When Cryoport – a global provider of temperature-controlled supply chain solutions for biopharmaceutical, in vitro fertilization (IVF) and animal health organizations – decided to expand its infrastructure last year, the Brentwood, Tenn.-based company quickly identified New Jersey as a logical location.
“Our Cryoport BioServices division opened a leased, 45,000-square-foot state-of-the-art facility in Morris Plains,” said Cryoport Systems President and CEO Mark Sawicki. “We provide global supply chain solutions for companies like Bristol Myers Squibb, and Cryoport has the ability to support the storage, fulfillment, and distribution of pharmaceutical and cell and gene therapies out of this location.”
New Jersey is a “major hub for the entire cell and gene industry and other industries,” he added. Gene therapy involves the transfer of genetic material and the uptake of the gene into the appropriate cells of the body, while cell therapy involves the transfer of cells with the relevant function into the patient. “Many of the top pharmaceutical companies are based in New Jersey, and in total there are more than 3,000 life science companies in the state. New Jersey is a strategic East Coast location with some of the best logistics infrastructure in the country, and the state is home to the nation’s highest concentration of scientists and engineers per square mile.”
Cryoport’s storage, fulfillment, and distribution facility offers a variety of behind-the-scenes services for pharmaceutical and biotechnology companies, including biostorage, packaging and labeling, regulatory and qualified persons, drug return and destruction, and kit production in addition to logistics services, such as packaging and transportation.
“Our Morris Plains facility houses cutting-edge equipment, systems, and processes to ensure GMP-compliant storage and fulfilment of critical materials — there is no room for failure in this industry,” Sawicki explained. “Our sister company CRYOPDP – a global provider of temperature-controlled logistics solutions to the clinical research, pharmaceutical and advanced therapy markets – also has operations in the same building, further enhancing our comprehensive logistics capabilities.”
Insiders say it’s no surprise that life science and biotech companies are attracted to New Jersey. For more than a century, the Garden State has had a history of developing lifesaving medicine, according to Choose New Jersey, a nonprofit economic development organization. “From incubators to stand alone laboratory space at research parks and hubs, you’ll find the support you need here, along with world-class research universities, medical schools and some of the best hospitals in the country,” the organization notes. “Our central location and infrastructure will get you to where you want to go. A location in New Jersey offers easy access to financial markets and regulatory centers. Northern New Jersey is less than 20 minutes away from Manhattan and Washington D.C., is three hours away by train.”
It’s an exciting time for research and development, according to Debbie Hart, president and CEO of the life sciences trade association BioNJ. “Biopharmaceutical innovation is ushering in the next generation of advanced medicines,” she explained. “We are on the brink of scientific breakthroughs, including gene editing and RNA-sequencing. Cell and gene therapies fight diseases at their source – the cellular or genetic level – through one-time administration, resulting in long-term, potentially curative benefits. These transformational therapies are revolutionizing health care and treatments for patients.”
But there are still challenges. “Unfortunately, there are still diseases that don’t yet have a cure,” Hart noted. “Drug discovery is difficult. Finding and developing an effective medicine is a years-long and very expensive process. However, experts say artificial intelligence – if properly integrated into scientists’ research – could revolutionize drug discovery, making it possible for more patients to get the treatments they need. Our member companies believe that AI will dramatically alter the future of drug development. And, in fact, BioNJ has established a committee to look at the possibilities and opportunities and to make sure that our members are on the cutting edge of this important new technology.”
Life sciences companies in New Jersey are advancing across a spectrum of activities, according to Dean Paranicas, CEO of The HealthCare Institute of New Jersey. The organization seeks to expand patient access to the most innovative biopharmaceuticals and medical technologies and devices, and to promote awareness of the industry’s significant impact on New Jersey’s quality of life and economic well-being.
“Our research-based life sciences companies relentlessly push out the boundaries of innovation to improve the quality of life for patients,” he said. “New research methods and technologies such as gene therapy, CAR-T, game-changing vaccines and innovative new medical devices and diagnostic tools are enabling advances unimaginable even a few short years ago. Not only are these discoveries attacking known conditions, they also are providing an opportunity to address the thousands of rare diseases that currently do not have an approved treatment, and to enhance precision medicine so that each patient can receive the most targeted and responsive care that their condition requires.”
New Jersey continues to earn its reputation as the “medicine chest of the world,” Paranicas added. “The industry is upbeat about the growing statewide commitment to a ‘Life Sciences 2.0’ era through the build-out of our innovation ecosystem that will further strengthen our standing as a global life sciences hub. This is taking the form of significant new investment by our universities, hospitals and government in state-of-the-art facilities across the state and bringing in world-class researchers to expand collaborations with our industry on research and development, clinical trials and patient care.”
But the overall upbeat outlook for the state’s life science segment did not prevent one industry executive from issuing a warning. “One of the challenges in health care today is funding important research for life-saving treatments,” said John Harlow, chief commercial officer at Melinta Therapeutics. “Most of research funding today is channeled into a small number of therapeutic areas such as oncology and immunology. Couple this with a rise and revitalization in the industry of areas such as rare disease and neurology, all of which are considered more significant market opportunities, and what’s left are many crucial areas with unmet medical needs, such as antimicrobial resistance. There is minimal development happening in this field, with approximately 95% of research in the antimicrobial space being conducted by small biopharmaceutical companies like Melinta. We believe there needs to be a better balance between being a financially sustainable business and helping people.”
Melinta, along with San Diego-based Cidara Therapeutics Inc., recently announced that the U.S. Food and Drug Administration approved REZZAYO for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved in over a decade for patients with candidemia and invasive candidiasis, Harlow added.
“In the United States, candidemia is, according to the CDC [Centers for Disease Control and Prevention], one of the most common causes of bloodstream infections in hospitalized patients, and it often results in long hospital stays and death,” he said. “It’s also responsible for high medical costs.”
Looking ahead, “I think two of the things that come to mind when I think about what’s coming to the forefront are a greater focus on infectious disease treatment and health care access for all,” Harlow said. “At Melinta, we’re looking to make people more aware of the danger of not putting enough attention on the need for new treatment protocols for life-threatening illnesses like candida, which can enter the bloodstream or internal organs and cause an infection.”
He also pointed to progress on another important issue. “We’re starting to see more focus, as a society, on access to health care. Health care access or lack of access is an issue that we all need to be concerned about. Our vision at Melinta is that all people who need our therapies will receive them and our passion propels our purpose.”
To help achieve that goal, the company is expanding its research capabilities. “We’re exploring the use of artificial intelligence to better support health care providers in addressing unmet medical needs by providing scientific information through our medical affairs team,” Harlow explained. “We are exploring using the AI data mining capabilities and AI response generation to quickly mine our data and provide responses to requests from health care providers. With an unsurpassed commitment to providers and the patients they serve, everyone at Melinta works to ensure that all people who need our therapies can receive them.”