Hassell: Vaccine Product Development Center
The Vaccine Product Development Center at IAVI is designed to serve the Collaboration for AIDS Vaccine Discovery (CAVD) and the broader field, with the primary goal of accelerating the development and testing of novel HIV vaccine candidates.
In essence, this program provides a methodology by which Principal Investigators, currently supported through the CAVD, could rapidly and confidently access additional HIV vaccine development expertise that helps to ensure the success of their project in reaching first-in-human studies. Done in a timely fashion, this results in an efficient way of taking the vaccine candidate(s) forward to clinical development with full regulatory support. Potential issues with the development of the candidate product will be identified and expertise provided in ways to address such issues.
1. Provide an expert range of development services from which the CAVD PI can select appropriate support (depending on their particular needs), specifically:
a. Product development planning, including development of a target product profile.
b. Provision of tools for monitoring objectives vs. deliverables.
c. Development of regulatory strategy and preparation of related filings, e.g. pre-IND and IND (domestic and international).
d. Design and management of preclinical studies, e.g. toxicology.
e. Identification, commissioning, and management of manufacturing partners; cGMP campaigns.
f. Distribution of clinical materials.
g. Clinical development planning and execution through Phase I/II.
h. Continuous project management assistance/support.
i. Quality assurance support across the entire process.
2. Work with the grantee to identify specific needs and then provide a proposal on how the grantee’s needs may be met. The proposal could include specific work recommended, internal and external resources that would be utilized, deliverables, and timelines.
3. Collaborate with the PI on the recommended services they would like to accept; liaise with CAVD Program Officers on overall plans and on likely impacts of any suggested modifications to the project (e.g. additional activities and associated costs).
4. Commence specific projects with an agreed-upon plan, timeline, milestones, and monitoring.
5. Request feedback from the CAVD PIs on the success of each project and lessons learned; implement a process of continuous improvement.