IRBs and Expanded Access: Ethical Considerations and Implementing FDA Guidance Webinar

Holly Fernandez Lynch, JD, MBE

Holly Fernandez Lynch, JD, MBE scholarly work focuses on the ethics and regulation of clinical research, pre-approval access to investigational drugs, FDA policy, and health care gatekeeping. She is founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), established in 2018. She served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019. Professor Fernandez Lynch joined PRIM&R's Board of Directors in 2020 and previously chaired the Public Policy Committee. She was named a Greenwall Faculty Scholar in 2019, a Hastings Center Fellow in 2021, and a National Academy of Medicine Emerging Leader in 2022. 

Megan Kasimatis Singleton, JD, MBE, CIP

In this role she is responsible for oversight and direction of JHM's 8 IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. In addition to her role in leading the Johns Hopkins Medicine HRPP, she serves as the director of central IRB (CIRB) activities for the Johns Hopkins/Tufts Trial Innovation Center (TIC), leading the charge for innovations in operationalizing single IRB (sIRB) review. Ms. Singleton serves as a member of the SMART IRB Harmonization Steering Committee, is an AAHRPP, Inc. site visitor and member of AAHRPP council and is a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research. 

Ms. Singleton currently teaches at the graduate level at the University of Pennsylvania and Johns Hopkins University, leading courses in research ethics and clinical trial management. She has developed research ethics curriculum and practical training in IRB administration tailored for national and international audiences. Ms. Singleton serves as Chair of PRIM&R’s Public Policy Committee and Nominations & Elections Committee.

Christine McCracken

Christine MacCracken is the Head of Patient Strategies & Solutions (PSS) for the Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Christine leads the strategic identification and implementation of patient-centered initiatives, collaborating closely with internal and external stakeholders to elevate the voice of the patient. She is an active member of the J&J Bioethics Committee, Patient Engagement Leadership Team, and a Strategic Advisory Board Member for Patient Focused Medicines Development.  

Christine joined Janssen in 2015 as a founding member of the PSS team, where she was responsible for growing the department as the steward of Janssen pre-approval access programs. In this role she developed best practices to help ensure the fair and consistent provision of investigational medicines, including the expansion of the Compassionate Use Advisory Committee with New York University.  In addition, Christine spearheaded efforts to develop a first in industry policy on Right to Try, and co-created with patients a novel resource: "Guide to Expanded Access" for patients, providers and caregivers in 28 European countries and Canada. 

Prior to joining Janssen, Christine was Senior Director, Business Insights at the National Comprehensive Cancer Network (NCCN), where she served as key liaison for health information technology organizations to create decision support tools for oncology stakeholders.  Christine also led the development of a patient dedicated website and collaborated with NCCN member institutions to establish an outcomes research program.  

Previous to her work at NCCN, Christine was with Merck where she held roles of increasing responsibility in clinical research, advocacy and External Scientific Affairs, and was a research associate at the Radiation Therapy Oncology Group.  She started her professional career at the Children’s Hospital of Philadelphia as an oncology nurse and holds Master of Health Education and Bachelor of Science, Nursing degrees.  Christine’s work is driven by the guiding principle that : “every patient is a person first”. 

Ann Meeker-O’Connell

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that serves as the FDA focal point for good clinical practice issues in clinical trials of FDA-regulated products and is responsible for coordinating and leading the development of human subject protection and good clinical practice policy across the agency. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance within the Center for Drug Evaluation and Research. She received an M.S. in Pharmacology and was an NIH Integrated Toxicology Fellow at Duke University.