Patricia Termini, M.S., RAC
Patricia Termini, M.S., RAC, is the Director of the Master of Professional Science (M.P.S.) in Regulatory Science and an Associate Professor in the Division of Pharmacotherapy and Experimental Therapeutics. She has more than 25 years of experience in the pharmaceutical, biotechnology, and consulting industries focused on regulatory affairs strategy, execution, and project management. Ms. Termini has experience working cross-functionally on pre-approval and post-approval regulatory activities and has worked in multiple therapeutics areas including dermatology, infectious disease, oncology, and rare diseases. She has a M.S. degree in Regulatory Affairs and Quality Assurance from Temple University, is RAC certified, and has certificates in drug development and project management.
Robert Dupuis, Pharm.D.
Robert Dupuis, Pharm.D., is a Clinical Professor and Vice Department Chair within the Division of Pharmacotherapy and Experimental Therapeutics. Dr. Dupuis is also the Division’s Director of Fellowship Programs. In this role, he advises postdoctoral fellows on clinical research in the areas of regulatory affairs, medical affairs, clinical development, and pharmacometrics. Dr. Dupuis has expertise in clinical pharmacology, drug metabolism, drug disposition, pharmacogenomics, adverse effects, outcomes, and enhancement of care.
Peter Ho, M.D., Ph.D.
Peter Ho, M.D., Ph.D., is an adjunct Associate Professor within the Division of Chemical Biology and Medicinal Chemistry. Dr Ho currently serves on the Board of Directors of Arvive Inc. and Celeris Therapeutics, the Scientific Advisory Boards of Accent Therapeutics and Tavotek Biotherapeutics, and the External Scientific Advisory Committee of the Cleveland Clinic Centre for Therapeutics Discovery. Through nearly 30 years of experience in the federal government and private industry, Dr. Ho has been directly responsible for the first-time-in-human dosing of 19 anticancer agents and has overseen the development of over 60 hematology and oncology compounds throughout all phases of clinical trials.
Mike Jarstfer, Ph.D.
Michael Jarstfer, Ph.D., is an Associate Professor within the Division of Chemical Biology and Medicinal Chemistry and the Associate Dean for Graduate Education. He is also the Director of Graduate Studies for the Pharmaceutical Sciences PhD program. Dr. Jarstfer has expertise in drug target identification, high-throughput-screening, medicinal chemistry, and compound optimization for drug discovery as well as pharmacology in preclinical animal models.
Matthew Loop, Ph.D.
Matthew Loop, Ph.D., is an Adjunct Assistant Professor within the Division of Pharmacotherapy and Experimental Therapeutics. He has more than 10 years of experience as a biostatistician, using cutting-edge tools to understand data complexities. Dr. Loop is currently an Assistant Professor at the Harrison College of Pharmacy at Auburn University. Dr. Loop has expertise in analyzing complex data sets related to human disease, using data generated from laboratory studies all the way up to population-level investigations. He has conducted pharmacoepidemiology studies of Medicare beneficiaries with heart failure.
Carmella Moody, Ph.D.
Carmella Moody, Ph.D., is an adjunct Associate Professor within the Division of Pharmacotherapy and Experimental Therapeutics. She has over 30 years of experience in the biopharmaceutical industry specializing in regulatory affairs, project management, and quality assurance. Dr. Moody has expertise in the development of small molecules, biotechnology, biologic and combination products. She is currently the Director for Regulatory Affairs at Research Triangle Institute (RTI). In this role, she provides non-clinical, clinical, and CMC (chemistry, manufacturing, and controls) support for central nervous system, oncology, anti-infective, respiratory and stem cell products.
Merrie Mosedale, Ph.D., RAC
Merrie Mosedale, Ph.D., RAC, is an adjunct Assistant Professor within the Division of Pharmacotherapy and Experimental Therapeutics. She has over 10 years’ experience securing and leading both industry and NIH-funded drug safety research projects. Dr. Mosedale is currently a Regulatory Science Lead within Global Regulatory Affairs at UCB Biosciences Inc., where she is responsible for regulatory activities related to product development and marketing authorizations in the US.
Diana Severynse-Stevens, Ph.D.
Diana Severynse-Stevens, Ph.D., is an adjunct Associate Professor within the Division of Pharmacotherapy and Experimental Therapeutics. She has over 25 years of experience in the biopharmaceutical industry specializing in regulatory strategy for the development of new drugs and biologics. Dr. Severynse-Stevens has expertise in pharmaceutical product development and regulatory affairs. She is currently the Senior Director of Drug Development in Global Health Technologies at Research Triangle Institute (RTI). In this role, she supports translational research in several therapeutic areas including infectious, metabolic and cardiovascular diseases.
