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May 12, 2023

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Welcome to the latest edition of the BioLines Weekender...

Yesterday, S1615 and S1616 — two bills in the package of legislation focused on prescription drugs — moved through the New Jersey Senate Budget and Appropriations Committee. S1615, which establishes data reporting requirements for manufacturers, was amended to incorporate language that eliminates advance notice provisions in addition to a variety of other changes. S1616, which addresses the business practices of Pharmacy Benefit Managers (PBMs), moved through the committee without amendments.

BioNJ, along with our coalition partners, submitted slips on S1615 focused on increasing the stringency of confidentiality provisions. BioNJ is also pursuing minor modifications regarding the permissiveness of companies to be able provide nationwide data in lieu of State data when necessary. 

During the hearing, Chairman Sarlo, along with several of his fellow senators from both parties, stated that they are certainly interested in considering these amendments moving forward — and that the amendments made to the Assembly counterpart of S1616 (A536/A2841) are also under consideration in the Senate. 


In addition, a tax reform bill (S3737) that positively reforms GILTI and IRC Section 174 policy in the State, among a variety of other provisions, was discussed and received generally supportive testimony. EisnerAmper submitted written testimony characterizing an opportunity to improve the bill’s language that focuses on Section 174 such that it achieves the underlying goal of enabling companies to deduct R&D expenses in the years that expenses are incurred.


BioNJ will continue to monitor and advocate on behalf of the State’s life sciences industry.

Given this news and what is coming out of the nation’s capital, it has never been more important for the life sciences community to come together and support and learn from one another. 


Being that BioNJ's mission is to help our Members help Patients, we are dedicated to working hard on behalf of our Members  while you are hard at work for Patients. BioNJ...

  • Advocates in both Trenton and Washington DC to ensure that government fosters medical innovation and Patient access (there's never been a more important time than today to be involved in policy)
  • Works with policymakers to secure incentives and programs that allow New Jersey's innovation ecosystem to flourish
  • Acts as a conduit for idea sharing, learning, collaboration and mentorship through its many networking and educational programs
  • Provides an extended marketing arm, offering a platform to showcase your science, services and organization to a broad network
  • Provides deep savings through our Purchasing Consortium so Member companies can preserve their working capital
  • Offers numerous business-building tools, such as BioNJ's Talent and Career Portal


Drug development is difficult. Let BioNJ help to make it easier. Make sure to take advantage of all the value-driven opportunities available to your organization through your BioNJ Membership.


Not a Member? Not a problem. Contact Cheri Hennessy, Vice President of Member Engagement and Strategic Partnerships, at today to learn more about Membership. 

Because Patients Can't Wait®,

Debbie Hart

President and CEO


BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to share with you BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Associate Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting the community, but benefitting from a wide variety of high quality organizations. 

Welcome New Members

Learn more at

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Upcoming BioNJ Events


BioNJ's HR Conference

Kean University

Register Today!

June 13, 2023

BioNJ's Member Café

Virtual (Members only)

Register Today!

September 7, 2023

BioNJ's Manufacturing Briefing

Rutgers University

Save the Date!

September 13, 2023

BioNJ's C-Suite Summit

Bridgewater Marriott

Save the Date!

October 6, 2023

Putting Patients First:

The Value of Medical Innovation -

Recent Stories in the News


New PhRMA Ad Campaign Sheds Light on PBM Abuses

The Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new ad campaign that continues to shed light on the role of pharmacy benefit managers (PBMs) in driving up health care costs and denying coverage of lifesaving medicines. The PBM industry claims it fights for lower drug costs. The fact is they often prefer medicines with higher prices because it pads their bottom line, and experts warn this can lead to reduced access and higher costs for patients at the pharmacy counter. As the new ad spotlights, it’s PBMs that decide what medicines patients can get and what people pay out of pocket. And because PBMs receive fees and rebates often tied to the price of medicines, they have a financial incentive to refuse coverage for lower-priced treatments. Ultimately, it’s patients who pay the price.

Democrats Think Drug Price Negotiations Require Discrimination

The drug price “negotiation” mechanism Democrats included in last year’s inaptly named Inflation Reduction Act will reduce innovation and the introduction of possible new cures. But a recently released document by the Centers for Medicare and Medicaid Services also suggests regulators may utilize the “negotiation” process to discriminate against people with disabilities. In March, CMS released a  91-page guidance document  providing the agency’s initial views of the drug “negotiation” process. The document indicated that when considering various factors to determine the “fair price” for the drug, regulators would exclude research that uses quality-adjusted life years, or QALYs, “in a manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as of lower value than extending the life of an individual” without those characteristics.

