Collaboration Aims to Revolutionize Vaccine Development

The physIQ Sensor System is a medical-grade biosensor that will be used as part of a new study examining vaccination responses.

physIQ, a pioneer in digital medicine, and CellCarta, a global contract research organization (CRO) specializing in precision medicine services, announced a partnership on a study to monitor individual differences in physiologic changes associated with immune system activation in patients receiving vaccinations. This includes mRNA vaccines for COVID-19. Dubbed “The VIII (Vaccine-Induced Inflammation Investigation): The ‘Eight’ Study and its Immunologic Response Sub-study,” patients have finished being enrolled and their physiology data will be monitored 24/7 with blood samples and medical-grade biosensors that capture data remotely. This groundbreaking method will utilize CellCarta’s unique capabilities to comprehensively measure both humoral and cellular immune responses and physIQ’s proprietary AI, FDA-cleared platform to identify even the most subtle changes in each individual’s unique physiology.

The precision approach enabled through this collaboration provides a new insight into safety and effectiveness not offered by the traditional method of collecting large population responses. The companies anticipate the VIII study will provide the most rigorous, detailed evaluation of vaccine-induced reactogenicity and immunogenicity to date.

“Our goal is to provide tools that help accelerate the therapeutic development of personalized vaccine regimens by looking at the full immune response. This is important because we know there are unique differences in how people react to all vaccines,” stated Steven Steinhubl, MD, physIQ Chief Medical Officer and principal investigator for the study. “This near real-time capture of patient data potentially allows us to rapidly correlate physiological changes to immune responses and minimize possible adverse reactions early.”

Using medical-grade biosensors, the researchers will measure vaccine-induced immune activation and subsequent inflammation to gather three metrics: 1) changes in physiologic variables such as ECG or skin temperature from that individual’s established baseline; 2) modifications in individual routine behaviors, including multiple aspects of activity and sleep derived from accelerometers and vital signs; and 3) the interactions between these variables and how they deviate from that individual’s expected results after vaccination.

“We are excited to generate new potential insights into what makes a successful vaccination at the individual level,” stated Dr. Scott Sugden, Immunologist and Principal Investigator of the study at CellCarta.

U.S. Purchases More Abbott COVID-19 Tests

The U.S. Army has signed a $1 billion contract with Abbott, requiring the company to supply an unknown number of its BinaxNOW and ID NOW tests, due by the end of June. The government is also purchasing 178.6 million over-the-counter tests from Abbott to make good on the Biden administration’s goal of delivering one billion free at-home tests following the rise of the coronavirus omicron variant. This is part of the administration’s plans to establish hundreds of nationwide “test to treat” centers outlined during Biden’s “State of the Union.” These centers would offer free COVID screenings and, if a person tests positive, provide immediate treatments in a single location.

EVERSANA Announces New Global Price Solution

The life sciences commercial solutions company has revealed NAVLIN by EVERSANA, a new, comprehensive ecosystem of price and access solutions to help established and emerging pharmaceutical companies navigate global market access complexities. The integrated platform combines best-in-class price and access data with software and experts.

“For more than 30 years, the industry was forced to navigate siloed, disparate price and insight platforms with little to no efficiency. It was a problem desperately in need of next-generation thinking,” Jim Lang, CEO of EVERSANA, said in a statement. “Our clients now have the insights, data, and software they need to navigate product performance from pre-launch through loss of exclusivity in over 100 global markets. It’s the perfect complement to EVERSANA’s fully integrated commercialization services.”

NAVLIN helps users set global pricing strategies and then apply those strategies to proprietary reference pricing, launch sequencing, and predictive pricing models to evaluate the impact of their pricing decisions. Additionally, NAVLIN provides in-depth market research insights into market access all the way through patient access, as well as custom insights leveraging an unmatched panel of industry experts in the medical, pharmaceutical, contracting, and hospital systems and pharmacy industries.

MacKenzie Scott Donates to Military-Focused Mental Health Org

Headstrong Project Inc., a national mental health practice providing military connected individuals and their family members with barrier-free mental health treatment, received a generous gift of $10 million from author and philanthropist MacKenzie Scott. The organization will use the donation to accelerate their novel model of mental healthcare for all those connected to the military.

Jim McDonough, Headstrong’s Chief Executive Officer, explained in a statement that “a portion of the donation will be leveraged immediately to prioritize accelerating clinical growth and to push forward our fiscal year 2023 growth plans. This, alongside our 2022 expansion plans into Florida, Massachusetts, and the Pacific Northwest, will allow Headstrong to provide the lifesaving mental healthcare our military community needs right now.”

The non-profit addresses the alarming rate of veteran suicide and is poised to save lives as the current events in Afghanistan and the Ukraine impact even more of the military community.

Ukraine Crisis Distracting from COVID-19 Threats

Russia’s invasion of Ukraine could further impact supply chain issues that are disrupting the administration of COVID vaccines.

Roughly 30% of the European Union’s population is still unvaccinated against SARS-CoV2, and the current fears surrounding Russia’s invasion of the Ukraine could be further complicating the administration of shots into susceptible populations. Supply chain disruptions due in part to the impacts of the ongoing pandemic could be further disrupted with the ongoing war. Novavax, a U.S.-based pharmaceutical company, hoped to counter fears surrounding “novel” mRNA technology with their protein-based COVID vaccine Nuvaxovid.

However, projections for Nuvaxovid administration have fallen short of expectations, with analysts at Jeffries noting that “only around 100,000 doses have been administered so far” out of the 47 million delivered doses. Novavax is hopeful that its educational campaign deliveries in Europe followed by their potential FDA authorization within the U.S. will improve dose administrations.

Jazz Pharma Ups Cannabis Productions in UK

Jazz is constructing a new, state-of-the-art facility in Kent Science Park to support manufacturing for cannabis-based medicines.

Jazz Pharmaceuticals and its subsidiary GW Pharmaceuticals are investing $100 million on a new manufacturing facility in the UK, which will support manufacturing of two approved cannabis-based medicines, Epidiolex and their multiple sclerosis candidate, known as Sativex outside of the U.S. The Kent Science Park location already houses 400 employees and is producing extract, but its manufacturing facilities are expected to be ready in 2024. The new construction is promised to be green-friendly, with animal refuge boxes installed for wildlife, reduction of single use plastics, and solar panels to provide a portion of the buildings’ energy.

“This facility will not only significantly increase our ability to support the growing demand for our medicines, but help us maintain our position as a world leader in cannabinoid science,”  Chris Tovey, EVP, Chief Operating Officer and Managing Director for Europe and International at Jazz, said in a statement.

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