Welcome to the latest edition of the  BioLines Weekender

We are sad to share the news of the sudden passing of industry colleague and leader, New Jersey-based BioAegis Therapeutics, Co-Founder and Chief Scientific Officer, Dr. Thomas Stossel. Our condolences to Dr. Stossel's family and the BioAegis Team.
Thank you to everyone who joined us at BioNJ's C-Suite Summit last Friday, November 8, where we brought together a wide-breadth of industry trailblazers for a day of lively discussions on the obstacles and opportunities that our industry is facing in bringing new treatments to market -- with an election year just around the corner.
Meanwhile, yesterday, we hosted our 7th Annual HR Conference, entitled "HR for Life Sciences: Workforce Planning Strategy and Future Trends," at Rutgers University in Piscataway. More than 100 HR life sciences professionals came together for a program focused on navigating talent and skill assessment, as well as the evolving challenges and opportunities powered by expansion, M&A, tech interface with innovation and paradigm shifts in developing Patient treatments.

Upcoming events include BioNJ's Inspiring Women in STEM Conference, entitled " Build Confident, Resilience and Define Your Own Career Path," on December 6 at Sanofi and  BioNJ's Cybersecurity Awareness Breakfast Briefing  on  December 12 at  Princeton Innovation Center BioLabs. We hope to see you there!

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

Inspiring Women in STEM Conference
Sanofi, Bridgewater, NJ
December 6, 2019
Cybersecurity Awareness Breakfast Briefing
Princeton Innovation Center BioLabs, Princeton, NJ
December 12, 2019
2020 Annual Dinner Meeting & Innovation Celebration
East Brunswick Hilton, NJ
February 6, 2020
BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
Save the date!
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.

The U.S. health care system is unique. It can offer the best medical care, including the most innovative treatment options. At the same time, it can deny access to basic care or may drive patients into personal bankruptcy. It is perplexing that these two contradictory tracks co-exist within the same system. A key question to address is: How can we help improve access to affordable and quality health care while maintaining medical innovation?

The Institute for Clinical and Economic Review is among several organizations in the United States that conducts value assessments of (mostly) medicines. These organizations are performing an important task by examining the financial tradeoffs from medical interventions through the lens of a "value assessment framework."  ICER recently released a  new version of its framework for public comment  and there are many reasons for concern, particularly for patients.  ICER states up front that its framework is intended for "broad guidelines on appropriate care, pricing, insurance coverage determinations, and payment mechanisms," explicitly excluding any use for "individual patients and their clinicians."

Recent research, supported by Lilly and conducted by Xcenda, found that step therapy has a significant and harmful impact on patients.  In fact, 35% of patients surveyed reported that step therapy has had a very/extremely negative impact on what they considered the one, main thing that gives them the most satisfaction in life. Additionally, 52% of patients and 44% of friends and family members reported that the restriction very/extremely negatively affected their emotional health.

As the debate over costs, value and insurance coverage in the U.S. continues to ramp up, it will be increasingly important to ensure the patient perspective is the centerpiece of these discussions.  Value assessment has become a critical part of these discussions as stakeholders look for better ways to measure the value of health care interventions, including drugs, devices and procedures. Patients have historically been-and often continue to be-excluded from decisions that shape the value assessment dialogue.  

BioNJ in the News

An Op-Ed by Debbie Hart, BioNJ President & CEO 

The issue of drug importation from abroad, particularly from Canada, continues to gain nationwide attention. The Department of Health and Human Services and the Food and Drug Administration issued the Safe Importation Action Plan, reportedly, to make prescription drugs more affordable via importation. Importation is also being explored in the states as a means to reduce drug costs by allowing cheaper drugs to enter our country. Will this really happen? And at what cost to the patient? Let's discuss the facts.

New Jersey Pride

Parsippany-based Onkos Surgical is a true New Jersey success story. In just four years, the startup has taken advantage of New Jersey's highly-skilled talent pool and robust innovation ecosystem to pioneer new treatments for some of the most difficult to treat cancers. By visiting Onkos's headquarters, representatives from the New Jersey Economic Development Authority (NJEDA) learned how Onkos's pioneering work 3D printing custom-designed implants and tools has made it possible for surgeons to complete procedures that used to require amputations or the installation of clunky implants with virtually no long-term effects.