New Resource Underscores the Importance of Small Molecule Medicines

A small molecule medicine is what most people think of when they imagine a medicine. These medicines typically come in the form of a tablet or capsule and are usually taken by mouth. These medicines play essential roles in the treatment of different diseases and are indispensable in providing patients, caregivers and health care providers with the tools necessary to achieve improved health outcomes. Despite the important advantages small molecule medicines offer in the treatment of many illnesses, government price setting provisions in the recently passed Inflation Reduction Act (IRA) could result in fewer of these medicines being developed for patients.

Why Are Policymakers Undermining One of FDA's Most Successful Programs?

Alzheimer's patients received great news in January when the FDA granted accelerated approval to lecanemab, a new treatment for the fatal dementia. The FDA's accelerated approval program expedites the release of new drugs to treat serious conditions. Over the years, these have included another Alzheimer's drug, aducanumab, as well as treatments for HIV/AIDS, leukemia, and a host of rare diseases. Unfortunately, several recent federal policy changes have added uncertainty to the accelerated approval program. Without more consistency from the FDA and Medicare, progress toward treating many deadly illnesses could grind to a halt. Approval on an "accelerated" basis doesn't mean the FDA rushed the review or that drug companies were allowed to cut corners. The FDA's accelerated approval pathway, just like the agency's traditional approval pathway, requires companies to demonstrate that the drug is safe and that there is abundant evidence of its effectiveness.

BioNJ in the News


Murphy, N.J. Officials Thrilled to Have Johnson & Johnson’s Billion-Dollar Spinoff Put Its HQ in Summit

In an SEC filing, J&J officials announced that Kenvue had entered into a long-term lease for a newly renovated office building and a newly constructed research & development building in Summit that — when completed — will encompass a total of approximately 290,000 square feet and serve as Kenvue’s new global corporate headquarters. In addition to corporate office space, officials wrote that the campus will house laboratory space to principally support R&D. Debbie Hart, the President and CEO of BioNJ, said she is hopeful that J&J’s continued commitment to New Jersey will make other life sciences companies want to join them in the Garden State. “Kenvue’s presence will add to the already rich ecosystem supporting the health care continuum. We could not be more elated and look forward to supporting their work.”

NJ’s Research Organizations Boost Pharmaceutical Discoveries

New Jersey is known as a pharmaceutical powerhouse, but behind the scenes, biotechnology, medical device and pharmaceutical companies depend on clinical research organizations or contract research organizations to conduct clinical trials and research support services. “The combination of the large presence of industry and a dense and diverse patient population make New Jersey an ideal place for CROs to do business,” according to Debbie Hart, president and CEO at BioNJ, a New Jersey life sciences trade association. “There are approximately 3,200 active clinical trials taking place today in New Jersey.” At the same time, Hart added, “Technology, AI and machine learning are increasing the capacity and efficiency in identifying and categorizing patients and patient data, accelerating the clinical research process and ultimately bringing new therapies to patients faster and more efficiently.”

NJ Company News


U.S. FDA Approves GSK’s AREXVY, the World’s First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has approved AREXVY (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world. Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. AREXVY is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

GSK’s Respiratory Syncytial Virus Older Adult Vaccine Candidate Gains Positive European Medicines Agency CHMP Opinion

Warren-based BioNJ Member GSK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion by consensus recommending approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. There are no RSV vaccines or specific treatments currently available for older adults. RSV causes over 270,000 hospitalisations and approximately 20,000 in-hospital deaths in adults aged 60 years and older each year in Europe. 

Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease

Princeton-based BioNJ Member Otsuka America Pharmaceutical, Inc. and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease. Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most complex and stressful aspects of caring for people living with the condition. It is reported in approximately half of people with Alzheimer’s dementia and is associated with earlier nursing home placement.

FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

Princeton-based BioNJ Member Otsuka America Pharmaceutical, Inc. and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII® (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. “We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “This approval underscores Otsuka’s commitment to innovate and continuously evolve to meet the needs of the communities we serve.”

Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix announced positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. The purpose of the study was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte™ and extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay.

Soligenix Enters into Exclusive Option Agreement With Silk Road Therapeutics for Rights to Topical Pentoxifylline Designed to Treat Behçet's Disease

Princeton-based BioNJ Member Soligenix announced that it has entered into an exclusive option agreement with Silk Road Therapeutics, a privately held company. The option agreement grants the company the right to acquire a novel topical formulation of Pentoxifylline (PTX), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patients suffering from Behçet's Disease (BD). BD is a rare multisystem inflammatory vasculitis with no cure, characterized by debilitating recurrent ulcers in the oral mucosa (95%), skin/genitalia (50%), and eye compartment (15%). An orphan disease and area of unmet medical need affecting approximately 18,000 people in the United States (U.S.) and 80,000 in Europe, there are as many as 1,000,000 people worldwide living with this painful and life altering disease.  

