Industry News and Notes – April 2012

Washington Report

BIO Submits Comments on FDA Draft Guidances on Biosimilars

WASHINGTON, DC — The Biotechnology Industry Organization (BIO) on April 17 submitted comments to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.

“BIO supports the FDA’s ongoing implementation of a science-based pathway for the review and approval of biosimilars that protects patient safety and promotes continued innovation,” stated Sara Radcliffe, Executive Vice President, Health. “We appreciate the opportunity to request clarity on scientific and policy issues within the three draft guidance documents.”

BIO intends to provide testimony at the FDA public hearing on the draft guidances scheduled for May 11, 2012.

Read BIO’s comments on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Read BIO’s comments on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Read BIO’s comments on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

BIO Lauds Signing of JOBS Act into Law

WASHINGTON, DC — The Biotechnology Industry Organization on April 5 expressed strong support for the signing of the Jumpstart Our Business Startups (JOBS) Act into law.

“I was honored to witness the signing of the JOBS Act into law. This legislation will make the pathway to capital formation more attainable for small biotechnology companies, encouraging American innovation by removing bureaucratic hurdles,” stated BIO President and CEO Jim Greenwood.

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 new therapies and cures before having to divert funds to address bureaucratic hurdles that cause unnecessary delays.

Through the JOBS Act, emerging companies will be exempt for their first 5 years on the public market from the compliance burdens of Sarbanes-Oxley (SOX) Section 404(b), which studies by the U.S. Securities and Exchange Commission (SEC) estimate cost companies up to $2 million per year. The Act will also ease private fundraising through an expansion of the eligibility requirements for SEC Regulation A offerings and broaden the investor base by reforming the SEC private shareholder limit and SEC Regulation D.

“This law will incentivize and encourage capital formation for small, emerging biotechnology companies that do not yet have products on the market,” Greenwood stated. “By allowing companies to focus their limited funds on research rather than on compliance, it will speed the development of new cures and treatments for patients living with debilitating diseases such as cancer, diabetes, Parkinson’s, and HIV/AIDS.”

“The American biotechnology industry thanks the Congress and President Obama for the enactment of the JOBS Act,” concluded Greenwood.

Editor’s note: BioNJ will be providing more detailed information on the opportunities provided by the JOBS Act to New Jersey companies in upcoming forums and briefings.

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

WASHINGTON, DC — Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified on March 29 on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor, and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”

In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the FDA’s implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.

BIO believes that a principal goal of the new biosimilar user fee program must be to ensure that the workload associated with biosimilar applications does not impede the Agency’s ability to efficiently review innovative new drugs and biologics, and that new treatments continue to have the highest review priority.

Radcliffe also testified in strong support of the PDUFA V recommendations, which will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science and strengthen post-market surveillance. The recommendations include enhancements that seek to reinforce the FDA’s review performance with the goal of minimizing development and review issues that can delay patient access to needed treatments.

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BIO Supports Permanent Reauthorization of Programs to Encourage Development of Lifesaving Medications for Children

WASHINGTON, DC — BIO President and CEO Jim Greenwood issued the following statement on March 28 in support of H.R. 4274, which will reauthorize the Best Pharmaceuticals for Children Act (BCPA) and Pediatric Research Equity Act (PREA):

“We thank Representatives Mike Rogers (R-MI), Anna Eshoo (D-CA) and Ed Markey (D-MA) for their leadership in introducing legislation to reauthorize BPCA and PREA in order to continue to incentivize the development of lifesaving therapies for children.

“Together, BPCA and PREA have been remarkably successful in ensuring the medicines used by children are tested and appropriately labeled for their use, contributing to improved health outcomes for pediatric patients. According to the FDA, these laws have resulted in nearly 425 pediatric labeling changes since 1998. America’s biopharmaceutical companies are currently researching more than 280 medicines to help meet the unique health care needs of children and adolescents.

“We are particularly pleased that this legislation will make both programs permanent. This will encourage continued investment in pediatric research and ensure that new drugs and biologics will be used safely and appropriately in pediatric patients.

“We encourage Congress to promptly pass this legislation.”


News from Our Colleges and Universities

Rutgers’ First Supercomputer Gains National Attention: Blue Gene system will allow Rutgers University researchers and NJ businesses to tackle big data challenges such as drug research and materials design.

New Brunswick — New Jersey’s largest university opened a high-performance computing center on April 17 where researchers hope to solve some of the state’s biggest big data challenges facing businesses and academia.

At the heart of the new HPC at Rutgers’ Discovery Informatics Institute (DII) is a new, $3.3 million IBM Blue Gene/P supercomputer with two racks, a configuration that is capable of providing processing power measured in teraflops. One teraflop is the equivalent of one trillion floating-point operations per second.

Blue Gene/P runs on IBM PowerPC 450 processors in a quad-core architecture. The system has been dubbed Excalibur, in recognition of Rutgers’ Scarlet Knights mascot. The center is located at Rutgers’ Busch Campus in Piscataway, NJ.

As more funding becomes available, Rutgers plans to add an IBM Blue Gene/Q system, which is the latest generation of the platform. Funding is being provided by university resources, federal grants, and the university’s partnerships with IBM and other technology providers.

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