Welcome to the latest edition of the BioLines Weekender. 

Other than the budget struggles in Trenton, it's been mostly a fun and very productive two weeks for the BioNJ Team since our last e-newsletter. Here's a look at some of the exciting activities we've been involved in. We...
  • Weighed in on important Budget matters in Trenton
  • Discussed the Governor Murphy Administration's plans for advancing innovation in New Jersey with Tim Sullivan, CEO, New Jersey Economic Development Authority, during BioNJ's Board Meeting
  • Presented the American Life Sciences Innovation Council "2018 Champion of Health Care Innovation" Award to Congresswoman Bonnie Watson Coleman  
  • Spoke at the Third Annual Precision Medicine Leaders Summit
  • Met with Cong. Leonard Lance, Asm. Gordon Johnson and Asw. Nancy Pinkin  
  • Presented the strengths of New Jersey's life sciences ecosystem at a Breakfast Briefing with a Chinese delegation from the Tianjin Binhai Hi-Tech Industrial Development Area
  • Participated in a planning call for a multi-state life sciences association Congressional staff briefing in September
  • Hosted our Sixth Annual HR Conference, entitled "Engagement: The Key to Retention in Transformational Times"
  • Held BioNJ's Clinical Trials Supply Chain in Transition Summit: Cell & Gene Therapy, Virtual Trials and Patient Centric Services
  • Met with BioNJ's C-Suite Summit; Manufacturing and Public Policy Steering Committees
  • Met with Springer Nature to discuss special offers for BioNJ Members as part of BioNJ's Purchasing Consortium program
  • Were asked by the New Jersey Department of Education to have BioNJ's HR Leadership Network weigh in on its biotechnology teacher certification guidelines 
Wishing you a Happy, Healthy and Safe Fourth of July! Thank you to all of those who have fought for our great country's freedom and for all of you who fight for Patients each and every day!

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

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
BioNJ's Patient Advocacy Summit
Celgene Corporation, 179 Passaic Ave, Summit, NJ

December 13, 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.

By Mark J. Alles, Celgene Chairman and Chief Executive Officer

A few decades ago, drug discovery was, for the most part, a matter of trial and error. The world's most successful pharmaceutical companies would often collect dirt from far-flung locales and screen that soil or sand for medically active components. Biology was often a secondary concern. It was the speed of trial and error that was important. Today, drug discovery is more targeted and intentional, building on a wealth of data that has grown exponentially since the early days of trial and error. Our knowledge of cell biology and genomics is now sufficiently advanced that it is possible to create medicines based on our individual immune cells or genetic profile. 

By Mark J. Alles, Celgene Chairman and Chief Executive Officer

Americans want and deserve better health care. Yet many patients are also concerned about the affordability of health care, including out-of-pocket costs which are rising faster than health care spending. When it comes to health care, we should not have to choose between access, quality and affordability. This is especially important for those patients suffering with life-threatening diseases who may only be able to be effectively treated with the newest, most innovative medicines. For the benefit of all patients, we must find ways to ensure that American health care improves access and quality, while becoming more affordable over time.

Legislation authored by Senator Paul Sarlo and Senator Robert Singer that would re-establish the former New Jersey Commission on Science and Technology and rename it the "New Jersey Commission on Science, Innovation, and Technology" was approved by the Senate.  The newly-resurrected commission would work to identify the fields of science, innovation, and technology in New Jersey that offer the potential for application or commercialization and to find funding sources.

Legislation sponsored by Assemblyman Christopher DePhillips establishing a state commission on science, innovation and technology heads to the governor's desk following Senate approval. DePhillips said the bill (A3652/S2329) will help make New Jersey one of the most innovative states in the country in science and technology. "I am pleased that the Senate passed this legislation unanimously and the bill is on the way to the governor's desk," added DePhillips. "We need this bi-partisan legislation to keep the life sciences industry right here in New Jersey."

