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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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Rare Diseases

NORD Unveils ‘Do Your Share for Rare,’ Year-Long Campaign for Rare Disease Public Awareness

Danbury, Conn., March 13, 2017 — The National Organization for Rare Disorders (NORD), the leading independent nonprofit organization representing the 30 million Americans with rare diseases, announced a year-long awareness campaign for rare disease.

Kicking off on February 28 — Rare Disease Day 2017 — “Do Your Share for Rare” features the voices and stories of many living with a rare disease, to inspire and encourage those living outside of the community to get involved in ways big or small. Continue reading

Event: NJ Rare Disease Alliance Commemorates Global Rare Disease Day 2017 on February 27; Focus on Innovation, Research and Access

Glen Ridge, NJ, February 25, 2017 — The New Jersey Rare Disease Alliance, dedicated to improving the lives of the more than 800,000 rare disease patients in New Jersey, will hold its annual Rare Disease Day commemoration on Monday, February 27, at the New Jersey Business and Industry Association (NJBIA), 10 West Lafayette Street, Trenton from 9:00 AM-12:00 PM.

The event is co-sponsored by BioNJ, the HealthCare Institute of NJ (HINJ) and the National Organization for Rare Diseases (NORD). 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 and The ALS Association Report More Than 560 Medicines in Development for Rare Diseases

Rare Disease 3Washington, DC, May 9, 2016 ― America’s biopharmaceutical research companies are currently developing more than 560 medicines for patients with rare diseases, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA) and The ALS Association.

Medicines in development include therapies for multiple myeloma, cystic fibrosis, amyotrophic lateral sclerosis (ALS) and enzyme deficiency disorders, providing treatment options for patients that had few or no treatment options before.

Today, there are 7,000 known rare diseases, or diseases that affect fewer than 200,000 people in the United States. Continue reading

Pharmalot: FDA Wants to Nix Voucher Program for Rare Pediatric Disease Drugs

STAT PharmalotBoston, MA, March 7, 2016 ― Pharmalot reporter-blogger Ed Silverman reports in STAT that the Food and Drug Administration (FDA) wants to end a voucher program designed to spur development of new drugs for rare pediatric diseases, although a new government report released on Wednesday said it’s too early to say whether it’s working.

Drug makers and advocacy groups, however, told the Government Accountability Office they see value in the program, which expires on Oct. 1.

At issue are pediatric review vouchers.  Created in 2012, the program awards a priority review voucher to a drug maker that wins approval of a treatment for a rare pediatric disease. Companies can later redeem vouchers when seeking approval for another medicine to treat any illness. Continue reading

HINJ, BioNJ Lead Rare Disease Day 2016 Event in Trenton

Trenton Capital Dome  MoonTrenton, NJ, March 1, 2016 ― Steve Wilson report in New Jersey Business that a rare disease is just that — specifically, a malady that afflicts fewer than 200,000 people in the United States.

But while many individual diseases may be rare, many individuals have rare diseases. Hence the slogan of The National Organization for Rare Disorders: “Alone we are rare. Together we are strong.”

That slogan also was the strategy employed by several healthcare organizations, led by BioNJ and the HealthCare Institute of New Jersey (HINJ), in organizing a State House event around the global Rare Disease Day 2016.

Wilson reports that about two dozen participants gathered at NJBIA’s headquarters in Trenton for an hour-long presentation followed by a group trip to the Capitol to meet with Senators who were in town for committee meetings. Continue reading

FDA Providing $2 Million in New Grants for Natural History Studies in Rare Diseases

FDA blueWashington, DC, March 1, 2016 ― The U.S. Food and Drug Administration (FDA) on Monday — Rare Disease Day 2016 — announced the availability of $2 million in research grants to fund natural history studies in rare diseases.

Rare diseases, as defined in the Orphan Drug Act, are diseases or conditions with a prevalence of less than 200,000 persons in the United States.  Though the diseases are individually rare, together, the 7,000 known rare diseases affect approximately 30 million Americans.

The aim of the research is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases. Continue reading

Event: NJ Rare Disease Alliance to Commemorate Rare Disease Day 2016 on February 29 in Trenton

Rare Disease DayTrenton, NJ, February 27, 2016 ― The New Jersey Rare Disease Alliance (NJRDA) — dedicated to improving the lives of the more than 800,000 rare disease patients in New Jersey — is hosting an event to observe global Rare Disease Day on Monday, February 29 starting at 10:00 a.m. at the New Jersey Business and Industry Association (NJBIA), 10 West Lafayette Street, Trenton.

Sponsored in conjunction with BioNJ, the HealthCare Institute of New Jersey (HINJ) and the National Organization for Rare Diseases (NORD), training will be provided on how to more effectively build relationships with legislators and other policymakers on behalf of rare disease patients.

Following a NORD-sponsored breakfast at 10:00 a.m. there will be an hour of training from 10:30-11:30 a.m. by state legislative experts from HINJ and BioNJ.  Senator Diane Allen (Burlington) will present a ceremonial resolution commemorating Rare Disease Day 2016 in New Jersey. Continue reading

NIH Genome Sequencing Program Targets the Genomic Bases of Common, Rare Disease

Genome colorBethesda, MD, January 15, 2016 ― The National Institutes of Health (NIH)yesterday announced it will fund a set of genome sequencing and analysis centers whose research will focus on understanding the genomic bases of common and rare human diseases.

The National Human Genome Research Institute (NHGRI), part of NIH, today launched the Centers for Common Disease Genomics (CCDG), which will use genome sequencing to explore the genomic contributions to common diseases such as heart disease, diabetes, stroke and autism. Continue reading

FDA Awards 18 Grants to Stimulate Product Development for Rare Diseases

Rare Disease 2Washington, DC, September 22, 2015 ― The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans.

A rare disease, also referred to as an orphan disease, is any diseasethat affects a small percentage of the population. Most rare diseasesare genetic, and thus are present throughout the person’s entire life, even if symptoms do not immediately appear.

These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally. Continue reading