PharmaSTART History

Purpose:   PharmaSTART, a unique pilot program founded in 2003, addresses the needs of many academic researchers seeking to advance potentially therapeutic compounds across the preclinical ‘Valley of Death” between discovery and clinical trial.  Specific aims have included:

• Defining technical and funding gaps in academic drug development.
• Guiding principal investigators and tech transfer personnel with preclinical development plans and identification of funding opportunities.
• Coordinating multi-institutional responses to translational research funding initiatives.
• Establishing partnerships with stakeholders in the venture community, pharmaceutical industry, foundations, and government to address the challenges of translational development.

Founders:  SRI International, Stanford University, University of California, Berkeley; University of California, San Diego; University of California, San Francisco

Partnering Vignettes

Academic Translational Partnership- Dr. Gerry Boss, a professor of medicine at UCSD, studies the properties of cobinamide, a compound produced in the biosynthesis of cobalamin (vitamin B12).  His work was submitted to the PharmaSTART program by UCSD and SRI drafted a preclinical development plan (PDP) for several applications of cobinamide as a chelating agent to neutralize toxic compounds.  Among the recommendations were applying for funding to develop cobinamide as a detoxifying agent for cyanide poisoning.  In 2006, Dr. Boss was awarded a 5 year, $3.3 million dollar grant from the NIH Department of Health and Human Services (DHHS) for Countermeasures Against Chemical Threats (CounterACT) Cooperative Research Projects.  Working with Dr. Boss, SRI will conduct preclinical studies outlined in the PharmaSTART plan.  The PharmaSTART program thus identified an alternative therapeutic indication and funding source, guiding this exciting work toward important national defense and domestic applications.

Government Translational Partnership- Botulinum toxin, the most poisonous substance known, was weaponized by Iraq and released over Tokyo by the Japanese cult Aum Shirikyo in the 1990s and is rated as one of the nation’s major biothreat concerns.  Based on the PharmaSTART preclinical development plan (PDP) concept, the National Institute of Allergy and Infectious Diseases (NIAID) contracted SRI to write a detailed preclinical and clinical plan to develop a set of monoclonal antibodies to neutralize Botulinum toxin A.  Following delivery of the plan, SRI teamed with experts in botulinum toxin antibodies at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the University of California, San Francisco, and with the antibody manufacturing experts at XOMA, Inc.   In September 2008, this project received $65 million to further development of these antibodies, the third contract awarded to the team, bringing the total awarded to the project to $99 million. 

PharmaSTART Evolution

Building on the successes of the initial PharmaSTART program and in response to requests from participating and non-participating institutions, SRI International is continuing the program and establishing new partnerships for translational development.  These include:

• Direct Translational Partnerships- SRI academic partnerships have produced marketed drugs (e.g., Targretin®, developed with The Burnham Institute and Ligand Pharmaceuticals,  marketed by Eisai Pharmaceuticals) and drugs in clincal development (e.g., pralatrexate, developed with Memorial Sloan Kettering Cancer Center and Southern Research Institute, NDA submitted by Allos Pharmaceuticals). SRI will work with individual institutions to establish alliances that match complementary capabilities, ranging from grant teaming to regional economic initiatives. See ' Partnering with SRI'

• Center for Advanced Drug Research (CADRE)- In partnership with the Commonwealth of Virginia, SRI has established a center in the Shenandoah Valley (SRI SV) focused on proteomics and drug development for emerging infectious diseases. For further information on partnering opportunities, please contact Krishna Kodukula at krishna.kodukula@sri.com

• SRI Five Disciplines of Innovation (DoI) Program- SRI has a long history of innovation, ranging from the first computer mouse to new drugs for malaria to robotic surgery.The processes and practices that drive these successes were recently elaborated by SRI’s CEO Curt Carlson in his book on “Innovation”. SRI is teaching these principles through its DoI program, and through this program is establishing new international centers for innovation encompassing multiple technological disciplines.  For additional information, contact: innovation@sri.com

• SRI IND Engine- To address the growing pharmaceutical pipeline gap at companies around the world, SRI has established the SRI IND Engine, a drug lead optimization and preclinical development program that includes proprietary SRI compounds as well as drug candidates from companies that lack the financial resources to advance some or all of their current portfolio.  This program combines public and private funding with SRI expertise to allow biotech companies to function in virtual mode, adding value and developing licensing opportunities.