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May 20, 2022

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Welcome to the latest edition of the BioLines Weekender...


BioNJ Members work tirelessly to bring cures to Patients who need them. From COVID-19 vaccines to therapies for devastating diseases, these cutting-edge treatments reduce overall health care costs and improve the quality of life for Patients and those who care for them. 


BioNJ is committed to ensuring Patients have access to medications they need when they need them while safeguarding future medical innovation. Consider these facts ... 


  • Medical innovation means that Hepatitis C now has a cure rate above 90% and HIV/AIDS is a chronic condition. 
  • COVID-19 vaccines averted 2.2 million deaths, 17 million hospitalizations and $900 billion in health care spending.
  • Biopharma invested nearly $200 billion globally in R&D in 2020.
  • Prescription Drug Affordability Boards stifle innovation ... a bad outcome for Patients. 


As lawmakers in New Jersey rightly look to find ways to address health care affordability, solutions shouldn’t come at the expense of limiting treatment access for Patients or discriminating against vulnerable populations. Unfortunately, that’s exactly what certain bills on the New Jersey legislature’s agenda would do – and we need to stop them.

 

One such proposal, New Jersey A-1747, would create a government-appointed Prescription Drug Affordability Board that would have the authority to determine drug price and value without taking Patient preferences into account. A-1747, which the Assembly Health Committee will consider next Tuesday, May 24, would be detrimental to Patients who rely on innovative medicines to manage their health.


BioNJ encourages you to join your fellow advocates and tell State legislators to oppose A-1747. It’s bad for Patients, and it is not the answer to lowering Patient out-of-pocket costs.


SEND A LETTER NOW: TELL LEGISLATORS TO OPPOSE A-1747


Please join us in our efforts to protect Patient access and ensure future innovation.

Thank you. 


Because Patients Can't Wait®,

The BioNJ Team

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CMS Coverage Determination for Alzheimer’s Treatments Is a Lesson On Patient Access


By Sue Peschin, President & CEO, Alliance for Aging Research

Welcome New Members


Learn more at www.BioNJ.org/Membership.

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Upcoming BioNJ Events

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BioNJ’s 29th Annual Dinner Meeting and Innovation Celebration

Register Today!

June 9, 2022

BioNJ’s IT/Cybersecurity Briefing

Register Today!

June 21, 2022

Putting Patients First:

The Value of Medical Innovation

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Why Drug Importation is Bad for Americans

Article Written by PhRMA

Drug importation schemes are dangerous and have significant negative consequences for both individuals and our health care system. Importation refers to when governments or individuals circumvent the U.S. Food and Drug Administration’s (FDA) regulatory review and approval process to acquire unapproved prescription drugs from other countries outside of our secure drug distribution system. Without proper FDA oversight and enforcement of laws designed to protect patient safety, which importation schemes undermine, there is increased potential for unsafe counterfeit, substandard or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting people in harm’s way.

Drug Prices: A Dysfunctional Market Limits Patient Access

A Podcast Led by BIO President & CEO Dr. Michelle McMurry-Heath

A convoluted, confusing and opaque system for pricing drugs has evolved that distorts the market and often limits patient access to the drugs they need to survive. In this episode, three experts explain how the system works — or doesn’t’ — and the consequences of a dysfunctional pricing system.

BioNJ Company News

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Announcing BioNJ's BioPartnering Company & Pitch Presentation Award Honorees

BioNJ announced the winners of its 2022 Company and Pitch Presentation Competition held in conjunction with the organization's 12th Annual BioPartnering Conference. The week-long Conference kicked off with an in-person Networking Reception at The Liberty House in Jersey City on the evening of Monday, May 9, 2022, followed by a two-day virtual program on Tuesday, May 10, and Wednesday, May 11, 2022, featuring interactive plenary sessions, networking and company and pitch presentations. Partnering meetings took place the entire week. Presented in concert with J.P. Morgan and Johnson & Johnson Innovation, the Conference brought together more than 500 life sciences professionals from 11 countries and 18 states as well as the District of Columbia — and attracted over 100 investors.

Spotlight On: Debbie Hart, President & CEO, BioNJ

What have been some highlights or takeaways from the past year? Despite the pandemic, it has been a very productive time for us. Our industry saved the world and many of those things that addressed COVID, such as the first vaccines, therapeutics and diagnostics, came from New Jersey companies. We are very proud of that, but it was a stark reminder of how critical this industry is both to New Jersey and the global economy – with an annual economic impact of $83.4 billion to the state, providing over 300,000 direct, indirect & induced jobs.

ROI-NJ Influencers: Manufacturing — Debbie Hart

The trusted voice of the life sciences industry, she works directly with legislative leaders in both Trenton and Washington, D.C., to advance the life sciences industry, foster medical innovation and patient access while ensuring health equity and health care affordability. Congratulations to these BioNJ Members for also making the list: Giovanni Caforio, Bristol Myers Squibb; Robert Davis, Merck & Co.; Joaquin Duato; Johnson & Johnson; Travis Epp, EisnerAmper; James Hannan, Withum Smith & Brown; Robert Hariri, Celularity; Paul Hudson, Sanofi; Thomas Kendris, Novartis; Nolan Lewin, Rutgers Food Innovation Center; Daniel Loughlin, Jones Lang LaSalle; Kevin Lyons, Rutgers Business School; Wesley Mathews, Choose New Jersey; Simon Nynens, New Jersey Innovation Institute; Stuart Peltz, PTC Therapeutics; John Shino, Rutgers MakerSpace; and Michele Siekerka, NJ Business and Industry Association.

