Clinical Development Lunch & Learn

If Drug Prices are Growing Below the Rate of Inflation, Why are Patients Still Feeling the Sting at the Pharmacy?

Between January 2021 and January 2022, prices for prescription drugs only increased marginally and well below the rate of general inflation. According to the Bureau of Labor Statistics, prescription drug prices rose just 1.3% over the last year. This reflects trends we’ve seen in recent years when it comes to prices for medicines. While lawmakers talk about the impact of inflation on American families, the facts show the price of medicines is not part of the problem. But that doesn’t mean patients aren’t hurting at the pharmacy. According to a recent survey, more than 30% of Americans who have insurance still face a financial barrier to care, including trouble paying medical bills or other out-of-pocket costs. That is due to an insurance system that shifts more and more costs onto vulnerable patients.

New Ipsos Poll Shows Americans are Frustrated With Abusive Insurance Practices that Exacerbate Access and Affordability Challenges

Americans overwhelmingly say they are frustrated with health insurance coverage that is difficult to navigate and unaffordable. According to a new Ipsos/PhRMA poll, nearly 9 out of 10 Americans (86%) agree that Congress should focus on cracking down on abusive health insurance practices that make it harder for people to get the care they need. The sentiment is shared widely among both Democrats (92%) and Republicans (84%). Voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system. According to the the Ipsos/PhRMA poll, Americans would like to see Congress focus more on reducing the overall costs of health care coverage such as premiums, deductible, and copays (71%) over reducing the costs of prescription drugs (29%). 

BioNJ Announces Lineup for BioPartnering Conference

BioNJ's Twelfth Annual BioPartnering Conference, developed in concert with J.P. Morgan and Johnson & Johnson Innovation, will take place May 9-13, 2022. The week-long Conference will kick off with an in-person Networking Reception at The Liberty House in Jersey City on the evening of Monday, May 9, 2022, followed by 1:1 partnering and 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 will be available the entire week. Click here for agenda.

Vyant Bio Issues Letter to Shareholders

Cherry Hill-based BioNJ Member Vyant Bio released a Letter to Shareholders from Chief Executive Officer, Jay Roberts. As we enter 2022, we are beginning to see the benefits of our 2021 strategic actions to transform Vyant Bio into a pure-play drug discovery and development biotechnology company. Based on this transformation, I believe we are now well-positioned to pursue the discovery and development of repurposed and novel therapeutics to treat neurological developmental and degenerative diseases such as for Rett Syndrome, CDKL5 Deficiency Disorders, and Parkinson’s Disease. We are incorporating the use of quantitative biomarkers that we believe are unique to our Rett and CDD programs that should provide meaningful human-biology-derived, preclinical signals of potential drug efficacy before the commencement of clinical trials.

Helsinn Group and BridgeBio Pharma Announce Update to Strategic Collaboration to Develop, Manufacture and Commercialize Infigratinib in Oncology Indications in the U.S.

Iselin-based BioNJ Member Helsinn Group and BridgeBio Pharma announced an update to their existing strategic collaboration to develop, manufacture and commercialize infigratinib for oncology indications. Under the terms of the amended and restated agreement, Helsinn will gain an exclusive license to commercialize infigratinib in the U.S. and will be responsible for developing, manufacturing and commercializing infigratinib in oncology indications worldwide except for achondroplasia or any other skeletal dysplasias and except in mainland China, Hong Kong and Macau. BridgeBio will be eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn. 

Celsion Receives $1.4 Million from Sale of its New Jersey State Net Operating Losses

Lawrenceville-based BioNJ Member Celsion Corporation announced it has received $1.4 million in net cash proceeds from the sale of approximately $1.5 million of its unused New Jersey net operating losses (NOLs). The NOL sales cover the tax year 2020 and are administered through the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) program. This non-dilutive funding adds to the over $55 million in gross proceeds from equity offerings completed in 2021, further strengthening the Company’s balance sheet. The company plans to sell an additional $3.5 million of unused New Jersey NOLs available to the Company under the program over the next 3 years.

