PORTAL is committed to expanding the field of bright young faculty interested in empirical research in regulatory science, public health law, bioethics, and policy related to therapeutics.
Since 2013, we have offered two fellowship programs: (1) a general medicine fellowship intended for physicians after their internal medicine residency training planning to pursue a career in health services or health policy research, and (2) a post-doctoral fellowship intended for law/social science scholars interested in the PORTAL areas of focus.
Fellows work closely with other faculty and advanced trainees in the Division, who include internists, epidemiologists, health policy experts, and statisticians. In the past, some fellows have also pursued Masters degrees at the Harvard T. H. Chan School of Public Health. Application details can be found here.
Since 2013, we have offered two fellowship programs: (1) a general medicine fellowship intended for physicians after their internal medicine residency training planning to pursue a career in health services or health policy research, and (2) a post-doctoral fellowship intended for law/social science scholars interested in the PORTAL areas of focus.
Fellows work closely with other faculty and advanced trainees in the Division, who include internists, epidemiologists, health policy experts, and statisticians. In the past, some fellows have also pursued Masters degrees at the Harvard T. H. Chan School of Public Health. Application details can be found here.
CURRENT FELLOWS AND COLLABORATORS
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William B. Feldman, M.D., D.Phil.
Instructor in Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics |
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Jacob Madden, J.D.
Postdoctoral Fellow, Boston University School of Law and PORTAL |
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Adam Raymakers, Ph.D.
Postdoctoral Fellow, PORTAL |
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CURRENT RESEARCH ASSISTANTS
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CURRENT STUDENTS
Rasha Alhiary, PharmD (MS Candidate, University of Pittsburgh): Rasha is a Fulbrighter from Jordan and a second-year master’s student in the pharmaceutical outcomes and policy research track at the University of Pittsburgh. Her research at PORTAL includes examining patenting practices by brand-name drug manufacturers and paragraph IV certifications and litigation that hinder generic competition, as well as analyzing revenue on brand-name inhalers after the expiration of primary patents. Rasha has previous experience in biotech business development and international projects coordination with the European Union, United Kingdom, and the Irish government.
Melissa Barber (PhD candidate, Harvard T.H. Chan School of Public Health): Melissa's research crosses economics, political science, and law to try to better understand and overcome structural barriers to access to medicines. Her dissertation uses econometric and mixed methods to untangle the dynamics of market failures in global pharmaceutical markets, as well as to evaluate the effectiveness of interventions aimed at addressing them. She has worked for the World Health Organization, Médecins Sans Frontières Access Campaign, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the World Bank, the Clinton Health Access Initiative, and the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) study.
Alex Benoit (A.B. candidate, Harvard College): Alex is in a gap year after having recently graduated from high school while simultaneously studying at the University of Georgia, majoring in mathematics and microbiology. Previously a member of the Research Science Institute and a fellow of the Governor’s Honors Program, Alex is interested in infectious diseases and healthcare infrastructure. At PORTAL, his current work revolves around the cost-effectiveness and value of priority review vouchers.
Sonya Davey, M.D., M.Phil: Sonya is a resident physician in Internal Medicine at Harvard Medical School / Brigham and Women’s Hospital. During residency, she studied socioeconomic and racial disparities in Covid-19 testing, vaccination, and treatment, and with PORTAL is studying state Medicaid policies on novel therapies for HCV treatment. In addition, she assists in the execution of Covid-19 vaccine clinical trials. During Sonya’s undergraduate and medical education at the University of Pennsylvania, she researched global models of care delivery, and led studies examining cervical cancer screening and mother-to-child HIV transmission. She performed public health research in Tanzania, Rwanda, Botswana, India, and Massachusetts. She was awarded research funding by the Bill and Melinda Gates-Cambridge Scholarship, Massachusetts General Hospital Ambulatory Practice of the Future Grant, and Doris Duke International Clinical Research Fellowship.
Brandon Demkowicz (A.B. candidate, Harvard College): Brandon is a current undergraduate at Harvard College studying Statistics on a Bioinformatics and Computational Biology track and Health Policy. After graduation, he intends to attend medical school where he is eager to pursue his interests related to pharmaceutical innovation and regulation. Brandon’s current work for PORTAL focuses on the role of device patents in prolonging market exclusivities for drug-device combination products.
Kimberly Feng (M.D. Candidate, Harvard Medical School): Kim is a fourth-year medical student in the M.D. Program at Harvard Medical School. Prior to medical school, she earned her B.S. in Biology and Ancient History from the Massachusetts Institute of Technology. She is broadly interested in health economics and physician and patient decision-making, and her work at PORTAL is focused on biosimilar drug policy and spending.
Simon Gunter, M.Phil (M.D./M.B.A. candidate, Harvard Medical School & Harvard Business School): Simon is a fourth-year medical student and first-year business student in the joint M.D./M.B.A. program at Harvard Medical School and Harvard Business School. He attended Washington University in St. Louis where he received a B.S.B.A in Finance and the University of Cambridge where he received an M.Phil in Translational Biomedical Research. At PORTAL, his scholarly work has focused on drug regulation, drug pricing, and clinical trial design and rigor.
ChangWon (Charlie) Lee (M.D. candidate, Harvard Medical School): Charlie is a first-year medical student, who graduated summa cum laude from Harvard College with a concentration in Integrative Biology. Prior to medical school, he was a research assistant with PORTAL, where his work with faculty focused on brand-name combination drug pricing and its effects on Medicare D and state Medicaid expenditures. Prior to PORTAL, he has previously worked at Harvard Medical School and Boston Children’s Hospital studying asthma control and psychosocial symptoms in underserved pediatric populations. His other research interests include drug pricing, drug safety and effectiveness, and strategies to improve physician prescribing behavior. He now attends Harvard Medical School.
Carolyn Lye (M.D./J.D. candidate, Yale University): Carolyn is a second-year law student and fifth-year medical student in the joint M.D./J.D. student program at Yale University. She attended the University of Pennsylvania, where she earned a B.A. in Biology, concentrating in Neurobiology, and Linguistics. Prior to PORTAL, her work has focused on transparency in patient care and the regulatory policies of health privacy and information. At PORTAL, Carolyn’s research interests include evaluating regulatory policies of orphan drugs, cancer drug development, and regulatory decision-making in times of crisis.
John Messinger (M.D. candidate, Harvard Medical School): John is a second-year medical student in the M.D. program at Harvard Medical School. He earned his B.S. in Neural Science from New York University, where his undergraduate research focused on using neuroeconomic principles to investigate decision-making in individuals receiving treatment for opioid use disorder. He current interests are bioethical analysis of policies related to treatment of opioid use disorder, as well as the evaluation of regulatory mechanisms for opioid pharmaceuticals.
Osman Moneer (M.D. candidate, Yale School of Medicine): Osman is a second-year medical student, who graduated from Columbia University with degrees in Chemical Physics and Biology. His research interests include the regulation of emerging healthcare technologies and computational cancer genomics. At PORTAL, he is working on vaccine policy.
Sarosh Nagar (A.B. Candidate, Harvard College): Sarosh is an undergraduate at Harvard College intending to study Government on a Data Science track and Molecular and Cellular Biology. After graduation, he plans to go to medical school to pursue his interests related to drug pricing and regulatory reform. Sarosh’s current work for PORTAL investigates the topics related to unbranded pharmaceutical advertising and its effects on consumers.
Tim “Anders” Olsen (M.D. candidate, Emory University School of Medicine and M.P.P. candidate, Harvard Kennedy School): Anders is a joint Master’s in Public Policy and 4th year medical student at the Harvard Kennedy School and Emory University School of Medicine. His policy focus is on issues surrounding chronic disease affordability in the U.S., and his medical interests are in the field of hematology and oncology. In his free time he enjoys playing the violin, seeing live music, cooking with friends and any activity he can enjoy outdoors.
Aayan Patel (B.S. Candidate, Stanford University): Aayan is an incoming undergraduate student at Stanford University who intends to study molecular biology and public policy. After graduation, he plans to attend medical school and conduct research in pharmacology and pharmaceutical policy. At PORTAL, Aayan's research is focused on health policy and examining trends in drug prices.
Neeraj Patel (M.D. Candidate, Yale School of Medicine): Neeraj is a medical student at Yale School of Medicine, who graduated from Yale University with a B.A. in Molecular, Cellular, & Developmental Biology and Political Science (concentrating in Health Policy). Prior to medical school, he was a research assistant at PORTAL. His research has focused on FDA regulatory decision-making, prescription drug prices and affordability, and pharmaceutical advertising. Neeraj is also broadly interested in public health communication and improving access to healthcare.
