De-Risking Cell & Gene Therapy Development With Integrated MRL Expertise
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About this webinar
Cell and gene therapy programs bring together scientific innovation and clinical complexity unlike many traditional drug development programs. From selecting meaningful biomarkers and designing fit-for-purpose laboratory strategies to managing patient safety, site execution, sample logistics and evolving clinical considerations, decisions made early in development can have significant downstream implications.
In this webinar, Medpace experts from medical, laboratory and clinical operations will explore how an integrated approach to cell and gene therapy development can help sponsors identify and address potential risks before they affect study timelines, data quality or clinical execution.
A medical director will provide a clinical perspective on the unique considerations associated with developing cell and gene therapies, including translating the underlying science and therapeutic goals into practical clinical trial strategies.
A Medpace reference laboratories (MRL) scientist will examine how integrated MRL expertise can support complex cell and gene therapy programs through specialized molecular, biomarker, flow cytometry and bioanalytical capabilities helping generate actionable data, anticipate challenges and keep development moving forward.
Two clinical operations experts will then bring the discussion into the realities of trial execution, addressing how complex laboratory requirements, patient and site considerations, sample handling, product logistics and study-specific processes must work together across the clinical development program. The panel will highlight where disconnects between scientific intent and operational execution can introduce avoidable challenges and how cross-functional collaboration can help mitigate them.
Drawing on Medpace’s experience supporting complex cell and gene therapy programs, the discussion will examine the importance of integrating medical, laboratory and clinical operations expertise together rather than treating each function as a separate component of development. Medpace’s integrated model combines specialized laboratory capabilities with therapeutic, medical, regulatory and operational expertise to support complex cell and gene therapy studies globally.
Attendees will gain practical perspectives on building an integrated development strategy, anticipating challenges earlier and connecting laboratory insights with clinical decision-making and operational execution. The goal is not simply to manage complexity once it arises, but to use cross-functional expertise proactively to reduce risk and create a more coordinated path from development strategy to clinical execution.
Register for this webinar to learn how integrated medical, laboratory and clinical operations expertise can help reduce risks and improve the execution of cell and gene therapy trials.
Who should attend
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What you will learn
- Connect laboratory strategy to clinical objectives from the beginning. Collaborating early with scientific and laboratory experts can assist sponsors in selecting suitable biomarkers, assays and testing strategies, while minimizing later adjustments that may impact timelines or data interpretation
- Anticipate operational challenges before they become trial risks. CGT studies can involve specialized sample handling, product logistics, chain of identity and custody, site requirements and complex workflows; aligning these considerations early can support more consistent execution
- Bring medical, laboratory and clinical operations perspectives together. Integrating expertise across functions helps translate scientific goals into executable trial strategies and allows potential issues to be identified and addressed before they impact study conduct
- Use integrated expertise to make complex development more predictable. A coordinated approach can help sponsors navigate the scientific, clinical and operational complexities of CGT development while maintaining focus on data quality, patient safety and development timelines
Featured Speakers
Gregory Hale, MD
Dr. Gregory Hale is a Physician with over 33 years of experience in all phases of clinical development, with expertise in cell and gene therapy.
Dr. Hale has severed as Clinical Director of the Transplant Gene Therapy at St. Jude Children’s Research Hospital and Medical Director of the Division of Hematology/Oncology at Johns Hopkins All Children’s Hospital. He was Professor of Oncology and Pediatrics at Johns Hopkins School of Medicine and has authored more than 200 peer-reviewed manuscripts, review articles and blood chapters. He has held leadership positions in the National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR).
Dr. Hale is currently Vice President of Medicine at Medpace. He earned his Medical Degree from the Joan C. Edwards School of Medicine at Marshall University. He completed his pediatrics residency at Children’s Hospital of Pittsburgh and his pediatric hematology/oncology fellowship at St. Jude Children’s Research Hospital.
El Mustapha Bahassi, PhD
Dr. El Mustapha Bahassi is an accomplished scientific leader with over two decades of expertise spanning global clinical laboratory operations, molecular oncology research and biomarker development. Currently serving as the Sr. Director of Clinical Laboratory Sciences at Medpace Reference Laboratories, he oversees global PhD scientists’ teams, drives research and development initiatives and ensures regulatory compliance (CAP, CLIA) across multiple Medpace molecular laboratories.
Prior to his leadership roles in corporate clinical diagnostics, Dr. Bahassi spent over 15 years as a Research Assistant Professor and Principal Investigator at the University of Cincinnati, where he spearheaded advancements in liquid biopsies, specifically utilizing circulating tumor DNA and exosomes and provided critical correlative studies for oncology clinical trials. He holds a PhD in Molecular Biology and Biotechnology with Highest Honors from the Free University of Brussels and is widely published in high-impact journals, including The Lancet Diabetes & Endocrinology, Nature Communications and The Proceedings of the National Academy of Sciences USA.
Kelly Millhaem
Kelly Millhaem is a Senior Director in Clinical Trial Management and has 18 years of clinical trial experience at Medpace. With extensive experience leading and overseeing Phase I-IV global clinical studies, Ms. Millhaem serves as the therapeutic group lead for CVRM-GI rare disease and advanced/gene therapy.
Her experience includes applying therapeutic and operational expertise to study feasibility, site strategy and the practical execution challenges associated with complex clinical development programs. She brings a strong operational perspective to study planning, with an emphasis on translating protocol requirements and therapeutic considerations into executable strategies for global study teams and investigative sites.
Matthew Morton
Matthew is a Senior Clinical Trial Manager and Therapeutic Group Lead for rare disease and advanced therapies at Medpace. He has more than seven years of clinical operations experience at Medpace, leading global clinical studies from early-phase development through pivotal and registrational programs. Matthew leads Medpace’s Cardio-Metabolic Gene Therapy Working Group and brings experience in rare metabolic and genetically defined diseases, early-phase study designs, and complex global trial execution. His experience spans operational strategy, site and recruitment strategy, cross-functional team leadership, risk management, clinical monitoring and Sponsor oversight.
Partner for this event
Medpace
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.