Grad Gathering Keynote Speakers
Marishka K. Brown, PhD '09 – Pharmaceutical Sciences
As director of the National Center on Sleep Disorders Research (NCSDR), Marishka K. Brown leads the science of sleep and chronobiology into innovative discoveries that improve health. NCSDR, located within the National Heart, Lung, and Blood Institute, is the nexus of the National Institutes of Health’s (NIH) sleep and circadian research activities for a network that includes professional associations, public stakeholders, and federal agencies. Brown’s leadership and experience in partnership building helps sustain and expand this network, bringing the benefits of NIH’s scientific research into medicine and public health.
Brown started her NIH career as a science and technology policy fellow in the American Association for the Advancement of Science’s Office of Strategic Coordination, located within the NIH’s Office of the Director. Brown earned her PhD in pharmaceutical sciences with an emphasis in pharmacology and neuroscience from the University of Maryland School of Pharmacy, and afterwards pursued a fellowship at the University of Pennsylvania in the Center for Sleep and Circadian Neurobiology, studying the role of the unfolded protein response in age-related sleep changes.
Alexander Gaffney, MS '20 – Regulatory Science
Alexander Gaffney is a regulatory and media executive responsible for founding and leading the research division of AgencyIQ, the regulatory analysis division of the media company POLITICO. As executive director of regulatory policy and intelligence, Gaffney directs the division’s analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device, and chemical companies.
Before joining AgencyIQ, Gaffney analyzed life sciences regulations as part of PricewaterhouseCoopers's Health Research Institute and was manager of regulatory intelligence at the Regulatory Affairs Professionals Society, where he also served as managing editor for the society’s flagship publication, Regulatory Focus.
Gaffney is regularly asked to speak to executive audiences about life science regulatory policy developments. His analysis and work (including his daily newsletter, FDA Today) is relied upon by many of the country's top life sciences companies, law firms, trade associations, regulatory professionals, legislative staffers, and public health officials. He has a MS in regulatory science from the University of Maryland School of Pharmacy and a Regulatory Affairs Certification in U.S. regulation. He also serves as the co-chair of the Drug Information Association’s Regulatory Policy and Intelligence Community.
Grad Gathering Panelists
Heather Boyce, PhD ‘17 - Pharmaceutical Sciences
Heather Boyce works for the Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. Boyce has more than 12 years of experience in the pharmaceutical industry including expertise in good manufacturing processes, pharmaceutical product development, bioequivalence trial design and analysis, and generic drug regulation. Boyce leads the development of product specific guidance development for modified release oral drug products. Her current topics of interest and research are focused on clinical study design, clinical pharmacology, and modified release oral drug products. Boyce received her PhD in pharmaceutical sciences at the University of Maryland School of Pharmacy where her research focused on excipient properties and formulation design of abuse deterrent formulations. She received her BS in chemistry with a minor in mathematics from Temple University.
Amy Defnet, PhD ‘21 - Pharmaceutical Sciences
Amy Defnet received her PhD in pharmaceutical sciences from the University of Maryland School of Pharmacy in 2021 after obtaining a BS in biology with a minor in chemistry from Fairleigh Dickinson University-Florham in 2016. After earning her PhD, Defnet became a GSK research and teaching postdoctoral fellow at the University of North Carolina-Asheville in the Department of Chemistry and Biochemistry. She is currently an assistant professor of chemistry and biochemistry at Elizabethtown College where she teaches general chemistry and biochemistry courses and labs and works on starting her own research lab.
Bansri Desai, PharmD ’15, PhD ‘23 - Pharmaceutical Health Services Research
Bansri Desai, PharmD, PhD, is a pharmacist in the Medicare Drug Rebate and Negotiations Group at the Centers for Medicare & Medicaid Services (CMS). Originally from Lansing, Michigan, Bansri trained in Neuroscience at the University of Michigan and received her PharmD (2015) and PhD in Pharmaceutical Health Services Research (2023) from the University of Maryland School of Pharmacy. She also completed a postgraduate residency in managed care pharmacy at Blue Cross Blue Shield of Michigan and previously served as a clinical advisor for Medicare Part D plans at CVS Caremark. Her interests include value and health technology assessment, health care decision-making, and patient-centered care.