BioNJ Member Deloitte  released its annual  North America Technology Fast 500 , a ranking of the fastest-growing North American companies in technology sectors, and nine New Jersey companies landed on the list with three in the Top 100.  Congratulations to BioNJ Members  PTC Therapeutics Inc.,  Palatin Technologies Inc., and  Scientist.com for making the list. 

NJ Company News

Pennington-based BioNJ Member OncoSec Medical Incorporated announced outcomes from a safety and biomarker analysis on its lead product candidate, TAVO™. Outcomes demonstrated treatment-related changes in key immune biomarkers coinciding with clinical outcomes across both KEYNOTE-695 and KEYNOTE-890 trials of TAVO in combination with KEYTRUDA® (pembrolizumab). Investigators noted that following TAVO administration, increased tumor infiltrating CD8+ T-cells were consistent with tumor shrinkage in anti-PD-1 antibody refractory melanoma and chemotherapy refractory metastatic triple negative breast cancer (mTNBC).

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced positive top-line results for its Phase 3 VANISH-303 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with vulvovaginal candidiasis (VVC). Specifically, ibrexafungerp achieved superiority over placebo at a highly statistically significant level (p≤0.001) for the primary endpoint and key study endpoints required for regulatory approval of the VVC indication. 

South Plainfield-based BioNJ Member   PTC Therapeutics, Inc.  announced positive results from part 2 of SUNFISH demonstrating that the study met its primary endpoint of change from baseline after 1 year of treatment with risdiplam compared to placebo as measured by the Motor Function Measure 32, a scale monitoring severity and progression of fine and gross motor function in patients with a neuromuscular disease such as spinal muscular atrophy (SMA). Risdiplam has been well tolerated and no treatment-related safety findings leading to withdrawal have been seen in any risdiplam trial to date. 

Princeton-based BioNJ Member Soligenix, Inc. announced its recent accomplishments and financial results for the quarter ended September 30, 2019. Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix stated, "We are now approaching data read-out in two Phase 3 clinical programs. We anticipate completing patient enrollment before the end of the year with final top-line results in the first quarter of 2020 for our pivotal double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin). 

BioNJ Member   IVERIC bio, Inc., with offices in  Princeton,  announced initial topline data confirming that Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. 

Hampton-based  BioNJ Member   Celldex Therapeutics, Inc.  presented data  from the company's ongoing CD40 agonist program at the  Society for Immunotherapy of Cancer's   34th Annual Meeting. CD40, expressed on dendritic cells and other antigen presenting cells, is an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses. CDX-1140 is a fully human agonist anti-CD40 monoclonal antibody that was specifically designed to balance good systemic exposure and safety with potent biological activity, a profile which differentiates CDX-1140 from other CD40-activating antibodies for systemic therapy.

Chester-based BioNJ Member Hillstream BioPharma, Inc. announced a collaboration with Ardena to secure manufacturing feasibility and capacity for Hillstream's QUATRAMER portfolio. This includes HSB-1216, a novel formulation of salinomycin encapsulated within the QUATRAMER technology, a potent cancer stem cell inhibitor with initial indications for small cell lung cancer. "Our strategic collaboration with Ardena represents our continued commitment to produce and provide the highest quality product to patients," said Randy Milby, President and CEO of Hillstream BioPharma. 

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of liver fibrosis in a highly regarded, Western Diet ("WD") animal model of NASH. Developed in the laboratory of Dr. Scott Friedman at Icahn School of Medicine at Mount Sinai, New York, this WD model employs a high-fat, high-fructose and high-cholesterol diet in combination with carbon tetrachloride ("CCl4") to cause significant fibrosis and hepatocellular carcinoma in mice.

