臨床試験における免疫原性評価

5月 1日 (木)

8:00 am - 5:00 pm Registration Open

リスクに基づいた評価プラン
RISKED-BASED ASSESSMENT PLANS

8:30 Chairperson's Remarks

8:35 Risk-Based Bioanalytical Approaches for Immunogenicity
Gopi Shankar, Ph.D., Director, Clinical Pharmacology, Centocor R&D, Inc.
American and European regulatory agencies are recommending that sponsors study immunogenicity using a risk-based approach, encouraging sponsors to for-mulate and implement their own risk management plans and to conduct discussions with the agencies when necessary. This presentation features a strategy to broadly assign immunogenicity risk levels to biological drug products. Then risk-level based, “fit-for-purpose”, bioanalytical schema for the detection and charac-terization of ADA in clinical and non-clinical studies shall be presented.

9:05 Case Study -Risk-based Immunogenicity Assessment Plan for an Antibody Drug Conjugate Therapeutic
Valerie Quarmby, Ph.D., Head of BioAnalytical Research & Development, Genentech, Inc. 

9:35 Problem Solving Break-Out Session - Drafting a Risk-Based Immunogenicity Plan for a New Biologic Drug Candidate
Delegates will have a unique opportunity to apply what they have learned in this conference by drafting risk-based immunogenicity assessment plans for new biologic drug candidates. This will be accomplished by delegates breaking-out into four interactive groups based on two different therapeutic areas; autoimmune disease and oncology. Within each group experts in the field will facilitate the group's development of a risk-based assessment plan. All of the groups will recon-vene after the morning coffee break to present their group's risk-based assessment plan. 
Facilitators
Larry Lo, Ph.D., Senior Scientist II, Human Genome Sciences
Valerie Quarmby, Ph.D., Head, Bioanalytical Research & Development, Genentech, Inc.
Meena Subramanyam, Ph.D., Director, Clinical Science and Technology,Biogen Idec, Inc.
Darshana Jani, M.S., Senior Supervisor, Clinical Science and Technology, Preclinical and Clinical Development Sciences, Biogen Idec, Inc. 

10:35 Coffee Break in the Exhibit Hall

11:05 Problem Solving Break-Out Session - Reporting back on Risk-Based Immunogenicity Plans

11:50 End of the Assessment of Immunogenicity in Clinical Trials Conference