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Adrienne Clements EganBy Adrienne Clements-Egan, Ph.D.

Within the top 100 selling drug products, the percentage of sales generated by biotherapeutics has increased from 17% in 2004 to 39% in 2012. Furthermore, it is predicted that by 2018, around 50% of sales (within the top 100 products) will be generated by biotherapeutics. With this expansion in the biotech industry and the dawn of opportunities in biosimilars, it has become important to expand access to education on the key topics related to biotherapeutic drug development. In 2011, as part of an effort to serve its members and the greater global pharmaceutical field, AAPS produced the eCourse Biotechnology 101: Fundamentals of Biotherapeutics Development eLearning Series, which provided the convenience of online learning without the need to travel to biotechnology conferences for the information.

Due to the importance of immunogenicity assessments for biotherapeutics, AAPS has now developed Immunogenicity 101:Immunogenicity of Biologically Based Therapeutics eLearning Series, a comprehensive online eCourse that covers basic through advanced topics for the assessment and interpretation of immunogenicity. This course is intended to support the growing biotechnology industry by providing convenient, yet thorough, online training from top subject matter experts in the immunogenicity field.

The administration of biotherapeutics is often associated with immunogenicity. Anti-drug antibodies (ADAs) may neutralize the therapeutic effects of drugs and/or alter its pharmacokinetics. The consequences of ADAs can vary, typically ranging from no observed impact to loss of drug efficacy or, in some cases, significant adverse events.ADAs can enhance or decrease efficacy by altering circulating biotherapeutic drug levels and the drug biodistribution in patients. Due to the variety of potential consequences to ADAs, immunogenicity assessments are integral to investigate the safety and efficacy of biotherapeutics. Immunogenicity information is a key aspect of regulatory filings, and in many recent FDA approval letters for biotherapeutics, post-marketing requests for improvements in immunogenicity assays and assessment strategies are described to further understand the impact of anti-drug antibodies to patients.

Immunogenicity 101, cosponsored by the AAPS Ligand Binding Assay Bioanalytical Focus Group and the Therapeutic Protein Immunogenicity Focus Group, will include approximately 28 lectures taught by industry experts from a range of disciplines. This course is available for continuing education credits, and was crafted to provide introductory material that builds to more in-depth presentations about data interpretation and analytical challenges. The eCourse also provides information on topics” such as immunogenicity strategies for biosimilars and novel non-monoclonal antibody biotherapeutic platforms.

Adrienne Clements-Egan, Ph.D. is an Associate Scientific Director of Bioanalytical Sciences within the Biologics Clinical Pharmacology Department of Janssen Research & Development, LLC (Johnson & Johnson).