Welcome to the latest edition of the  BioLines Weekender

As we celebrate the first day of summer, we take a quick look back at the last two weeks filled with Member meetings, speaking opportunities, celebrations, planning and more!

The BioNJ Team had the opportunity to: 
  • Speak on a panel at the University Industry Interaction Network Conference in Helsinki, Finland on the "New Jersey Innovation Ecosystem and the Role of Enablers in University-Industry Collaboration"
  • Attend the ribbon cutting ceremony of Erytech Pharma's new GMP Manufacturing Facility in Princeton
  • Meet with BioNJ Member Rutgers University-Camden to learn about the latest happenings taking place on campus
  • Attend and be inspired at Amicus Therapeutics' company event at the Make-a-Wish Foundation's Castle 
  • Host BioNJ's Legal, Compliance and Regulatory Forum: "When the Government Comes Knocking . . . Understanding & Minimizing the Risk -- Criminal & Civil Investigations & Enforcement Actions Targeting Life Sciences Companies"
  • Meet with BioNJ's C-Suite Summit, Patient Advocacy Summit and Manufacturing Briefing Planning Committees 
Excitement is building around BioNJ's new Career Portal at www.BioNJTalentNetwork.org. Whether looking for your next job opportunity or looking for new talent for your organization, click here to learn more! 

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

New X2 BioCruise with NewYorkBIO
New York Harbor
World Yacht at Pier 81, Manhattan
July 18, 2019

Manufacturing Briefing
New Jersey Innovation Institute, Newark, NJ
SAVE THE DATE!
September 20, 2019
Patient Advocacy Summit 
Celgene, Summit, NJ
SAVE THE DATE!
October 4, 2019
C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ
SAVE THE DATE!
November 8, 2019
Putting Patients First: The Value of Medical Innovation
Brought to You by Celgene Corporation

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


 
Summit-based BioNJ Member Celgene  launched the  MS MindShift campaign  to help lift up the conversation around the importance of  brain health  for those living with MS. The MS MindShift campaign aims to educate about the critical role the brain plays in MS and what people living with MS can do to keep their brain as healthy as possible, for as long as possible. In partnership with the Multiple Sclerosis Association of America (MSAA), the campaign will help bring a new perspective to the way people think about the disease.


 
Patients with relapsed/refractory non-Hodgkin's  lymphoma  (NHL) often face a poor prognosis. For instance, a systematic international literature review from 2000-2016 found only 27 percent of patients with diffuse large B-cell lymphoma (DLBCL)  live five years or longer  from the time of relapse after first-line therapy. But, encouraging results from trials of  chimeric antigen receptor (CAR) T cell therapy  are giving patients a reason to be optimistic.


 
Bridgewater-based BioNJ Member Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping into the power of emerging data technologies. "We stand on the forefront of a new age for biology and human health, with the opportunity to transform healthcare through partnerships with pioneering technology and analytics companies," says Ameet Nathwani, M.D., Chief Digital Officer, Chief Medical Officer & Executive Vice President, Medical at Sanofi. 

Policy News


 
Gov. Phil Murphy launched the New Jersey Innovation Skills Accelerator, a free, online program to train public officials to leverage technology and data to drive innovation in their day-to-day work, and to tap into the intelligence and expertise of residents of the Garden State. Designed by the State's Chief Innovation Officer Beth Simone Noveck, this program includes video instruction, interviews with leading public-sector innovators from around the world, readings and self-assessments.

Showing Our NJ Pride


 
Forbes partnered with market research company  Statista to pinpoint the organizations liked best by employees in our first-ever ranking of America's best employers by state. The ranking is divided into 51 lists: one for each of the 50 states, plus the District of Columbia. Congratulations to these New Jersey-based BioNJ Members for making the list: Johnson & Johnson Hackensack UMC; Merck & Co.Morgan Stanley The College of New Jersey Rowan University Seton Hall University Sanofi; and  Rutgers University.

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.

 
Pennington-based BioNJ Member OncoSec Medical Incorporated  announced that it has initiated a research collaboration with Roswell Park Comprehensive Cancer Center to evaluate the use of Roswell Park's intravital microscopy (IVM) and OncoSec's proprietary plasmid, TAVOPLUS, in combination with the company's recently announced APOLLO electroporation generator in preclinical studies. 


 
Edison-based BioNJ Member  ContraVir Pharmaceuticals, Inc.  announced findings from its first study with human precision cut liver slice cultures. Liver disease was simulated in this unique experimental model by application of the potent, profibrotic molecules, TGFβ and PDGF. Co-administration of ContraVir's clinical phase drug candidate, CRV431, was found to be 100% effective at preventing fibrosis induction beyond baseline levels. 