Nevakar Closes on $12M in Convertible Notes

BioNJ Member Nevakar announced it closed on $12 million in convertible notes with both existing and new investors. Additionally, the Bridgewater-based company and Oxford Finance LLC agreed to an extension of the interest-only period on its existing debt. “The convertible note, combined with the extension of the interest-only period by Oxford, are important components of our financing strategy and will allow for the continued development of our various programs. We anticipate our first commercial launch, additional FDA approvals and filings, as well as the data readout for the Phase III clinical study for NVK002, Vyluma’s first-in-class pharmaceutical treatment for slowing the progression of myopia in children.” Navneet Puri, Founder, Chairman and CEO of Nevakar, said.

Morningside Ventures Launches Adiso Therapeutics to Advance Novel Therapies for Inflammatory Diseases

Morningside Ventures announced the launch of Adiso Therapeutics, a clinical-stage biotechnology company advancing a pipeline of novel therapeutics targeting inflammatory diseases with an office in Hopewell, NJ. BioNJ Member Adiso is advancing an innovative pipeline of small molecules with novel mechanisms of action and single strain live biotherapeutic products (SS-LBP), pursuing lead indications in ulcerative colitis (UC), and C. difficile infection (CDI). In addition to two Phase 1 programs (UC & CDI) and a Phase 2 program (UC), Adiso is developing a novel inflammasome program in discovery phase which is being initially explored in respiratory inflammation, with multiple future potential therapeutic areas to pursue. 

Pfizer Initiates Phase 2/3 Study of Novel COVID-19 Oral Treatment in Pediatric Participants

BioNJ Member Pfizer, with offices in Peapack, announced that it has initiated a Phase 2/3 study, EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients), to evaluate the safety, pharmacokinetics, and efficacy of Pfizer’s PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease. The Phase 2/3 trial is an open-label, multi-center, single-arm study in approximately 140 pediatric participants under 18 years of age. Initial enrollment features two cohorts; Cohort 1 includes participants aged 6 to 17 weighing at least 40 kg [88 lbs], and Cohort 2 includes those aged 6 to 17 weighing more than 20 kg [44 lbs] and less than 40 kg [88 lbs].

Pfizer Completes Acquisition of Arena Pharmaceuticals

BioNJ Member Pfizer, with offices in Peapack, announced the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Arena Pharmaceuticals brings to Pfizer a portfolio of diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including ulcerative colitis, Crohn’s Disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata.

Phase 3 CLOVER Trial for Pfizer’s Investigational Clostridioides Difficile Vaccine Indicates Strong Potential Effect in Reducing Duration and Severity of Disease Based on Secondary Endpoints

BioNJ Member Pfizer, with offices in Peapack, announced results from the CLOVER trial (CLOstridium difficile Vaccine Efficacy TRial), a pivotal Phase 3 study evaluating its Clostridioides difficile (C. difficile) vaccine candidate (PF-06425090) in the prevention of C. difficile infection (CDI). Initial analyses of two protocol defined secondary endpoints indicated a highly favorable benefit in reducing CDI severity and 100% vaccine efficacy in preventing medically attended CDI, although the trial did not meet its pre-specified primary endpoint of prevention of primary CDI. Safety reviews indicated that the investigational vaccine was safe and well tolerated.

Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women

BioNJ Member Pfizer, with offices in Peapack, announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women. The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants. 

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. The filing was based on results from the pivotal CheckMate -816 study, the first positive Phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. In the trial, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) and event-free survival (EFS) versus chemotherapy alone when given before surgery.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) With Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients With Resectable Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Opdivo plus chemotherapy is approved regardless of PD-L1 status. The approval is based on the CheckMate -816 trial, the first positive Phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS) and pathologic complete response (pCR), which were evaluated using independent blinded review, and an additional efficacy outcome measure was overall survival (OS). 

