Washington, DC (February 20, 2019) – The Biotechnology Innovation Organization (BIO) announced today it will join the Taiwan Bio-Industry Organization (Taiwan BIO) to host BIO Asia-Taiwan from July 24-28 in Taipei, Taiwan. The event is expected to attract more than 1,500 people from 25 countries representing biomedical, pharmaceutical, genomics, biotech services, equipment and instruments, academic research, cosmetology products and bio-based healthcare. Themed “Biotech as the Next Growth Engine for Asia”, the five-day event will feature rich programming, company presentations from Asia and around the world, BIO One-on-One Partnering™ meetings, seminars and workshops, and an exhibition featuring more than 1,700 booths from over 600 companies. “Taiwan is already a global powerhouse in technology, IT and computing systems,” noted Jim Greenwood, President and CEO of BIO. “As biotech evolves, we are marrying new breakthroughs like artificial intelligence with Big Data derived from the human genome. That’s why Taiwan is uniquely situated to play an integral role in the future of our industry.” Johnsee Lee, Chairman of the BIO Asia-Taiwan 2019 Organizing Committee agreed with this analysis. “As many innovative biomedical advances in the future will be closely integrated with digital technologies, and with the ICT industry being a unique advantage of Taiwan, this year's BIO Asia-Taiwan conference will showcase Taiwan's digital advantage in this sector,” he noted. “Applications such as AI, smart hospital and medical devices, precision medicine, etc., will be showcased as Taiwan takes the opportunity to encourage its electronics industry leaders to invest resources in biotech.” BIO’s One-on-One Partnering™, a major feature at the conference, will offer attendees a user-friendly way to schedule individual meetings with potential partners or collaborators by accessing a database with abundant profiles and other information. Meetings can be arranged prior…

BIO Executive Vice President for Health Policy Dan Durham issued the following statement regarding the CMS proposed decision memo for the CAR-T National Coverage Determination.

The Biotechnology Innovation Organization (BIO) applauds Sens. Thom Tillis (R-NC), Kyrsten Sinema (D-AZ), Gary Peters (D-MI), and David Perdue (R-GA) for introducing the Fostering Innovation Act (S.452) to build on the success of the Jumpstart Our Business Startups (JOBS) Act. 

Washington, DC (February 11, 2019) – Today, to recognize National Inventors’ Day, the Biotechnology Innovation Organization (BIO) released a new report, “Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?” The report shows the detrimental impact of Sarbanes-Oxley 404(b) on biopharmaceutical emerging growth companies (Bio-EGCs) and demonstrates how this regulatory requirement harms innovation and capital formation without any corresponding investor benefit. “It’s an exciting time for the life sciences sector,” BIO’s President and CEO Jim Greenwood noted, “but we must do more to protect small business innovators from regulatory burdens that are counterproductive to their mission. As this study proves, failing to exempt pre-revenue biotech companies from costly and unnecessary regulations is harming innovation, capital formation, and the ability of companies to develop breakthrough medicines and cures.” The study was conducted by renowned economists, Craig Lewis, a Senior Advisor at Patomak Global Partners and Professor of Finance and of Law at Vanderbilt University, and Joshua T. White, Assistant Professor of Finance at Vanderbilt University.  In it, the scholars point to mounting evidence that links Section 404(b) compliance to reduced market capitalization, higher audit fees, exiting of public markets, and a direct reduction in innovation such as R&D that results in fewer patents.   Under the JOBS Act, enacted in 2012, small companies like Bio-EGCs were granted a five-year exemption from the costly Section 404(b). Since the law’s passage, more than 300 Bio-EGCs have gone public representing a 270 percent increase compared to the same period prior to JOBS Act. However, because drug development is an exceptionally time-consuming endeavor and often requires a decade or more of research and development, many life science startups are still pre-revenue when…

The Biotechnology Innovation Organization (BIO) announced today that after 19 years leading the Industrial and Environmental Section, Executive Vice President Brent Erickson will step down from the organization in March 2019 to begin new business ventures. 

But New Legislative Proposals Endanger Progress

BIO applauds the leadership of Senator Thom Tillis (R- NC) and Congressman Bill Flores (R-17 TX) for introducing the “Hatch-Waxman Integrity Act of 2019” to preserve the time-tested approach of the HWA while strengthening the ability of patent owners to fairly defend against abusive efforts to invalidate patents for innovative life-saving medical therapies.