 
Edison-based BioNJ Member  ContraVir Pharmaceuticals, Inc.  announced findings from a preclinical study where CRV431, a novel cyclophilin inhibitor, significantly decreased the extent of fibrosis in a second animal model of liver fibrosis. Fibrosis, or scarring, of the liver is a hallmark symptom of NASH that results in impaired liver function. Obeticholic acid ("OCA"), a semi-synthetic bile acid analogue drug approved for the treatment of primary biliary cholangitis ("PBC") and being evaluated in Phase 3 trials by another company, was used as a comparator drug in the study and did not decrease the extent of fibrosis in this study conducted by ContraVir.


 
In a Phase 3 study evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Bridgewater-based BioNJ Member Sanofi's Soliqua®/Suliqua® (insulin glargine 100 Units/mL and lixisenatide) met the primary study objective by demonstrating a statistically superior reduction of average blood sugar level (HbA1c) after 26 weeks, compared with continuing GLP-1 RA treatment.


 
Princeton-based BioNJ Member Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from BioNJ Member Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. The two candidates are in late-stage clinical development by Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka. Taiho Oncology is also part of the Otsuka group of companies.


 
BioNJ Member J azz Pharmaceuticals plc , with offices in Ewing, announced that the  U.S. Drug Enforcement Agency  (DEA) has designated solriamfetol, also known as Sunosi, as a Schedule IV medicine. With  U.S. Food and Drug Administration  ( FDA ) approval on  March 20, 2019 Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).



 
Bridgewater-based BioNJ Member Eli Lilly and Company announced a  new post-hoc analysis of data from the EMPA-REG OUTCOME ®  trial indicates a consistent effect of Jardiance ®  (empagliflozin) on reducing cardiovascular and renal risk in adults with type 2 diabetes and known cardiovascular disease, who also have a form of chronic kidney disease without overt proteinuria (high levels of protein in the urine), as well as others in the trial.  



 
Summit-based BioNJ Member Celgene Corporation announced the U.S. Food and Drug Administration (FDA) approved REVLIMID ® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin's lymphoma (NHL) that does not include chemotherapy.




 
East Hanover-based BioNJ Member Novartis announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. 


 
East Hanover-based BioNJ Member Novartis announced new data from the FUTURE 5 trial showing no radiographic progression (mTSS <0.5) in almost 90% of psoriatic arthritis (PsA) patients treated with Cosentyx® (secukinumab) 300 mg over 2 years. The trial investigated the effect of Cosentyx on the signs and symptoms of PsA, in addition to inhibition of radiographic progression of PsA.


 
Long-term follow-up data from the ongoing, pivotal open-label ENESTfreedom and ENESTop trials showed sustained treatment-free remission (TFR) after stopping frontline and second-line Tasigna (nilotinib) therapy in eligible adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP). Separate data demonstrate promising results for asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors (TKIs) in heavily pre-treated Ph+ CML-CP patients.



 
Basking Ridge-based BioNJ Member Ipsen and Debiopharm announced renewal of their Decapeptyl® agreement, which extends and strengthens their strategic partnership through 2034 for the development, manufacturing and distribution of Decapeptyl® across Europe and certain Asian and African markets. This extension represents a long-term commitment to patients, offering the benefits of Decapeptyl® in the treatment of metastatic and non-metastatic patients with locally advanced prostate cancer, endometriosis, uterine fibroids, central precocious puberty and endocrine-responsive early stage breast cancer.


 
Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil (FU), a commonly used chemotherapy regimen, for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). 


 
Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This accelerated approval is based on tumor response rate and durability of response.


 
Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that the European Commission has approved LYNPARZA as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (BRCAm) (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.


 
Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved LYNPARZA as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated (BRCAm) ovarian cancer. The approval in Japan was based on data from the randomized, double-blinded Phase 3 SOLO-1 trial which evaluated LYNPARZA as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.


 
Kenilworth-based BioNJ Member Merck & Co. announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Tilos for total potential consideration of up to $773 million, including an upfront payment as well as contingent milestone payments.


 
Raritan-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20 percent improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and TREMFYA® current prescribing information.  


 
Princeton-based BioNJ Member Genmab announced it has entered into an exclusive worldwide license and option agreement with BioNJ Member Janssen Biotech, Inc. to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab's proprietary HexaBody technologyUnder the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development activities until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma.