Sanjay Reddy (J.D./ M.P.P. Candidate, Georgetown University Law Center and Harvard Kennedy School): Sanjay is a third-year JD/MPP student at Georgetown Law and Harvard Kennedy School. He holds a BS in Cellular and Molecular Biology from the University of Michigan. Previously, he has worked on health fraud and FDA enforcement cases as a law clerk at the U.S. Attorney’s Office for the District of Maryland, on drug pricing and surprise billing issues as a legislative aide to U.S. Rep. Haley Stevens (D-MI), and as a data analyst for Tempus Labs, a precision medicine startup. At PORTAL, Sanjay’s research interests include the relationship between intellectual property, competition, and pharmaceuticals.
Leigh Sharpless (A.B. candidate, Harvard College): Leigh is a current undergraduate at Harvard College studying History and Science, as well as Molecular and Cellular Biology. After graduation, she intends to go to medical school to pursue her interests in healthcare policy and hospital administration. Leigh's current work for PORTAL involves identifying inconsistencies between approved migraine drug pivotal trial endpoints.
Frazer Tessema (M.D. candidate, Pritzker School of Medicine at the Univeristy of Chicago): Frazer is a first-year medical student, who graduated from Yale University with a B.A. in History. Prior to medical school, he was a research assistant at PORTAL, where he supported the program in its many projects, especially those focused on drug pricing, intellectual property law, post-marketing studies of prescription drugs, and pharmaceutical innovation. During his time at Yale, Frazer did research at both the Yale Decision Neuroscience Lab and Yale Cardiovascular Research Center. His first-author work at PORTAL has appeared in Hastings Law Journal and The Journal of Law, Medicine, and Ethics, and he has 9 publications with PORTAL faculty.
Victor Van de Wiele, LL.B., LL.M.: Victor is a law graduate with an LL.B. from Queen Mary, University of London (UK) and an LL.M. in Global Health Law (Food & Drug Law Certificate) from Georgetown University Law Center. As a Research Coordinator at PORTAL, his research focused on generic drug and biosimilar competition, barriers to market access for FDA-approved therapeutics, BPCIA & Hatch Waxman litigation and regulatory exclusivities. He is currently a Pharmaceutical Policy Researcher and Ph.D. student at the University of Cambridge's Centre for Law, Medicine & Life Sciences.
Mike Zhai, M.D., M.B.A. (medical resident, BWH): Mike graduated from the joint M.D./M.B.A. program at Harvard after attending the University of Pennsylvania, where he earned a B.A. in Economics and Biology concentrating in Neurobiology. He is interested in evaluating regulatory policies of biologics and biosimilars as well as comparative and cost-effectiveness of pharmaceuticals.
Melissa Barber (PhD candidate, Harvard T.H. Chan School of Public Health): Melissa's research crosses economics, political science, and law to try to better understand and overcome structural barriers to access to medicines. Her dissertation uses econometric and mixed methods to untangle the dynamics of market failures in global pharmaceutical markets, as well as to evaluate the effectiveness of interventions aimed at addressing them. She has worked for the World Health Organization, Médecins Sans Frontières Access Campaign, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the World Bank, the Clinton Health Access Initiative, and the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) study.
Alex Benoit (A.B. candidate, Harvard College): Alex is in a gap year after having recently graduated from high school while simultaneously studying at the University of Georgia, majoring in mathematics and microbiology. Previously a member of the Research Science Institute and a fellow of the Governor’s Honors Program, Alex is interested in infectious diseases and healthcare infrastructure. At PORTAL, his current work revolves around the cost-effectiveness and value of priority review vouchers.
Sonya Davey, M.D., M.Phil: Sonya is a resident physician in Internal Medicine at Harvard Medical School / Brigham and Women’s Hospital. During residency, she studied socioeconomic and racial disparities in Covid-19 testing, vaccination, and treatment, and with PORTAL is studying state Medicaid policies on novel therapies for HCV treatment. In addition, she assists in the execution of Covid-19 vaccine clinical trials. During Sonya’s undergraduate and medical education at the University of Pennsylvania, she researched global models of care delivery, and led studies examining cervical cancer screening and mother-to-child HIV transmission. She performed public health research in Tanzania, Rwanda, Botswana, India, and Massachusetts. She was awarded research funding by the Bill and Melinda Gates-Cambridge Scholarship, Massachusetts General Hospital Ambulatory Practice of the Future Grant, and Doris Duke International Clinical Research Fellowship.
Brandon Demkowicz (A.B. candidate, Harvard College): Brandon is a current undergraduate at Harvard College studying Statistics on a Bioinformatics and Computational Biology track and Health Policy. After graduation, he intends to attend medical school where he is eager to pursue his interests related to pharmaceutical innovation and regulation. Brandon’s current work for PORTAL focuses on the role of device patents in prolonging market exclusivities for drug-device combination products.
Kimberly Feng (M.D. Candidate, Harvard Medical School): Kim is a fourth-year medical student in the M.D. Program at Harvard Medical School. Prior to medical school, she earned her B.S. in Biology and Ancient History from the Massachusetts Institute of Technology. She is broadly interested in health economics and physician and patient decision-making, and her work at PORTAL is focused on biosimilar drug policy and spending.
Simon Gunter, M.Phil (M.D./M.B.A. candidate, Harvard Medical School & Harvard Business School): Simon is a fourth-year medical student and first-year business student in the joint M.D./M.B.A. program at Harvard Medical School and Harvard Business School. He attended Washington University in St. Louis where he received a B.S.B.A in Finance and the University of Cambridge where he received an M.Phil in Translational Biomedical Research. At PORTAL, his scholarly work has focused on drug regulation, drug pricing, and clinical trial design and rigor.
ChangWon (Charlie) Lee (M.D. candidate, Harvard Medical School): Charlie is a first-year medical student, who graduated summa cum laude from Harvard College with a concentration in Integrative Biology. Prior to medical school, he was a research assistant with PORTAL, where his work with faculty focused on brand-name combination drug pricing and its effects on Medicare D and state Medicaid expenditures. Prior to PORTAL, he has previously worked at Harvard Medical School and Boston Children’s Hospital studying asthma control and psychosocial symptoms in underserved pediatric populations. His other research interests include drug pricing, drug safety and effectiveness, and strategies to improve physician prescribing behavior. He now attends Harvard Medical School.
Carolyn Lye (M.D./J.D. candidate, Yale University): Carolyn is a second-year law student and fifth-year medical student in the joint M.D./J.D. student program at Yale University. She attended the University of Pennsylvania, where she earned a B.A. in Biology, concentrating in Neurobiology, and Linguistics. Prior to PORTAL, her work has focused on transparency in patient care and the regulatory policies of health privacy and information. At PORTAL, Carolyn’s research interests include evaluating regulatory policies of orphan drugs, cancer drug development, and regulatory decision-making in times of crisis.
John Messinger (M.D. candidate, Harvard Medical School): John is a second-year medical student in the M.D. program at Harvard Medical School. He earned his B.S. in Neural Science from New York University, where his undergraduate research focused on using neuroeconomic principles to investigate decision-making in individuals receiving treatment for opioid use disorder. He current interests are bioethical analysis of policies related to treatment of opioid use disorder, as well as the evaluation of regulatory mechanisms for opioid pharmaceuticals.
Osman Moneer (M.D. candidate, Yale School of Medicine): Osman is a second-year medical student, who graduated from Columbia University with degrees in Chemical Physics and Biology. His research interests include the regulation of emerging healthcare technologies and computational cancer genomics. At PORTAL, he is working on vaccine policy.
Sarosh Nagar (A.B. Candidate, Harvard College): Sarosh is an undergraduate at Harvard College intending to study Government on a Data Science track and Molecular and Cellular Biology. After graduation, he plans to go to medical school to pursue his interests related to drug pricing and regulatory reform. Sarosh’s current work for PORTAL investigates the topics related to unbranded pharmaceutical advertising and its effects on consumers.
Tim “Anders” Olsen (M.D. candidate, Emory University School of Medicine and M.P.P. candidate, Harvard Kennedy School): Anders is a joint Master’s in Public Policy and 4th year medical student at the Harvard Kennedy School and Emory University School of Medicine. His policy focus is on issues surrounding chronic disease affordability in the U.S., and his medical interests are in the field of hematology and oncology. In his free time he enjoys playing the violin, seeing live music, cooking with friends and any activity he can enjoy outdoors.
Aayan Patel (B.S. Candidate, Stanford University): Aayan is an incoming undergraduate student at Stanford University who intends to study molecular biology and public policy. After graduation, he plans to attend medical school and conduct research in pharmacology and pharmaceutical policy. At PORTAL, Aayan's research is focused on health policy and examining trends in drug prices.
