Agenda Details
BioSafe General Membership Meeting Schedule of Events
Last updated September 15, 2023, schedule and contents subject to change
Here is what you can expect to see and do while attending the BioSafe General Membership Meeting. Please check back to this page regularly as we get closer to the meeting in October at Janssen R&D, 1400 McKean Rd, Lower Gwynedd Township, PA 19002.
Tuesday
Oct 3
October 3, 2023 ・ 12:00 PM - 5:45 PM
12:00 PM - 1:00 PM | Registration & Lunch |
1:00 PM - 1:15 PM | BioSafe Annual Meeting Welcome & Opening Remarks - Sam Gunter (2023 GMM Chair, BIO), Sven Kronenburg (Roche), Helen Haggerty (Janssen)Message from the BioSafe Co-Leads - Christina de Zafra (Seagan) and Sven Kronenberg (Roche) |
SESSION 1: | Artificial Intelligence (AI) -Chairs: Tonya Fuller (Genmab) and Krishna Allamneni (Concarlo Therapeutics Inc. |
1:15 PM - 1:45 PM | New Frontiers in Artificial Intelligence for Biopharma - Hisham Hamadeh (Genmab) |
1:45 PM - 2:15 PM | AI-Powered Integrative Models to Decipher Immunotoxicity Mechanisms -Zhichao Lio (Boehringer Ingelheim) |
2:15 PM - 2:45 PM | AI in Discovery of Biologics: Beyond In Silico Modeling -Peter DiMaggio (Janssen) |
| 2:45 PM - 3:15 PM | Panel Discussion and Q&A for AI Session -All Speakers |
3:15 PM - 3:45 PM | Coffee Break |
SESSION 2: | Cell and Gene Therapy -Chairs: Jessica Lynch (Janssen) and Shawna Jackman (CRL) |
3:45 PM - 4:15 PM | Targeted CNS Delivery of AAV and Considerations for Alternate Species to NHPs - Simon Authier (Charles River) |
| 4:15 PM - 4:45 PM | In Vivo CAR-T - Alissa Brandes (Umoja) |
4:45 PM - 5:15 PM | Approaches to Safety Assessments to AAV Integration -Ali Nowrouzi (Spark Therapeutics) |
5:15 PM - 5:45 PM | Gene Editing -Christina Chaivorapol (Sana Biotechnology) |
Wednesday
Oct 4
October 4, 2023 ・ 8:00 AM - 7:30 PM
7:45 AM - 8:30 AM | Breakfast |
SESSION 3: | Alternative Species to NHP for In Vivo Safety Testing - Chairs: Lori Aschenbrenner (Labcorp) and Amy Sharma (Pfizer) |
8:30 AM - 8:50 AM | From Hoof to Hair: Large Animal Alternatives to NHPs in Non-Clinical Safety Assessments - Napoleon Alejandro and Amanda Lucchini (Labcorp) |
8:50 AM - 9:10 AM | Outcome of IQ Minipig WG and Case Study of a Recombinant Protein Program in Minipig - Thierry Flandre (Novartis) |
9:10 AM - 9:30 AM | Dog Tolerability to Human Antibodies: A Case Study -Hui Ling and Tim MacLachlan (Novartis) |
| 9:30 AM - 9:50 AM | Dog as an Alternative Preclinical Toxicity Model for Biologics -Mike Oropallo (Merck) |
9:50 AM - 10:10 AM | Panel Discussion and Q&A for Alternative Species to NHP Session -All Speakers |
10:10 AM - 10:30 AM | Break |
SESSION 4: | Innovative Testing Approaches -Chairs: Smita Salianmehta (Gilead) and Ulrike Hopfer (Roche) |
10:30 AM - 10:50 AM | Complex In Vitro Models in Drug Development -Kim Homan (Genentech) |
| 10:50 AM - 11:10 AM | Light-Sheet Microscopy - Holistic 3D Imaging for Drug Development -Thomas Poeschinger (Roche) |
11:10 AM - 11:30 AM | Platform Approach for Antibody Drug Conjugates: Leveraging Two Decades of Nonclinical Studies to Streamline ADC Development - Sarah Carratt (Seagen) |
| 11:30 AM - 11:50 AM | NHP Reduction Opportunities in the Development of ADCs with Cytotoxic Payloads - Li Li (Novartis) |
| 11:50 AM - 12:30 AM | Panel Discussion and Q&A for Innovative Testing Approaches Session -All Speakers |
12:30 PM - 1:30 PM | Lunch |
SESSION 5 | Breakout Groups |
1:30 PM - 2:30 PM | CGT: Prophylactic Immunosuppression in Tox Studies with (AAV) GTs -Jessica Lynch (Janssen) and Maggie Willer (Takeda) |
1:30 PM - 2:30 PM | What NHP Studies are Necessary When NHP is Your Only Relevant Tox Species? -Wendy Freebern (Janssen) Kathryn Fraser (Takeda), and Lucinda Weir (GSK) |
1:30 PM - 2:30 PM | Use of Virtual Control Groups - Wolfgang Muster (Roche), Lennart Anger (Genentech) |
2:30 PM - 2:45 PM | Break |
2:45 PM - 3:30 PM | Feedback on Breakout Sessions to All Participants -All Leads |
| 3:30 PM - 3:45 PM | Coffee Break |
SESSION 6: | Regulatory/Hot Topics -Chairs: James Smith (Boehringer) and Samira Brooks (Amgen) |
3:45 PM - 4:15 PM | A Regulatory Roller Coaster: The Ride to a Two Year Rat Carcinogenicity Study with a mAb - Lori Aschenbrenner (Labcorp) |
4:15 PM - 4:45 PM | An Industry Perspective on the Opportunities and Challenges of Comparative Oncology -Cathy Ruff (Genentech) |
5:00 PM - 5:30 PM | An In Vitro Mechanism Study of Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates - Michihiko Aoyama (NIHS) |
5:30PM - 6:00 PM | Panel Discussion and Q&A for Regulatory/Hot Topics Session - All Speakers |
6:00 PM - 7:30 PM | Reception |
Thursday
Oct 5
October 5, 2023 ・ 8:00 AM - 1:00 PM
8:00 AM - 8:30 AM | Breakfast |
SESSION 7: | Extended Joint Session with MARTA (Middle Atlantic Reproduction and Teratology Association) - Chairs: Pallavi Mcelroy (Janssen) and Diann Blanset (Boehringer) |
8:30 AM - 9:00 AM | Challenges of Using NHPs in DART/ePPND Data Interpretation - Kristina York (Charles River) |
9:00 AM - 9:30 AM | HESI Work Group Update: Monkey use for DART, We Can Do Better - Christopher Bowman (Pfizer) |
9:30 AM - 10:00 AM | Use of Mouse Surrogate for DART Package -Dian Blanset (Boehringer) |
10:00 AM - 10:30 AM | How to Address the Safety of Gene Therapy Products in Developmental and Reproductive Toxicology Testing - Elise Lewis (Charles River) |
10:30 AM - 11:00 AM | Discussion Using Voting on Preformulated Questions on Regulatory Interactions -All Speakers |
11:00AM - 12:00 PM | Panel Discussion and Q&A for Extended Joint Session with MARTA Session - All Speakers |
12:00 PM - 1:00 PM | Feedback from General Membership and Closing Remarks |
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