Welcome to the latest edition of the  BioLines Weekender !  
 
BioNJ is excited to release our  2019 Annual Report Video  as debuted at our Annual Meeting on February 6. As you'll see, 2019 was an extraordinary year for the industry, for Patients and for BioNJ!

We saw breakthrough science, with more than 50% of all new FDA novel medicine approvals in 2019 coming from companies with a footprint in New Jersey. Plus, with the advancements in cell and gene therapy, we saw the industry enter a promising new era of discovery where landscape-altering innovations are attacking the root cause of disease and changing the trajectory of life-threatening illness.
 
In Washington, we witnessed some frightening legislative proposals, such as importation, international pricing and H.R.3. -- as well as value assessments by organizations like ICER -- endangering the future of innovation and threatening Patient safety. Through it all, BioNJ has taken a proactive approach to advocating for the industry, medical innovation and for Patients. 

Enjoy a look back at 2019 by clicking here. 

Thank you to all of our Members for your support -- allowing us to help you...help Patients. 

Because Patients Can't Wait®,
The BioNJ Team

P.S.  Registration is now open for BioNJ's BioPartnering Conference with J.P. Morgan & J&J Innovation, taking place May 13 at The Palace Somerset. Companies can apply to present to over 500 life sciences industry leaders, public & private company investors and academic partnering professionals. The application submission deadline is March 27. Click here to learn more!
Blue Divider
The 2020 Dr. Sol J. Barer Award Presented to Kenneth C. Frazier
Video produced by Pulse Productions

During BioNJ's 27th Annual Dinner Meeting and Innovation Celebration, Dr. Sol Barer presented the 13th Annual Dr. Sol J. Barer Award for Vision, Innovation and Leadership to industry icon Kenneth C. Frazier, Chairman and CEO, Merck & Co., Inc.  "We were honored to present Mr. Frazier with the 2020 Dr. Sol J. Barer Award for his visionary work on behalf of Patients, medical innovation and New Jersey's ever-growing life sciences ecosystem," said BioNJ President and CEO Debbie Hart. 
BioNJ Calendar

BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
Register today!
May 13, 2020
Putting Patients First: The Value of Medical Innovation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of health care. Share with our community how your medical innovation is improving lives and impacting health care costs. Send us your Patient and related stories to BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.



Since finishing medical school nearly 40 years ago, I've witnessed American scientists develop hundreds of lifesaving medicines that once seemed unimaginable.  While leading the National Heart, Lung, and Blood Institute at the National Institutes of Health, I saw scientists pioneer novel ways to treat rare and serious blood disorders in children.  These cutting-edge medicines weren't developed overnight. They required decades of research, hundreds of millions of dollars in seed funding, and a policy environment that fosters innovation. Unfortunately, our innovation ecosystem is now under assault.



America's biopharmaceutical researchers are committed to studying, developing and testing medicines to meet the unique needs of pediatric patients. New treatment options for infants, children and adolescents can be complex and often require different clinical approaches than adult treatment pathways. According to a  new report , there are nearly 600 pediatric medicines currently in development. There are more than 2,100 industry-sponsored pediatric clinical trials underway, testing 580 investigational medicines and involving more than 1.2 million pediatric patients across a variety of therapeutic areas, including diseases where there is a significant unmet medical need.


Biopharma industry in the U.S. is rooted in a strong R&D sector, with the employment percentage being three times larger than the industry average, suggests PhRMA. The pursuit of biologic treatments and the development of these over the different clinical stages has formed a strong industry sector in the U.S., pivotal for the country's economy, a recently published report by the Pharmaceutical Research and Manufacturers of America (PhRMA) and TEConomy  Partners suggests.  The report's findings indicate that the growth of the biopharmaceutical industry in the U.S. is based to a large extent on innovation, with the industry holding a leading position in R&D employment and investments.



Across the country, the biopharmaceutical sector supports millions of jobs in its pursuit to discover ground-breaking treatments and cures for patients around the world.  The impact of the industry is far-reaching. Along with the researchers who play pivotal roles in driving biopharmaceutical research forward, the industry employs people with a diversity of educational backgrounds in a wide range of occupations, all of whom play a crucial part in the development, production and delivery of medicines. A new report from TEConomy Partners found that the biopharmaceutical industry supports over four million jobs and over $1.1 trillion in economic output. 

