ClinChoice, a leading global Contract Research Organization (CRO), announced expanding its global footprint with the acquisition of CSI Medical Research (CSI). CSI is a regional clinical CRO with professional staff and partners located across Southeast Asia (SEA), Australia and New Zealand (ANZ), to provide innovative and cost-effective clinical solutions. Through this strategic acquisition, ClinChoice further broadens its global footprint and full-service capabilities in more than 30 countries throughout Asia, Europe and North America around the world.
In recent years, the overall environment and infrastructure to support clinical research in Southeast Asia have been significantly improved. With large population, improving economy, maturing regulatory processes and healthcare systems, the SEA has attracted increasing number of biotech and pharmaceutical companies to conduct clinical research and drug development trials in the region.
CSI, incorporated in 2017, has quickly grown into a prominent regional CRO with proven track record of executing clinical trials in Southeast Asia. The management team at CSI consists of seasoned clinical research professionals that had worked in some of the biggest names in the industry before establishing CSI. The Company has managed a wide range of clinical trials with their extensive knowledge of local practice, requirements and regulations.
ClinChoice, as a global CRO, is dedicated to providing full-service and functional solutions across the entire development lifecycle for pharmaceutical, biotechnology, medical device, and consumer product companies locally and globally. With over 4,000 professionals worldwide, ClinChoice has established deep regulatory know-how, clinical trial execution and data management capability across all major markets and regions around the world. With the history dating back to 1995, ClinChoice has completed over 1,500 full-service clinical studies across all clinical trial phases and covering all major therapeutic areas.
"This is an exciting time for ClinChoice, and we are thrilled to welcome the talented CSI team to the ClinChoice family." said Mr. Ling Zhen, Global Chairman and CEO of ClinChoice, "With their wide-range of highly valuable service offering and seasoned professional team, the acquisition of CSI will further expand our presence in SEA and ANZ, and enhance our capability to well fulfill our clients' need locally and globally."
"Joining with ClinChoice is the ideal next chapter in CSI growth story. We are excited to leverage on our familiarity with the SEA and ANZ regulations as well as the clinical sites within a region we called home, to assist more customers to navigate through the challenges with great speed and better cost efficiencies." said Mr. Nelson Wong, Founder and CEO of CSI Medical Research, "CSI's vision and mission in the approach to manage clinical trials are very much aligned with ClinChoice, and the company's high-quality, efficiency and teamwork culture will be fantastic for our talented employees and clients alike. We are very looking forward to what we can achieve together."
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Bhubaneshwar-based healthcare startup CureBay, focused on solving primary healthcare in remote locations through an innovative hybrid model, has successfully raised approx Rs 62 crore in a Series A1 funding round.
The round was led by Elevar Equity, their existing investor and saw participation from CureBay founders and some of the leadership team members. The newly raised funding will enable the health-tech innovator to continue creating access to high quality and affordable healthcare in medically underserved locations, build an intelligent and robust health data platform and hire the best tech and healthcare talent in the industry.
As part of its growth strategy, the company aims to focus on driving profitability and data monetisation by investing in recurring revenue streams such as its membership program and building its data practice - both in technology and on the go-to-market front.
The funding amount will further be used to hire over 200 professionals including data scientists, healthcare experts, specifically in diagnostics and pharmacy and to build their membership program that strongly drives their longitudinal data and affordability initiatives.
Underscoring its commitment to enhancing primary healthcare access in rural India, the fresh funding will also be instrumental in driving CureBay's ambitious expansion plans over the next 6-12 months, raising its count of clinics - from the existing 90+ - to over 200 across Odisha, Chhattisgarh and entering a new market - Jharkhand.
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BIOS Health announced it is partnering with the City of Bakersfield, Kern County, and Kern Venture Group (KVG) to establish a state-of-the-art precision medicine center in Bakersfield, California. BIOS Health is pioneering the technology to read and interpret neural signals in real-time with AI, giving crucial insights previously inaccessible to clinicians, and pharmaceutical and medical device companies.
A major challenge in the healthcare industry today is a lack of any clear data and usable insights around the nervous system’s response to novel medicines and medical devices. This leads to high failure rates in clinical trials, costing the industry billions a year, and prevents potentially life-saving treatments from reaching patients - both of which the center aims to address.
BIOS has developed adaptive dosing technology, using neural biomarkers and AI, to observe and adjust in real-time, the effects of drugs and stimulations on patients’ nervous systems. For example, during implantation of neural stimulation devices, clinicians and their patients can now access real-time measurements of the effectiveness of their treatment, optimizing the dosing in under 10 minutes compared to what normally takes 12 months or more of trial and error.
BIOS will establish its West Coast hub to serve as the premier center for neural clinical trials and R&D, and to accelerate its broader commercialization in the US market. By setting up a center dedicated to real-time neural research for clinical trials, BIOS aims not only to scale up operations and reach more patients faster, but to also create an ecosystem of clinicians, pharmaceutical and medical device companies, and clinical trial partners around this new capability in accessing and understanding neural data. It will also enable BIOS to partner with leaders in clinics, more rapidly commercialize its technology in the clinical environment, and better serve pharmaceutical, biotechnology, and healthcare partners in the United States.
