Welcome to the latest edition of the BioLines Weekender. 

It's been a busy three weeks since our last Weekender. Here's a sampling of what we have been doing:
  • Led the New Jersey Biotechnology Task Force in its release of recommendations to boost New Jersey's biotechnology sector
  • Joined the New Jersey delegation at BIO in Boston
  • Attended press conference with Governor Murphy on new STEM initiatives at Stevens Institute
  • Attended the launch of "Research with NJ" -- New Jersey's new research portal to drive industry/academic collaboration

  • Participated in a discussion with Asm. Andrew Zwicker and Christopher DePhillips at New Jersey Innovation Council Meeting
  • Met with Sens. Tom Kean and Paul Sarlo
  • Presented the American Life Sciences Innovation Council "2018 Champion of Health Care Innovation" Award to Cong. Josh Gottheimer (D-5)
  • Discussed BioNJ and New Jersey's robust life sciences ecosystem to delegation of French companies considering locating in New Jersey
  • Chaired Commercialization Center for Innovative Technologies' (CCIT) Advisory Board Meeting
  • Attended Union County ELC with Sen. Joe Cryan
  • Published op-ed entitled "New Jersey Budget: It's All About the Company We Keep"
  • Met with BioNJ's Patient Advocacy Summit; Legal, Compliance & Regulatory and Value of Medical Innovation Steering Committees
  • Spoke with several companies to discuss a possible health insurance program offering for our Members
  • Opened registration for the 2018 BioCruise taking place July 19
Important reminder: Today is the deadline to submit your nominations for the 2019 Dr. Sol J. Barer Award  for Vision, Innovation and Leadership. Click here for details.

BioNJ Calendar

Clinical Trials Supply Chain in Transition
NJIT Campus, Newark, NJ

June 19, 2018
BioNJ's 6th Annual HR Conference 
Institute for Life Science Entrepreneurship/Kean University, Union, NJ

June 22, 2018
New X2 BioCruise with NewYorkBio
New York Harbor World Yacht at Pier 81, New York, NY

July 19, 2018
Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop
Amicus Therapeutics, Cranbury, NJ

October 11, 2018
Save the date!
BioNJ's C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ

October 25, 2018

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 BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.

For years, former BioNJ Chair Michael Becker was one of the drug executives navigating swarms of cancer doctors at the annual meeting of American Society of Clinical Oncology, where 40,000 people gather every year to talk about the hottest cancer-killing drugs. This year he came back, but it was very different. This time he spoke to an audience of drug executives as a patient living on borrowed time.

A study released at the  BIO International Convention  shows that the U.S. bioscience industry has reached $2 trillion in annual economic impact while maintaining accelerated venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry has held a leading position as an economic driver and job generator.

The Board of the New Jersey Economic Development Authority (EDA) approved two actions to help nurture the growth of the State's innovation economy. Echoing the priorities set by Governor Murphy, the Board authorized an agreement with the New Brunswick Development Corporation (DEVCO) to advance development of "The Hub" in downtown New Brunswick, and a venture fund investment that will support growth-stage, software and technology-enabled companies in New Jersey.

New Jersey life sciences companies produced 357 of the roughly 1,120 cancer treatments produced in the U.S. in 2017.  That's second only to California, where life sciences companies produced 388 new cancer drugs. The figures were compiled by the national biopharma trade group the Pharmaceuticals Research and Manufacturers of America. PhRMA data show Massachusetts produced the third most cancer treatment drugs with 261, while New York State was fourth with 114, and Maryland was fifth with 74.

BioNJ in the News

Organizations offer detailed information on sector in State

A joint report from the  Biotechnology Innovation Organization and  TEConomy Partners shows growth in the bio and life sciences sectors in New Jersey, despite an increasingly competitive environment with states such as Massachusetts.  New Jersey, which employs 93,824 people in the industry, was highlighted in the report in a number of areas.  "Given what's going on in New Jersey right now, it is such an exciting time between some of the incubators that have opened and are opening, the brand new Hackensack Meridian School of Medicine (at Seton Hall), the new governor who talks about innovation at every turn, this Research with New Jersey database -- it's just an exciting time like none other than I've ever seen," said BioNJ president and CEO Debbie Hart.

