Drug Development Process

ICAV is an institutional innovation that bridges the anti-viral gap by connecting promising academic research directly to an experienced drug development team, bridging the so-called innovation gap. ICAV provides the resources and knowledge to move drug candidates from discovery stage through pre-clinical and clinical development to licensing. ICAV provides expertise to complete the “translational research” required to convert academic opportunities into the mid- to late-stage compounds desired by the industry or NGOs and governments.

The centrepiece of the ICAV business model is the added value that ICAV creates by rapidly and cost-effectively moving anti-viral discoveries from research institutions into clinical trials. ICAV functions as a two-stage process. First, the ICAV Senior Management Team evaluates discovery-stage candidates from academic labs through an Initial Review of Opportunity (IRO) and seeks support for proof-of-concept (POC) experiments with most promising candidates.

Candidates with viable activity at POC are then considered by the Technical Review Committee (TRC). The TRC—an ICAV innovation composed of industry experts—further evaluates compounds and constructs a development plan encompassing all aspects of the drug development process, including pre-clinical proof of efficacy, toxicology, pharmacology, formulation development and manufacturing, and clinical development. Resources are sourced along the way from CMOs, CROs, and the ICAV global scientific network.

ICAV provides the missing institutional link—coupling academic discoveries to industry and development expertise—that bridges the innovation gap between academic research and clinical development. This ‘virtual’ drug development model allows ICAV to leverage existing resources and comparative advantages, reducing the cost of the drug development process. ICAV’s public-private approach mitigates a great deal of the risk of drug development and encourages the realization of therapies for diseases that would otherwise be discounted by commercial drug companies. Through public and philanthropic support and cooperation with industry, ICAV will offer low-cost drugs to lower- and middle-income countries while meeting urgent health needs in the developed world.

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