Andrew Do, JD, MS ‘15 - Regulatory Science
Andrew Do is an attorney in Covington & Burling's Food, Drug, and Device Practice Group. Do draws on his scientific training, years at the U.S. Food and Drug Administration (FDA), and experience in political campaigns to provide strategic advice to clients on a broad range of regulatory compliance and policy issues. He has assisted companies, trade associations, and private equity clients on a myriad of matters, including in complying with FDA regulations, assessing regulatory and consumer litigation risks, responding to FDA enforcement actions and Congressional inquiries, analyzing proposed bills and legislative priorities on Capitol Hill, and conducting due diligences of FDA regulated companies for acquisition. Before joining Covington & Burling, Do was an ORISE research rellow with the Center for Food Safety and Applied Nutrition at FDA, where he conducted research on food allergens, gluten, and pathogens to support the agency’s regulation and enforcement concerning food products. His research and work have been published in numerous scientific peer-reviewed journals.
Shamia Faison, PhD ‘15 - Pharmaceutical Sciences
Shamia Faison is a director of clinical pharmacology with Certara Strategic Consulting, where she works with clients in the biotech, pharmaceutical, and global health sector to design clinical trials, analyze data, and prepare regulatory submissions. Prior to joining Certara in 2020, Faison worked in the pharmaceutical industry as a clinical pharmacologist with responsibility for designing clinical development plans, managing Phase 1 studies, and reporting clinical pharmacology aspects to the U.S. Food and Drug Administration. Faison earned her PhD in pharmaceutical sciences from the University of Maryland School of Pharmacy in 2015.
Mathilda Fienkeng, PharmD ’08, MS ’18 - Regulatory Science
Commander Mathilda Fienkeng is director of the Division of Medical Policy Development in the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, Office of Medical Policy. In this role, Fienkeng leads a diverse staff of medical, pharmacy, nursing, public health, legal, project management, and administrative professionals in the development of new and ongoing policy initiatives pertaining to human drug development, human drug approval, bioresearch monitoring, and human subject protection. Fienkeng joined the FDA 15 years ago and has public health experience in prescription drug advertising and promotional labeling review, surveillance and enforcement, drug shortage, and domestic and international emergency response. Feinkeng previously worked as a registered nurse and a high school teacher. She holds Doctor of Pharmacy and MS in regulatory science degrees from the University of Maryland School of Pharmacy, an executive certificate in public policy from Harvard Kennedy School of Executive Education, an associate’s degree in nursing from Essex Community College, and a bachelor of arts in bilingual education from Ecole Normale Supérieure, University of Yaoundé, Cameroon.
Keisha Hines-Harris, MS ‘18 - Regulatory Science
Keisha Hines-Harris graduated from the University of Maryland School of Pharmacy in 2018 with a MS in regulatory science degree. She is currently a quality assurance manager for global compliance at The Emmes Company. At Emmes she manages a team of four and advises an additional 10 auditors based around the globe. Prior to obtaining her graduate degree, she worked as a bench scientist for Leidos, the National Cancer Institute, and the National Human Genome Research Institute in their sequencing laboratories. Since obtaining her MS in regulatory science, Hines-Harris has grown professionally in the areas of compliance, auditing, pharmacovigilance, and vendor management. To continue to advance professionally, she currently serves as the secretary for the National Capital Area Regional Chapter executive board of the Society of Quality Assurance.
Ellen Loh, PhD ’16 - Pharmaceutical Health Services Research
Dr. Loh, BPharm, Ph.D., MBA, is a health services researcher with expertise in pharmacoeconomics and pharmacoepidemiology and experience in pharmaceutical business. Her research interest focuses on medication use, adherence, and outcomes in the Medicare population with chronic diseases and Medicare Part D policy. She has contributed to many federal, foundation and industry-funded research projects and has numerous peer-reviewed publications and presentations at professional conferences. She has recently been awarded the Touro Presidential Research Development Grant to study the impact of awareness of osteoporosis on BMD testing and osteoporosis medication use among Male vs. Female Medicare beneficiaries.
Angela Nguyen, PhD ‘16 - Pharmaceutical Sciences
Dr. Nguyen graduated from Dr. Amanda Oglesby’s Lab in 2016 and began an ORISE fellowship at the FDA, Center for Food Safety and Applied Nutrition (CFSAN) in College Park, Maryland. She worked as a research microbiologist on method development for toxin detection in food. In 2018, Angie accepted a position as Molecular Research Project Manager at Merieux NutriSciences, a global food testing company, headquartered in Chicago, IL. She managed a business unit offering microbiology and molecular biology-testing services for the food industry. Angie is currently the Research Director at the Silliker Food Science Center in Crete, IL, the contract research and specialized testing center within Merieux NutriSciences. She oversees molecular, GMO, and method validation testing services and works closely with the R&D team to transfer new microbiology and molecular based methods into operations.
