Welcome to the latest edition of the  BioLines  Weekender. 

First of all congratulations to William Lewis, CEO, and the entire Team at Insmed for  the ir first ever FDA approval of Arikayce, a new treatment for nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults who don't respond to conventional treatment.  It's the first and only therapy in the U.S. specifically approved for th is indication ! An awesome milestone for the company, the New Jersey ecosystem and most importantly for the Patients they will serve. As you will see throughout this issue of the Weekender, it was a banner period for FDA approvals to New Jersey companies. Congratulations to all! 

Thank you to Greg Oakes, Corporate Vice President and General Manager, U.S. Inflammation and Immunology, of Celgene, one of our newest Board members for coming in to meet the BioNJ Team and to share his perspective on some of the challenges and opportunities the industry faces. 

BioNJ kicked the week off by attending Governor Murphy's press conference announcing his economic development strategic plan. The plan includes groundbreaking ideas and opportunities that will attract and support new innovation and investment. In particular, the announcement of the  New Jersey Innovation Evergreen Fund, a $500 million co-investment venture fund , rivals strategies that have been successful in other life sciences hubs.  BioNJ stands ready to support the Governor and his team at every turn. 

In BioNJ's mission to help our Members help Patients, we recently...
  • Testified in opposition to price controls before the New Jersey Senate Health Committee
  • Provided comments on proposed amendments to the State's prescriber gift ban regulations
  • Met with numerous members of the New Jersey legislature to advocate for innovation and growth and support of the life sciences industry
  • Supported the Governor's Mansion Drumthwacket Gala
  • Spoke with three life science companies interested in coming to New Jersey
  • Spoke at the New Jersey Association of Health Underwriters 10th Annual State of the State in Healthcare Symposium 
  • Attended the MedTech Conference: Innovation Transforming Healthcare 
  • Co-hosted with the NJEDA a Pitch Presentation program, in collaboration with executive coaching and professional development experts, for resident companies of New Jersey incubator and accelerator facilities, academic and institution start-ups
  • Facilitated a call with BioNJ's Human Resources Leadership Network to discuss future opportunities to build New Jersey's talent pool and mentor future scientists
We hope to see you at BioNJ's Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop taking place next Thursday, October 11, at Amicus. We look forward to bringing together Patients, industry, payers, academia and government for a multi-stakeholder discussion on how to understand, navigate and influen ce   value framework decisions . 

Because Patients Can't Wait®,
The BioNJ Team

BioNJ Calendar

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

October 11, 2018
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 [email protected]. Plus, click here for valuable tools and resources on the Value of Medical Innovation.



Horizon Blue Cross Blue Shield of New Jersey announced that in 2017, members receiving care from doctors who participated in one of its patient-centered, value-based care programs were less likely to be admitted to the hospital, more likely to have essential health screenings, and had a lower overall cost of care. The company also reported that more than 70% of its in-network primary care doctors participated in one or more of Horizon BCBSNJ's value-based care programs -- a 20% increase over the last two years.  


 
Gov. Phil Murphy has reached out to more than 20 of the world's leading international research universities to encourage them to create a global footprint in New Jersey.
In a letter to foreign universities across North and South America, Europe, the Middle East and East Asia, Governor Murphy emphasized his commitment to reclaiming New Jersey's leadership in the global innovation economy and provided a vision for how a foreign research university could extend its reach while playing an important role in New Jersey's quest to reclaim its place at the center of the global innovation economy.



"Governor Murphy's economic development strategic plan marks an unprecedented and important step forward for New Jersey's economic future. It includes groundbreaking ideas and opportunities that will attract and support new innovation and investment. In addition to numerous other strategies, the announcement of the New Jersey Innovation Evergreen Fund, a $500 million co-investment venture fund, rivals strategies that have been successful in other life sciences hubs and promises to bring New Jersey's innovation ecosystem to a whole new level," said BioNJ President and CEO Debbie Hart.



Most patients diagnosed with lymphoma discuss the possibility of chemotherapy with a healthcare professional at some point. Chemotherapy is a standard of care for many forms of lymphoma, but most patients will experience multiple relapses. While the benefits of chemotherapy often outweigh the risks, patients are eager for alternative solutions. Thankfully, research continues to look at different treatment pathways.



