Date: Tuesday, September 12th from 1:30-7pm
Location: CIC - Cambridge, 245 Main Street, Cambridge, MA 02142
The application of model-informed drug discovery and development (MID3) approaches in the early stages of discovery can help determine feasibility of drugging a target, prioritize between targets, and define optimal drug properties for a target product profile (TPP). However, applying MID3 in early discovery can be challenging due to the lack of pharmacokinetic (PK) and pharmacodynamic (PD) data at this stage. Early Feasibility Assessment (EFA) is the application of mechanistic PKPD models, built from first principles, and parameterized by data that is readily available early in drug discovery to make effective dose predictions.
- What is Early Feasibility Assessment (EFA), and how can it be used to inform early drug discovery decisions
- How to select (or develop) an appropriate model for EFA
- Strategies to use published data to parameterize and validate models
- Simulation strategies to answer specific questions such as dose feasibility, challenges with Therapeutic Index, setting screening cutoffs, and identify key knowledge gaps
- How to communicate EFA results effectively to drive decisions
1:30 - 2:00pm | Registration
2:00 - 5:00pm | Workshop
The workshop will be divided into three, one-hour sessions.
Session 1: Lecture style session to provide a deep understanding of the Early Feasibility Assessment (EFA) methodology and how it can be used to inform early drug discovery decisions.
Session 2: We will explore an EFA case study based upon a complex biotherapeutics drug. Participants will break into small teams to implement an EFA for their target. Using provided web based software, models, and literature, teams will be expected to select an appropriate model, parameterize it with data from the provided literature, and analyze the model to answer their specific questions. Experts will be available to help participants.
Session 3: Teams will present the conclusions of their assessment to the group, and their recommendation for the program. The organizers will then present an analysis for discussion. Participants will discuss the challenges of implementing EFA and the potential opportunities for EFA and MID3 more broadly to have impact at their organization.
5:00 - 7:00pm | Networking and refreshments