PHARMA TECH
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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PHARMACY MARKET
PR Newswire | September 21, 2023
Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs.
Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas.
The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area.
Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. 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."
Market-leading enhancements to the Digital Clinical Trials solution include
Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience.
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. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide."
About Biofourmis
Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.
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PHARMACY MARKET
Business Wire | October 17, 2023
BioMap announced a groundbreaking strategic collaboration with Sanofi to co-develop cutting-edge AI modules for biotherapeutic drug discovery leveraging BioMap’s AI platform.
“As the largest foundational model-based approach within life sciences, we are thrilled to collaborate with Sanofi and leverage the potential of BioMap’s cutting-edge AI engine to help solve complex problems associated with new protein therapies to drive drug discovery,” said BioMap’s Chief Technology Officer, Le Song. “We have built what is essentially a biological map of proteins using data sets from public and private sources to inform our foundational models. Utilizing automation and integrated workflows to enhance the collection of high-quality data, we can catalyze the process of new hit discovery and lead optimization.”
Traditional AI methods require vast amounts of labeled data to make accurate predictions. However, in life science, labeled data are often in short supply. BioMap’s foundational models are revolutionizing AI in biology by enabling one large model, trained on ubiquitous unlabeled data, to inform multiple downstream task models. This approach enables superior prediction from limited data in a range of therapeutic areas, including immunology, neurology, oncology, and rare diseases.
Leveraging BioMap’s custom-built foundational models and world-leading AI expertise, as well as Sanofi’s proprietary data, computational innovations in protein engineering, and deep biologics development experience, both parties aim to create advanced AI models and protein Large Language Models that will enable biologics design and multiparametric optimization.
"By combining Sanofi’s proprietary data sets, digital infrastructure, AI and data science capabilities, and drug development expertise with BioMap’s protein Large Language Models, high-performance computing, and deep understanding of AI, we can optimize the process of discovery and development of breakthrough biotherapeutics,” said Matt Truppo, Global Head of Research Platforms at Sanofi. “Our collaboration with BioMap further underscores Sanofi’s commitment to becoming the first pharma company powered by artificial intelligence at scale.”
Under the terms of the agreement, BioMap will receive an upfront cash payment and near-term payments for reaching module development milestones from Sanofi. BioMap will be eligible to receive payments of over $1 billion based on achievement of pre-clinical development, clinical development, regulatory, and commercial milestones.
About BioMap
Founded in 2020 by Robin Li and Wei Liu, BioMap is a disruptive life science AI company responsible for building xTrimo, the first and largest protein-centric large language model platform. Their technology allows scientists to model life more accurately, from proteins to a system level, and extract novel insights and predictions from limited data. Supported by an international, cross-functional team of over 300 experts, BioMap is solving critical, protein-related drug development problems and charting a course to radically improve patients’ lives.
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