Lisa Carlton, Ph.D.
Lisa Carlton, Ph.D., is the Vice President of Global Regulatory Affairs at REGENXBIO Inc. She has over 25 years of experience in regulatory affairs and medical/technical writing in the government/nonprofit sectors, with the majority of her career spent in the pharmaceutical/biotech industry. After completing her B.S. in Biochemistry at NC State University, Dr. Carlton obtained an M.S. degree in Medicinal Chemistry and a Ph.D. in Pharmaceutics from the UNC Eshelman School of Pharmacy. She then completed a postdoctoral fellowship at NIH’s National Institute of Allergy and Infectious Disease in the Laboratory of Immunogenetics before beginning her regulatory career in the NCI Cancer Therapy Evaluation Program.
Kevin B. Johnson, Ph.D., M.B.A., RAC
Kevin B. Johnson, Ph.D., M.B.A., RAC is the Chief Regulatory Officer at Tourmaline Bio. He has 30 years of experience in the implementation of global regulatory and development strategies for a variety of drugs, biologics, combination products, and cell/gene therapies. Dr. Johnson has directed the preparation of numerous INDs, CTAs, BLAs, NDAs, and MAAs and orchestrated a variety of meetings and communications with regulatory authorities on a global basis. Before joining Tourmaline, Dr. Johnson served as the Chief Regulatory Officer for Ring Therapeutics developing novel gene therapy modalities. Prior to that, Dr. Johnson held several positions of increasing responsibility for regulatory, quality, pharmacovigilance and product development activities at Inozyme, Imara, Sucampo Pharmaceuticals, and Vtesse. He also served as Director, Global Regulatory Affairs for Rare Diseases and Gene Therapies at GSK, working on the regulatory team for the European approval of the gene therapy Strimvelis®. Additional past accomplishments include successful negotiations for the US regulatory approval of TachoSil® Fibrin Sealant Patch and Daliresp® (roflumilast). Dr. Johnson earned a Ph.D. in Neurobiology from UNC Chapel Hill School of Medicine and an M.B.A. from the Kenan-Flagler School of Business, also at UNC. He is RAC certified and is a Registered Member of The Organization for Professionals in Regulatory Affairs (TOPRA) in Europe.
Joanne Lemmo, RAC
Joanne Lemmo, RAC, is the Vice President, Global Regulatory Affairs at Sarepta Therapeutics Inc. In this role Ms. Lemmo has global responsibility for development and lifecycle regulatory strategy for Sarepta’s portfolio of products. She is also accountable for operational excellence for the operational integrity, compliance, planning and execution of submission activity. Prior to joining Sarepta, Ms. Lemmo was Executive Director of Global Regulatory Affairs -CMC for Merck Inc’s biologic and devices/combination products. At Merck, she also served as the Chief of Staff for the CMC Regulatory Affairs Organization. In these roles, Ms. Lemmo was responsible for the regulatory strategy for Merck’s early development biologic programs and leading the development of integration of organizational and compliance processes, global regulatory development and lifecycle management of the devices and combination products. Prior to joining Merck, Ms. Lemmo worked at Allergan Inc. At Allergan she worked in various regulatory functions including leading Regulatory CMC, International, Strategy and led a global development program. Ms. Lemmo earned a B.S. in Chemistry from Guilford College and is RAC certified.
J. Kaitlin Morrison, Ph.D.
Kaitlin Morrison, Ph.D. is an Assistant Professor of Medicine in the Division Hematology at the University of North Carolina Chapel Hill (UNC) and the Executive Director, LCCC Clinical Research for Lineberger Comprehensive Cancer Center (LCCC) at UNC. Dr. Morrison is responsible for the leadership and oversight of the LCCC clinical research infrastructure and co-leads strategic planning driving clinical research infrastructure optimization, process improvements, recruitment/retention of employees and alignment of LCCC and UNC Healthcare system goals. Dr. Morrison is also responsible for the oversight of LCCC’s clinical development program that includes investigator-initiated trials using investigational drugs/ biologics provided by pharmaceutical partners, and UNC developed and/or manufactured investigational products (e.g., CAR-T cells, personalized and adaptive neoantigen dose-adjusted vaccine (PANDA-VAC), C11-AMT, 68Ga-PSMA-11). Dr. Morrison collaborates with preclinical and clinical scientists to aid in the translation of UNC developed investigational products from the bench to the clinic through the authoring of clinical protocols, informed consent forms, patient education materials, Investigator’s Brochures, and Investigational New Drug (IND) applications. Her work has contributed to the development of a successful portfolio of >60 clinical protocols and >40 INDs, and the receipt of a Regenerative Medicine Advanced Therapy (RMAT) designation with FDA and accelerated assessment of PRIority MEdicines (PRIME) designation with the European Medicines Agency (EMA).