Soligenix Announces Pricing of $8.5 Million Public Offering

Princeton-based BioNJ Member Soligenix announced the pricing of its public offering of 6,538,500 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 6,538,500 shares of common stock at a combined public offering price of $1.30 per share and accompanying warrant for aggregate gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses. The warrants will have an exercise price of $1.50 per share, will be exercisable immediately and will expire five years from the issuance date. The company intends to use the proceeds to fund its research and development and commercialization activities and for general corporate and working capital purposes.

SPEVIGO® Granted Breakthrough Therapy Designation in the U.S. for the Prevention of Generalized Pustular Psoriasis Flares

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that spesolimab (marketed as SPEVIGO®) received Breakthrough Therapy Designation (BTD) as an investigational treatment for the prevention of flares in adolescents and adults with generalized pustular psoriasis (GPP) from the U.S. Food and Drug Administration (FDA). “GPP flares may appear suddenly, intensify quickly and can be life-threatening if left untreated, leaving those affected feeling anxious and uncertain about their future” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “The FDA’s recognition of the urgent need for preventing GPP flares is a major step towards empowering people living with the condition to plan critical moments in their lives, despite their disease.” 

Boehringer Ingelheim and Zealand Pharma Announce Phase II Trial Showed 14.9% Weight Loss in People Living With Obesity or Overweight

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Zealand Pharma A/S announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose. The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint. In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease. Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades.

Boehringer Ingelheim Begins Clinical Development of First-In-Class Treatment for Fibrotic Diseases

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that it has launched clinical development of its first-in-class IL-11 inhibitor antibody BI 765423 with a Phase 1 study to assess the safety, tolerability, and pharmacokinetics in healthy volunteers. Boehringer Ingelheim is already a global leader in the treatment of pulmonary fibrosis, and the initiation of clinical development of the anti-IL-11 treatment reflects the company’s long-term commitment to combat fibrotic disease across therapeutic areas. The IL-11 inhibitor antibody is the first of its kind to reach clinical development stage and is based on a partnership between the company and Enleofen Bio Pte. Ltd. (Enleofen), with a goal to improve patient outcomes.

First Wave BioPharma Completes Patient Screening for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

BioNJ Member First Wave BioPharma, Inc., with an office in Roseland, announced that it has completed patient screening in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The Phase 2 multi-center clinical trial (NCT05719311) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Topline results from the study are anticipated by mid-2023.

Sandoz Strengthens Pipeline Expansion Through Partnership to Develop and Manufacture Multiple Biosimilars

Princeton-based BioNJ Member Sandoz, a Novartis division, announced a multi-year partnership with Just - Evotec Biologics, the Seattle-based subsidiary of Evotec SE. The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion and is the most recent step towards strengthening the Sandoz foundation as a stand-alone off-patent medicines company. Access to Just - Evotec Biologics’ highly efficient drug substance development platform and manufacturing technology complements Sandoz capabilities, supporting expansion of the current pipeline from 15+ to 24 assets and the continued development of its early stage biosimilar pipeline.

Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera

BioNJ member Gilead Sciences, Inc., with a site in Morris Plains, announced the acquisition of all outstanding shares of XinThera, a privately held biotech company in San Diego. The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

CHMP Adopts Positive Opinion Recommending Hepcludex® (Bulevirtide) for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus (HDV)

BioNJ member Gilead Sciences, Inc., with a site in Morris Plains, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

Four Analyses of Data for REBYOTA™ (fecal microbiota, live – jslm), the First FDA-Approved Microbiome-Based Treatment for the Prevention of Recurrent C. difficile Infection, Presented at DDW 2023

Parsippany-based BioNJ Member Ferring Pharmaceuticals announced three oral presentations and one poster presentation at Digestive Disease Week® for REBYOTA™ (fecal microbiota, live – jslm) a first-in-class single-dose microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection. The analyses reviewed the safety of REBYOTA (previously known as RBX2660) in patients with inflammatory bowel disease, as well as safety and efficacy in immunocompromised patients and when administered by colonoscopy. An additional analysis looked at microbiome compositional changes and clonal engraftment following treatment with REBYOTA.

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

Parsippany-based BioNJ Member Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics. 

Celularity Announces Multi-Million-Dollar Intent to Purchase Branded Stem Cell Technology

Florham Park-based BioNJ Member Celularity announced it was advised by the Tamer Group to expect $60 to $80 million in 2023 purchase orders for its branded biomaterial products. Tamer Group is a pharmaceutical and medical products distributor and manufacturer based in the Kingdom of Saudi Arabia. With this significant planned purchase, the Tamer Group can provide Celularity’s products to patients in need across the Kingdom of Saudi Arabia. Once complete, the transaction will mark one of the company’s largest sales and validate the power of Celularity’s proprietary postpartum placental-derived stem cell technology. Celularity stands out as one of the few companies with a commercially viable biomaterials product pipeline as it produces next-generation therapeutics focusing on oncology, inflammaging and infectious diseases.

