In yet another high-profile, federally-funded initiative similar in scope to its partnership with Texas A&M on the new CIADM influenza vaccine facility in College Station, British multinational pharmaceutical, biologics, vaccines and consumer healthcare company GlaxoSmithKline plc (GSK) has been awarded up to $200 million by the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) in a first-of-its-kind collaboration to develop several new antibiotics to counter threats of antibiotic resistance and bioterrorism.
GSK, which describes itself as “one of the few large pharmaceutical companies still pursuing antibacterial research,” already has contracts with BARDA and other agencies for vaccines and antibiotics development, but this new public-private agreement marks the first time that HHS has taken a “portfolio approach” to funding drug development with a private sector company, an arrangement that will facilitate flexibility to move funding around GSK’s antibacterial portfolio rather than focusing on just one drug candidate, and will allow medicines to be studied for the potential treatment of both conventional and bioterror threat pathogens.
Under terms of the agreement, HHS will provide GSK with $40 million in funding for the initial 18 months of the agreement, and subsequently up to a total of $200 million if the agreement is renewed over five years.
Treatment of drug resistant bacterial infections is apprehended to have the potential to become a global crisis at any time due to scarcity of new antibiotics and antivirals in the pharmaceutical industry’s pipeline, combined with a decrease in investment in research and development. A GSK release notes that many companies have in recent years withdrawn from antibacterial R&D due to the scientific challenges and lower returns on investment, affecting medical and public health ability to treat bacterial infections, and compromising national security preparedness to tackle biothreat pathogens. Consequently, they contend that public-private partnership is important to help sustain effort in this area of science.
“There is an urgent need to address antibiotic resistance, and new models are needed to deal with this challenging area of drug development,” says David Payne, head of GSK’s Antibacterial Discovery Performance Unit. “We strongly believe that innovative public-private partnerships such as this are integral to solving this critical healthcare issue and we are delighted to work with BARDA in a more strategic way.”
Work under the new GSK/BARDA agreement will be governed by a joint oversight committee that will monitor progress, make decisions on the allocation of funds, and determine the addition or removal of drug candidates from the development portfolio.
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GlaxoSmithKline’s Partnership With Texas A&M on the CIADM Influenza Vaccine Facility
GSK is an industry leader in government research collaborations and as noted has had other contracts with BARDA and other agencies for vaccines and antibiotics development. In March, the Texas A&M System and GlaxoSmithKline received U.S. government approval for establishment of an influenza vaccine facility in Texas to develop and manufacture GSK’s next generation influenza vaccines to be kept in readiness against global pandemics. The $91 million influenza-vaccines manufacturing operation will anchor Texas A&M‘s Center for Innovation in Advanced Development and Manufacturing (CIADM) at Bryan-College Station.
[adrotate banner=”9″]At the March 26 project announcement, Texas Governor Rick Perry said: “Today’s announcement is a huge win for Texas and for the nation. The Texas A&M Center, anchored by this facility, is expected to bring more than $41 billion in expenditures within the State of Texas over the next 25 years, and will add more than 6,800 direct and related jobs to Texas.”
“We are honored to welcome GSK to Texas A&M as a key partner in the Center for Innovation,” commented Texas A&M System Chancellor John Sharp. “GSK’s dedication to public service is well-aligned with the Texas A&M tradition of serving the nation and defining its future through research and scholarship. Equally important is the cultural and philosophical match between GSK and the A&M System, as reflected by GSK’s desire to collaborate with academia and the U.S. government, and their ongoing commitment to helping address global health scourges such as pandemic influenza and malaria.”
“GSK is privileged to deepen our commitment to U.S. public health, as part of this unprecedented public-private collaboration to protect against pandemics and bio-threats,” noted Antoon Loomans, Senior Vice President, GSK Vaccines. “In Texas A&M we have found a partner with a rich tradition of service, and with pioneering technologies that will benefit the entire pharmaceutical industry in making vaccines available and accessible to all in need.”
The Texas A&M Center for Innovation in Advance Development and Manufacturing (CIADM), lead by Dr. Brett Giroir, Vice Chancellor for Strategic Initiatives at the Texas A&M System, and a core team of A&M experts in biotechnology, infectious diseases, facilities planning and construction, federal acquisitions/contracting, and government affairs, is one of three centers established in June, 2012 by the US Department of Health and Human Services to enhance the nation’s emergency preparedness against emerging infectious diseases, including pandemic influenza, and chemical, biological, radiological and nuclear threats.
The Texas A&M Center is at the vanguard of U.S. pandemic-preparedness efforts and represents unprecedented public-health collaboration among state and federal governments, academia and private industry. Once constructed and operational, the Center’s influenza manufacturing facility will be able to supply 50 million doses of pandemic influenza vaccine within four months of an outbreak. BARDA conceived the public-private formula to assure a strong biosecurity product development and manufacturing base on U.S. soil, ensuring that the nation would have rapid access to vaccines and therapeutics in the instance of pandemics or bioterrorist attacks.
The Center is founded on an initial $285.6 million investment, including a $176.6 million contribution from the US Department of Health and Human Services, with the remainder cost-shared by commercial and academic proposal partners. The partnership with GSK was founded on a long, collaborative relationship between Texas A&M and the Wallonia Region of Belgium, with specific planning for this project having begun in the spring of 2010.
The TAMUS influenza vaccines manufacturing center will provide GSK with the capability to eventually manufacture influenza vaccine based on French pharmaceutical company Vivalis’s proprietary cell-culture line, EB66. Most existing influenza vaccine is manufactured using fertilized chicken eggs. The cell-culture process will supplement the vaccine supply from eggs, and facilitate a rapid national vaccine response in the event of a pandemic.
The Center will perform research and advanced development to accelerate vaccines and other medical products through pre-clinical and clinical development and produce these products in cases of pandemics or other national emergencies. Through these activities, the Center will address a recognized shortcoming in preparedness and response to known and unknown threats, and will improve our nation’s ability to protect the health of its citizens in emergency situations.
GSK Vaccines produces 30 vaccines worldwide, eleven of which are licensed by the FDA. The Texas A&M-GSK venture will complement and support the company’s existing influenza vaccines operations, based in Quebec, Canada, and Dresden, Germany. GSK’s operations hub in Marietta, Pennsylvania will package, inspect and distribute influenza vaccine manufactured at the Texas A&M Center. In 2012, GSK provided more than 20 million flu shots for the U.S. market and recently became the first major U.S. vaccines provider to gain FDA-approval for a broader-protection, four-strain (quadrivalent) influenza vaccine shot that will be available in time for the 2013-14 flu season.
As one of the few large pharmaceutical companies still pursuing antibacterial research, GSK also has creative collaborations and funding partnerships with other companies, academia, and funding bodies such as the Innovative Medicines Initiative, Europe’s largest public-private initiative and the Defense Threat Reduction Agency, which is part of the U.S. Department of Defense.