BIOS chose Bakersfield for its proximity to large customers, access to talent, efficient operational costs, and its existing network of innovation and medical research. In particular, KVG, a partner and existing investor in BIOS, is attracting leading deep tech companies to the area to establish the industries of the future, and has extensive experience in accelerating their growth there. KVG, Kern County, and the City will also bring together their existing networks of local research organizations and large healthcare systems to facilitate the work of the center.
Emil Hewage, CEO of BIOS Health, said: “We are excited to be creating the infrastructure, alongside our regional, clinical and commercial partners, to deliver a new future for precision medicine development. This investment is in reaction to the massive and unmet demand for more effective and affordable clinical trials. Our adaptive dosing technology can offer a new type of clinical trial in which we observe and interpret the neural response of patients in real-time. Soon, treatment decisions that used to take months, or even prove to be impossible, will be available to clinicians and patients at their fingertips.”
David Higdon, Co-founder and Managing Partner of Kern Venture Group, said: “BIOS Health is leading us into a new era of precision neural insight, much like how reading DNA transformed medicine, and continues to do so. We see the potential to transform Bakersfield and the Central Valley with BIOS by establishing a critical mass of researchers, trials, and experts in the area. The potential really is unbounded for impact and for growth.”
Jenni Byers, Interim Director, City of Bakersfield’s Economic & Community Development Department: “BIOS’s work is unique and has the potential to transform modern medicine as we know it today. Bakersfield is a prime West Coast location with an abundant labor force, robust job training programs, and has the resources to support BIOS's growth. We are confident that our support of BIOS will be an important investment in Bakersfield’s and BIOS’s future.”
Jim Damian, Chief Economic Development Officer in Kern County, said: “Kern County is thrilled to partner with the City of Bakersfield and Kern Venture Group to welcome BIOS Health Ltd’s West Coast Hub to Kern County. This new business will not only generate quality jobs within our growing biotech and artificial intelligence sectors, but will support our region’s ambition of being the best place in California to start and grow a business.”
Lord David Prior, former Chair of NHS England and investor in BIOS, said: “There is a huge backlog in clinical trials in part because they do not have the insight needed into how their therapies are affecting patients’ nervous systems or the means to adjust the dosing to reduce side effects. BIOS Health’s technology is a game-changer that will be able to reduce that backlog and accelerate better therapies through to clinical trial success so more patients are able to benefit faster.”
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WuXi Biologics a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it will increase the total manufacturing capacity of its facility in Worcester, Massachusetts to 36,000 liters.
In response to global clients' increasing demand for contract manufacturing services, the Worcester facility, known as MFG11, will add 12,000 liters of commercial drug substance capacity, up from a planned 24,000 liters. Construction of the 189,500-square-foot facility is underway and recently achieved weather tight status. The facility anticipates being operational in 2025 with GMP release in 2026.
WuXi Biologics currently employs over 400 people in the U.S., and the Worcester facility will create an additional 200 new jobs when fully operational.
Dr. Chris Chen, CEO of WuXi Biologics, noted, "The new commercial capacity in Worcester, Massachusetts represents a key part of our global biomanufacturing network, reflecting our commitment to continuously strengthen our capabilities in line with anticipated market and client needs. We look forward to providing more efficient and cost-effective manufacturing processes and enabling our clients to bring new biologics to patients."
Last year, WuXi Biologics launched its first Boston Research Service Center, marking its fourth site in the U.S. after its clinical manufacturing facility in New Jersey and process development and characterization laboratories in Pennsylvania. Upon the Worcester facility construction work going at full speed and operational by 2025, the company is well set to provide full-spectrum integrated services in the U.S., encompassing biologics discovery and development as well as clinical and commercial manufacturing.
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Novartis announced that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States. The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world. The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come. We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach.”
The Indianapolis facility, centrally located within the US, is purpose-built from the ground up to manufacture RLTs now and into the future and includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry. The new site will supply the growing demand for patients in the US and eventually in Canada, upon approval, together with the company’s Millburn, New Jersey location. The site in Ivrea, Italy will continue to supply patients in and outside the US while the facility in Zaragoza, Spain will solely provide RLTs for patients outside the US.
Novartis recently announced that supply of Pluvicto is unconstrained. Having doubled weekly production, Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly.
Novartis is committed to improving access to its RLTs, Pluvicto and Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) by adding more treatment sites in closer proximity to patients over the coming months.
With four active manufacturing facilities, and a RLT production capacity of 250,000 doses in 2024 and beyond, Novartis continues to expand its worldwide RLT manufacturing network as ongoing clinical trials may present the potential to bring Pluvicto and Lutathera to more patients in earlier lines of treatment.
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