NJ Company News

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PTC Therapeutics Receives Positive CHMP Opinion for Upstaza™ for the Treatment of AADC Deficiency

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that Upstaza™ (eladocagene exuparvovec; PTC-AADC) received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. Once ratified by the European Commission, Upstaza will be the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency for patients 18 months and older and the first marketed gene therapy directly infused into the brain. The CHMP opinion is based on the findings of clinical studies conducted in Taiwan. In addition, data from the compassionate use treatment of patients in Europe were included in the application. In the clinical studies, patients went from no display of any motor milestone development to developing clinically meaningful motor skills and neuromuscular function from as early as three months following treatment, with transformational improvements shown to continue up to nine years after treatment.

FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients With COVID-19

Bridgewater-based BioNJ Member Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first. The FDA's approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study), announced previously. No new safety signals potentially related to the use of OLUMIANT were identified in the studies. 

FDA Approves Lilly's Mounjaro™ (Tirzepatide) Injection, the First and Only GIP and GLP-1 Receptor Agonist for the Treatment of Adults With Type 2 Diabetes

The U.S. Food and Drug Administration approved Mounjaro™ (tirzepatide) injection, Bridgewater-based BioNJ Member Eli Lilly and Company's new once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes mellitus. As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.

Boehringer Ingelheim’s Latest Investigational Treatment Slowed Lung Function Decline in People Living With Idiopathic Pulmonary Fibrosis

North Brunswick-based BioNJ Member Boehringer Ingelheim announced Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine. The promising 12-week data that showed a reduction in the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IPF). The primary endpoint of the trial was the change from baseline in forced vital capacity (FVC) – meaning the maximum amount of air (measured in mL) that can be forcibly exhaled from the lungs after fully inhaling – at week 12. The trial also met its secondary endpoint, demonstrating that BI 1015550 showed acceptable safety and tolerability in IPF patients over 12 weeks. 

New Japan-Originated ALS Treatment Option Available to Patients in the U.S. FDA Approval of RADICAVA ORS® for the Treatment of ALS

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma announced that the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS® (edaravone) for the treatment of amyotrophic lateral sclerosis. RADICAVA ORS® is an oral suspension formulation that contains the same active ingredient as edaravone for intravenous infusion (Japanese product name: Radicut® Injection 30 mg and Radicut® Bag for I.V. Infusion 30 mg) for ALS treatment and being developed globally, primarily by Mitsubishi Tanabe Pharma Development America, Inc. The route of administration of edaravone is limited to intravenous infusion so far. With the approval of RADICAVA ORS®, ALS patients have flexibility in how they take their medicine. 

SCYNEXIS Presents New Interim Positive Data of Ibrexafungerp for Refractory Vulvovaginal Candidiasis from Ongoing Phase 3 FURI Study at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting

Jersey City-based BioNJ Member SCYNEXIS announced the presentation of new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). 

Palatin Announces $15 Million Private Placement of Convertible Redeemable Preferred Stock

East Windsor-based BioNJ Member Palatin Technologies announced that it has entered into a securities purchase agreement with institutional investors pursuant to which Palatin will issue and sell 8,100,000 shares of its Series B convertible redeemable preferred stock and 900,000 shares of its Series C convertible redeemable preferred stock to such investors. Each share of Series B and Series C preferred stock has a purchase price of $1.67. Each share of Series B and Series C preferred stock is convertible into shares of Palatin’s common stock at an initial conversion price of $0.45 per share. 

Vyant Bio Reports First Quarter 2022 Results and Provides Strategic and Business Highlights

Cherry Hill-based BioNJ Member Vyant Bio expects to file its Form 10-Q for the First Quarter 2022 with the Securities and Exchange Commission. Cash and cash equivalents totaled $16.4 million as of March 31, 2022. The company implemented two new vehicles to facilitate the raising of additional equity capital at the company’s option with the finalization of the Lincoln Park Equity line of credit allowing access to raise up to $15 million, as well as signing a $14.5 million ATM with Canaccord Genuity. “During the first quarter of 2022, we progressed our scientific work by using our proprietary drug discovery platform centered on human iPSC-derived neurospheroids to unveil novel targets and potentially disease-modifying therapeutics to treat patients suffering from severe neurodevelopmental and neurodegenerative diseases,’” stated Jay Roberts, the CEO.

Soligenix Announces Recent Accomplishments and First Quarter 2022 Financial Results

Princeton-based BioNJ Member Soligenix, Inc. announced its recent accomplishments and financial results for the quarter ended March 31, 2022. Christopher J. Schaber, Ph.D., President and CEO of Soligenix stated, "We remain focused on our significant upcoming milestones for 2022. We anticipate submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte™ (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) in the second half of this year. We expect to initiate a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) in the second half of this year as well. With approximately $22.9 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones."

Celularity Inc. Announces $30 Million Private Placement Priced At-The-Market Under Nasdaq Rules

Florham-based BioNJ Member Celularity Inc. announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 4,054,055 shares of its common stock at a purchase price of $7.40 per share and warrants to purchase 4,054,055 shares of its common stock at an exercise price of $8.25 per share (together the “Securities”) in a private placement priced at-the-market under Nasdaq rules, resulting in total gross proceeds of approximately $30.0 million before deducting placement agent commissions and other estimated offering expenses. The warrants will be exercisable immediately after the date of issuance and will expire five years following the initial issuance date. 

Kyowa Kirin and LUCA Science Announce Joint Research Agreement on Mitochondrial Disease Treatment With Novel Mitochondria Modality

Princeton-based BioNJ Member Kyowa Kirin and LUCA Science Inc. are pleased to announce they have entered into a research collaboration agreement on the treatment of mitochondrial diseases using platform of an innovative mitochondrial modality. Through this research collaboration, Kyowa Kirin, a leading specialty pharmaceutical company with deep disease science research knowledge based on diverse experiences in biopharmaceutical drug discovery, will leverage LUCA Science's proprietary functional mitochondria therapy platform to develop an innovative treatment for mitochondrial diseases. Mitochondria are organelles known as "intracellular power plants" that produce more than 90% of the body's energy. Mitochondrial disease, which occurs when mitochondria function is impaired due to a genetic abnormality, has been designated an intractable disease by the Ministry of Health, Labour and Welfare in Japan.

