WEDNESDAY, MARCH 18, 2020 | 8:00 AM – 5:00 PM.
Why You Should Attend!
Sandra Visser, PhD
Sriram Krishnaswami, 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
- Background on molecule, endpoints, indication, medicine vision
- Nominal time and a nominal budget
- Simulated Phase 1 results for PK + Biomarker for single and repeated dose will be distributed
- Decision point 1
- What dose(s)/schedule(s) to take into a POC trial? (increased N comes with cost penalty)
- What duration should the POC trial be? (longer or shorter duration than standard option will come with time penalty or gain)
- Distribute Phase 2a (POC) results for PK + Biomarker + clinical endpoint + safety info
- Decision point 2
Go / no go for the molecule
- Potential to bring in back-up molecule (time penalty) or external compound (cost penalty)
- Design of dose-ranging trial and primary method of analysis (selection of number of doses, sample size and duration will come with both cost and time consequences)
- Distribute Phase 2b (dose ranging) results for PK + Biomarker + clinical endpoint + safety info
- In addition, results of E/R analysis and emerging competitor information will be shared
- Decision point 3
- Go / no go for the molecule
- Potential to co-develop with other team (cost penalty)
- Design of Ph 3 confirmatory trial (selection of number of dose and duration will come with both cost and time consequences)
- Distribute Phase 3 results for Efficacy and Safety
- Comparison of compound results for each team
- Integrate cost / time penalties to create the full landscape across teams
Attendance for the Pre-Conference is limited to 100 attendees. Registration opens in early September, register early to secure your seat!