NJ Pride



New Jersey remains the world's "medicine chest" in many ways, according to the new Life Sciences 2020 report from real estate firm  Cushman & Wakefield, which found continued growth in the industry throughout the Garden State bodes well for the real estate sector.
With mergers and consolidations continuing throughout the industry, both regionally and nationally, New Jersey has seen an increase in the number of small- and mid-sized pharmaceutical and biotech companies in recent years, Cushman & Wakefield said.



Despite oft-cited concerns from lawmakers and business groups that New Jersey lacks a competitive edge against other states -- and worries about so-called "outmigration" -- a new study would suggest that the Garden State's economy is actually quite healthy. Online magazine SeniorLiving.org, in a recent study, ranked New Jersey as the fourth healthiest economy out of 50 states in its 2020 Economic Health Index. The study looked at factors such as nationwide November 2019 unemployment rates, changes in unemployment between 2015 and 2019, average annual wages in 2018, and 2018's total gross domestic product and its changes since 2014.



According to  Business.org, after analyzing the most recent data on the increase of fatal and non-fatal accidents across the United States, New Jersey is second safest state to work in.
More than 5,000 people suffer fatal work injuries every year, according to data from the U.S. Bureau of Labor Statistics. As a business owner, data like this can be an important factor to decide things such as how much workers compensation coverage is needed.

BioNJ in the News


Op-ed by Debbie Hart, President and CEO, BioNJ as Published in ROI-NJ

I was heartened on Feb. 6 at  BioNJ's  Annual Dinner Meeting when Senate President Steve Sweeney announced to a crowd of 650 life sciences professionals, patient advocates and patients his enthusiastic support for the New Jersey Innovation Evergreen Fund.
Under the fund, the state would auction tax credits to New Jersey corporations over five years in order to raise $250 million to invest into startups, while seeking to pair those funds with at least $250 million from private venture capital sources. The combined $500 million infusion would target New Jersey-based startups that show the promise and potential to scale up and create jobs.  

NJ Company News



Princeton-based BioNJ Member Soligenix, Inc. announced that its ongoing collaboration with the University of Hawaii at Manoa (UHM) and Hawaii Biotech Inc. (HBI) has resulted in what the company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus,  Sudan  virus and Marburg virus).



Edison-based BioNJ Member  Hepion Pharmaceuticals, Inc. announced results from in vitro studies showing that CRV431 can decrease production of the extracellular matrix (ECM) molecules, collagen and fibronectin, from fibroblastic cells derived from five different organs. Collagen and fibronectin over-production from these types of cells cause fibrotic scarring of injured organs, and therefore these results suggest that CRV431 could exert anti-fibrotic activity across a range of diseases.



Edison-based BioNJ Member  Hepion Pharmaceuticals, Inc. announced the advancement to the third dose level in its ongoing clinical trial of CRV431, a Phase 1 multiple ascending dose ("MAD") study. The open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days. The study is examining doses of 75 mg, 150 mg, 225 mg and 300 mg, or higher in anticipation of progressing to a Phase 2 program.



Bedminster-based BioNJ Member  Matinas BioPharma Holdings, Inc. announced that the independent Data Safety Monitoring Board (DSMB) for the EnACT study has completed its planned review of initial safety and tolerability data from the Part 1 dose escalation phase and unanimously approved proceeding with enrollment in the Part 2 efficacy phase at 2g of MAT2203 daily, the highest dose tested in Part 1. The 2g dose will be tested in the 2-week induction phase of treatment. 



Princeton-based BioNJ Member Agile Therapeutics, Inc.   announced the pricing of its underwritten public offering of 15 million shares of its common stock at a public offering price of  $3.00  per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by  Agile Therapeutics , are expected to be approximately  $45 million . In addition,  Agile Therapeutics  has granted the underwriters a 30-day option to purchase up to 2.25 million additional shares of common stock at the public offering price, less the underwriting discounts and commissions. 



Princeton-based BioNJ Member  Advaxis, Inc.  announced updated results from the combination arms of the Company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC). The trial is evaluating ADXS-503, part of the Company's ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.



Princeton-based BioNJ Member  Advaxis, Inc.  announced results from the monotherapy and combination arms of the company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting in  Santa Monica, California.  The trial is evaluating ADXS-503, part of the company's ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.



Cranbury-based BioNJ Member  Palatin Technologies, Inc. announced that it has enrolled the first patient in a Phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease (DED). The Phase 2 study is a multi-center, randomized double-masked and placebo-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye. The study is designed to enroll up to 150 participants at three sites in the U.S.



