Early Feasibility Assessment

When designing a biological therapeutic agent, it is critically important to establish the feasibility of achieving a desired target product profile (TPP) as early in the program as possible, typically at the New Target Proposal Stageor at the start of Lead Identification (LI). This case studies outlines an example of where systems pharmacology modeling and analysis helped eliminate targets with low developability and helped set up a screening funnel for top candidates.

Situation:

  • Long list of potential multi-targeting pairs for a chronic inflammatory disease
  • The marketing requirement for this drug was monthly subcutaneous administration
  • It was anticipated that dosing would be a challenge
  • It was unclear how to pick compatible pairs of targets among 90 potential molecules with no known efficacy differences

Our Solution:

  • Developed a systems pharmacology model for each target
  • Established affinity and dose requirements for each target
  • Benchmarked predictions using data from known monotherapies
  • Eliminated targets with low developability
  • Set up screening funnel for top candidates based on predicted affinity requirements

Result:

  • Eliminated dead ends early before significant time and resource investment
  • Freed up researchers to pursue other promising business objectives
  • Accelerated timelines for promising candidates

For more details please contact us at: info@appliedbiomath.com

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