Nirsevimab Significantly Protected Infants Against RSV Disease in Phase 3 Trial

Bridgewater-based BioNJ Member Sanofi announced The New England Journal of Medicine (NEJM) published detailed results from a Phase 3 trial evaluating nirsevimab, the first investigational long-acting antibody designed to protect all infants across the respiratory syncytial virus (RSV) season with a single dose. The trial involved healthy infants born at term or late preterm (35 weeks gestational age or greater) entering their first RSV season and met the primary endpoint, reducing the incidence of medically attended lower respiratory tract infections (LRTI), such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6 to 87.1; P<0.001) compared to placebo.

Sanofi Recognized by S&P as One of the Most Sustainability-Committed Companies

Bridgewater-based BioNJ Member Sanofi was recognized as one of the most sustainability-committed companies in an ESG Evaluation performed by Standard & Poor’s Global Ratings. The ESG Evaluation awarded Sanofi a score of 86 out of 100 points, one of the highest scores across all sectors globally. Sanofi’s ESG profile was awarded 80 points for its solid fundamentals, completed with an additional strong preparedness opinion of 6 points awarded for its ‘excellent awareness of risks and opportunities’ and its capacity to ‘anticipate and adapt to a variety of long-term plausible disruptions’. Sanofi's Social Profile was ranked as ‘leading’ in the category of communities highlighting the recent 2021 creation of its global health unit which aims to provide 30 of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries.

Efanesoctocog Alfa Met Primary and Key Secondary Endpoints in Pivotal Study in Hemophilia A, Demonstrating Superiority to Prior Factor Prophylaxis Treatment

Bridgewater-based BioNJ Member Sanofi and Swedish Orphan Biovitrum AB (publ) announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ≥12 years of age with severe hemophilia A. The study met the primary endpoint, showing a clinically meaningful prevention of bleeds in people with severe hemophilia A receiving weekly prophylaxis with efanesoctocog alfa over a period of 52 weeks. The median annualized bleeding rate (ABR) was 0 with a mean ABR of 0.71. The key secondary endpoint was also met, demonstrating once weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison.

Evotec Expands Molecular Patient Database With Unique Nephrotic Syndrome Cohort from the University of Bristol

Princeton-based BioNJ Member Evotec announced that the company has entered into a collaboration with the University of Bristol (“UoB”) to expand the company’s molecular patient database in the field of kidney diseases with a focus on nephrotic syndrome. The nephrotic syndrome is a group of symptoms like proteinuria and oedema that indicate kidneys are not working properly. Diagnosis remains challenging and current treatment regimens are mostly symptomatic. Under the collaboration, Evotec receives access to longitudinal samples from an international cohort which includes several hundreds of patients from Asia, India and Africa linked to anonymized clinical records. 

Evotec Presents Strategic Roadmap Towards Precision Medicine and Confirms Goals of Action Plan 2025 at Capital Markets Day

Princeton-based BioNJ Member Evotec presented at its virtual Capital Markets Day how artificial intelligence and machine learning enabled precision technologies in discovery and development processes are driving up Probability of Success, i.e. an increasing rate of approvals in the long-run. To leverage the power of molecular data, Evotec is launching E.MPD, the company's molecular patient database. E.MPD is one of the largest and highest quality molecular databases globally. Evotec's integrated technology platforms show that the best way to effectively treat disease is to identify underlying disease mechanisms and find the most suitable therapy on the basis of molecular data guiding all experimental processes towards early disease relevance.

U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. 

Janssen Seeks Approval of a New Indication for IMBRUVICA® (ibrutinib) for Use in Patients With Untreated Mantle Cell Lymphoma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA® (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT). Ibrutinib is a once-daily Bruton's tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior line of therapy. MCL is a rare and aggressive type of blood cancer involving the B-lymphocytes, a type of white blood cell. It is currently incurable, with many patients relapsing and requiring multiple lines of subsequent therapy.

Johnson & Johnson Announces Landmark Agreement to Enable its COVID-19 Vaccine to be Manufactured and Made Available by an African Company for People Living in Africa

New Brunswick-based BioNJ Member Johnson & Johnson announced the completion of a landmark agreement between Janssen Pharmaceuticals, Inc., and manufacturer Aspen SA Operations (Pty) Ltd, based in South Africa, to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent. Expanding global vaccination coverage is critically important to controlling the COVID-19 pandemic and reducing the risk of emergence of new SARS-CoV-2 variants. Currently, only about 12 percent of people in Africa are fully vaccinated, which is well below the World Health Organization’s target of 70 percent population coverage for all countries.