Princeton-based BioNJ Member Oyster Point Pharma, Inc. announced the pricing of its initial public offering of 5,000,000 shares of its common stock at a price to the public of $16.00 per share. The shares began trading on The Nasdaq Global Select Market under the symbol "OYST." All of the shares are being offered by Oyster Point Pharma. The gross proceeds to Oyster Point Pharma from the offering, before deducting underwriting discounts and commissions and estimated offering expenses to be payable by Oyster Point Pharma, are expected to be $80.0 million.

Cranbury-based BioNJ Member  Rafael Pharmaceuticals Inc.  announced that it has joined the Scientific & Medical Affairs Industry Membership of the Pancreatic Cancer Action Network ("PanCAN"), a worldwide leader in the fight against pancreatic cancer. Rafael will join other industry members, PanCAN's Scientific and Medical Advisory Board and global leaders in the pursuit of improving outcomes for pancreatic cancer patients. Through this membership, Rafael will have a 'seat at the table' with the strategic decision-makers across the PanCAN community, as well as access to meetings for a variety of innovative and groundbreaking scientific and clinical initiatives.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020.

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of an important new analysis from the landmark Phase 3 CREDENCE study, which found that INVOKANA® (canagliflozin) consistently reduced the risk of renal and cardiovascular (CV) events in patients with various levels of kidney function, or estimated glomerular filtration rates (eGFR) . This analysis showed that INVOKANA® provides a strong, consistent safety profile and efficacy at all tested eGFR levels.

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced 24-week Phase 3 data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with TREMFYA® (guselkumab) achieved at least a 20 percent improvement in disease signs and symptoms (American College of Rheumatology ACR20 response) compared to placebo. These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies, which were designed to evaluate the efficacy and safety of investigational use of TREMFYA for the treatment of adult patients with active PsA. 

New Brunswick-based BioNJ Member  Johnson & Johnson announced that its Janssen Pharmaceutical Companies have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by  Zaire ebolavirus  species. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). In September 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment for these applications.

BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson, with offices in Raritan, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to expand the IMBRUVICA (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The submission is based on positive results from the investigational Phase 3 E1912 study designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI).

Kenilworth-based BioNJ Member  Merck announced that the European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019. 

The U.S. Food and Drug Administration approved a supplemental Biologics License Application for the influenza vaccine Fluzone High-Dose Quadrivalent from Bridgewater-based BioNJ Member Sanofi, for use in adults 65 years of age and older.  Fluzone High-Dose was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose contains an additional influenza B strain. It is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.

Bridgewater-based  BioNJ Member  Sanofi's new indication for Dupixent® (dupilumab) in chronic rhinosinusitis with nasal polyposis (CRSwNP) was approved by The European Commission (EC). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

Princeton-based  BioNJ Member   Sandoz , a Novartis division, announced that the U.S. Food and Drug Administration approved its biosimilar Ziextenzo (pegfilgrastim-bmez).  Approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, Sandoz now intends to launch Ziextenzo in the U.S. by the end of the year. Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

East Hanover-based BioNJ Member  Novartis announced detailed results from the Phase III PREVENT trial, evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing trial met its primary endpoint of ASAS40 at Week 16, with 42.2% of nr-axSpA patients treated with Cosentyx 150 mg showing a significant and clinically meaningful reduction in disease activity versus placebo (42.2% vs 29.2%: p<0.05). 

BioNJ Member  Pfizer Inc., with offices in Madison, and Merck KGa announced that the European Commission (EC) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The study included patients across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups. Improvement in progression-free survival (PFS) was observed across pre-specified subgroups in patients receiving the treatment combination. Merck KGaA, Darmstadt, Germany, and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.

Bridgewater-based BioNJ Member Allergan plc announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years. With the FDA approval, LILETTA has the longest approved duration of use for a hormonal intrauterine device (IUD or IUS) in the U.S., and is available at the lowest Wholesale Acquisition Cost (WAC) of any IUD in the U.S.

Parsippany -based BioNJ Member  Teva Pharmaceuticals USA, Inc., Celltrion, Inc. and Celltrion Healthcare, Co., Ltd. announced that TRUXIMA® (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan® (rituximab) now available in the United States with a full oncology label. TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

Bridgewater-based BioNJ Member   Eli Lilly and Company  presented detailed results demonstrating Taltz ®  (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a 52-week placebo-controlled Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. 

