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Adele Kaplan Gilpin

Adele Kaplan Gilpin

•Visiting Faculty, Department of Neurobiology and Behavior, University of California Irvine
•Chief Executive Officer, GilpinPhillips BIOMED, LLC

Biography

Adele Kaplan Gilpin, JD, PhD, is Visiting Faculty in the Department of Neurobiology and Behavior at the University of California Irvine and Chief Executive Officer of GilpinPhillips BIOMED, LLC. She received a PhD in Quantitative Psychology from Temple University and a JD cum laude from Georgetown University Law Center. Gilpin has pursued two parallel career paths: academic biomedical research and FDA regulatory law practice, with particular focus on clinical trials methodology and medical device and pharmaceutical regulation.

Gilpin spent twenty years in full-time academic positions at three institutions, including The Johns Hopkins Bloomberg School of Public Health, where she served as course director of "Design and Conduct of Clinical Trials" for six years and held positions ranging from Research Associate to Adjunct Associate Professor in the Center for Clinical Trials. At Johns Hopkins, she directed coordinating center activities for multiple FDA-regulated multicenter randomized controlled trials, including the Monoclonal Antibody Cytomegalovirus Retinitis Trial and the Sleep Heart Health Study, which collected over 6,000 in-home polysomnograms. As Research Director of the Center for Integrative Medicine at the University of Maryland School of Medicine, she led an international team that secured $10 million in NIH funding through two program projects. She has served as Principal Investigator on an NIH SBIR grant and as Study Chair for multicenter clinical trials in neurostimulation.

Gilpin practiced FDA regulatory law for eight years at three AmLaw 100 firms in Washington, DC, including five years in close association with a former FDA Chief Counsel, and has maintained a solo practice since 2014. She is a member of the Maryland, District of Columbia, Pennsylvania, and United States Supreme Court bars. Her legal practice has focused on medical device regulatory pathway analysis, IND and IDE matters, PMA and NDA submissions, clinical trials agreements, and research compliance. She has provided over 3,000 hours of pro bono consultation to the Department of Defense Traumatic Injury Research Program at the Uniformed Services University of the Health Sciences, contributing to study design and regulatory matters that resulted in over $13 million in funding. She has served as Chair of Data and Safety Monitoring Boards and as a member of Institutional Review Boards for over two decades, including twenty years on a Veterans Administration Human Rights Committee.

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Education

  • BA in Psychology, Temple University, 1974
  • MA in Quantitative Psychology, Temple University, 1980
  • PhD in Quantitative Psychology, Temple University, 1984
  • JD, Georgetown University Law Center, 1991
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Distinctions

  • Named in top 10% of peer reviewers by the Annals of Internal Medicine, 2005
  • E. Randolph William Pro Bono Award, Hunton & Williams LLP, 2009, 2011
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Areas of Expertise

  • Regulatory Clinical Trials Methodology
  • Multicenter Coordinating Center Operations
  • Sleep Medicine Cardiovascular Outcomes
  • HIV AIDS Ophthalmology
  • Traumatic Brain Injury Assessment
  • Neurostimulation Device Development
  • Complementary Alternative Medicine Arthritis