The current benchmark for efficacy in clinical trials of new plaque psoriasis treatments is a 75 percent reduction in the Psoriasis Area and Severity Index (PASI), which is a measure of the area of skin affected along with the skin's appearance. But the most bothersome symptom, according to a survey of patients with plaque psoriasis, was not skin appearance, but itching.



A non-Hodgkin  lymphoma  diagnosis can come with many uncertainties, especially for patients with subtypes that remain chronic and incurable. Patients may feel anxious about not knowing when their lymphoma may progress or how their treatment may impact their lives. As a result, more than one-third of survivors  experience symptoms of post-traumatic stress disorder . Those uncertainties can make navigating diagnosis and treatment emotionally crippling. 



Kimberly Jewett is one of the  266,000 women each year who have to come home from the doctor's office and tell their families that they have breast cancer. These conversations are never easy. They can be even more difficult when young children are involved, which happens frequently; an estimated  30 percent of all breast cancer in women under the age of 45 is diagnosed within a few years after giving birth.  Now in remission, Kimberly is teaming up with her daughter Kalli to share their stories to help other families better navigate the difficult conversation and emotions that come with a breast cancer diagnosis.


NEW! PUBLIC POLICY NEWSFEED 

Visit www.BioNJ.org for the latest happenings taking place in Trenton and Washington D.C. With BioNJ's Vice President of Government Affairs, John Slotman's finger on the pulse of the most critical issues facing the industry, our Members and Patients, BioNJ's Public Policy Newsfeed will keep you and your Team in the know. 

BioNJ in the News


 
The cost of this innovation is significant and depends on public funding for success, according to BioNJ, the trade association for life sciences research; in fact, the 3,200 life-sciences organizations in New Jersey depend heavily on this funding for early research. For each novel therapy approved it requires an investment of at least $2 billion on average and a decade of work, the group said.

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.

 
  Berkeley Heights-based BioNJ Member  Cyclacel Pharmaceuticals, Inc. and the University of Texas MD Anderson Cancer Center announced a three-year strategic alliance agreement that will enable clinical evaluation for safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and other advanced leukemias.






 
The U.S. Food and Drug Administration has approved  Bridgewater-based  BioNJ Member Sanofi's Libtayo ®  (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and available for advanced CSCC in the U.S.


 
Princeton-based BioNJ Member Evotec AG announced that it has established an initiative with BioNJ Member Sanofi through the launch of a newly created BRIDGE, called LAB031, designed to accelerate drug discovery across multiple therapeutic areas. The BRIDGE LAB031 collaboration enables Evotec to access resources to enter research collaborations with academic institutions worldwide to collaborate on early-stage translational projects addressing indications in disease areas with a high unmet medical need. 








 
Princeton-based BioNJ Member  Sandoz Inc.  announced that the  U.S. Food and Drug Administration  has approved its Symjepi for the emergency treatment of allergic reactions in children.  Sandoz will distribute and commercialize Symjepi (epinephrine) 0.15 mg Injection and Symjepi 0.3 mg Injection in the U.S. under an exclusive agreement with  Adamis Pharmaceuticals Corp. Symjepi 0.15 mg Injection is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis.


 
Princeton-based BioNJ Member Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim,® a long-acting version of supportive oncology care medicine filgrastim.





 
Results from a Phase 2b clinical trial of  Bridgewater-based BioNJ Member  Eli Lilly and Company's  dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA, LY3298176) showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. The six-month data showed  average HbA1c reductions of up to 2.4 percentage points and an average weight reduction up to 11.3 kg (12.7 percent).



 
Readouts from two Phase 3 clinical trials demonstrated that  Bridgewater-based BioNJ Member Eli Lilly  and Company's  Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog ®  (insulin lispro) and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes. URLi is Lilly's novel mealtime insulin formulation that was developed to help better control blood glucose levels after meals by more closely mirroring the way insulin works in people without diabetes.


 
Berkeley Heights-based BioNJ Member  Chugai Pharmaceutical Co., Ltd.  and BioNJ Member  Eli Lilly and Company  announced they have entered into a license agreement for OWL833, Chugai's oral non-peptidic GLP-1 receptor agonist. OWL833 is a Phase 1-ready asset that is being studied for the treatment of type 2 diabetes. Under the terms of the agreement, Lilly will receive worldwide development and commercialization rights to OWL833. 