Rafael Pharmaceuticals, Inc. Announces Corporate Name Change to Cornerstone Pharmaceuticals, Inc.

Cranbury-based BioNJ Member Rafael Pharmaceuticals, Inc. announced that it is changing its name to Cornerstone Pharmaceuticals, Inc. (“Cornerstone”), its original company name. All company branding, including the website and logo have been updated accordingly. “Over these last few months, the Board of Directors has worked to determine the direction of our company. With communities of patients and physicians relying on us to deliver hope, the Board of Directors tasked ourselves with figuring out how we can best serve them moving forward,” said Sanjeev Luther, President & CEO of Cornerstone Pharmaceuticals. “Who are we today? Ultimately, the answer was very simple: we are who we have always been – an organization that is dedicated to addressing significant unmet needs with therapies for rare cancers. That has not changed."

Helsinn Healthcare SA and Knight Therapeutics Enter into Exclusive License, Distribution and Supply Agreement for Akynzeo® and Aloxi®

Iselin-based BioNJ Member Helsinn Healthcare SA and Knight Therapeutics announced that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI® oral/IV (palonosetron) in Canada (the “Products”). According to IQVIA, sales of AKYNZEO® in Canada and Brazil were approximately $7 million in 2021. Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees.

Evotec and Almirall Enter into a Multi-Target Alliance in Medical Dermatology

Princeton-based BioNJ Member Evotec SE and Almirall S.A. (ALM), a global biopharmaceutical company focused on skin health, announced a multi-target alliance in Medical Dermatology. The companies aim to discover and develop novel therapeutics for severe skin diseases, including immune-mediated inflammatory conditions such as atopic dermatitis and non-melanoma skin cancer such as basal cell carcinoma. The alliance will leverage Evotec’s fully integrated multimodality platform and combine it with Almirall’s leading expertise in Medical Dermatology. Both partners will contribute drug targets in the research process. Leveraging the Company’s end-to-end integrated, AI/ML-driven EVOiR&D platform, Evotec will be responsible for drug discovery and pre-clinical development. Almirall will lead the clinical development and marketing.

Evotec and Sernova Announce Exclusive Strategic Partnership for iPSC-based Beta Cell Replacement Therapy to Advance a 'Functional Cure' for Diabetes

Princeton-based BioNJ Member Evotec SE and Sernova Corp. announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2. The partnership leverages iPSC-based beta cells from Evotec's QRbeta initiative. Evotec reliably produces human iPSC-based beta cells in islet-like clusters in a quality controlled ("QC") scalable bioreactor process. Those islet-like clusters are functionally equivalent to primary human islets in their ability to normalize blood glucose levels in in vivo models over several months.

Evotec and Bristol Myers Squibb Extend and Expand Strategic Partnership in Protein Degradation

Princeton-based BioNJ Member Evotec SE announced that the company has extended and expanded its partnership with Princeton-based BioNJ Member Bristol Myers Squibb in targeted protein degradation, originally signed in 2018. The initial collaboration has proven to be highly productive in generating a promising pipeline of molecular glue degraders. Based on this success, Bristol Myers Squibb and Evotec extend and expand this partnership for an additional 8 years with the goal to further broaden and deepen the strategic alliance. Molecular glue degraders are small, drug-like compounds that induce interactions between an E3 ubiquitin ligase and a molecular target.

New Two-Year Deucravacitinib Data Reinforce Durable Efficacy and Consistent Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis. Clinical efficacy was maintained through up to two years of deucravacitinib treatment, with response rates at Week 60 in the LTE of 77.7% and 58.7% for Psoriasis Area and Severity Index (PASI) 75 and static Physicians Global Assessment (sPGA) 0/1 (clear/almost clear skin), respectively. The overall safety profile of deucravacitinib observed through two years spans 2,482 patient years of treatment and was consistent with that observed in the previously presented pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials. 

Bristol Myers Squibb Provides Update on CheckMate -901 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced the Phase 3 CheckMate -901 trial, comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival (OS) in patients whose tumor cells express PD-L1 ≥1% at final analysis. The company remains blinded to the data, and an independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary endpoints. No new safety signals were observed at the time of the analysis.

New Nirsevimab Data Analyses Reinforce Efficacy Against RSV

Bridgewater-based BioNJ Member Sanofi announced results from a prespecified pooled analysis of the pivotal Phase 3 MELODY and Phase 2b nirsevimab trials demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9 to 87.7; P<0.0001) against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season. In a separate pooled post-hoc analysis of the trials, blood samples taken from infants dosed with nirsevimab exhibited RSV neutralizing antibodies that were approximately 50-fold higher than baseline at Day 151 post-dose. RSV neutralizing antibody levels remained greater than 19-fold higher than placebo recipients with no known RSV infection through Day 361, suggesting protection may extend beyond Day 151.

Sarclisa® (Isatuximab) Combination Provides Unprecedented Median Progression Free Survival in Patients With Relapsed Multiple Myeloma Receiving a Proteasome Inhibitor Therapy

Bridgewater-based BioNJ Member Sanofi announced latest results from the Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) demonstrated a median progression free survival (mPFS) of 35.7 months (Hazard Ratio HR 0.58; 95% Confidence Interval CI: 25.8 to 44.0; n=179), compared to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to 25.1; n=123), as evaluated by an Independent Review Committee. These results, presented at the Controversies in Multiple Myeloma World Congress, represent the longest mPFS among studies investigating a proteasome inhibitor backbone in the second-line setting for the treatment of relapsed multiple myeloma (MM). 

