Welcome to the latest edition of the  BioLines Weekender

We are excited to kick off an action-packed fourth quarter, featuring a number of BioNJ events! Please join us on Friday September 20, for 
BioNJ's Cell and Gene Therapy Manufacturing Briefingwhere you'll  hear from FDA and industry thought leaders on lessons learned, outstanding challenges and what kinds of technologies are poised to alter expectations for the future of cell and gene therapy manufacturing.  Click here  to review the agenda.

Then, on Friday, October 4, BioNJ will host its Fourth Annual Patient Advocacy Summit. Focused on  Education, Engagement and Empowerment, attendees will gain valuable tools and insights, share best practices and meet key stakeholders within the health care ecosystem. Patient advocates are invited to attend at no cost. Please share with your Patient advocate organizations!   

Meanwhile, registration recently opened for  BioNJ's C-Suite Summit , taking place Friday, November 8. In its seventh year, the Summit brings together more than 200 life sciences executives representing a wide breadth of companies from early to late stage, public and private, and revenue and pre-revenue for a full-day program of timely discussions impacting C-Suite decision-making in bringing new innovative treatments to market. Click here for the agenda.

Lastly, we are accepting nominations for the   2020 Dr. Sol J. Barer Award for Vision, Innovation and Leadership  that will be presented at BioNJ's 27th Annual Dinner Meeting and Innovation Celebration on Thursday, February 6, 2020. The deadline for submissions is next week, September 10. Click here to learn more.

Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

Manufacturing Briefing
New Jersey Innovation Institute, Newark, NJ
September 20, 2019
Patient Advocacy Summit 
Celgene, Summit, NJ
October 4, 2019
C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ
November 8, 2019
Human Resource Conference
Rutgers University, Busch Student Center, Piscataway, NJ
November 14, 2019
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.

BIO's Jim Greenwood joined CSPAN's Washington Journal for a conversation about drug pricing, the latest proposals being considered on Capitol Hill, the need to sustain biomedical innovation and ways to ensure patients have access to the medicines they need with out-of-pocket costs they can afford.

The FDA Oncology Center for Excellence (OCE) and Syapse  have signed  a multi-year Research Collaboration Agreement (RCA) focused on using real-world evidence to support regulatory decision-making in cancer care.  OCE and Syapse will work with stakeholders across the FDA to address key regulatory questions about testing and treatment patterns, dosing and safety and outcomes in oncology, with a focus on precision medicine.

The Government Accountability Office (GAO) recently  released a new report  looking at Medicare Part D and the role of Pharmacy Benefit Managers (PBMs) in the program. While the report provides a wealth of information about the growth of manufacturer rebates and discounts in Part D and provides helpful context in today's discussion about ways to improve the program, there are three facts about the report's findings to keep in mind.

Much of the recent focus on containing the rising costs of American health care has been on pharmaceuticals. But a focus on cost containment without due attention to quality, including quality from the patient's perspective, threatens to negatively affect patient outcomes and erode value. While methods have been established for value assessment, accounting for the patient's perspective on what constitutes quality and value remains a challenge. Better capturing the patient's voice in care is the next step in the evolution of a patient-centered delivery system. 

BioNJ in the News

Medicare Rebates Should Reduce Out-of-pocket Costs for Patients
The Government Accountability Office (GAO) recently released a report that should have received more attention. The agency looked at Medicare Part D and the role of the pharmacy benefit managers (PBMs) in the program and uncovered where rebates are going.  Who is the GAO and why is this report so important? The Government Accountability Office is an independent, nonpartisan agency that works for Congress. Often called the "congressional watchdog," it examines how taxpayer dollars are spent and provides Congress and federal agencies with objective, reliable information to help the government save money and work more efficiently and effectively.

NJ Company News

Ever proud of our ecosystem, we are pleased to share our New Jersey Company News. Be sure to click on the article titles below to read the full release.

Princeton-based BioNJ Member   Soligenix, Inc. announced it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the company's Phase 3 "DOM-INNATE" study (D usquetide treatment in O ral M ucositis -- by modulating INNATE immunity) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).  

Ramsey-based BioNJ Member   ADMA Biologics, Inc. announces the commercial relaunch and its first commercial sales of BIVIGAM ® As previously reported, BIVIGAM® had a Biologics License Application ("BLA") manufacturing change Prior Approval Supplement ("PAS") approved by the United States Food and Drug Administration ("FDA") on May 9, 2019, enabling ADMA to resume marketing BIVIGAM® to U.S.-based prescribers and health care professionals. BIVIGAM® is approved for the treatment of patients diagnosed with primary humoral immunodeficiency ("PI"). 

