HPA Achieves Major Success in Obtaining US Biodefence Funding

On July 21st 2004 President George W Bush signed into law Project Bioshield, which provides new tools to improve medical countermeasures protecting Americans against a chemical, biological, radiological or nuclear (CBRN) attack. A large proportion of the multimillion dollar funding has been allocated to the National Institute of Allergy and Infectious Diseases (NIAID), which conducts and supports research aimed at developing and improving medical tools against bioterrorism agents, particularly the development of new vaccines, therapies and diagnostics.

Being a government laboratory with over 50 years worth of experience in the handling of highly infectious microorganisms and the development and manufacture of vaccines, the HPA’s recently renamed Centre for Emergency Preparedness and Response at Porton Down was in an ideal position to bid for various “Requests For Proposals” issued by NIAID. A number of specialist teams including researchers, technical experts and managers were therefore put together in order to write comprehensive contract tenders for specific projects.

Following systematic reviews by the US authorities, the HPA has received a significant number of Task Order awards from NIAID which will contribute considerably to income at the centre over the next few years. To date a total of five different Task Orders have been awarded which in total could be worth up to $18 million over the next few years, if all the contracts continue for their full term.

The income from these Task Orders covers not only the cost of undertaking the research, but there is also provision for the purchase of equipment, as well as some money to build new state of the art facilities on the Porton site, since some of our existing laboratories are already fully committed to existing programmes.

Examples of the scope of the work include studies to evaluate the effectiveness of antibiotics against anthrax, work on developing models for the next generation smallpox vaccine and screening compounds for antimicrobial activity.

Partnering with US Companies

As well as being successful in obtaining direct funding from the US government, the expertise inherent within Porton has also enabled us to achieve further success in partnering with US companies who have received their own funding under project Bioshield.

Since the HPA is one of the few organisations in the world that has the facilities to undertake a full spectrum of work with infectious organisms (from basic and applied research, through process development, scale-up and manufacture of clinical grade material, plus the necessary quality and regulatory support) we were in a great position to be partners of choice for companies that wanted to bid for funds, but did not necessarily have all the facilities required within their own organisations.

Two companies with which we have developed successful relations are VaxGen and Emergent.

In November 2004 VaxGen were awarded a supply contract for 25 million doses of anthrax vaccine based on a recombinant form of the Protective Antigen (rPA) by 2006. This next generation vaccine is intended for the strategic national stockpile which will be held at the US Centres for Disease Control and Prevention.

The HPA has been undertaking contract analysis of serum samples to provide support to preclinical and clinical studies. This has been ongoing since … and we currently envisage providing this support into the next few years as the product approaches licensure.

In January 2205 the HPA and Emergent BioSolutions Inc of Gaithersberg Maryland announced a two year $2m collaboration to develop vaccines to prevent botulism. Emergent, through its subsidiary BioPort Corporation, manufactures and markets BioThrax™ the licensed US anthrax vaccine.

The initial objective of the programme will be the development of both multivalent botulinum toxoid vaccines and multivalent recombinant botulinm toxoid vaccines. The parties have agreed to share their technology and expertise and Emergent believes that this approach offers the fastest and most reliable route to producing an IND stockpile and ultimate regulatory approval of a multivalent vaccine.