BII-ISTC-Supported Commercialization Effort at Bioiod LLC in Kirov 

BII-funded television advertisements are being shown nationwide in Russia to promote the dietary supplement, IodDar, to combat iodine deficiency disorders. Iodine deficiency, which increases the risks of serious disorders of the endocrine and central nervous system, particularly in children, is a common ailment in Russia and CIS. BioIod LLC was founded to develop and produce food additives and dietary supplements based on natural, protein-bound forms of iodine. The product, IodDar, has been certified and recommended for use by the Russian Ministry of Health.

Despite the great potential of the market, BioIod needed to stimulate sales via a large promotional campaign. BII-ISTC commercialization support funded the production and broadcasting of a television advertisement. The campaign was launched on July 18, and will last through the end of October. In November, an independent consultant will evaluate the efficiency of the campaign and make recommendations to BioIod.

This BII project promotes Russian public health and ensures the commercial sustainability of BioIod LLC, which has a production facility at Kirov-200 and employs 36 former weapons specialists in lucrative civilian production.

Download the video of the advertisement.

Preclinical development of L-Asparaginase - an Anticancer Therapeutic

L-Asparaginase in various forms has been used for more than 30 years as a therapeutic to treat children with acute lymphocytic leukemia. A Russian team of investigators has developed a new recombinant L-asparaginase with lower toxicity and lower production cost. The BII-funded project seeks to take this novel compound through preclinical trials, as well as develop industrial technology for production of the substance. The goal is to generate FDA-compliant preclinical data to file an IND for a new & improved form of L-asparaginase that would be licensable in North America. BII has arranged for collaboration with leading experts at the National Cancer Institute (NCI) in Frederick and St. Jude Children’s Research Hospital in Memphis, Tennessee.

Recently, the L-asparaginase team from Russia met with their counterparts at St. Jude Children’s Research Hospital and agreed that St. Jude would collaborate on filing the IND with the US FDA and the performance of multi-center clinical trials of the drug, once acceptable indicators of safety and effectiveness were obtained in preclinical trials. The two groups also agreed to the exchange of L-asparaginase products for biochemical testing and an extended visit by Russian scientists to the Protein Production Facility at St. Jude.

Biokombinat , Georgia

BII continues to work closely with the Biokombinat facility in Tabakhmela, Georgia , to establish a new animal feed production facility. BII's Implementation Partner CRDF has entered into an initial contract with Ibberson International, Inc., a US industry-preferred engineering and construction company with over a century of experience in feed manufacturing. With assistance from CRDF and its in-country partners at the Georgian Research and Development Foundation (GRDF), Ibberson International Inc. will select and work with a local Georgian engineering company to complete the design and to secure Georgian permits and licenses.

In October, BII has sponsored a two-month personalized training at North Carolina State University for two new employees of Biokombinat--Mr. Gela Kodalashvili, the new General Manager and Mr. David Kurpava, the Quality Control Manager of the new feel mill.

VetBio Training in Ames, Iowa

BII sponsored the participation of 11 Russian and 5 Kazakh scientists in the World Organization for Animal Health (OIE) Veterinary Biologics Training, which took place in Ames , Iowa from 16-25 May 2005. The course comprised of a lecture series, hands-on lab work and facility tours. The delegation had an opportunity to work in the Iowa State University (ISU) College of Veterinary Medicine laboratories and trained in various techniques: ELISA, Western Blot, PCR, Poultry Virology, Molecular Techniques, Bioinformatics etc. The group also toured the biologics production facilities of Arco-Jewel and DowAgro Sciences. CRDF and ISTC provided logistical support for the trip.

Second AAALAC site visit to Pushchino

AAALAC International returned to Pushchino to inspect and certify the animal care program at another BII-supported facility, the Biological Testing Laboratory (BTL) of the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences (BIBC RAS). The AAALAC experts examined the BTL’s Laboratory Animal Care and Use Program, toured the facility and intended to recommend BTL for full accreditation when the Council meets in September. AAALAC accreditation is important to create a sustainable GLP-compliant preclinical studies center at BTL.

TEMPO Awarded a Session at BIO 2006

In recognition of TEMPO’s leadership role in the biotechnology sector in Russia, the Biotechnology Industry Organization (BIO) has approved the TEMPO proposal to host a session, "Issues in International Biotechnological Technology Transfer: Russia" in the "Doing Business Globally" Track of the annual trade fair BIO 2006. Participation at BIO Annual Meetings is a model activity sponsored by BII to showcase the expertise and technologies of BII partner institutions in Russia and the CIS to Western industry. BII will be sponsoring a delegation of scientists and business leaders from Russia and the CIS at BIO 2006, which will be held in Chicago from 9-11 April 2006.

Research Management at IPAC

The BII Program Director has called for the certification of BII Partner Institutions to receive grants from international funding agencies, such as the NIH, WHO, and others, as part of of the strategy for "graduation" from USG Nonproliferation funding. Currently, the ability of many Russian institutes to compete for research funding on an international basis is limited by their lack of internal regulations and processes that conform to the requirements of funding agencies. The CIMIT/BII team is providing expert consultation to position IPAC to receive NIH funding. CIMIT has provided IPAC with a self-assessment questionnaire, which formed the basis for both a gap analysis followed by a thorough review of the NIH grant regulations and the specific policies and procedures IPAC needs to implement to comply with those regulations. This process proved instructive for both IPAC and the CIMIT/BII team to compare how RAS institutes manage research with U.S. NIH-funded organizations.