Colin Choi
Associate Scientific Director Biogen
Colin Choi is Associate Scientific Director at Biogen, supporting early discovery through IND-filing stage research programs. He specializes in assessing safety risks and designing in vitro and in vivo toxicology studies to generate data for program advancement and regulatory filings. Colin conducts on-target and off-target safety assessments, guiding research teams on potential risks associated with specific targets and modalities. He evaluates NAMs, including 3D systems, to de-risk toxicity questions and to increase the probability of success. Colin is also a member of the IQ MPS Affiliate and co-leads its Regulatory Engagement Workstream to facilitate science-based advancement of complex in vitro models for enhanced drug development processes and 3Rs.
Seminars
- How pharma teams are collaborating within IQ MPS Affiliate to progress simple and complex in vitro NAM platforms toward regulatory acceptance
- Review insights from recent FDA publication on submitted NAM case examples and reviewer feedback – what works and what can be improved (need for well-articulated context-of-use)
- Discuss the value of a strong regulatory strategy: Suggestions for the qualification of alternative approaches leveraging toxicology data, statistical modelling, and AI – based on VICT3R experience
- Gain practical guidance for integrating in vitro and in silico NAMs into toxicology packages without over-claiming translatability
- What industry needs from consortia, regulators, and data-sharing frameworks to accelerate adoption of novel platforms covering diverse mechanisms of injury
This practical, discussion-driven workshop brings together regulatory experts clarify evolving expectations for preclinical packages, the use of NAMs, in vitro models, and AI- enabled approaches, and the realities of preparing an IND for multiple global markets.
Through real case studies, both successful and challenged, participants will gain a clear understanding of how to position innovative toxicology data for regulatory acceptance.
- Current FDA Expectations & Global Alignment: Insights from FDA representatives and regulatory experts on IND readiness, emerging trends, and how to ensure early- stage toxicology programs map cleanly to U.S., EU, and APAC requirements.
- Using NAMs, In Vitro Models & AI in Regulatory Filings: Real case studies, successful and unsuccessful, showing how alternative assays and computational approaches were positioned, justified, and reviewed, including instances of regulator pushback.
- Building a Multi-Market Regulatory Strategy from Day One: Designing preclinical packages that meet multiple agencies’ expectations, bridging data gaps, and knowing when to consult your regulatory team.
- Expert Insights from Industry & Consultants: Addressing pitfalls, how to support IND strategy, and how early engagement with regulators can de-risk development.