BioNJ in the News

BioNJ has launched its Entrepreneurship Fellowship Program, choosing its first-ever fellow for a two-year stint with four top life sciences firms.  Irina Katz, a member of the Class of 2018 at  University of the Sciences  in Philadelphia, was chosen from a number of candidates. Under the program, designed to mentor, develop and train prospective life sciences entrepreneurs in New Jersey - to encourage the establishment of startups in the Garden State - Ms. Katz will spend six months at each of four participating companies: Amicus TherapeuticsPfizerPhotocure and Rafael Pharmaceuticals.

VIDEO: Taskforce Releases Recommendations on How To Increase Biotech Jobs. Click here to watch (starting at the 6 minute mark).

Interested in Receiving BioNJ's Biweekly Jobs Beat Featuring the Latest Job Opportunities? Click here!

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 HR / Talent Acquisition / Professional Development 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.

Edison-based BioNJ Member  ContraVir Pharmaceuticals, Inc.  announced dosing of the first subject in its single ascending dose (SAD) Phase 1 trial in  the United States  with cyclophilin inhibitor, CRV431.  The randomized, partially-blinded, placebo-controlled ascending sequential dose group study will assess safety, tolerability and pharmacokinetics (PK) of CRV431 in healthy volunteers as part 1 of the first clinical study. Part two of the clinical trial will consist of a single dose of CRV431 in a drug to drug interaction study assessing the safety, tolerability and PK co-administered with Viread® (tenofovir disoproxil fumarate), and part three of the study will assess the safety, tolerability, PK and preliminary signal for antiviral efficacy of CRV431 in stable HBV patients already treated with Viread®.

Boonton-based BioNJ Member  Enteris BioPharma  announced positive results today from the final treatment arm of the Phase 2a clinical trial of Ovarest®, an oral formulation of leuprolide, for the treatment of endometriosis. Ovarest® leverages Enteris' proprietary Peptelligence® technology, which the Company uses to develop innovative oral drug formulations for clients, in addition to advancing its own internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities.

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.

Bridgewater-based BioNJ Member  Insmed Incorporated  announced that the  Division of Antimicrobial Products  of the  U.S. Food and Drug Administration  ( FDA ) has notified the company of a planned advisory committee meeting to review data supporting Insmed's New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The tentative date for the meeting is set for  August 7, 2018 .

Iselin-based BioNJ Member ThromboGenics NV announced its intention to change its name to "Oxurion NV".  Patrik De Haes, M.D., CEO of ThromboGenics, shared "The new name, Oxurion, is designed to better reflect our ambition to deliver best in class therapies for back of the eye disorders. The renaming comes at a moment when we have reached important clinical milestones and are accelerating the execution of our unique pipeline of disease modifying compounds for diabetic eye disease."

Iselin-based BioNJ Member ThromboGenics NV announced that it has successfully enrolled the first patient in a Phase 1 open-label, multicenter, dose escalation study evaluating the safety of THR-149 in the treatment of DME (NCT03511898). THR-149 is a novel plasma kallikrein inhibitor generated using Bicycle Therapeutics' Bicycles® technology platform, and the kallikrein-kinin system is considered a valid target for the treatment of DME through inhibition of plasma kallikrein.

After years trying to push a thrice-failed Duchenne drug into the US market (and ultimately failing to do so), PTC Therapeutics is finally onto something interesting. The New Jersey company's stock $PTCT is soaring on news of a completely different program - one partnered with Roche - that's just impressed analysts and investors with updated data from a Phase I trial.

Cranbury-based BioNJ Member  Oncobiologics, Inc.  announced that it has entered into a Master Services Agreement (MSA) with  Sonnet BioTherapeutics, Inc. , a privately held development stage biopharmaceutical company, and has officially launched its BioSymphony™ Platform based contract development and manufacturing (CDMO) business. 

