Monday, April 25 2022
Assessing the Regulatory Pathway for an Alternative Format Conjugate
9:00 – 12:00
For tried and trusted formats, the regulatory pathway is evidently a lot more established. Join this workshop to learn about the regulatory
pathway for alternative formats which show promise of being first in class agents.
- What does a path to IND look like for something that is less traditional?
- Discussing CMC and regulatory filings for alternative formats
- What are the considerations and what is the capacity out there for manufacturing alternative formats?
- Sharing experiences in FIH studies
- Reviewing commercialization pathways for novel formats, making this commercially viable
Head of Pre-Clinical Development
Associate Director & Project Team Lead
Understanding How to Take a Novel Format Conjugate Through Lead Candidate Selection into Technical Development
1:00 – 4:00
This workshop is an opportunity to learn and discuss the important aspects of developability assessment at the interface between research and CMC for novel format conjugates. The workshop will be of interest to CMC and research leads new to the conjugate field. The workshop is run by two experts in the field with a cumulative industrial experience of over 40 years and expertise in bioconjugate development gained over the last 10-15 years.
Join this workshop to learn about:
- Introduction: program integration for developability assessment at the interface between research and CMC
- Developability assessment study design for novel format conjugate selection
- Selected case studies that highlight key aspects of novel format conjugate developability and lead selection criteria
- Analytical approaches in developability assessment