Novartis Receives European Commission Approval for Jakavi® to be the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease

East Hanover-based BioNJ Member Novartis announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. The approval of Jakavi follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GvHD patients

New Data Show TREMFYA® (guselkumab) Binds to Both Inflammatory Cells and Interleukin (IL)-23, Supporting a Hypothesis for a Differentiated Mechanism from Risankizumab

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the first results of the in vitro MODIF-Y studies, supporting a hypothesis that may differentiate the mechanism of first-in-class TREMFYA® (guselkumab) from risankizumab due to the ability of TREMFYA to bind to CD64 positive (CD64+) cells in addition to interleukin (IL)-23 — both of which are key components of the immune system. These findings demonstrate TREMFYA binds simultaneously to CD64 via its native fragment crystallizable (Fc) region and to IL-23 via its antigen-binding region, suggesting the potential to neutralize IL-23 right at the site where it is secreted. Further studies will be conducted in vitro and in vivo to generate additional evidence supporting this hypothesis.

Janssen Discontinues Collaboration and License Agreements With Bavarian Nordic in Hepatitis B and Human Papillomavirus

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the termination of its collaboration and license agreements with Bavarian Nordic that leverage Bavarian Nordic’s MVA-BN® (Modified Vaccinia Ankara - Bavarian Nordic) technology to develop potential vaccines against the hepatitis B virus and human papillomaviruses. Janssen remains committed to its strong collaboration with Bavarian Nordic in the quest to prevent and cure infectious diseases – with collaborations in HIV and Ebola still ongoing. No clinical studies in hepatitis B have been initiated by Janssen utilizing the MVA-BN® technology. Janssen will continue to prioritize investigation of its hepatitis B combination therapies using alternative investigational vaccine platforms and therapeutics within its broad portfolio and has multiple studies ongoing. 

Novo Nordisk and Flagship Pioneering Announce a Strategic Collaboration to Create a Portfolio of Transformational Medicines

Plainsboro-based BioNJ Member Novo Nordisk and Flagship Pioneering announced a collaboration to create a portfolio of novel research programs to develop transformational medicines. The companies will explore opportunities to apply Flagship’s innovative bioplatforms ― an ecosystem that currently comprises 41 companies ― to scientific challenges in disease areas within cardiometabolic and rare diseases and initiate research programs based on these. This is a novel approach to collaboration, between companies providing extensive access to innovation, leveraging the technology platforms of multiple biotech companies to create a portfolio of medicines across several disease areas. Novo Nordisk will provide funding for initiated research programs and have an exclusive option to license each program. The ambition is to initiate three to five research programs within the first three years of the collaboration.

Teva to Present Findings on Short-Acting Beta Agonist (SABA) Use in Asthma Patients and the Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Help Inform Treatment Decisions at American Thoracic Society 2022 Annual Meeting

Parsippany-based BioNJ Member Teva Pharmaceuticals announced new findings will be presented that apply clinical thresholds for short-acting beta agonist (SABA) use established by independent expert consensus to objective patient data from ProAir Digihaler (albuterol sulfate) Inhalation Powder. These findings are the first to examine daily SABA usage captured by the ProAir Digihaler based on the clinical thresholds. “Our latest data at ATS will showcase how objective data from ProAir Digihaler, an FDA-approved reliever medication with a built-in sensor, could help capture reliable reliever usage and inhaler event data that physicians and their patients can use to help support informed treatment discussions and assessments,” said Tanisha Hill, Senior Medical Director, Respiratory at Teva.

Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. 

Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement With European Commission

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine. This amendment rephases planned deliveries to help support the European Commission and Member States' ongoing immunization programs, and is aligned to the companies’ commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022, will now be delivered in September through fourth quarter 2022. This change of delivery schedule does not impact the companies’ full-year 2022 revenue guidance or the full-year commitment of doses to be delivered to EC Member States in 2022.

Pfizer to Acquire Biohaven Pharmaceuticals

BioNJ Member Pfizer, with offices in Peapack, Biohaven Pharmaceutical Holding Company Ltd. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Biohaven, the maker of NURTEC® ODT, an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share. 

Upadacitinib (RINVOQ®) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients With Crohn's Disease

Madison-based BioNJ Member AbbVie announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. Use of upadacitinib in Crohn's disease has not been evaluated by health authorities. 

AbbVie and Cugene Announce Collaboration in Autoimmune Diseases

Madison-based BioNJ Member AbbVie and Cugene announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. Selective IL-2 muteins have the potential to represent a major advancement in the standard of care for patients with autoimmune and inflammatory diseases. Cugene's lead candidate, CUG252, is an engineered IL-2 mutein designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases. CUG252 is currently in a Phase 1 study in healthy volunteers.

Athenex Announces Clinical Collaboration With Merck to Evaluate Oraxol plus KEYTRUDA® (pembrolizumab) in Patients With Non-Small Cell Lung Cancer (NSCLC)

Athenex announced a clinical trial collaboration and supply agreement with BioNJ Member Merck & Co. The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex’s oral paclitaxel in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for certain NSCLC patients. The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients. The two companies will form a Joint Development Committee to review the clinical trial results. KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. 

Still the Medicine Chest: Cancer-Fighting Firm Beigene Picked N.J. for its New Facility — Further Evidence that State Remains Key Pharma Player

BeiGene announced that it plans to deliver big on that statement during the groundbreaking for its new U.S. manufacturing and clinical research & development center at the Princeton West Innovation Park in Hopewell. The center is expected to include up to approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing, including up to 16,000 liters of biologics capacity, along with clinical R&D and office space. And hundreds of high-paying jobs. John Oyler, BeiGene’s Co-Founder, Chairman and CEO, said one of the reasons the Princeton-Hopewell location was chosen was for the State’s deep talent pool — one that will allow BeiGene to expand its workforce and advance its pipeline of lifesaving oncology medications, and then provide them worldwide. 