Princeton -based BioNJ Member  Evotec announced having signed a transaction agreement with Bridgewater-based BioNJ Member Sanofi to integrate Sanofi's infectious disease unit into its organisation. Pursuant to this agreement, Evotec will also licence-in the majority of Sanofi's infectious disease research portfolio and initiatives. This successfully seals the exclusive negotiations between the two companies and completion of the required legal social process, initiated on 08 March 2018. 

Bridgewater-based BioNJ Member Sanofi presented positive non-inferiority results of the BRIGHT study comparing its long-acting insulin Toujeo® to insulin degludecAt the end of the BRIGHT study, Toujeo demonstrated comparable blood sugar (HbA1c) control versus insulin degludec (-1.64% vs. -1.59%, respectively). During the first 12 weeks of therapy, a period when patients and physicians work to determine the most appropriate individual insulin dose, Toujeo reduced the rate of low blood sugar (hypoglycemia) events by 23 percent and the incidence of low blood sugar events by 26 percent, compared to insulin degludec (p<0.05).

Kenilworth-based BioNJ Member Merck & Co. through its Merck for Mothers initiative announced study results on an investigational heat-stable formulation of carbetocin for the prevention of excessive bleeding after childbirth, also known as postpartum haemorrhage (PPH). The results demonstrated that heat-stable carbetocin is clinically non-inferior to the standard of care, oxytocin, for the primary outcome of ≥500 ml blood loss or additional uterotonic use.

Kenilworth-based BioNJ Member Merck & Co.  announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA ®  (olaparib) tablets.  Women with  BRCA- mutated ( BRCA m) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. 

Kenilworth -based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019. 

Kenilworth -based BioNJ Member  Merck & Co. announced new data from the Comparative Trials with Sitagliptin (CompoSIT) clinical trials with JANUVIA® (sitagliptin). In the CompoSIT-I study, initiation of insulin therapy while continuing treatment with JANUVIA resulted in greater blood glucose reductions and more patients reaching A1C goal compared to those who discontinued JANUVIA. 

Keytruda, Kenilworth-based BioNJ Member Merck & Co.'s best-selling drug, was granted accelerated approval by the U.S. Food and Drug Administration to treat patients with B-Cell Lymphoma, a rare type of blood cancer, and cervical cancer. In May 2017, the FDA granted accelerated approval of Keytruda for patients whose cancers have a specific genetic features. It was the first time the agency had granted approval for an immunotherapy drug, and helped cement immuno-oncology as the wave of the future for cancer treatment.

Plainsboro-based BioNJ Member Novo Nordisk announced the successful completion and headline results of the phase 3a trials PIONEER 4 comparing oral semaglutide as a treatment for adults with type 2 diabetes to Victoza® (1.8 mg liraglutide) and placebo, and PIONEER 7 comparing oral semaglutide as a treatment for adults with type 2 diabetes to sitagliptin 100 mg. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet.

Plainsboro-based BioNJ Member Novo Nordisk announced that oral semaglutide, an investigational GLP-1 analogue taken as a once-daily tablet, achieved significant reductions in blood sugar versus placebo in adults with type 2 diabetes, according to findings from the PIONEER 1 Phase 3a trial. The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo as monotherapy over 26 weeks in adults with type 2 diabetes.

Plainsboro-based BioNJ Member Novo Nordisk announced that adults with type 2 diabetes treated with Tresiba® (insulin degludec injection) had a significant reduction in HbA1c and a 30% lower rate of hypoglycaemic episodes after starting basal insulin. The retrospective, non-interventional comparative effectiveness study, which included more than 4,000 adults with type 2 diabetes who were starting basal insulin for the first time, showed that after six months those treated with Tresiba® had significantly lower HbA1ccompared to those treated with insulin glargine U300 (-1.5% vs. -1.2% respectively; p=0.029).

