From revealing phenotypic and functional characterization of CAR T-cell products, along with mechanistic markers of efficacy and predictive markers of safety and response, biomarkers of all types play a central role in delivering critical insights that support informed decisions at every step of therapeutic development. As is the case with adoptive cell therapies, the probability of successful progression from discovery to first in human (FIH) to registrational trials and beyond depends more heavily on a holistic approach to therapeutic development.
In this roundtable, expert speakers will focus on the design and approach for preclinical efficacy studies, understanding how these studies fit into the larger safety and toxicology package to bridge into the clinic and inform the implementation of successful biomarker strategies to accelerate development of a therapeutic.
Bring questions to this roundtable where the speakers will discuss topics ranging from:
- Advantages and disadvantages of a variety of preclinical oncology models and approaches
- How these models and supporting assays can enable preclinical advancement
- Key considerations for holistic investigational new drug (IND)-enabling studies and insights supporting effective clinical trial design
- Implementation of biomarker strategies that enable success of complex clinical trials for CAR T therapies
- Evaluation of the types of biomarkers to analyze, key considerations for assay development, and the diverse array of biomarker tests currently available and those on the horizon
Register for this webinar to learn how to design preclinical efficacy studies utilizing key biomarkers to support further clinical development of novel CAR T-cell therapeutics.
Speakers
(Moderator) Maryland Franklin, PhD, Vice President, Enterprise Head of Cell and Gene Therapy, Labcorp Drug Development
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 Labcorp Drug Development in 2019. She was previously the Executive Director, Scientific Development for the Labcorp Drug Development 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
Akanksha Gupta, PhD, Head, Immunology Biomarker Solution Center, Labcorp Drug Development
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 Labcorp Drug Development. 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 therapeutic areas, including immuno-inflammation, immuno-oncology, respiratory, dermatology and other auto-immune disorders.
Dr. Gupta draws on 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
Bruce J. Hamilton, PhD, MSc, Drug Development Team Leader, Early Phase Development Solutions, Labcorp Drug Development
Dr. Bruce Hamilton manages a team of drug development leaders specializing in the development of biological (mAB, cell, gene) therapies, oligonucleotides, and vaccines. With more than 20 years of experience in pharmaceutical research and development, he has been responsible for the end-to-end delivery of several compounds, overseen many more programs at different phases of drug development, and holds more than a half-dozen patents. Before joining Labcorp, he was Director, New Product Development, Abcam, and had previous positions with Medimmune, Bicycle Therapeutics, GlaxoSmithKline, and Astex Therapeutics. Dr. Hamilton received his PhD in Pharmacy from Manchester University and MSc in Biochemistry from Oxford University in the United Kingdom.
Message Presenter
Sheri Barnes, PhD, Associate Director, Scientific Development, Preclinical Oncology, Labcorp Drug Development
Dr. Sheri Barnes serves as Associate Director of Scientific Development, Preclinical Oncology, at Labcorp Drug Development. Sheri holds a PhD in Cell and Developmental Biology from the University of North Carolina at Chapel Hill and has been in the CRO industry for 17 years. She began her career in Business Development and Technical Support, then transitioned to Study Direction where she developed deep expertise in the use of in vivo tumor models for oncology and immuno-oncology early drug development.
Sheri joined Labcorp in 2017 where she currently oversees the Research and Development efforts within Preclinical Oncology and also assists clients in the biopharmaceutical industry in designing scientifically rigorous studies using Labcorp Drug Development’s wide breadth of capabilities.
Message PresenterWho Should Attend?
This webinar will be of interest to directors, C-level executives, researchers, scientists, clinicians, academicians and professionals from pharmaceutical and biopharma companies working in:
- Biomarker discovery/development
- Adoptive cell therapies
- Oncology therapeutic development
What You Will Learn
- Advantages and disadvantages of a variety of preclinical oncology models
- How these models and supporting assays can help enable preclinical advancement
- Key considerations for holistic IND-enabling studies and insights supporting effective clinical design
- Biomarker strategy implementation to enable more sophisticated clinical studies, such as CAR-T therapy
Xtalks Partner
Labcorp
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Learn more about Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.
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