Autologous CAR-T Development: Safety Assessment and Monitoring in Preclinical and Clinical Programs

Comprehensive Drug Development Strategy for Adoptive T-cell Therapies

Cancer remains one of the leading causes of mortality worldwide, but impressive advances in adoptive T-cell therapies, such as chimeric antigen receptor (CAR) T-cell immunotherapies, have led to drug development breakthroughs that offer new hope to many patients. However, the development pathway for these engineered cell-based therapies faces several unique challenges, particularly with safety assessment and medical monitoring.

Join this educational webinar to learn how to create successful development paths for CAR-T and T-cell receptor (TCR) therapies. Along with a historical overview of these engineered T-cell products, published guidelines will be covered and how development is shaped by the attributes of the therapeutic itself will be discussed.

The speakers will also cover safety biomarkers that can help predict cytokine release syndrome (CRS) or neurologic adverse events and will discuss predictive biomarkers that can assist with patient stratification. They will also provide insights on handling immune-related adverse events and best practices in toxicity management to manage ongoing safety monitoring challenges.

Register for the webinar today to learn from three thought leaders in the field as they share their knowledge on adoptive T-cell therapies across the entire spectrum of development.

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 upcoming webinars on topics such as adoptive cell therapies, biomarker technologies for the detection of cancer driver mutations, novel targeted therapies, and more.

Speakers

Brian E. McIntosh, PhD, Study Director and Scientific Lead, Cell, Gene and Regenerative Therapies, Covance

Dr. Brian McIntosh is a scientist and therapeutic research professional passionate about delivering safe and effective cell and/or gene therapies to patients. Dr. McIntosh serves as a Study Director, as Lead Scientist for Cell, Gene and Regenerative Therapies, and is a contributing member of the Covance Advanced Therapies Drug and Device Development Group. With over 25 combined industry and academic experience years, Dr. McIntosh leverages his experience in cancer biology, immunology, genetic engineering, toxicology and developmental stem cell biology to assist sponsors in designing successful scientific preclinical safety packages. His shared expertise may be gleaned through more than two dozen authored or co-authored professional journal articles, awarded patent and conference presentations.

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Akanksha Gupta, PhD, Head, Immunology, Biomarker Solution Center, Covance

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 has shared experience as author or co-author of multiple peer-reviewed research publications, abstracts and patent submissions.

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Carlo Lanza, MD, PhD, Executive Medical Officer at Covance and Subject Matter Expert in Hematology Oncology

Dr. Carlo Lanza has provided medical guidance to support several collaborative projects at both large pharma and emerging biotech companies. At Covance, he has successfully delivered Phase I-II, Phase III registrational studies and Expanded Access Programs in several Hematology Oncology indications. He offers 30 years of combined experience with 15 years in academia and 15 years in pharmaceutical clinical research, where he held global leadership roles in clinical development and medical affairs. As a global clinical program head and medical head, Dr. Lanza has supported the approval of new drugs in leukemia and oncology and continues to provide medical leadership across all strategic aspects of Phase I-IV drug development and medical affairs.

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