Jardiance® Provided a Significant Clinical Benefit in Adults Stabilized in Hospital Following Acute Heart Failure in Empulse Phase III Trial

Bridgewater-based BioNJ Member Eli Lilly and Company and North Brunswick-based BioNJ Member Boehringer Ingelheim announced adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance® (empagliflozin) following stabilization and prior to discharge compared with placebo in the phase III EMPULSE trial. Heart failure is a leading cause of hospitalizations, accounting for more than 1 million per year in the U.S. Outcomes for those who have been admitted to the hospital for heart failure are poor, with over 30% of patients readmitted within 90 days between 2010 and 2017, according to the National Readmission Database.

European Medicines Agency (EMA) Accepts Marketing Authorization Application for Daprodustat

Warren-based BioNJ Member GlaxoSmithKline announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anemia of chronic kidney disease (CKD). Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The MAA includes positive data from the ASCEND Phase III clinical trial program, which included five pivotal studies assessing the efficacy and safety of daprodustat for the treatment of anemia across the course of CKD. 

Novartis Peer-Reviewed Safety and Tolerability Data Further Strengthens Kesimpta’s (Ofatumumab) Favorable Benefit-Risk Profile in Patients With Relapsing Multiple Sclerosis

East Hanover-based BioNJ Member Novartis announced that new data from the ALITHIOS open-label extension study was published in the peer-reviewed Multiple Sclerosis Journal. The data showed that with up to 3.5 years of treatment with Kesimpta® (ofatumumab), no incidences of opportunistic infections were reported, and observed COVID-19 infections showed no evidence of an increase in incidence or severe outcomes in adults with relapsing forms of multiple sclerosis (RMS). Mean immunoglobulin G (IgG) levels remained stable and immunoglobulin M (IgM) levels remained above the lower limit of normal in most patients. The overall incidence of serious infections was low and no new safety risks were identified. 

Novartis, Voyager Therapeutics Reach License Option Agreement for Next-Generation Gene Therapy Vectors for Neurological Diseases

East Hanover-based BioNJ Member Novartis announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets. A leader in gene therapy with a strong commitment to developing treatments for diseases of the central nervous system, Novartis seeks to apply its expertise and recent learnings to neurological diseases that manifest in deep brain regions where commonly used vectors have not been shown to effectively target and penetrate.

AbbVie Announces Positive Phase 3 Atogepant (QULIPTA™) Data for the Preventive Treatment of Chronic Migraine

Madison-based BioNJ Member AbbVie announced that the Phase 3 PROGRESS trial evaluating atogepant (QULIPTA™ in the United States), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventive treatment of chronic migraine in adults, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily (QD) and 30 mg twice daily (BID) doses, across the 12-week treatment period. The study also demonstrated that treatment with atogepant 60 mg QD and 30 mg BID resulted in statistically significant improvements in all secondary endpoints after adjustment for multiple comparisons.

AbbVie Provides Update Regarding SKYRIZI® (risankizumab-rzaa) for the Treatment of Moderate to Severe Crohn's Disease in the U.S.

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) has extended its review period for SKYRIZI® (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in patients 16 years and older. The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication. Currently approved indications for SKYRIZI are not affected by this extension. SKYRIZI was approved in the U.S. in 2019 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 

AbbVie Acquires Syndesi Therapeutics, Strengthening Neuroscience Portfolio

Madison-based BioNJ Member AbbVie announced it has completed the acquisition of Syndesi Therapeutics SA, which will help to expand AbbVie's neuroscience portfolio. This acquisition gives AbbVie access to Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder. The lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency.

