Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy

Why Should You Attend:

This webinar will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.

This presentation will be a broad ranging systematic plan of evaluating immunogenicity during all phases of the product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.

In conclusion, this webinar will educate the participant on the processes and effects of immunogenicity, commonly adapted screening methodologies to measure immune responses, the application of regulatory mandates, and commercial repercussions of unwanted immune responses.

• Overview on the processes and effects of immunogenicity.
• Impact on efficacy and safety.
• Screening and confirmatory methods to measure immune responses.
• Regulatory guidelines on immunogenicity of biologics; FDA, ICH, CHMP, EMEA.
• Risk management strategy.

• Executive management
• R&D investigators
• Product development
• Pre-clinical and clinical
• Regulatory affairs
• QA/ QC
• Marketing
• Consultants
• Training

Instructor Profile:

Chitra Edwin, Ph.D., RAC. has significant product development and management experience in start-ups, mid-sized and large biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been a key member in the development of products for AIDS and cancer that have obtained regulatory approval. She has successfully established and managed GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals. Dr. Edwin’s responsibilities have included the pre-clinical development of therapeutic biologics, vaccines and diagnostics. She has functioned as a facilitator between academia and industry that culminated in contractual service agreements, and organized professional meetings with representatives from academia and the bioscience industry.

Dr. Edwin has held management positions at Chiron Corporation (currently Novartis) and MassBiologics (formerly the Massachusetts Biologic Laboratories). Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, Director of the Capstone project, College of Pharmacy, University of Cincinnati where she teaches regulatory compliance and pharmaceutical product development, and mentors students in the Master’s in Drug Development program. She offered a training course in GMP as part of the Global Training Network, WHO Department of Vaccines and Biologicals, and frequently conducts webinars on product development and regulatory compliance for reputed e-learning companies

Dr. Edwin has been a consultant for the biotechnology and diagnostics industry since 2005, and founded Biotechnology Consulting Solutions, Ltd. in 2006. Consulting projects have included strategic product development plans, pre-clinical proof of concept studies, due diligence and audits of CROs, and grant and technical report writing.

Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, followed by post-doctoral training in Infectious Diseases at the Harvard Medical School and the Dana Farber Cancer Institute. She has secured Regulatory Affairs board certification (RAC). She is a Review Board member of Opus Institutional Review Board (IRB). She was a co-founder and President of the Graduate Women in Science (Massachusetts chapter).

Memberships have been held in Sigma Xi – Scientific Research Society, ASM, AAAS, RAPS, MIT Forum, GWIS, the Foreign Policy Leadership Council of Greater Cincinnati, BioOhio and Kindervelt.

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