The regulatory process for biological products differs significantly from that used for drugs and medical devices, and requires specific expertise based on the unique biochemical nature of the products. This two-day workshop, offered in collaboration with Biologics Consulting Group (BCG) and led by former FDA officials, provides a unique opportunity for biotechnology industry professionals to gain insight into the expectations and policies of FDA's Center for Biological Evaluation and Research (CBER) as well as how to interact productively with the agency.
Day one provides a detailed look at the IND process as it applies to biologic products, including the timing, structure and content of pre-IND meetings and reviews currently acceptable IND formats. The content, format, and post-approval considerations of INDs are covered in depth.
Day two conducts a thorough review of the Biologics License Application (BLA) process including the information necessary for successful BLA planning and filing. GMP, GCP, and GLP requirements are reviewed including validation issues, bioresearch monitoring inspections, and pre-approval inspections.
This course also reviews the requirements of combination products using a biological product. This course is designed for bioscience industry professionals with a basic understanding of the drug development process.
To learn more about BCG, visit www.biologicsconsulting.com.
Course Instructional team:
James G. Kenimer, Ph.D. is the founder and president of the Biologics Consulting Group, Inc. (BCG). Before founding BCG, he spent more than 15 years at the Food and Drug Administration as researcher, laboratory chief, and inspector. Prior to leaving the Center for Biologics Evaluation and Research (CBER) he was Deputy Director of the Division of Vaccines and Related Products Applications (DVRPA) where he supervised the review of INDs and participated in the development of CBER policies and standard operating procedures (SOPs) for review of biological products. He has extensive experience in IND, PLA and ELA review as well as pre-license and annual inspections of biological manufacturers.
Ronald Marchesani is Head of West Coast Operations for the Biologics Consulting Group, Inc. Ronald has over 29 years of biologics and biopharmaceuutical industry experience in GMP quality systems, GMP compliance audits, GMP oversight of contract manufacturers, biodefense vaccines, regulatory compliance and GMP training. Prior to joining BCG, Ronald held various senior quality managerial positions with ID Biomedical/Shire Biologics, Acambis, Immulogic Pharmaceutical, and Genzyme. He most recently was Senior Director for Corporate GMP Compliance at Genentech.
Carl Anderson, senior consultant with the Biologics Consulting Group, Inc., is a regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. From 1987 to 2005, he worked for the FDA, first in the San Francisco District Public Affairs office and then in the district laboratory. In 1994 he began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research. Mr. Anderson's experience also includes postmarketing surveillance of adverse drug experiences and good manufacturing practice of drug products.
Janice B. Wilson, Ph.D., Senior Consultant with Biologics Consulting Group, is a quality and compliance executive with over 25 years of global and international experience in the bioscience industry. Dr. Wilson was most recently the Global Head of Compliance for Novartis Vaccine and Diagnostics. Her experience includes development, implementation, and directing of sustainable Quality Systems, Quality Assurance programs, and extensive Regulatory Compliance programs for GMP and ISO activities.
Familiarity with the drug development process, gained through professional experience and/or formal course work.