Bedminster-based BioNJ Member   Amarin Corporation plc announced that the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have updated their Clinical Practice Guidelines for the Management of Dyslipidaemias. This 2019 update incorporates findings from the REDUCE-IT™  cardiovascular outcomes study and includes the recommendation that icosapent ethyl, 2g twice a day, should be considered for patients with cardiovascular disease who have triglyceride levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of cardiovascular events, such as heart attack, stroke or death.

Princeton-based BioNJ Member   Kyowa Kirin Co., Ltd. subsidiary BioWa Inc. and Cantargia AB have signed an extension of the license agreement around the BioWa proprietary POTELLIGENT® Technology for production of Cantargia's antibody drug candidate CAN04, which gives Cantargia broader rights to use the technology. Since the original agreement allowing use of POTELLIGENT® Technology was signed in 2015, Cantargia has advanced CAN04 to phase IIa clinical development for potential use in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

Princeton-based BioNJ Member  Genmab A/S announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).  DARZALEX is being developed under an August 2012 agreement in which Genmab granted BioNJ Member Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product. 

Titusville-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the Company's investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults aged 60 years or older. Older adults are among the populations at highest risk of developing RSV, a highly-contagious, potentially life-threatening respiratory infection that affects more than 64 million people each year worldwide.

Titusville-based BioNJ Member   The Janssen Pharmaceutical Companies of Johnson & Johnson have announced positive top-line results from the Phase 3 ATLAS-2M study of the investigational, long-acting two-drug injectable regimen of its rilpivirine and ViiV Healthcare's cabotegravir for the treatment of HIV. The study achieved its primary objective, showing that administering the long-acting (LA) injectable regimen of Janssen's rilpivirine and ViiV's cabotegravir every two months was as effective in maintaining viral suppression throughout the 48-week study period as monthly dosing in adults living with HIV-1 infection, whose viral load is suppressed and not resistant to rilpivirine or cabotegravir.

New Brunswick-based BioNJ Member Johnson & Johnson announced that its Janssen Pharmaceutical Companies has expanded the New Horizons Collaborative to Zimbabwe-a first-of-its-kind integrated approach to improve pediatric HIV care-to ensure that children and adolescents living with HIV in countries with the highest burden of pediatric HIV have access to sustainable, high-quality, and appropriate antiretroviral (ARV) therapy.

Princeton-based BioNJ Member   Bristol-Myers Squibb Company  announced that the European Commission (EC) has approved Empliciti  (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.

The   Bristol-Myers Squibb-Pfizer Alliance announced findings from NAXOS (EvaluatioN of ApiXaban in strOke and Systemic embolism prevention in patients with nonvalvular atrial fibrillation in the real-life setting in France), the largest real-world data analysis on oral anticoagulant (OAC) effectiveness and safety in Europe among patients with non-valvular atrial fibrillation (NVAF). NAXOS is a retrospective cohort analysis including nearly all patients in France aged 18 years or older with NVAF newly initiating one of the OACs between 2014 and 2016 (n=321,501).

BioNJ Member   Pfizer Inc., with offices in Madison, and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI®  (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. 

Iselin-based BioNJ Member   Helsinn together with Blanver Farmoquímica e Farmacêutica S.A. and Laboratorio Varifarma SA announce they have signed exclusive distribution and licensing agreements for Pracinostat in South America. Under the terms of the agreements, São Paulo-based Blanver will register, promote, distribute and commercialize Pracinostat in Brazil, while Varifarma, located in Buenos Aires, will cover Argentina, Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru and Uruguay. 

East Hanover-based BioNJ Member   Novartis announced results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto® (sacubitril/valsartan) in patients with heart failure with reduced ejection fraction (HFrEF). Results suggest that Entresto, an essential treatment for HFrEF, not only positively impacts a biomarker shown to be associated with prognosis of clinical outcomes in HFrEF, but also that the effect is associated with significant improvement in the structural and functional changes, known as cardiac remodeling, that occur with this disease. 

East Hanover-based BioNJ Member   Novartis announced positive results for ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio ®  (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS). The ASCLEPIOS studies investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral Aubagio ®  14mg in adults with RMS.