A study released at the 2018 BIO International Convention shows that the U.S. bioscience industry has reached $2 trillion in annual economic impact while maintaining accelerated venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry has held a leading position as an economic driver and job generator.  "New Jersey's biosciences industry has been an important source of the State's and the nation's economies for generations and that continues to be true as we have witnessed here today," said BioNJ President and CEO Debbie Hart. 

Strong leadership from the state's trade associations makes innovation possible.

New Jersey has a rich history of being an innovation leader in spheres such as life sciences, healthcare and the various STEM fields. The State is ripe with businesses that bleed innovation, large and small. A lot of what these businesses are able to do, however, would not be possible without the outstanding leadership and advocacy of their respective industries' agencies and trade associations. These organizations, such as BioNJ, the HealthCare Institute of New Jersey, R&D Council of New Jersey, the New Jersey Tech Council, and more, are tapped into the inner workings of their industries, and advocating for positive change that will continue to allow businesses in the State to flourish -- enabling New Jersey to continue to legitimize its moniker as the Innovative State.

"Move Over, New Jersey". That's the opening line in The Boston Globe story we were greeted to upon arrival at the International BIO Conference in Boston last week. In a story quoting Massachusetts Life Sciences Center CEO Travis McCready, it was reported that "The state continues to field calls from New Jersey life sciences companies looking to relocate or expand in Massachusetts". The Globe touted Massachusetts' advancing status as a top biotech hub having just outpaced New Jersey. And the following day, Mass. Governor Charlie Baker announced a $400M investment into biotech on top of the billions they have already invested.

Whatever your services needs may be,  BioNJ's Member Service Provider Directory    can guide you to the right source. This Member-only categorical listing by service sector is your "one-stop-shop" solution to support and drive your business.  Click on the RESOURCES tab at www.BioNJ.org to view the full BioNJ Member Service Provider Directory categories. Here's a sample for Financial / Investment / Funding Sources and Services providers:                   

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.

Morris Plains-based BioNJ Member Immunomedics, Inc. announced that the company plans to initiate a Phase 2 pivotal TROPHY U-01 study of sacituzumab govitecan, the company's lead investigational ADC, as a single agent in patients with locally advanced or metastatic urothelial cancer (mUC) who have relapsed after a platinum-based regimen and/or immune checkpoint inhibitor (CPI) therapy.

Morris Plains-based BioNJ Member Immunomedics, Inc. announced results from a Phase 1/2 study of its lead investigational ADC, sacituzumab govitecan, in advanced stage estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).

Morris Plains-based BioNJ Member Immunomedics, Inc. announced their intent to enter into a clinical collaboration to investigate the combination of Clovis' Rubraca® (rucaparib), a poly (ADP ribose) polymerase inhibitor (PARPi), and Immunomedics' lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, as a treatment of patients with metastatic triple- negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC). 

Princeton -based BioNJ Member  Evotec announced the formation of the LAB591 academic BRIDGE with Arix Bioscience plc ("Arix", London Stock Exchange: ARIX ) and the Fred Hutchinson Cancer Research Center ("Fred Hutch"). LAB591 aims to accelerate research discoveries at Fred Hutch and leverage these discoveries to form new companies focused on cancer and infectious disease drug development. 

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced that the  Committee for Medicinal Products for Human Use  (CHMP) of the  European Medicines Agency  (EMA) has recommended approval of expanding the indication of Translarna™ (ataluren) to include ambulatory children aged two to five years with nonsense mutation Duchenne muscular dystrophy (nmDMD). 

Somerville-based BioNJ Member Symphogen announced that it has enrolled the first patients into two separate Phase 1 clinical trials with two new investigational antibody therapies discovered from its immuno-oncology (I-O) activities with Shire targeting LAG3 (Sym022) and TIM3 (Sym023). These are the second and third clinical programs to have been initiated under the I-O activities, the first being a Phase 1 trial of Sym021, an anti-PD1 antibody discovered by Symphogen, for solid tumors or lymphomas.

