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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

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Choose New Jersey’s RFP Watch provides up-to-date information on business opportunities throughout the Garden State at a cost that is affordable for all companies – with a place of business in New Jersey – large and small.

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Biologics

PhRMA Offers Consumers Online Resources on Biologics and Biosimilars

Washington, DC, September 7, 2017 ― Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available.

A biosimilar product is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA.

To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, the Pharmaceutical Research and Manufacturers of America (PhRMA) in March 2016 launched a new section of our website today that provides educational resources on these topics. Continue reading

FDA Awards 21 Grants to Stimulate Product Development for Rare Diseases

FDA blueWashington, DC, October 20, 2016 — The U.S. Food and Drug Administration on October 17 announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases.

These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites.

“We are proud of our 30-year track record of fostering and encouraging the development of safe and effective therapies for rare diseases through our clinical trials grant program,” said Gayatri R. Rao, M.D., J.D., director of FDA’s Office of Orphan Product Development, within the Office of Special Medical Programs. Continue reading

PhRMA Offers Consumers Online Resources on Biologics and Biosimilars

phrma-logo-whiteWashington, DC, October 17, 2016 ― Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available.

A biosimilar product is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA.

To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, the Pharmaceutical Research and Manufacturers of America (PhRMA) has launched a new section of our website today that provides educational resources on these topics. Continue reading

New Jersey Health Foundation Awards $50,000 Innovation Grant to Rutgers Professor to Advance Therapeutic Drug Delivery

Rutgers SealNew Brunswick, NJ, August 15, 2016 ― New Jersey Health Foundation has awarded a $50,000 Innovation Grant to Charles Roth, PhD, to advance the development of a more effective platform for systemic delivery of therapeutic biologics, announced James M. Golubieski, president.

Dr. Roth is a professor in the Department of Biomedical Engineering and the Department of Chemical and Biochemical Engineering at Rutgers, The State University of New Jersey.

He is working in close collaboration with David Devore, PhD, a visiting scientist in the New Jersey Center for Biomaterials at Rutgers and a co-inventor of the technology. Continue reading

Target ALS Foundation Selects RUCDR Infinite Biologics

Rutgers RNew Brunswick, NJ, June 21, 2016 — The Target ALS Foundation has selected RUCDR Infinite Biologics to bank and distribute the foundation’s human stem cell lines for use by researchers in academia and industry worldwide.

A unit of Rutgers’ Human Genetics Institute of New Jersey, RUCDR is the world’s largest university-based biorepository.

Target ALS Foundation is a privately funded non-profit foundation “entirely focused on finding treatments for patients living with ALS” or amyotrophic lateral sclerosis, a fatal neurodegenerative disease known as Lou Gehrig’s disease. Continue reading

FDA Commissioner Releases Statement on Efforts for ‘Compassionate Use’ Access to Investigational Drugs and Biologics

FDA Commissioner Dr. Robert Califf

FDA Commissioner Dr. Robert Califf

Washington, DC, June 3, 2016 ― U.S. Food and Drug Administration Commissioner Dr. Robert Califf yesterday issued a statement regarding the agency’s finalized efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients.

Dr. Califf said:

“As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.

“Access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible. Continue reading

PhRMA Offers Consumers Online Resources on Biologics and Biosimilars

PhRMA jpgWashington, DC, March 27, 2016 ― Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available.

A biosimilar product is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA.

To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, the Pharmaceutical Research and Manufacturers of America (PhRMA) has launched a new section of our website today that provides educational resources on these topics. Continue reading

PhRMA Launches Biologics and Biosimilars Online Resources

Pills red white blueWashington, DC, January 31, 2016 ― Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available.

A biosimilar product is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA.

To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, the Pharmaceutical Research and Manufacturers of America (PhRMA) has launched a new section of our website today that provides educational resources on these topics. Continue reading

PhRMA Launches Biologics and Biosimilars Online Resources

PhRMA jpgWashington, DC, December 19, 2015 ― Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available.

A biosimilar product is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA.

To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, the Pharmaceutical Research and Manufacturers of America (PhRMA) is excited to launch a new section of our website today that provides educational resources on these topics. Continue reading

Wonkblog: How Controversy Over Drug Prices Could Take Down President’s Trans-Pacific Partnership Deal

TPPWashington, DC, October 12, 2015 ― Carolyn Y. Johnson reports in The Washington Post’s Wonkblog that a political firestorm is building over the protections for drug companies in the Obama administration’s massive Trans-Pacific Partnership (TPP) trade deal, threatening support for a key piece of the president’s legacy.

The chapter addressing the issue, which was posted online Friday by WikiLeaks, grants at least five years of exclusivity to the makers of next-generation biologic medicines for diseases ranging from cancer to rheumatoid arthritis.  That is less than what drug companies enjoy in the United States.   Continue reading