Legal Barriers to Patient Involvement and Potential Pathways to Overcome Them

Sue Gregory spent over 26 years at Merck in the Office of General Counsel.  Her most recent position was as Managing Counsel in the Regulatory and Commercial group responsible for the Oncology Franchise.During her time at Merck, Ms Gregory provided legal advice to the US and Global businesses on issues such as advertising and promotion, training and compliance.  She also provided legal advice to the research division on issues relating to clinical studies, marketing authorizations, post-market safety surveillance, compliance, and labeling.Ms Gregory joined Merck in 1993 and held a number of positions of increasing responsibility.  Prior to joining Merck, she practiced law at Morgan, Lewis & Bockius in Washington, DC.Ms Gregory is a graduate of Georgetown University School of Law, Washington, DC, and Duke University, Durham, NC.

Kate Harr-Sponsler is Associate General Counsel, Global Commercial, for Spark Therapeutics, Inc., a leading gene therapy company, and an Adjunct Professor of Drug and Medical Device Law at Temple University School of Law.  At Spark, Ms Harr-Sponsler provides broad counsel to the commercial team on a range of patient-related topics including data privacy, patient advocacy, and patient services.  Prior to joining Spark, she was Senior Corporate Counsel at Bristol-Myers Squibb, where she supported both global and US commercial teams.  Prior to BMS, Ms Harr-Sponsler held positions in several international and domestic medical device companies, providing counsel on all legal matters as well as holding business analytic and operational roles.  She began her career as a litigator in private practice.  Ms Harr-Sponsler received her BA from Oberlin College and her JD from Temple University School of Law.

Candace Lerman, Esq., is an attorney, consultant, and author of the rare disease blog, RareCandace.com. She earned her Juris Doctorate with a concentration in Health Law at the Shepard Broad School of Law at Nova Southeastern University and a certificate in Healthcare Compliance from Seton Hall University School of Law. In addition, she holds a Bachelor’s and Master’s degree in International Affairs from Florida State University. Ms Lerman researched and repurposed a drug to put her rare blood disorder into remission twice! Inspired by her struggle of living with Immune Thrombocytopenia, she launched the ITP Patient Driven Research Initiative, which works with multiple stakeholders to improve treatments for the ITP community. She works closely with members of Congress on federal healthcare policy and can often be found on Capitol Hill. Ms Lerman is Of Counsel to the Lerman Law Firm, assisting clients in healthcare, compliance, and corporate law.  Besides practicing law, Candace consults on projects for pharmaceutical companies and non-profit organizations on topics ranging from patient registries, natural history studies, clinical trial design, patient engagement, Real World Evidence, and patient assistance programs. Coming from a diverse background as both an attorney and patient, she provides unique insights while breaking down the silos that plague drug development.

Marilyn Metcalf, PhD, is the newly appointed Patient Engagement Vaccines Lead at GSK. She is excited to build partnerships promoting health and preventing disease. She co-chaired US Patients as Partners in 2020 and 2021; co-chaired the National Academies of Sciences, Engineering and Medicine Science of Patient Input Action Collaborative workshop; and is a lead author of CIOMS Working Group XI’s guidance for patient involvement in the development and safe use of medicines. Previously she was Family Health International’s project director of the NIH master contract for HIV vaccine research, was the head of GSK’s international Decision Sciences team, led Centocor’s Decision Sciences and R&D Portfolio Management team, led GSK’s Benefit Risk Evaluation team, was the head of GSK’s Pharmacovigilance Centre of Innovation and led GSK’s patient engagement in Oncology. She began her current role in January 2023.

Parthena Psyllos is a Senior Corporate Counsel on the Clinical Development (CD) Legal team at Pfizer, Inc. in New York, where she is the lead counsel for Clinical Innovation. In this role, Ms Psyllos provides support and counsel on legal and regulatory issues impacting Pfizer’s clinical research activities globally, including Good Clinical Practice (GCP) advice and policy support to enable decentralized clinical trials, patient engagement and digital initiatives in clinical development such as eConsent, eSource, mobile apps, wearables and social media. She is also the CD Legal subject matter in several areas, including informed consent, study recruitment, diversity in clinical trials, and patient engagement activities.  Ms Psyllos has held several prior roles supporting clinical development issues at Pfizer. These included negotiating clinical development agreements, handling GCP and regulatory compliance issues in clinical trials, and conducting U.S. compliance investigations.  Prior to joining Pfizer, Ms Psyllos worked at Bloomberg as a Legal Analyst and in private practice at Kramer Levin Naftalis and Frankel as a litigation associate, with a focus on the pharmaceutical and medical device industries. She has served as Vice-Chair of the New York State Bar Association’s Food, Drug, and Cosmetic Law Section. Ms Psyllos has a BA in English and American Literature and Psychology from New York University, where she graduated magna cum laude and Phi Beta Kappa, and a JD from Brooklyn Law School. 

Roslyn Schneider, MD is a catalyst toward intentional human-centered medicine development and healthcare.Dr Schneider is an internist, pulmonologist, intensivist, and patient, transforming healthcare quality and efficiency by partnering with patients who are experts in what they need and want, along with traditionally included experts.She applies person centered design toward better health outcomes, and to create and communicate with stakeholder communities.Patient centeredness has been a common thread through Dr Schneider’s clinical practice, hospital administration, academic and industry career, the Global Patient Affairs role she created at Pfizer, independent consulting, in her current role at Theravance Biopharma and Board service with the NJ Chapter of the American Lung Association.Dr Schneider received an MD from Mount Sinai School of Medicine, and MSc in Pharmaceutical Medicine from Hibernia College in Dublin. She practiced and taught at Mount Sinai Beth Israel Medical Center in New York for 20 years and was a Clinical Professor of Medicine at the Albert Einstein College of Medicine.