Princeton -based BioNJ Member   Sandoz, a Novartis division, announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license.

Plainsboro-based BioNJ Member   Novo Nordisk announced that the European Commission has granted an extension of the indication for Fiasp ®  (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and children (aged one year and above). This complements the previous indication, which covered adults only. Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer said, "With this expanded indication, we hope that adolescents and children who are at least one year old will find in Fiasp® a good option in the management of their diabetes."

Bridgewater-based BioNJ Member   Eli Lilly and Company  announced that the  U.S. Food and Drug Administration  ( FDA ) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved by the  FDA  in  March 2016  for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by the  FDA  in  December 2017  for the treatment of adults with active psoriatic arthritis.

Bridgewater-based BioNJ Member   Eli Lilly and Company   announced that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase 3 trial in the BREEZE-AD program to be completed in 2019.  BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, to treat moderate to severe atopic dermatitis (AD) in adults met its primary endpoint.

The Food and Drug Administration (FDA) has approved updated labeling for Ke nilworth-based BioNJ Member Merck & Co.'s  Asmanex HFA (mometasone furoate ) and Dulera (mometasone furoate, formoterol fumarate) to include use in pediatric patients with asthma. Asmanex HFA is now indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

Madison-based BioNJ Member   Allergan plc  announced it received  U.S. Food and Drug Administration  ( FDA ) approval for the use of Juvéderm VOLUMA® XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21. A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvéderm VOLUMA® XC in the cheek area.

Summit-based BioNJ Member   Celgene has  paid  Immatics $75 million (€68 million) upfront to collaborate on the development of anti-cancer adoptive cell therapies. The deal gives Celgene the chance to opt in to T-cell treatments for solid tumor programs once they reach candidate selection. Immatics has the technology to develop multiple types of adoptive cell therapies, from selected and expanded pools of a patient's own T cells through to off-the-shelf therapies engineered to recognize cancer cell targets.

Morristown-based BioNJ Member  BioAegis Therapeutics announces publication of research results in the Journal of Infectious Diseases demonstrating that recombinant human plasma gelsolin therapy dramatically improves survival in a multidrugresistant pneumonia animal model. Furthermore, it works synergistically with previously ineffective antibiotics, making them work again.

Parsippany-based BioNJ Member   Teva Pharmaceutical Industries Ltd. announced that results from the Phase IIIb FOCUS study, which examined fremanezumab versus placebo in adult migraine patients who previously experienced inadequate responses to two to four classes of preventive treatments, were published online ahead of print in  The LancetThe study found fremanezumab was superior versus placebo across all primary and secondary endpoints. 

Ridgefield Park-based BeiGene, Ltd.  announced that the  U.S. Food and Drug Administration  ( FDA ) has accepted the company's New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The  FDA  granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of  February 27, 2020 . This follows the FDA's Breakthrough Therapy designation for zanubrutinib in this setting earlier this year.

Mahwah-based Glenmark Pharmaceuticals Inc. has been granted final approval by the United States Food & Drug Administration for Pimecrolimus Cream, 1%, a generic version of Elidel® Cream, 1%, of Bausch Health U.S., LLC. Glenmark's current portfolio consists of 160 products authorized for distribution in the U.S. marketplace and 55 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Cranbury-based BioNJ Member   Outlook Therapeutics, Inc.  announced that it has completed patient enrollment in the NORSE 1 Phase 3 clinical trial, which is evaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD. NORSE 1 has enrolled a total of 61 patients at 9 sites in  Australia . The study is the first of two ongoing, adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab for wet AMD.

Cresskill-based Vascular Therapies announced completion of enrollment in its U.S. Phase III prospective randomized, multicenter, clinical study (ACCESS Trial). The company is developing a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery. The ACCESS Study was designed to evaluate the effectiveness of the sirolimus drug product to improve outcomes in patients undergoing surgical creation of an arteriovenous fistula ("AV fistula") to provide vascular access for hemodialysis.  

GlaxoSmithKline plc, with offices in Warren, announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. 

Parsippany-based  The Medicines Company announced the presentation of results from ORION-11, its first pivotal Phase 3 clinical study of inclisiran, an investigational twice-yearly therapy to reduce low-density lipoprotein cholesterol (LDL-C) and the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA or "sir-nah") class. In ORION-11, twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well-tolerated and demonstrated an excellent safety profile.