Plainsboro-based BioNJ Member Novo Nordisk and Kallyope, Inc. announced that they have entered into a research collaboration and option agreement to discover novel peptide therapeutics to treat obesity and diabetes. Kallyope will receive an upfront payment and research support for activities conducted in the collaboration. Under the terms of the agreement, Novo Nordisk has an option to license exclusive worldwide rights to develop and commercialise up to six products discovered in the collaboration. 

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced results from a post-hoc analysis which demonstrated efficacy of Emgality ™    (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with BOTOX ®*  (onabotulinumtoxinA). Lilly also announced today that the intended brand name, Emgality, has been conditionally accepted by the  U.S. Food and Drug Administration  ( FDA ).

Bridgewater-based BioNJ Member Eli Lilly and Company announced that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first AS study focusing on a difficult-to-treat population of patients who had an inadequate response to one or two tumor necrosis factor (TNF) inhibitors (90 percent of enrolled patients) or intolerance to a TNF inhibitor (10 percent).

Bridgewater-based BioNJ Member  Eli Lilly and Company's  Humulin ®  R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System) provided greater A1C reduction with less daily insulin needed compared to multiple daily injections (MDI) in adults with type 2 diabetes on high dose insulin (201-600 units/day). Humulin® R U-500 is Lilly's highly concentrated insulin formulation that is used to control high blood sugar in people with diabetes who are insulin-resistant and need daily doses of more than 200 units of insulin.

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.

Two investigational doses of Lilly's dulaglutide (4.5 mg and 3.0 mg), as well as Trulicity ®  (dulaglutide) 1.5 mg, provided significantly better blood sugar control with weight benefits compared to placebo in adults with type 2 diabetes.   Trulicity is  Bridgewater-based BioNJ Member  Eli Lilly and Company 's  once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist (RA) approved to improve blood sugar (glucose) in adults with type 2 diabetes. Trulicity should be used along with diet and exercise.

Bridgewater-based BioNJ Member  Eli Lilly and Company and Boehringer Ingelheim announced  that both randomized controlled trials in the EASE Phase III program, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in A1C after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10 and 25 mg).

Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim announced findings from two new analyses of the landmark EMPA-REG OUTCOME® trial. Results include a post-hoc analysis demonstrating consistent effects for Jardiance® versus placebo on renal outcomes in patients with established cardiovascular (CV) disease and type 2 diabetes, irrespective of control of certain CV risk factors.

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson  announced new findings from two real-world studies comparing sodium glucose co-transporter-2 inhibitor (SGLT2i) INVOKANA ®  (canagliflozin) and glucagon-like peptide-1 receptor agonists (GLP-1s) in treating adults with type 2 diabetes. One study showed INVOKANA ®  treatment resulted in similar blood glucose control while achieving greater treatment adherence, less therapy discontinuation and lower treatment cost, while a second study showed INVOKANA ®  resulted in greater and longer-lasting weight loss. 

East Hanover-based BioNJ Member Novartisannounced 14-month results from the pivotal JULIET clinical trial showing ongoing durable responses are achievable with Kymriah® (tisagenlecleucel) when administered to adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The overall response rate (ORR) was 52% (95% confidence interval [CI], 41% - 62%), among 93 evaluable patients who were followed for at least 3 months or discontinued earlier. 

Princeton-based Sandoz, a division of BioNJ Member Novartis, announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly® (infliximab) and biosimilar Erelzi® (etanercept). Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi showed that each biosimilar matched its reference biologic in terms of safety, efficacy and quality, reinforcing previously-presented findings.

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) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). 

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 Bristol-Myers Squibb Company announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with EPd compared with pomalidomide and dexamethasone (Pd) alone. 

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the China National Drug Administration (CNDA) has approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This is China's first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase 3 CheckMate -078 trial, in which 90% of the patients enrolled were Chinese.