Dr. Morrison has served a variety of regulatory and clinical operations roles within LCCC including serving as the inaugural Director of UNC Lineberger Sponsored clinical Research, performing IRB submissions as a Regulatory Associate, serving as the interim Assistant Director for Multicenter Clinical Trial Operations, aiding in the operations of the Advanced Cellular Therapy (ACT) Good Manufacturing Practice (GMP) Facility, and acting as a regulatory project manager (Senior Regulatory Affairs Specialist) for FDA submissions. Prior to joining UNC, Dr. Morrison received her B.S. in Chemistry from UNC and her Ph.D. in Biochemistry from Brody School of Medicine at East Carolina University.
Prem K. Narang, Ph.D., F.C.P.
Prem Narang, Ph.D., F.C.P., is the President of P.K. Narang Strategic Consulting advisory practice for the life-science industry. Dr. Narang has over 30 years of experience in large pharma, devices/diagnostics, generics, and smaller start-ups focused on development, regulatory, and risk-management strategies designed to accelerate product approval, access, and commercial value. He has led global organizations at Novartis & Pharmacia (Oncology), GE (Medical Diagnostics), Dr. Reddy’s (generic Biologics) in Regulatory, Quality, and/or Pharmacovigilance domains, and provided scientific, strategic and operational oversight to deliver business results. Most recently as a VP of ‘Scientific & Regulatory Strategy’ at Camargo, he advised clients on development strategies leveraging the 505(b)(2) NDA pathway. Before regulatory roles, Dr. Narang was the US Head of the Clinical Pharmacology/Pharmacokinetics group for Pharmacia. Throughout his career, Dr. Narang has contributed significantly to the development, approval, label expansion, and/or launch of multiple new drugs (e.g., Tasigna, Gleevec, Femara, Exajde, Camptosar, Xalatan, Mycobutin, Detrusitol, Estring, etc.) and diagnostics (DatScan, Cysview) in major markets. Dr. Narang brings a global perspective with regulatory insights and scientific rigor into business decisions, R&D operations, and relevant strategies across development, marketing authorization, and brand protection. Dr. Narang received his MS from West Virginia University and his PhD from University of Maryland. He started his career at National Institutes of Health, has edited two books, and authored >60 peer reviewed publications. He currently serves in an Advisory capacity to few start-ups.
Jian Wang, Ph.D., M.S.R.S, F.C.P.
Jian Wang, Ph.D., M.S.R.S., F.C.P., is the Global Head of Translational, Oncology Regulatory Science, Strategy & Excellence at AstraZeneca. In this role he leads a team of global translational regulatory strategists who are responsible for developing appropriate translational regulatory strategies for oncology and hematology programs. The objective of this work is to translate innovative approaches (e.g., ctDNA, computational pathology, or digital health technologies) into regulatory strategies to support early and late stage drug development, and to effectively bring these innovations to drug development and regulatory approval. Prior to joining AstraZeneca, Dr. Wang served more than 13 years in the Office of New Drugs (OND) and Office of Translational Science at CDER, FDA, with increasing responsibilities in drug review, guidance development and regulatory science. As the Associate Director for Regulatory Science in the clinical office in OND, he led development of clinical guidance for trial design and indication-specific guidelines. He contributed to the FDA guideline on surrogate endpoints for drug development, as well as the guideline on acceptable imaging biomarkers as clinical outcomes for drug development. He also contributed to various FDA guidances related to clinical pharmacology and model- informed drug development. Dr. Wang has over 10 years of multi-disciplinary review experience for numerous small molecules and biological products at various stages of development in oncology, hematology and other disease areas. He supervised various regulatory clinical research projects that received multiple FDA awards. Dr. Wang received his Ph. D. in Molecular Pharmacology & Clinical Pharmacogenomics and an M. S. in Regulatory Science from the University of Southern California. He has received FDA and national awards, and published 65 articles in peer-reviewed journals and book chapters. Nationally, he is a Fellow of the American College of Clinical Pharmacology and serves as adjunct associate professor at the UNC Chapel Hill.
Karl Whitney, Ph.D., RAC
Karl Whitney, Ph.D., RAC, is the Vice President of Regulatory Affairs at Precision Biosciences. Dr. Whitney has over 19 years of experience in the pharmaceutical industry with a focus on regulatory affairs, clinical trial management, and people management. His experience spans the development spectrum from early IND-enabling research and regulatory activities through to NDA/BLA submission work in small molecules, cell therapy, and gene therapy. Dr Whitney’s therapeutic areas of experience include neuroscience, metabolic disease, infectious disease, and oncology. Dr. Whitney received his Ph.D. from Duke University.