Where Will Your CGT Study Go? Solving the Site Capacity Challenge

Jessica Merryfield, Vice President, Project Delivery, Cell & Gene Therapy, Premier Research

Jessica Merryfield has been involved in global clinical research for over 20 years, with a focus on rare diseases for the past decade. As Vice President of Gene and Cell Therapy, Ms. Merryfield advises, consults, plans and directs the design and strategy for prospective and ongoing gene and cell therapy studies. In her role, she provides operational excellence by driving best practices, identifying global needs for innovation and improvements and leading Premier’s Continuous Learning Program for Advanced Therapeutics.

Through stakeholder engagement and cross-functional management, Ms. Merryfield operates at a strategic support level for complex, critical and therapeutically aligned programs. She coordinates strategic direction and delivery for gene and cell therapy with Premier’s innovative partners, including regulatory and statistical consulting, therapeutic experts, patient engagement and strategic development.

Ms. Merryfield has extensive experience in Phase I-IV studies, including autosomal, neurological, metabolic and hematology diseases, utilizing innovative precision medicine technologies. Her key experience areas include pediatrics, rare/ultra-rare disease, cardiology, immunology/autoimmune disorders, dermatology and CNS.

Brittany Groner, Director, Clinical Operations, BridgeBio Gene Therapy

Brittany Groner has over 14 years of experience in clinical research, spanning all phases of clinical trials across multiple indications, with a focus on rare disease and gene therapy. She has visited more than 200 research facilities nationwide during her tenure as a Clinical Research Associate, gaining firsthand insight into site operations and patient needs. As Director of Clinical Operations, Brittany leads the management of clinical trials, overseeing cross-functional teams, sites and vendors to ensure the successful execution of studies and the advancement of new therapies for patients.

Brian Shayota, MD, MPH, Assistant Professor of Pediatrics and Medical Genetics, University of Utah

Dr. Brian Shayota completed his Medical Degree at St. George’s University, School of Medicine. He then completed his Pediatric residency at New York Medical College in Paterson, NJ, and his Medical Genetics residency and Medical Biochemical fellowship at Baylor College of Medicine. Dr. Brian Shayota is an Assistant Professor of Pediatrics and Medical Genetics at the University of Utah/Primary Children’s Hospital. He is also the Director of Metabolic Services, Director of the Telegenetics Consultation Services offered to Level III NICUs throughout Utah and Director of the ReSeq clinic.

Dr. Shayota’s career has focused on caring for patients with rare inborn errors of metabolism and discovering new/rare genetic conditions. Dr. Shayota is particularly interested in identifying new therapeutic approaches to rare genetic disorders, including serving as the primary investigator on several clinical trials of novel treatments, such as gene therapy, in human trials. He is also the lead metabolic specialist reviewing newborn screens for the states of Utah, Nevada and Alaska. He is passionate about expanding access to genetic services in rural communities and creating innovative public health programs that prioritize the interests of patients and their families.

Garry Coulson, Senior Director of Regulatory and Quality Assurance, Sabai

Garry Coulson is a Senior Director of Regulatory and Quality Assurance at Sabai, a client-centric commercial IRB and IBC service provider with extensive experience in the cell and gene therapy space across a wide range of therapeutic areas. Garry has approximately 20 years of experience in research, biosafety and regulatory compliance. In his current role, Garry oversees a team of IBC Chairs who are collectively responsible for the IBC’s oversight of clinical trials at approximately 750 institutions nationwide.

Before joining Sabai, Garry served as the Biological Safety Officer at the University of North Carolina at Chapel Hill, where he oversaw biosafety operations and managed internal IBC operations. This experience has provided Garry with the added perspective of some of the unique challenges that sites and institutions often face from an administrative, operational and regulatory standpoint.