When it comes to pharma partners, doctors prefer quality digital content. While that makes sense, new research shows that it also fosters trust with U.S. physicians. For the first time, DRG Digital's Manhattan Research queried doctors about which pharma companies they trust in its annual Taking the Pulse survey. And the three drugmakers who ranked as most trusted were Bristol-Myers Squibb, Biogen and Celgene, in that order, among physicians who had digital interactions with them. Not coincidentally, doctors also praised those companies for their strong, relevant online content. 

Cardiac patients are one step closer to obtaining a medical device that can alert them to a potential Acute Coronary Syndrome (ACS) event whether they experience symptoms or not, following recent  U.S. Food and Drug Administration approval  of the AngelMed Guardian® System. Considered Monmouth County-based  Angel Medical Systems'  flagship product, the AngelMed Guardian System is the world's first implantable cardiac monitor and patient alerting system for ACS. While FDA approval brings renewed optimism to Angel Medical Systems, Chief Operating Officer David Keenan says the company would likely have folded were it not for funding it received through New Jersey's Technology Business Tax Certificate Transfer Program.

Lexicon Pharmaceuticals, with offices in Basking Ridge, announced positive 52-week results from the Phase 3 inTandem1 study for sotagliflozin in adults with type 1 diabetes. In the North American study, administration of sotagliflozin 200 mg or 400 mg in combination with maximally tolerated standard of care insulin therapy resulted in statistically significant reductions in A1C levels and weight compared to optimized insulin alone. A lower incidence of severe hypoglycemia was observed with sotagliflozin 200 mg and 400 mg compared to placebo.

Basking Ridge-based Daiichi Sankyo announced that positive results from the pivotal QuANTUM-R Phase 3 study of single agent quizartinib were presented at the 23rd Congress of the European Hematology Association. QuANTUM-R study results showed that patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations who received single agent quizartinib had a 24 percent reduction in the risk of death compared to patients who received salvage chemotherapy. 

Progenics Pharmaceuticals, with offices in Hanover,  announced that it has completed enrollment in its Phase 2/3 OSPREY clinical trial evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL™ (18F-DCFPyL), in prostate cancer. The OSPREY study enrolled 266 patients with localized high risk prostate cancer and 117 patients with recurrent or metastatic disease in  the United States  and  Canada  for a total of 383 patients. 

Parsippany-based Castle Creek Pharmaceuticals announced that the first patient has been enrolled at UNC-Chapel Hill Dermatology & Skin Cancer Center in a new Phase 1 study evaluating the pharmacokinetics (PK) and safety of diacerein 1% ointment (CCP-020) under maximum use conditions in patients with epidermolysis bullosa (EB). In addition to the PK study, the company is currently evaluating CCP-020 in the ongoing DELIVERS study for the treatment of patients with epidermolysis bullosa simplex (EBS), a subtype of EB. 

Vertex Pharmaceuticals Incorporated,  with offices in Plainsboro,  announced that ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, ages six and older, will be reimbursed in  Sweden  after concluding the three-party negotiations with TLV and the county councils. Reimbursement is effective from  July 1 . The innovative, long-term access agreement also provides a framework for the assessment and access of our future CF medicines.

Hackensack-based Champions Oncology announced that they have partnered with NSABP Foundation, Inc. (formerly National Surgical Adjuvant Breast and Bowel Project) and Puma Technology, Inc. to develop patient derived xenograft (PDX) models in two multi-center co-clinical PDX trials. The first trial, NSABP FB10 is a phase II study evaluating the combination of trastuzumab emtansine (T-DM1) with neratinib in women with metastatic HER2-positive breast cancer (NCT02236000) and is currently enrolling patients.

Glen Rock-based RespireRx Pharmaceuticals is pleased to announce that it entered into a letter of intent with Noramco, Inc., pursuant to which the parties have entered into a ninety-day period during which they will negotiate a definitive agreement regarding the company's development of dronabinol. Subject to successful completion of due diligence and execution of a definitive agreement, the company and Noramco will cooperate in the co-development of both a first-generation gel capsule of dronabinol in sesame oil and a second-generation modified formulation of dronabinol with enhanced pharmaceutical properties.

