Adoptive cell therapies have ushered in a paradigm shift in the treatment of cancers with the watershed FDA approvals of two Chimeric Antigen Receptor T-Cell (CAR-T) therapies in 2017. In addition to CAR-Ts, other cell-based immunotherapies in development have emerged including modified T-cell receptor T-cells (TCR-Ts), Natural Killer (NKs) cells and Dendritic Cells (DCs).
In this webinar, presenters will discuss aspects of an adoptive cell therapy preclinical program that are central to an IND/IMPD submission – namely, in vitro and in vivo pharmacology, toxicology and pharmacokinetics (PK) assessments using the appropriate models & test systems. Together, these studies help to guide determination of clinically safe and biologically relevant dose levels, establish safety endpoints for clinical study monitoring and elucidate the biological disposition of administered cell product.
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.
Maryland Franklin, PhD, Executive Director of Scientific Development, Preclinical Oncology, Covance
Dr. Maryland Franklin has over 20 years of experience with preclinical pharmacology models, more than half spent in biotech and pharma companies. Dr. Franklin worked as a member of numerous multi-disciplinary teams to deliver agents from Research into Development and was a key leader in bringing four drugs into Phase I clinical trials. She started her industry career as a Research Scientist in the Preclinical Development Group at ZymoGenetics, working on animal models of lung fibrosis, anti-virals and psoriasis. In 2003, Dr. Franklin joined the In Vivo Pharmacology Department 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.
Dr. Franklin was a key contributor in the discovery and early clinical development of the small molecule IGF-1R/IR dual inhibitor, OSI-906 (linsitinib), and provided key drug combination data and novel tumor models to support further clinical development of the small molecule EGFR inhibitor erlotinib (Tarceva®). She received her PhD in Medical Genetics from the University of Alabama at Birmingham.Message Presenter
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.Message Presenter
Who Should Attend?
- Cell Therapies
- Gene Therapies
- Medical Affairs
- Project Management
- Regulatory Specialist
- Clinical Operations
- Commercial and Sales
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Development Manager
- Procurement Manager
What You Will Learn
In this webinar, attendees will learn about and understand:
- In vitro verification of product function
- Animal model selection in preclinical studies
- Pharmacology and toxicity studies to guide determination of biologically relevant and clinically safe dose levels
- The biological disposition of product including tumor cell infiltration, persistence and viral shedding
Covance is a business segment of LabCorp, 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 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance 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. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.
This webinar is part of a scientific series Covance is offering focused on trends, challenges and opportunities 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.