Calliditas Receives Positive CHMP Opinion in IgA Nephropathy

Hoboken-based Calliditas Therapeutics AB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorization for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. If confirmed by the European Commission (EC), Kinpeygo will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD). Upon approval Kinpeygo, which was developed under the name Nefecon, will be marketed exclusively by STADA Arzneimittel AG.

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

Nutley-based Eisai and Princeton-based BioNJ Member Biogen announced that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. 

BD Launches Fully Automated, High-Throughput Infectious Disease Molecular Diagnostic Platform in the U.S.

Franklin Lakes-based Becton Dickinson and Company (BD) announced the U.S. launch of its new, fully automated, high-throughput infectious disease molecular diagnostics platform. With 510(k) clearance from the U.S. Food and Drug Administration (FDA), the new BD COR™ MX instrument is a new analytic instrument option for the BD COR™ System. The first test available on the new system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections (STIs) — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV). These three STIs can include a range of negative patient outcomes, from pregnancy complications to increased risk of HIV.

BD Partnership Aims to Make Blood Tests More Convenient

Franklin Lakes-based Becton Dickinson and Company (BD) and fellow health care technology company Babson Diagnostics of Austin, Texas, want to make it more convenient for patients to collect blood samples. To that end, they announced an expanded partnership May 11 to develop a system that allows patients to collect samples at home for diagnostic testing. The companies have collaborated since 2019 to create a capillary blood collection and testing system – which is now in advanced development – to enable lab-quality, small-volume collection at retail pharmacy sites by employees with no previous experience in the process. As part of the expanded agreement, the companies will build upon their research to develop a system for self-collection, mobile services and at-home collection.

Prosperdtx Launches Strategic Collaboration With Health Equity Researchers and Seqster to Improve Health Equity for Cancer Patients

Short Hills-based Prosperdtx™ announced that it will be collaborating with health equity researchers from the Office of Minority Health & Health Disparities Research at the Georgetown University Lombardi Comprehensive Cancer Center and Seqster, the leader in patient-centric healthcare technology, to empower patients with real-time access to their health data enabling supportive care for cancer patients and survivors in Washington DC’s medically underserved communities. "We are excited to work with Prosperdtx and Seqster to deliver on our mission," Lucile Adams-Campbell, Associate Director of the Office of Minority Health and Health Disparities Research said, "There is much we can do together to increase health equity through greater access to personalized continuity of care.”

Aspargo Acquires Bandol® Sildenafil Spray, Currently Marketed in Spain

Englewood Cliffs-based Aspargo Laboratories announced the acquisition of the prescription brand BANDOL® (sildenafil oral suspension) from Laboratorios Rubio S.A., a specialty pharmaceutical company headquartered in Barcelona, Spain. BANDOL® is indicated for the treatment of erectile dysfunction (ED). Concurrent with the acquisition, Aspargo entered into a distribution agreement with Rubio for the continued marketing and promotion of BANDOL® in Spain and a license and supply agreement with Farmalider, S.A. (Madrid, Spain) for the supply of BANDOL® to the Spanish market. BANDOL®, offered in a convenient and discreet metered dose container that delivers the equivalent of 12.5 mg per actuation, is manufactured in Spain and is prescribed predominantly by primary care physicians and urologists.

Med-Metrix Announces the Acquisition of PatientPal, Bolstering the Company's Front-End RCM Software and Service Solutions

Parsippany-based Med-Metrix announced it has acquired PatientPal, Inc. PatientPal is a provider of patient engagement, front-end RCM software solutions, including patient scheduling, price estimation, eligibility verification, prior authorization and payment solutions. PatientPal's proprietary front-end RCM software further improves Med-Metrix's patient intake technology and service capabilities. Financial terms of the transaction were not disclosed. PatientPal will continue to serve over 40 customers in 35 states across a diversified mix of healthcare providers. The acquisition augments Med-Metrix's Robotic Process Automation ("RPA") capabilities as PatientPal's software interacts with Electronic Medical Record ("EMR") systems, allowing for the automation of traditional front desk responsibilities. 

Intercept Sells International Rights to Liver Drug in $400M Deal

Morristown-based Intercept Pharmaceuticals announced it will sell rights to its liver disease drug Ocaliva outside of the U.S. to U.K.-based Advanz Pharma, which agreed to pay Intercept $405 million upfront in a deal. The upfront payment Advanz will exchange for ex-U.S. rights to Ocaliva is nearly equivalent to Intercept’s market value and will substantially increase the biotech’s available cash on hand. In a statement, Intercept CEO Jerry Durso said the deal would help Intercept continue to invest in its U.S. business and to fund further drug development, such as in NASH. Intercept’s first and only approved drug, Ocaliva is cleared in the U.S. and Europe to treat primary biliary cholangitis, an inflammatory liver disease that particularly affects bile ducts. 

Luzsana Biotechnology Launched in Princeton

Jiangsu Hengrui Pharmaceuticals Co., Ltd. has launched Princeton-based Luzsana Biotechnology™, (Luzsana) a global, innovative medicines company committed to delivering medicines that are available, accessible and affordable to more people around the world. Luzsana has developed a strategic plan with Hengrui Pharma that provides the company access to a world-class pipeline of more than 250 clinical studies in areas of high unmet medical need, such as oncology, cardiovascular, metabolic/diabetes, pain management, immunology and liver and renal disease. Luzsana is being led by a highly skilled team of industry veterans who average more than 25 years of experience with success delivering global execution excellence and building, leading and commercializing products at scale.

Glenmark Pharmaceuticals Receives Tentative ANDA Approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005% | 0.064%

Mahwah-based Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar® Foam, 0.005%|0.064%, of Leo Pharma AS. According to IQVIATM sales data for the 12-month period ending March 2022, the Enstilar® Foam, 0.005%|0.064% market2 achieved annual sales of approximately $115.2 million. Glenmark’s current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA’s pending approval with the U.S. FDA. 