Dinci Pennap, PhD ’18 - Pharmaceutical Health Services Research
Dr. Pennap is a Pharmacoepidemiologist and Therapy Area Lead for respiratory and immunology products at AstraZeneca. Prior to joining AstraZeneca as an Associate Director, Safety Epidemiology in September of 2022, she was an epidemiologist with the Food and Drug Administration. Dr. Pennap earned a Master of Public Health from Boston University and her doctorate from the University of Maryland School of Pharmacy.
Rana Rais, PhD ’10 - Pharmaceutical Sciences
Rana Rais is an Associate Professor of Neurology (Primary) and Pharmacology and Director of the drug metabolism, pharmacokinetics (DMPK) at Johns Hopkins. Dr. Rais received her Ph.D. in Pharmaceutical Sciences with substantial experience in biopharmaceutics, drug permeability, drug transport, drug metabolism, pharmacokinetics, and drug delivery including prodrug design and characterization. Her lab has expertise in invitro and in vivo ADME as well as in novel drug delivery approaches specifically intranasal delivery and prodrug approaches for successfully enhancing bioavailability, brain delivery and targeted delivery of compounds with poor physicochemical properties. She has impacted drug discovery projects in Oncology, NeuroAIDS, Neuropathic pain, Inflammatory bowel disease, multiple sclerosis and Alzheimer’s disease. She is a co-inventor of over 15 JHU patents; and has published over 125 coauthored manuscripts including recent ones in Science, PNAS, Science Advances and Science Translational Medicine. She has also co-founded two JHU start-up companies, which have amassed over $60M in external funding.
Alexandria Reinhart, PhD ’16 – Molecular Biology
Dr. Alexandria Reinhart finished her PhD in Dr. Mandy Oglesby’s lab in 2016. After completing an ORISE post-doctoral fellowship, followed by a senior scientist position at a chemical company, she joined the University of Washington, Seattle in 2020 as a clinical chemistry fellow. She specialized in toxicology, analyzing the increasing amount of fentanyl found in drug users in the Seattle area. Upon completing her fellowship in 2022, she took a position at NMS Labs, a reference toxicology lab for both clinical and forensic toxicology, as an assistant laboratory director in quality assurance.
Jessica Rowe, MS ’16 – Regulatory Science
Jessica Rowe, MA, MS, CCRP, CIP is the Quality and Education Director for the Yale Cancer Center, Clinical Trials Office. Previously, Ms. Rowe was the Associate Director for Regulatory, Compliance, and Quality within the Yale Center for Clinical Investigation (YCCI) and Yale Human Research Protection Program (HRPP). Prior to joining Yale, Ms. Rowe was the HRPP Director for WellSpan Health overseeing comprehensive HRPP. Previously, Jessica was with the University of Maryland, Baltimore (UMB) for 13 years. During her tenure she held numerous positions in the research field and sat on several research review committees. Currently, Ms. Rowe is an IRB member of the UMB and Yale IRBs. Jessica is Chair of the Southern Pennsylvania SOCRA Chapter, SOCRA Board member and current President. Ms. Rowe is an active member of The Consortium to Advance Effective Research Ethics Oversight and adjunct instructor for the University of Maryland, Baltimore Graduate School teaching courses in research compliance and administration. She is also faculty on several SOCRA workshops including Quality Management and GCP Prep Course. Jessica has extensive experience in human subject research compliance, IRB, quality, clinical trial management, and education and training. Ms. Rowe is a Certified Clinical Research Professional (CCRP), Certified IRB Professional (CIP), and holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. She is passionate about human subject protections and enjoys teaching and educating on all topics related to research.
Juan David Rueda, MD, PhD ’19 – Pharmaceutical Health Sciences Research
Juan-David Rueda is the global value strategies director for oncology at AstraZeneca. He has expertise in development global market access and pricing strategy, focusing on value-based health care and economic modeling. He has a special interest in the application of artificial intelligence/machine learning in the market access space. Rueda is responsible for global international partnership development of managed entry agreements in Europe, Latin America, and Asia. He joined AstraZeneca in 2019 and has held multiple roles in market access including health economics, market access in emerging markets, and value strategies. He earned his medical degree in 2010 from the Pontificia Universidad Javeriana in Bogota, Colombia. He earned a master of science and PhD in pharmaceutical health services research from the University of Maryland School of Pharmacy and master of science in epidemiology and preventative health from the University of Maryland School of Medicine.