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Rachel Church, Ph.D.

Rachel Church, Ph.D., is a Teaching Assistant Professor within the Division of Pharmacotherapy and Experimental Therapeutics and the Director of the Organ Injury Biomarker Core within the UNC Institute for Drug Safety Sciences. Dr. Church has expertise in identifying and characterizing novel translational biomarkers of drug-induced organ injury, especially drug-induced liver injury, and developing innovative methodologies to maximize the utility of traditional biomarkers.


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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

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.


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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

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

Merrie Mosedale, Ph.D., R.A.C.

Merrie Mosedale, Ph.D., R.A.C., 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.


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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.

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Jessica Benjamin, M.P.H.

Jessica Benjamin, M.P.H., is the Associate Director for Regulatory Affairs in the Office of Clinical Pharmacology (OCP), within FDA’s Center for Drug Evaluation and Research, Office of Translational Sciences.  Ms. Benjamin has more than 17 years of experience in regulatory and product development at the NIH and FDA. She also provides direction, oversight, and leadership to the Executive Program and Project Management staff in OCP.  The staff is currently engaged in clinical pharmacology regulatory review, policy development and implementation, research, stakeholder engagement and outreach on national and international levels, and plays a pivotal role in the FDA’s Model-Informed Drug Development Paired Meeting Pilot. Prior to joining the FDA, Ms. Benjamin was at the National Institute of Allergy and Infectious Diseases, NIH, where she was a member of the Radiation/Nuclear Product Countermeasures Program charged with developing medical countermeasures against radioactive threats. She received her MPH at the University of Maryland, College Park.


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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.


Laura-DiMichele

Laura DiMichele, Ph.D., R.A.C, C.C.R.P.

Laura DiMichele, Ph.D., R.A.C., C.C.R.P., is the Vice President of Clinical Strategy at CATO SMS. Dr. DiMichele has over 19 years of clinical and translational research experience.  She has led many projects including writing and reviewing regulatory, clinical, and scientific documents; providing clinical trial management, pharmaceutical development, and project management; assisting with Clinical Trial Operations; preparing for and attending FDA meetings; and providing scientific consulting. Dr. DiMichele has experience in therapeutic areas such as infectious disease, oncology, nephrology, neurology, psychiatry, dermatology, and hematology. Her product experience includes biologics, small molecules, and vaccines. Dr. DiMichele also leads the CATO SMS Clinical Strategy Department and Fellows Department.  Prior to joining CATO SMS, Dr. DiMichele was a post-doctoral fellow at the University of North Carolina, Chapel Hill.  She received her BS from Providence College and her PhD from the UNC, Chapel Hill.


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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.


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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.


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Lauren Neighbours, Ph.D., R.A.C.

Lauren Neighbours, Ph.D., R.A.C., is the Vice President of Regulatory Affairs at Istari Oncology, Inc., a clinical-stage biotechnology company developing novel cancer immunotherapy. Dr. Neighbours has over 15 years of research experience in the academic, government, and industry sectors. Prior to joining Istari, Dr. Neighbours led the regulatory affairs and program management strategy for Optum’s Digital Research Network. Dr. Neighbours also served as Head of Regulatory Affairs, North America at PSI CRO and led clinical trial and regulatory submission management as a Senior Research Scientist at Rho. In addition, Dr. Neighbours is an active participant in local and regional professional societies, including as a former executive committee member as VP, Programs for the North Carolina Regulatory Affairs Forum and as a Committee Member and Triangle’s Finest honoree for the Cystic Fibrosis Foundation. Dr. Neighbours received her PhD from the University of North Carolina at Chapel Hill.


Karl_Whitney

Karl Whitney, Ph.D., R.A.C.

Karl Whitney, Ph.D., R.A.C., 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 PhD from Duke University.

 

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