Workshop
Immunogenicity Prediction and Assessment of Biotherapeutics and its Clinical Relevance
Speakers:
Amy Rosenberg, (FDA), Diana Montgomery (Merck & Co., Inc.), Boris Gorovits, (Pfizer), Shoshana Oberstein (PPD), Shobha Purushothama (Biogen), Lin-Zhi Chen (Boehringer Ingelheim), Daniel Baltrukonis (Pfizer), Tim Hickling, (Pfizer)
Organizers:
Pratap Singh (Alexion Pharma.) and Darshana Jani (Pfizer, Inc.)
Date:
2019-10-15
Time:
8:00-17:00 Eastern Time
Registration fee:
(USD): Regular: $175; For Academic / Unemployed: $125
Location:
Boston Area: Marriott Kendall Square, 50 Broadway, Cambridge, MA
Major Sponsor:
Vendor show vendors registered to date:
(7)AIT Bioscience; CMIC Inc.; Fidelta d.o.o.; Medpace; MicroConstants; PRIMERA ANALYTICAL SOLUTIONS CORP; QPS
Registration: http://www.PBSS.org
Registration deadline:2019-10-14
(it will close sooner if the seating cap is reached)
About the Topic
Immunogenic response in human can have fundamental consequences for safety and efficacy of biotherapeutics such as antibodies, recombinant proteins and novel modalities such as gene therapy vectors or cell based therapies. Immunogenicity testing in preclinical species is often an unreliable guide towards predicting development of anti-drug antibodies (ADA) and/or neutralizing antibody (nAb) response in human. Furthermore, data generated using ADA or nAb assays may not always provide clear insights into the clinical impact of observed immunogenicity. Thus, development of anti-drug immunogenic response is one of the key challenges hindering successful development of new therapies to treat human diseases.
During this 1-day symposium we will bring together experts in the field to discuss relevant topics such as methodologies to assess immunogenicity in preclinical and clinical space, determining clinical relevance of immunogenicity, risk assessment tools to drive bioanalytical strategies, and techniques to deal with pre-existing antibodies. Current state of the art on modeling based approaches to predicting immunogenicity will be highlighted. In addition, emerging data on revolutionary Chimeric Antigen Receptor T-Cell therapeutics (CAR-T) and gene therapy products will also be discussed. Lastly, technical challenges in developing ADA assays, mitigation strategies and fresh perspective on regulatory guidance will be provided by the speakers.
The subject of this 1-day symposium will be relevant to all stakeholders involved in therapeutic drug discovery and development, whether in large pharmaceutical or small biotechnology companies.
Workshop Agenda and speakers:
8:00 – 8:45a: Coffee/breakfast
8:45 - 9:00a: Introduction and opening remarks (Pratap Singh, Ph.D., Alexion Pharmaceuticals; Darshana Jani, Pfizer, Inc.)
9:00 - 9:45a: Keynote Presentation: Clinical relevance of immunogenicity (Amy Rosenberg, FDA)
9:45 – 10:30a: Risk assessment tools to drive the bioanalytical and clinical strategy (Diana Montgomery, Merck & Co., Inc.)
10:30 –11:10a: Immunogenicity cutpoints (Daniel Baltrukonis, Pfizer)
11:10 – 11:30a: Coffee break
11:30 - 12:00p: Immunogenicity of Chimeric Antigen Receptor T-Cell (CAR-T) Therapeutics (Boris Gorovits, Pfizer)
12:00 – 12:10p: Major sponsor
12:10 – 1:10p: Lunch break
1:10 – 1:50p: Pre-existing Abs – specific challenges in development of ADA assays for AAV and PEG-LNP based CGT products (Shoshana Oberstein, PPD)
1:50 – 2:35p: Considerations of immunogenicity assay life cycle management: Case studies (Shobha Purushothama, Biogen)
2:35 – 3:20p: LC/MS approach to overcome drug interference in ADA analysis (Lin-Zhi Chen, Boehringer Ingelheim)
3:20 – 3:30p: Major sponsor
3:30 – 3:45p: Coffee break
3:45 – 4:30p: Immunogenicity predictions using In-Silico and In-vitro Approaches (Tim Hickling, Pfizer)
4:30 – 5:00p: Panel discussion and closing Remarks (Darshana Jani, Pfizer Inc.)
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