PR Newswire | January 09, 2024
DotLab, a medical diagnostics company, announced top-tier pharmaceutical research clients for its DotEndo platform. The customers include global companies with interests in diagnosing or monitoring endometriosis on a Research Use Only basis in clinical trial subjects to support the development of new medicines.
"We're proud to share the news of our global pharmaceutical partners, which are complementary to our planned, large clinical offering for commercial endometriosis tests based on our technologies," said DotLab's founder, Heather Bowerman. "Our pharma partners conducted rigorous diligence of our science and intellectual property prior to the execution of our contracts, and they view our platform as the first of its kind and the leader in this space."
The DotEndo™ platform's AI/ML technology was developed via DotLab's EMPOWER clinical trial, a prospective, observational, multi-center study run at endometriosis centers of excellence across the United States. EMPOWER is the most robust clinical study of its type ever performed for diagnosing and monitoring endometriosis, making it an excellent foundation for the platform. Based on these successes, DotLab announced Morgan Stanley as a new investor in late 2023.
"We intend to continue to offer our pharma clients – and, ultimately, clinicians – a comprehensive endometriosis menu of tests and tools. Endometriosis is notorious for its complex biology, and there has long been a need for tests and tools to diagnose and monitor endometriosis – and ultimately, to improve endpoints for the disease in therapeutic trials," said Bowerman.
Dot Laboratories, Inc. ("DotLab") is solving some of the world's most significant diagnostic challenges via the latest advancements in multiomics and computational biology. The company delivers clinical innovations to areas of significant unmet need via novel, cutting-edge biomarkers and the power of machine learning to deliver non-invasive tests. The company has driven a paradigm shift in the identification and management of endometriosis. DotLab is female-founded and female-led.
PR Newswire | January 05, 2024
Cognizant and Fortrea, a leading global provider of clinical development and patient access solutions to the life sciences industry, today announced that Cognizant has been selected as Fortrea's strategic technology transformation provider.
By partnering with Cognizant, Fortrea aims to continue advancing its mission and delivering solutions to its pharmaceutical, biotechnology and medical device customers – and to the patients those customers serve – within the confines of a sound and secure digital infrastructure.
Over the four-year agreement, Cognizant is expected to transform Fortrea's global technology environment. Cognizant's approach to the project is expected to bring the speed and agility necessary for the deployment of the next generation hybrid cloud and platforms required for a new era of digital innovation for Fortrea. The state-of-the-art technologies and services are designed to empower Fortrea to transform into a "born digital" organization, enabling a seamless digital experience with agility and efficiency across many different touchpoints.
In June 2023, Fortrea successfully completed its spin-off from its former parent company in a move designed to enhance its agility; capitalize on growth opportunities in phase I-IV clinical trials and patient access; and extend its leading positions in oncology, clinical pharmacology and partnership models. In 2024, Cognizant will play a fundamental role in the exit from Fortrea's Transition Service Agreements with its former parent company, facilitating a smooth switch and the establishment of the global Fortrea infrastructure, application management, and end-user services.
Cognizant's strategic services are expected to elevate Fortrea's data and analytical capabilities with the goal of setting new standards in the CRO industry and driving modernization required to support Fortrea's global operations. Fortrea also expects to benefit from Cognizant's robust life sciences and healthcare technology experience to help address the evolving needs of its customers, including some of the industry's leading enterprises.
"Today's announcement reflects Fortrea's renewed organizational agility following our spin-off," said Alejandro Martinez Galindo, Chief Information Officer of Fortrea. "We are selectively investing in clinical applications and platforms that give us and our customers an advantage in the race to bring life-changing treatments to patients faster. As we build the infrastructure that's essential to supporting these platforms and quickly delivering the insights our customers rely on, we have the opportunity to be 'born digital.' Our new modern ecosystem will be designed to speed decision making with innovation in clinical development. Cognizant's deep expertise will help make our vision a reality."
"Cognizant is proud to partner with Fortrea as they leverage technology to build a world-class culture of excellence that benefits customers, patients, employees and shareholders," said Cognizant EVP, Software and Platform Engineering, Prasad Sankaran. "With our deep domain expertise in clinical trial platforms, medical administration automation and secure collaboration, we can help Fortrea fortify its position as an independent, best-in-class digital, global Contract Research Organization."
"We're looking forward to bringing Cognizant expertise from across our service portfolio to support Fortrea's goal of providing a seamless digital experience for their customers. And we expect our work together will help Fortrea achieve a step-change from the legacy systems common across the industry, to a fully digital ecosystem leveraging the latest technology, which should result in better customer experiences and greater efficiency," said Cognizant EVP & President of the Americas, Surya Gummadi.
Cognizant engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life.
Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea's solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.
PR Newswire | January 08, 2024
Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today their exclusive multi-national agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases, to commercialize Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in select European markets and additional markets around the world.
Libtayo was invented in laboratories at Regeneron, which acquired exclusive worldwide development, commercialization, and manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work together with all stakeholders and regulatory authorities to facilitate a seamless transition of commercialization activities to Medison during the first half of 2024.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is currently approved by regulatory authorities in more than two dozen countries, including by the European Medicines Agency (EMA). In select markets, it is approved as monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), as monotherapy treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC), as both monotherapy or in combination with chemotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) and/or as monotherapy treatment for certain patients with recurrent or metastatic cervical cancer. Libtayo is a leading and first-in-class PD-1 inhibitor approved for the treatment of two non-melanoma skin cancers and is considered standard of care in these indications.
"Our multi-regional commercial platform is a great fit for Regeneron's go-to-market plan and another great opportunity for Medison to facilitate access to highly innovative therapies for people suffering from rare and severe diseases," said Meir Jakobsohn, Founder and Executive Chairman of Medison. "Regeneron's selection of Medison is yet another testimony of the unique value that our multi-regional solution can generate for innovative biotech companies wishing to focus on selected markets."
"We are proud to partner with Regeneron," said Gil Gurfinkel, CEO of Medison. "Our one-of-a-kind centralized, unified commercial platform, with single alliance management across multiple markets and regions, is of great value to more and more leading biotech companies. Our platform enables biotech companies to transform numerous complex and fragmented markets and regions into a unified territory."
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced BCC, advanced CSCC and advanced NSCLC, as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron. Outside of the U.S., the generic name for Libtayo is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.