Industry News and Notes – February 2012

Trenton Report

CCIT Awarded Soft-Landings International Incubator Designation

TRENTON — New Jersey’s growing reputation as a prime location to place and grow a business was further validated recently when the National Business Incubation Association (NBIA) awarded its Soft Landings International Incubator designation to the Commercialization Center for Innovative Technologies (CCIT), which is part of the New Jersey Economic Development Authority’s (EDA’s) Technology Centre of New Jersey in North Brunswick. The EDA announced the designation on January 25.

The designation recognizes incubators that are especially capable of helping nondomestic companies enter the domestic market with translation services, cutting through red tape, accessing capital, domestic market research, and other programs.

“This designation makes New Jersey even more attractive to fledgling foreign businesses seeking to establish a United States presence,” said Lt. Governor Kim Guadagno. “As these small foreign companies come to New Jersey to mature and grow, they’ll stay in New Jersey, expand their workforce by hiring New Jersey residents, and contribute further to our economy.”

New Jersey is now home to two of only 23 small business incubators in the world that have earned the Soft Landings designation. The Enterprise Development Center (EDC), a business incubator operated and sponsored by the New Jersey Institute of Technology (NJIT), was awarded the designation in 2010.

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EDA Approves $50 Million Citibank Loan Program to Help Companies Expand International Trade

TRENTON — The New Jersey Economic Development Authority (EDA) on January 22 agreed to partner with Citibank N.A. in a 3-year program to provide low-interest loans to businesses looking to expand through international trade.

The program will provide companies already engaged in global trade with a source of low-interest loans, where they previously would have had to find a regularly priced loan to help them expand, said Tim Lizura, senior vice president for the EDA.

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Washington Report

TREAT Act Offers Renewed Hope for Patients

WASHINGTON, DC — The Biotechnology Industry Organization (BIO) on February 15 praised Sen. Kay Hagan (D-NC) for introducing the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act.

The following statement can be attributed to BIO President and CEO Jim Greenwood:

“The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act will help unleash the promise of biotechnology to speed life-saving cures, novel medicines, and scientific breakthroughs to patients living with debilitating diseases such as cancer, HIV/AIDS, Parkinson’s, and diabetes.

“The TREAT Act will help break the institutional barriers to a faster idea-to-market pathway and speed new cures to patients most desperately in need. Through this bill, Senator Hagan has offered renewed hope to patients desperately in need of cures and breakthrough new medicines as well as a boost to our nation’s economy. The legislation will help the U.S. Food and Drug Administration (FDA) retain its leadership position as the global ‘gold standard’ for regulatory science and consumer protection.

“This bill will modernize the FDA and allow the agency to keep up with the fast pace of American scientific breakthroughs. Further, it will ensure a transparent and more predictable pathway for the development of safe and effective next-generation medicines and cures while maintaining U.S. leadership in biomedical innovation. A more streamlined and forward-thinking regulatory review process will ensure that innovative biotech firms can focus their resources where they belong – in research and development that leads to breakthrough medicines and cures, and job creation – rather than navigating an overly complicated regulatory process that discourages the innovation that leads to cures.”

Click here to read the full statement.

Administration’s 2013 Budget Could Discourage Development of Cures and Breakthrough Medicines, Limit Patient Choice and Forestall Job Growth

WASHINGTON, DC — Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Obama’s FY 2013 budget proposal released on February 13:

“While BIO supports the broad goals of the President Obama’s FY2013 budget, many of the provisions included in the proposal jeopardize continued biotech research and development that will lead to cures and breakthrough medicines for patients worldwide living with debilitating diseases. These provisions also threaten to undermine job growth here in the United States and run counter to the President’s expressed desire to ‘create an economy that is built to last.’

“The Administration’s proposal to reduce the period of data exclusivity for innovative biologics manufacturers, for example, will discourage biotech innovation. The 12-year term of data protection for biologics included in the Affordable Care Act received widespread bipartisan support in the Congress during the consideration of the biosimilar pathway and is now settled U.S. law. The 12-year period continues to maintain strong bipartisan support in the Congress. A reduction in the exclusivity period will jeopardize the careful balance established to reduce costs, expand access, ensure patient safety, and encourage continued biotechnology innovation that will create jobs and lead to breakthrough therapies and cures for deadly diseases.

“We continue to have strong concerns about strengthening the powers of the unelected Independent Payment Advisory Board (IPAB), as called for in the President’s budget proposal. IPAB could enact broad changes to Medicare without Congressional oversight. Repealing IPAB is essential to protecting American access to quality medical care and is particularly important to populations such as seniors and the uninsured who rely on Medicare.