Bridgewater-based BioNJ Member   Eli Lilly and Company and  Boehringer Ingelheim announced the initiation of EMPULSE, the sixth phase III study in the Jardiance® (empagliflozin) heart failure program. The study will assess whether in-hospital administration of Jardiance 10 mg daily improves heart failure outcomes when initiated in people hospitalized for any type of acute heart failure event once they have been stabilized. The study will include participants both with and without type 2 diabetes.

BeiGene, Ltd., with offices in  Ridgefield Park,  announced  announced that BRUKINSA™ (zanubrutinib) has received accelerated approval from the United States Food and Drug Administration (FDA) as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.  BRUKINSA is the first BeiGene-discovered product to be approved, an important milestone toward the company's goal of transforming treatment for cancer patients around the world.  This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

BeiGene, Ltd., with offices in  Ridgefield Park,  announced a global strategic oncology collaboration for the commercialization and development in  China  of Amgen's XGEVA ®  (denosumab), KYPROLIS ®  (carfilzomib), and BLINCYTO ®  (blinatumomab), and the joint global development of 20 oncology assets in Amgen's pipeline, with BeiGene responsible for development and commercialization in China. In connection with the collaboration, Amgen will purchase a 20.5% stake in BeiGene for approximately $2.7 billion in cash at $174.85 per American Depositary Share (ADS).

Princeton-based  Vyome Therapeutics, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, today announced the completion of enrollment of 471 subjects in its Phase 2 clinical trial of VB-1953, a first-in-class topical bactericidal antibiotic, for the treatment of moderate to severe inflammatory acne. The Phase 2 dose ranging trial (NCT03900676), initiated in April of 2019, is a double-blind, randomized, vehicle controlled, dose ranging study evaluating the safety and efficacy of VB-1953 topical gel when applied once versus twice daily for twelve weeks in subjects with moderate to severe inflammatory facial acne vulgaris.

ERYTECH Pharma announced two important milestones for the TRYbeCA1 Phase 3 clinical trial of eryaspase in second line metastatic pancreatic cancer. TRYbeCA1 was opened for patient enrollment in the United States last week, and the first of a planned total of 30 U.S. sites was activated. This marks an important step to expand the trial to approximately 100 sites across several European countries and the U.S. The manufacturing of eryaspase for the patients to be treated in the U.S. will take place at the newly established manufacturing facility in Princeton, N.J.

Paramus-based  Ichnos Sciences announced that it has completed enrollment of two Phase 2b clinical trials for two candidates in clinical development: ISB 830, an OX40 antagonist monoclonal antibody currently in development for the treatment of atopic dermatitis, and ISC 27864, a non-opioid, potent, selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) currently in development for osteoarthritic pain. In the randomized, double-blind, placebo-controlled study of ISB 830, three different doses/regimens of the monoclonal antibody are being evaluated in adult patients with moderate to severe atopic dermatitis.

Bridgewater-based  Foamix Pharmaceuticals Ltd.  announced the peer review publication of the long-term open-label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) in the Journal of Clinical and Aesthetic Dermatology. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ™ (minocycline) topical foam, which was approved by the U.S. Food and Drug Administration( FDA ) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Woodcliff Lake-based  PDI  has acquired a majority share of ultraviolet disinfection company  Tru-D SmartUVC Tru-D SmartUVC is the maker of the first UVC -- ultraviolet C light -- robot. Tru-D's technology helps calculate the precise amount of UVC light needed to kill up to 99.9% of harmful pathogens in a health care environment. PDI said health care-associated infections can affect as many as 1 in 31 hospital patients, with C. difficile representing one of the most deadly and hard-to-kill microorganisms. UVC energy is an effective and ecofriendly method of reducing C. difficile and other microorganisms.