South Plainfield-based BioNJ Member  PTC Therapeutics, Inc. announced the launch of the sixth annual STRIVE grant awards program for Duchenne muscular dystrophy. The STRIVE Awards provide a grant to patient advocacy organizations to develop programs that make meaningful contributions to those in the rare disease community. The deadline for submissions is  Thursday, April 30 , and organizations can apply through an application form available here. Winners will be announced later this year on World Duchenne Awareness Day.



Teva Respiratory LLC, an affiliate of Parsippany-based BioNJ Member  Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) approved ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid (ICS) delivered via Teva's Digihaler device.  The device contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma.



Parsippany-based BioNJ Member  Teva Pharmaceutical Industries Ltd. announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS). In the data received this week, the most commonly reported adverse event in the ARTISTS 1 and ARTISTS 2 studies were headache, somnolence and fatigue. 



Warren-based BioNJ Member  GlaxoSmithKline plc announced the U.S. Food and Drug Administration (FDA) approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults 18 years and older. According to GSK, with the FDA's approval, Voltaren Arthritis Pain becomes the first and only prescription-strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States.



Warren-based BioNJ Member  GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) accepted the company's submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.



Clover Biopharmaceuticals announced that it has entered into a research collaboration with Warren-based BioNJ Member GlaxoSmithKline plc for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer). GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.



Princeton-based BioNJ Member Photocure ASA is pleased to announce that the United States Patent and Trademark Office (USPTO) has granted US Patent No. 10,556,010 covering the use of Blue Light Cystoscopy (BLC®) with Hexvix as neoadjuvant therapy in the treatment of bladder cancer in patients who are scheduled for a cystectomy. Early stage study results have shown an antitumor effect and induced systemic immune effects of hexaminolevulinate (HAL) and blue light in an orthotopic model of rat bladder cancer. 



Princeton-based BioNJ Member Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company's autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.



Princeton-based BioNJ Member Bristol-Myers Squibb announced five-year follow-up results from the Phase 3 CheckMate -025 study, which continue to demonstrate that treatment with Opdivo (nivolumab) delivers superior overall survival (OS) and objective response rates (ORR) in patients with previously treated advanced or metastatic renal cell carcinoma (RCC) compared to those treated with everolimus. With an extended minimum follow-up of 64 months, patients treated with Opdivo continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with everolimus.



Princeton-based BioNJ Member Bristol-Myers Squibb Company announced Japan's Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy. This approval is based on the Phase 3 ATTRACTION-3 trial, which evaluated Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC) refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. 



Berkeley Heights-based BioNJ Member  Amgen , Cytokinetics, Incorporated and Servier announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis, which included consideration of pre-specified criteria for futility and superiority. The DMC reviewed data from GALACTIC-HF and recommended that this Phase 3 clinical trial of omecamtiv mecarbil continue without changes to its conduct.



East Hanover-based BioNJ Member Novartis and the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, have signed a collaboration and licence agreement to jointly develop LXE408, as a potential new oral treatment for visceral leishmaniasis, one of the world's leading parasitic killers.  LXE408 is a first-in-class compound, discovered at Novartis with financial support from the Wellcome Trust.  Within the scope of the agreement, Novartis is responsible for completing Phase I clinical trials. In addition, it will drive pharmaceutical development and regulatory submissions.



East Hanover-based BioNJ Member  Novartis announced that both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favorable safety profile.



East Hanover-based BioNJ Member  Novartis announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints). Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase. 



Bridgewater-based BioNJ Member  Eli Lilly and Company  announced that a  U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee  (ODAC) voted 6-5 that CYRAMZA® (ramucirumab) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC), based on the results of the positive Phase 3 RELAY study. The ODAC considered the safety and efficacy data from the Phase 3 RELAY trial, which is the basis for the CYRAMZA supplemental Biologics License Application (sBLA) currently under review by the FDA.



Bridgewater-based BioNJ Member  Eli Lilly and Company  announced that the  U.S.  Food and Drug Administration (FDA) has approved Trulicity® (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. This decision makes Trulicity the first and only type 2 diabetes medicine approved to reduce the risk of MACE for both primary and secondary prevention populations.



Bridgewater-based BioNJ Member  Eli Lilly and Company  announced the successful completion of its acquisition of  Dermira, Inc.  The acquisition expands Lilly's immunology pipeline with the addition of lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity that is being evaluated in a Phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. 