Parsippany-based The Medicines Company announced positive topline results from the first pivotal Phase 3 clinical trial evaluating the efficacy, safety and tolerability of inclisiran to decrease LDL-cholesterol (LDL-C) through twice-yearly dosing. The ORION-11 study of inclisiran sodium 300 mg met all primary and secondary endpoints with efficacy consistent with findings from Phase 1 and 2 studies. The trial showed that inclisiran was well tolerated and confirmed that the safety profile was at least as favorable as that demonstrated in the ORION-1 Phase 2 and ORION-3 open label extension studies.

HotSpot Therapeutics, Inc. announced the acquisition of  Monmouth Junction -based Macroceutics, Inc., a provider of DNA-encoded library (DEL) screening technologies. The outgrowth of a strategic collaboration, the acquisition will enhance HotSpot Therapeutics' SpotFinder™ platform, the first drug discovery platform to systematically predict, drug and differentiate unique regulatory hotspots on proteins. Macroceutics will remain in New Jersey as HotSpot South.

Heron Therapeutics, Inc., with offices in  Jersey City,  announced that the results from EPOCH 2, a Phase 3 study of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published in the journal,  Hernia , in an article entitled "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study." HTX-011 achieved all primary and key secondary endpoints in EPOCH 2, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery and an increase in the proportion of patients who were opioid-free.

Woodcliff Lake-based Eisai Co., Ltd. announced that it has entered into a business alliance agreement for exclusive development and commercialization of a cognitive function test - Cogstate Brief Battery (CBB) -- developed by Cogstate Ltd. in Japan as a digital tool for self-assessment of cognitive function. The CBB consists of four tests, each measuring different cognitive domains: psychomotor function, attention, working memory, and learning, and it has been developed and already in use as a digital tool for self-assessment of cognitive function overseas, including the United States.

Murray Hill-based ADC Therapeutics and Freenom announced that they have entered a biomarker development collaboration in which ADC Therapeutics will use Freenome's platform to identify patients who are most likely to respond to treatment with ADCT-402 (loncastuximab tesirine). ADC Therapeutics is currently evaluating ADCT-402 in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Boonton-based Enteris BioPharma, Inc. announced its entry into a definitive licensing agreement with Cara Therapeutics for Enteris' Peptelligence® technology in the ongoing development of an oral formulation of Cara's first-in-class KOR agonist, CR845/difelikefalin (KORSUVA™). Peptelligence® is Enteris' proprietary platform for the oral delivery of peptides and BCS class II, III and IV small molecules. The oral tablet formulation of KORSUVA™ (Oral KORSUVA™) was engineered using Peptelligence®.

Boonton-based  Enteris BioPharma Inc.  has been acquired by  SWK Holdings Corp Under terms of the deal, Enteris will operate as an independent, wholly-owned subsidiary of SWK. The company will continue to focus on advancing partnerships built around its proprietary oral drug delivery technology, Peptelligence, as well as its internal drug development pipeline.  

Florham Park-based Cello Health announced it acquired Morristown-based  Innovative Science Solutions LLP (ISS).  Cello Health said the acquisition of ISS reflects the company's strategy of expanding further in the U.S. and adds a key incremental component to Cello's offering of technical services along critical drug development pathways. It is anticipated that there will be strong mutual client opportunity over time.

Earlier this summer,  Marlabs  in Piscataway opened its new  Divergence Digital Innovation Labs , an on-site collaboration center with a twist. But, it wasn't all fun and games. The day was designed to generate awareness of Marlabs, which appears to be a bit of a hidden New Jersey treasure. Clients bring their hardest problems to this company, and, through a collaborative process, Marlabs figures out various ways to solve them. The key for Marlabs is to use out-of-the-box thinking to create true digital transformation, speakers at the event said.

People in the News

Raritan-based Ortho Clinical Diagnostics announced it has a new CEO.  The company's board of directors said it has appointed Chris Smith to serve at the helm of the organization, effective Sept. 9. Prior to Ortho Clinical, Mr. Smith was CEO of Cochlear Ltd. from 2015 to 2018. He also served as president of Cochlear Americas for more than a decade. Before that, he held several senior-level roles including CEO in residence for Warburg Pincus and Global Group President of Gyrus Group Plc.