Neeraj Patel (M.D. Candidate, Yale School of Medicine): Neeraj is a medical student at Yale School of Medicine, who graduated from Yale University with a B.A. in Molecular, Cellular, & Developmental Biology and Political Science (concentrating in Health Policy). Prior to medical school, he was a research assistant at PORTAL. His research has focused on FDA regulatory decision-making, prescription drug prices and affordability, and pharmaceutical advertising. Neeraj is also broadly interested in public health communication and improving access to healthcare.
Sanjay Reddy (J.D./ M.P.P. Candidate, Georgetown University Law Center and Harvard Kennedy School): Sanjay is a third-year JD/MPP student at Georgetown Law and Harvard Kennedy School. He holds a BS in Cellular and Molecular Biology from the University of Michigan. Previously, he has worked on health fraud and FDA enforcement cases as a law clerk at the U.S. Attorney’s Office for the District of Maryland, on drug pricing and surprise billing issues as a legislative aide to U.S. Rep. Haley Stevens (D-MI), and as a data analyst for Tempus Labs, a precision medicine startup. At PORTAL, Sanjay’s research interests include the relationship between intellectual property, competition, and pharmaceuticals.
Leigh Sharpless (A.B. candidate, Harvard College): Leigh is a current undergraduate at Harvard College studying History and Science, as well as Molecular and Cellular Biology. After graduation, she intends to go to medical school to pursue her interests in healthcare policy and hospital administration. Leigh's current work for PORTAL involves identifying inconsistencies between approved migraine drug pivotal trial endpoints.
Frazer Tessema (M.D. candidate, Pritzker School of Medicine at the Univeristy of Chicago): Frazer is a first-year medical student, who graduated from Yale University with a B.A. in History. Prior to medical school, he was a research assistant at PORTAL, where he supported the program in its many projects, especially those focused on drug pricing, intellectual property law, post-marketing studies of prescription drugs, and pharmaceutical innovation. During his time at Yale, Frazer did research at both the Yale Decision Neuroscience Lab and Yale Cardiovascular Research Center. His first-author work at PORTAL has appeared in Hastings Law Journal and The Journal of Law, Medicine, and Ethics, and he has 9 publications with PORTAL faculty.
Victor Van de Wiele, LL.B., LL.M.: Victor is a law graduate with an LL.B. from Queen Mary, University of London (UK) and an LL.M. in Global Health Law (Food & Drug Law Certificate) from Georgetown University Law Center. As a Research Coordinator at PORTAL, his research focused on generic drug and biosimilar competition, barriers to market access for FDA-approved therapeutics, BPCIA & Hatch Waxman litigation and regulatory exclusivities. He is currently a Pharmaceutical Policy Researcher and Ph.D. student at the University of Cambridge's Centre for Law, Medicine & Life Sciences.
Mike Zhai, M.D., M.B.A. (medical resident, BWH): Mike graduated from the joint M.D./M.B.A. program at Harvard after attending the University of Pennsylvania, where he earned a B.A. in Economics and Biology concentrating in Neurobiology. He is interested in evaluating regulatory policies of biologics and biosimilars as well as comparative and cost-effectiveness of pharmaceuticals.
PAST TRAINEES AND COLLABORATORS
Past Fellows
Rachel E. Barenie, Pharm.D., J.D., M.P.H.: Dr. Barenie completed her postdoctoral fellowship with PORTAL from 2018-2020, focusing her research on cost and access issues related to care for substance use disorders and chronic pain, public funding for drug development, and others. She also served as a clinical consultant to Alosa Health, a non-for-profit academic detailing organization, for opioid use disorder-related content during her fellowship.
Reed F. Beall, Ph.D., M.A.: Dr. Beall was a postdoctoral fellow at PORTAL from 2017-2018. Reed is a population health researcher who works largely with medicine patent and regulatory data to investigate the long-term impacts of national and international policy decisions which aim to balance incentives between equitable drug innovation and equitable drug access. Dr. Beall’s work has been published in Nature Biotechnology, Health Affairs, PLoS Medicine, and Social Science and Medicine, among others.
Doni Bloomfield, J.D.: Doni Bloomfield was a postdoctoral research fellow with PORTAL. His research focuses on the relationship between competition, intellectual property, and pharmaceuticals. His current working papers include pieces on competition and risk and revamping merger review. Prior to law school, he worked as a biotechnology journalist for Bloomberg News. His work has appeared in Bloomberg, Businessweek, Slate, the Boston Globe, and the Seattle Times. He has held summer positions at the Federal Trade Commission’s Bureau of Competition, the U.S. Department of Justice’s Antitrust Division, the San Francisco Office of the Public Defender, and in Davis Polk & Wardwell’s antitrust practice. Doni holds a J.D. from Yale Law School and a B.A. from the University of Chicago.
Laura E. Bothwell, Ph.D., M.A.: Laura has researched the history, ethics, and international regulatory uses of adaptive design clinical trials. Her projects related to the political and economic history of novel drug discovery and comparative national and international drug pricing systems. She also worked on a book on historical, ethical, and policy dimensions of randomized controlled trials. Laura earned a Ph.D. in 2014 in the History and Ethics of Public Health and Medicine at Columbia University. Laura published two papers in the New England Journal of Medicine on randomized controlled trials.
Chintan V. Dave, Pharm.D., Ph.D.: As a postdoctoral fellow from 2017-2019, Chintan studied post-marketing drug safety, generic drug pricing, and prediction modeling. He published articles with PORTAL faculty in the New England Journal of Medicine, the Annals of Internal Medicine, and the Journal of General Internal Medicine.
Anjali Deshmukh, M.D., J.D.: Dr. Deshmukh is a board-certified primary care pediatrician and was a clinical research fellow at PORTAL. Her research focuses on the relationship between patient care, patent litigation, and pharmaceutical pricing, including understanding competition in U.S. pharmaceutical markets and implications of FDA approval on pediatrics. Anjali worked on Hatch-Waxman and pharmaceutical patent litigation as an associate at Wilson Sonsini Goodrich and Rosati and Demarais LLP. After completing pediatric residency at Stanford in 2016, she practiced at Stanford Children's Health and Marin Health. Anjali is an active volunteer, leading a team funding education initiatives for underprivileged children with San Francisco's chapter of Asha for Education and serves on the American Academy of Pediatrics' Education and Advocacy work group for Early Career Physicians. She is a graduate of Dartmouth College, Vanderbilt School of Medicine, and Stanford Law School, where she served as an extern to the Honorable Judge Lucy H. Koh at the U.S. District Court for the Northern District of California and Editor-in-Chief of the Stanford Journal of Law, Science and Policy.
Michael Fralick, M.D., Ph.D., M.Sc.: Dr. Fralick completed a Master's of Science in Clinical Epidemiology at Harvard T.H. Chan School of Public Health as a General Internal Medicine Fellow with PORTAL from 2016-2018. Areas of research interest include use of claims data for assessing post-marketing drug safety and effectiveness, clinical trial design implications, and understanding the metrics of cost-effectiveness studies. Michael has published with PORTAL faculty in BMJ, JAMA, JAMA Internal Medicine, and NEJM, among other journals.
Bishal Gyawali, M.D., Ph.D.: Dr. Gyawali was a research fellow at PORTAL from 2018-2019. He graduated medical school in Nepal with seven gold medals and received his PhD from Nagoya University, Japan as a MEXT scholar. His clinical and research interests include cancer policy, global oncology, evidence-based oncology, financial toxicities of cancer treatment, clinical trial methods, and supportive care.
Spencer P. Hey, Ph.D.: Dr. Hey was a postdoctoral fellow at PORTAL from 2015-2017. He works on issues at the intersection of methodology, ethics, and regulation in clinical trials, with a particular focus on challenges surrounding the use of biomarkers in drug development. His work has been published in such venues as Science, PLoS Medicine, and BMJ.
Nicole Levidow, J.D., M.S.P.H.: As a PORTAL postdoctoral fellow from 2015-2016, Nicole studied informed consent issues as they relate to antipsychotic medications. She also studied the clinical trials and prescribing patterns of accelerated approval drugs, drug compounding, and the growth of limited distribution pharmacy networks. She published an article in Drug Safety with PORTAL faculty.
Lois S. Liu, J.D., M.Sc.: Lois holds a J.D. from American University Washington College of Law, an M.Sc. in Global Health from Duke University, and a B.S. in Pharmacy from China Pharmaceutical University. Her interests include intellectual property, off-label use, and clinical trial regulations. While at PORTAL, Lois focused her work on expedited regulatory policies and the Bayh-Dole Act.
