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Workshop

[In-Person] Nonclinical Safety Assessments of Biologics and Other Novel Modalities for IND/NDA/BLA Filings


Speakers: Christina de Zafra, Seagen; Kaushik Datta, BMS; Xiaoting Wang, Amgen; Haley Neff-LaFord, Seagen; Mayur Mitra, Genentech; Jessica Sims, Genentech; Majlinda Thomas, Gilead Sciences; Carolyne Dumont, CRL; Ijeoma Uzoma, FDA
Organizers: Smita Salian-Mehta (Gilead Sciences)
Date: 2024-09-20
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (1)WuXi AppTec;(Major Sponsorship - morning session still open)
Vendor show vendors registered to date: (6)Abzena; BioIVT; Emery Pharma; Frontage Laboratories, Inc.; Inotiv; Meadowhawk Biolabs
Registration: http://www.PBSS.org
Registration deadline:2024-09-19  (it will close sooner if the seating cap is reached)

About the Topic

With the advent of complex biologics and the increasing use of novel modalities over traditional antibodies during drug development, it has become critical to develop our understanding on their unique safety assessments and challenges. Pharmaceutical companies are challenging the dogma of traditional safety packages and providing evidence with more robust in-vitro packages demonstrating specificity and challenging use of in-vivo studies where pharmacologically relevant nonclinical species are not available. This workshop will focus on fostering deeper understanding of the participant on the inclusion of in-vitro and in-vivo safety packages and various unique first in human dose determination strategies for biologics and their unique modalities. Workshop will be initiated with an overview of biologics followed by presentations that will cover non-clinical safety assessment strategies with case study examples of a wide range of biologics including CD3 bispecific, peptide MHC, Antibody-drug conjugates and novel modalities like peptides and protein degraders. Common risk assessment like immunogenicity assays and cytokine assays will also be provided in shorter talks. The intent of this workshop is to enlighten the develop an understanding of toxicity risk assessments and share latest progress in the field of biologics to activate discussions that will lead to more successful IND/BLA submissions.

Time PST Topic Speaker
8:45-9:00 am PBSS Welcome  Shichang Miao, PhD, President, PBSS
9:00-9:10 am Workshop Introduction  Smita Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Nonclinical Safety and Pathobiology, Gilead Sciences
9:10-9:50 am Setting the Stage: an Overview of Biotherapeutics Christina de Zafra, PhD, DABT, Director, Drug Safety Research & Development, Pfizer
9:50-10:30 am CD3 bispecific: An Important Modality in Cancer Immunotherapies – Considerations for Nonclinical Development Kaushik Datta (KD), PhD, DABT, Senior Scientific Director, Bristol Myers Squibb
10:30-11:10 am Nonclinical Safety Assessment Strategies for Peptide-MHC Targeting Therapeutics Xiaoting Wang, PhD, DABT, Director Translational Safety and Bioanalytical Sciences, Amgen
11:10-11:20 am Major Sponsor Presentation Sponsor
11:20-11:40 am Break and Vendor Show  Break and Vendor Show 
11:40am-12:40 pm Lunch Lunch (BioIVT)
12:40-1:15 pm Using a Platform Approach to Assess Nonclinical Safety of ADCs Haley Neff-LaFord, PhD, DABT, Executive Director, Drug Safety Research & Development, Pfizer
1:15-1:50 pm Evolution of Peptide Therapeutics - Nonclinical Considerations for Drug Development Mayur Mitra, PhD, DABT, Distinguished Scientist, Toxicologist, Genentech
1:50-2:30 pm A Sticky Situation: Current Safety Considerations for Developing Molecular Glues and Other Targeted Protein Degraders Jessica Sims, PhD, DABT, Principal Scientist, Toxicologist, Genentech
2:30-2:40 pm Major Sponsor Presentation Sponsor
2:40:3:00 pm Break and Vendor Show  Break and Vendor Show 
3:00-3:25 pm Managing Immunogenicity of Biologics During Nonclinical Safety Assessment Studies Majlinda Thomas, Senior Research Scientist II, DMPK, Gilead Sciences 
3:25-3:50 pm Overview of in-vitro Cytokine Releases Assays in the Context of Preclinical Safety Assessments Carolyne Dumont, DABT, Scientific Director, Immunology, Charles River Laboratories
3:50-4:30 pm Regulatory perspectives Ijeoma Uzoma, PhD, Pharmacology/Toxicology Team Lead, FDA
4:30-5:00 pm All Speakers Panel Discussion
5:00-6:00 pm Happy Hour Happy Hour Sponsor (Sponsor) 

About the Speakers

Dr. Christina de Zafra received her PhD in Toxicology from the University of Rochester and conducted postdoctoral research at the University of Colorado. Christina has been a part of the nonclinical toxicology departments at Genentech, Amgen, and Seagen, supporting development of multi-modality biotherapeutics (including mAbs, fusion proteins, ADCs, and oncolytic viruses) across a range of therapeutic areas, and is currently a Director in Drug Safety R&D at Pfizer. Christina’s interests include product quality risk assessments and the 3Rs of ethical animal use, and she is a member of the Society of Toxicology and a Diplomate of the American Board of Toxicology.

