6250 Biomanufacturing Novel Therapies and Imaging Agents; REG 6400 Capstone I; REG 6410 Capstone II
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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Eileen Doyle, PharmD
REG 6120 Introduction to Drug Development
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Eileen Doyle, PharmD
REG 6120 Introduction to Drug Development
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.
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Dawn Lundin, MS
REG 6160 Quality Assurance
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.
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Michele Roy, BSN, MS
REG 6150 Post-Approval Maintenance of Drugs, Biologics and Devices
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Narendra Chirmule, PhD
REG 6240 Applied Regulatory Processes of Vaccines and Biologics
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Narendra Chirmule, PhD
REG 6240 Applied Regulatory Processes of Vaccines and Biologics
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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Joanna Brougher, MPH, Esq.
REG 6260 Patent Law for Drug Development
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Joanna Brougher, MPH, Esq.
REG 6260 Patent Law for Drug Development
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.
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Melissa Byrne, MS, MBE
REG 6190 Research Ethics in Regulatory Affairs
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Melissa Byrne, MS, MBE
REG 6190 Research Ethics in Regulatory Affairs
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.
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Christine Lee
REG 6100 Fundamentals of FDA Regulation
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.
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Jeff Barrett, PhD
REG 6180 Introduction to Vaccine Development
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Jeff Barrett, PhD
REG 6180 Introduction to Vaccine Development
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.
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Megan Kasimatis Singleton, JD, MBE, CIP
REG 6110 Clinical Study Management
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Megan Kasimatis Singleton, JD, MBE, CIP
REG 6110 Clinical Study Management
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.
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Amy Marshall, MPH
REG 6110 Clinical Study Management
Amy Marshall, MPH is the Director of Clinical Operations for the Center of Cellular Immunotherapies (CCI) at the University of Pennsylvania. The CCI is focused on driving scientific innovation in cellular and gene therapy research and the translation of new novel investigational therapies into the clinical trial setting. The Clinical Operations Team is responsible for managing and optimizing the clinical research infrastructure necessary for bringing these novel/personalized cell and gene therapies to patients. As the Director of the Clinical Operations Team, Ms. Marshall is responsible for overall team leadership/direction, as well as directing and managing the essential functions of Clinical Trials Development Clinical Project Management and Clinical Data Management. She earned her undergraduate degree from Georgetown University and her Master’s of Public Health from Thomas Jefferson University. Prior to assuming her current role within the CCI in 2014, Ms. Marshall worked in the Abramson Cancer Center for over 7 years in multiple roles directly supporting oncology clinical research including budget/finance, regulatory affairs, and site team leadership.
Ms. Marshall teaches Clinical Study Management for the Master of Regulatory Affairs Program at the University of Pennsylvania. In addition to developing innovative research training programs within the CCI, Amy participates in SOM-led initiatives to support the larger Penn Research Community.
In addition to her work, Ms. Marshall enjoys spending time as much time as possible with her family and friends, especially her 5 year old daughter Emerson.
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Claudine Bruck, PhD
MTR/REG 6220 New Trends in Medicine and Vaccine Discovery
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Claudine Bruck, PhD
MTR/REG 6220 New Trends in Medicine and Vaccine Discovery
Before her current roles, Dr. Bruck was Vice-President and Head, Ophthalmology Discovery Unit at GlaxoSmithKline from 2008 to 2015. Before that, Dr. Bruck was a founding member and Vice-President of the Center of Excellence for External Drug Discovery (CEEDD) and part of the leadership team responsible for managing a diverse drug discovery portfolio of external research alliances. In the CEEDD, she helped design GSK’s initial externalization strategy and gained valuable business development experience. Before that she held various positions in the Biopharmaceutical and Vaccine R&D groups at GSK. Dr. Bruck has a PhD from University of Brussels. She was a post-doctoral student at Harvard University Medical School and an Assistant Professor at Tufts Medical School.
