Advocacy Takes Center Stage

We are entering that time of year when legislation and policy are moving fast, and because this year is a Presidential election year, things are moving along at an even more rapid pace than usual. This means that the New Jersey biotech industry needs an advocate — someone to be on the lookout for opportunities to advance our industry — and at BioNJ we consider advocacy in its many forms to be Job 1.

We are supporting and monitoring federal legislation, working with our partners, such as the Biotechnology Industry Organization (BIO), to advocate for and advance important proposals in Washington, DC. We’re also serving as the advocate for New Jersey’s biotech industry in Trenton to ensure that policies crucial to growing our companies and advancing their innovations are considered and put into action.

At the same time, we are working to provide our Members with regular opportunities throughout the year to engage in one of the hallmarks of the biotechnology industry — networking, collaborating, and partnering — which continues with our Third Annual International BioPartnering Conference on May 10-11 in Princeton. As the only biopartnering conference in New Jersey, the Conference represents a unique opportunity for companies to connect with like-minded companies and organizations based in New Jersey, the region and the world.

Plenty of Possibilities for Partnering

Our Third Annual International BioPartnering Conference will take place in a few weeks on May 10 and 11 at the Westin Princeton Forrestal Village. We are excited to be able to build on the momentum of our highly successful 2012 Annual Dinner Meeting, Awards Program and Networking Event as well as our Diagnostics and Personalized Medicine Summit by providing myriad opportunities for partnering and collaborations that will attract senior executives from global biotech and pharmaceutical companies, the funding community, and entrepreneurs from throughout the Eastern United States, Europe, and Asia.

I am pleased to announce that our Keynote Speakers will include Marc Bonnefoi, DVM, PhD, Head of the Scientific Core Platform Disposition, Safety and Animal Research and Head of the North America R&D Hub at Sanofi; Walter Moos, PhD, Vice President of the Bioscience Division at SRI International; and Peter N. Kellogg, Executive Vice President and Chief Financial Officer at Merck & Co., Inc.

Dr. Bonnefoi will provide the Dinner Keynote Remarks on Thursday, May 10, when he will discuss the Transformation of Sanofi as a Global Healthcare Leader.

In his talk, Pharmaceutical Innovation, Dollars, and “Sense” Research Saves Lives, Dr. Moos will address the costs of drug discovery and development — and how it reflects on the need for innovative ideas for the greatest impact. He will discuss important roles played by organizations ranging from industry giants to biotech start-ups, nonprofit research institutes, and academia.

Peter Kellogg in his talk, Combining Our Strengths: New Pathways to Life Science Innovation, will discuss industry challenges that big pharma faces, Merck’s strategy for building shareholder value, and how new approaches to collaborating with pharma, biotech, and academic institutions are bringing about change that is good for patients and shareholders alike.

There are still some spots remaining for R&D companies interested in presenting their technologies to potential partners and investors.

I hope you’ll join us for this unique event; it is truly not to be missed.

You can read more about BioNJ’s Third Annual International BioPartnering Conference here.

Legislative Season Heating Up

With June approaching, BioNJ continues to monitor the New Jersey State budget process as it moves along as well as other legislation on the State level, such as the New Jersey Angel Investor Act (S581).

As I noted in last month’s column, BioNJ has provided testimony in support of legislation that would provide angel investors a 10 percent tax credit to incentivize investments in New Jersey technology start-ups, including biotech companies. This could contribute to the economic development of our State by stirring the formation of new companies and, in turn, providing opportunities for the many talented New Jersey citizens.

However, while BioNJ supports this legislation, we are hoping that the amount will be increased to 25 percent, as we are told by the investment community that 10 percent may not be enough of an incentive to offset the risk of investing in a company at its earliest stage.

A recent article, “Angels Sought for NJ’s Emerging Technologies” in the NJ Spotlight e-letter, documents the need to develop and support programs that foster the continuing growth of emerging companies, such as biotechnology companies, in New Jersey through legislation encouraging greater involvement by Angel Investors, and the steps other states are considering to do the same.

On the federal level, there are many different pieces of legislation that we are keeping our eye on, including the TREAT Act, PDUFA reauthorization, the FAST Act, and the GAIN Act.

Also on the radar is the U.S. Food and Drug Administration (FDA) guidances on biosimilars.

We are also thrilled that the Jumpstart Our Business Startups (JOBS) Act was signed into law earlier this month. BioNJ had written to our Congressional delegation in support of the JOBS ACT.

Aimed at stimulating job growth at emerging biotech companies, the JOBS ACT creates an “on-ramp” to the public market by allowing emerging companies five 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. BIO President and CEO Jim Greenwood, who attended the White House ceremony, praised the signing.

BioNJ will be sharing more detailed information on the opportunities provided by the JOBS Act to New Jersey companies in upcoming forums and briefings. You can also read more about the JOBS Act in the Industry News and Notes section.

In addition, we are continuing to support the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which was introduced in February. It is intended to speed up the approval process for therapeutics that treat an unmet need or significantly advance the standard of care, helping smaller firms get a drug to market with more flexibility. As the proposal moves through Congress, it is possible that parts of the TREAT Act may be included in legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires in September.

BIO and BioNJ are advocating for quick reauthorization of PDUFA and enactment of enhancements recommended in the PDUFA V agreement. These enhancements will improve the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most important, PDUFA modifications can provide patients and doctors with earlier access to breakthrough therapies, which is in line with the goals of the TREAT Act.

Another legislative item, the Faster Access to Specialized Treatments (FAST) Act was introduced in March. It proposes 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 other rare diseases where there is currently no treatment. Similar to the TREAT Act, this legislation would update the Accelerated Approval process at the FDA.

Finally, BioNJ is monitoring the Generating Antibiotic Incentives Now (GAIN) Act, bipartisan legislation introduced by Senator Richard Blumenthal (D-CT) and Senator Bob Corker (R-TN) to spur development of new antibiotics to combat the spread of antibiotic-resistant bacteria. The GAIN Act will provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process so that pioneering infectious disease products can reach patients.

Each of these pieces of legislation is focused on the importance of speeding up the time it takes for innovative, new treatments to reach patients. BioNJ will continue to monitor and advocate for these bills as well as any new developments on the State or federal level that could impact New Jersey’s biotech industry.

Just last week, BIO released its written comments to the FDA on the three draft guidances issued by the Agency on the introduction of biosimilar products.

BIO’s written comments were directed to three specific areas:

  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
  • Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act (BPCIA) of 2009

In releasing its comments, BIO noted: “Our comments below are grounded by the specific hands-on experience of BIO member companies, experience that is crucial to understanding biological products. These answers are also consistent with BIO’s long-standing Principles on Biosimilars, which state that any pathway for the approval of biosimilars must protect patient safety and preserve incentives to innovate.”

This position is in line with BioNJ’s 2009 Biosimilars position statement. Click here to review BioNJ’s position statement on this important topic.

BIO intends to provide public testimony to the FDA at a public hearing on May 11. BioNJ has been in contact with BIO on this critical topic since the FDA first issued its guidances in February and will continue to report important developments as they occur.

Whether it’s in the halls of Congress or the State House in Trenton or finding new ways to help companies collaborate and partner, BioNJ is committed to advocating for our Members and the greater biotechnology community.

But to be your voice, we also need to hear from you. Tell us how we are doing. Tell us where we can do more. It is your voice that guides ours.

Yours in BioNJ,

Debbie

Debbie Hart