New business model for researching, producing vaccines
Relying on venture capital-funded biotech research is problematic when it comes to vaccines for pandemics and bioterrorism; an expert proposes a private-public partnership within the HHS Biomedical Advance Research and Development Authority
There are many problems with the venture capital-funded biotech business model, and leaders in the public health area offer we examine other models. University of Pittsburgh Medical Center CEO Jeffrey Romoff testified before congress two weeks ago, proposing a public/private model for vaccine production. Before outlining his proposal, Romoff defined the fundamental problem of developing vaccines against pandemics and bioterrorism in the United States:
There is no commercial market for these products [vaccines] outside the government, there are substantial opportunity costs for these companies [traditional pharma], and they have largely not seen the government as a predictable partner in this enterprise.
As a consequence, the current U.S. approach to biodefense medicine and vaccine development relies almost completely on small biotech companies. These companies are innovative and focused, but few have demonstrated the capability to produce licensed vaccines or medicines, and few have in house the technical expertise and/or regulatory experience needed to do this work.
His proposal calls for creating a nonprofit partnership that would build a facility incorporating single-use technologies to produce prophylactics for pandemic disease — but also bioterror countermeasures.
Romoff told the Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies that traditional business approaches “have not yielded the biologics, vaccines and countermeasures required.” He noted that universities lack the ability to bring great ideas to market, and drug companies do not regard the government — which is often the sole customer of pandemic and bioterror vaccines — as “a predictable partner in this enterprise.”
Romoff proposed that a public/private partnership be set up within the HHS Biomedical Advance Research and Development Authority. This would allow for a flexible, multi-product medical countermeasures development and manufacturing facility which is capable of making multiple products concurrently in different suites, using disposable technology “that can easily be changed depending on the needs and requirements of the government.” All suites could be converted to the manufacture of a single product in the event of a bioterror attack.