Kenilworth-based BioNJ Member  Merck confirmed that four African countries, including the Democratic Republic of the Congo (DRC), have approved ERVEBO. ERVEBO was granted a conditional marketing authorization by the European Commission on November 11, 2019 and approved by the U.S. Food and Drug Administration (FDA) on Dec. 20, 2019. In the United States, ERVEBO is indicated for the prevention of disease caused by  Zaire ebolavirus  in individuals 18 years of age and older. The duration of protection conferred by ERVEBO is unknown. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus.   



New Brunswick-based BioNJ Member Johnson & Johnson's Janssen Pharmaceutical Companies will expand its existing partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services, to seek treatment solutions for COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2 (also known as 2019-nCoV). 



Ramsey-based BioNJ Member  ADMA Biologics, Inc. announced the closing of the issuance of an additional 3,525,000 shares of its common stock at a public offering price of $3.50 per share. The shares were issued pursuant to the full exercise of the underwriters' overallotment option in connection with ADMA's previously announced underwritten public offering of 23,500,000 shares of its common stock.



Cranbury-based BioNJ Member  Outlook Therapeutics, Inc.  announced that it has closed its previously-announced registered direct offering priced at-the-market under Nasdaq rules of 7,598,426 shares of its common stock, at a combined purchase price of $1.016 per share and associated unregistered warrant, for aggregate gross proceeds of approximately $7.72 million . The company also issued to the investors in the registered direct offering unregistered warrants to purchase up to an aggregate of 3,799,213 shares of its common stock. 



Perrigo Co. and its partner, Somerset-based  Catalent Pharma Solutions, announced that the U.S. Food and Drug Administration approved Perrigo's abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA.  Perrigo Executive Vice President and President, Rx Pharmaceuticals, Sharon Kochan said, "Achieving FDA approval of this complex generic product was the outcome of an industry-leading collaboration in product development and regulatory expertise between Perrigo and Catalent that spanned over a decade. We are immediately launching with limited commercial quantities and anticipate that we will be in a position to provide a steady supply of this product by the fourth quarter of 2020."



Summit-based Seqirus announced that the U.S. Food and Drug Administration (FDA) has approved the first adjuvanted quadrivalent influenza vaccine, FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), to help protect adults 65 years and older against seasonal influenza. In the U.S., influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults. During the 2017/18 influenza season, 70 percent of influenza-related hospitalizations and 90 percent of influenza-related deaths occurred in this age group.



Warren-based  Bellerophon Therapeutics, Inc.  announced positive top-line data from a recently completed acute, intra-patient, dose escalation, hemodynamics study (PHPF-002) of INOpulse® for the treatment of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF). The top-line results from PHPF-002 demonstrated that acute treatment with INOpulse provided statistically and clinically significant improvements in hemodynamic parameters.



Mount Olive-based Flowonix Medical Inc. said that the United States Food and Drug Administration granted approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen, a muscle relaxant medicine.  Flowonix introduced the Prometra II 40mL pump to the U.S. market in November 2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an intrathecal pump delivery device. The new indication expands the market significantly.



Short Hills-based AB Science SA announced that the Phase 2B/3 study (AB07002) evaluating oral masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis met its primary endpoint (p=0.0256) with masitinib dose of 4.5 mg/kg/day. This treatment effect was numerically maintained for subpopulations of PPMS and nSPMS. The study enrolled 301 patients in the 4.5 mg/kg/day treatment arm (200 treated with masitinib and 101 treated with placebo). The pre-specified primary endpoint was absolute change from baseline on Expanded Disability Status Scale (EDSS) considering all measurements from week-12 to week-96.



Bridgewater-based Foamix Pharmaceuticals Ltd.  announced results from an integrated efficacy analysis on the two pivotal Phase 3 clinical trials for FMX103 (minocycline, 1.5% foam) currently under review by the  U.S. Food and Drug Administration  ( FDA ) for the treatment of moderate to severe papulopustular rosacea in adults. Foamix previously announced that the  FDA  has accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for  June 2 nd, 2020 under the Prescription Drug User Fee Act (PDUFA).



Monmouth Junction-based CytoSorbents Corporation entered into an agreement to bring CytoSorb to mainland China to treat critically-ill patients with COVID-19 (fka Wuhan or 2019-nCoV) coronavirus infection. Under the terms of the agreement, CytoSorbents and CMS will partner together to earn regulatory clearance to import CytoSorb into China under the "fast-track" review process established by the National Medical Products Administration of the People's Republic of China (NMPA) to respond to the 2019 novel coronavirus (COVID-19) pandemic.