BioNJ Member Kyowa Kirin International, with offices in Princeton, and Ultragenyx Pharmaceutical Inc. announced that the results of a pediatric Phase 2 clinical trial of Crysvita® (burosumab) for the treatment of X-linked hypophosphatemia (XLH) in children aged 5 to 12 years were published online by the New England Journal of Medicine (NEJM). The results demonstrated that Crysvita improved rickets severity, growth, pain and physical function, and increased serum phosphorus and renal phosphate reabsorption.

BioNJ Member Genmab A/Swith offices in Princeton, announced that topline results from the Phase III study of Arzerra® (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, compared to those given bendamustine alone. 

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from PIONEER 2, the second phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. The 52-week, open label trial investigated the efficacy and safety of 14 mg oral semaglutide compared with 25 mg empagliflozin in 816 people with type 2 diabetes, inadequately controlled on metformin. The confirmatory endpoints were defined after 26 weeks of treatment.

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co. announced that the U.S. Food and Drugs Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® [US generic name: emicizumab-kxwh] for adults and children with hemophilia A without factor VIII inhibitors. The FDA is expected to make a decision on approval by 4 October, 2018.

Bridgewater-based BioNJ Member  Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. Use of OLUMIANT in combination with other Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Bridgewater-based BioNJ Member  Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. 

Bridgewater-based BioNJ Member  Eli Lilly and Company announced new safety and efficacy data from a Phase 2 study evaluating mirikizumab in patients with moderate-to-severe ulcerative colitis (UC). The results showed that patients treated with mirikizumab achieved significantly greater rates of clinical remission at 12 weeks compared to placebo.  The Phase 2 study evaluated the safety and efficacy of mirikizumab compared to placebo in patients with moderate-to-severe UC who had previously failed conventional or biologic therapy. 

BioNJ Member Pfizer Inc., with offices in Madison, announced that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company's New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). 

BioNJ Member Pfizer Inc., with offices in Madison, announced that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis (UC).

BioNJ Member Pfizer Inc., with offices in Madison, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

BioNJ Member Pfizer Inc., with offices in Madison, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA™, a potential biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Kenilworth -based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company's 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine. 

Kenilworth -based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®, the company's anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. This indication is approved under the FDA's accelerated approval regulations based on tumor response rate and durability of response. 

Kenilworth -based BioNJ Member  Merck & Co. announced results from KEYNOTE-407, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC). In this study, the KEYTRUDA plus chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008). 

Kenilworth -based BioNJ Member  Merck & Co. and AstraZeneca presented data which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer (mCRPC). LYNPARZA is being jointly developed and commercialized by AstraZeneca and Merck.

Kenilworth -based BioNJ Member  Merck & Co. announced results from KEYNOTE-042, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. In this study, KEYTRUDA monotherapy resulted in significantly longer overall survival (OS) than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. 

Kenilworth -based BioNJ Member  Merck & Co. announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma (RCC). Interim data showed an overall response rate (ORR) of 38.2 percent (95% CI, 29.1-47.9) in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. 

Kenilworth -based BioNJ Member  Merck & Co. announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Findings showed an overall response rate (ORR) of 18.7 percent in patients in the SCLC cohort (95% CI, 11.8-27.4), the primary endpoint of the study. Additionally, in a pre-specified exploratory analysis, ORR was 35.7 percent in patients whose tumors expressed PD-L1 with a combined positive score (CPS) of ≥1 (95% CI, 21.6-52.0).