Summit-based Concord Health Partners announced it has named Christi Shaw to its advisory board.  The health care investment firm said Ms. Shaw most recently was named CEO of Kite, a Gilead company.  "Having seen such remarkable advances in health care over the last few decades while also personally and professionally navigating our U.S. health care system, I'm excited to play a part in advancing and ensuring access to important, life-saving therapies that have the potential to change the way cancer is treated," Ms. Shaw said.

Oldwick-based Provention Bio, Inc.  announced an addition to its leadership team.  The biopharmaceutical company focused on immune-mediated diseases said it has appointed Sherron Kell as Senior Vice President of Clinical Development. Dr.  Kell will be responsible for leading the company's PRV-031 (teplizumab) program, including oversight of its Phase 3 study and clinical support of anticipated regulatory submissions. 

Institution and Education News

The New Jersey Department of Labor and Workforce Development (DOL) welcomed four apprentices to the Princeton Plasma Physics Lab (PPPL) on Sept. 3, as the total number of New Jersey apprenticeships surpassed 8,000, a new high for the Murphy administration.
The milestone is part of a concerted effort by the Murphy administration and DOL Commissioner Robert Asaro-Angelo to dramatically increase New Jersey's use of apprenticeships to fill a chronic skilled labor gap. NJBIA supports the programs as a way to help businesses struggling to find job candidates who have the skills they need.

The  Stevens Institute of Technology is scheduled to construct two student residential towers and a three-story university center through $270 million in bonds approved by the  New Jersey Educational Facilities AuthorityStevens says these projects are crucial to the university as it continues to accommodate growing enrollment and associated student demand for on-campus student housing and related student-life services.

The  U.S. Small Business Administration announced it has named the  New Jersey Institute of Technology one of 12 winners of its  Makerspace Training Collaboration and Hiring Pilot CompetitionThe Newark-based educational institution received a $125,000 award under the "Scale" category, according to SBA Regional Administrator Steve Bulger, who oversee's the agency's operations across the Atlantic Region. "As a winner of SBA's MaTCH Pilot Competition, NJIT will provide a program designed to offer the needed foundation for individuals to secure an entry level advanced manufacturing job, and the option to pursue further training in an Apprenticeship Program or a college education in Advanced Manufacturing," Bulger said.

The Research & Development Council of New Jersey is honored to present the 2019-2020 class of the Governor's STEM Scholars  (GSS). The GSS Advisory Board selected 95  of New Jersey's best and brightest STEM students to join the sixth Governor's STEM Scholars class. The scholars hail from twenty of the twenty-one counties in New Jersey. The Governor's STEM Scholars program is a public-private partnership among the R&D Council of New Jersey, the Governor's Office, the New Jersey Department of Education, the Office of the Secretary of Higher Education and Fortune 500 companies, designed to immerse the top STEM talent in grades 10 through the doctoral level in New Jersey's vast STEM economy and bolster the State's education and career pipeline.

Three Rutgers University professors have been recognized by the White House as outstanding early career researchers, the highest honor that a beginning scientist or engineer can receive in the United States. Jinglin Fu, Rutgers University-Camden; Jessica Ware, Rutgers University-Newark; and Saman Zonouz, Rutgers University-New Brunswick, are among the more than 300 young researchers to receive the prestigious Presidential Early Career Award for Scientists and Engineers (PECASE) given to those who show exceptional potential for leadership in science and technology.

Researchers at Rutgers and other institutions have discovered how muscle contraction (bronchospasm) in the airway, which causes breathing difficulty in people with asthma, occur by creating a microdevice that mimics the behavior of the human airways.  The  study , published in the journal Nature Biomedical Engineering, could lead to new treatment strategies for respiratory diseases, said co-author Reynold Panettieri, Director of the  Rutgers Institute for Translational Medicine and Science .

Dawood Farahi, the President of  Kean University, is stepping down from his role in 2020 after spending 17 years at the helm of the Union-based institution.  "It has been more than my honor and my privilege to lead this amazing university; it has been a significant part of my life," Dr. Farahi said. "We will continue this academic year on our path of progress and transformation, building a financially strong and academically vibrant institution like no other in New Jersey. The future for Kean students is bright."

Montclair State University has appointed Carley Graham Garcia as Executive Director of the Feliciano Center for Entrepreneurship and Innovation. Ms.  Garcia spent the last 12 years at Google, most recently as Head of External Affairs, responsible for public policy, government relations and community engagement for the New York City region, including New Jersey. She succeeds Dennis Bone, the center's Founding Director, who retired after serving in that role for six years.

