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 RESEARCH SCIENTISTS & POSTDOCTORAL FELLOWS
Michael S. Sinha, M.D., J.D., M.P.H.
Research Fellow, PORTAL and Harvard-M.I.T. Center for Regulatory Science (CRS) |
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CURRENT RESEARCH ASSISTANTS
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CURRENT STUDENTS AND COLLABORATORS
Dalia Deak, M.P.H., HLS 2019 (J.D.): Dalia is studying 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, publishing with PORTAL faculty in Annals of Internal Medicine.
Thomas Hwang, A.B.: Thomas's work focused on cancer drug effectiveness, value-based pricing, and the impact of regulation on pharmaceutical and medical device innovation, publishing over 40 peer-reviewed papers on these and other topics. Thomas graduated from Harvard with a special concentration in Biomedicine.
Nina Jain, M.D., M.B.A., M.Sc.: Nina is an internal medicine resident at Brigham and Women's Hospital, interested in policies motivating drug and vaccine development for neglected tropical diseases. She holds an M.Sc. in evidence-based social intervention from Oxford.
Sana Mostaghim, HSPH 2018 (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.
Rahul Nayak, HMS 2019: Rahul graduated from Duke University with a B.S.E. in biomedical engineering and economics. He then spent two years as a pre-doctoral fellow at the NIH Department of Bioethics before beginning medical school at HMS. His current research interests at PORTAL include examining the role of academic and public-sector contributions to pharmaceutical development. Rahul was also selected as one of six student fellows for 2018-2019 at the Petrie-Flom Center for Health Law Policy, Bioethics, and Biotechnology at Harvard Law School.
Benjamin N. Rome, M.D.: Ben has studied the prevalence and characteristics of supplements to widely used high-risk devices, the FDA regulation of device approval, and the cost/benefit balance of market exclusivity extensions for prescription drugs. He published three articles with PORTAL faculty, including ones in JAMA and Health Affairs.
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.
Thomas Hwang, A.B.: Thomas's work focused on cancer drug effectiveness, value-based pricing, and the impact of regulation on pharmaceutical and medical device innovation, publishing over 40 peer-reviewed papers on these and other topics. Thomas graduated from Harvard with a special concentration in Biomedicine.
Nina Jain, M.D., M.B.A., M.Sc.: Nina is an internal medicine resident at Brigham and Women's Hospital, interested in policies motivating drug and vaccine development for neglected tropical diseases. She holds an M.Sc. in evidence-based social intervention from Oxford.
Sana Mostaghim, HSPH 2018 (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.
Rahul Nayak, HMS 2019: Rahul graduated from Duke University with a B.S.E. in biomedical engineering and economics. He then spent two years as a pre-doctoral fellow at the NIH Department of Bioethics before beginning medical school at HMS. His current research interests at PORTAL include examining the role of academic and public-sector contributions to pharmaceutical development. Rahul was also selected as one of six student fellows for 2018-2019 at the Petrie-Flom Center for Health Law Policy, Bioethics, and Biotechnology at Harvard Law School.
Benjamin N. Rome, M.D.: Ben has studied the prevalence and characteristics of supplements to widely used high-risk devices, the FDA regulation of device approval, and the cost/benefit balance of market exclusivity extensions for prescription drugs. He published three articles with PORTAL faculty, including ones in JAMA and Health Affairs.
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.
PAST TRAINEES
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.
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 has published two recent papers in the New England Journal of Medicine on randomized controlled trials.
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.
Vincent C. Capati, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Chana Sacks, M.D., M.P.H.: Chana completed the Harvard Medical School General Internal Medicine fellowship while at PORTAL, and studied FDA regulatory and approval processes, medication pricing, and the clinical and economic impact of drug shortages. She has also focused on gun violence prevention, and has published on this and other topics in NEJM and JAMA Internal Medicine. Most recently, her work with Drs. Kesselheim and Avorn on Medicare reimbursement for combination drugs was published in JAMA.
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.
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.
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.
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.
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.
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.
Audrey D. Zhang, NYU School of Medicine 2019 (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.
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 has published two recent papers in the New England Journal of Medicine on randomized controlled trials.
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.
Vincent C. Capati, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Chana Sacks, M.D., M.P.H.: Chana completed the Harvard Medical School General Internal Medicine fellowship while at PORTAL, and studied FDA regulatory and approval processes, medication pricing, and the clinical and economic impact of drug shortages. She has also focused on gun violence prevention, and has published on this and other topics in NEJM and JAMA Internal Medicine. Most recently, her work with Drs. Kesselheim and Avorn on Medicare reimbursement for combination drugs was published in JAMA.
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.
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.
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.
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.
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.
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.
Audrey D. Zhang, NYU School of Medicine 2019 (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.