 
Bridgewater-based BioNJ Member Eli Lilly  and Company and  Boehringer Ingelheim  presented the full results of the long-term cardiovascular outcome trial, CARMELINA ® , which studied the impact of Tradjenta ®  on cardiovascular safety and kidney outcomes in adults with type 2 diabetes at high risk for heart and/or kidney disease. The study met its primary endpoint, with Tradjenta demonstrating a similar cardiovascular safety profile compared with placebo when added to standard of care. 














 
Working Mother released its 2018 list of the 100 Best Companies for working moms, and 10 New Jersey firms made the list.  Companies were selected based on a 400 question application on leave policies, benefits, childcare, flexibility policies and more. Among the New Jersey companies recognized were BioNJ Members, Johnson & Johnson, Merck & Co., Novo Nordisk Inc. and Sanofi. Congrats to all!





 
Parsippany-based GlaxoSmithKline  and Innoviva, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the use of Trelegy Ellipta (fluticasone furoate/ umeclidinium/vilanterol 'FF/UMEC/VI') in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD.


 
Parsippany-based GlaxoSmithKline and Aeras reported that GSK's M72/AS01E  candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection  in an ongoing Phase IIb clinical trial testing. These primary results published in the  New England Journal of Medicine  after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.


 
Basking Ridge-based Daiichi Sankyo Company announced that it has entered into a clinical trial collaboration agreement with a subsidiary of BioNJ Member Merck & Co., Inc., to evaluate the combination of Daiichi Sankyo's investigational HER2 targeting antibody drug conjugate DS-8201 and KEYTRUDA ®  (pembrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC).


 
Basking Ridge-based Daiichi Sankyo Company announced that the first patients have been dosed in DESTINY-Breast03 and DESTINY-Breast02, two global Phase 3 studies evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with previously-treated HER2 positive unresectable and/or metastatic breast cancer. 


 
Basking Ridge-based Daiichi Sankyo Company announced that updated phase 1 safety and efficacy data for [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), were presented for a subgroup of patients with heavily pretreated HER2 mutated or HER2 expressing non-small cell lung cancer (NSCLC) during an Oral Session at the IASLC 19th World Conference on Lung Cancer (#WCLC2018) hosted by the International Association for the Study of Lung Cancer in Toronto, Canada.


 
Whippany-based Bayer AG's long-acting treatment for hemophilia A has won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.  While final approvals are up to the European Commission, it generally follows recommendations from the Committee for Medicinal Products for Human Use (CHMP) and endorses them within a couple of months. The benefits of Jivi, chemically known as damoctocog alfa pegol and available as a powder and solvent for solution for injection, are its ability to prevent and control bleeding when used on demand and during surgical procedures, CMPH said.


 
Freehold-based Avalon GloboCare Corp. announced that the company has officially commenced operation of Epicon Biotech Co. Ltd. ("Epicon"), a joint venture with Jiangsu Unicorn Biological Technology Co. Ltd., located within the Nanjing BenQ Hospital - a prestigious Grade 3A medical center in Jiangsu Province, China. As previously announced in June 2018, Avalon formed a joint venture with Jiangsu Unicorn to establish a provincial network of translational cellular therapies and bio-banking programs.












 

 
Woodcliff Lake-based  Eagle Pharmaceuticals, Inc. announced that it has entered into an agreement with the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the nation's leading science and technology laboratory in the area of medical chemical countermeasures research and development, to conduct a study to evaluate the neuroprotective effects of RYANODEX ®  (dantrolene sodium).



People in the News



Edison-based BioNJ Member ContraVir Pharmaceuticals, Inc. announced the appointment of Robert Foster, Pharm.D., Ph.D. as its acting Chief Executive Officer. Dr. Foster has an accomplished history of leadership success in the global biotech industry, playing a critical role in drug discovery, developing corporate strategy and driving strategic partnerships and licensing transactions. Since 2016, Dr. Foster has served as ContraVir's Chief Scientific Officer, overseeing all aspects of its drug development programs.  



Kenilworth-based BioNJ Member Merck & Co. announced that its Board of Directors has rescinded its policy subjecting the company's Chief Executive Officer to mandatory retirement at age 65. Merck also announced that its current Chief Executive Officer, Kenneth C. Frazier, has agreed to remain in his position beyond December 2019, when he turns 65.