TeleVet and Boehringer Ingelheim Announce Strategic Collaboration

North Brunswick-based BioNJ Member Boehringer Ingelheim and TeleVet announced a strategic collaboration to deliver innovative technology and services that will make it easier for veterinary practices to provide the best patient care while alleviating stress on their teams. As part of the collaboration, Boehringer Ingelheim has made a minority investment in TeleVet and Randolph Legg, President and Head of the Commercial Business for Boehringer Ingelheim Animal Health USA, Inc. will join TeleVet’s Board of Directors. Veterinarians and their teams are under more pressure than ever before. This collaboration will leverage TeleVet’s leading technology to increase efficiency in practice management and enable veterinarians to seamlessly engage with patients and pet owners alike.

ArrePath Announces $20 Million Seed Financing to Advance its Machine Learning-based Platform for Discovery of Novel Anti-infectives Addressing Antimicrobial Resistance

Princeton-based ArrePath announced that it has raised $20 million in seed financing to advance its proprietary, machine learning (ML)-based platform for the discovery of new classes of anti-infectives to overcome antimicrobial resistance (AMR). The Boehringer Ingelheim Venture Fund, Insight Partners and Innospark Ventures co-led the financing, which also included Viva BioInnovator, Arimed Capital, PTX Capital and Nor’easter Ventures. ArrePath also announced that Dr. Lloyd Payne has been named President and CEO. Dr. Payne, who serves on the Novo REPAIR Impact Fund Scientific Selection Board and the AMR Action Fund Scientific Advisory Board, brings more than 25 years of scientific and business leadership in the discovery and development of anti-infectives.

Coviello Promoted to Chief Economic Transformation Officer; Maples to Join as Chief Strategy Officer

Kathleen Coviello, a longtime leader at the New Jersey Economic Development Authority, is being promoted to Chief Economic Transformation Officer, and University Hospital executive Mary Maples is joining the EDA in the newly created role of Chief Strategy Officer. Ms. Coviello will transition into her new role immediately. EDA CEO Tim Sullivan said he was thrilled to be able to make the announcement. Ms. Coviello, who was elevated to the EDA’s Executive Committee last year, has been with the EDA since 2005, serving in a variety of roles. BioNJ congratulates Ms. Coviello, who serves as a BioNJ Board Advisor, on her recent promotion and looks forward to watching Ms. Coviello continue to make a difference on behalf of New Jersey.

Genmab Announces Appointments of Birgitte Stephensen to Chief Legal Officer and Chris Cozic to Chief People Officer

Princeton-based BioNJ Member Genmab announced that Birgitte Stephensen has been appointed to Chief Legal Officer and Chris Cozic has been appointed to Chief People Officer within the Genmab Executive Management Team and promoted to Executive Vice Presidents. Birgitte Stephensen joined Genmab in 2002 and previously served as Genmab’s Senior Vice President, Intellectual Property Rights and Legal. Chris Cozic joined Genmab in 2017 and most recently served as Senior Vice President Global Human Resources. Both have served on the Executive Management Team with Genmab’s President and Chief Executive Officer, Dr. Jan van de Winkel; Chief Development Officer, Dr. Judith Klimovsky; Chief Financial Officer, Anthony Pagano; Chief Medical Officer, Dr. Tahi Ahmadi; and Chief Operating Officer, Anthony Mancini.

Organon Names Rivera its U.S. Managing Director

Jersey City-based BioNJ Member Organon has named a U.S. Managing Director. In her new role, Meghan Rivera will lead Organon’s 400-employee U.S. commercial operations team, maximizing growth potential across the company’s portfolio of women’s health, biosimilars and established brands. Ms. Rivera brings more than 20 years of experience in the biopharmaceutical and digital therapeutics industries. Most recently, she was Chief Marketing Officer and Head of Commercial for Akili Interactive, and she has worked at AMAG Pharmaceuticals and Boehringer Ingelheim, among other roles.

Tevogen Bio™ Appoints Prominent Industry Leader Susan Podlogar to the Company’s Corporate Advisory Board

Metuchen-based BioNJ Member Tevogen Bio announced that its Board of Directors has appointed Susan Podlogar to its Corporate Advisory Board. Ms. Podlogar is currently MetLife's Chief Human Resources Officer, an Executive Vice President and member of MetLife’s Executive Leadership Team. The Corporate Advisory Board provides guidance to Tevogen leadership as the company continues to expand its next generation precision T cell platform, overcoming the barriers of existing T cell-based immunotherapies and allowing one of nature’s most powerful weapons against diseases to be harnessed to its full potential for clinical applications.