Dr. Kaushik Datta (KD) is a Senior Scientific Director at Bristol Myers Squibb (BMS), where he is responsible for the strategic oversight and execution of nonclinical safety activities and Health Authority interactions. He has been working in the Pharma industry for approximately 24 years in the field of toxicology. He has been involved in several industry leadership and working group activities for scientific/regulatory enrichment and issue resolution , supporting numerous drug submissions and post-marketing commitments. KD received his PhD in Toxicology from The University of South Florida, College of Public Health , and completed a post-doc in biochemical toxicology at The University of Texas at Austin.

Dr. Xiaoting Wang is currently a director in the Translational safety and bioanalytical sciences group in Amgen at South San Francisco. Her specialty is in the field of immunology and immunotoxicology. She works as a project lead toxicologist on inflammation and oncology programs. Also, she leads a group of scientists primarily focusing on developing a variety of in vitro model systems to predict and evaluate clinical safety related to immunotoxicity and off-target activity. Xiaoting received her PhD in Viral Immunology and Pathology department in UMass Chan Medical School in Massachusetts and had her postdoc training in tumor immunology in La Jolla institute of Immunology in California.

Dr. Haley Neff-LaFord, is an Executive Director and the ADC Therapeutic Area Lead for Pfizer Drug Safety R&D. Her team characterizes the safety of novel anti-cancer therapies. Haley was at Seagen for 16 years and has contributed to the development of multiple ADCs and targeted therapies from research through global registration. She is active in consortia and outreach including the PNW chapter of SOT, IQ DruSafe Immunosafety WG, and the HESI ADC Safety Committee. Haley received her PhD in Pharmacology/Toxicology from Washington State University and her postdoctoral training at the University of Washington.  She is certified by the American Board of Toxicology. 

Dr. Mayur Mitra is a board-certified toxicologist and currently serves as a Distinguished Scientist - Toxicologist within Safety Assessment at Genentech Inc. As part of his role, he serves as the Therapy Area Lead for Genentech’s Oncology portfolio and as a Cross-functional Drug Development Team Lead. Previously, Mayur was employed as a Toxicologist at Bristol-Myers Squibb. Mayur received a PhD in Toxicology from the University of Louisiana at Monroe and a postdoctoral fellowship at the Washington University School of Medicine in St. Louis. Mayur is well published and has authored more than 25 peer reviewed article and book chapters.

Dr. Jessica Sims is a Principal Scientist in the Safety Assessment Department at Genentech where she provides toxicology support to project teams from small and large molecule project teams from discovery through late-stage development and IND filing. She is also the SME for molecular glues/targeted protein degraders. She received her doctorate in Cellular and Molecular Physiology from Tufts University-School of Biomedical Sciences and was a postdoctoral scholar at Cedars-Sinai Medical Center. Jessica has over 15 years of combined academic and industry experience in target identification, drug screening and drug development. She is a board-certified toxicologist and has served on the executive board for the SOT Biotechnology Specialty Section.

Dr. Majlinda Thomas is a Senior Research Scientist II in Drug Metabolism and Pharmacokinetics (DMPK) at Gilead Sciences. With extensive expertise in biologics bioanalysis, she specializes in ligand binding assays, LC/MS/MS, and immunogenicity assessment. She earned her PhD in bioanalytical chemistry from the Barnett Institute at Northeastern University in 2011. Following her doctoral studies, Majlinda dedicated three years to a postdoctoral position at the Canary Institute at Stanford University. Currently, she oversees the Biologics BioA team within DMPK at Gilead.

Carolyne serves as Scientific Director, Immunology at Charles River laboratories, located at the Senneville site (Canada). She has over 21 years of experience in preclinical drug development and pharmacology. She is a diplomate of the American Board of Toxicology (ABT), a member of the American College of Toxicology (ACT) and a member of the immunotoxicology technical committee (ITC) which is part of HESI.

Dr. Ijee (pronounced ‘EJ’) is a PharmTox Team Leader in the Division of PharmTox for Immunology and Inflammation supporting the clinical Divisions of Rheumatology and Transplant Medicine and Division of Pulmonology, Allergy, and Critical Care, within the Office of New Drugs in the Center for Drug Evaluation and Research at the FDA. She has been with the Agency since 2017. Dr. Uzoma earned a PhD in Pharmacology and Molecular Sciences and postdoc in compound screening for antimicrobial activity. She also serves on the FDA’s Nonclinical Biologics Subcommittee and the Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Committee.


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2024-09-10, [In-Person] Translational PK/PD and Human Dose Projection for Antibodies/ADCs and Novel Therapeutic Modalities
2024-09-25, [Free Online] Development of Protein Degraders: Computational Modeling, Medicinal Chemistry and Early Development
2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
2024-10-25, [Free Online Workshop] Unleashing the Power of Real-World Evidence / Data (RWE/RWD) to Facilitate Drug Discovery, Development, and Beyond
2024-11-01, [In-Person] Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing: Strategies, Design, Conduct, Analysis and Regulatory Aspects
2024-11-13, [Free Online Workshop] Career Transition for Research Scientists: Business Development & BioPartnering
2024-11-15, [In-Person] Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapeutics
2025-01-22, [In-Person] Small-Molecule Formulation for Discovery & Early Development (jointly by PBSS / AAPS-BADG / Syner-G)
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