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Ginkgo Bioworks Advances Collaboration with Novo Nordisk on Expression Systems for Pharmaceutical Products

Ginkgo Bioworks Advances

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced the completion of the pilot phase of their previously announced partnership with Novo Nordisk, a leading global healthcare company, to develop expression systems for pharmaceutical products. With the pilot phase completed and the first milestone achieved, the two companies will now move into the development phase to work towards making a more effective production process. Achievement of the first milestone included extensive modification and testing of a microbial expression system to understand the impact of the modifications on key performance parameters.

"Ginkgo's achievement of the first milestone has both excited and inspired us, giving us the confidence to move into the next phase of this ambitious project," said Brian Vandahl, Senior Vice President, Global Research Technologies at Novo Nordisk. "This progress is a strong indicator of the potential we have to engineer biological systems that will expand the chemical space of biological medicines."

"We're excited to continue our work with Novo Nordisk to help provide innovative treatment options for patients with diabetes, obesity, and other serious chronic diseases," said Jason Kelly, CEO and co-founder, Ginkgo Bioworks. "The next phase of this project will build on our existing microbial design, engineering, and phenotyping expertise while expanding Ginkgo's capabilities in genome-scale design and engineering. We believe this work will enable us to support even more pharmaceutical products, helping to achieve better outcomes for patients."

About Ginkgo Bioworks.

Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats.

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Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." 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Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. 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Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. 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Business Wire | October 05, 2023

OM1, a leading real-world data, AI, and technology company with a focus on chronic diseases, announced the launch of two new clinical datasets, Chronic Rhinosinusitis (CRS) and Asthma. Both datasets are derived from longitudinal follow-up of patients seen by specialists and focus on patient characteristics, symptoms, treatments, clinical outcomes and healthcare resource utilization. Rapidly growing, the CRS and Asthma datasets each follow approximately 500,000 patients in the U.S. The research-grade, real-world data available in the OM1 Respiratory & ENT Network is built with an exclusive partnership between OM1 and the American Academy of Otolaryngology and Head and Neck Surgery Foundation (AAO-HNSF). With access to thousands of clinicians and more than 25 million patient visits across all 50 states, the data is rich with the most representative network available, including patient reported outcomes, social determinants of health, and patient subtypes and classification data. Millions of Americans are impacted by respiratory diseases, and the number continues to rise as respiratory illnesses become more common and air quality declines. Taking a deeper look, it’s estimated that 25 million people in the United States are diagnosed with asthma and 5-12% of the global population is affected by CRS. Not only do the numbers continue to rise, it’s common for patients with respiratory diseases to have multiple illnesses. Studies show that up to 67% of people with CRS with nasal polyps, small noncancerous growths that increase the severity of the disease, also have asthma. "Having access to deep clinical information on clinical presentation, treatments, and outcomes opens a world of incredible opportunity to improve care at both the population and individual patient level,” said Dr. Richard Gliklich, CEO, OM1. Alongside AAO, OM1 and Dr. Gliklich will be participating and presenting at the AAO-HNSF Annual Meeting and OTO Experience in Nashville, October 1-4. About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world evidence and insights by developing large electronically connected networks of clinicians and health data in dermatology, rheumatology, gastroenterology, cardiology, metabolism, respiratory, mental health, neurology and other specialty areas. Leveraging its data automation platform, OM1 Aspen, extensive clinical networks and artificial intelligence (AI) platform, PhenOM™, OM1 offers industry-leading enriched healthcare datasets, retrospective and prospective studies, advanced analytics, and AI-driven guidelines adherence and decision-support around diagnosis, risk management, and treatment. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

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PR Newswire | October 03, 2023

Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announced that it has completed the acquisition of MedAlliance, a Switzerland-based developer of drug-eluting balloon technology. This acquisition adds a key growth driver to the company's coronary and peripheral vascular portfolios as we expect SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloons (DEB) will be the first Sirolimus DEB to market in key geographies. SELUTION SLR™ DEB technology is designed to balance both safety and efficacy with its use of MicroReservoirs made from biodegradable polymers intermixed with the anti-proliferative drug Sirolimus. The MicroReservoirs control the sustained release of the drug and is designed to provide the longest and most effective pharmacokinetic release profile of any device on the market. SELUTION SLR™ DEB has demonstrated early efficacy across studies in both the coronary and peripheral vasculature and is now being studied in 4 FDA IDE trials to gain US market access. "This acquisition is key in advancing Cordis' legacy of cardiovascular innovation," said Shar Matin, CEO of Cordis. "We are creating leverage by joining the MedAlliance team and their world-class innovation with the reach and breadth of Cordis' global infrastructure. This combination will add value to millions of patients and clinicians, revolutionizing vascular care." Ron Waksman, a cardiologist at the Washington Hospital Center and Primary Investigator of the SELUTION SLR™ DEB Coronary De Novo study added, "Cordis introduced the first coronary drug-eluting stent to the market over twenty years ago. SELUTION SLR™ DEB has a similar opportunity to improve the health of patients and revolutionize the way clinicians deliver vascular care." "The Cordis acquisition will accelerate access to this breakthrough technology for patients suffering from coronary and peripheral disease around the globe," said Jeffrey B. Jump, Founder, Chairman and CEO of MedAlliance. "The team set out to disrupt the coronary and peripheral markets and provide physicians with a new safe and effective technology. The arsenal of SELUTION SLR™ DEB clinical data is designed to change medical practice and improve patient outcomes." About Cordis Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and minimally invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world. Cordis is backed by private equity firms Hellman & Friedman and KKR. About MedAlliance MedAlliance is headquartered in Nyon, Switzerland. It specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products, initially for the treatment of coronary and peripheral artery disease. The SELUTION SLR™ DEB, is a novel sirolimus-eluting balloon platform technology.

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