Case Study

Client: Preclinical platform company

Therapeutic area: Solid tumors

Modality: Small molecule

Challenge: Lean team struggling to prioritize indications and best deploy remaining capital prior to next raise.

Radyus approach: We initially engaged to help with indication prioritization but extended engagement to a monthly retainer, working with them for over 3 years now.

Our Process

  • Step 1 - Indication prioritization

    Selected top 3 indications, triangulated in vitro efficacy data with commercial attractiveness

  • Step 2 - Animal efficacy pilot study

    Designed and executed studies with two lead compounds in relevant animal efficacy models of 3 selected indications

  • Step 3 - Target product profile

    Developed a TPP for a lead compound in 1 indication with superior efficacy, engaged KOLs and payors to build strong case

  • Step 4 - Regulatory strategy

    Drafted a high-level regulatory path to approval in selected indication, outlined strategies to accelerate approval

  • Step 5 - Manufacturing strategy

    Consulted a CDMO partner on initial formulation and process development, including manufacturing cost estimates

  • Step 6 - Product development plan

    Outlined critical development, manufacturing, regulatory and clinical milestones in lead indication

  • Step 7 - Pitch deck

    Refined client’s fundraising pitch deck to include clear positioning, TPP, and use of proceeds for Series A raise

  • Step 8 - Dose-range studies with toxicokinetics

    Designed and executed animal PK/PD/safety study to elucidate maximum tolerated dose

  • Step 9 - Pre-IND meeting

    With lead candidate selected, planned, and coordinated Pre-IND FDA meeting, including writing the brochure & submission

  • Step 10 - On going work

    IND-enabling tox

    CDMO vendor selection

    Clinical development strategy