Paramus-based PGI Holding Corporation (PsychoGenics) announced that it has been awarded an Indefinite Delivery Indefinite Quantity contract by the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH), Department of Health and Human Services, for the screening of investigational agents through the "NINDS Preclinical Screening Platform for Pain" (PSPP). The maximum value of the contract is $49.9 million over a five-year ordering period. 



Princeton-based Certara announced it has acquired a range of modeling and simulation technology assets from  In Silico Biosciences Inc.  The assets include a platform of multiple integrated quantitative system pharmacology or QSP, modules of the brain and pathology developed for the study of neurodegenerative conditions, such as Alzheimer's, Parkinson's and Huntington's disease.



People in the News



Congratulations to all of BioNJ's Members that are featured on NJBIZ's 2020 Power 100 list below. And, a special congratulations to our own President and CEO, Debbie Hart, for making the list eight years in a row!
  • Joel Bloom, President, New Jersey Institute of Technology
  • Tom Bracken, President and CEO, New Jersey Chamber of Commerce
  • Dale Florio, Managing Partner, Princeton Public Affairs Group
  • Kenneth Frazier, Chairman and CEO, Merck & Co., Inc. 
  • Robert Garrett, CEO, Hackensack Meridian Health
  • Alex Gorsky, CEO, Johnson & Johnson
  • Jonathan Holloway, Incoming President, Rutgers University
  • Jose Lozano, President and CEO, Choose New Jersey 
  • Patrick Murray, Director, Monmouth University Polling Institute
  • George Norcross, Executive Chairman, Conner Strong & Buckelew
  • Christopher Porrino, Partner, Chair, Litigation Department, Lowenstein Sandler
  • Greg Schiano, Football Coach, Rutgers University
  • Donald Sebastian, CEO, New Jersey Innovation Institute
  • Michele Siekerka, CEO, New Jersey Business & Industry Association
  • Tim Sullivan, CEO, New Jersey Economic Development Authority
  • Michael Tardugno, President and CEO, Celsion Corp.



Princeton-based PDS Biotechnology Corporation announced that it has appointed Kamil Ali-Jackson, Esq. to its Board of Directors. Ms. Ali-Jackson will be a member of the Board's audit committee. Kamil Ali-Jackson, Esq. has more than 30 years of experience as legal counsel in the life sciences industry with public and private specialty pharmaceutical, biotech and biopharmaceutical companies. Ms. Ali-Jackson has extensive domestic and international experience with strategic alliances, drug development and commercialization collaborations and M&A transactions. 


Institution and Education News



In what is the largest state investment in college affordability in more than a decade, Gov. Phil Murphy, alongside Secretary of Higher Education Dr. Zakiya Smith Ellis, formally announced the "Garden State Guarantee" - a $50 million investment in public, four-year senior public colleges and universities through his proposed FY2021 budget.



Hoboken-based Stevens Institute of Technology has announced the kickoff of its 150th anniversary celebration, commemorating the university's progress since its founding on Feb. 15, 1870 and looking ahead to its future. The celebration will begin in mid-February with the launch of  stevens150.com , which will include 150 stories recognizing the university's storied past and present, and highlighting the future built on a foundation of innovation, drive and collaboration.



New Jersey Institute of Technology (NJIT) in collaboration with New Jersey Innovation Institute (NJII), an NJIT corporation, has launched a Professional Science Masters (PSM) degree program and professional graduate certificate in the rapidly expanding field of cell and gene therapy. The objective of the Professional Science Master's Cell and Gene Therapy Sciences option in Master of Science in Pharmaceutical Chemistry is to prepare students, as well as professional scientists and engineers, for dynamic careers in the biopharmaceutical industry.



Steve K. Libutti, M.D., FACS , was awarded a $1.2 million  'Petersen Accelerator Award'  from the Neuroendocrine Tumor Research Foundation ( NETRF ) to pursue work leading to precise treatments for  neuroendocrine tumors  -- an uncommon cancer impacting an estimated 171,000 Americans. The award to Dr. Libutti, who is also Senior Vice President of Oncology Services for RWJBarnabas Health, will support a new pioneering approach to neuroendocrine tumor immunotherapy.  



Research from Rutgers Cancer Institute of New Jersey shows administering the immunotherapy drug pembrolizumab together with chemotherapy given at the same time as radiation treatment (chemoradiation) is safe and tolerable as a first-line therapy for patients with stage 3 non-small cell lung cancer (NSCLC). The work, stemming from a multi-center phase 1 clinical trial led by Rutgers Cancer Institute, is published in JAMA Oncology.



