Welcome to the Small Biotechnology Business Coalition Website
The Small Biotechnology Business Coalition (SBBC) is an advocacy organization for America’s small, innovative biotechnology and medical device companies. We advocate for government programs and policies that help small bio-tech firms bring innovative products and technologies to market, thereby creating sustainable economic and job growth, curing or mitigating many diseases, and ultimately reducing health care costs.
Our 2015 Legislative Priorities – The 21st Century Cures Act
The House of Representatives’ 21st Century Cures Act and Senate counterpart Innovation for Healthy Americans are key 2015 priorities for Congress (link), is expected to significantly impact the manner in which drugs, devices and diagnostics are developed, regulated, and reimbursed. The SBBC is the only organization working to include specific provisions in the Cures Act that help small biotech companies, the source of one-half of all new cures, advance and commercialize their technologies.
We are presently working to help shape two key sections of the Cures Act:
Commercialization of NIH funded R&D
Our proposed Commercialization Advisory Councils would give small businesses a seat at the table in setting funding priorities at the largest institutes at the NIH. These Councils would recommend the levels of SBIR allocations each year along with policies to improve the SBIR review process. The Councils would also ensure that adequate funding is allocated to academic researchers to reproduce and validate their discoveries in order to reduce the time and costs of small businesses that license technologies from universities. Click here to download details.
Encouraging Diagnostics Innovation
Recent announcements by the FDA to regulate laboratory developed tests (LDTs) has prompted action by members of Congress. The SBBC has drafted language to for inclusion into the Cures Act to protect innovative diagnostics tests that address unmet medical needs from excessive and unpredictable regulation. Also recommended are incentives for investment in diagnostics which historically receives less venture capital than drugs or medical devices. Click here to download details.