Challenge:
A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations. Alacrita was asked to help create a detailed early clinical plan for the company's lead asset, to be used as a foundation piece of the business strategy.
Solution:
Our oncology consultant created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch, which involved the below.
- reviewing relevant documents, including the technology; pre-existing corporate, scientific, and clinical goals; and any preclinical data
- holding interviews with key stakeholders including company founders, the CEO and the internal R&D team
- reviewing potential target cancer indications and establishing up-to-date standards of care
- reviewing relevant biomarkers to inform PK/PD activity and patient enrichment strategies
- preparing a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites
- developing an interval-to-IND filing gap analysis.
Our consultant presented to the Board and was retained as an ongoing medical advisor to the company.