Hillstream BioPharma Announces Closing of Public Offering of Common Stock

Bridgewater-based BioNJ Member Hillstream BioPharma, Inc. announced the closing of its previously announced public offering of common stock. Hillstream sold 5,300,000 shares of its common stock at a public offering price of $0.50 per share for gross proceeds of $2,650,000 before deducting underwriting discounts and offering expenses. In addition, the company has granted the underwriters a 45-day option to purchase up to an additional 795,000 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount. The company intends to use the net proceeds from the offering for the advancement of its lead drug candidate HSB-1216, the development of other product candidates in the company’s pipeline and general corporate purposes and working capital. 

Janssen Enters Worldwide Collaboration and License Agreement With Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. These investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) in China, with the majority of study participants having diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.

Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients With Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational anti-PD-1 monoclonal antibody administered intravenously) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy. The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). 

First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data from the Phase 3 QUASAR Induction Study evaluating the investigational use of TREMFYA® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to conventional and/or advanced therapies. The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures. Safety data were also consistent with the known safety profile of TREMFYA in approved indications. Study author Dr. Jessica R. Allegretti, Medical Director, Crohn’s and Colitis Center, Brigham and Women’s Hospital, said “These Phase 3 data represent an important step in the advancement of a new treatment for moderately to severely active ulcerative colitis, as researchers continue to investigate therapeutic options that have the potential to provide relief for individuals at all stages of disease.”

Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. This approval covers all European Union (EU) member states. The approval is based on results from the pivotal Phase 3 TRANSFORM trial in which Breyanzi demonstrated statistically significant and clinically meaningful improvements in the study’s primary endpoint of event-free survival (EFS), and key secondary endpoints of complete responses (CR) and progression-free survival (PFS) compared to standard therapy (consisting of salvage immunochemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant [HSCT]), along with a manageable and well-established safety profile. 

U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Application for Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults With Lower-Risk Myelodysplastic Syndromes (MDS)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the Type II Variation Application for Reblozyl® (luspatercept-aamt), a first-in-class treatment option, to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions. In the U.S., the FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023. Priority Review designation underscores the high unmet need and value that Reblozyl could bring to this patient population. 

Bristol Myers Squibb’s TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi (lisocabtagene maraleucel)in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma Meet Primary Endpoint of Overall Response Rate

Princeton-based BioNJ Member Bristol Myers Squibb announced positive topline results from two studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel) in patients with relapsed or refractory follicular lymphoma (FL), and TRANSCEND NHL 001, an open-label, multicenter, pivotal Phase 1, single-arm study evaluating Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma (MCL). Results showed both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and clinically meaningful responses in relapsed or refractory FL and MCL. The studies also met the key secondary endpoint of complete response rate, demonstrating high rates of complete responses in both relapsed or refractory FL and MCL. 

Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease. Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer's Disease Rating Scale (iADRS). The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies and conversing about current events. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits with similar magnitude. Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the U.S. Food and Drug Administration (FDA) yet this quarter. 

Lilly Provides $500,000 in Grants to Support Equitable Access to Education for Dreamers in Indiana

To remove barriers and create more equitable, affordable post-high school education opportunities for Indiana's growing immigrant population, BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced grants totaling $500,000 to four local nonprofits that offer education assistance to Deferred Action for Childhood Arrivals (DACA) recipients, also known as Dreamers. Currently, Indiana is one of only two states that does not offer DACA eligible students living in Indiana in-state tuition to its state-run colleges and universities. "Dreamers deserve the same chance to succeed as their classmates, and right now, many who live in Indiana are unable to afford college because they must pay higher out-of-state tuition fees, which can pose a real challenge for them and their families," said Patrik Jonsson, Executive Vice President and President of Lilly USA and Lilly Immunology, and Chief Customer Officer.

Lilly Discloses First-in-Class, Interim Phase 2 Data in Pediatric Patients and New Analysis from Phase 3 Program in Adult Patients for Mirikizumab in Ulcerative Colitis

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced new investigational data for mirikizumab in patients with moderately to severely active ulcerative colitis (UC) that further support the efficacy and safety seen in previous pivotal studies. Data presented include an interim analysis of mirikizumab as induction therapy in pediatric patients with moderately to severely active UC from the Phase 2 SHINE-1 study, and a new analysis from LUCENT-1 and LUCENT-2 studies evaluating the relative association of bowel urgency remission on Inflammatory Bowel Disease Questionnaire (IBDQ) scores, which assess the impact of UC on quality of life in adults.

XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer Versus Placebo Plus Leuprolide

BioNJ Member Pfizer, with a site in Peapack, and Astellas Pharma Inc. announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). The overall safety profile was consistent with the known safety profile of each of the medicines. The most common adverse events in those treated with XTANDI plus leuprolide were fatigue, hot flush and arthralgia and in those treated with XTANDI monotherapy were fatigue, gynecomastia and arthralgia.

U.S. FDA Approves PREVNAR 20®, Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®. The FDA’s decision is based on results from the Phase 2 and Phase 3 clinical trial programs for the pediatric indication for PREVNAR 20. Three core Phase 3 pediatric studies contributed to data on the safety, tolerability and immunogenicity of PREVNAR 20, including previously announced positive, top-line results of the pivotal U.S. Phase 3 study (NCT04382326). 

Regeneron and Alnylam Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, and Alnylam Pharmaceuticals, Inc. announced positive interim results from the ongoing single ascending dose part of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA). Twenty patients have been enrolled in three single-dose cohorts in Part A of the ongoing Phase 1 study in patients with early onset Alzheimer’s disease. In this study to date, single doses of ALN-APP, which are administered by intrathecal injection, have been well tolerated. All adverse events were mild or moderate in severity, with available cerebrospinal fluid data for white blood cells and protein appearing similar to placebo. 

JOGO Health Granted FDA Designation for Chronic Pain Product

Bridgewater-based digital therapeutics company JOGO Health announced that the U.S. Food and Drug Administration (FDA) granted the Breakthrough Device Designation for its chronic lower back pain product, JOGO-CLBP.Gary Krasilovsky, JOGO’s chief scientific officer, said that while electromyography biofeedback has been studied since the 1970s to treat chronic pain, it’s not widely used in practice because of technological limitations. “JOGO’s 21st century technology and modern telemedicine-based approach will make EMG biofeedback widely available to patients,” Krasilovsky added. JOGO’s products are used to treat conditions such as chronic pain, cancer pain, stroke, pelvic floor disorders and Parkinson’s disease.

New Publication: Clinical Data Demonstrates Reduced Risk of Recurrence in Non-Muscle Invasive Bladder Cancer With the Use of BLC

Photocure ASA, with a site in Princeton, announced the publication of the study “The Impact of Blue Light Cystoscopy Use Among Non-Muscle Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on Recurrence and Time to Recurrence”. The article was published in the peer-reviewed medical journal Clinical Genitourinary Cancer. The data demonstrated a significant decrease in the risk of recurrence and prolonged time to recurrence following Blue Light cystoscopy (BLC®) with Cysview® compared to White Light cystoscopy (WLC) alone. The study was conducted with support from Photocure and aims to describe bladder cancer outcomes and the impact of blue light cystoscopy (BLC®) with Cysview® among non-muscle invasive bladder cancer (NMIBC) patients in an equal access setting, i.e., the United States Veterans Affairs Healthcare System (VA). 

Health Canada Approves QUVIVIQ (daridorexant) for the Management of Adult Patients With Insomnia

Idorsia Ltd, with a site in Cherry Hill, announced that Health Canada has granted marketing authorization for QUVIVIQ™ (daridorexant) for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Insomnia is one of the most prevalent sleep disorders in Canada. QUVIVIQ is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently. Rather than inducing sleep through broad inhibition of brain activity (sedation), QUVIVIQ blocks only the activation of orexin receptors which promote wakefulness. Consequently, for patients with insomnia, QUVIVIQ decreases the over-active wake drive, allowing sleep to occur, without altering the proportion of sleep stages.

Mallinckrodt Presents Clinical Data for TERLIVAZ® (terlipressin) for Injection in Adults With Hepatorenal Syndrome (HRS) at Digestive Disease Week (DDW) 2023

Mallinckrodt, with a site in Bedminster, announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function treated with TERLIVAZ® (terlipressin) for injection. TERLIVAZ is the first and only FDA-approved product indicated for the treatment of adults with HRS involving rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. Presented by Jasmohan S. Bajaj, School of Internal Medicine, Virginia Commonwealth University, Richmond, Va., the pooled analysis used the largest-to-date prospective database of three North American Phase III, randomized, placebo-controlled trials (OT-0401, REVERSE, CONFIRM) to evaluate the incidence of reported bradycardia and arrhythmias in adult patients with HRS treated with terlipressin vs. placebo. 

Eisai Enters Into Joint Development Agreement With BLISSBIO for Antibody Drug Conjugate BB-1701 With Option Rights for Strategic Collaboration

Nutley-based Eisai Co., Ltd announced that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration. BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2. The linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by Eisai's U.S. research base, and Eisai is investigating the possibilities of using this platform to link to various antibodies. Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload. 