Woodcliff Lake-based Eagle Pharmaceuticals Inc. announced it has appointed David Pernock its new Chief Operating Officer. Mr.  Pernock, in addition to his new role, will continue to serve as the company's President. "We are delighted to appoint Mr. Pernock as Chief Operating Officer as we continue to build Eagle and advance to our next phase of commercialization," said Scott Tarriff, CEO of Eagle Pharmaceuticals.


Institution and Education News






 
As part of his overarching plan to modernize New Jersey's economy, Gov. Phil Murphy announced new education grants focusing on STEM -- science, technology, engineering and math. Gov. Murphy also announced that the current Office of Educational Technology within the Department of Education will be reconstituted as the Office of Science, Technology, Engineering and Mathematics.



 
A new  Rutgers New Jersey Medical School  study shows that most people at high risk for tuberculosis (TB) relapse can be identified by testing the  Mycobacterium tuberculosis  bacteria that causes TB before the patient begins treatment. The study, led by Roberto Colangeli, assistant professor in the Department of Medicine, and David Alland, professor and chief of infectious disease in the Department of Medicine, appears in the New England Journal of Medicine.


 
In a new study published in the Journal of Internal Medicine, a Rutgers New Jersey Medical School (NJMS) faculty researcher and colleagues found that individuals with high levels of urinary Hcy-thiolactone, a chemically-reactive and toxic homocysteine metabolite, experienced 58% more heart attacks than individuals with low Hcy-thiolactone. To read the full study, visit the Journal of Internal Medicine website via the following link: b it.ly/wenbit92018.


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


 
The funding will support basic science research that will target breast, colorectal, lung and other cancers. The Pre- and Post-Doctoral Fellowship Grants were awarded by the  New Jersey Commission on Cancer Research.


 
Hackensack Meridian Health announced a new organizational structure, splitting the large health system into three regions: North, Central and South.  The regionalized strategy is not new in the country, or in the State --  RWJBarnabas Health  has already been using it - but Hackensack Meridian has added another component.  There will also be care transformation leaders, which will include  Carrier Clinic  CEO Don Parker if its merger with Hackensack is finalized, for behavioral health and mental health services.


 
Hackensack Meridian Health  has named Mark Sparta as President of  Hackensack University Medical Center . Dr.  Sparta will continue in his current role as the Executive Vice President of Population Health for Hackensack Meridian Health network. "I want to congratulate Dr. Sparta on his new executive leadership position. I am confident that his expertise and vision will best serve our patients, their families and our team members as Hackensack University Medical Center looks toward a promising future," said Robert C. Garrett, co-CEO of HMH.


 
Hackensack Meridian  Health  Hackensack University Medical Center is among the first hospitals in the world to acquire the innovative da Vinci single port (SP) system, a cutting-edge robotic-assisted technology used by surgeons to perform complex urological procedures. Hackensack University Medical Center, a center for excellence in advanced robotic surgery, is the first and only hospital in New Jersey to have access to this groundbreaking technology.


 
The new campus sits on 17-acres in Clifton and Nutley and houses Seton Hall's College of Nursing, School of Health and Medical Science and of course the brand-new medical school with Hackensack Meridian Health. It's one of few in the nation to cross health care disciplines in an academic setting. That means students from all three schools will get to use the shiny, new labs and latest technology. 

Funding News


 
HealthStartNJ, established by Princeton-based BioNJ Member New Jersey Health Foundation, made a financial investment of  $50,000  in Paracelsus Neuroscience I, LLC ., , a startup company founded by Roland G.W. Staal, Ph.D. that focuses on the study and therapeutics of neuropathic pain. "Neuropathic pain is chronic, pathological pain caused by a lesion of the nervous system resulting in a significant decrease in the quality of life of an affected individual. Recent studies suggest that central and peripheral immune cells may play a significant role in its development and chronicity," explained Dr. Staal. 

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. 
Special Programs from Our Partners for BioNJ Members


October 9, 2018 | Webinar

It's not easy to go from a nascent scientific concept to a fully-funded life sciences organization. In this upcoming web panel discussion, we'll delve into the best ways to navigate this path successfully. The discussion will provide examples of how executive teams can partner business with science in order to overcome stumbling blocks and achieve results. You'll hear real stories from experienced scientific founders who have been in the trenches from founding to funding to exit.