Madison-based  LEO Pharma A/S and Ubiquigent Limited announced that they have entered into an option agreement granting LEO Pharma access to two novel compounds. The announcement follows on from an earlier agreement between the parties entered into as part of LEO Pharma Open Innovation. Under the terms of this latest agreement LEO Pharma will pay Ubiquigent an upfront fee, followed by a further fee on exercise of the option and potential downstream milestone payments.

Bridgewater-based  Amneal Pharmaceuticals, Inc.  announced that it has entered into a licensing agreement with Kashiv BioSciences, LLC for the development and commercialization of Kashiv's orphan drug K127 (pyridostigmine) for the treatment of Myasthenia Gravis. Through this partnership, Amneal gains exclusive rights within the United States (U.S.) to the New Drug Application (NDA) and commercialization of K127

Warren-based  Bellerophon Therapeutics, Inc.  presents data from Cohort 1 of its ongoing Phase 2/3 randomized, double-blind, placebo-controlled clinical study (iNO-PF) of INOpulse® for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) "The new data further substantiate the significant improvement previously demonstrated in Cohort 1 of our ongoing iNO-PF study," said  Fabian Tenenbaum , Chief Executive Officer of Bellerophon. "In this analysis, INOpulse demonstrated a consistent and clinically meaningful benefit in moderate to vigorous physical activity (MVPA) across both low and intermediate/high probability of pulmonary hypertension groups.      

Bridgewater-based  Amarin Corporation plc announced a summary of results from a patient-level, cost-effectiveness analysis of icosapent ethyl (Vascepa® ).  This comprehensive analysis evaluated the cost-effectiveness of icosapent ethyl in reducing cardiovascular (CV) risk among high-risk patients as demonstrated in the landmark REDUCE-IT®  cardiovascular outcomes study. In this newly reported analysis, use of icosapent ethyl was projected to not only be cost-effective but also to reduce long-term health care costs in a majority of the scenarios analyzed.

Hutchison China MediTech Limited, with offices in Florham Park,  announces that its New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors ("NET") has been accepted for review by the China National Medical Products Administration. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors -- extra-pancreatic patients in China for whom there is no effective therapy.  

Cushman & Wakefield announced CMIC CMO USA, a contract manufacturer serving the pharmaceutical industry, has committed to a 233,000-square-foot, long term lease in Cranbury.  CMIC CMO USA will use the facility for office, research and development, production, packaging, manufacturing, warehousing and distribution of pharmaceutical and related products.

People in the News

New Jersey will look quite different five, 10 and 25 years from now. The people whose achievements and influence we recognize on our Power 50 List will be the primary agents of those changes. They are developers, builders, brokers, policymakers and -- above all -- visionaries. What they see in their mind's eye will one day be rendered in brick, mortar and sculpted earth. Congratulations to these individuals from BioNJ Member companies:  Jeff Babikian, CBRE;  Antonio M. Calcado, Rutgers University;  Robert Glenning, Hackensack Meridian Health;  Jose Lozano, Choose NJ; and  Andrew Merin, Gary Gabriel, David Bernhaut, Brian Whitmer and Kyle Schmidt, Cushman Wakefield.

Cranbury-based BioNJ Member Rafael Pharmaceuticals Inc. announced that José Octávio Costa Filho, M.D., will join the company as Chief Medical Officer. He will work alongside Timothy Pardee, M.D., Ph.D., who will continue in his role as Co-Chief Medical Officer. They will both work together to continue the development of highly selective, well-tolerated and effective cell metabolic therapies to combat cancer. Dr. Costa Filho will oversee the solid tumor programs, while Dr. Pardee will remain focused on hematologic malignancies. 

BioNJ Member   IVERIC bio, Inc., with offices in  Princeton,  announced the appointment of  Abraham Scaria , Ph.D., to the position of Chief Scientific Officer. Dr. Scaria will lead the company's research and pre-clinical gene therapy activities. His extensive experience includes positions at Genzyme,  Sanofi  and most recently at Casebia Therapeutics, leading multiple ocular gene therapy programs. Dr. Scaria has more than 25 years of experience in gene therapy, ranging from discovery research to early stage clinical trials.