 
Raritan-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of a new subgroup analysis from the landmark Phase 3 CREDENCE study, showing INVOKANA® (canagliflozin) significantly reduced the risk of major cardiovascular (CV) events and kidney failure in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). These positive results were observed in patients taking INVOKANA®, including those with CV risk factors but no history of CV disease (primary prevention group) and patients with history of CV disease, defined as a history of coronary, cerebrovascular or peripheral vascular disease (secondary prevention group).


 
BioNJ Member Pfizer Inc., with offices in Madison,  announced positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX.


 
BioNJ Member Pfizer Inc., with offices in Madison,  and Array BioPharma Inc. announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. 


 
Princeton-based BioNJ Member Evotec SE announced that the company has entered into a five-year partnership with the Bill & Melinda Gates Foundation to discover new treatment regimens that better address tuberculosis ("TB"), a severe global health burden and one of the leading causes of death due to infectious diseases worldwide. The current standard treatment regimen for TB consists of a minimum of 6 months of treatment with 4 drugs administered under direct observation, but treatment is much longer when TB is drug resistant.


 
Bridgewater-based BioNJ Member  Nevakar Inc. announced that it recently entered into a $50 million product financing agreement (the "Agreement") with an affiliate of NovaQuest Capital Management, L.L.C. for the continued development of five differentiated, sterile injectable products. Pursuant to the Agreement and to the previously announced agreement with Endo Ventures Limited, a subsidiary of Endo International plc dated August 8, 2018 (the "Endo Agreement"), Nevakar will develop and seek U.S. Food and Drug Administration (the "FDA") approval for these products; Endo has the ability to launch and distribute the products upon approval through its Sterile Injectables Segment, doing business as Par Sterile Products.  


 
Basking Ridge-based Daiichi Sankyo Company, Limited announced  that the Ministry of Health, Labor and Welfare (MHLW) of Japan has approved VANFLYTA® (quizartinib), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test.  Approval of VANFLYTA in Japan is based on the results from the global pivotal phase 3 QuANTUM-R study and a phase 2 study of VANFLYTA in Japan in patients with relapsed/refractory FLT3-ITD AML. 


 
Lawrenceville-based  Celsion Corporation  announced that the University Medical Center Utrecht in the Netherlands has received Institutional Review Board (IRB) approval to begin a Phase I study to determine the safety, tolerability and feasibility of ThermoDox ® (lyso-thermosensitive liposomal doxorubicin) in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer (mBC). The secondary objective of this study is to assess radiological objective response of distant metastases and of the primary breast tumor.


 
Princeton -based Sun Pharmaceutical Industries Ltd. announced interim results from a Phase 2 study of interleukin-23 (IL-23) inhibitor ILUMYA™ (tildrakizumab-asmn) in patients with active psoriatic arthritis.  The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study. The interim results showed ILUMYA™ was well tolerated with a low rate of serious treatment-emergent adverse events.


 
Boehringer Ingelheim, with offices in New Brunswick, and OSE Immunotherapeutics SA  announced that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors. The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim's monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor. 


 
Boehringer Ingelheim, with offices in New Brunswick,  and the University of Dundee extended their collaboration to develop new medicines that target and destroy key cancer causing proteins. This brings together the expertise of Professor Alessio Ciulli, one of the pioneers in the field of Proteolysis targeting chimeras (PROTACs), based in the School of Life Sciences at Dundee, with Boehringer Ingelheim's pharmaceutical expertise and commitment to bring innovative medicines to patients with cancer.


 
Morristown-based  Melinta Therapeutics, Inc.  announced the U.S. Food and Drug Administration ( FDA ) has accepted a supplemental New Drug Application (sNDA) for BAXDELA ® (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).  The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. 


 
Bedminster-based  Mallinckrodt plc  is reporting that all primary and secondary outcome measures were met in its Phase 4, multicenter study assessing the efficacy and safety of Acthar ®  Gel (repository corticotropin injection, or RCI) in patients with persistently active RA who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids. Acthar Gel is U.S. Food and Drug Administration ( FDA )-approved as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy).


 
IVERIC bio, Inc. and Somerset-based Catalent Biologics, announced that they have entered into an agreement for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio's gene therapy product candidates, IC-100 for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) and IC-200 for the treatment of BEST1 related retinal diseases.


 
Somerset-based Catalent Biologics  announced an agreement to purchase BioNJ Member Bristol-Myers Squibb's (BMS) premier biologics and oral dose form facility in Anagni, Italy.  Through the years, the Anagni facility has served as the primary launch center for new medicines from BMS that have helped millions of patients in the fight against serious diseases such as cancer, cardiovascular disease and hepatitis. 