Pacira Biosciences Reports Preliminary Net Product Sales for Exparel and Iovera° of $45.8 Million for April 2022

Parsippany-based Pacira Biosciences reported preliminary unaudited net product sales for EXPAREL® (bupivacaine liposome injectable suspension) and iovera° for the month of April 2022. EXPAREL net product sales were $44.8 million, compared with $43.1 million for April 2021. EXPAREL average daily sales for the month of April 2022 were 109 percent of April 2021. “We are pleased to report solid EXPAREL growth as we support the market transition to outpatient sites of care, with utilization expanding and significantly outperforming the elective surgery market amidst pockets of persistent operating disruptions and healthcare labor shortages,” said Dave Stack, Chairman and CEO, Pacira BioSciences.

People in the News

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Van den Bosch Named CFO of Johnson & Johnson MedTech

Johnson & Johnson MedTech announced it named Kurt Van den Bosch as chief financial officer, group finance. Mr. Van den Bosch will be a member of BioNJ Member Johnson & Johnson’s global finance team, reporting to company Executive Vice President and CFO, Joe Wolk. Mr. Van den Bosch’s role includes providing financial leadership to the global Johnson & Johnson MedTech organization. He most recently served as area Vice President of mid-sized markets for J&J MedTech EMEA, overseeing the Europe, Middle East and Africa business that included the markets of Austria, Belgium, Greece, Israel, Portugal, Switzerland, the Netherlands and Scandinavian countries.

Johnson & Johnson Names CEO, CFO Designates of New Consumer Health Company

New Brunswick-based BioNJ Member Johnson & Johnson announced the appointment of Thibaut Mongon as Chief Executive Officer Designate and Paul Ruh as Chief Financial Officer Designate of New Consumer Health Company that will be created following the planned separation. Directors and additional executive leadership appointments will be decided in the coming months as the planned separation process progresses. Mr. Mongon has served as Executive Vice President and Worldwide Chairman of Consumer Health at Johnson & Johnson since 2019. Mr. Ruh joined Johnson & Johnson five years ago to become the CFO of the Consumer Health business. 

Legend Biotech Appoints Lori Macomber as Chief Financial Officer

Somerset-based BioNJ Member Legend Biotech announced the promotion of Lori Macomber, CPA, to Chief Financial Officer (CFO), effective immediately. Ms. Macomber assumes the role from Dr. Ying Huang, who has been both CFO and Chief Executive Officer (CEO) since September 2020. Dr. Huang will continue to serve as CEO of Legend Biotech. As CFO, Ms. Macomber will lead the company’s financial operations and retain her responsibilities as the company’s principal financial and accounting officer. Since joining Legend Biotech in September 2019, Ms. Macomber has served as Vice President of Finance and Vice President of Supply Chain Finance and Controller.

Mary Lynne Hedley Elected to Lilly Board of Directors

The Board of Directors of Bridgewater-based BioNJ Member Eli Lilly and Company has elected Mary Lynne Hedley, Ph.D., as a new member. As a member of Lilly's board, she will serve on both the Science & Technology Committee and the Ethics and Compliance Committee. Dr. Hedley is an immunologist and cancer cell biologist with considerable pharmaceutical industry experience, particularly within oncology. Dr. Hedley has served as a Senior Scientific Fellow at the Broad Institute of MIT and Harvard. Prior to that, she served as Director, President, and Chief Operating Officer at TESARO, Inc., a biotechnology company she co-founded in 2010, focused on the development and global commercialization of oncology therapeutics. 

Lee-Jeffs to Head Corporate Sustainability at Modern Meadow

Ann Lee-Jeffs, who has spent the past two decades transforming leading multinational companies in the life sciences sector to sustainability leaders, has been named Senior Director of Corporate Sustainability at Nutley-based BioNJ Member Modern Meadow. Ms. Lee-Jeffs’ immediate objectives in the role include promoting and advancing the renewable and circular economy within the Modern Meadow technology platforms, Bio-Alloy and Bio-Farm, and instilling structure and foundation to establish ambitious long-term sustainability goals. Ms. Lee-Jeffs, who came to the company from Teva Pharmaceutical, has previously worked at numerous top companies. “Ann has a track record of building exceptional sustainability platforms and relationships to promote and advance sustainability at numerous multinational companies such as Teva, Johnson & Johnson, Pfizer and Colgate Palmolive,” said Modern Meadow President and Chief Operating Officer, Catherine Roggero-Lovisi.

Helsinn appoints Dr. Melanie Rolli as Group Chief Operating Officer

Iselin-based BioNJ Member Helsinn Group is pleased to announce the appointment of Dr. Melanie Rolli as Group Chief Operating Officer, effective June 1, 2022. Dr. Rolli has over 20 years’ experience in the pharmaceutical and biotech sectors, with a focus on oncology. Her previous management experience includes Chief Executive Officer roles at AELIX Therapeutics, Barcelona, Spain and at Piqur Therapeutics, Basel, Switzerland, developing molecules in oncology and dermatology. Prior to this, Dr. Rolli spent 14 years at Novartis Pharma in various roles including Member of Development Leadership Team at Novartis Oncology, Head of Medical Affairs across divisions including oncology, and latterly Global Head Medical Safety, Group Drug Development.

Why Eagle Pharmaceuticals is One to Watch as the Economy Recovers

Woodcliff Lake-based Eagle Pharmaceuticals emerges from the pandemic in great shape. The Woodcliff Lake-based company has a strong pipeline and has just added two products to market through its acquisition of Acacia Pharma. In short, Eagle is ready to take flight. So, what’s the next step? NJBIZ recently spoke with Scott Tarriff, Founder, President and CEO of the company, about how Eagle has conducted its business over the past few years and how its executives plan to continue that success. “Fortunately for us, if you just look at the way we’ve run our business over the past five or six years, we’ve been very profitable relative to our size. We generated a lot of money, we put it in the bank,” Tarriff said.

