Preclinical Development and IND Filing for Antibody Therapeutics: the Nuts, Bolts and Best Practices
The investigational new drug application (IND) is an important step to achieve in antibody-based therapeutics, and understanding the requirements for a successful IND filing is important to ensure fast and efficient development. While the principles and basics are similar across different modalities for an IND filing such as safety studies, there are important aspects that need to be considered for antibody-based therapeutics. In this workshop, we will cover the best practices for a successful IND package of an antibody candidate. Our highly experienced speakers will discuss the preclinical studies for antibody-based therapeutics IND packages.
Topics to be covered:
- Overview of preclinical development and IND filing requirements for antibody-based therapeutics
- Required preclinical studies for
- Safety assessment
- Pharmacology
- Pharmacokinetics
- CMC (Chemistry, Manufacturing, Control)
- Clinical development plans
- Regulatory strategies and agency interactions
- FDA’s perspective
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Event Agenda
| Time PST | Topic | Presenter(s) |
| 8:45 – 8:55 AM | PBSS Welcome and Workshop Introduction | Peter Korytko, PhD, MBA, CEO, Preclinical GPS LLC; Chair, Seattle PBSS |
| 8:55 – 9:10 AM | Overview of Preclinical Development and IND Filing Requirements for Antibody Therapeutics | Peter Korytko, PhD, MBA, CEO, Preclinical GPS LLC; Chair,Seattle PBSS |
| 9:10 – 9:30 AM | Overview of Antibody Therapeutics: Structure, Generation, Design, and Optimization | Che-Leung Law, PhD, CSO, Abacus Bioscience |
| 9:30 – 10:15 AM | Pharmacological Evaluation of Antibody Therapeutics | Che-Leung Law, PhD, CSO, Abacus Bioscience |
| 10:15 – 10:25 AM | Major Sponsor’s presentation- Morning Session | TBD |
| 10:25 – 10:45 AM | Break & Vendor Show | – |
| 10:45 – 11:30 AM | Pharmacokinetic and Toxicokinetic Characterization of Antibody Therapeutics | Kelly Byrnes-Blake, PhD, PK Consultant, Northwest PK Solutions, LLC; Affiliate, Cascadia Drug Development Group |
| 11:30 AM – 12:20 PM | Lunch | Sponsor TBD |
| 12:20 – 01:05 PM | Nonclinical Safety Evaluation of Antibody Therapeutics | Paramita Mookherjee, PhD, DABT, Director, Toxicology, Regeneron |
| 1:05 – 1:50 PM | Chemistry, Manufacture and Control of Antibody Therapeutics | Aaron Pilling, PhD, Senior Consultant, Pharmefex |
| 1:50 – 2:35 PM | Clinical Development Plans | Jan L Hillson, MD, Partner, Cascadia Drug Development Group |
| 2:35 – 2:45 PM | Major Sponsor’s Presentation- Afternoon Session | TBD |
| 2:45 – 3:05 PM | Break & Vendor Show | – |
| 3:05 – 3:40 PM | When Pharmacology Becomes Toxicology | Madelin Fort, PhD, DABT, Scientific Director, Amgen Inc. |
| 3:40 – 4:25 PM | Key Regulatory Considerations for Planning, FDA Interactions, Submission and Review of INDs for Biologics | Jill Herendeen, PharmD, Principal, Rubicon Consulting Group |
| 4:25 – 5:00 PM | Project Management in Preclinical Development and IND Filing | Declan Richards, MS, Associate Director, Spannerwerks, LLC |
| 5:00 – 5:30 PM | Panel Discussion | All Presenters |
| 5:30 – 6:30 PM | Happy Hour | Sponsor TBD |
Speakers’ Bios
Dr. Kelly Byrnes-Blake has been a pharmacokinetic consultant supporting drug development since 2011. She obtained a PhD in pharmacology, with specific training in pharmacokinetics, in 2001 from the University of Arkansas for Medical Sciences. Previous industry experience includes large pharma, as well as a mid-sized biotech company (ZymoGenetics), with the primary focus of her work being the development of protein therapeutics. She is experienced in the design, analysis, and reporting of PK, PK/PD, TK, and biodistribution studies, providing support for early-stage preclinical research through Phase 1 and 2 clinical studies.
Dr. Che-Leung Law, PhD, is a molecular immunologist by training. He has 25+ years of experience in developing novel therapies for the treatment of cancer and immunological diseases, from discovery, translational research, clinical development to regulatory approval. Che and his teams have advanced 15+ experimental drug programs utilizing modalities that include T cells, engineered antibodies, antibody-drug conjugates, and T cell engaging molecules. He is currently the CSO at Abacus Bioscience. Before this he worked at Harpoon Therapeutics, Seagen, and Xcyte Therapies. Che received his PhD in Pathobiology at the University of Minnesota and his post-doctoral training at University of Washington.
Dr. Madeline Fort, PhD in Immunology and Diplomate of the American Board of Toxicology, has over two decades of experience in translational safety. After early work in inflammation research at small biotech firms, she has spent 19 years at Amgen Inc. developing and executing nonclinical safety packages for multiple IND submissions and late-stage clinical programs. Her focus has been on advancing protein therapeutics with diverse structures and mechanisms of action, contributing to the safe translation of innovative therapies to patients.
Jill Herendeen, PharmD, is a regulatory affairs leader with 20+ years of experience in oncology drug development. She has contributed to the global approvals of Vectibix®, Opdivo®, and Imbruvica®, and her expertise spans small molecules, biologics, cell therapies, and companion diagnostics across all phases of development. She has held senior regulatory roles at Amgen, Bristol Myers Squibb, Pharmacyclics/AbbVie, Silverback Therapeutics, and Orca Bio. Jill is the founder of Rubicon Consulting, where she partners with biopharma companies to design and execute regulatory strategies that accelerate patient access to innovative therapies.
Declan Richards, MS, earned a Master of Science in Biotechnology and Business and has since built a career in project management. He completed several professional certifications including Project Management Professional (PMP) and Lean Six Sigma Black Belt. With 10 years of experience across multiple industries, he continues to specialize in biotechnology. At Spannerwerks, he led several manufacturing operations projects and supported biotech startups through IND submissions, overseeing clinical and nonclinical study tracking as well as clinical manufacturing. Declan has also led global process optimization initiatives for quality, and manufacturing operations. He is known for effectively managing complex, cross functional, and regulated projects.