Webinar Summary
- 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
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 will provide key considerations for ATMP development with a focus on CMC development to deliver clinical material for patients.
Presenters
Grace Lee
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.
Frederik Deroose
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.
Content Partners
Scientist.com
Scientist.com is the world’s largest and first platform built for the intricacies of scientific outsourcing.
We help pharmaceutical and biotechnology organizations discover, engage, manage, and scale relationships with the providers that support every stage of the pipeline—from discovery and preclinical research to clinical development, manufacturing, medical affairs, and commercialization. Through a centralized platform, organizations can access a global network of 6,000+ providers, streamline sourcing and procurement workflows, maintain compliance, manage supplier relationships, and leverage data-driven insights to make faster, more informed decisions.
Today, Scientist.com supports more than 130 life science organizations, including 24 of the world's top 30 pharmaceutical companies, helping teams reduce operational complexity, accelerate timelines, and bring innovations to patients faster. Our mission is to make it possible to cure all human disease by 2050.
