Consortium to drive medical countermeasures
Every type of work has its unique tools and equipment developed specifically to protect employees from the hazards of the job at hand. For many occupations, protection focuses on gear designed to prevent external injury to the body, such as construction workers’ hard hats and steel-toed boots or professional hockey players’ protective helmets and body gear. For members of the Canadian Forces (CF) and first responders to natural or accidental catastrophes or acts of terrorism, such external physical protection addresses only part of the safety and security equation.
CF personnel and first responder teams of police, firefighters, paramedics, and humanitarian aid workers must perform extraordinary duties in some of the most extreme environments and hazardous conditions imaginable. Whether on the battlefield or within a disaster zone, an invisible layer of danger may exist in the form of chemical, biological, or radiological (CBR) threats.
As an agency of National Defence, Defence Research and Development Canada (DRDC) supports the Surgeon General to prepare for, protect from, and mitigate the results of such threats through research, development, and delivery of effective medical countermeasures (MedCMs), which can include vaccines, drugs and diagnostic equipment. Some MedCMs are given prior to entering a danger zone and others are designed to neutralize or reduce harm caused by exposure to agents present in the operational environment or as a result of intentional release by an adversary.
One such area of major concern is finding countermeasures against nerve agents, some of which can be fatal within minutes of exposure. For more than 35 years, Canada has led and conducted research on HI-6, a promising antidote that provides superior effectiveness against a broad range of nerve agents. The CF has chosen it as its lead nerve agent MedCM. Since the early 1990s, defence personnel from several nations, including Canada, have relied upon an auto-injector containing oxime HI-6 for immediate treatment of chemical agent exposure. Although approved for this special use, HI-6 is still undergoing safety and effectiveness testing and DRDC Suffield and its partner, UGM Engineering of Toronto, are investigating an intravenous version for public security use.
In today’s post-9/11 environment, rapid development of new MedCMs to counter known and emerging threats continues to be a priority across the world. One clear example of a challenge to international readiness to stop a major public health threat was the successful handling of the global pandemic influenza outbreak of 2009.
Despite the urgency and vital need for MedCMs, there are no short cuts to placing them in the hands of medical practitioners. Consider, for example, that a medicine dispensed routinely at any neighbourhood pharmacy is the one victorious candidate out of perhaps several hundred that were originally researched, tested and approved, often internationally, over a typical 10- to 15-year period.
Not only are long lead times necessary for such multidisciplinary research, most MedCMs that address chemical, biological or radiological threats cannot be entered into the usual Health Canada process of approvals for clinical use. Many MedCMs address situations for which there is no known counterpart in general medicine, requiring a different development and approval process. Of course, in life-or-death situations, both DND and the Public Health Agency of Canada (PHAC) can be authorized under a special program to deploy MedCMs still waiting approval.
The successful and timely development of MedCMs demands coordinated national and international action, given the costs, complexity and regulatory requirements that exist between countries.
“There is no strategy or mechanism to complete the safety and effectiveness assessment of medical countermeasures that are so very important to national and public security,” Dr. Kent Harding, chief scientist at DRDC Suffield, points out.
To remedy this, in 2009, DRDC and its national partners, which include DND, Health Canada and PHAC, began working on a medical countermeasures consortium concept to support MedCMs development nationally and internationally. The consortium model is a whole-of-government approach involving defence and public health organizations as well as industrial and academic partners.
Taking a leadership role, DRDC has approached national and international partners to build a robust business model and secure predictable, consistent funding to advance the MedCMs agenda. Partnerships are being forged within the health and defence portfolios of four key countries: Canada, the United States, the United Kingdom and Australia.
“The definition of ‘consortium’ is key to how we have structured this concept and engaged our national and international partners,” says Dr. Camille Boulet, director general for DRDC Suffield, who is leading the national and international engagement. “A consortium is intended to bring together communities to achieve something that separately they could not. This consortium allows all partners to contribute in an equitable and purposeful manner to ensure that our respective nations have the needed countermeasures.”
To this end, a major international coordination meeting will take place in Washington, D.C. on February 6 and 7, 2012 to discuss collaboration plans, to be followed by an international MedCMs conference that will include input from government, industry, health institutes such as the Canadian Institutes of Health Research (CIHR), and academia.
“We reached out to our closest allies for the defence aspect, and to public health because of their role and common cause with defence,” Harding notes.
As part of the formulation of the consortium, DRDC looked for models in other nations that currently have strategies in place to achieve final MedCM products with the necessary regulatory approvals. The U.S. was the only nation to have such a strategy, and after exploring the mutual benefits, the first international partnership was formed.
Important, new regulations in Canada have recently been recommended to provide an opportunity for extraordinary drugs, such as the MedCMs envisioned in this partnership, to be submitted for consideration of their safety and efficacy. Notably, related legislation already exists in the U.S. Regulatory approval is the key objective in these MedCM partnerships, and these new regulations provide a critical path for candidate MedCMs to prove their worth.
The consortium model envisions an integrated capability to produce MedCMs according to the common or separate requirements of defence and health, addressing various departmental obligations, national requirements, and the ability to capitalize on international opportunities. Another benefit of the consortium approach includes the sharing of manufacturing among countries so that each country would not have to manufacture and stockpile every MedCM, leading to cost reduction while increasing the number of final MedCM products.
“This critical activity is beyond what any one company, government department or country could achieve alone,” Harding explains. “We need a consortium to each do their part to deliver needed MedCMs from the laboratory to approved use by military and first responders,”
DRDC Suffield has a number of unique, world-class facilities and capabilities that could be shared through collaboration with national and international academic and government institutes as well as with industry. These include genetics, neurobehaviour, modelling of injury mechanisms and treatment, and broadly-based chemical synthesis and analytical capabilities. The research centre has the mandate and capability to synthesize, maintain and use listed chemicals in small-scale defensive experiments and operates specialized facilities and equipment to work safely with viruses and bacteria.
“As we’ve seen with potential pandemic and emerging diseases and the deployment of Canadians to countries where there are diseases we do not normally see, as well as the possibility of chemical and biological exposure, it is critically important to be able to provide MedCMs to protect CF members while deployed,” says Dr. Harding. “Those realities require that we find ways to complete the development of MedCMs to preserve both civilian and CF members’ health and protect them at home and abroad.”
Lynn Capuano is a writer with Defence R&D Canada.