Overview
Next-generation immunotherapies create interconnected CMC, nonclinical, clinical and regulatory challenges. If key decisions around potency, comparability, model relevance, biomarkers and first-in-human strategy are addressed too late, they can result in avoidable development delays and rework. Addressing these considerations early can help identify cross-functional risks, strengthen development strategies and support more informed decision-making throughout the development process.
This webinar brings together regulatory, CMC and nonclinical experts to explore five critical decisions that can strengthen an immunotherapy program from preclinical development through clinical translation and global development. The discussion will examine approaches to establishing credible nonclinical strategies when conventional models have limited relevance, anticipating potency and comparability challenges associated with manufacturing changes and identifying opportunities for early regulatory alignment. Attendees will gain insights into how these considerations can support more effective development planning and reduce potential setbacks as programs advance toward clinical evaluation.
Register for this webinar to learn how early strategic decisions can help reduce risks, minimize delays and strengthen immunotherapy development programs.
What you will learn
Attendees will learn how to:
- Identify cross-functional risks before they disrupt development
- Build a credible nonclinical strategy when conventional models have limited relevance
- Anticipate potency, manufacturing-change and comparability challenges
- Determine which issues would benefit from early regulatory alignment
Who should attend
This webinar will appeal to professionals at emerging, small and mid-sized biotechnology companies involved in immunotherapy development, including:
- Chief Medical, Development and Scientific Officers
- Heads of Regulatory Affairs, CMC and Clinical Development
- Program and Portfolio leaders
- Biotechnology Executives preparing for IND/CTA submission, first in-human development, global expansion or pivotal-stage transition
Speakers:
Tamie MalaskaT
Tamie brings extensive experience in regulatory affairs, quality assurance and drug development, with a career spanning biotechnology and pharmaceutical organisations including Genentech, Johnson & Johnson, Immunex and Targeted Genetics. She has held senior roles across regulatory affairs, manufacturing controls and compliance, immunotherapy and quality assurance, as well as more than two decades leading her own consulting practice before joining ICON.
Gabriel Bohl
Gabriel has more than 30 years of experience in regulatory affairs, including 25 years in chemistry, manufacturing and controls (CMC) and 15 years focused on large and innovative molecules. He specialises in regulatory CMC strategy and delivery across biologics, vaccines, advanced therapy medicinal products, cell and gene therapies and other complex biological products. His experience spans development through marketing applications, including INDs, BLAs and MAAs, with expertise in complex CMC risks, agency interactions, submission strategy and inspection-ready documentation across multiple regions.
Philip Coan
Philip has approximately 25 years of experience investigating the genetics of disease and advancing therapeutic approaches across academia and biotechnology. He has led multiple teams in progressing assets through nonclinical drug development and into clinic development, including serving as head of a preclinical department for gene therapy programmes spanning haematological disorders, complement biology and immune modulation. His research experience includes complement pathway modulation, the molecular mechanisms underlying M1/M2 transition in inflammatory responses and discovery research in autoimmune diseases.