Faculty Bios
FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference
Gabrielle Swain
Gabrielle Swain is a BIMO FDA Investigator based out of the Philadelphia District Office. She is experienced in a wide range of BIMO establishment types, especially with corporate headquarters (Sponsors/PADEs) and institutional review boards. Investigator Swain has identified regulatory violations in both domestic and international inspections and worked with various regulatory groups and center collaborators.
Investigator Swain will be participating in the Knock Knock – The FDA Inspection, Quality by Design, and Improving Informed Consent presentations. Prior to joining FDA in 2019, Investigator Swain was involved in viral vector manufacturing for industry.
Mishelle Harriger
Mishelle L. Harriger, Division Director (acting) Office of Inspections and Investigations, Office of Bioresearch Monitoring Inspectorate, Division 1 (Northeast). Ms. Harriger has been with the Food and Drug Administration since 2000. She has served the agency as an investigator, branch chief and recently as the acting division director for the Northeast. She has experience in navigating the regulatory environment for various FDA commodities and program areas and has been focused on bioresearch monitoring since 2017. Providing coverage for an area that is home to large medical institutions and medical product development companies, has presented Ms. Harriger with a wide variety of experience related to clinical research from the regulatory perspective.
D'Arbra Blankenship, MS
D’Arbra Blankenship, MS, is an OBMI Investigator committed to ensuring public safety through comprehensive inspections of study date integrity and efficacy. She is in her fifth year with the FDA after a 17-year career in academic research in non-clinical drug and medical device development from the preliminary phase into clinical human trials. D’Arbra has more than 13 publications covering topics in neuroscience, physics, and infectious disease. She holds two patents.
Kathryn Suttling
Kathryn Suttling is a BIMO FDA Investigator Specialist based in Cincinnati, Ohio, with extensive inspection experience both domestically and internationally, having conducted inspections in more than 10 countries. Since joining the FDA as a college intern, she has built her career at the agency, conducting a diverse range of inspections across clinical research settings. At SOCRA, Investigator Suttling will present on regulatory requirements for Institutional Review Boards (IRBs) and Clinical Investigators, as well as the critical role of the Clinical Research Pharmacist in ensuring compliance and patient safety.
Meredith Miller
Meredith Miller is a BIMO FDA Investigator based out of the Boston office. She is experienced in all the types of inspections BIMO conducts, especially the less common ones such as Institutional Review Boards and Risk Evaluation and Mitigation Strategies. Investigator Miller has identified regulatory violations at all levels of clinical trials, from private practice clinical investigators to multinational sponsors.
Investigator Miller will be presenting on FDA conduct of clinical investigator inspections and informed consent regulations. Before joining FDA, Meredith worked on a lab benchtop optimizing the manufacturing of chemicals used in COVID PCR testing.
Alyssa Gateman, MPH, CCRP
Alyssa Gateman currently serves as the Executive Director of the Yale Cancer Center Clinical Trials Office. Since joining Yale in July 2014, she has also held the role of Senior Associate Director of Quality Assurance and Research Regulatory Initiatives at the Yale Center for Clinical Investigation. Prior to her time at Yale, Ms. Gateman was Director of the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center.
Ms. Gateman is deeply committed to advancing the clinical research workforce through education and mentorship. In addition to her long-standing involvement with SOCRA, she serves as Adjunct Faculty at Southern Connecticut State University, where she teaches Good Clinical Practices and Clinical Trial Administration as part of the Healthcare Studies undergraduate program. A dedicated SOCRA member, she will celebrate 23 years of membership and 20 years of certification in 2026. She is a former SOCRA Board member, frequent presenter for SOCRA and currently serves as the inaugural President of the Connecticut SOCRA Chapter.
Outside of work, Ms. Gateman enjoys supporting the Yale Junior Bulldogs hockey team as a coach’s wife and goalie mom, and spending time with her golden retriever, Biscuit.
Jessica Rowe, MA, MS, CCRP, CIP
Jessica Rowe, MA, MS, CCRP, CIP, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously, she served as the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive human research protection program.
Jessica has an extensive 13-year background at the University of Maryland, Baltimore (UMB), where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA.
Jessica is an adjunct instructor at the University of Maryland, Baltimore Graduate School, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops, including Quality Management and the GCP Prep Course.
With extensive experience in human subject research compliance, IRB, quality, clinical trial management, education, and training, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. Her passion lies in human subject protections, bioethics, quality, and compliance.