Infectious Disease Expert, Former CDC Director Gerberding to Retire from Merck

Dr. Julie Gerberding, Kenilworth-based BioNJ Member Merck’s Chief Patient Officer and Executive Vice President, Population Health and Sustainability, will be retiring in May. Dr. Gerberding will become CEO of the Foundation for the National Institutes of Health. An American infectious disease expert, Dr. Gerberding was the first woman to serve as the Director of the U.S. Centers for Disease Control and Prevention. Dr. Steven Paul, Chairman of the FNIH board of directors, said Dr. Gerberding’s accomplishments and mix of biomedical and health sciences acumen, strategic outlook and executive management ability make her the ideal person to lead the foundation.

Bayer Strengthens Government and Industry Affairs Group in Key U.S. Market With 2 Appointments

Whippany-based Bayer said it named Michael Parrish as Vice President of Public Affairs, Science and Sustainability, U.S., and Duane Simpson as Vice President of North America Crop Science Public Affairs, Science and Sustainability. Mr. Parrish will be responsible for driving a unified organization and strategy, including oversight of the company’s U.S. government relations, policy and corporate engagement teams. Mr. Simpson and his team will be responsible for engaging with key federal and state agencies, as well as industry and trade associations, that help govern the technologies that farmers use and support the growth of the U.S. and Canadian agriculture sectors.

Game-Changing Innovation Evergreen Fund to Launch This Spring

The New Jersey Innovation Evergreen Fund, a program in which the State becomes an equity investor in start-ups that has been a favorite of Gov. Phil Murphy’s since it was first proposed in 2018, will be formally launched. State officials promise it will be worth the wait. Final details are expected to be approved by the board of the New Jersey Economic Development Authority in the spring. And this much is certain: This will not be the typical tax incentive program. Under this fund, the State will invest $500 million into start-ups — and not just any start-ups, these will be companies that have been vetted by venture capital groups, helping to ensure more companies start here, grow here and stay here, the theory goes.

32 Early Stage Companies Set to Reap the Benefits of Selling Over $58 Million Through 2021 NJ Net Operating Loss Program

The New Jersey Innovation Evergreen The New Jersey Economic Development Authority (NJEDA) announced that 32 early stage companies have been approved to share a combined $58.1 million in funding through New Jersey’s 2021 Net Operating Loss (NOL) Program. The NOL Program, jointly administered by the NJEDA and the New Jersey Department of Treasury’s Division of Taxation, enables qualified companies to sell up to $20 million in benefits generated from their unused New Jersey net operating losses and research and development (R&D) tax credits for cash to unaffiliated, profit-generating corporate taxpayers in the state of New Jersey. The cash can then be used for working capital or to fund research.

New Jersey Ranks in Top 10 States for VC Dollars Invested

The New Jersey Economic Development Authority (NJEDA) announced that New Jersey now ranks ninth in the nation based on venture capital (VC) dollars invested per state. According to PitchBook, innovation-focused companies in New Jersey secured $5.5 billion in 219 venture capital deals in 2021, up from $1.7 billion thorough 154 deals in 2020. This represents a significant improvement for New Jersey relative to 2017, when the State saw a total of $818 million in 143 venture capital deals. In this latest ranking, New Jersey jumped three spots from where it stood at #12 in 2020, and seven spots from #16 in 2013. 

BIRD HLS Call for Proposals

The U.S. Israel Binational R&D (BIRD) Homeland Security (HLS) 2022 Call for Proposals was recently published. The deadline for executive summaries is April 25. The BIRD HLS program is a joint initiative funded by the U.S. Department of Homeland Security (DHS) and the Israel Ministry of Public Security to develop advanced technologies for the homeland security mission. Each approved project will receive a grant of up to 50% of the combined project budget, maximum $1 million. Refer to www.birdf.com for submission details.

