About
Product development for innovative therapies, particularly Advanced Therapy Medicinal Products (ATMPs), requires careful planning and cross-functional collaboration to enable a fast path to Investigational New Drug (IND) application. This is especially crucial and challenging for biotech companies transitioning from research-focused environments to clinical development. The process involves coordinating various aspects of non-clinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) timelines, while also navigating partnerships, vendor selection, and regulatory challenges. This presentation provides key considerations for ATMP development with a focus on CMC development to deliver clinical material for patients.

Key Topics:

  • Create a comprehensive development plan that integrates multiple functional areas

  • Prioritize critical aspects of product characterization and manufacturing (CMC)

  • Strategically select and manage external partnerships and vendors

  • Stay informed about evolving regulatory guidelines and expectations

Presenters
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Grace Lee, PhD, MBA, CQA
Founder, Elevalue Consulting LLC
Dr. Grace Lee is a founder and consultant of Elevalue Consulting LLC. She brings over 20 years of experience in research, technical development, quality, and regulatory fields, with a focus on analytical development and quality control for Cell and Gene Therapies, and Biologics. Her extensive scientific background in academia from Stanford Univ and UC Berkeley is complemented by her industry expertise in CMC and GxP disciplines in big pharma and start up, enriching her unique strategic, business-oriented approach to drug development. Dr. Lee is adept at navigating complex CMC technical challenges and guiding strategic decisions in program management.
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Frederik Deroose, PhD
Vice President Chemistry & CMC @ Scientist.com Discovery, Process Development and Manufacturing
Frederik has over 25 years of experience in the pharmaceutical industry, and oversees the chemistry and CMC functions at Scientist.com, the world's largest marketplace for medical research. Using his experience and knowledge, he supports scientists throughout the world in their search for life-saving medicines, accelerating discovery and reducing cost.

His core competencies include medicinal chemistry, organic chemistry, life sciences, drug discovery, CMC, outsourcing, and business development. He has built and managed successful teams of scientists, established strategic partnerships with academic institutes, biotechs, and CROs, and created corporate compound screening collections. He is a recognized world-wide expert and key opinion leader in outsourcing drug discovery, and has published multiple papers in prestigious journals. His mission is to make it possible to cure all human diseases by 2050, by connecting scientists and facilitating their exchange of ideas and transactions online.
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