The  National Cancer Institute (NCI) has designated  Atlantic Health System as a National Community Oncology Research Program (NCORP) site of the Atlantic Health Cancer Consortium (AHCC).  Clinical trial enrollment in the AHCC NCORP began Aug. 1. According to Atlantic Health, NCORP, AHCC will help develop and implement NCI cancer prevention, screening, care delivery and treatment studies with leading health care systems across the State.

Seton Hall University reported more than 23,000 applicants for the Class of 2023, breaking a record at the Catholic institution for the fifth consecutive year.  Over the last three years the number of applicants to Seton Hall has risen by about 40 percent. Of those 23,000-plus applicants, more than 1,615 freshmen are registered and set to begin classes, according to Seton Hall. That makes for the largest undergraduate class in Seton Hall history, beating last year's record-breaking class of 2022, which enrolled 1,524 freshmen.

Funding News

The New Jersey Economic Development Authority (NJEDA) issued a Request for Expressions of Interest (RFEI) for New Jersey-based companies interested in participating in the New Jersey-Israel Innovation Partnership Initiative. New Jersey companies that participate in the initiative will gain both access to international partners and to research and development (R&D) funds from an Israeli company and the Israel Innovation Authority (IIA).

New Jersey Institute of Technology (NJIT)  spinout  OculoMotor Technologies  is garnering worldwide attention for the creation of virtual reality games that help optometrists offer vision therapy to their patients. The start-up, which was founded by a management team that includes NJIT graduates John Vito d'Antonio-Bertagnolli and Chang Yaramothu and NJIT professor Tara L. Alvarez, recently became the third company to benefit from rent support through the  New Jersey Economic Development Authority's  (NJEDA's)  NJ Ignite Program  following its move to NJIT's  VentureLink  business incubator.

Thought Leadership from BioNJ Members

We invite our Innovation and Associate Members at the Executive, Preferred and Market Maker levels to submit their white papers for consideration for this new section of the Weekender. Please submit papers to RBromberg@BioNJ.org.

McKinsey partners Jeff Smith and Tara Azimi, along with consultant Kate Chavez, recently sat down for a discussion with Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). Among its various regulatory responsibilities, CBER regulates cell and gene therapies in the United States. The discussion provides interesting insights into how the FDA has approached regulating the rapidly evolving field of cell and gene therapies, and how it has played an important role in the broader innovation ecosystem.

An article by BioNJ Member McKinsey & Company

Gene therapy holds great promise for treating a variety of diseases, but without changes, today's payment system could limit the number of patients who benefit.

Gene therapy has the potential to eradicate the increasing number of diseases we know are associated with faulty or missing genes-or at least provide a functional cure for a period of time. Take hemophilia A, for example. Patients with this debilitating disease lack a gene that produces an essential blood-clotting protein, factor VIII. Gene therapy replaces that gene. Moreover, in contrast with other forms of therapy for hemophilia, in which weekly or monthly infusions of clotting-factor drugs are often necessary, gene therapy has the potential to be "once and done." 

Special Programs from Our Partners for BioNJ Members

September 11, 2019 l   Rutgers Club, Piscataway
Hear real case studies and best practices from Members of Corporate Engagement departments of Princeton, NJIT and Rutgers as well as healthcare investors and corporate development professionals active in tech and pharma. 

This year's Governor's Conference on Housing and Economic Development will gather industry experts and decision makers in business and government, housing and economic development, and the non-profit community from throughout the State for two days of informed discussion, empowering ideas and engaging trade and industry exhibitors.

This annual conference brings together academic and industry scientists intent on accelerating the development of innovative treatments for Alzheimer's disease and related dementias. The ADDF's funded investigators and leading scientists in the field present their current research progress and stimulate discussion. The conference offers ample opportunity for collaboration and partnering. BioNJ Members receive a 25% discount using code BIONJ19.

September 18, 2019 l Rutgers University Cook Student Center
The U.S. Small Business Administration is hitting the road and will visit Rutgers University Cook Student Center on September 18. The SBA's excursion aims to connect entrepreneurs to its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.  Also known as America's Seed Fund, the SBIR/STTR programs provide over $3 billion in funding to small businesses each year in a wide variety of technology areas. The programs are considered by many to be the best source of early stage risk capital to develop a promising new technology. Each SBIR Road Tour stop will provide attendees with an opportunity to hear directly from the participating federal agency program managers that administer over 5,000 new awards annually and to meet one-on-one with program decision makers.