Jing Luo, M.D., M.P.H.: As a PORTAL faculty member from 2016-2019, Jing researched prescription drug pricing, access to medicines like insulin, and generic competition. Jing's work has appeared in JAMA, JAMA Internal Medicine, Lancet Diabetes & Endocrinology and the Harvard Health Policy Review.
Mallika Mundkur, M.D.: Dr. Mundkur is general medicine fellow who recently completed an informatics fellowship at the National Institutes of Health. She is a graduate of the University of Massachusetts Medical School and trained in internal medicine at the University of Alabama at Birmingham. She recently published a paper on electronic health records and racial disparities.
Brooke L. Raunig, J.D., R.N.: Brooke earned her J.D. from California Western School of Law and is admitted to the State Bar of California. Prior to law school, Brooke received her A.S.N. from Montana Tech and her B.S.N. from Chamberlain College of Nursing, and she now holds an active R.N. license in both Montana and California. Brooke’s interests in health law are vast and she has previously published work on women’s health in the context of hospital mergers and religious doctrine. During her time at PORTAL as a postdoctoral fellow, her research focused on issues related to addiction, intellectual property, drug supply chains, and improving transparency in the pharmaceutical industry.
Chana A. Sacks, M.D., M.P.H.: Dr. Sacks was a General Internal Medicine fellow with PORTAL from 2016 - 2018, studying health policy, including FDA regulatory and approval processes, medication pricing, and the clinical and economic impact of drug shortages. Her recent work on Medicare spending on brand-name combination drugs was published in JAMA. She has also focused on gun violence prevention, and has published on this and other topics in NEJM and JAMA Internal Medicine.
Michael S. Sinha, M.D., J.D., M.P.H.: Dr. Sinha is a graduate of Dartmouth College, with M.D. and J.D. degrees from Southern Illinois University and an M.P.H. in Law and Public Health from Harvard T.H. Chan School of Public Health. He trained in internal medicine at Griffin Hospital in Connecticut and at Boston Medical Center before joining PORTAL. He was a PORTAL fellow from 2016-2018 before transitioning in August 2018 to a role as fellow at the Harvard-MIT Center for Regulatory Science at Harvard Medical School. Current research work covers intellectual property law, corporate, tax, and antitrust law, and current health policy issues like the 21st Century Cures Act and the opioid epidemic. Published work with PORTAL also includes a JAMA Viewpoint on antitrust law and pharmaceutical companies, a PLOS Medicine Editorial on off-label promotion, and two JAMA Internal Medicine Special Communications -- one on physicians and insider trading and the other on market exclusivities for prescription drugs.
Kerstin N. Vokinger, M.D., J.D., Ph.D., LL.M.: Dr. Vokinger studied law and medicine at the University of Zurich (J.D. 2012, M.D. 2015), and was a fast track candidate in the Ph.D.-program Biomedical Ethics and Law at the University of Zurich (Ph.D. 2015). She obtained her Master of Laws (LL.M.) degree from Harvard Law School in 2016 and worked from 2015 to 2016 as a Researcher at Harvard Law School studying global access to medicines.
Bryan Walsh, J.D.: Bryan Walsh was a postdoctoral research fellow with PORTAL. He holds a J.D. with a concentration in health law from George Washington University Law School, a graduate certificate in Health Policy from Milken Institute School of Public Health at George Washington University, and a B.A. in Philosophy and Criminology from University of North Carolina Wilmington. While completing his law degree, Bryan held positions in FDA’s Office of Chief Counsel, the Domestic Violence Legal Empowerment and Appeals Project, and Bread for the City, as well as served as a Kahan FDA/Health Law Fellow, Executive Articles Editor for The George Washington International Law Review, and Vice President of the Moot Court Board at GW Law. His research focuses on competition and regulatory actions that increase access to affordable prescription drugs, as well as the utilization of biosimilars and generics. His prior work has appeared in the Domestic Violence Report.
Rebecca Wolitz, J.D., M.Phil.: Rebecca was a postdoctoral research fellow with PORTAL from 2019-2021 and is a PhD Candidate in Philosophy at Yale. She is currently on the law school faculty at The Ohio State University's Moritz College of Law. Rebecca holds a J.D. from Yale Law School, an M.Phil. from Yale, and a B.A. from Rutgers University. Prior to joining PORTAL, she was a fellow with Stanford Law School’s Center for Law and the Biosciences, a litigation associate in private practice, and a pre-doctoral bioethics fellow with the National Institutes of Health. Ms. Wolitz’s scholarship focuses on various ethical and legal issues at the intersection of health law, intellectual property, and corporate law. Her research explores the normative problems that arise when the law allows private rights and market incentives to govern access to important goods, and she is particularly interested in the implications and justifications for laws and policies governing drug development and accessibility. Her articles have appeared or are forthcoming in the Northwestern University Law Review, the Indiana Law Journal, the Journal of Legal Medicine, Bioethics, and the Lancet.
James S. Yeh, M.D.: As a fellow in the HMS general medicine and primary care faculty development program, James worked on understanding the association between physician financial relationships and prescribing decisions. James has also served as a 2015-2016 Editorial Fellow at the New England Journal of Medicine. James published six articles with PORTAL faculty, including first author papers in JAMA Internal Medicine, Drug Safety, and PLoS Medicine.
Past Harkness Fellows
Huseyin Naci, M.H.S., Ph.D.: Dr. Naci worked with PORTAL as a 2018-19 Commonwealth Fund Harkness Fellow in Health Care Policy and Practice. Research to date has evaluated the quality and quantity of the evidence base that underpins the approval, adoption, and reimbursement of new health technologies in Europe and the U.S. His research appeared in leading health policy and general medical journals including JAMA, BMJ, Health Affairs, and The Milbank Quarterly. Huseyin has a Ph.D. in Health Policy from the Department of Social Policy at LSE and an M.H.S. in International Health from Johns Hopkins Bloomberg School of Public Health.
Véronique Raimond, Ph.D., M.P.H., M.Sc.: Véronique worked with PORTAL as a French 2019-20 Commonwealth Fund Harkness Fellow in Health Care Policy and Practice. She holds a Ph.D. in Economics from Paris-Sorbonne University, an M.Sc. in Public Health from France Conservatoire National des Arts et Métiers, and a second M.Sc. in Health Economics from both France Paris-Sorbonne University and Paris-Descartes University. Her interests include evidence use in coverage decisions for prescription drugs and prescription drug pricing. Her previous works has been published in Value in Health, Pharmacoeconomics, and the International Journal of Technology Assessment in Health Care.
Past Research Assistants and Research Specialists
Beatrice (Bea) Brown, M.B.E.: Bea was a Research Specialist with PORTAL. She received her B.A. in Ethics, Politics, & Economics from Yale University and her MBE (Master of Bioethics) from Harvard Medical School. During her MBE, Bea was a Student Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Some of her research interests include prescription drug pricing, affordability, and access; the effects of drug pricing on patient care and health disparities; and research ethics. Bea's work with PORTAL has appeared in Annals of Internal Medicine and Health Affairs. She continues to regularly contribute to Petrie-Flom’s blog, Bill of Health—her posts can be found here.
Emily Jung, A.B.: As an undergraduate at Harvard College (A.B. 2018), Emily published with PORTAL faculty in Clinical Pharmacology & Therapeutics. After graduating with a concentration in History of Science, she spent a year as a PORTAL Research Assistant supporting PORTAL projects focused on expanded access policies and drug pricing. She now attends Emory School of Medicine.
Lara Maggs, M.Bioethics: As a research associate with PORTAL, Lara studied orphan drug trials, access to drugs and devices with limited supporting data, and FDA law. Her research resulted in a JAMA Viewpoint article and two Health Affairs Blog posts.
Tuli Mitra-Majumdar, M.P.H.: was a research specialist with PORTAL. Her research interests include drug pricing, patents and market exclusivities, and comparative effectiveness research. Prior to joining PORTAL, Tuli provided strategic support to the MassHealth pharmacy team around their authority to directly negotiate supplemental rebates with manufacturers. She was also a Research Analyst at the Urban Institute, where her work focused on pay-for-performance contracts, the opioid epidemic, and health disparities more broadly. Tuli holds an MPH in Health Policy from the Harvard T.H. Chan School of Public Health, and a B.A. in Biology from the University of Pennsylvania.
Past Harvard Medical School Students
Kirsten E. Austad, M.D.: Kirsten's work with PORTAL as an HMS student addressed the role of pharmaceutical marketing in medical school education, and other ethical issues relating to financial relationships in medical education. Most notably, she helped lead a national survey of medical students and residents to determine the extent of their interactions with pharmaceutical marketing representatives. Kirsten published several articles with PORTAL faculty, including in JAMA, New England Journal of Medicine, and PLoS One, on these topics.
