Who We Are

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.

Choose NJ’s RFP Watch

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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Medical Device

After 2-Year Hiatus, 2.3 Percent Medical Device Tax Could Be Reinstated on January 1; Industry Launches Campaign

Washington, DC, August 15, 2017 — Bob Salsberg reports in The Washington Post that the industry that makes medical devices from artificial hips to miniature pumps for IV drips is looking for a fallback plan to permanently repeal a widely reviled sales tax that almost met its end in Republicans’ health care legislation.

The 2.3 percent medical device excise tax — one of several taxes and fees in the Affordable Care Act that pay for expanded insurance coverage — has been the subject of ferocious lobbying by manufacturers seeking its permanent death.

Yet for now it’s on track to be reinstated on Jan. 1 after a two-year hiatus, leaving industry leaders worried it will hurt employment and stifle development of innovative, even lifesaving products. Continue reading

FDA Commissioner Delays Layoff Notices and Reassures Staff Congress Will Reauthorize User Fees

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, July 27, 2017 — Michael Mezher reports on Endpoints News that, in a July 24 email to agency staff, FDA commissioner Scott Gottlieb, M.D., said he will delay issuing layoff notices until after September 30, which is when the agency’s current user fee agreements expire.

Previously, the FDA indicated it could issue layoff notices to thousands of staffers funded by user fees should Congress not act by August 1.

In the email, Gottlieb said he is optimistic the Senate will take up the matter soon and the agency can “reasonably expect” reauthorization to occur before the September 30 deadline. Continue reading

Kean University Students Present Innovative Medical Device at Tech Council Event

Union, NJ, July 2, 2017 — Kean University computer science students Andrey Suvorov of Edison, Claudia Fortes of Union and Peter Krivoshik of Ringoes presented at What’s Next in Medical Devices, an the NJ Tech Council event, on Tuesday, June 13 at Princeton University.

Kean computer science professor Jenny Li, Ph.D., and her students developed LifeLine, an autonomous life-saving device, in collaboration with researchers from Carnegie Mellon University. Continue reading

Trump Administration Seeks to Hike Life Sciences Industry’s FDA User Fees Paid to Help Review, Approve Medical Advancements

Washington, DC, April 20, 2017 — Thomas M. Burton reported in The Wall Street Journal that a bipartisan bill in Congress calls for sharp increases in user fees paid by medical industries to the Food and Drug Administration (FDA) to bear the cost of reviewing brand-name and generic drugs, medical devices and a type of generics called biosimilars.

The total base fees for prescription drugs to be collected for fiscal year 2018 under the legislation would be about $878.8 million, up 22% from the current fiscal year’s amount of $718.7 million, according to congressional aides.

The payments from industry have previously accounted for 70% of the FDA’s brand-name drug review budget, 36% of the medical device review budget, 75% of the budget for generic drug reviews and 29% of that for biosimilars, which mimic complex biological drugs. Continue reading

I-ACT for Children Launches to Promote Innovative Medicines Development for Young Patients in Need

Washington, DC, April 19, 2017 — Lucy Vereshchagina reports on PhRMA’s Catalyst blog that, in an exciting step forward to support research and development of innovative new medicines and devices for pediatric patients, the Critical Path Institute (C-Path) announced the launch of a new nonprofit to address challenges in bringing new therapies to children in need.

Called the Institute for Advanced Clinical Trials for Children (I-ACT for Children), this new organization will seek to foster public-private collaboration in finding solutions to barriers to pediatric medicines development as well as improving the pediatric clinical trials process.

Specifically, it will work to optimize pediatric study designs, protocols, best practices, training and engagement of patients and parents to advance clinical trials to improve children’s health. Continue reading

FDA and Industry Fear Wave of Medical-Device Hacks

Washington, DC, April 12, 2017 — Casey Harper reports in The Hill that Regulators and medical-device-makers are bracing for an expected barrage of hacking attacks even as legal and technical uncertainties leave them in uncharted territory.

Tens of millions of electronic health records have been compromised in recent years, a number that is growing and, some say, underreported.

 

High-profile attacks have hit hospitals and health insurers, and now attention is turning to a new vulnerability: medical devices like pacemakers and insulin pumps. Continue reading

HINJ’s ‘Value of Medical Innovation’ Portal Showcases How Life Sciences Is Saving Money — And Lives

New Brunswick, NJ, February 27, 2017 ― The HealthCare Institute of New Jersey (HINJ) continues to update its Value of Medical Innovation, a fact-driven, consumer-friendly digital library that delves into the myriad benefits of research-driven medical innovation, which saves money — and saves lives.

Introduced in September 2015, HINJ’s Value of Medical Innovation presents statistics from a number of resources, including the Advanced Medical Technology Association (AdvaMed), the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), U.S. government sources and various medical research organizations. Continue reading

MedTech Industry Lost Nearly 29,000 Jobs While Device Tax in Effect, U.S. Commerce Reports

Washington, DC, February 9, 2017 — The U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 while the medical device excise tax was in effect, according to the latest figures from the U.S. Department of Commerce.

Specifically, from 2012 to 2015, the number of U.S. medtech jobs declined from 401,472 to 372,638 – a loss of 28,834 jobs or a 7.2 percent decrease for the time period.

“These numbers reveal just how devastating of an impact the device tax had on our industry and underscore the urgent need for permanent repeal,” said Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed). Continue reading

President Trump’s FDA Pick Could Undo Decades of Drug Safeguards

Washington, DC, February 6, 2017 — Katie Thomas reports in The New York Times that President Donald J. Trump’s vow to overhaul the Food and Drug Administration (FDA) could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk.

President Trump has been vetting candidates to run the agency, which regulates the safety of everything from drugs and medical devices to food and cosmetics. Continue reading

FDA Establishes the Oncology Center of Excellence; Dr. Richard Pazdur to Serve as Director

FDA blueWashington, DC, January 23, 2017 — Outgoing Food and Drug Administration (FDA) Commissioner Dr. Robert Califf on January 19 announced that the agency was founding the Oncology Center of Excellence (OCE) and that Dr. Richard Pazdur would serve its inaugural director.

Califf said this will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. Continue reading