Princeton-based Sandoz, a division of BioNJ Member Novartis, announced that the European Commission (EC) has approved Zessly® (infliximab) for use in Europe. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

BioNJ Member Helsinn, with offices in Iselin, and MEI Pharma, Inc. announced that a planned interim analysis in the ongoing Phase 2 study of pracinostat and azacitidine in higher risk MDS patients successfully met a predefined patient retention threshold. The positive outcome supports continuation of the study.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of 62.6%, the primary endpoint of the study, versus 50.2% for Yervoy (HR: 0.66, P<0.0001) at a minimum follow-up of 24 months across key subgroups, including disease stages and BRAF mutation status.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced patient-reported outcomes data from the Phase 3 CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) treated with the Immuno-Oncology combination Opdivo (nivolumab) plus low-dose (1mg/kg) Yervoy (ipilimumab) versus sunitinib over a two-year follow-up period. Patients in the study treated with Opdivo plus low-dose Yervoy reported significant benefits in disease-related symptoms and improvements to their cancer-related quality of life and well-being.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced results from a part of the Phase 3 CheckMate -227 trial that evaluated Opdivo(nivolumab) plus low-dose Yervoy (ipilimumab) and Opdivo plus chemotherapy versus chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC) with PD-L1 expression <1%, across squamous and non-squamous tumor histologies (Part 1b).

Princeton-based BioNJ Member Ophthotech Corporation announced that it has entered into an exclusive global license agreement with the University of Florida Research Foundation and the University of Pennsylvania to develop and commercialize a novel adeno-associated virus (AAV) gene therapy product for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic disease that is characterized by progressive and severe loss of vision leading to blindness. 

Jersey City-based BioNJ Member SCYNEXIS announced the publication of results from a Phase 1 study of SCY-078, assessing the risk for drug-drug interactions when administered with drugs metabolized by the CYP family of enzymes, in The Journal of Clinical Pharmacology. SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.

Parsippany-based BioNJ Member  Allergan announced positive results from CGP-MD-01, a Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of orally administered atogepant. All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from baseline in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks. 

Mahwah-based Glenmark Pharmaceuticals Inc. announced that the company has
submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris™, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. 

Parsippany-based GlaxoSmithKline plc and Innoviva, Inc. announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease (COPD). This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.

AbbVie and Woodcliff Lake-based Eisai's subsidiary for gastrointestinal diseases EA Pharma announced that the autoinjection delivery system for HUMIRA® (generic name: adalimumab [recombinant], "HUMIRA"), HUMIRA® for Subcutaneous Injection 40 mg Pen 0.4 mL and HUMIRA® for Subcutaneous Injection 80 mg Pen 0.8 mL, was listed in the National Health Insurance Drug Price Standard on 30th May. AbbVie and Eisai have launched the products today. HUMIRA is a fully human anti-TNF-α monoclonal antibody formulation.

Woodcliff Lake-based Eisai Co., Ltd. announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai's antiepileptic drug (AED) Fycompa® (perampanel). This application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (PGTC) seizures. Furthermore, Eisai has included a study in this sNDA requested by the FDA in a Pediatric Written Request, and therefore FDA has designated this application for Priority Review, which means the review period will be six months. 

Woodcliff Lake-based Eisai Co., Ltd. and Biogen announced that elenbecestat was generally safe and well tolerated in a Phase II clinical study (Study 202) of the oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) conducted in the United States, and the results demonstrated a statistically significant difference in amyloid beta (Aβ) levels in the brain measured by amyloid-PET (positron emission tomography). 

Basking Ridge-based Daiichi Sankyo announced that the Phase 3 ENLIVEN study showed a statistically significant 39 percent overall response rate (ORR) at week 25 based upon central review of MRI scans using Response Evaluation Criteria in Solid Tumors, version 1.1 (the primary endpoint) for patients treated with oral pexidartinib compared to no tumor response among patients who received placebo (P<0.0001). Patients enrolled in the trial were those with tenosynovial giant cell tumor (TGCT) for whom surgery would be associated with potentially worse function or severe morbidity. 

East Windsor-based ARKAY Therapeutics announced that the U.S. FDA has approved its IND application and the clinical study "may proceed." ARKAY Therapeutics plans to evaluate the safety, tolerability, and superiority of RK-01 over metformin in newly diagnosed drug-naïve as well as obese type 2 diabetes patients with inadequate glycemic control with metformin monotherapy. RK-01 is a proprietary formulation of valsartan plus celecoxib dual add-on to metformin-HCl XR. Metformin is the current first-line of therapy.