 
Oldwick-based Provention Bio, Inc. announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a registered underwritten public offering of 5,500,000 shares of its common stock. In addition, Provention Bio intends to grant the underwriters a 30-day option to purchase up to an additional 825,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.


 
Murray Hill-based ADC Therapeutics announced that it has closed a $76 million expansion of its Series E financing, bringing the total gross proceeds raised in the Series E financing to $276 million. The financing was supported by existing and new investors. The company has raised $531 million since its inception in 2011 to advance the development of pyrrolobenzodiazepine (PBD)-based ADCs for the treatment of hematological cancer and solid tumors.


 
Iselin -based ONCURIOUS NV  announces that it has received from Flanders Innovation and Entrepreneurship (VLAIO) a project grant of close to €1 million to support the further pre-clinical development of its pipeline of next generation cancer immunotherapies. ONCURIOUS will do this in close collaboration with VIB Discovery Sciences, steered by the scientific input of the VIB founding labs.


 
Hamilton-based  Genesis Drug Discovery & Development (GD 3), the contract research organization (CRO) of Genesis Biotechnology Group (GBG), announced it has expanded its drug development services through the acquisition of a majority interest in  NexusPharma.
In a statement, the company said that the acquisition creates a fully integrated portfolio of services for GD 3 by integrating NexusPharma's unique collection of patient-derived xenograft (PDX) models, with GD 3's existing platforms that include syngeneic/cell line derived xenograft models, radiotherapy, flow cytometry and in-vivo imaging modalities.


 
Princeton-based Dr. Reddy's Laboratories Ltd. announced that  Upsher-Smith Laboratories has agreed to purchase two of its neurology-branded assets for up to $110 million or more.  The two products, Zembrace Symtouch (a sumatriptan injection) and Tosymra (a sumatriptan nasal spray), were commercialized through Dr. Reddy's wholly-owned subsidiary, Promius Pharma LLC.



Funding News


 
BioNJ Member The  New Jersey Economic Development Authority (NJEDA)  announced that it has closed a $250,000 convertible note to Monmouth County-based  Additive Orthopaedics  through the  NJ CoVest Fund . The Fund is designed to help emerging technology and life sciences companies bridge the funding gap between product development and commercialization and further the NJEDA's ability to support the businesses throughout their growth lifecycle.


 
Berkeley Heights-based CorMedix Inc. rang the closing bell at the New York Stock Exchange in celebration of the successful Phase 3 results of its lead investigational product, Neutrolin®, for use in hemodialysis patients requiring central venous catheters. The biotechnology company credits New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss (NOL) Program, with providing growth capital necessary to continue development of Neutrolin®.

People in the News


 
Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the appointment of Nkechi Azie, M.D., MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp's potential approval and commercial launch. Dr. Azie will report to SCYNEXIS' Chief Medical Officer, David Angulo, M.D. Dr. Azie was most recently Senior Vice President of Medical Affairs at The Medicines Company, where she managed the infectious disease franchise.


 
Cranbury-based BioNJ Member Amicus Therapeutics announced two new additions to its senior leadership team. Jill Weimer, a developmental neuroscientist has been named Senior Vice President of Discovery Research and Gene Therapy Science, and Simon Jordan, a biotechnology industry executive, has been named Senior Vice President of International. 
Prior to her appointment, Dr. Weimer led a research team at Stanford Research. Dr.  Jordan joins Amicus from Biogen, where he most recently served as Regional Vice President. 


 
Parsippany-based Pacira BioSciences, Inc. announced the appointment of Max Reinhardt as the company's President. Mr. Reinhardt will report to Dave Stack, Chairman and Chief Executive Officer of Pacira, and be responsible for overseeing all commercial and medical affairs functions at Pacira. Mr. Stack will maintain leadership of the Pacira commercial and corporate strategy.


 
Cranbury-based PMV Pharmaceuticals, Inc. announced the appointment of regulatory leader, Deepika Jalota, Pharm.D. as Senior Vice President and Head of Regulatory Affairs. Prior to joining PMV Pharma, Dr. Jalota was employed by Bayer HealthCare Pharmaceuticals. Dr. Jalota will lead the regulatory efforts for PMV Pharma's mutant p53 restoration drug pipeline drawing upon her experience leading global regulatory strategy for both early and late-stage oncology therapeutics.