“We also oppose proposals to institute a Medicare Part D rebate for dual-eligibles. Medicare Part D is working well. Consumers are overwhelmingly pleased with this benefit, and the private competition between various drug plans keeps costs down. We should not disrupt this properly working benefit by adding unnecessary reforms.

“The provisions described above undermine the hope of cures and breakthrough new medicines for patients living with debilitating diseases including cancer, HIV/AIDS, and MS. They jeopardize much-needed job growth in our nation. And they threaten to end our nation’s global leadership in biotech innovation.”

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BIO Calls on the Administration and Congress to Embrace Proposals to Unleash the Promise of Biotechnology

WASHINGTON, DC — Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement on January 25 in response to President Obama’s State of the Union speech:

“We commend President Obama’s call for creating an economy that is ‘built to last.’ We strongly believe that biotechnology can meet this challenge. Our industry sustains and creates high-wage, high-value U.S. jobs, fuels 21st-century manufacturing, and helps drive U.S. leadership in competitiveness and innovation. Most importantly, biotechnology offers lifesaving and innovative scientific breakthroughs through the development of new cures and treatments for debilitating diseases including cancer, multiple sclerosis, and HIV/AIDS and by providing cutting-edge technologies to address pressing concerns in creating alternative energy sources, combating hunger, and protecting against bio-terror.

“Increasing investment in federally funded research, as the President called for in his address, is important. It takes public and private companies to translate that research into cures and useful technologies. We look forward to working with the Administration and the Congress to pursue public policies that will unleash the promise of biotechnology.

“Curing diseases, first and foremost, means saving lives. But it also means reducing healthcare costs. With science-based regulatory systems, appropriate tax policy, and incentives to encourage continued innovation, America’s biotechnology sector can help drive substantial job growth in the United States and advance our nation’s competitiveness over the long term. The proposals detailed in our ‘Unleashing the Promise of Biotechnology’ plan are designed to transform the innovative ideas of today into the realities of tomorrow,” Greenwood said.

Click here to read the full statement.

BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations

WASHINGTON, DC — Richard Pops, Chairman and CEO of Alkermes plc, testified on February 1 on behalf of the Biotechnology Industry Organization (BIO) before the House Energy and Commerce Subcommittee on Health during a hearing entitled, “Reauthorization of PDUFA: What It Means for Jobs, Innovation, and Patients.”

In his testimony, Pops stressed the need for a quick reauthorization of the Prescription Drug User Fee Act (PDUFA) and enactment of the enhancements recommended in the PDUFA V agreement that will improve the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA modifications can provide patients and doctors with earlier access to breakthrough therapies.

Pops also indicated BIO’s strong support for the reauthorization of the Best Pharmaceuticals for Children Act (BCPA) and Pediatric Research Equity Act (PREA), which have been remarkably successful in ensuring the medicines used by children are tested and appropriately labeled for their use. Further, both programs should be made permanent by eliminating the sunset provisions in current law in order to provide certainty in the regulatory environment for pediatric drug development.

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Funding Opportunities

BIRD Foundation Deadline for Executive Proposal Is March 14

The deadline for submitting executive proposals to the Israel-US Binational Industrial Research Development (BIRD) Foundation is March 14.

The BIRD Foundation works to encourage cooperation between Israeli and American companies in the various areas of technology, and provides assistance in locating strategic partners from both countries for developing joint products. Approaching its 35th birthday, the BIRD Foundation has invested in close to 830 projects, which have yielded revenues of about $8 billion.

The BIRD Foundation supports projects without receiving any rights in the participating companies or in the project itself. The financial assistance is repaid as royalties from sales. The Foundation provides support of up to 50 percent of a project’s budget, beginning with R&D and ending with the initial stages of sales and marketing. The Foundation shares the risk and does not demand that the investment be repaid if the project fails to reach the sales stage.

The BIRD Foundation works in full cooperation with the Chief Scientist’s Office at the Ministry of Industry, Trade, and Labor in Israel, and with the U.S. Commerce Department’s National Institute of Standards and Technology (NIST).

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Real Estate Opportunities

Biotech Company Seeking Lab Space

A biotechnology company currently operating in Central New Jersey notes that it is seeking laboratory spaces of approximately 1,500 to 2,000 square feet in the New Brunswick-Somerville-Princeton area for its ongoing R&D and service-oriented activities involving tissue culture and basic cell and molecular biology research.

For more information, please contact BioNJ Headquarters by email.


News from Our Colleges and Universities

February Edition of Working with Rutgers Now Available

Click here to access the latest version of the e-letter Working with Rutgers.

Working with Rutgers is designed as an e-resource to facilitate increased communications between Rutgers and corporations and businesses interested in working with the state university.