Monmouth Junction-based Biotech Support Group announced that it has filed a patent application for Stroma Liquid Biopsy™, a biomarker panel of cancer dysregulation derived from blood. Stroma Liquid Biopsy™ offers methods to monitor and potentially modulate the systemic response to cancer, offering new avenues for early detection, personalized medicine and therapeutic modalities. This is groundbreaking in the medical field where there still remains a significant unmet need for biomarkers reportable in blood that can profile each person's unique physiological response to cancer.

Lawrenceville-based Lipocine announced the dosing of the first subject in the ambulatory blood pressure ("ABPM") clinical study for TLANDO™, the company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. This study was initiated after receiving FDA feedback on the ABPM clinical study protocol and is being conducted to definitively characterize TLANDO's blood pressure effect, if any.

People in the News

Summit-based BioNJ Member Celgene Corporation announced the hiring of David V. Elkins as Executive Vice President, Chief Financial Officer. Mr. Elkins will join Celgene on July 1, 2018, and become CFO effective August 1, 2018. Mr. Elkins will succeed current CFO Peter N. Kellogg, who will become Celgene's EVP, Chief Corporate Strategy Officer until his retirement, planned for mid-2019.

Franklin Lakes-based BD has promoted an executive to Executive Vice President and Chief Technology Officer. The company, also known as Becton, Dickinson & Co., said John A. DeFord, Senior Vice President of Research and Development for the Interventional Segment, will now be responsible for leading all R&D activities for the company, including product portfolio development.

Princeton-based BioNJ Member Advaxis, Inc. announced the appointment of Molly Henderson as Executive Vice President and Chief Financial Officer. Ms. Henderson joins Advaxis from Cedar Cliff, LLC, where she served as a financial and business consultant to high-growth entrepreneurial companies. Previously she was Chief Financial Officer at Iovance Biotherapeutics, Inc.

Institution and Education News

A ribbon-cutting ceremony was held for the new Hackensack Meridian School of Medicine at Seton Hall University located in Nutley. It is the first private medical school to open in the state in more than 50 years. The building is part of Prism Capital Partners' ON3 development, which entails the entire 116-acre former Hoffman LaRoche campus.
Classes will commence at the medical school on July 9, with 60 students making up the inaugural class.

Dr. Andrew Pecora, the Chief Innovation Officer for Hackensack Meridian Health, has a vision for the  Hackensack Meridian Health Center for Discovery and Innovation.  CDI, as it is being called, will be an area set aside for clinical research and startup companies.  "The whole idea here is I want to create what the equivalent of Silicon Valley is in life science here. This is not just a research institute. This is a private-public partnership," said Dr. Pecora.

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.

Rutgers researchers have created an automated blood drawing and testing device that provides rapid results, potentially improving the workflow in hospitals and other health-related institutions to allow health care practitioners to spend more time treating patients.

MD Anderson Cancer Center at Cooper University Health Care has joined an early detection study aimed at improving lung cancer screening methods.  Part of the University of Texas MD Anderson Cancer Center's Moon Shots Program, the study invites smokers in the state to participate for a possible early detection of lung cancer.

Funding News

Governor Phil Murphy praised the New Jersey Economic Development Authority (EDA) for its creation of an Innovation Challenge that gives eligible communities the opportunity to receive funds for plans that strengthen their local innovation ecosystems. The Challenge will launch as a pilot round with awards of up to $100,000 per recipient.  "Now is the time for the creativity and entrepreneurial spirit of New Jersey to shine as we ignite our potential to grow an innovation economy, said Governor Murphy. "We want specific plans that will support inclusive economic development and enhance the local business ecosystem."

The  New Jersey Economic Development Authority  approved a 10-year, $40 million tax savings incentive package for  Teva Pharmaceuticals USA Inc.  to move its domestic headquarters to Parsippany from Pennsylvania. The move is expected to bring 843 jobs to New Jersey, while keeping 232 the company already has in Parsippany. The EDA estimates Teva's move to Parsippany would have an estimated net benefit to the state of $247.4 million over 20 years.

