Cultivating Research Integrity Summit

Andrew Adorboe is a research compliance leader currently serving as the System Director and Research Compliance Officer at Tower Health, Reading, Pennsylvania, for the last couple of years. He is also an instructor at Clinical Research Fastrack for accelerated training, coaching and mentoring. He has 17 years' experience in research compliance, healthcare quality improvement measures, research administration and public speaking.

He holds a nursing degree from the University of Texas at Arlington and a Master’s degree in Biotechnology from the University of Texas at San Antonio. He is also certified in Healthcare Research Compliance (CHRC) by the premier organization, the Healthcare Compliance Association (HCCA) in 2012.

Dr. Bryan Carmody is a pediatric nephrologist at the Children’s Hospital of the King’s Daughters in Norfolk, Virginia, and an associate professor of pediatrics at the Macon and Joan Brock Health Sciences Center at Old Dominion University, where he directs the kidney module for second-year medical students and serves as an associate residency program director for the pediatric residency program. He frequently analyzes and comments on medical education on social media and on his website, thesheriffofsodium.com.

Dr. Wei Du is Chief Academic Officer and Senior Vice President, Academic Affairs at Tower Health. He is associate dean for graduate medical education at Drexel University College of Medicine and serves as the designated institutional official for its residency and fellowship programs at Tower Health. Dr. Du is a professor and chair of the Department of Psychiatry.

He also has a secondary appointment as a professor of pharmacology and physiology at Drexel University College of Medicine. At Tower Health, he also leads the behavioral health service line as service line medical director. He is the founding program director of the Drexel-Janssen Fellowship in Psychiatric Drug Development.

He has served as program director for the Drexel University College of Medicine General Psychiatry Residency Program and as thesis advisor for several MD/PhD and PhD students at Drexel. At Drexel, he co-directs Drexel University’s Medical Cannabis Research Center. Currently, he serves as the principal investigator of a clinical trial examining the impact of medical cannabis on quality of life in patients with HIV, neuropathy pain and PTSD.

He is a diplomat of the American Board of Psychiatry and Neurology, the American Board of Addiction Medicine, and the American Board of Preventive Medicine. He is currently on the editorial board of PIPE (Psychiatrist-in-Practice Examination), the American College of Psychiatrists. He has served on many leadership committees at the national and local levels. He is the author of many book chapters and peer-reviewed articles. Recently, he was awarded the 2024 Paul Fink Leadership Award by the Philadelphia Psychiatric Society.

Dr. Garfinkel is the owner of Research Integrity Partners, offering support to institutions and Research Integrity Officers in managing research misconduct and integrity issues, as well as assisting editors and publishers with publication ethics challenges.

Formerly, she held the role of Associate Vice President for Research Compliance at The Ohio State University, where she managed research misconduct matters, assisted in coordinating institution-wide research compliance policies and procedures, ensured the university’s compliance with federal and state regulations, and fostered ethical research practices. Previously, she served as the Director for the Division of Investigative Oversight at the U.S. Office of Research Integrity. She was responsible for the oversight of research misconduct matters nationally and internationally.

Dr. Garfinkel was also Director of Research Grants for a non-profit organization that funded research in age-related degenerative diseases and stem cell research, and Program Officer at the National Heart, Lung and Blood Institute, National Institutes of Health. She has been faculty for conferences to train State and Federal court judges on molecular biology technologies, is a founding member of the Asian Pacific Rim Research Integrity network (APRI), and a COPE Board of Trustee member.

Dr. Harris oversees Drexel’s Research Compliance team, managing export control, research conflicts of interest, research security, and research integrity. She reports to the Associate Vice Provost for Research Compliance and Regulatory Affairs.

Previously, Lacee worked at Georgia Tech (GT) as Export Control and Trade Empowered Official, where she supported the Institute’s research mission through compliance monitoring of research plans and activities. There, she provided educational programming, advice on managing research awards, and personnel from a compliance perspective. Prior to GT, she worked with UCLA on export control and research compliance issues related to trade agreements, export licenses, research conflicts of interest, as well as intellectual property matters. Lacee has more than a decade of industry experience.

She is a licensed customs broker (DHS/CBP) and a certified customs specialist (NCBFAA). Lacee earned a BS in International Business from the University of North Florida, an MS in International Relations and Management from Webster University and completed her PhD in Public Policy Administration.

Subject: Artificial intelligence and Research Integrity

Dr. Jina Huh-Yoo is an Associate Professor at Stevens Institute of Technology. Her research areas are human-computer interaction (HCI), social computing, and health informatics. Her work has been supported by the National Institutes of Health and the National Science Foundation. 