 
Alcresta Therapeutics Inc. , a Warren-based developer of novel, enzyme-based products, announced it has appointed Daniel Orlando as its new CEO. Mr.  Orlando, who has more than 18 years of experience in executive roles, previously served as Chief Operating Officer at Vericel Corp. Before that, he held business development, marketing and sales roles at Takeda and Abbott Laboratories.


 
Medicure Inc., with offices in Princeton, announced that Dr. Neil Owens has been appointed President and Chief Operating Officer effective July 1, 2019. In this capacity, Dr. Owens will be responsible for implementing the company's strategic plans, and overseeing day-to-day operations, including the advancement and management of new and existing pharmaceutical products. Dr. Neil Owens has worked at Medicure since 2014, in various positions of increasing responsibility, most recently as Director, Scientific Affairs. 


Institution and Education News


 
New Jersey Innovation Institute (NJII) announced that it has joined in a new State-funded effort to combat the national opioid epidemic's impact on New Jersey.  With support from a $6 million grant by the New Jersey Department of Health (NJDOH) and New Jersey Department of Human Services (NJDHS), the institute has said that it will help lead the statewide "Promoting Interoperability for New Jersey Substance Use Disorder Providers" initiative -- a program designed to bolster the State's health information technology infrastructure and incentivize a greater number of its substance use disorder (SUD) medical professionals to transition from traditional paper-based medical records to electronic health record (EHR) technology.



 
The Henry M. Rowan College of Engineering at  Rowan University is part of an international team working to preserve the vision of patients with some of the leading causes of blindness.  Mark Byrne, Founding Department Head and Professor in the Department of Biomedical Engineering, is an advisor and collaborator in the ORBITAL (Ocular Research By Integrated Training and Learning) European Training Network program. ORBITAL was funded with €4m (about $4.5 million U.S.) by the European Union, and will work to develop improved, less-invasive treatments of diseases of the back of the eye, such as age-related macular degeneration and diabetic eye disease.


 
Investigators at Rutgers Cancer Institute of New Jersey have developed a computational method that uncovers clinically relevant gene expression patterns in large cohorts of breast cancer patients. This method, which is applicable to the analysis of all cancers, can robustly describe molecular processes that are associated with tumor subtypes and can identify predictive markers of response to treatment or disease recurrence.


 
T he  Robert Koch Foundation  announced that Martin J. Blaser, Director of  Rutgers University 's  Center for Advanced Biotechnology and Medicine , will receive its  2019 Robert Koch Gold Medal  for his research on the relationship between humans and their microbiome.  The foundation said Blaser's work on the biology of Helicobacter pylori, a gut bacterium found in the stomach and the global consequences of antibiotic overuse, was the reason he was awarded the honor.


 
The launch of New Jersey's largest academic health system, increased access and opportunities for students and the rise of new state-of-the-art learning and research spaces are among major accomplishments at  Rutgers University, President Robert Barchi said as he delivered a five-year report on the University Strategic Plan to the Rutgers board of governors.  Looking back since his arrival at Rutgers in 2012, Dr. Barchi shared some of the most significant advances at the university .


 
Investigators at  Rutgers Cancer Institute of New Jersey have developed a computational method that uncovers clinically relevant gene expression patterns in large cohorts of breast cancer patients.  This method, which is applicable to the analysis of all cancers, can robustly describe molecular processes that are associated with tumor subtypes and can identify predictive markers of response to treatment or disease recurrence.

Special Programs from Our Partners for BioNJ Members


 
The New Jersey Innovation Institute provides Strategic Doing 301, a 2.5-day training in the deep skills, tools and frameworks of agile strategy and collaboration. Called Strategic Doing, this discipline teaches participants how to design and guide complex collaborations by following simple rules. The training is ideally suited to anyone interested in developing the skills to lead complex collaborations and to innovate in open, loosely connected networks. The course has inspired hundreds of collaborative initiatives for communities, regions, businesses, health systems, government agencies and universities.


 
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 nonprofit community from throughout the State for two days of informed discussion, empowering ideas and engaging trade and industry exhibitors.


September 18, 2019 l New Brunswick
 
The  U.S. Small Business Administration  is hitting the road and Middlesex County's own New Brunswick has been announced as a stop on the 16 spot tour. The SBA's excursion aims to connect entrepreneurs to its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, according to the organization the largest source of early stage funding in the country. The SIBR Road Tour will arrive in New Brunswick on Sept. 18 to be hosted by an as yet unnamed local organization. The SBA said host groups will be involved in next-generation research and development and supporting entrepreneurs.


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 [email protected] or call 609-890-3185 
with any questions.