The Michael J. Fox Foundation Funding Opportunities

The Michael J. Fox Foundation is accepting pre-proposals for three open RFA programs. All accept applications from academia and industry researchers. We want to support the most promising research toward better brain health for all. Our three open programs are as follows: Translational Pipeline, Biomarkers to Support Therapeutic Trials and Novel PET Tracer Development. The deadline for pre-proposals is April 26, 2022. More information can be found at www.michaeljfox.org/funding.

Career Accelerator Internship Grant Program

The New Jersey Office of the Secretary of Higher Education (OSHE) Career Accelerator Internship Grant Program will provide funding to New Jersey employers who are interested in hosting undergraduate interns from New Jersey’s institutions of higher education (IHEs). The purpose of the grant program is to foster innovative ways to connect New Jersey college students with companies located in NJ. Any New Jersey-based for-profit company, non-profit organization, not-for-profit organization and small business within the STEM industry and other NJ key industry sectors, are eligible to apply for this funding to underwrite undergraduate intern salaries.

NJ STEM Month March 2022 Kicks Off

For the fourth year in a row, March is recognized as NJ STEM Month. NJ STEM Month is a celebration co-hosted by the New Jersey STEM Pathways Network (“NJSPN”) and its parent organization the Research & Development Council of New Jersey (R&D Council of NJ). Keeping with tradition, Gov. Phil Murphy issued a gubernatorial proclamation in support of NJ STEM Month. The month highlights the Garden State’s many accomplishments in science, technology, engineering, math (“STEM”) and innovation. The goal of NJ STEM Month 2022 is to impact 35,000 learners.

Priestley Named Dean of Princeton’s Graduate School

Rodney Priestley, the highly regarded Vice Dean of Innovation at Princeton University, has been selected for an even bigger role at the school: Dean of the Graduate School. Dr. Priestley, the Pomeroy and Betty Perry Smith Professor of Chemical and Biological Engineering, will begin in the role June 1. In this role, Dr.Priestley not only will oversee the nearly 3,000 students enrolled in the Graduate School pursuing master’s and doctoral degrees in 42 department and programs, but he will be tasked with leading the Graduate School through a period of growth, new investment and an invigoration of its mission.

Rowan Launching Fund that will Assist Entrepreneurs from Underserved Communities

It’s one thing to conceive an idea for a business while you’re in college. It’s another to have money to fund it — especially if you are from an underserved community. Rowan University’s new School of Innovation & Entrepreneurship, which opened in January, aims to change that. The school will begin accepting applications next week for the Start-up Opportunity Fund, an initiative that will give grants of up to $2,500 for entrepreneurs from underserved communities. Eric Liguori, who heads the SIE within the Rohrer College of Business, said the fund was established in partnership with the Rowan Innovation Venture Fund to do good deeds. 

A Look at Mark Manigan, New President and Soon-to-Be CEO of RWJBarnabas Health

When longtime leader Barry Ostrowsky told the board of RWJBarnabas Health that he intended to retire, the board hired an internationally known executive search firm to identify and interview potential candidates across the country. In the end, it determined the person it was looking for already was in the building. Mark Manigan, 50, who joined RWJBarnabas Health as Executive Vice President, Business Development, and was promoted to Chief Strategy and Development Officer, was the choice to replace Mr. Ostrowsky. Mr. Manigan will assume the role of President, effective immediately, then add the title of CEO on Jan. 1, 2023, after working through the transition with Mr. Ostrowsky.

Doll Named Chief Operating Officer at RWJBH

John Doll has been appointed to the newly created position of Senior Executive Vice President and Chief Operating Officer for RWJBarnabas Health. Mr. Doll will lead the day-to-day operations of RWJBH, and report to Manigan. Marc Berson, chair of the RWJBarnabas Health board of trustees, said the board has selected a proven leader who has successfully guided RWJBH’s financial operations through mergers, consolidations and challenges, such as its response to the pandemic. Mr. Doll, who currently serves as Chief Financial and Administrative Officer, has held a number of key leadership positions since joining RWJBH in July 2010.

