Adoptive cell therapies such as chimeric antigen receptor T-cells (CAR T cells) have transformed cancer therapies and hold great promise for a widening range of oncology indications. However, orchestration of these products and lab testing in clinical trials is complex and presents unique challenges to ensuring product safety and efficacy. This includes maintaining product integrity, chain of identity, chain of custody, as well as demonstration of control of the product’s critical quality attributes, all on a per-patient basis.
Moreover, biomarker analyses play a critical role in patient identification, pharmacokinetic (PK) assessments of the treatment dose, characterization of pharmacodynamics (PD) and target engagement response. All of these factors need to be addressed during clinical trials of these products, and often require creative solutions to meet the diverse needs of sponsors, patients and investigator sites.
Register for this webinar to learn more about running clinical trials for adoptive cell therapies.
This webinar is part of a scientific series Covance is offering, focused on trends, opportunities and challenges associated with current and future applications in Oncology. Learn more and register for webinars on topics such as adoptive T-cell therapies, biomarker technologies for the detection of rare cancer driver mutations, novel targeted therapies and more.
Maryland Franklin, PhD, Vice President and Enterprise Head of Cell and Gene Therapy, Covance by Labcorp
Dr. Maryland Franklin has over 20 years of experience with preclinical pharmacology models with most of that time spent in biotech, pharma and the CRO industry. Dr. Franklin worked as a member of numerous multi-disciplinary teams to deliver therapeutic candidates from research into development and was a key leader in bringing four drugs into Phase I clinical trials. She worked in the Preclinical Development Group at ZymoGenetics, working on animal models of lung fibrosis, anti-virals and psoriasis and at OSI Pharmaceuticals, where she supervised the internal and external placement of oncology-focused in vivo pharmacology studies and established and managed external collaborations around target identification, biomarkers, animal models and imaging.
In 2014, Dr. Franklin joined MI Bioresearch which was acquired by Covance in 2019. She was previously the Executive Director, Scientific Development for the Covance Ann Arbor facility that focuses on preclinical oncology where she led efforts to establish immuno-oncology capabilities and services, including a focus on the models and assays supporting the early development of cell therapies.
Dr. Franklin is currently Vice President and Enterprise Head of Cell and Gene Therapy. She has a PhD in Medical Genetics and is the co-author of more than two dozen peer-reviewed publications.Message Presenter
Maria Taboada, Lead, Global Logistics and Global Investigator Services, Covance by Labcorp
Maria Taboada has over 20 years of operational management experience in the drug development industry and currently leads Global Logistics and Global Investigator Services for Covance Clinical Trial Testing Solutions. Maria is responsible for leading distribution strategy, vendor selection and investigator relations as well as strategic projects for pharma clients.Message Presenter
Paul Byrne, PhD, Principal Scientist at Covance by Labcorp
Dr. Paul Byrne is a Principal Scientist at Covance, focusing on the evolving field of cell and gene therapies, providing scientific and regulatory leadership and direction on projects throughout the drug development continuum. In addition, he leads an integrated global Covance team delivering innovative analytical solutions for clients’ cell and gene therapy programs. In this role, Byrne also brings clients specialized expertise in the development and validation of analytical tools and strategies, development of regulatory-compliant and molecular biology.
Byrne has over 20 years of industry experience and can frequently be found speaking at symposia on topics such as: analytical development challenges for ATMPs, biodistribution and safety assessment considerations for cell and gene therapies and more. Paul received his BSc (Hons) in biology from the University of Stirling (UK) and his MSc in research from the University of Glasgow (UK).Message Presenter
Akanksha Gupta, PhD, Head, Immunology Biomarker Solution Center, Covance by Labcorp
Dr. Akanksha Gupta leads the immunology therapeutic team for the Biomarker Solution Center, a team that delivers biomarker solutions and strategy to clients, leveraging the laboratory resources of both Covance and Labcorp. Her strategic leadership provides scientific direction on biomarker strategies integrating innovative technologies, emerging scientific knowledge, clinical feasibility and regulatory requirements for a precision medicine approach across multiple therapy areas including immuno-inflammation, immuno-oncology, respiratory, dermatology and other auto-immune disorders. Dr. Gupta draws more than 15 years of pharmaceutical industry experience in drug development, translational research and supporting development strategies for early to late stage assets. She shares her experience as author or co-author of multiple peer-reviewed research publications, abstracts and patent submissions.Message Presenter
Who Should Attend?
This webinar will appeal to biopharmaceutical sponsors and researchers developing new therapeutics for solid tumors and hematologic malignancies.
What You Will Learn
In this webinar, sponsors will learn about autologous cell products in clinical trials, including:
- An overview of product orchestration and process flows from apheresis to therapy administration
- Supply chain quality management and the role of the logistics coordinator from a patient, investigator site and sponsor perspective
- Demonstration of control of the manufactured product’s critical quality attributes to meet acceptance criteria for batch release
- Biomarker strategies and assessments for PK/PD, including characterization of product persistence, expansion, phenotype, immunogenicity and minimum residual disease (MRD)
Covance by Labcorp
Covance by Labcorp is a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 26,000 people worldwide, we provide comprehensive drug development solutions and are on a mission to advance health and power clear, confident decisions.
Covance by Labcorp is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise.
Together with our clients, Covance by Labcorp supports the development of innovative, life-changing treatments. Visit us at www.covance.com.