Parsippany-based  Pacira Pharmaceuticals  and  Nuance Biotech Co.  announced that they have entered into an agreement with Nuance, a  China  based specialty pharmaceutical company, to advance the development and commercialization of EXPAREL® (bupivacaine liposome injectable suspension) in  China . EXPAREL is a non-opioid option for achieving long-lasting pain control after surgery via infiltration into the surgical site or administration as an interscalene brachial plexus nerve block.

Monmouth Junction-based Kadmon Holdings announced the closing of its previously announced offerings of common stock for gross proceeds of approximately  $113.2 million , which includes the full exercise of the underwriters' option to purchase additional shares. Proceeds from the offerings will be used for preclinical and clinical development of Kadmon's lead product candidates, discovery, research and preclinical studies of its other product candidates and for other general corporate purposes.

Eatontown-based American CryoStem Corporation  announced a new scientific project to create a Histological Scoring System for Collected Lipoaspirate. This project is based upon the company's extensive experience with its ATGRAFT™ product and requests from the physician community to provide additional data related to the results of different tissue harvesting techniques, processing, storage and post-storage tissue and cell viability. The company's Chief Scientific Officer, Michael Moeller, Ph.D., will be performing the study with the assistance of the Histology Core at Rutgers University in New Jersey.

People in the News

Cranbury-based BioNJ Member  Oncobiologics, Inc.  announced that Randy Thurman , a current member of Oncobiologics' Board of Directors will assume the role of Executive Chairman. Oncobiologics' Board of Directors also appointed Lawrence A. Kenyon , its Chief Financial Officer, as interim CEO to continue leading Oncobiologics in its advancement of ONS 5010 and its new contract development and manufacturing (CDMO) strategy, as well as other product candidates in the pipeline. 

Summit-based BioNJ Member Celgene Corporation announced it has appointed Jonathan Biller its Executive Vice President and General Counsel, effective July 3. Mr. Biller will be responsible for global legal strategy and will serve on the Summit-based biopharmaceutical company's executive committee.

Rutherford-based BioNJ Member Cancer Genetics, Inc. announced the appointment Michael McCartney as the company's Chief Commercial Officer, effective immediately. Mr. McCartney will be responsible for developing and overseeing Cancer Genetics' commercial strategy and spearheading the company's business development initiatives.

Hasbrouck Heights-based Unichem Pharmaceuticals USA Inc. announced it has a new CEO for its parent company.  Scott Delaney has joined the company as its CEO and President, North America, for  Unichem Laboratories Ltd. . He has also been named a member of the company's Board of Directors. Most recently, Mr. Delaney was President  of Heritage Pharmaceuticals Inc., a division of Emcure Pharmaceuticals.

BrainStorm Cell Therapeutics Inc.  announced the appointment of  Joseph Petroziello  as vice president of scientific & corporate communications, and   Susan Ward , Ph.D. as head of clinical operations. Dr. Ward served as Director,  Early Clinical Development  at Pfizer, has more than 20 years of operational leadership experience in clinical trials, IND-enabling studies, protocol development and management of cross-functional teams. Mr. Petroziello joins  BrainStorm Cell Therapeutics  from Juno Therapeutics.

Institution and Education News

When Jimmy Carter was diagnosed with end-stage metastatic melanoma in 2015, he began taking a drug developed in part using 3D molecular data. Insights like these into drug discovery and other fields of scientific research are possible using the 140,000-plus 3D molecular structures made freely available in the  RCSB Protein Data Bank  at  Rutgers University-New Brunswick .

Several physicians from Rutgers Cancer Institute of New Jersey have been named as a 'Top Doctor' or 'Top Doctor for Cancer Care' by Castle Connolly Medical Ltd., which publishes resource guides on top healthcare professionals across the nation. The listings appeared recently in several magazines along the East Coast. A physician-led research team assembled by Castle Connolly collected peer surveys that highlighted various career aspects. 