Evan S. Caplan, M.D., M.B.A.: Evan studied the principles underlying successful drug development with PORTAL as a Harvard M.D./M.B.A. student. He collaborated with PORTAL faculty on a qualitative analysis of the development of VEGF-inhibitors used for ophthalmologic disease, one of the most transformative drugs in that field in the past 25 years.
Kyle Checchi, M.D.: As a medical student at HMS, Kyle conducted a systematic review of studies evaluating medical devices used to improve patient adherence to prescription drugs. He focused on the features of these devices most associated with successful interventions, as well as the applicability of the technology to resource-poor settings without substantial health information technology infrastructure. Kyle published a paper in JAMA with PORTAL faculty.
Devan Darby, M.D., M.P.H.: With PORTAL, Devan investigated how major legal events during the DOJ investigation into fraudulent off-label promotion of the antiepileptic drug gabapentin (Neurontin) affected trends in prescribing and spending for approved and off-label indications, which was published in Health Affairs.
Alex Misono, M.D., M.B.A.: With PORTAL, Alex focused on the intersection between generic and brand-name drugs, including a systematic review of brand-name and generic drug effectiveness and a study of how color and shape differences among brand-name and generic drugs may affect patient adherence to essential medicines. He published three papers with PORTAL faculty.
Rahul Nayak, M.D.: Rahul graduated from Harvard Medical School in 2019 and from Duke University with a B.S.E. in biomedical engineering and economics before completing a medicine residency at MGH. At PORTAL, Rahul's research interests included examining the role of academic and public-sector contributions to pharmaceutical development and studying healthcare reforms.
Prashant V. Rajan, M.D.: Prashant graduated summa cum laude from Miami University in Oxford, Ohio in 2013 and holds a B.S. in zoology and a B.A. in biochemistry. Prashant was a 2012 Goldwater Scholar and a 2013 Astronaut Scholar. Prashant studied current and future prospects for FDA post-market regulation of medical devices and the FDA regulation of medical device approval, and has published two articles with PORTAL faculty.
Y. Tina Tan, M.D., M.B.A.: Tina is interested in innovation at the intersection of medicine, business and technology. Her current research focuses on medical innovation within drug and medical device development. She is also an aspiring healthcare entrepreneur eager to learn about new startups and everything related to health care and biotech entrepreneurship. With PORTAL, Tina conducted a cross-national comparison of medical device regulation in the US and China, and supplemented her review of the literature with a qualitative research process involving interviews with key experts from regulatory, academic, and industry sectors in China. She has published with PORTAL faculty in Health Affairs, Food & Drug Law Journal, and PLoS Medicine.
Carolyn L. Treasure, M.D.: Carolyn's work focused on the Bayh-Dole Act, which underlies technology transfer policies from the government and universities to the private sector. She studied past petitions for NIH use of “march-in” rights and outcomes of those cases. She has also studied patent policy and the Orphan Drug Act. She has published with PORTAL faculty in JAMA, Milbank Quarterly, and JAMA Internal Medicine.
Bo Wang, M.D., Pharm.D.: Bo spent 5 years with PORTAL before and during medical school at HMS studying the epidemiology of drug recalls, and analyzed conflict of interest disclosures in whistleblower complaints relating to improper off-label marketing of drugs. He has also focused on the effects of supplemental FDA approvals on drug prescribing, and drug market exclusivity periods. He is first author on several papers with PORTAL faculty, including articles in JAMA, PLoS One, JAMA Internal Medicine, and BMJ.
Shuai (Steve) Xu, M.D., M.Sc.: As a medical student at HMS, Steve worked with PORTAL faculty to conduct a case study investigating the sources of innovation for bare metal stents used in treating coronary artery disease. In doing so, he employed combined methodologies of qualitative interviews and a systematic review of comprehensive patent databases. He published five articles with PORTAL faculty, including papers in the New England Journal Medicine, PLoS One, and the Journal of Law, Medicine & Ethics.
Past Residents
Dave Chokshi, M.D., M.Sc.: As an internal medicine resident at Brigham & Women's Hospital, Dave focused on equitable access to therapeutics and evidence-based medicine, and evaluated both vaccine policy and the emerging place of comparative effectiveness research. Dave published two papers with PORTAL faculty.
Nina Jain, M.D., M.B.A., M.Sc.: As an internal medicine resident at Brigham and Women's Hospital, Nina researched policies related to drug and vaccine development for neglected tropical diseases. Nina published papers in JAMA and the American Journal of Law & Medicine with PORTAL faculty. She holds an M.Sc. in evidence-based social intervention from Oxford.
Rahul Rajkumar, M.D., J.D.: Rahul focused his research during his residency at Brigham and Women's Hospital on legal issues related to pharmaceutical patents and the Supreme Court’s interpretation of the Bayh-Dole Act. He has published with PORTAL faculty in JAMA, New England Journal of Medicine, and Health Affairs.
Past Graduate Students
Louise C. Druedahl, Pharm.D., M.Sc. (Ph.D. candidate, University of Copenhagen, Denmark): In her current research, Louise is focusing on stakeholder perspectives on opportunities and hurdles for biosimilar development and for the regulation of biosimilars. Louise’s work with PORTAL includes examining the challenges with establishing biosimilarity and a manufacturing process for biosimilars.
Daniel Feldman, M.P.H., D.O.: Upon obtaining his undergraduate degree at The George Washington University, Daniel went on to earn a M.P.H. from Boston University focusing in epidemiology, biostatistics, and pharmaceutical policy. He completed medical school at Rowan University, where his pharmaceutical research interests included affordability, access, and comparative effectiveness. He is now a resident in internal medicine.
Sana Mostaghim, Dr.P.H.: Sana is interested in the role that the life sciences industry plays to improve global public health. In his role as director of the Tuberculosis Access team for the Clinton Health Access Initiative (CHAI), Sana oversaw teams providing technical support to Ministries of Health in 8 countries across Africa and Asia, and managed relationships with global stakeholders (e.g. WHO, donors, and generic drug suppliers). He holds a BA with Distinction from the Richard Ivey School of Business at the University of Western Ontario in Canada. Sana's work with the PORTAL team focuses on assessing special regulatory pathways and incentives designed to encourage pro-public health drug development and safety related label changes for new drugs after approval.
Colin Schwartz, M.P.P.: Colin worked with PORTAL as a student at Harvard Kennedy School. He reviewed the origins of AZT and protease inhibitors for use in the treatment of HIV infection, focusing on the collaborations between academia and industry scientists and the role of patents and intellectual property in properly assigning credit for the key innovative steps.
Rick Vreman, Pharm.D., M.Sc. (Ph.D. candidate, University of Utrecht, Netherlands): Rick is a collaborator at PORTAL. His project focuses on the (mis)alignment of regulation and health technology assessment for innovative drugs, related to benefit-risk and comparative benefit evaluations. He is a PhD candidate at Utrecht University, The Netherlands and is trained as a pharmacist and health economist. He promotes the optimization of health technology assessment throughout the drug lifecycle by investigating pharmaceutical policies and by developing methodologies for cost-effectiveness analyses and value-based healthcare.
Past Law Students
Vincent C. Capati, J.D., Pharm.D, M.S.: During law school at the University of New Hampshire, Vincent systematically categorized a range of product life cycle management strategies and evaluated their compliance with antitrust law, leading to a paper on drug product life-cycle management and anticompetitive behavior.
Dalia Deak, J.D. M.P.H.: As a student at Harvard Law School, Dalia studied a range of topics related to drug and device policy, including drug rediscovery and repurposing, the state of antibiotic development, the ethics of FDA approval pathways, and the history of biotechnology innovation. She published with PORTAL faculty in Annals of Internal Medicine.
Vrushab Gowda, J.D.: Vrushab worked with PORTAL as a second-year law student at HLS on topics related to product hopping and antitrust law. Previously, Vrushab pursued regulatory policy projects at the Parliament of the United Kingdom, MGH - Institute for Technology Assessment, a venture-backed fertility preservation startup, and through independent field studies in the Netherlands. He has also pursued an M.D. at the University of North Carolina.
Phebe Hong (J.D. candidate, Harvard Law School): Phebe is a third-year law student, who graduated from Harvard College with a degree in Human Developmental and Regenerative Biology. She is interested in FDA regulation of therapeutics and pharmaceutical patent law. Phebe worked in in healthcare consulting between college and law school.
