Bureau of Nonproliferation
September 16, 2003
The BioIndustry Initiative’s mission is to counter the threat of bioterrorism through targeted transformation of former Soviet biological weapons research and production capacities.
The U.S. Department of State BioIndustry Initiative (BII) is a nonproliferation program authorized in the Defense and Emergency Supplemental Appropriations Act for FY 2002 (Public Law 107-117). BII focuses on two objectives:
BII focuses on peaceful, transparent and ultimately self-sustainable redirection of biological research and production facilities in the former Soviet Union. BII facilitates partnerships between U.S. pharmaceutical companies and their Russian counterparts; utilizes consultation of both western and Russian marketing, business and engineering experts to assess and characterize core capabilities and strategic planning for the institutes; and develops skills and infrastructure required for a viable biotech sector in Eurasia. BII is a unique U.S. Government program providing patenting, commercialization, training, and business and market development for both the research institutes and large-scale production facilitates in the former Soviet Union.
Targeted Transformation of BW Capacities
By fostering new partnerships and diversifying funding sources, BII hopes to achieve its long-term goal of transforming former BW facilities into viable research and production institutions. BII engages specific institutes, assesses their core capabilities as well as the appropriate domestic and international market, then pairs Russian laboratories with American researchers in both academic and industrial sectors. BII may also fund projects in support of U.S. and Russian partnerships where promising technologies offer alternative routes to research and development. BII brings intensive partnering and facilitation through marketing, legal and business expertise to both the institute and the individual scientist. This strategy allows the institute to decrease the reliance on nonproliferation funding sources while increasing transparency on a defined pathway toward greater self-sustainability.
The BioIndustry Initiative’s initial funding was authorized in the Department of Defense and Emergency supplemental appropriations for Recovery from and Response to Terrorist Attacks on the United States Act, 2002 (P.L. 107-117), Division B – Fiscal Year 2002 supplemental appropriations, Chapter 3. This appropriation transferred $30,000,000 to the Department of State, Nonproliferation, Anti-terrorism, Demining, and Related Programs "for the purpose of supporting expansion of the Biological Weapons Redirect and International Science and Technology Centers programs, to prevent former Soviet biological weapons experts from emigrating to proliferant states and to reconfigure former Soviet biological weapons production facilities for peaceful uses."
BII also receives annual funding through the U.S. Department of State’s Office of Proliferation Threat Reduction, which supports both the Science Centers and Bio-Redirect nonproliferation programs working in Eurasia. BII works as part of a coordinated effort with the Department of Health and Human Services (DHHS), Department of Agriculture (USDA), and the Environmental Protection Agency (EPA).
Accelerating Vaccine Development
In close cooperation with the Biotechnology Engagement Program (BTEP) of the U.S. DHHS, BII identified a novel vaccine platform technology, currently being validated through a BTEP sponsored project at the State Research Center of Virology and Biotechnology VECTOR (Koltsovo, Novosibirsk region). BII organized an independent technical validation of the HIV-1 vaccine in collaboration with Dr. Jeffrey Gelfand of Massachusetts General Hospital / CIMIT, Dr. Barton Haynes of Duke University Medical Center’s Human Vaccine Institute and Dr. Richard Markham of Johns Hopkins University. Initial in vitro testing supports Vector’s data, indicating broad reactivity to HIV-1. In addition to these initial results, BII has organized contact between the inventor and Wyeth Vaccines as well as Aventis Pasteur, both leading the race to develop a vaccine against the AIDS virus. Based upon positive technical and market feedback, BII has supported a strategic patent filing to extend Vector’s proprietary approach beyond applications for HIV to include infectious diseases such as Hepatitis C and Influenza.
This work represents a model activity for BII’s accelerated drug and vaccine program. BII continues to support a variety of such activities, including a extensive program on multi-drug resistant tuberculosis in Russia.
A major challenge to Russian institutes attracting an international, commercial clientele for contract research and testing services is meeting internationally recognized standards of Good Laboratory Practice (GLP). The goal of the Russian -- American BioIndustry Initiative, Integrated Toxicology Testing (RABIITT) program is to ensure sustainability of the Russian research institutions by: a) developing an international client base for certified toxicology testing services, b) building institutional pre-clinical toxicology capacities, and c) validating data to U.S. Government regulatory agencies. BII staff performed initial assessments of five target institutes in July 2003. Currently, BII is selecting vendors to provide GLP validation and auditing services to these institutes. Based upon the audit results, specific upgrades, training and other remedial actions will be undertaken in cooperation with participating institutes to make them compliant with GLP and other international standards.
‘Graduation’ for RCMDT
The Research Center of Molecular Diagnostics & Therapy (RCMDT) is a multidisciplinary research institution specializing in molecular medicine. It is the first institute to be engaged by the BioIndustry Initiative with the specific goal of graduating into transparent, sustainable research through a mixture of academic and commercial partnerships.
Applied research: With BII support, RCMDT is undertaking a drug discovery program to identify and develop new methods of treatment of drug resistant tuberculosis based upon drug-loaded polymeric nanoparticles. RCMDT is working in collaboration with the Moscow Medical Academy to improve the treatment of MDR TB and also potentially extend this technology to other drug resistant infections.
U.S. Industry Partners: RCMDT has established a relationship with a U.S. biotech company to develop new drug delivery systems for the treatment and prevention of tuberculosis and cancers.
Academic Funding: RCMDT was recently included in an NIH grant to receive funding for a collaborative research project on the development of novel approaches to disease research.
BII at Vostok
Joint Stock Company (JSC) Vostok was first established as a biologics manufacturing facility utilizing large-scale fermentation under the auspices of Biopreparat. It recently became a joint venture between private investors and Biopreparat. Currently, Vostok’s major activities include production and sale of medical infusions, pharmaceuticals, and industrial enzymes. BII learned that Vostok is underutilizing its fermentation manufacturing capacity due to insufficient downstream manufacturing capabilities. To achieve long-term sustainability of this facility, BII and Vostok began a joint effort to analyze the marketing environment to determine how to best utilize its manufacturing capabilities and resources. Collaboration with Vostok began in March 2003 with a market assessment of the fermentation products industry in Eurasia. In late April 2003, BII and Vostok began planning a workshop to conduct a market analysis for the microbiological business of the plant, to include a thorough assessment of the fermentation products market opportunities in Russia and Europe. Vostok is currently working towards a production line upgrade to address the results of the market study.
BII continues to support Vostok’s redirection to commercial, transparent and ultimately profitable activities.
Russian Biotech Presence at BIO 2003
BII sponsored over a dozen Russian researchers from former BW institutes and supported the Russian booth at the Biotechnology Industry Organization’s (BIO) 2003 trade show. Visitors to the BII booth often noted that they did not realize that there was a world-class biotech capability in Russia. An important outcome of the BioIndustry Initiative’s presence at BIO 2003 was the establishment of a partnership with the Global Alliance for TB Drug Development, which will visit Russia in September 2003 to leverage the Initiative’s access to TB drug and vaccine developers in Russia.
BIO 2003 represents a model activity for BII in that it fosters both new partnerships as well as new exposure of world-class Russian research and production.