PHARMA TECH
PR Newswire | January 23, 2024
CGI, one of the largest business and IT consulting companies in the world, today announced a partnership with Körber aimed at enabling pharmaceutical and life sciences companies to improve their production processes by combining CGI's end-to-end services with Körber's Werum PAS-X Manufacturing Execution System (MES) Suite. The global partnership is designed to help clients increase efficiency, accuracy, and safety in pharma products and enhance decision-making through access to real-time data.
"CGI works side-by-side with clients to transform data into actionable insights to drive smart, sustainable and resilient operations," said Tim Hurlebaus President, U.S. Commercial & State Government operations and global executive sponsor for CGI's health and life sciences business. "This includes combining the benefits of MES and Industry 5.0 to gather rich insights to enable operational excellence. Our partnership with Körber complements our offerings portfolio, enabling us to deliver innovative new services and solutions to support the needs of our pharma and life sciences clients."
Körber's platform serves as a digital, real-time process controller to shorten time-to-market, lower production costs and enable a more patient-centric approach, improving outcomes and leading to improved health. Compliant with Good Manufacturing Practices, PAS-X MES presents a comprehensive view of data from diverse integrated systems, enabling faster and more informed decisions, which can be a critical advantage in an industry where timing and accuracy are paramount.
"Our PAS-X Products and Service Suites facilitate seamless digital transformation projects at our customers globally. By combining forces with CGI's global presence, expertise and complementary service portfolio in pharma and life sciences, we can offer a unique and compelling value proposition. CGI is one of the key partners to continue to expand our offering to our global customers" says Jan-Henrik Dieckert, COO Software, Körber Business Area Pharma.
Embedding robust IT and operational technology (OT) security, CGI's business consulting and MES services expertise enables faster, more seamless, and operationally integrated implementation of the platform, including transformation through technical integration, data migration, and organizational change management and adoption.
"In our global client insights research, pharma and life sciences executives said optimizing operations is their top business priority. CGI serves as a trusted advisor to help them achieve this priority through ROI-led digitization investments," said Maiken Lykke, Senior Vice-President, CGI Denmark. "We work collaboratively with clients to build solutions that tailor the right mix of services and technologies for their needs. We are pleased to partner with Körber to address the unique client challenges in this industry."
CGI delivers clinical and IT solutions for 11 of the top 20 global biotech and pharmaceutical companies, including helping these organizations optimize their processes; launch new therapies for cancer and rare diseases; and drive digital transformation across their research & development, manufacturing and commercial functions globally.
About CGI
Founded in 1976, CGI is among the largest independent IT and business consulting services firms in the world. With 91,500 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2023 reported revenue is C$14.30 billion.
About Körber
We are Körber – an international technology group with more than 12,000 employees at over 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, and Technologies, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.
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PHARMA TECH
PR Newswire | January 08, 2024
Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has added three new endocrinology therapies to its specialist portfolio, following an exclusive distribution agreement with Danish company Ascendis Pharma A/S.
Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide).
The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
Two of the products included in this agreement are already internationally approved:
Once-weekly SKYTROFA is a human growth hormone (hGH) approved in the United States for the treatment of paediatric patients aged >1 years weighing >11.5 kg with growth failure due to inadequate secretion of endogenous growth hormone (GH)1 and in the European Union for growth failure in children and adolescents aged from 3 to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]).
YORVIPATH is a first-in-class parathyroid hormone (PTH) replacement therapy to treat chronic hypoparathyroidism, a rare and potentially serious condition where the body produces no or abnormally low levels of PTH. It is approved in the European Union for the treatment of adults with chronic hypoparathyroidism.
The third product – TransCon CNP – is in development by Ascendis Pharma for the treatment of achondroplasia (ACH), the most common genetic form of skeletal dysplasia and resulting disproportionate short stature, following successful Phase 2 trial results.
Australian endocrinologist Dr Veronica Preda noted that YORVIPATH would be the first specialist therapeutic option for Australian patients living with hypoparathyroidism.
"Hypoparathyroidism can seriously impact quality of life and has potentially life-threatening consequences," Dr Preda said.
"To have an option that is able to treat the underlying cause of the disease, moving beyond standard oral calcium and active Vitamin D, is a great step forward."
Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine.
Mr Montagner commented: "We are delighted to have been selected as Ascendis Pharma's exclusive partner for commercialising their portfolio in Oceania and these South-East Asia countries and look forward to launching these critical endocrinology products in our regions as soon as possible.
"All three products are valuable inclusions to our broad therapeutic pipeline and our international business, as we continue to leverage our substantial experience commercialising specialist medicines across multiple regions.
"We look forward to working with endocrinologists across our territories to make these endocrine therapies available to all eligible patients who may benefit."
Ascendis Pharma Executive Vice President and Chief Commercial Officer Camilla Harder Hartvig said ST had been selected to launch the endocrinology portfolio in these countries based on its strong track record commercialising specialist products in multiple regions.
"We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said.
About Specialised Therapeutics
Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA).
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PHARMA TECH
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.
About Cognizant
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.
About Fortrea
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.
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