Industry News and Notes – March 2012

Washington Report

BIO Applauds House Committee Vote to Repeal IPAB

WASHINGTON, DC — The Biotechnology Industry Organization (BIO) on March 6 applauded the House Energy and Commerce Committee’s passage of the Medicare Decisions Accountability Act, H.R. 452, which would repeal the Independent Payment Advisory Board (IPAB) established in the health care reform law.

“Repealing IPAB is essential to protecting Americans’ access to quality medical care and is particularly important to populations such as seniors who rely on Medicare,” stated BIO President and CEO Jim Greenwood. “We urge Congress to pass the Medicare Decisions Accountability Act in order to safeguard patient access to life-saving therapies.”

BioNJ was in communications with the New Jersey Congressional delegation, advocating for the repeal of H.R. 452.

FAST Act Would Provide Patients with Accelerated Access to Innovative Therapies

WASHINGTON, DC — Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood on March 6 issued the following statement of support for the Faster Access to Specialized Treatments (FAST) Act, H.R. 4132, which was introduced the previous day:

“BIO thanks Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) for their leadership in introducing the FAST Act to speed access to innovative new therapies and cures to patients living with debilitating and life-threatening diseases such as Parkinson’s, Alzheimer’s, diabetes, and numerous rare diseases for which there is currently no treatment or cure.

“The legislation will modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving the Food and Drug Administration’s (FDA) robust standards for safety and effectiveness.

“Like the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, S. 2113, which was introduced by Senator Kay Hagan (D-NC), the FAST Act will update the Accelerated Approval process at the FDA so that it works in a transparent, predictable way for all therapies intended to treat debilitating conditions for which there is an unmet medical need. Making this change will better enable biotechnology companies to bring new, safe and effective treatments and cures to patients in need at the earliest point in time.

“We look forward to working with Representatives Stearns and Towns, Senator Hagan, and their colleagues to ensure that this critical legislation is enacted.”

Biotech Leader Provides Testimony at Congressional Hearing on “Spurring Job Growth through Capital Formation While Protecting Investors”

WASHINGTON, DC — On March 6, the Senate Committee on Banking, Housing, and Urban Affairs held a hearing on “Spurring Job Growth through Capital Formation While Protecting Investors, Part II.” On behalf of the Biotechnology Industry Organization (BIO). William D. Waddill, Senior Vice President and Chief Financial Officer of OncoMed Pharmaceuticals, presented testimony at the hearing on the importance of capital formation to encourage investment in the biotechnology industry and spur job growth across the country.

The hearing focused on several bills that aim to support emerging biotechnology companies, including:

  • The Reopening American Capital Markets to Emerging Growth Companies Act (S. 1933) to create an “on-ramp” to the public market for emerging growth companies to allow a transition period for certain accounting and disclosure requirements, including Sarbanes-Oxley Section 404(b).
  • The Small Company Capital Formation Act (S. 1544) to reform SEC Regulation A by expanding its eligibility requirements to include companies conducting direct public offerings of up to $50 million.
  • The Private Company Flexibility and Growth Act (S. 1824) to increase the limit that requires private companies to register with the SEC from 500 to 2,000 shareholders.
  • The Access to Capital for Job Creators Act (S. 1831) to require the SEC to revise Rule 506 of Regulation D to permit general solicitation in direct public offerings, broadening the investor base.

Click here to learn more.

BIO Hails Senate Passage of PAHPA Reauthorization

WASHINGTON, DC — Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood on March 8 issued the following statement applauding Senate passage of the Pandemic All-Hazards Preparedness Act (PAHPA) Reauthorization of 2011, S. 1855:

“BIO thanks Senators Richard Burr (R-NC), Tom Harkin (D-IA), Mike Enzi (R-WY), and Bob Casey (D-PA) for their leadership on the critical issues of public health and emergency preparedness as original sponsors of the legislation.

“Biotech companies are willing and active partners in the national security endeavor. The reauthorization of PAHPA streamlines, strengthens, and improves the current system and reaffirms our government’s commitment to this national security priority.”

Click here to learn more.

BIO Praises House Passage of the Jumpstart Our Business Startups Act

WASHINGTON, DC — The Biotechnology Industry Organization (BIO) on March 8 applauded the House on the passage of H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act. The JOBS Act, which passed the House by a vote of 390-23, contains several provisions that would make the pathway to capital formation more attainable for small biotechnology companies.

The JOBS Act creates an “on-ramp” to the public market for emerging growth companies, allowing them 5 years to focus on conducting critical research that can lead to cures for debilitating diseases before having to divert funds to costly regulations. Through this legislation, emerging growth companies would be exempt for their first 5 years on the public market from the compliance burdens of Sarbanes-Oxley (SOX) Section 404(b), which SEC studies estimate cost companies up to $2 million per year. An on-ramp would ease certain accounting and disclosure requirements for a company’s first 5 years.

Click here to learn more.


News from Our Colleges and Universities

4th Annual Entrepreneurship Day at Rutgers University

NEW BRUNSWICK — Rutgers’ Fourth Annual Entrepreneurship Day on April 17 will bring together leading social entrepreneurs, impact investors, business support organizations, faculty, students, and alumni for a unique event designed to address some of the most pressing social issues of modern times. Is entrepreneurship the way out of poverty? Should the poor have to pay the same to get access to the food and medicine they need to live? Can developed and developing nations work together to create a better tomorrow?

Join us for a full day of dynamic keynotes, insightful panels, interactive breakout sessions, and high-value networking as we explore the frontiers of social entrepreneurship. Hear from:

  • Ewa Wojkowska, one of Advance’s 50 emerging women leaders who left a decade of service with the United Nations to launch Kopernik, an online marketplace for cutting-edge technologies designed specifically for emerging economies
  • Matt Pelak of Team Rubicon, an organization that “recognizes and harnesses the skills of military veterans,” praised by First Lady Michelle Obama
  • Dr. Ilya Raskin, an award-winning scientist, inventor, and entrepreneur, and co-founder of the Global Institute for Bioexploration and Food4Good
  • Joe Shure, co-founder of The Intersect Fund, a nonprofit begun by Rutgers students that was featured on CNN’s The American Morning

Entrepreneurship Day will be held on April 17 from 10:00 a.m. to 4:00 p.m. at the Rutgers Student Center, College Avenue, New Brunswick.

Entrepreneurship Day is FREE to attend, but space is limited. Click here to learn more and register.

The University-Industry Demonstration Partnership to Be Held April 23-25

NEW BRUNSWICK — Convened by the National Academies of Science, the University-Industry Demonstration Partnership provides a forum for member universities and companies to develop R&D partnerships through networking and demonstration projects. The meeting will be held April 23-25 at the Heldrich Conference Center and Hotel in New Brunswick.

Members include private and public universities, as well as companies in healthcare, pharma, manufacturing, hardware, software, chemicals, aerospace, and more.

The upcoming conference is sponsored by Rutgers, The State University of New Jersey. Conference topics will include open innovation, the role of universities in developing innovation clusters, and new approaches to university/industry engagement.

Click here to learn more about UIDP and the upcoming conference.

Rutgers Business School Places Third at Wake Forest Biotechnology Case Competition

NEW BRUNSWICK — Congratulations to Rutgers Business School, which placed third at the 2012 Wake Forest University Biotechnology Case Competition held on February 24-25.

Sponsored by Johnson & Johnson, the Rutgers case entailed providing J&J Diabetes Care a long-term business strategy that specifically incorporated mobile health and any other emerging technology.

Click here to learn more.