Rutgers Cancer Institute of New Jersey is offering a clinical trial targeting an advanced form of colorectal cancer with a combination vaccine/immunotherapy drug treatment. The standard way of treating colorectal cancer that has spread to the liver or has recurred is with a combination of chemotherapy and removal of the cancer through surgery.  This however, is not always effective as the majority of patients suffer a recurrence of their cancer following standard treatment. 

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. Integrating miniaturized robotic and microfluidic (lab-on-a-chip) systems, this technology combines the breadth and accuracy of traditional blood drawing and laboratory testing with the speed and convenience of point-of-care testing.

Facing pediatric cancer as a patient or caregiver is challenging enough, but to understand the impact of the late effects of treatment is equally challenging to this population. That is why Rutgers Cancer Institute of New Jersey consistently educates childhood cancer survivors about this topic through its LITE Program. The LITE Program at Rutgers Cancer Institute provides long-term evaluation, support and health education for the growing number of childhood cancer survivors. The program utilizes a multidisciplinary team approach to provide services for this population.  

Gillian Knapp, an emeritus professor of astrophysical sciences at Princeton, has received the National Science Foundation's Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring (PAESMEM). The award honors outstanding efforts of mentors to encourage the next generation of innovators, and to develop a science and engineering workforce that reflects the country's diverse talents.

Memorial Sloan Kettering unveiled its newest outpatient treatment center, MSK Bergen in Montvale.  The site will welcome new patients in the coming weeks. The 110,000-square-foot facility represents the latest expansion in North Jersey for the cancer care provider, as the third wholly owned and operated location in the State and the seventh outpatient treatment center outside MSK's New York City base.

Funding News

ASPR under HHS has charged BARDA with launching DRIVe to accelerate innovations, and improve the availability of transformative countermeasures to protect Americans from natural and intentional health security threats.  DRIVe is seeking abstracts for efforts to develop revolutionary health security products, technologies and innovations in order to increase USG's capability and capacity to respond to national security health threats. DRIVe seeks unconventional approaches that are outside the mainstream, challenge assumptions, require multi-disciplinary teaming, and have the potential to radically change established practice, lead to extraordinary outcomes and create entirely new fields. 

Thought Leadership from BioNJ Members

A white paper by BioNJ Member EY

Whether M&A contributes to shareholder value creation has been an ongoing debate for decades. EY conducted research based on 278 life sciences transactions that closed between 2010 and 2017 to further evaluate this question. It investigated how transaction type (transformative, bolt-on or geographic expansion) affected total shareholder return (TSR) over several time frames. EY's findings suggest that bolt-ons were the winner in getting to incremental value faster -- impressively so. Click here to review the full report.

As the biotech/pharma stage is pushed toward a Patient-focused path, the voice of the Patient is increasingly demanded throughout the drug development process. As this demand rises, Patient advocates in life sciences emerge. The new landscape and the growing responsibilities of such a role, as well as the regulatory and compliance-related restrictions that surround it, bares the question of how to properly prepare individuals for this role. Professional Patient Advocates in the Life Science (PPALS), a non-profit professional patient advocacy organization working to support and improve Patient advocacy in the biotech/pharmaceutical sphere, have noted, as many others have, this need for a solid background for those who wish to join this field. 

In order to undertake the task of assessing the need for such a program, PPALS has organized a feasibility study with a short survey component. The survey allows for four major groups to voice their views on this important idea, HR/hiring professionals, Patient advocates who have/have not participated in the PPALS's Patient Advocacy Certificate Training, and Patients. PPALS needs help in understanding the future of Patient advocacy and how to improve it not only for the benefit of Patient advocates, but also for industry, non-profit partners, regulatory groups, and, most importantly, for patients and caregivers. Please participate by July 20th. Click here to get started.

Special Programs from Our Partners for BioNJ Members

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.