About PharmaSTART
PharmaSTART™ is a consortium of research organizations led by SRI International that offers translational drug development services to help California-based universities, research institutes, and small biotech companies bridge the gap between identifying exciting new drug discoveries and bringing them successfully through clinical development. The goal of PharmaSTART is to facilitate the translation and funding of discovery research from California based Universities and small cap companies, by offering drug development consulting, networking, and drug development services including lead development, GLP toxicology, analytical and regulatory services and cGMP manufacturing.
A breakthrough drug may show great promise based on early data, but at this stage is usually considered too risky for investment by venture capital or as a licensing candidate by the biopharmaceutical industry. However, significant market value can be created once the drug completes clinical studies that establish safety and preliminary efficacy. For the inventor with little or no access to drug development services, expertise or funding, PharmaSTART offers a roadmap and guidance to bridge the gap and help bring a drug candidate to clinical use.
Resources to Jumpstart Your Success
PharmaSTART is a center for sharing resources for drug development in California and beyond. Consulting services include:
- Consulting Services to Foster Drug Translation
PharmaSTART funds up to 30 hours of consultation per project to establish a specific drug development plan, focusing on tasks needed to efficiently move the drug to the clinic according to FDA guidelines. Typical consulting services include the areas of lead development and optimization, cell line characterization and banking, manufacturing, toxicology, analytic methods, pharmacokinetics and ADME, biomarker assay development and validation, IND compilation, regulatory affairs and FDA interaction. SRI will also provide assistance to investigators and small companies in preparing needed government grants and contracts for translational drug development and business plans.
- Government Funding Assistance
PharmaSTART will help investigators navigate the web of government procurement regulations and procedures, identify potential funding programs, and comply with FDA regulations. SRI can assist the investigator in preparing proposals for National Institutes of Health (NIH) Small Business Innovative Research (SBIR) and Small Technology Transfer (STTR) grant programs and other programs that facilitate drug development. SRI can interact with government project officers to determine interest, provide the environment and team for conducting the research as a subcontractor when appropriate, and identify, qualify, and manage other subcontractors to carry out specific parts of the work as required.
- Resources and Networking
PharmaSTART provides resources to network specialized, complicated and expensive developmental tasks such as cell therapy or gene therapy cGMP processing; cell line banking and protein cGMP manufacturing; small molecule cGMP manufacturing; GLP toxicology, synthesis and scale up, formulation, analytical services and stability testing, pharmacology and regulatory affairs. A goal of PharmaSTART is to foster inter-institutional collaboration in drug development.
- Regulatory Compliance
PharmaSTART can provide universities with regulatory quality assurance guidance for various university development projects leading to clinical studies.
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