Her ongoing research efforts include understanding, designing, and evaluating generative AI (GAI) systems and how GAI can support health through social connectedness. She has published her work in premier journals and conference venues, including CHI, CSCW, AMIA, JMIR, JBI, and IJMI. Her work has been funded by NLM, NSF, and AHRQ regarding improving online health information quality, family wellness, and support for caregiving and older adults. 

She completed a postdoctoral fellowship from the University of Washington Medicine and a PhD in Information from the University of Michigan.

Paul Hryvniak has 18 years' experience working in the field of human subjects protection. He joined Tower Health in 2022, where he served as the Director of Human Subjects Protection for Reading Hospital before becoming the System Director of Human Subjects Protection for all Tower Health entities in 2023.

He has worked at several academic institutions, including the Harvard School of Public Health and Princeton University, as well as in IRB administration for a genomics testing company. Paul holds a Master of Science in Bioethics from Union Graduate College and a Bachelor of Arts in English from Rutgers University. Additionally, he obtained his Certification for IRB Professionals (CIP) in 2011.

Dr. Joyner, Jr. is the director of the Tidal Health Richard A. Henson Research Institute and supports research and scholarship activities across the healthcare system. Joyner earned an associate of applied science degree in respiratory therapy from the California College for Health Sciences in 1989, a bachelor’s degree in respiratory care from Salisbury University in 1991 and a doctorate in physiology from the Geisel School of Medicine at Dartmouth in 1998.

Dr. Kashyap is the medical director of research, WellSpan Health, York, PA. He is a faculty member at Drexel University College of Medicine. He is an avid researcher with 18 years' clinical research experience, with 280+ PubMed-cited publications. He also holds the academic rank of Assistant Professor of Anesthesiology and Critical Care Medicine and Supplemental Research Scientist at the Mayo Clinic in Rochester, MN.

He has an MBA from Augsburg University and completed his Global Clinical Scholars Research Training (GCSRT) at Harvard Medical School. He received a fellowship in Critical Care Medicine (FCCM). He is an award-winning public speaker at Toastmasters International.

Subject: Importance of Research Integrity in Advancing Clinical Research in Healthcare System

Frederick W. Luthardt, Jr., D.Be., MA, Director, Compliance Monitoring Program, Johns Hopkins University School of Medicine, Office of Human Subjects Research, has been involved in clinical research as a study coordinator, investigator, research oversight and compliance expert, educator, and ethicist.

Fred has been specifically engaged in post-approval monitoring activities as part of the Johns Hopkins IRB since 2004. Fred currently advises and consults with researchers in designing and implementing quality management systems, including internal monitoring and auditing procedures. Also, Fred provides guidance and assistance to investigators in the development of Data Safety Monitoring Boards and charters.

Fred has presented many education and training sessions in research oversight, investigator responsibilities, and research ethics for the Johns Hopkins University schools of Medicine, Nursing, and Public Health.

Linda Malek is a partner in Crowell & Moring LLC's Health Care and Privacy Group and Cybersecurity Group in New York and a managing director of Crowell Health Solutions. She advises a wide array of health care and life sciences clients on compliance with federal, state, and international laws governing clinical research, data privacy, cybersecurity, and fraud and abuse. In the health care context, Linda is particularly focused on regulatory compliance issues related to clinical research and clinical trials.

She creates and implements comprehensive policies governing the conduct of research involving human subjects and advises clients on human subject research compliance issues. Linda also counsels on legal issues related to conducting secondary research in existing data repositories and tissue banks, including on data privacy and informed consent issues related to the ability to conduct future research. She has experience advising clients in a wide variety of research areas, including biologics, pharmacogenomics, translational research, secondary research, tissue banking, and data repositories.

Subject: Healthcare Compliance

Ms. Murtha has served as Vice President, and U.S. Compliance Officer since December 2022. She oversees compliance for Walgreens retail and specialty pharmacies and all of Walgreens Health including the clinical trials business. She was formerly a partner in Moses & Singer’s Health Care Group. Ms. Murtha has over 25 years of experience working on complex legal and compliance issues in healthcare. She focuses her practice on healthcare privacy, HIPAA compliance issues, contract negotiations, and other healthcare legal risk areas. These include Medicare and Medicaid billing and coding issues, FCPA and UK Bribery Act issues, internal investigations, and corporate governance/ethics. Ms. Murtha has been Chief Compliance Officer and Senior Counsel for a large government contractor. She has significant experience working with federal agencies on procurement issues, the Federal Acquisition Regulation, and related contracting matters.

