Orbit Discovery | March 08, 2022
Orbit Discovery a ground-breaking peptide discovery company is pleased to announce the commencement of a partnership with WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry.
Orbit will combine its leading peptide discovery platform and experience with WuXi AppTec’s downstream capabilities. Specifically, Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid timeframe. Orbit will also utilise other capabilities within WuXi AppTec, in particular their expertise in cell line and assay development and biophysical analysis.
Incorporating these capabilities into the Orbit platform will enable functional assays to be developed against a wider range of targets, facilitating direct functional screens using novel bead-based technologies and microfluidics.
This is the first strategic technology link Orbit has penned since its formation in 2016. The partnership underlines the commitment of the new management team to deliver ground-breaking technology and broader capabilities to the Partners engaged in applying the Company’s technology for the discovery of peptide therapeutic leads.
“We aim to move Orbit to the forefront of peptide discovery, and relationships such as this help us leverage expertise that would take far longer to grow organically. We see the partnership with WuXi AppTec as being a key relationship and a great asset to our current Partners, and Partners of the future.” He added: “We see particular value in the development and manufacturing platform of WuXi AppTec, that will enable us to generate peptides at small or large scale that incorporate chemical modifications to facilitate peptide optimisations and the journey towards a therapeutic candidate.”
Dr Neil Butt, Chief Executive Officer of Orbit Discovery
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."
SAS is the leader in analytics. Through innovative software and services, SAS empowers and inspires customers around the world to transform data into intelligence. SAS gives you THE POWER TO KNOW®.
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Medidata | June 16, 2022
Medidata, a Dassault Systèmes company, announced its renewed, expanded partnership with Novotech, a leading contract research organisation to continue scaling clinical studies in various therapeutic areas from 2022.
Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S.
Since its partnership in 2018, Novotech has doubled its growth and has also acquired CRO companies in APAC and the U.S. as well as invested in advanced DCT and data companies to deliver a seamless CRO platform amidst the increasing demand for clinical trials services in the region. The partnership extends access to a suite of end-to-end solutions from Medidata Clinical Cloud, the industry's only unified platform dedicated to clinical research. It also underscores Medidata and Novotech's commitment to work collaboratively towards accelerating clinical trials and research efficiently, while improving clinical trial timelines and patient experiences.
The Medidata Clinical Cloud is the only unified technology platform dedicated to clinical research, with solutions that leverage centralized data to address the holistic research process from start to finish. With the physical limitations and fragmentation of healthcare ecosystems caused by the COVID-19 pandemic, the need for digital integration for accelerated clinical development is crucial, and a unified platform allows for streamlined management of studies, sites, users, and access from a single location.
"The pandemic has underscored the importance of redesigning how trials are run, with more stakeholders realising the vital role that technology plays in clinical development. Medidata is pleased to continue our strong partnership with Novotech and is dedicated to providing support in their acceleration of clinical studies. Working with leading technologies, we can deliver better patient experiences and accelerate drug development in the new normal in clinical research."
Edwin Ng, Senior Vice President, Asia Pacific, Medidata
Andries Claassen, Senior Director Biometrics, Novotech, added, "We are excited to continue our partnership with Medidata, with their sustained support in driving clinical research and business growth with customers. Novotech has always invested heavily in the latest technology to provide our clients with better data visibility for improved decision-making. Together, we will help sponsors deliver more efficient, effective, and scalable trials."
Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers.
About Dassault Systèmes
Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries.
3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.
Novotech is the leading Asia Pacific biotech specialist CRO with labs, phase I facilities, and drug development consulting services. Novotech has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally and serves biotechs globally leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. As of May 2022, Novotech has over 2,500 FTEs working across our offices in 12 geographies in Asia-Pacific and the United States.
TendoNova | March 24, 2022
TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510 clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 which is routinely used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry. The Ocelot System's form factor and price point make it an exciting alternative to existing tools.
Using technology licensed from Georgia Institute of Technology and Emory University School of Medicine, the Ocelot facilitates procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format. TendoNova was able to achieve this success through grants and investor backing of groups such as the Georgia Research Alliance and the NFL Players' Association.
"According to studies cited by the Centers for Disease Control and Prevention, more than 30 million people in the U.S. suffer from chronic tendon pain, and half of those have little or no relief from physical therapy or medication. The Ocelot is the company's first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool."
TendoNova CEO, Mark A Samuels
Dr. Mautner, who practices at Emory, commented that, "After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible."
The Ocelot System performs mechanical fragmentation or debridement of a targeted area. The use of fragmentation and debridement is part of a common treatment for encouraging the growth of healthy tendon to supplant painful pathologic tendon tissue. Chronic tendon pain disorders, or tendinopathies, include tennis elbow, plantar fasciitis, and jumper's knee. Tendinopathy is prevalent in athletes and anyone else who engages in repetitive tasks. If left untreated, can lead to months or years of pain and even career-ending injuries.
TendoNova plans to manufacture the Ocelot in Georgia and is presently working to validate the Ocelot disposable component production. The Ocelot is expected to be available to physicians in the second half of 2022.
Founded in 2017, TendoNova is a medical device company that is an emerging leader in microinvasive sports medicine procedures. The company's initial product is the Ocelot™ TSD 1000, a patented, FDA cleared medical device for fragmentation or debridement of soft tissue. TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes. Dedicated to helping people live healthier lives with less pain and fewer injuries, the company plans a series of instrumented microinvasive tools designed to help physicians better heal patients suffering from advanced tendon and other pathologies.