CorMedix Inc. Announces Leadership Updates and Operational Changes

Berkeley Heights-based CorMedix announced updates regarding its leadership team and changes regarding its international operations. Joe Todisco, Chief Executive Officer of CorMedix, officially joined the organization. Liz Hurlburt, Executive Vice President of Clinical Operations, has been promoted to an expanded role as Executive Vice President of Clinical & Medical Affairs, assuming oversight of Medical Affairs, Drug Safety and Pharmacovigilance, in addition to her existing Clinical Operations responsibilities. Donna Ucci has joined the company as Senior Vice President and Head of Global Quality, reporting directly to the CEO. Frank Raffaele has joined the company as Vice President of Supply Chain and brings more than 30 years of manufacturing and supply chain experience, most recently with Quotient Sciences and Teva Pharmaceuticals.

BrainStorm Strengthens Executive Team With Key Appointments in R&D and Legal

Paramus-based BrainStorm Cell Therapeutics announced two senior management appointments. Netta Blondheim Shraga, P.hD. has been appointed as Vice President, Research & Development, and Antal Pearl-Lendner, Adv. has been appointed to the newly created position of Chief Legal Counsel. Both will report directly to Chaim Lebovits, CEO. Dr. Blondheim-Shraga will be responsible for advancing the company's pipeline and steering the R&D team towards significant breakthroughs in the field of cell therapy and development of novel solutions to positively impact patients' health. Antal Pearl-Lendner, Adv. is an experienced bilingual attorney with a proven track record in legal and business development capacities. 

Aquestive Therapeutics Announces CEO Transition

Warren-based Aquestive Therapeutics announced that Keith Kendall, President and Chief Executive Officer and member of the Board of Directors of the company, is leaving the company. The Board of Directors has appointed Daniel Barber, the current Chief Operating Officer and long-tenured executive of the company, to succeed Mr. Kendall as the President and Chief Executive Officer of Aquestive and member of its Board of Directors, effective immediately. Mr. Kendall will assist in the transition of the role of CEO and the execution of the Company’s business strategy and operations until the end of the year.

Academia/Institutions/Incubators

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For NJII and NJIT, Sale of BioCentriq for $73M is Ultimate Proof of Concept

For the New Jersey Innovation Institute, the sale of BioCentriq for $73 million to GC Corp. was more than just proof that the company started at New Jersey Institute of Technology literally was worth millions. It was proof of concept for NJII itself. So said NJIT President Joel Bloom and NJII CEO Simon Nynens. “Thanks to the foresight of the NJIT board of trustees in supporting the creation of NJII, we were able to create an entity that has built upon NJIT’s strengths in life sciences and engineering to serve as a catalyst for entrepreneurship and industry partnership,” Bloom said. The sale is the largest in NJII’s history. BioCentriq manufactures autologous and allogeneic cell therapies and gene therapies and specializes in viral vector production, cell and viral banking, and upstream and downstream processing.

NJIT Ranks No. 14 Nationally in Money’s 2022 List of ‘Best Colleges’

The New Jersey Institute of Technology (NJIT) was ranked No. 14 in the U.S. by Money in its list of Best Colleges for 2022. Money evaluated more than 600 institutions, focusing on 24 factors in three main categories that surveys have shown are the most important to students: quality of education, affordability and alumni outcomes. The rankings analyzed data points such as graduation rates, net price of a degree, family borrowing and alumni earnings to find the country’s top values. “This is a great recognition for NJIT, to be ranked 14th in the country, because the Money ranking specifically examines the factors that are most important to students,” NJIT President Joel Bloom said. 

Princeton Partners With UNCF and HBCUS to Expand Research and Innovation

Princeton University is partnering with UNCF (United Negro College Fund) and five historically Black colleges and universities to launch a groundbreaking program designed to enable research collaborations between Princeton faculty and their peers at HBCUs. In the initial phase, Princeton researchers and researchers from Howard University, Jackson State University (JSU), Prairie View A&M University (PVAMU), Spelman College and the University of Maryland Eastern Shore (UMES) will co-lead research projects. These projects will be funded by Princeton University through its new Princeton Alliance for Collaborative Research and Innovation. Teams of Princeton-HBCU researchers are invited to submit proposals by June 30. The initiative’s aim is to fund multiple collaborative projects each year between Princeton and each partnering institution.

Our COVID-19 Vaccines Would Not Exist Without This Unsung Princeton Technology

It might not look like much — a plastic box that fits in the hand, with tiny tubes jutting out the top and bottom. Too simple to be cutting edge. Too humble to save so many lives. But for 20 years, researchers in Robert Prud’homme’s lab have fine-tuned this little box that has revolutionized drug manufacturing, enabling everything from mRNA-based COVID-19 vaccines to malaria drugs. The life-saving molecules that treat those diseases are fragile, and they must survive an epic voyage from a lab bench, through the supply chain, into a blood cell. Encapsulation gives them a secure vehicle and a final heading. It’s a delicate craft backed by complex mathematics, and over the arc of his career, Dr. Prud’homme has become a master craftsman.

Arnold Appointed Vice Dean for Innovation at Princeton

Craig Arnold, the Director of the Princeton Institute of Materials, holder of 13 patents and cofounder of two companies based on research conducted at the university, was appointed as Princeton University’s new Vice Dean for Innovation. Dr. Arnold will be the university’s second Vice Dean for Innovation, to provide academic leadership for innovation and entrepreneurship activities across campus. He succeeds Rodney Priestley, who recently was promoted to Dean of the Graduate School. Dr. Arnold will join the Office of the Dean for Research and work closely with DFR offices, including the Office of Technology Licensing, Corporate Engagement and Foundation Relations and the Princeton Entrepreneurship Council.

