SAS | June 22, 2022
Bringing life-changing therapies to market requires pharmaceutical companies to efficiently design and run clinical trials, gather and analyze massive amounts of data, and manage a complicated regulatory review process. SAS, a leader in clinical research analytics, delivers powerful technologies to support the life sciences industry – including machine learning, AI and analytics for IoT – through the SAS® Life Science Analytics Framework on Azure.
The advanced analytics platform – a single, open, cloud-native statistical computing environment for clinical trial analysis and submission – helps pharmaceutical companies navigate the heavily regulated world of clinical research analytics and bring new therapies to the world faster.
Delivering the power of analytics in the cloud
From drug discovery to regulatory approval, developing a new medicine can take over a decade with a price tag in the billions. The clinical research required to achieve approval from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities involves massive amounts of data that can be difficult to manage, share and analyze, creating delays that affect patients' well-being.
The cloud-based SAS Life Science Analytics Framework on Azure features an integrated and collaborative environment to manage and analyze clinical trial information as well as deliver trial results for the FDA and other global regulatory agencies' review. With the analytic solution, life sciences organizations can extract valuable insights from clinical data, mitigate risk, increase efficiency, and speed time to market for lifesaving pharmaceuticals.
"The primary goal is to get drugs approved so that they can reach patients. The faster you can do that, the greater benefit for the patient and to help save lives."
Bhawna Goel, CEO of Gunvatta
Gunvatta USA, Inc, a contract research organization (CRO) headquartered in Washington, DC, helps clients collect, manage, analyze and visualize the terabytes of clinical and healthcare data produced by pharmaceutical and biotechnology companies, hospitals, and provider groups.
With the SAS Life Science Analytics Framework, Gunvatta has modernized the way it approaches clinical trials. The CRO helps life sciences organizations reduce risk with secure data access, ensure data and results are validated, maintain an audit trail, and report their data to health authorities like the FDA.
"The biggest advantage of the SAS Life Science Analytics Framework is that the analytics platform is cloud-based," said Goel. "I feel like SAS has jumped 15 to 20 steps ahead of where the market is."
For more about Gunvatta's experience, see the customer story Helping pharmaceutical companies bring new therapies to the world faster using analytics for life sciences.
Developing cutting-edge clinical research tools
SAS life science experts will attend the DIA Global Annual Meeting this week in Chicago to share next generation approaches for driving excellence and innovation in clinical trial operations.
At DIA, SAS will preview SAS Clinical Enrollment Simulation Cloud – a cloud-native, solution based in SAS® Viya® 4 – that enables life sciences and contract research organizations to simulate the outcome of the complex clinical trial enrollment process in a virtual world, resulting in faster, more strategic clinical trial enrollment plans.
The new SaaS offering – available later this year on the Microsoft Azure Marketplace – uses a powerful discrete event simulation analytical engine to model the clinical trial enrollment process as it evolves over time, facilitating improved insights to guide enrollment strategy and meet contracted patient targets.
"SAS Clinical Enrollment Simulation Cloud is highly differentiated from traditional methodologies for predicting trial enrollment," said Jim Box, Life Sciences Principal Data Scientist at SAS. "The technology helps life sciences organizations reduce timelines, minimize costs, and gain greater insight to inform clinical enrollment planning and rescue."
Modernizing clinical trials for the future
While the current clinical development research model can be an obstacle to the creation of safe, cost-effective therapies, the COVID-19 pandemic and other events set the stage for disruption in clinical trials.
"The silver lining of the pandemic for the life sciences industry is the acceleration of digital transformation and modernization of clinical research," said Simon Tilley, Health and Life Sciences Product Director at SAS. "We experienced widespread adoption of innovative approaches, such as decentralized clinical trials for the development of new vaccines."
"While the business benefits of modernizing clinical research include significant cost savings, efficiency improvements, accelerated time to regulatory approval and faster time to market, it is patients who stand to gain the most from clinical trial innovation."
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BD | July 19, 2022
BD announced it has completed the acquisition of Parata Systems.
Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years.
"Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations."
Tom Polen, chairman, chief executive officer and president of BD
The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Hyfe, Inc. | July 20, 2022
Hyfe, Inc., the global leader in AI-powered cough detection, tracking and classification, has entered into an agreement with Merck, known as MSD outside the United States and Canada, to integrate its artificial intelligence-powered (AI) cough tracker technology into Merck’s consumer disease educational efforts..
Hyfe’s AI-powered technology passively and remotely monitors the number of times a person coughs and the sound of the cough through any smart device, such as a mobile phone. This data collected over time provides the user with helpful information by revealing patterns and potential triggers like seasonal allergies that may be causing the cough that would otherwise go unnoticed or unaddressed.
“The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day. In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.”
Peter Small, M.D., chief medical officer of Hyfe, Inc
Users of the app will be able to determine when and how long to track their coughing. The AI-powered technology records cough-related sounds and allows the user to compare the frequency and quality of their coughs against their own benchmark. This personalized approach provides users with more detailed information and confidential data about their individual situations to share with their health care providers.
Hyfe, Inc. is the global leader in AI-powered cough detection and classification that provides insight into cough patterns and correlations that can greatly improve treatment and prevention. With more than 280 million samples, Hyfe maintains the largest cough dataset in the world enabling the building of powerful models to track, manage and diagnose respiratory illnesses. Hyfe provides platforms and data for pharmaceutical companies, medical researchers, government agencies, health care providers and patients and has partnerships with leading academic institutions including Johns Hopkins University and the University of California at San Francisco. The company was founded in 2020 and is headquartered in Wilmington, Delaware.
Enable Injections, Inc. | August 12, 2022
Enable Injections, Inc. a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce the appointment of John DeFord, Ph.D. to the company's Board of Directors, effective July 29, 2022.
Enable Injections' enFuse is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, dedicated to improving the patient experience.
Dr. DeFord brings over three decades of expertise as a global medical technology executive, most recently the executive vice president and chief technology officer for Becton, Dickinson and Company (BD) (BDX), a global medical technology company. Prior to BD, Dr. DeFord served in senior science, technology and leadership roles of increasing responsibility at organizations such as C.R. Bard and Cook Incorporated, with additional experience in venture capital as managing director of Early Stage Partners venture capital fund. He is currently also a member of the board of directors at Nordson Corporation (NDSN), NuVasive (NUVA), and Blue Spark, Inc. DeFord graduated from Purdue University with a bachelor's degree and master's degree in electrical engineering, and a Ph.D. in electrical/biomedical engineering, dedicating his career to innovative medical technologies to save lives, enhance quality of life and improve the patient experience.
"Enable Injections is at the forefront of both simplifying the therapeutic delivery of critical medications and enhancing quality of life for the patient. I am excited to join the Board of Directors at this important time in the company's growth and development; and I look forward to working with the management team and Board to help accelerate translation of this important technology to the clinical setting."
"We are pleased to welcome Dr. DeFord as a new director to Enable's Board," said Mike Hooven, President and CEO of Enable Injections. "We believe adding depth of experience in the global medical technology space such as Dr. DeFord's is key to the strong growth of our business."
About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.