EDA recognizes how influential entrepreneurship is in building resilient, regional economies. The EDA is excited to announce that the Notice of Funding Opportunity (NOFO) for the  2018 Regional Innovation Strategies (RIS) program has been published and the competition is now open!  With up to $21 million available through the  2018 RIS NOFO , this year's program will help spur innovation capacity-building activities in regions across the nation through two separate grants: the i6 Challenge and the Seed Fund Support (SFS) Grant competitions.

Medical device maker Acuitive Technologies is reaping the benefits of locating in New Jersey as it ramps up development of orthopedic implants. The early-stage company has leveraged resources from both the State and the New Jersey Institute of Technology (NJIT) as it continues to grow. 

Thought Leadership from BioNJ Members

The traditional biopharma business model is being disrupted by biopharma companies ushering potentially curative treatments to market. However, these companies will need to navigate an outdated reimbursement model and challenge traditional commercialization approaches to succeed in the market.

Special Programs from Our Partners for BioNJ Members

June 22, 2018 | White and Williams, One Liberty Place, Philadelphia

You are invite you to attend the World Trade Center of Greater Philadelphia (WTCGP) Breakfast Briefing exchange with a Chinese delegation from the Tianjin Binhai Hi-Tech Industrial Development Area. The delegation is interested in meeting with companies in the biopharma, healthcare and medical equipment sector as well as other tech and various industry sector companies looking to develop business ties to the Binhai region.  For more information or to RSVP contact Susan Farrington at sfarrington@wtcphila.org or 215-586-4249.

Sponsored by BioNJ
June 26-28, 2018 | Jersey City

The Precision Medicine Leaders' Summit has firmly established itself as the definitive thought leadership  event within this burgeoning sphere. After two successful years in San Diego, we are bringing  the conference to the friendly confines of Jersey City. With close proximity to numerous biopharma  companies, academic institutions, leading medical centers and Wall Street, the 2018 event promises to  engage a diverse group of participants. Join us and learn from the many forward-thinking speakers and  play an integral part in the narrative through interactive roundtables and networking opportunities.  With a format weighted towards panel discussions, coupled with lengthy Q&A, it aims to be the  highlight in the 2018 Precision Medicine calendar. 

July 10-11, 2018 | New York City

Come meet, interact and network with more than 500 VCs, Corporate VCs, angel investors, investment bankers and CEOs of early stage and emerging growth companies on the Life Sciences Track at the prestigious  New York Venture Summit Whether you're a healthcare start - up seeking capital and exposure, or a medtech investor seeking new deals, the New York Venture Summit presented by youngStartup Ventures -- is the event you won't want to miss. The summit will feature more than 100 VCs on interactive panels; presentations from more than 50 top innovators and high-level networking opportunities. BioNJ has made special arrangement for our Members to receive a special discount of 10% off the existing "early bird" rates Click here to register. Email RBromberg@BioNJ.org for the BioNJ discount code.
Call for Top Innovators: A select group of  more than 50 Top Innovators from the life sciences/healthcare, as well as technology, CleanTech and Edtech sectors will be chosen to present their breakthrough investment opportunities.  For more information or to be considered for one of the Top Innovator slots click here .

July 17-18, 2018 | Bedminster

The 14th annual Public Relations Communications Summit, taking place on July 17­-18 at Mallinckrodt's Bedminster, NJ offices, is designed to help life sciences communicators push boundaries and move outside of your comfort zone to better position the industry, your company, your brands and yourself. This is the only meeting place exclusively designed for life sciences communicators, and it provides you with the content and networking you need to improve your communications strategy and expand your professional network. Learn more about the conference and its attendees here: https://goo.gl/RNFApx.

September 24-26, 2018 | Philadelphia

The MedTech Conference is the leading North American gathering of global medtech executives. More than 2,700 attendees will network, gain access to capital and share insights in Philadelphia, PA. from September 24-26. The conference features world-class plenary speakers, networking and business development. BioNJ Members receive a 10% discount. Contact RBromberg@BioNJ.org for BioNJ's special discount code. Visit www.themedtechconference.com to learn more about the conference.