Exploring Cancer and Health Data on Asian American and Pacific Islanders

The Asian American and Pacific Islander (AAPI) community collectively represents people of many different origins who speak a diverse array of languages and have unique cultural backgrounds. This population consists of approximately 50 ethnic groups with connections to Chinese, Japanese, Filipino, Vietnamese, Korean, Pakistani, Indian and other South Asian, Native Hawaiian, Guamanian/CHamoru, Polynesian, Samoan, and other Asian and Pacific Islander ancestries. This diversity is an important feature of the AAPI community. Yet despite this diversity, members are often aggregated into one group as “Asian/Pacific Islander” or “Asian American/Pacific Islander”. This can lead to an overgeneralization of health statistics and masking of potentially significant disparities between distinct cultural groups.

Colon Microbes Provide Clues to Favorable Treatment Options in a Subset of Colon Cancer Patients

Investigators from Rutgers Cancer Institute of New Jersey, New Jersey’s only National Cancer Institute-Designated Comprehensive Cancer Center, led a collaborative study to examine the patterns of druggable oncogenic fusions in colon cancer specimens including microsatellite-stable and unstable (MSI) tumors. Subhajyoti De, PhD, researcher at Rutgers Cancer Institute and Shridar Ganesan, MD, PhD, chief of molecular oncology, associate director for translational research, and Omar Boraie Chair in Genomic Science at Rutgers Cancer Institute, who are both faculty members at Rutgers Robert Wood Johnson Medical School, are senior authors of the work and share more about the findings published in the online version of JCO Precision Oncology

Amy Murtha Named Dean of Rutgers Robert Wood Johnson Medical School

Amy Murtha, an accomplished researcher and a specialist in maternal-fetal medicine, has been named Dean of Rutgers Robert Wood Johnson Medical School.

Most recently, Dr. Murtha was a professor and chair of the Department of Obstetrics, Gynecology and Reproductive Services at the University of California, San Francisco. Formerly at Duke University, she was a professor in the Department of Obstetrics and Gynecology and Department of Pediatrics and Past Vice Chair for Research in Obstetrics and Gynecology. Dr. Murtha led the establishment and direction of the Duke Clinical and Translational Science Institute’s clinical research unit and raised the department’s National Institute of Health’s funding ranking from No. 57 to No. 17.

Atlantic Health System Names Maureen Schneider as President of Chilton Medical Center

Atlantic Health System announced that Maureen Schneider, Ph.D., MBA, RN, has been named President of Chilton Medical Center, following a successful tenure as Chief Nurse and Operations Officer at Chilton that saw numerous clinical care and quality achievements. Dr. Schneider has served as Interim President of Chilton since November 2021, following the transition of Stephanie Schwartz to President of Atlantic Health’s Overlook Medical Center. Working closely with the leadership team and frequently rounding among frontline team members throughout the hospital, Dr. Schneider has maintained her patient-centered focus in her new role, to continue building success at Chilton.

Tony Cava to Retire as President/CEO of RWJUH

Anthony V. Cava will be retiring from his position as President and Chief Executive Officer of Robert Wood Johnson University Hospital (RWJUH) Somerset, an RWJBarnabas Health facility, effective Jan. 2, 2023. Patrick Delaney, the hospital’s Chief Operating Officer, will succeed Cava as the hospital’s Chief Administrative Officer. During his tenure, he oversaw renovations that modernized nearly every part of the hospital campus, including a three-year cardiology renovation and expansion project, which included renovations to the hospital’s Cardiac Catheterization Lab, 60-bed Cardiology Pavilion and newly renovated space for Cardiac Diagnostic Testing Services; a new Same Day Surgery Center; a new Rehabilitation Services Department and renovations to the Maternity Pavilion, Radiology Department and Behavioral Health Unit. 

Funding/Economic Development

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CSIT Board Approves the Maternal and Infant Health Seed Grant Program

Trenton-based BioNJ Members New Jersey Commission on Science, Innovation and Technology (CSIT) and the New Jersey Economic Development Authority (NJEDA) announced plans to enter into an agreement that will lead to the establishment of a $750,000 Maternal and Infant Health Research and Development (R&D) Seed Grant Program. Through the program, CSIT will award 10 grants of $75,000 each to help New Jersey-based early stage innovation-based companies accelerate the development of technologies, products, and services that support pregnant women from pre-natal, through birth and post-partum, and into infancy. With the Maternal and Infant Health R&D Seed Grant Program, CSIT will advance the innovation economy through the development of critically necessary research, products and services designed to enhance maternal and infant health.

Events

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BIO 2022 in San Diego

June 13-16, 2022

BIO is thrilled to be back in person for the 2022 International Convention happening in San Diego, CA June 13-16, 2022. The Convention theme ‘LIMITLESS’ is BIO's commitment to unlocking possibilities for attendees while paving the path to the future of our industry. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships. BIO brings together a wide spectrum of life sciences and application, including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy. Reach out to RBRomberg@BioNJ.org if you are interested in being part of the New Jersey Pavilion at BIO.

New Jersey Research Cores Partnering Conference

June 29, 2022

The New Jersey Research Cores Partnering Conference will showcase cutting-edge resources and facilities available to innovators at universities and companies across the Garden State. Hosted at Rutgers University, the conference will include sessions on successful collaborations between companies and universities, posters and presentations from Princeton, NJIT, Rowan, Rutgers, Montclair and Hackensack Meridian Health. Attendees who do not have a Rutgers parking permit are required to register your vehicle here.

ON Helix

July 7, 2022

This one-day conference will address the main bio innovation trends, from the developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Don’t miss this opportunity to reconnect with the One Nucleus network and keep up to date with the latest trends in BIO Innovation for Health. BioNJ Members receive a 10% discount to attend the conference.

BioNJ Member Services Provider Directory


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BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:




Please contact BioNJ with any questions.

BioNJ@BioNJ.org  | 609-890-3185 | www.BioNJ.org

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