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.
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BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 03, 2023
ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems, and MEPHARMA, a strategic regulatory consulting services company, have partnered to provide a range of regulatory intelligence, compliance, and validation and automation solutions for companies in the United Arab Emirates (UAE) and the Middle East and North Africa (MENA).
MEPHARMA provides high-quality regulatory consulting services in addition to a host of other specialized services, including pharmacovigilance, GxP, due diligence and auditing for pharmaceutical, biotechnology and contract research organizations (CRO).
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world's leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.
Combining their extensive experience, MEPHARMA and ValGenesis are poised to expand next-generation digital validation and compliance solutions into countries in the MENA region.
"We are excited to partner with MEPHARMA and empower companies in this region with cutting-edge digital transformation tools that advance them on their Pharma 4.0 journey," says Bo Olsen, ValGenesis' SVP of Partners. "Together we provide well-defined, robust validation lifecycle management strategies and solutions that enable companies adhere to the most stringent global regulatory requirements."
"We are thrilled to collaborate with ValGenesis, the enterprise Validation Lifecycle Management Systems leader, to bring comprehensive regulatory intelligence, compliance, and validation solutions to local manufacturing companies in the UAE and MENA region," says Dr. Ayman Mahmoud, Managing Director at MEPHARMA. "Our partnership with ValGenesis will empower regional life sciences companies to streamline their validation processes and achieve maximum compliance with the highest GMP regional and global standards. Together, we are committed to delivering exceptional value to our clients and supporting their digital transformation journey towards Pharma 4.0."
ABOUT VALGENESIS
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
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BUSINESS INSIGHTS, PHARMACY MARKET
Prnewswire | April 05, 2023
PathAI, a global leader in AI-powered pathology, announced the launch of PathExplore™, the world's first structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. Powered by artificial intelligence, PathExplore1 spatially characterizes the TME with single-cell resolution, giving oncology drug developers the ability to unlock insights to inform the next phase of targeted oncology drug development.
The last decade has seen significant strides in oncology therapeutic development, but challenges remain – many cancer patients do not respond to available treatment, and many aren't eligible for potentially transformative therapies because of a lack of actionable insight into their disease. Researchers are looking to the tumor microenvironment, one of the most promising areas of oncology research, for answers and insights that will impact patient outcomes.
"PathExplore will enable researchers to identify novel spatial signatures predictive of outcomes," said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. "We're hopeful that by giving oncology drug developers access to this level of detail and data from routine H&E samples, this next generation of pathology will drive advances in cancer therapy development."
Current technologies to measure and analyze the TME force researchers to make tradeoffs between resolution and scalability. Now with PathExplore, drug developers will have the ability to analyze the TME with deep resolution using a scalable platform that can be deployed on massive numbers of patient samples. PathExplore produces a panel of more than 600 quantitative HIFs: standardized and reproducible measures of counts, densities, areas and spatial relationships across cell types and tissue regions. PathExplore also generates overlay visualizations of cell types and tissue regions, delivered on PathAI's AISight™ Translational Research platform.
PathExplore has been trained using over 6.5 million pathologist annotations on 66,000 slides. It is currently available for breast cancer, colorectal cancer, gastric cancer, melanoma, non-small cell lung cancer, pancreatic cancer, prostate cancer, and renal cell carcinoma, with more indications planned to launch later this year, including ovarian and bladder cancers. The standardized, structured quantification of the TME across disease areas will enable reproducible, comparable, and scalable analysis across drug programs.
"PathExplore will shift the research paradigm, bypassing long standing constraints we experience with some of the existing multi-omics modalities and allowing for more open exploration and discovery of relationships that were not identifiable by human analysis alone," said Mike Montalto, PhD, chief scientific officer at PathAI. "The degree of granularity, speed, efficiency and scale delivers unmatched insights that will change the way we view the tumor microenvironment."
PathAI's HIFs have been used in over 15 scientific abstracts, presentations, and publications. To learn more about PathExplore, visit www.PathExplore.com or visit us at booth 315 at the American Association for Cancer Research (AACR) April 14th-19th in Orlando, FL.
About PathAI
PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve diagnostic efficiency and accuracy, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases.
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