This workshop brings together industry experts and FDA perspectives to examine the key preclinical, bioanalytical, regulatory, and development considerations for successful IND filings for antibody-based therapeutics. Discussions will cover antibodies, antibody-drug conjugates, and multispecific antibodies, with topics ranging from pharmacology, PK/PD, bioanalysis, and toxicology to CMC activities, clinical development planning, and strategies for regulatory interactions.
Topics:
- Overview of antibody-based therapeutics: structure, generation, design, and optimization
- Overview of preclinical development and IND filing requirements for antibody-based therapeutics
- Non-clinical pharmacology considerations antibodies and in vivo disease modeling
- Pharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings
- Human dose projection through clinpharm quantitative modeling
- Preclinical toxicology studies
- IND-enabling CMC activities
- Clinical Development Plan
- Regulatory strategies and interactions with FDA: Industry perspective & how to prepare for FDA meetings
- The regulatory perspective: the do’s and don’ts and avoiding a clinical hold
Contact Us to Learn More and Start a Conversation
Are you attending PBSS? Don’t miss the chance to discuss your project’s needs with Sara Hermann and Derek McCartney. Contact us to schedule a meeting and explore how our services can support your bioanalytical and drug development objectives.