CLSI is urging CLSA Fellows to take advantage of a valuable offering from Pharma Directions. The JumpStart Grant provides the winning company with a comprehensive development plan that includes a strategic plan, GANTT chart with milestones, critical path and itemized budget that can be used to raise funds and execute your path to IND (an estimated value of $25,000). Applicant companies should be privately-held therapeutic (small molecule or biologics) company, must be located in California, and be a member of CLSA and/or BioCom.
Each grant recipient will receive a product development plan and a commercial plan consisting of the following.
Description of CMC activities required to support the toxicology program and first-in-human clinical study
Discussion of the proposed nonclinical program to support the intended indication, including justification
Overall regulatory strategy
High-level synopsis of the first-in-human clinical study
A detailed development plan budget including selection of clinical CRO (approximate timeline and budget for clinical plan)