Holy Name Medical Center said that it is the first site in the U.S. to open enrollment for a new clinical study focused on women with advanced  ovarian cancer.  The MIRASOL study assesses a promising agent, mirvetuximab soravtansine, which is an antibody linked to a chemotherapy drug. This agent is designed to target and kill tumor cells that express a protein that is often observed in ovarian cancer, while sparing healthy cells and reducing side effects.



Hackensack Meridian Health  announced three appointments: Dorie Klissas to the role of Senior Vice President and Chief Marketing Officer, Dr. Daniel Varga as Chief Physician Executive and the promotion of Dr. Amy Frieman to Chief Wellness Officer.

Special Programs from Our Partners for BioNJ Members


March 1 & March 11, 2020 | Hackensack

Over 100 judges are needed for our annual ISEF affiliated science fair, the BCA Research Expo taking place at the Bergen County Academies on Sunday, March 1, 2020, from 9am until noon. Experts from all fields of science, technology, engineering, and math are needed, not only to help judge the exhibits, but also to interact with students. Those who judge at science fairs describe the experience as challenging, but one of the most rewarding experiences, as you have the ability to motivate the next generation of young innovators. Therefore, participating as a judge is critically important to the success of the BCA Research Expo as well as enhancing the learning experience for the participating students. Judges can request disciplines to evaluate and should be knowledgeable in the field chosen. Sign up at researchexpo.bergen.org. Click on "Judge" link under "Volunteer" menu. 


March 11, 2020 | Virtual

Delaware Bio Science Association is hosting a Science and Technology Career Fair which connects employers with exemplary candidates in search of new career opportunities. Organizations looking to fill full- and part-time roles are encouraged to exhibit. Individuals interested in pursuing employment in regional engineering, health care, science and technology industries are encouraged to attend. Jobs are available for individuals with Associates, BS, MS, Ph.D., BSN, LPN, RN and experience levels from entry to advanced. 
Job Seekers may register for FREE here and must register by Wednesday, March 4th: https://debiosatcf.easyvirtualfair.com/ or by going to www.delawarebio.org.


March 21, 2020 | Union

STEM professionals will present highlights on their careers and hot topics in science, technology, engineering and math with a Q&A session following. Geared for all audiences.  Registration is required. All seminars are FREE for NJAS members. Students can attend for free with a student ID. A nominal donation of $5 for the general public. Click here for more information and to register.


March 31, 2020 | North Brunswick

Hear insight into alternative sources of funding to advance life sciences companies in New Jersey.  The panel will focus on securing funding from non-traditional sources. Topics include: How will the next generation of drugs, diagnostics and devices be funded? What new models are there that might change the paradigm? Is there a better way to fund early and emerging commercial medical research? There is no cost to attend, but registration is requested prior to the event. To register, visit March2020AlternativeFundingForLifeSciences.eventbrite.com. 


April 7, 2020 | Morristown

Students 2 Science is delighted to invite you to S2S: The Salon, a community gathering in celebration of S2S' 10-year anniversary. It will be a wonderful event with key influencers in the State of New Jersey representing both public and private sectors, including corporate leaders, educators, administrators and policy officials. A panel discussion will engage participants in a dialogue on the urgent and important topics of equity and diversity in STEM education: "How Do We Encourage a Ready and Diversified Workforce in STEM?" For more information on tickets and sponsorship contact S2S@students2science.org. 


April 26-28, 2020 | Philadelphia

This interactive workshop is designed as an introductory course covering all aspects of drug discovery for neurodegenerative diseases, including Alzheimer's, Parkinson's, Huntington's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Degeneration and Multiple Sclerosis. Delegates are drawn from academia, industry, associations/societies, government and media. The event attracts about 150-170 attendees allowing for a higher degree of interactivity and networking. Contact RBromberg@BioNJ.org for the BioNJ Member 20% discount registration code.


June 8-11, 2020 | San Diego

The BIO International Convention is hosted by the  Biotechnology Innovation Organization  (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The BIO International Convention offers a range of opportunities to increase your brand exposure and connect with a global audience of 17,000+ attendees from 65+ countries. 

BioNJ Member Services Provider Directory

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 remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations.  To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:

The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7.

Please contact BioNJ at BioNJ@BioNJ.org or call 609-890-3185 
with any questions.