Parsippany-Based Astellas Pharma Acquires Princeton-Based Iveric Bio for $5.9B

Parsippany-based Astellas Pharma Inc. announced that it has an agreement to acquire Princeton-based Iveric Bio for $5.9 billion. Astellas CEO Naoki Okamura stated, “We are pleased to reach an agreement with Iveric Bio, a company with exceptional expertise in the R&D of innovative therapeutics in the ophthalmology field. Iveric Bio has promising programs, including Avacincaptad Pegol, an important program for Geographic Atrophy secondary to Age-Related Macular Degeneration, and capabilities across the entire value chain in the ophthalmology field. We believe that this acquisition will enable us to deliver greater value to patients with ocular diseases at high risk of blindness.”


OncoSec Receives $3.49 Million to Strengthen its Balance Sheet After Selling its Net Operating Loss Tax Benefits Through the New Jersey Economic Development Authority NOL Program

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the receipt of $3.49 million in tax credit certificates from the New Jersey Economic Development Authority (NJEDA). The tax credit certificates are offered to qualified companies through the NJEDA's Technology Business Tax Certificate Transfer Program, which enables eligible technology and biotechnology companies based in New Jersey to sell unused net operating losses (NOLs) and research and development (R&D) tax credits for cash proceeds. "The NJEDA NOL program provides non-dilutive funding for OncoSec by allowing us to sell our unused NOLs and R&D tax credits for cash, without reducing investor value or adding debt to our balance sheet, which supports our efforts to advance development of our interleukin 12 (IL-12) encoding plasmid delivered by intratumoral electroporation as novel immunotherapy for patients with cancer, including in the neoadjuvant setting for melanoma,” said Robert H. Arch, President and CEO, OncoSec.

Cyclacel Pharmaceuticals Announces Receipt of $4.7 Million R&D Tax Credit

Berkeley Heights based BioNJ Member Cyclacel Pharmaceuticals, Inc. announced that it received a payment of £3.9 million ($4.7 million) as a research & development (R&D) tax credit from HMRC, the tax agency of the United Kingdom government. The tax credit is for R&D costs incurred in the year ended December 31, 2022, and represents the amount disclosed in the company’s audited financial statements at December 31, 2022. “The R&D tax credit is an important source of non-dilutive capital. We appreciate the UK government’s support as we develop our novel, oral medicines, fadraciclib and plogosertib, to address unmet medical needs of oncology patients, including patients with women’s cancers and lymphoma,” said Paul McBarron, Executive Vice President, Finance & Chief Operating Officer.

Woman-Led SciMar ONE is All-In on New Jersey as its Drug Development Offering Evolves

For Donna and Mike Conroy, co-founders of SciMar ONE, the opportunities available to them in New Jersey to speed up their start-up’s progress have been game changing — due to programs sponsored by the New Jersey Economic Development Authority (NJEDA); BioNJ; and the Merck Digital Sciences Studio (MDSS), at NJIT’s New Jersey Innovation Institute (NJII). Through MDSS the company has received support from Microsoft for Start-ups and advice and support from three pivotal healthcare investment groups. recently spoke to Donna Conroy about the company. She explained that SciMar has pioneered “Development Velocity,” an artificial intelligence (AI)-based process with a lot of intellectual property (IP) behind it.

NJEDA Opens 2023 Net Operating Loss Program Application

The New Jersey Economic Development Authority (NJEDA) opened applications for its 2023 Technology Business Tax Certificate Transfer Program, commonly known as the Net Operating Loss (NOL) Program. The program enables early stage life sciences and technology businesses in the Garden State to sell a percentage of their New Jersey net operating losses and unused research and development (R&D) tax credits to unrelated profitable corporations for cash. The NOL Program is accepting applications through June 30, 2023, at Participants can use the capital raised through the NOL Program to help cover allowable costs incurred in connection with operating their businesses such as salaries, R&D and other working capital expenditures.

NJEDA Highlights Over $8 Million in Support Approved for Manufacturers to Date Under the New Jersey Manufacturing Voucher Program

The New Jersey Economic Development Authority (NJEDA) has already approved over $8 million in vouchers to 69 New Jersey manufacturers under the New Jersey Manufacturing Voucher Program (MVP). Approved awardees can use the vouchers to purchase equipment to help New Jersey manufacturers upgrade their businesses. Governor Murphy announced the New Jersey MVP in October 2022 as a pilot program. Originally funded with $20 million from the Governor’s Fiscal Year 2023 budget, the program offers vouchers valued at 30 to 50 percent of the cost of eligible equipment, including installation, up to a maximum award amount of $250,000. In March, in order to fulfill a robust pipeline of eligible applications, the NJEDA’s Board voted to increase available funding to $33.75 million. 

