CfPIE - The Center for Professional Innovation & Education, Berlin, Germany
23 - 25 May, 2018
CMC Regulatory Compliance
Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with the strategic ICH Q8/Q9/Q10 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
Why This Course Matters
The Chemistry, Manufacturing & Controls (CMC) landscape of biologics is undergoing rapid development and constant change. Manufacturing processes now include transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars have been in the marketplace in Europe for almost a decade, and are now under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Therefore, it is most important for a biologic company to have an effective CMC regulatory compliance strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from a CMC regulatory compliance perspective to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Deficiencies in the CMC regulatory compliance strategy have resulted in devastating clinical holds and market approval delays.
Who Should Attend
This three-day CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for biopharmaceuticals, biosimilars or other biologics. Typical attendees include: Senior Management, Project Managers, Regulatory Affairs, Manufacturing, and Quality and Development personnel.
John Geigert, Ph.D.
Specialties: Regulatory, Biotechnology, Management
John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.
Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development for Cetus Corporation in Emeryville, CA. At these companies, he led the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products (4 recombinant proteins and 2 monoclonal antibodies) now commercially available in the U.S. and Europe.
He has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board, and served as an expert member of the USP Biotechnology Committee.
He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.
Dr. Geigert is the author of the book The Challenge of CMC Regulatory Compliance For Biopharmaceuticals (and Other Biologics), with the 2nd edition released in 2013. He has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus: "What Senior Management Needs to Know About CMC Regulatory Compliance For Biotech Products" (Aug-Nov 2009, 4-part series); "Demystifying CMC Regulatory Strategy" (Sept 2011-Mar 2012, 4-part series).