Day 1
9:30 AM | BioSafe Annual Meeting Opening RemarksChristina de Zafra (Seagen), BioSafe Vice Chair |
9:40 AM | BioSafe OverviewJacintha Shenton (Amgen), BioSafe Chair |
Oct 4
Session 1: Non-Human Primate Availability and Use
October 4, 2022 ・ 10:00AM - 2:35PM ET
Session Chairs: Lucinda Weir (GSK) and Jennifer Brown (MacroGenics)
10:00 AM | Session OverviewSession Chairs |
10:30 AM | Proceedings from the 2021 FDA/BioSafe/DruSafe Annual MeetingJorg Blumel (Genentech) |
11:05 AM | Update on NHP Availability: CRO PerspectiveCandace Heining (Charles River Laboratories) |
11:40 AM | Reuse of Protein Non-Naïve Monkeys in Pharmaceutical Research and DevelopmentChuck Mattis (Abbvie) |
12:15 PM | Break |
12:45 PM | BioSafe White Paper - Non-Human Primates in the PKPD Evaluation of Biologics: Needs and Options to Reduce, Refine and ReplaceKarelle Menochet (UCB), Hongbin Yu (Boehringer Ingelheim) |
1:20 PM | Alternatives to Supporting Human Dose and Drug Exposure Predictions with Cynomolgus Monkey PKPD StudiesDan Rycroft (GSK), James Yates (GSK) |
1:55 PM | Further Opportunities for NHP Use in Toxicology Studies with mAbs: Update from an MEB/Industry/NC3Rs Project Sponsored by EPAADavid Clarke (Eli Lilly & Co.) |
2:30 PM | Session Closing RemarksLucinda Weir (GSK), Jennifer Brown (MacroGenics) |
Afternoon Networking Session at 2:35PM ET
Day 2
Morning Networking Session @ 9:30AM ET
Oct 5
Session 2: RNA and Oligonucleotide Therapeutics
October 5, 2022 ・ 10:00AM - 1:55PM ET
Session Chairs: Katie Heinz-Taheny (Eli Lilly & Co.) and Kevin Donnelly (Eli Lilly & Co.)
10:00 AM | Session OverviewChairs |
10:05 AM | Concepts of Nucleic Acid PharmaceuticalsRebecca Kohnken (Abbvie) |
10:50 AM | PK/ADME of Nucleic Acid PharmaceuticalsChris Wiethoff (Eli Lilly & Co.) |
11:20 AM | Break |
11:35 AM | Safety Assessment of siRNA and ASO PharmaceuticalsJen Sisler (Eli Lilly & Co.) |
12:00 PM | Case Study: siRNA DART StrategiesMark Carfagna (Eli Lilly & Co.) |
12:20 PM | Nucleic Acid-Based VaccinesCindy Rohde (Pfizer) |
12:50 PM | MRI Investigation of Total and Local CSF Volumes in Juvenile and Mature NHPs for the Preclinical Safety Assessment of ASOsLutz Mueller (Roche) |
1:20 PM | Panel Discussion/Q&A |
Afternoon Networking Session @ 1:55PM ET
Day 3
Oct 6
Session 3: Novel Approaches in Biopharmaceutical Development
October 6, 2022 ・ 9:00AM - 12:25PM ET
Session Chairs: Ulrike Hopfer (Roche) and Chandrashekhar Korgaonkar (Regeneron)
9:00 AM | Session OverviewChairs |
9:05 AM | EIH Approach and Discussion with Health Authorities for an MHC Targeting Bispecific Antibody for a Non-Oncology IndicationHisashi Ikegami (Chugai Pharmaceuticals) |
9:35 AM | Applications for a Virus-Like Particle and its TLR9 Agonist CargoMeredith Crosby (Regeneron) |
10:05 AM | Bringing T Cell Receptor Therapeutics to Cancer Patients with a Patient-Centric in Vitro / ex Vivo Only Translational ApproachEstelle Marrer-Berger (Roche) |
10:35 AM | Break |
10:50 AM | Artificial Intelligence in Toxicology/PathologyAndy Vo (Abbvie), Bhupinder Bawa (Abbvie) |
