WEDNESDAY, MARCH 18, 2020 | 8:00 AM – 5:00 PM. *Sold out - Wait-list only
Why You Should Attend!
Sandra Visser, PhD
Sriram Krishnaswami, PhD
Darren Austin, PhD
Welcome and step aboard the Model-informed Drug Discovery and Development (MID3) Rollercoaster Workshop where you will experience the highs and lows of (hyper) accelerated drug development. Ten teams of ten participants each will take a small molecule from first in human through to Phase 3 (maybe) with real-time trial execution! This unique workshop will offer attendees an opportunity to submerse themselves in developing a drug and decision-making around this. Participants will gain learnings with respect to decision-making around trial design, dose and schedule selection, therapeutic benefit vision relative to standard of care, changing competitive landscape, and go/no go decisions.
High Level Summary of Workshop
- The format would be new, interactive, various scenarios, dynamic with real time simulations
- At each decision point, some key concepts around interpretation, extrapolation, and decision-making tools will be laid out and discussed in addition to each team rationalizing their decisions.
- Clinical pharmacology understanding is critical to the determination of the optimal dose.
- Emerging external data from competitors and backup compounds will be added to the mix.
- Semi-competitive element by keeping a score on decisions that have impact on costs and time.
- Teams will start with the following
- Simulated Phase 1 results for PK + Biomarker for single and repeated dose will be distributed
- Distribute Phase 2a (POC) results for PK + Biomarker + clinical endpoint + safety info
- Distribute Phase 2b (dose ranging) results for PK + Biomarker + clinical endpoint + safety info
- Distribute Phase 3 results for Efficacy and Safety
- Michael A. Tortorici, PharmD, PhD
- Jing Liu, PhD
- Stacey Tannenbaum, PhD
- Chunze Li, PhD
- Karthick Vishwanathan, PhD
- Georgios Vlasakakis, PhD
- Benjamin Weber, PhD
- Neeraj Gupta, PhD
- Ana Hazra, PhD
- Sreeraj Macha, PhD
- Tjerk Bueters, PhD
- Timothy M. Nicholas, PhD
Attendance for the Pre-Conference is limited to 100 attendees. Registration has filled up! Attendees on the wait list will be notified when a spot becomes available. ASCPT is not responsible for travel costs incurred when moving from the waitlist. ASCPT cannot guarantee housing availability.