BUSINESS INSIGHTS, PHARMA TECH
ClinChoice | March 03, 2023
ClinChoice, a leading global clinical CRO, recently announced that it has acquired CROMSOURCE S.r.l., an ISO-certified full-service contract research organization. CROMSOURCE has its corporate headquarters in Verona, Italy, its US headquarters in Cary, NC, and subsidiaries in the US and seven countries throughout eastern and western Europe.
With a proven track record of providing excellent clinical research and staffing services to multinational pharmaceutical, biotechnology, and medical device clients, CROMSOURCE's acquisition will strengthen ClinChoice's global network and further enhance its full-service capabilities.
ClinChoice is known for its commitment to providing high-quality services and timely delivery, resulting in the successful completion of clinical trials and functions, including regulatory, biometrics, safety, medical, and clinical operations across various sectors such as drug, medical devices, vaccines, cosmetics, and consumer health using both project-based and FSP models.
The company offers services covering the development lifecycle for biotechnology, pharmaceutical, consumer products and medical device companies worldwide. With a broad clientele ranging from the largest multinationals to startup and emerging companies, ClinChoice has completed over 1,500 clinical studies in various therapeutic areas such as CNS, oncology, ophthalmology, rare disease, respiratory and metabolic.
CROMSOURCE's acquisition was advised by Fairmount Partners, while Crosstree Capital represented ClinChoice.
ClinChoice is a leading global clinical CRO that provides comprehensive services to biotechnology, pharmaceutical, medical device, and consumer products clients worldwide. With a successful 25-year track record, it is considered the standard for excellence in clinical operations, biostatistics, data management, CDISC, statistical programming, regulatory affairs, medical affairs, and pharmacovigilance. The company has established major delivery centers in Europe, the US, Canada, China, India, Japan, and the Philippines, employing over 3,000 people worldwide. ClinChoice has a strong and talented team and is expanding its clinical operations in seven countries across North America, Asia, and Europe.
PHARMACY MARKET, PHARMA TECH
prnewswire | April 18, 2023
Science and technology company Merck and XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, have jointly published a study that highlights the benefits of combining computational workflows with wet lab experiments to advance drug development.
Traditional methods like milling and micronization, used to address undesirable crystal morphologies, can be disruptive and costly. In contrast, molecular dynamics simulations offer valuable insights for better crystallization experiment designs.
The collaboration between Merck and XtalPi focused on the impact of different polymer additives on the crystal habit of metformin HCl, a diabetes medication. By combining Merck's experimental capabilities with XtalPi's morphology prediction platform, a comprehensive screening approach for crystal morphology engineering was developed. XtalPi's custom-made force fields successfully predicted the influence of polymer additives on metformin HCl's crystal habits. The addition of HPMC led to a transformation from a needle-like to a prismatic morphology, in agreement with experimental observations. The publication demonstrates the potential of merging computational methods and experimental expertise for drug formulation optimization.
Dr. Peiyu Zhang, XtalPi's Chief Scientific Officer, said, "By integrating XtalPi's molecular dynamics predictions with Merck's experimental validation, we have taken a step towards the rational engineering of desirable crystal habits. We hope to continue improving this 'dry + wet lab' method with leading industry experts like Merck, in the production of novel therapeutics worldwide."
Dr. Jan Gerit Brandenburg, Head of Digital Chemistry at Merck, added, "Our collaboration with XtalPi is transforming pharmaceutical development. By seamlessly incorporating computer simulations with our experimental formulation expertise in a 'digital-first' approach, we are boosting drug development processes and positively impacting patients' lives."
XtalPi is a quantum physics and AI-powered pharmaceutical technology platform that provides integrated drug discovery solutions for global pharmaceutical companies. XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. The company applies this three-pronged approach in its R&D platform to accelerate the drug discovery and development process and address unmet needs for patients worldwide.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | April 24, 2023
PCI Pharma Services a leading global contract development and manufacturing organization announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.
“As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.
“There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.”
To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.