NJEDA Board Approves Inaugural Group of Qualified Venture Firms for the New Jersey Innovation Evergreen Fund

The New Jersey Economic Development Authority (NJEDA) Board approved the first three venture capital firms that will be onboarded to the New Jersey Innovation Evergreen Fund (NJIEF) platform. Qualified Venture Firms (QVFs) will be able to apply and access up to $12.5 million annually from the NJIEF to co-invest in innovative, high growth New Jersey-based businesses. The qualification of these three firms marks a significant milestone in the creation of the NJIEF, a first-of-its-kind tool to increase New Jersey startups’ access to venture capital and strategic resources. Established under the New Jersey Economic Recovery Act (ERA) of 2020, signed by Governor Phil Murphy in 2021, the NJIEF allows the State to become an equity investor in innovative early-stage businesses based in New Jersey, investing a total of up to $600 million in New Jersey companies alongside approved QVFs.



Rutgers Innovation Ventures Bulletin, Volume 1, Issue 2

Rutgers Office for Research proudly presents you with the Technology Transfer Bulletin, which will provide updates on Rutgers innovations and highlight collaborative and partnership opportunities for intellectual property-based assets.

Life Sciences and Healthcare Institutions: Partners for Life

Recorded Webinar Presented by Rutgers Master of Health Administration Program

The interplay between health systems and the life sciences is a critical driver in the discovery and development of new therapies and cures. This symposium was designed to provide insight into the respective roles of health systems and the life sciences that foster the development of lifesaving and life-enhancing research and solutions. This half-day event included several panel discussions and included representatives from select health systems, pharmaceutical and life sciences companies and patient advocates. 

BioCentriq and panCELLa Execute Research Agreement to Study Stem Cell-Derived Natural Killer Cell Expansion Technology

BioNJ Member BioCentriq and panCELLa, a Pluristyx Company, announced that they have signed a research agreement designed to evaluate the ability of panCELLa's genetically-engineered, induced Pluripotent Stem Cell (iPSC)-derived, feeder cells to activate and positively impact the expansion rate, total yield and potency of manufactured NK cells. BioCentriq, a contract development and manufacturing organization (CDMO) focused exclusively on accelerating the development and manufacturing of cell therapies, will expand and cryopreserve the feeder cell bank for use as a reagent to activate adult and iPSC-derived NK cells and evaluate viable cell yield and potency in static and dynamic culture conditions.

Groundbreaking Held for Liberty Science Center High School

Slated to open in 2025, LSCHS is a world-class public magnet STEM (science, technology, engineering and math) academy that will be operated by the Hudson County Schools of Technology. LSCHS will provide programs in Earth (Sustainable Engineering and Climate Science), Life (Biological Sciences) and Space (Astrophysics) to 400 students in grades 9 – 12 from across Hudson County. During a groundbreaking ceremony, speakers addressed the promise and importance of LSCHS to Hudson County and the transformative impact it will have on students aspiring for careers in the STEM fields, on diversifying those fields and on cementing the region’s and the State’s position as a center of scientific and technological discovery and innovation.

Cooper Medical School of Rowan University Ranked No. 1 Med School in N.J. (No. 50 nationally) by U.S. News for Primary Care

Cooper Medical School of Rowan University was ranked No. 1 in New Jersey — and No. 50 nationally — in the 2023-2024 Best Medical Schools: Primary Care rankings by U.S. News & World Report, which were released Thursday morning. Dr. Annette Reboli, Dean of CMSRU, said the school takes great pride in the ranking, considering the coming shortfall of primary care physicians. The Association of American Medical Colleges has projected the country could be short between 17,800 to 48,000 doctors by 2034. “CMSRU takes great pride in its recognition as a leading institution in replenishing the physician workforce both in New Jersey and across the nation,” she said. “This accomplishment is achieved through our traditional four-year medical school pathway as well as our innovative PC3 program, a three-year accelerated primary care track.”


Spotlight On: Chris Cozic, Executive Vice President & Chief People Officer, Genmab

In an interview with Invest, Chris Cozic, Executive Vice President & Chief People Officer of Genmab and BioNJ Board Member, talked about some of the company’s milestones achieved over the last year, including the FDA’s acceptance for priority review the biologics license application (BLA) for subcutaneous epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma and the expansion of its partnership with BioNTech for developing and commercializing novel mono-specific antibody candidates for cancer indications.

