A new report commissioned by the Biotech Industry Organization (BIO) proposes new creative solutions to the current problems facing the biotech industry. While the report recognizes that changes cannot happen overnight, the suggestions here may be the first small steps on the path to improving the sector’s potential for growth.
“The Road to a Brighter Future for Biotech” provides “an in-depth analysis of the current state of the biotech industry and identifies specific ‘game changing’ actions that, if taken, could provide significant benefit to its future health.” The report, not available to the general public, is the result of a request from BIO president and CEO Jim Greenwood to former NIH director Elias Zerhouni, who now heads R&D for sanofi-aventis.
A representative from BIO told Pharm Exec: “The report is a compilation of ideas for BIO’s Board to consider and prioritize. BIO President & CEO Jim Greenwood has been saying this is a three- to five-year project, and some items (particularly those that would require increased funding) may not be feasible now but may be in a few years. Not all of the ideas will be accepted and additional ideas from Board members may be incorporated.”
The report emphasizes that biotech is a “high risk, high public interest industry,” The strategies for improvement that are outlined throughout most of the report aim to accomplish four goals: reduce risk; enhance reward; reduce uncertainty; and “reinforce the position of the industry as a major contributor to the solution of some of the public’s most pressing needs.”
Many of the strategies the report suggests involve rethinking the roles and duties of the FDA, from small changes such as making better use of the FDA’s Fast Track program, to larger, structural changes such as “making FDA a cabinet level agency reporting to the President or other legislative approaches that can provide the agency with the resources and talent necessary to insure its critical missions.”
Another key area for improvement, according to the report, is the possibility of “re-engineering the economic model.” Suggestions in this category include lengthening the period of data exclusivity for drugs that meet criteria for unmet needs, and creating “new financial sources of support adapted to the specific challenges of the industry to sustain its contribution to US competitive innovation.” Other strategies the report outlines include re-focusing on the national innovation imperative and re-defining the industry’s relationship with patient groups.
Communication of the industry’s value proposition is an underlying theme that the report turns to again and again. “In short, it is time that biotech be understood for what it is—a high risk industry with fundamental challenges, but of the highest national interest,” the report says. Wrapping the industry’s fortunes in the political cloak of national interest and security is clearly one of the tools BIO intends to use in enhancing its capacity to shape the policy agenda. Whether it will work depends heavily on whether Congress and other key stakeholders accept the global perspective that BIO believes is critical to success in this sector going forward.