Ms. Murtha graduated from Dickinson School of Law, JD, 1986; The Pennsylvania State University, BA, 1983, and is certified in Healthcare Compliance and Healthcare Research Compliance. She is a member of the Pennsylvania Bar and the District of Columbia Bar. She has applied for admission to the New York Bar.

Ms. Murtha previously served as Senior Managing Director and Clinical Research and Compliance practice leader for Ankura Consulting, FTI Consulting, and Huron Consulting Group. She led the research practice for Dentons US, LLP's international law firm as a partner. Moreover, she previously served as Vice President of Audit and Compliance, and Chief Privacy Officer for The Children’s Hospital of Philadelphia (CHOP), the Stokes Research Institute, and The Children’s Hospital of Philadelphia Practice Association. Ms. Murtha worked as the Chief Compliance Officer for the University of Pennsylvania and the University of Pennsylvania Health System, and before that as the Corporate Compliance Director for Pennsylvania Blue Shield (focusing primarily on Medicare Carrier Contract Compliance). Ms. Murtha is a former board member of the International Association of Privacy Officers.

Ms. Murtha is a founding and former Board Member of the Health Care Compliance Association and the Society of Corporate Compliance and Ethics. She served on the Board of the International Association of Privacy Professionals.

Ms. Murtha is the author of numerous articles and books on research, healthcare compliance, and fraud and abuse topics in publications including HC Pro, The Journal of Health Care Compliance, Widener University Law Journal, The Philadelphia Business Journal, Aspen Publishers Compliance Handbook, Medical Research Law and Policy Report (BNA), The HCCA Compliance Newsletter, CCH publications, and Patient Safety Meets Corporate Compliance (Book-HCPro Publisher). Ms. Murtha lectures nationally on compliance-related issues and provides advisory services to BNA, HCCA, and other publications.

John Roberts is the Executive Director of Human Research Protections at Drexel University. He joined Drexel in September 2022 and is responsible for managing the university’s Human Research Protection Program (HRPP). Previously, he served as Interim Director and Associate Director for Regulatory Affairs & Compliance at the University of North Carolina at Chapel Hill. He holds a BA in Environmental Science and Policy from Duke University and is a Certified IRB Professional (CIP).

Subject: Challenges Facing the Academic Entities in the Dynamic Regulatory Environment

Dr. Aleister Saunders’ research focuses on identifying and characterizing genes and pathways involved in Alzheimer’s disease pathogenesis. Utilizing a variety of AD models, his work has been funded by NIH, NSF, and foundations.

As Drexel’s Executive Vice Provost for Research & Innovation, Dr. Saunders has provided University-level research and innovation leadership since 2014. He is principally responsible for helping Drexel University achieve Carnegie Classification as a “Very High Research Activity” (R1) institution, first attained in 2018 and reaffirmed in 2022. In 2020, Drexel also achieved recognition as the top-ranked mid-sized University for Innovation impact. Aleister oversees Drexel’s successful collaboration with MIT to win and manage the Manufacturing USA institute Advanced Functional Fabrics of America.

Regionally, Aleister has facilitated Drexel’s academic/industrial partnership with Spark Therapeutics to create a state-of-the-art gene therapy facility on Drexel’s campus. He also manages Drexel’s response to federal regulations related to undue foreign influence while maintaining academic freedom.

Dr. Kenny J. Simansky is senior vice dean for research at Drexel University College of Medicine. Previously, he served as director of the graduate programs in pharmacology and neuroscience and as associate dean for Biomedical Graduate Studies. After earning his PhD, Dr. Simansky completed a postdoctoral fellowship in behavioral neuroscience at Cornell University College of Medicine, for which he received an individual fellowship from the National Institutes of Health.

The NIH funded him as a principal investigator throughout his academic career at the College of Medicine. His research focuses on the cellular mechanisms involved in the regulation of eating. These brain mechanisms are known to be relevant for understanding obesity, drug addiction, and some behavioral disorders. Much of Dr. Simansky’s work has contributed to understanding how serotonin in the brain and gut promotes satiation during eating. His current work also focuses on the mechanisms by which cannabinoids and opioids in the brain influence dietary selection based on the sensory properties of food.

In addition to serving as senior vice dean for research, Dr. Simansky is a professor in the Departments of Pharmacology & Physiology and Psychiatry at Drexel University College of Medicine. He has mentored graduate students and postdoctoral fellows who have begun careers in the academy, the pharmaceutical industry, and in education. He received the Graduate Student Association Teaching Award from the College of Medicine.