Recent Publications

  • Rapp PE, Gilpin AMK, “Biomarkers in clinical practice: opportunities and challenges”, Medical Research Archives, vol. 13, no. 1, 2025.
  • Rapp PE, Keyser DO, Gilpin AMK, “Procedures for the Comparative Testing of Noninvasive Neuroassessment Devices”, J Neurotrauma, vol. 32, no. 16, pp. 1281-1286, 2015.
  • Lixing Lao, Marc Hochberg, David Y.W. Lee, Adele M.K. Gilpin, Harry H.S. Fong, Patricia Langenberg, Kevin Chen, Edmund K. Li, Lai Shan Tam, Brian Berman, “Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for Patients with Osteoarthritis of the Knee: A Multi-site, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial”, Osteoarthritis and Cartilage, vol. 23, no. 12, pp. 2012-8, 2015.
  • Rapp PE, Cellucci CJ, Keyser DO, Gilpin AMK, Darmon DM, “Statistical Issues in TBI clinical studies”, Front Neurol, vol. 4, no. Article 177, pp. 1-19, 2013.
  • Rapp PE, Rosenberg BM, Keyser DO, Nathan D, Toruno KM, Cellucci CJ, Albano AM, Wylie SA, Gibson D, Gilpin AMK, Bashore TR, “Patient characterization protocols for psychophysiological studies of traumatic brain injury and post-TBI psychiatric disorders”, Front Neurol, vol. 4, no. Article 91, pp. 1-34, 2013.
  • Kracov D, Dodds-Smith I, Gilpin A, Mulryne J, “Transparency of Clinical Trial data: The Position in Europe and the U.S.”, Bloomberg BNA Medical Research Law & Policy Report, vol. 12, no. 23, pp. 791-5, 2013.
  • Messplay GCM, Reschovsky AL, Gilpin AMK, “Congress Calls FDA to Action: A new era of clinical trial transparency enforcement”, Contract PHARMA, 2012.
  • Gilpin AMK, Moore JG, “Clinical Trial Misconduct: Once it's alleged, what happens next?” (opens in new tab), Contract PHARMA, 2012.
  • Rapp PE, Cellucci CJ, Gilpin AMK, Jimenez-Montano MA, Korslund KE, “Communication patterns in a psychotherapy following traumatic brain injury: A quantitative case study based on symbolic dynamics”, BMC Psychiatry, vol. 11, pp. 119, 2011.
  • Moore JG, Gilpin AMK, “FDA Draft Companion Guidance Documents on Distinguishing Devices from Drugs: Controversial draft guidance challenges established precedent and may favor drug jurisdiction” (opens in new tab), Contract PHARMA, 2011.
  • Messplay GCM, Gilpin AMK, “Adaptive Clinical Trials: FDA cautiously encourages use of adaptive design clinical trials”, Contract PHARMA, 2010.
  • Heisey C, Gilpin AMK, “Reporting Requirements for IND Trials: FDA sharpens criteria for reporting”, Contract PHARMA, 2010.
  • Pradhan EK, Baumgarten M, Langenberg P, Handwerger B, Gilpin AK, Magyari T, Hochberg MC, Berman BM, “Effect of Mindfulness-Based Stress Reduction in rheumatoid arthritis patients”, Arthritis Rheum, vol. 57, no. 7, pp. 1134-42, 2007.
  • McWilliams R, Hebden CW, Gilpin AMK, “Concept Paper: A Virtual Centralized IRB System”, Accountability in Research, vol. 12, pp. 25-45, 2006.
  • Iber C, Redline S, Kaplan Gilpin AM, Quan S, Zhang L, Gottleib D, Rapoport D, Resnick H, Sanders M, Smith P, “Polysomnography performed in the unattended home vs the attended laboratory setting - The Sleep Heart Health Study”, Sleep, vol. 27, no. 3, pp. 536-40, 2004.
  • Berman B, Lao L, Langenberg P, Lee WL, Gilpin AMK, Hochberg M, “Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee: A Randomized, Controlled Trial”, Annals of Internal Medicine, vol. 141, no. 12, pp. 901-10, 2004.
  • Gilpin AMK, Holbrook JT, Jabs DA, Meinert CL, “Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial”, Controlled Clinical Trials, vol. 24, no. 1, pp. 92-98, 2003.
  • Resnick HE, Redline S, Shahar E, Gilpin A, Newman A, Walter R, Ewy GA, Howard BV, Punjabi N, “Diabetes mellitus and sleep disturbances: Findings from the Sleep Heart Health Study”, Diabetes Care, vol. 26, no. 3, pp. 702-9, 2003.
  • Jabs DA, Gilpin AMK, Min Y, Erice A, Kempen J, Quinn T, “HIV and CMV viral load and clinical outcomes in patients with AIDS and CMV retinitis: The Monoclonal Antibody Cytomegalovirus Retinitis Trial”, AIDS, vol. 16, pp. 877-887, 2002.
  • Huss K, Winkelstein M, Calabrese B, Butz A, Reshef S, Rand C, Gilpin A, “Asthma Management Practices and Education Needs of Head Start Directors and Staff”, J Sch Health, vol. 72, no. 8, pp. 327-331, 2002.
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Contact Information

Email: agilpin@uci.edu

Address: 1400 Biological Sciences III

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This profile was created with the help of AI.

Last updated on 5/19/2026.