Nathan Shiu, J.D., M.P.H.: As a law student at UCLA, Nathan worked with PORTAL to evaluate legal approaches to truth and determinations of scientific evidence as “false and misleading.” He published on issues involved with the FDA v. Actavis Supreme Court case and a paper on biomarker patents in personalized medicine.
Past Undergraduate Students
Sophia Fend
Audrey D. Zhang, M.D.: As an undergraduate at Harvard (A.B. 2015), Audrey studied the use of biomarkers in FDA decision-making about investigational drugs, and tracing their conceptual evolution as shaped by academia, industry, and regulatory agencies.
Past Research Science Institute Students
Sharif Gauri
Shreyas Kar (B.S. Candidate, Stanford University): Shreyas is an incoming undergraduate student at Stanford University planning to study Computer Science on an Artificial Intelligence track & Mathematics on a Data Science track. The founder of Community AI and a member of the Research Science Institute, he intends on using artificial intelligence and machine learning to better the world. For his work, he has received several national and international awards and recognition. At PORTAL, his work focuses on quantifying the impact of EHR-Discontinuity on prediction modeling algorithms.
Jamie Meindl (B.S. Candidate, MIT): Jamie is a rising junior at MIT studying computer science and mathematics. He is interested in machine learning and data science and hopes to use these cutting-edge technologies to solve many exciting problems in the future. At PORTAL, Jamie's research focused on using machine learning methods to predict prescription drug switchbacks.
Elizabeth Nyamwange
Aayan Patel (B.S. Candidate, Stanford University): Aayan is an incoming undergraduate student at Stanford University who intends to study molecular biology and public policy. After graduation, he plans to attend medical school and conduct research in pharmacology and pharmaceutical policy. At PORTAL, Aayan's research is focused on health policy and examining trends in drug prices.
Rachel E. Barenie, Pharm.D., J.D., M.P.H.: Dr. Barenie completed her postdoctoral fellowship with PORTAL from 2018-2020, focusing her research on cost and access issues related to care for substance use disorders and chronic pain, public funding for drug development, and others. She also served as a clinical consultant to Alosa Health, a non-for-profit academic detailing organization, for opioid use disorder-related content during her fellowship.
Reed F. Beall, Ph.D., M.A.: Dr. Beall was a postdoctoral fellow at PORTAL from 2017-2018. Reed is a population health researcher who works largely with medicine patent and regulatory data to investigate the long-term impacts of national and international policy decisions which aim to balance incentives between equitable drug innovation and equitable drug access. Dr. Beall’s work has been published in Nature Biotechnology, Health Affairs, PLoS Medicine, and Social Science and Medicine, among others.
Doni Bloomfield, J.D.: Doni Bloomfield was a postdoctoral research fellow with PORTAL. His research focuses on the relationship between competition, intellectual property, and pharmaceuticals. His current working papers include pieces on competition and risk and revamping merger review. Prior to law school, he worked as a biotechnology journalist for Bloomberg News. His work has appeared in Bloomberg, Businessweek, Slate, the Boston Globe, and the Seattle Times. He has held summer positions at the Federal Trade Commission’s Bureau of Competition, the U.S. Department of Justice’s Antitrust Division, the San Francisco Office of the Public Defender, and in Davis Polk & Wardwell’s antitrust practice. Doni holds a J.D. from Yale Law School and a B.A. from the University of Chicago.
Laura E. Bothwell, Ph.D., M.A.: Laura has researched the history, ethics, and international regulatory uses of adaptive design clinical trials. Her projects related to the political and economic history of novel drug discovery and comparative national and international drug pricing systems. She also worked on a book on historical, ethical, and policy dimensions of randomized controlled trials. Laura earned a Ph.D. in 2014 in the History and Ethics of Public Health and Medicine at Columbia University. Laura published two papers in the New England Journal of Medicine on randomized controlled trials.
Chintan V. Dave, Pharm.D., Ph.D.: As a postdoctoral fellow from 2017-2019, Chintan studied post-marketing drug safety, generic drug pricing, and prediction modeling. He published articles with PORTAL faculty in the New England Journal of Medicine, the Annals of Internal Medicine, and the Journal of General Internal Medicine.
Anjali Deshmukh, M.D., J.D.: Dr. Deshmukh is a board-certified primary care pediatrician and was a clinical research fellow at PORTAL. Her research focuses on the relationship between patient care, patent litigation, and pharmaceutical pricing, including understanding competition in U.S. pharmaceutical markets and implications of FDA approval on pediatrics. Anjali worked on Hatch-Waxman and pharmaceutical patent litigation as an associate at Wilson Sonsini Goodrich and Rosati and Demarais LLP. After completing pediatric residency at Stanford in 2016, she practiced at Stanford Children's Health and Marin Health. Anjali is an active volunteer, leading a team funding education initiatives for underprivileged children with San Francisco's chapter of Asha for Education and serves on the American Academy of Pediatrics' Education and Advocacy work group for Early Career Physicians. She is a graduate of Dartmouth College, Vanderbilt School of Medicine, and Stanford Law School, where she served as an extern to the Honorable Judge Lucy H. Koh at the U.S. District Court for the Northern District of California and Editor-in-Chief of the Stanford Journal of Law, Science and Policy.
Michael Fralick, M.D., Ph.D., M.Sc.: Dr. Fralick completed a Master's of Science in Clinical Epidemiology at Harvard T.H. Chan School of Public Health as a General Internal Medicine Fellow with PORTAL from 2016-2018. Areas of research interest include use of claims data for assessing post-marketing drug safety and effectiveness, clinical trial design implications, and understanding the metrics of cost-effectiveness studies. Michael has published with PORTAL faculty in BMJ, JAMA, JAMA Internal Medicine, and NEJM, among other journals.
Bishal Gyawali, M.D., Ph.D.: Dr. Gyawali was a research fellow at PORTAL from 2018-2019. He graduated medical school in Nepal with seven gold medals and received his PhD from Nagoya University, Japan as a MEXT scholar. His clinical and research interests include cancer policy, global oncology, evidence-based oncology, financial toxicities of cancer treatment, clinical trial methods, and supportive care.
Spencer P. Hey, Ph.D.: Dr. Hey was a postdoctoral fellow at PORTAL from 2015-2017. He works on issues at the intersection of methodology, ethics, and regulation in clinical trials, with a particular focus on challenges surrounding the use of biomarkers in drug development. His work has been published in such venues as Science, PLoS Medicine, and BMJ.
Nicole Levidow, J.D., M.S.P.H.: As a PORTAL postdoctoral fellow from 2015-2016, Nicole studied informed consent issues as they relate to antipsychotic medications. She also studied the clinical trials and prescribing patterns of accelerated approval drugs, drug compounding, and the growth of limited distribution pharmacy networks. She published an article in Drug Safety with PORTAL faculty.
Lois S. Liu, J.D., M.Sc.: Lois holds a J.D. from American University Washington College of Law, an M.Sc. in Global Health from Duke University, and a B.S. in Pharmacy from China Pharmaceutical University. Her interests include intellectual property, off-label use, and clinical trial regulations. While at PORTAL, Lois focused her work on expedited regulatory policies and the Bayh-Dole Act.
Jing Luo, M.D., M.P.H.: As a PORTAL faculty member from 2016-2019, Jing researched prescription drug pricing, access to medicines like insulin, and generic competition. Jing's work has appeared in JAMA, JAMA Internal Medicine, Lancet Diabetes & Endocrinology and the Harvard Health Policy Review.
Mallika Mundkur, M.D.: Dr. Mundkur is general medicine fellow who recently completed an informatics fellowship at the National Institutes of Health. She is a graduate of the University of Massachusetts Medical School and trained in internal medicine at the University of Alabama at Birmingham. She recently published a paper on electronic health records and racial disparities.
Brooke L. Raunig, J.D., R.N.: Brooke earned her J.D. from California Western School of Law and is admitted to the State Bar of California. Prior to law school, Brooke received her A.S.N. from Montana Tech and her B.S.N. from Chamberlain College of Nursing, and she now holds an active R.N. license in both Montana and California. Brooke’s interests in health law are vast and she has previously published work on women’s health in the context of hospital mergers and religious doctrine. During her time at PORTAL as a postdoctoral fellow, her research focused on issues related to addiction, intellectual property, drug supply chains, and improving transparency in the pharmaceutical industry.
Chana A. Sacks, M.D., M.P.H.: Dr. Sacks was a General Internal Medicine fellow with PORTAL from 2016 - 2018, studying health policy, including FDA regulatory and approval processes, medication pricing, and the clinical and economic impact of drug shortages. Her recent work on Medicare spending on brand-name combination drugs was published in JAMA. She has also focused on gun violence prevention, and has published on this and other topics in NEJM and JAMA Internal Medicine.
