Late last week, the Department of Health and Human Services released its report on responding to health emergencies — a process known as “medical countermeasures” or “MCMs” (see press release, fact sheet, and full report. The report, with the official title of The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs, grew out of the concerns over the response to the H1N1 (swine flu) pandemic. According to the report:
Our Nation must have the nimble, flexible capacity to produce MCMs rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease.
. . .
Findings in several key areas led to the development of the new strategy, including: (1) enhancing regulatory innovation, science, and capacity; (2) improving domestic manufacturing capacity; (3) providing core advanced development and manufacturing services to development partners; (4) creating novel ways for the enterprise to work with partners; (5) developing financial incentives, (6) addressing roadblocks from concept development to advanced development; and (7) improving management and administration within the enterprise.
The review recommends new infrastructure initiatives as well as enhancements to the current system. The new initiatives include: (1) enabling innovative regulatory science and oversight, (2) fostering flexible manufacturing and advanced development core services partnerships that focus on new platforms for novel product development and manufacturing, (3) expanding the product pipeline by exploiting new concepts emerging from the science base and addressing multiuse potential for these products, and (4) consideration of the development of an independent strategic investment firm for innovation in MCMs.
This is a great example of a strategy for the I-Cubed Economy — quick response, flexibility and innovation. There is a lot here, including product development and domestic production capability. One immediate outcome of the report, according to the press release, will be draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing:
The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the U.S. rather than relying on foreign manufacturing.
The review found that some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing. Therefore, the Centers of Innovation for Advanced Development and Manufacturing will also serve as resources for young companies, helping them bring products to market and helping the U.S. government increase the number of new countermeasures available in an emergency.
A key point on the manufacturing process. The review highlighted the need for facilities that can process multiple medications or vaccines and produce them quickly. Setting up a dedicated manufacturing process once a specific threat has been identified simply takes too long. The manufacturing needs to be in place before hand and ready to deal with whatever product is needed. This nimble manufacturing is a key part of the I-Cubed Economy. These new Centers, therefore, should be able to provide groundbreaking work on the movement toward more nimble medical manufacturing in general, not just for emergencies.
Likewise, the Centers working with small biotech companies on product development should result in new processes that would be applicable to a wide range of bio-medical products. As a result, such Centers will not only help meet the need for rapid response to health emergencies but may help transform the industry.