BioNJ Board Member Christine Ann Miller of Melinta Therapeutics Named as One of ROI-NJ 2023 Corporate Growth Award Honorees

Melinta Therapeutics LLC has earned a powerful reputation for providing innovative therapies to people impacted by acute and life-threatening illnesses. With an unsurpassed commitment to both the providers and the patients, it works to ensure that all people who need its therapies can receive them. To accomplish this, it has focused on serving patients with an unmet need because that's how it makes the most meaningful impact. Under the visionary leadership of Christine Ann Miller, CEO, the company has been dedicated to embracing innovation while staying grounded in what matters most: Patients. As such, its Mission is "To provide innovative therapies to people impacted by or acute and life-threatening illnesses." Its Vision is "All people who need our therapies will receive them."

Soligenix Announces Appointment of Timothy R. Coté, M.D. to its Board of Directors

Princeton-based BioNJ Member Soligenix announced the appointment of Timothy R. Coté, M.D., M.P.H. to its Board of Directors. Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Centers for Disease Control (CDC), Dr. Coté served as the Director of the FDA Office of Orphan Products Development (OOPD) from September 2007 to May 2011. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics. 

Tris Pharma Expands Leadership Team as it Broadens its Commercial Portfolio

Monmouth Junction-based Tris Pharma announced the appointments of Thomas Englese as Chief Commercial Officer and Dr. Marc Lesnick as Chief Development Officer. Founder and CEO Ketan Mehta welcomed them to the team. “We are thrilled to welcome Tom and Marc to the Tris Pharma executive team, and I am confident that their expertise will play a critical role in helping us continue to develop and commercialize differentiated approaches that enhance therapeutic benefit and optimize outcomes for patients,” he said. “Their strategic mindsets and demonstrated success achieving key commercial and pipeline milestones will be invaluable as we continue to innovate and bring novel therapeutic approaches to people in great need.”

ESG Best Practices: Tools to Learn From

Managing and Growing Supplier Diversity Spending Meet Your Funding Objectives and Help Build a Better World

A guide developed by BioNJ Member Fisher Scientific

A robust supplier diversity program that includes best practices for meeting diverse spending goals is critical to complying with U.S. federal subcontracting requirements and securing contracts and FDA approvals. But an effective program and spending plan can do more — a lot more.

Sustainability in Business: Staying Ahead of the Curve

A resource developed by BioNJ Member Deloitte

When the business environment changes, strategies must adapt. Business sustainability has become an extraordinarily disruptive phenomenon impacting corporates, and in a multitude of different ways. Digital transformation has been a tremendous challenge for organizations, but sustainability strategies go further by fundamentally rewriting the rules. From globally rising inequality and social fragility to the lack of access to clean water, sanitation, health care and education, or the increasing speed at which biodiversity is being lost — the topics are as diverse as they are crucial.

Industry Events


FDA Centers of Excellence Initiative

Hosted by Rutgers University

May 16, 2023

Rutgers University is leading a major initiative to be designated as a National Centers of Excellence in Advanced and Continuous Manufacturing. These centers will be selected and robustly funded by the FDA to support the adoption of advanced and continuous methodologies in the pharmaceutical space. Rutgers and its partners have organized six events across the country to present the initiative and to gather stakeholders’ input. Industry’s opinion is essential, so join Rutgers’ event on May 16. Learn more and register:

Navigating the Funding Landscape: Insights for Early Stage Biotechs

Hosted by LES USA & Canada

May 18, 2023

Join us for an engaging and timely event on May 18 at the Basking Ridge Country Club. Discover what it takes for early stage biotechs to secure funding in today's challenging market conditions. This event will shed light on the unique challenges and opportunities facing the industry through in-depth case studies, insightful discussions, and a comprehensive analysis of current funding trends. Don't miss out on this invaluable opportunity to gain a competitive edge in the world of pharma deals. Register now and be a part of the conversation!

19th Annual Global Business Conference

Hosted by World Trade Center of Greater Philadelphia (WTCGP) and the Temple University Center for International Business Education and Research (CIBER).

May 22, 2023

Mark your calendars for May 22 from 7:45AM to 12PM for WTCGPhila’s 19th Annual Global Business Conference! Get the latest insights and strategies for success from industry-leading experts as they discuss growth opportunities in fluctuating international markets, share leadership lessons and practical advice, explore the future of artificial intelligence and its impact on global trade and more.

Stand Up for Science at BIO 2023 Hosted by BIO International Convention

June 5-8, 2023

Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor and recognize the true value of the breakthrough work biotech performs for society. Today. And every day. Well into the future. Join the global power players in the biotech and pharma industry at the world's most influential biotech meeting! Sign up for updates to receive everything you need to know about the BIO International Convention.

ON Helix Hosted by One Nucleus

July 6, 2023

This one-day conference will address key bio innovation trends, from developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Delegates and Supporters will connect with the One Nucleus network to explore New Horizons for Bio Innovation. BioNJ Members enjoy a 10% discount. Contact for the discount code.

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming, and networking, with global deal making opportunities. The month of May will be here before we know it! Register before May 1, 2023 and save.

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