Michael S. Sinha, M.D., J.D., M.P.H.: Dr. Sinha is a graduate of Dartmouth College, with M.D. and J.D. degrees from Southern Illinois University and an M.P.H. in Law and Public Health from Harvard T.H. Chan School of Public Health. He trained in internal medicine at Griffin Hospital in Connecticut and at Boston Medical Center before joining PORTAL. He was a PORTAL fellow from 2016-2018 before transitioning in August 2018 to a role as fellow at the Harvard-MIT Center for Regulatory Science at Harvard Medical School. Current research work covers intellectual property law, corporate, tax, and antitrust law, and current health policy issues like the 21st Century Cures Act and the opioid epidemic. Published work with PORTAL also includes a JAMA Viewpoint on antitrust law and pharmaceutical companies, a PLOS Medicine Editorial on off-label promotion, and two JAMA Internal Medicine Special Communications -- one on physicians and insider trading and the other on market exclusivities for prescription drugs.
Kerstin N. Vokinger, M.D., J.D., Ph.D., LL.M.: Dr. Vokinger studied law and medicine at the University of Zurich (J.D. 2012, M.D. 2015), and was a fast track candidate in the Ph.D.-program Biomedical Ethics and Law at the University of Zurich (Ph.D. 2015). She obtained her Master of Laws (LL.M.) degree from Harvard Law School in 2016 and worked from 2015 to 2016 as a Researcher at Harvard Law School studying global access to medicines.
Bryan Walsh, J.D.: Bryan Walsh was a postdoctoral research fellow with PORTAL. He holds a J.D. with a concentration in health law from George Washington University Law School, a graduate certificate in Health Policy from Milken Institute School of Public Health at George Washington University, and a B.A. in Philosophy and Criminology from University of North Carolina Wilmington. While completing his law degree, Bryan held positions in FDA’s Office of Chief Counsel, the Domestic Violence Legal Empowerment and Appeals Project, and Bread for the City, as well as served as a Kahan FDA/Health Law Fellow, Executive Articles Editor for The George Washington International Law Review, and Vice President of the Moot Court Board at GW Law. His research focuses on competition and regulatory actions that increase access to affordable prescription drugs, as well as the utilization of biosimilars and generics. His prior work has appeared in the Domestic Violence Report.
Rebecca Wolitz, J.D., M.Phil.: Rebecca was a postdoctoral research fellow with PORTAL from 2019-2021 and is a PhD Candidate in Philosophy at Yale. She is currently on the law school faculty at The Ohio State University's Moritz College of Law. Rebecca holds a J.D. from Yale Law School, an M.Phil. from Yale, and a B.A. from Rutgers University. Prior to joining PORTAL, she was a fellow with Stanford Law School’s Center for Law and the Biosciences, a litigation associate in private practice, and a pre-doctoral bioethics fellow with the National Institutes of Health. Ms. Wolitz’s scholarship focuses on various ethical and legal issues at the intersection of health law, intellectual property, and corporate law. Her research explores the normative problems that arise when the law allows private rights and market incentives to govern access to important goods, and she is particularly interested in the implications and justifications for laws and policies governing drug development and accessibility. Her articles have appeared or are forthcoming in the Northwestern University Law Review, the Indiana Law Journal, the Journal of Legal Medicine, Bioethics, and the Lancet.
James S. Yeh, M.D.: As a fellow in the HMS general medicine and primary care faculty development program, James worked on understanding the association between physician financial relationships and prescribing decisions. James has also served as a 2015-2016 Editorial Fellow at the New England Journal of Medicine. James published six articles with PORTAL faculty, including first author papers in JAMA Internal Medicine, Drug Safety, and PLoS Medicine.
Past Harkness Fellows
Huseyin Naci, M.H.S., Ph.D.: Dr. Naci worked with PORTAL as a 2018-19 Commonwealth Fund Harkness Fellow in Health Care Policy and Practice. Research to date has evaluated the quality and quantity of the evidence base that underpins the approval, adoption, and reimbursement of new health technologies in Europe and the U.S. His research appeared in leading health policy and general medical journals including JAMA, BMJ, Health Affairs, and The Milbank Quarterly. Huseyin has a Ph.D. in Health Policy from the Department of Social Policy at LSE and an M.H.S. in International Health from Johns Hopkins Bloomberg School of Public Health.
Véronique Raimond, Ph.D., M.P.H., M.Sc.: Véronique worked with PORTAL as a French 2019-20 Commonwealth Fund Harkness Fellow in Health Care Policy and Practice. She holds a Ph.D. in Economics from Paris-Sorbonne University, an M.Sc. in Public Health from France Conservatoire National des Arts et Métiers, and a second M.Sc. in Health Economics from both France Paris-Sorbonne University and Paris-Descartes University. Her interests include evidence use in coverage decisions for prescription drugs and prescription drug pricing. Her previous works has been published in Value in Health, Pharmacoeconomics, and the International Journal of Technology Assessment in Health Care.
Past Research Assistants and Research Specialists
Beatrice (Bea) Brown, M.B.E.: Bea was a Research Specialist with PORTAL. She received her B.A. in Ethics, Politics, & Economics from Yale University and her MBE (Master of Bioethics) from Harvard Medical School. During her MBE, Bea was a Student Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Some of her research interests include prescription drug pricing, affordability, and access; the effects of drug pricing on patient care and health disparities; and research ethics. Bea's work with PORTAL has appeared in Annals of Internal Medicine and Health Affairs. She continues to regularly contribute to Petrie-Flom’s blog, Bill of Health—her posts can be found here.
Emily Jung, A.B.: As an undergraduate at Harvard College (A.B. 2018), Emily published with PORTAL faculty in Clinical Pharmacology & Therapeutics. After graduating with a concentration in History of Science, she spent a year as a PORTAL Research Assistant supporting PORTAL projects focused on expanded access policies and drug pricing. She now attends Emory School of Medicine.
Lara Maggs, M.Bioethics: As a research associate with PORTAL, Lara studied orphan drug trials, access to drugs and devices with limited supporting data, and FDA law. Her research resulted in a JAMA Viewpoint article and two Health Affairs Blog posts.
Tuli Mitra-Majumdar, M.P.H.: was a research specialist with PORTAL. Her research interests include drug pricing, patents and market exclusivities, and comparative effectiveness research. Prior to joining PORTAL, Tuli provided strategic support to the MassHealth pharmacy team around their authority to directly negotiate supplemental rebates with manufacturers. She was also a Research Analyst at the Urban Institute, where her work focused on pay-for-performance contracts, the opioid epidemic, and health disparities more broadly. Tuli holds an MPH in Health Policy from the Harvard T.H. Chan School of Public Health, and a B.A. in Biology from the University of Pennsylvania.
Past Harvard Medical School Students
Kirsten E. Austad, M.D.: Kirsten's work with PORTAL as an HMS student addressed the role of pharmaceutical marketing in medical school education, and other ethical issues relating to financial relationships in medical education. Most notably, she helped lead a national survey of medical students and residents to determine the extent of their interactions with pharmaceutical marketing representatives. Kirsten published several articles with PORTAL faculty, including in JAMA, New England Journal of Medicine, and PLoS One, on these topics.
Evan S. Caplan, M.D., M.B.A.: Evan studied the principles underlying successful drug development with PORTAL as a Harvard M.D./M.B.A. student. He collaborated with PORTAL faculty on a qualitative analysis of the development of VEGF-inhibitors used for ophthalmologic disease, one of the most transformative drugs in that field in the past 25 years.
Kyle Checchi, M.D.: As a medical student at HMS, Kyle conducted a systematic review of studies evaluating medical devices used to improve patient adherence to prescription drugs. He focused on the features of these devices most associated with successful interventions, as well as the applicability of the technology to resource-poor settings without substantial health information technology infrastructure. Kyle published a paper in JAMA with PORTAL faculty.
Devan Darby, M.D., M.P.H.: With PORTAL, Devan investigated how major legal events during the DOJ investigation into fraudulent off-label promotion of the antiepileptic drug gabapentin (Neurontin) affected trends in prescribing and spending for approved and off-label indications, which was published in Health Affairs.
Alex Misono, M.D., M.B.A.: With PORTAL, Alex focused on the intersection between generic and brand-name drugs, including a systematic review of brand-name and generic drug effectiveness and a study of how color and shape differences among brand-name and generic drugs may affect patient adherence to essential medicines. He published three papers with PORTAL faculty.
Rahul Nayak, M.D.: Rahul graduated from Harvard Medical School in 2019 and from Duke University with a B.S.E. in biomedical engineering and economics before completing a medicine residency at MGH. At PORTAL, Rahul's research interests included examining the role of academic and public-sector contributions to pharmaceutical development and studying healthcare reforms.