Biden Nominates University Hospital CEO to Serve in Administration

Dr. Shereef Elnahal has served as President and CEO of University Hospital in Newark since 2019. Now, he’s up for a big promotion. President Joe Biden announced his intent to nominate 12 individuals to serve as key leaders in his administration, including Dr. Elnahal as his pick for under Secretary for Health, Veterans Health Administration at the U.S. Department of Veterans Affairs. Gov. Phil Murphy said, “Everyone who has worked with Shereef, myself included, knows that President Biden has made the right choice. When I asked Shereef to join my administration as our first Commissioner of Health in 2018, it was because of his record in improving transparency and care for our nation’s veterans as Assistant Deputy Under Secretary for Health.”

Morristown Named Top Hospital in N.J. — and One of 250 Best in World by Newsweek

Morristown Medical Center was named the top hospital in New Jersey by Newsweek for the fourth consecutive year. Morristown, part of Atlantic Health System, was rated No. 46 in the country — one of two New Jersey hospitals to make the Top 100. Hackensack University Medical Center, part of Hackensack Meridian Health, was ranked No. 57 overall. The rankings were part of Newsweek’s massive World’s Best Hospitals list, which ranked the leading hospitals in 27 countries. The media company ranked 420 hospitals in the U.S. (among the more than 6,000). Seven N.J. hospitals earned that distinction:

No. 46: Morristown (Atlantic Health)

No. 57: Hackensack (Hackensack Meridian Health)

No. 111: Valley Hospital

No. 168: Overlook Medical Center (Atlantic Health)

No. 235: Newark Beth Israel Medical Center (RWJBarnabas Health)

No. 333: Englewood Hospital and Medical Center

No. 414: Monmouth Medical Center (RWJBarnabas Health)

NYC Tiger Entrepreneurs Conference

April 7-8, 2022

Princeton Entrepreneurship Council (PEC) is excited to invite you to join fellow alumni, students and faculty at the 2nd NYC Tiger Entrepreneurs Conference. The conference will kick off with a virtual Start-up Showcase featuring several exceptional alumni and faculty founders, to be held on Thursday evening, April 7. The following day, Friday, April 8, the conference will be an in-person event in midtown Manhattan featuring panel discussions, fireside chats, workshops and a closing reception. The 2022 NYC Tiger Entrepreneurs Conference will celebrate both Princeton entrepreneurship and Princeton's contribution to the vibrant NYC start-up scene.  

2022 AIChE Mid-Atlantic Student Conference

April 8-9, 2022

The 2022 AIChE Mid-Atlantic Student Conference will be held in-person on April 8-9. Hosted by AIChE and NJIT's Otto H. York Department of Chemical and Materials Engineering, this Career Fair is a rare opportunity for companies from the greater NJ & NYC greater area to connect with some of the brightest and most motivated undergraduates from the AIChE’s Mid-Atlantic region schools.

I-Corps Northeast Hub: New Training Program

April and May 2022

Researchers in the Northeast: Explore ways that your discovery can meet the needs of people and industries. Teams are eligible for grants of up to $3,000. The Hub emphasizes inclusive innovation and our programs are open to researchers at universities, colleges and research institutions throughout the Northeast. Our next training program for researchers will be held Tuesday, April 12, and Thursdays April 14, April 21 and May 5, from 1-4 p.m. ET online. Learn more and apply for the program at icorpsnortheasthub.org.

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.

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:



• Accounting Services
• Biobanking/Bioprocessing
• Clinical Research Centers
• Communications / Marketing / PR / IR
• Contract Manufacturing / Supply Chain & Logistics Management
• Contract Research Organizations & Consulting Services
• Digital Health & Life Sciences IT/Data Science Technologies
• Financial / Investment / Funding Sources and Services
• HR / Talent Acquisition / Professional Development
• Insurance Services
• IT/Data Management and Software Platform Technologies/Cybersecurity
• Laboratory Services
• Legal Services
• Other Services
• Publications
• Real Estate / Engineering and Construction / Property Development
• Supplies - Laboratory / Environmental / Research Instrumentation & Other