11:40 PM | Preclinical Development of a Novel, Half-Life Extended Enzyme Biologic: Immunogenicity ConsiderationsHema Gursahani (Jazz Pharmaceuticals) |
12:05 PM | Panel Discussion/Q&A |
12:25 PM | Break |
Oct 6
Session 4: Biologics, Part I
October 6, 2022 ・ 12:40PM - 3:05PM ET
Session Chairs: Katy Fraser (Takeda), Maggie Willer (Takeda), Smita Salian-Mehta (Gilead)
12:40 PM | Session OverviewChairs |
12:45 PM | FIH Dose Strategies: Case Study Perspectives for ImmunomodulatorsRyan Polli (Novartis) |
1:15 PM | Novel FIH Approaches and Considerations for BiologicsAmy Sharma (Pfizer) |
1:45 PM | Adventures in “IND-ing” with Immunostimulatory BiologicsCarole Harbison (Takeda) |
2:15 PM | First-in-Human Dosing for an Immuno Modality in a Non-Oncology Indication: A Case StudyRutwij Dave (Gilead) |
2:45 PM | Panel Discussion/Q&A |
Day 4
Morning Networking Session @ 9:30AM ET
Oct 11
Session 5: Fluid-Based Neurobiomarkers
October 11, 2022 ・ 10:00AM - 12:35PM ET
Session Chairs: Ingrid Pardo (Biogen)
10:00 AM | Session OverviewChair |
10:15 AM | Validation of Fluid-Based Neurobiomarkers in Nonclinical Toxicology SpeciesMadhu Sirivelu (Pfizer) |
10:35 AM | Fluid-based Biomarkers of Neurotoxicity with Gene Therapy Toxicology Studies in NHPsKelly Penraat (Novartis) |
11:05 AM | Safety Biomarkers of Peripheral Neurotoxicity in the Rat: (IMI, NeuroDeRisk Project)Diethilde Theil (Novartis) |
11:35 AM | Neurofilament to Monitor ALS and MSDanielle Graham (Biogen) |
12:05 PM | Panel Discussion/Q&A |
12:35 PM | Break |
Oct 11
Session 6: Biologics, Part II
October 11, 2022 ・ 1:00PM - 12:45PM ET
Session Chairs: Katy Fraser (Takeda), Maggie Willer (Takeda), Smita Salian-Mehta (Gilead)
1:00 PM | Session OverviewChairs |
1:05 PM | Contribution of 3-month Toxicology Studies to the Safety Assessment of ICH S9-Directed Bispecific T Cell EngagersPetra Lutterbeuse (Amgen) |
1:25 PM | De-Risking Liver Toxicity for a Biologic ModalityNichole Vansell (Pfizer) |
1:55 PM | Case Studies Assessing the Immunogenicity Risk of Host Cell Proteins in Antibody BiotherapeuticsJeanine Bussiere (Amgen) |
2:25 PM | Intravesical Delivery for an ADC TherapeuticChris Carosino (Seagen) |
Day 5
Morning Networking Session @ 9:30AM ET
Oct 13
Session 7: Cell and Gene Therapy
October 13, 2022 ・ 10:00AM - 2:15PM ET
Session Chairs: Payal Rana (Pfizer) and Tynisha Glover (Janssen)
10:00 AM | Session OverviewChairs |
10:05 AM | Measuring Integration of Gene Therapy AAV Vectors into the Host GenomeTom Lanz (Pfizer) |
10:35 AM | Ocular Safety Associated with AAV Gene TherapyNick Buss (Kriya) |
11:05 AM | Regulatory Considerations for the Nonclinical Safety Assessment of Gene TherapiesJeff Moffit (Carbon Bio) |
11:35 AM | PK Considerations in Gene TherapyNancy Chen (Takeda) |
12:05 PM | Break |
12:20 PM | Product Quality Issues for Cell and Gene Therapy ProductsSheri Nidositko (Novartis) |
12:50 PM | Root-Cause Investigation of Nonclinical Human T Cell Lymphoma to Enable CTN FilingLauren Gauthier (Takeda) |
1:50 PM | CAR T Consortium on Cytokine Independent Growth AssayShon Greene (Umoja Biopharma) |
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