Paramus-based  PsychoGenics Inc. announced it has appointed Mark A. Varney as Chief Scientific Officer.  The appointment, PsychoGenics said, reflects growth in its central nervous system drug discovery and clinical development.  "We are very excited that Mark has joined PsychoGenics, which reflects our dedication to drug discovery," Emer Leahy, CEO and President, PsychGenics, said. "Mr. Varney's leadership, track record and extensive knowledge of CNS R&D and translational research will help drive our internal and partnered discovery programs forward."

Monmouth Junction-based  Tris Pharma Inc.  announced it has named Jonathan N. Provoost as General Counsel, responsible for all company legal functions. "With our continued growth and evolution to a larger, more complex operation, one of our priorities have been to bring a seasoned pharmaceutical lawyer in to join Tris' senior leadership team. Mr. Provoost, who has more than 20 years of experience in the legal industry, most recently served as general counsel for business development and licensing at Mallinckrodt Pharmaceuticals. He's also worked at Ikaria, PTC Therapeutics, Kos Pharmaceuticals, Bristol-Myers Squibb and Exxon Mobile Corp.

Murray Hill-based  ADC Therapeutics SA announced the appointment of Jennifer Herron as Chief Commercial Officer. In this newly created role, Ms. Herron will lead all global commercial activities as a member of the company's senior management team. She is based in ADC Therapeutics' New Jersey office. Ms. Herron joins ADC Therapeutics with more than 27 years of international biotechnology and pharmaceutical experience. Most recently, Ms. Herron served as Executive Vice President and Chief Commercial Officer at Immunogen.

Bedminster-based  Aerie Pharmaceuticals, Inc.  announced the appointment of  David A. Hollander , M.D., M.B.A., as  Chief Research & Development Officer , an executive officer position reporting to  Vicente Anido, Jr. , Ph.D., Aerie's Chairman and Chief Executive Officer. Dr. Hollander will direct the company's pre-clinical and clinical research and development groups, as well as medical and professional affairs. He was most recently Chief Medical Officer, Senior Vice President at  Ora, Inc.

Institution and Education News

José Miguel Román has been appointed Vice President for Research Administration at Rutgers University's Office of Research and Economic Development. Mr.  Román joins Rutgers from New York University, where he has served as Assistant Vice President of sponsored programs administration since 2010. He will begin at  Rutgers  on Jan. 6, 2020. "With a wealth of experience at some of America's leading research universities, Mr. Román brings a deep understanding of the research life cycle to Rutgers along with an intensely collaborative approach to success," said S. David Kimball, Senior Vice President for Research and Economic Development. 

Rutgers, The State University of New Jersey was selected as one of five new hubs under the National Institutes of Health's Research Evaluation and Commercialization Hubs (REACH) program to speed up the translation of biomedical discoveries into commercially viable diagnostics, devices, therapeutics and tools to improve patient care, enhance health and train the next generation of innovators.

The American Cancer Society has approved funding for 75 research and training grants totaling $38,422,250 in the second of two grant cycles for 2019. The grants will fund investigators at 57 institutions across the United States. Yibin Kang, Ph.D, the Warner-Lambert/Parke Davis Professor of Molecular Biology at Princeton University and the Associate Director for Consortium Research of Rutgers Cancer Institute of New Jersey, has been awarded an American Cancer Society Research Professorship, receiving a lifelong designation accompanied by a five-year $400,000 commitment.

Rutgers Cancer Institute of New Jersey researcher  Hossein Khiabanian, Ph.D. , has received a $600,000 Translational Award from the V Foundation for Cancer Research to study chronic lymphocytic leukemia (CLL) with the aim of developing research models that may help investigators better understand how CLL cells are influenced by new therapies. The most common leukemia in the Western world, CLL starts in the bone marrow in a type of white blood cell known as B-lymphocytes.

A Rutgers-led team has created better biosensor technology that may help lead to safe stem cell therapies for treating Alzheimer's and Parkinson's diseases and other neurological disorders.  The technology, which features a unique graphene and gold-based platform and high-tech imaging, monitors the fate of stem cells by detecting genetic material (RNA) involved in turning such cells into brain cells (neurons) and characterizes different kinds of stem cells with greater reliability, selectivity and sensitivity .