October 11, 2018 | Coalition of State Bioscience Institutes (BSBI)

With the breakneck speed of new discoveries and shifting global and regulatory environments, the need for the right talent to drive innovation in the life science industry (which includes biotechnology, pharmaceuticals, digital health, medical devices, etc.) is a leading concern of life sciences employers. The 2018 CSBI Workforce Trends Report identifies the most pressing talent needs of the life sciences industry and the key trends that are driving talent acquisition. Please join the CSBI Chair and Workforce Committee Co-Chair for a 45-minute webinar exploring the needs of this innovative STEM sector.


October 16, 2018 | Philadelphia

Hear what happens AFTER a start-up company presents to an investor group! Usually after the company representatives leave the room, the investors have a private discussion to decide whether the opportunity merits further investigation and possible investment. 1st Pitch Life Science offers presenters and audience members the chance to hear what happens in those closed-door discussions, and to learn what really matters to investors. At the end of the event, the audience will vote on a "Best in Show" winner to determine who will go on to the final "Best of the Best" event in New York City to compete against other teams in the Mid Atlantic region.


October 18, 2018 | New York

In this novel format, two or three companies will receive coaching from a MABA investor prior to competing at the live 1st Pitch event. Their pre-coaching pitch will be recorded and later presented to the audience, just prior to their "new and improved" live pitch. After the presentations, a panel of the coaches and the entrepreneurs will take questions, while the audience votes on "Best in Show". This format will allow audience members to see what areas the companies improved on and how they were able to make a more effective pitch.


November 7, 2018 | Philadelphia Marriott Downtown

Healthcare professionals providing diagnosis, therapy or management to patients with Chronic Obstructive Pulmonary Disease (COPD) are invited to attend the 3rd Annual International COPD Conference, one of the nation's largest continuing education programs for COPD, at the Downtown Marriott, Philadelphia.


November 8, 2018 | Princeton

Celebrate Princeton Innovation is an event, website and video series that honors faculty, students and staff researchers who engage in the transfer of discoveries into real-world applications through entrepreneurship. The10th anniversary is an opportunity to reflect on the truly astounding transformation of Princeton's innovation ecosystem. For more information and to register, click here. 


November 14-15, 2018 | Newark

The two-day program is led by BIS's professional counseling staff and provides an in-depth examination of the Export Administration Regulations (EAR). The program will cover the information exporters need to know to comply with U.S. export control requirements on commercial goods. We'll focus on what items and activities are subject to the EAR, steps to take to determine the export licensing requirements for your item, how to determine your export control classification number (ECCN), when you can export or reexport without applying for a license, export clearance procedures and record keeping requirements and real life examples in applying this information.  


November 15, 2018 | Hackensack Meridian Health

NJ Tech Council is developing a Mid Atlantic Immuno-Oncology Conference which will showcase I/O efforts taking place among companies and universities in the mid-Atlantic region. The goal of the conference is to give an overview of research in the region and establish a network among researchers. Questions or inquiries should be sent to Paul at [email protected]. More information including panels will be posted on the Council's website.


November 15, 2018 | Piscataway

The New Jersery Academic Drug Discovery Consortium is hosting its 2nd annual meeting at Rutgers University this year. The conference is taking place on Thursday, November 15 at the Ernest Mario School of Pharmacy. Please contact Vince Smeraglia for sponsorship opportunities at [email protected] or 732-956-6123.


November 16, 2018 | NJEDA Commercialization Center

This seminar is intended to provide entrepreneurs and small businesses with an overview of the SBIR and STTR programs with a focus on the National Institutes of Health (NIH) and 3 of its largest Institutes, The National Institute on Aging (NIA), the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases NIAID). Following the morning seminar and a networking lunch, the speakers will be available for 1-to-1 appointments with attendees in the afternoon. For more information and online registration visit NJSBDC.com/sbir.


December 12, 2018 | Boston

The 13th annual New England Venture Summit, presented by youngStartup Ventures, is an industry gathering connecting venture capitalists, corporate VCs, angel investors, technology transfer professionals, senior executives of venture backed, emerging and early stage companies, university researchers, incubators and premier service providers.