Prashant V. Rajan, M.D.: Prashant graduated summa cum laude from Miami University in Oxford, Ohio in 2013 and holds a B.S. in zoology and a B.A. in biochemistry. Prashant was a 2012 Goldwater Scholar and a 2013 Astronaut Scholar. Prashant studied current and future prospects for FDA post-market regulation of medical devices and the FDA regulation of medical device approval, and has published two articles with PORTAL faculty.
Y. Tina Tan, M.D., M.B.A.: Tina is interested in innovation at the intersection of medicine, business and technology. Her current research focuses on medical innovation within drug and medical device development. She is also an aspiring healthcare entrepreneur eager to learn about new startups and everything related to health care and biotech entrepreneurship. With PORTAL, Tina conducted a cross-national comparison of medical device regulation in the US and China, and supplemented her review of the literature with a qualitative research process involving interviews with key experts from regulatory, academic, and industry sectors in China. She has published with PORTAL faculty in Health Affairs, Food & Drug Law Journal, and PLoS Medicine.
Carolyn L. Treasure, M.D.: Carolyn's work focused on the Bayh-Dole Act, which underlies technology transfer policies from the government and universities to the private sector. She studied past petitions for NIH use of “march-in” rights and outcomes of those cases. She has also studied patent policy and the Orphan Drug Act. She has published with PORTAL faculty in JAMA, Milbank Quarterly, and JAMA Internal Medicine.
Bo Wang, M.D., Pharm.D.: Bo spent 5 years with PORTAL before and during medical school at HMS studying the epidemiology of drug recalls, and analyzed conflict of interest disclosures in whistleblower complaints relating to improper off-label marketing of drugs. He has also focused on the effects of supplemental FDA approvals on drug prescribing, and drug market exclusivity periods. He is first author on several papers with PORTAL faculty, including articles in JAMA, PLoS One, JAMA Internal Medicine, and BMJ.
Shuai (Steve) Xu, M.D., M.Sc.: As a medical student at HMS, Steve worked with PORTAL faculty to conduct a case study investigating the sources of innovation for bare metal stents used in treating coronary artery disease. In doing so, he employed combined methodologies of qualitative interviews and a systematic review of comprehensive patent databases. He published five articles with PORTAL faculty, including papers in the New England Journal Medicine, PLoS One, and the Journal of Law, Medicine & Ethics.
Past Residents
Dave Chokshi, M.D., M.Sc.: As an internal medicine resident at Brigham & Women's Hospital, Dave focused on equitable access to therapeutics and evidence-based medicine, and evaluated both vaccine policy and the emerging place of comparative effectiveness research. Dave published two papers with PORTAL faculty.
Nina Jain, M.D., M.B.A., M.Sc.: As an internal medicine resident at Brigham and Women's Hospital, Nina researched policies related to drug and vaccine development for neglected tropical diseases. Nina published papers in JAMA and the American Journal of Law & Medicine with PORTAL faculty. She holds an M.Sc. in evidence-based social intervention from Oxford.
Rahul Rajkumar, M.D., J.D.: Rahul focused his research during his residency at Brigham and Women's Hospital on legal issues related to pharmaceutical patents and the Supreme Court’s interpretation of the Bayh-Dole Act. He has published with PORTAL faculty in JAMA, New England Journal of Medicine, and Health Affairs.
Past Graduate Students
Louise C. Druedahl, Pharm.D., M.Sc. (Ph.D. candidate, University of Copenhagen, Denmark): In her current research, Louise is focusing on stakeholder perspectives on opportunities and hurdles for biosimilar development and for the regulation of biosimilars. Louise’s work with PORTAL includes examining the challenges with establishing biosimilarity and a manufacturing process for biosimilars.
Daniel Feldman, M.P.H., D.O.: Upon obtaining his undergraduate degree at The George Washington University, Daniel went on to earn a M.P.H. from Boston University focusing in epidemiology, biostatistics, and pharmaceutical policy. He completed medical school at Rowan University, where his pharmaceutical research interests included affordability, access, and comparative effectiveness. He is now a resident in internal medicine.
Sana Mostaghim, Dr.P.H.: Sana is interested in the role that the life sciences industry plays to improve global public health. In his role as director of the Tuberculosis Access team for the Clinton Health Access Initiative (CHAI), Sana oversaw teams providing technical support to Ministries of Health in 8 countries across Africa and Asia, and managed relationships with global stakeholders (e.g. WHO, donors, and generic drug suppliers). He holds a BA with Distinction from the Richard Ivey School of Business at the University of Western Ontario in Canada. Sana's work with the PORTAL team focuses on assessing special regulatory pathways and incentives designed to encourage pro-public health drug development and safety related label changes for new drugs after approval.
Colin Schwartz, M.P.P.: Colin worked with PORTAL as a student at Harvard Kennedy School. He reviewed the origins of AZT and protease inhibitors for use in the treatment of HIV infection, focusing on the collaborations between academia and industry scientists and the role of patents and intellectual property in properly assigning credit for the key innovative steps.
Rick Vreman, Pharm.D., M.Sc. (Ph.D. candidate, University of Utrecht, Netherlands): Rick is a collaborator at PORTAL. His project focuses on the (mis)alignment of regulation and health technology assessment for innovative drugs, related to benefit-risk and comparative benefit evaluations. He is a PhD candidate at Utrecht University, The Netherlands and is trained as a pharmacist and health economist. He promotes the optimization of health technology assessment throughout the drug lifecycle by investigating pharmaceutical policies and by developing methodologies for cost-effectiveness analyses and value-based healthcare.
Past Law Students
Vincent C. Capati, J.D., Pharm.D, M.S.: During law school at the University of New Hampshire, Vincent systematically categorized a range of product life cycle management strategies and evaluated their compliance with antitrust law, leading to a paper on drug product life-cycle management and anticompetitive behavior.
Dalia Deak, J.D. M.P.H.: As a student at Harvard Law School, Dalia studied a range of topics related to drug and device policy, including drug rediscovery and repurposing, the state of antibiotic development, the ethics of FDA approval pathways, and the history of biotechnology innovation. She published with PORTAL faculty in Annals of Internal Medicine.
Vrushab Gowda, J.D.: Vrushab worked with PORTAL as a second-year law student at HLS on topics related to product hopping and antitrust law. Previously, Vrushab pursued regulatory policy projects at the Parliament of the United Kingdom, MGH - Institute for Technology Assessment, a venture-backed fertility preservation startup, and through independent field studies in the Netherlands. He has also pursued an M.D. at the University of North Carolina.
Phebe Hong (J.D. candidate, Harvard Law School): Phebe is a third-year law student, who graduated from Harvard College with a degree in Human Developmental and Regenerative Biology. She is interested in FDA regulation of therapeutics and pharmaceutical patent law. Phebe worked in in healthcare consulting between college and law school.
Nathan Shiu, J.D., M.P.H.: As a law student at UCLA, Nathan worked with PORTAL to evaluate legal approaches to truth and determinations of scientific evidence as “false and misleading.” He published on issues involved with the FDA v. Actavis Supreme Court case and a paper on biomarker patents in personalized medicine.
Past Undergraduate Students
Sophia Fend
Audrey D. Zhang, M.D.: As an undergraduate at Harvard (A.B. 2015), Audrey studied the use of biomarkers in FDA decision-making about investigational drugs, and tracing their conceptual evolution as shaped by academia, industry, and regulatory agencies.
Past Research Science Institute Students
Sharif Gauri
Shreyas Kar (B.S. Candidate, Stanford University): Shreyas is an incoming undergraduate student at Stanford University planning to study Computer Science on an Artificial Intelligence track & Mathematics on a Data Science track. The founder of Community AI and a member of the Research Science Institute, he intends on using artificial intelligence and machine learning to better the world. For his work, he has received several national and international awards and recognition. At PORTAL, his work focuses on quantifying the impact of EHR-Discontinuity on prediction modeling algorithms.
Jamie Meindl (B.S. Candidate, MIT): Jamie is a rising junior at MIT studying computer science and mathematics. He is interested in machine learning and data science and hopes to use these cutting-edge technologies to solve many exciting problems in the future. At PORTAL, Jamie's research focused on using machine learning methods to predict prescription drug switchbacks.
Elizabeth Nyamwange
Aayan Patel (B.S. Candidate, Stanford University): Aayan is an incoming undergraduate student at Stanford University who intends to study molecular biology and public policy. After graduation, he plans to attend medical school and conduct research in pharmacology and pharmaceutical policy. At PORTAL, Aayan's research is focused on health policy and examining trends in drug prices.