Read the latest news on research, treatment, prevention and education from the State's National Cancer Institute-designated Comprehensive Cancer Center in Cancer Connection Monthly.

The  New Jersey Department of Labor and Workforce Development in recognition of National STEM Day has expanded its  Career Accelerator Internship ProgramThe program offers financial assistance to people working STEM jobs and opens up opportunities to careers in key sectors of the State by increasing funding incentives to businesses.  It focuses on first-time interns in high school or college with placement offers in STEM fields such as IT/software, life sciences and health care and energy. Participating employers can expect to be reimbursed up to 50% of wages paid to new interns ($3,000 max per student).

The surge in mail-order drug deliveries, amid rising temperatures and climate volatility, presents a growing challenge to the security of the pharmaceutical supply chain, according to the  New Jersey Institute of Technology Every time a vaccine is subject to excessive heat or cold, its potency may be diminished, according to the Centers for Disease Control and Prevention. A single exposure to freezing temperatures can destroy a batch entirely. With these trends in mind, a pair of New Jersey inventors set their sights on the "cold chain" -- the controlled transport environment of medications traveling from manufacturer to customer -- with a device that will alert health care providers if a medication has reached a temperature that may have compromised it.

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).

Thought Leadership

A Whitepaper by BioNJ Member Cortelligent

Cybersecurity is a growing problem in the life sciences industry. With hackers and the type of threats constantly evolving, it's important that you are keeping your firm safe from the threats by using a comprehensive cybersecurity strategy. This whitepaper takes a deeper dive into the risks that are specifically challenging in the life sciences sector, and how you can best mitigate those threats.

Special Programs from Our Partners for BioNJ Members

November 18, 2019 | Somerset

The goal of this CE Conference is to assist pharmacist attendees and participants in gaining the ability to recognize challenges facing health care within New Jersey and areas for collaboration among different stakeholders; to understand the importance of healthcare data within population health and the benefits of patient risk stratification, predictive analytics, and reporting of outcomes; to describe best practices within drug transparency, consumer engagement, and value-based models to improve care quality, clinical outcomes, and efficiency all while reducing health care costs; to identify trends within diabetes and collaborative solutions among stakeholders to improve outcomes. Click here for more information and to register. 

December 3-4, 2019 | Boston

Meet, interact and network with more than 800 VCs, corporate VCs, angel investors, investment bankers and founders of venture backed, emerging and early stage companies at the New England Venture Summit being held on December 4 at The Hilton, Dedham, MA. BioNJ Members enjoy a registration discount. Contact Randi Bromberg at RBromberg@BioNJ.org to learn more.  Register now at http://bit.ly/2MutkwR.

December 5, 2019 |  Rutgers University,  Piscataway

Save the date to join Reynold Panettieri, Vice Chancellor for Translational Medicine and Science, for an event from the New Jersey Alliance for Clinical and Translational Science (NJ ACTS), a clinical and translational science consortium led by Rutgers University, with partnership from Princeton University and New Jersey Institute of Technology. 

December 10, 2019  | Webinar

Join this free webinar to learn more and understand how the favourable regulatory pathway works in Australia. The featured speakers will draw upon their experience with U.S. biopharmaceutical companies and will discuss the strategies being followed by U.S. biopharmaceutical companies in planning their first in human studies, which are ultimately accelerating their drug development pathway.

December 19, 2019  | Galloping Hill Golf Course, Kenilworth

This is the 22nd year for the New Jersey Chapter of the Licensing Executives Society to host his holiday event. Click here to register. The New Jersey Chapter uses online registration for members and non-members. Members should login to the registration page with their LES online account.

January 14, 2020 | Allentown High School

Showcase your college/university, technical program, military service branch and more! Set up a table or demonstration!  This year's event will be held during the school day to enable all students to explore the variety of careers offered to them within Science, Technology, Engineering & Math (STEM).  Please RSVP to Dale Cruzan at cruzand@ufrsd.net or 609-259-7292 ext. 1443 by December 16, 2019. 

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.