Sept. 19, 2019 | New Jersey Institute of Technology (NJIT), Newark

TEDxNJIT aims to bring innovation and remarkable people together to share a TED-like experience to Newark.  Speakers will explore ways that individuals, organizations, and civic entities can become stronger by focusing on initiatives that address social problems. Topics will include arts, entertainment, technology, and design. The event will bring together faculty and students to share their passion for new ideas and innovation. For more information, please visit tedxnjit.com.

Deer Isle Group  CEO and President,  Dianna Raedle , will host a workshop where she will present best practices for raising capital from venture capital funds and other institutions. Ms. Raedle will walk through some concrete examples of how companies should think about positioning themselves. This will be an interactive session where participants will be encouraged to share their own entrepreneurial experiences in order to provide real examples of the concepts. Click here for more information about the event and registration. 

October 2, 2019 l Princeton University
Princeton's Science and Technology Job Fair is ideal for finding exceptionally talented individuals to staff critical projects, as well as bringing in the best prospects for summer internships. Last year, over 1,000 undergraduate and graduate students attended.  Please visit Princeton's website  for further details and the link to online registration. Space is limited and is allocated on a first-come, first-served basis.  Please contact Traci Miller at traci@princeton.edu with any questions.

China IP Road Show
October 3, 2019 | Princeton Innovation Center BioLabs

If you are a business owner or inventor, you need to protect your intellectual property (IP). Come to this free, one-day USPTO China IP Road Show and learn from government experts, IP attorneys and local businesspeople about how U.S. rights holders can protect their IP in China. Space is limited; click here to learn more and  register early .

October 3, 2019 l Hoboken
If you're in the innovation community in the northeast you belong at the Propelify Innovation Festival. Learn from amazing speakers, connect with start-ups and investors, hire and be hired. Plus virtual reality, drones, music and a start-up competition. And lots more. Last year, 10,000+ innovators from 43 states and 10 countries were there. BioNJ Members receive complimentary tickets. Contact Randi Bromberg at RBromberg@BioNJ.org for a special promo code.

October 4, 2019 l Somerset
The eighth annual National Manufacturing Day event will be held at The Marigold in Somerset, New Jersey from 7:30 AM - 3:00 PM, October 4, 2019.  The event will bring together manufacturers, students, supporters and industry expert speakers. Educational sessions will be presented by leaders focused on expanding knowledge of pertinent industry information. Early Bird Admission discount -- now until Aug. 16th. Click here for more information and to register.

October 11, 2019 l Rutgers University, New Brunswick
The New Jersey Core Facility Showcase  will highlight the research services that are provided by academic institutions from around the state. These services span all disciplines including structural biology, genomics, imaging and materials science. Flash talks and poster presentations by core facilities will provide attendees (faculty, staff and potential industry customers) with first-hand insight into the services that are available in New Jersey. This event is catalyzed by the recent release of the  ResearchwithNJ  platform, which highlights research expertise and core facility operations at Rutgers, Princeton, Montclair State, Rowan, NJIT and Stevens.

October 22-23, 2019 | San Francisco
The BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations and BIO One-on-One Partnering™ meetings. Partnering is now open!

November 13, 2019 | Philadelphia

The American Cancer Society Cancer Action Network (ACS CAN) will host its annual Tri-State (Delaware, New Jersey, Pennsylvania) policy forum in Philadelphia in the fall of 2019. This event will bring together key leaders and decision makers in government, research and academia to discuss emerging oncology and health care policy issues that affect the physical and economic health of Americans. For more information, please contact Sam Dealmeida at Sam.Dealmeida@cancer.org.

November 14, 2019 | Princeton

Save the date! Annual evening reception highlighting the innovative research  emerging from our labs and working spaces and the translation of that research through entrepreneurship, technology transfer and engagement with industry. We invite you to join us as we strengthen connections, exchange ideas and build our innovation ecosystem among our external partners and our world-renowned faculty, research teams, students and alumni. The reception will be held at the Frick Chemistry Laboratory, Princeton University, Princeton NJ 08544. See technologies from previous events at Celebrate Princeton Innovation.

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 to 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.