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BUSINESS INSIGHTS

NAMSA Acquires Leading Clinical Research Organization Clinlogix to Enhance Therapeutic Expertise and Global Footprint

NAMSA | August 03, 2021

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021.

Clinlogix, founded in 1999, is well-recognized for providing comprehensive clinical research services for novel and emerging technologies to the medical device industry. Supporting more than 500 trials across 3,500 sites worldwide, Clinlogix provides an unparalleled breadth and depth of global expertise in the areas of Cardiovascular, Neurology, Nephrology, Urology, Oncology and Venous/Wound Care clinical research.

“Today is an exciting day as the Clinlogix Team joins NAMSA. We are thrilled to partner with an organization that is equally committed to client success, evidenced through Clinlogix’s consistent delivery of reliable clinical outcomes to global device Sponsors,” commented NAMSA President and CEO, Dr. Christophe Berthoux. “NAMSA’s 54-year history of providing successful development results, coupled with the clinical expertise and global reach of Clinlogix, now offers medtech innovators a clear choice when seeking safe, accelerated clinical development and commercialization of life-changing medical products,” Dr. Berthoux concluded.

As the pioneer of the medical device testing industry, NAMSA provides testing services to Sponsors in addition to quality, reimbursement, clinical research and regulatory solutions. The CRO’s end-to-end development services are proven to help Sponsors successfully address varying global regulatory requirements, including recently expanded criteria for medical device and In Vitro Diagnostic research and conduct.

“Clinlogix is extremely pleased to join NAMSA, an organization that shares the same patient-centric, client-focused philosophy as we do. For over 20 years, our focus has been on providing a global ‘innovation pathway’ for Clients developing novel and emerging technologies,” stated Clinlogix CEO, JeanMarie Markham. “Now together, with NAMSA, we are expanding and leveraging our respective services to truly provide end-to end development solutions to our Clients,” Markham concluded.

The acquisition of Clinlogix adds to NAMSA’s rapidly growing global footprint, now serving Sponsors throughout 17 locations in Asia-Pacific, Europe, Latin America and North America.

ABOUT NAMSA
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by its global expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes.

ABOUT CLINLOGIX
Clinlogix is a global Clinical Research Organization (CRO) working to improve human quality of life by supporting and accelerating novel and emerging technologies in the life science industry. Its full suite of clinical research services supports the regulatory and clinical development pathway of medical devices, biotechnologies and pharmaceuticals from bench to bedside. The company delivers this global expertise by way of its regional office locations in the U.S., Germany, Colombia and Japan.

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Simulations Plus Receives U.S. FDA Renewal for DILIsym Software Licenses

businesswire | April 19, 2023

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions. Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, commented, “The FDA’s renewal of these licenses endorses the value of DILIsym software in both predicting liver safety liabilities and defining the underlying mechanisms, which are critical to evaluating risk. The recent signing of the FDA Modernization Act 2.0 by President Biden, which encourages the FDA to limit animal use in drug development, should be a positive catalyst for greater utilization of DILIsym software in drug development. In my role as Chair of the SAB, I am very excited about the direction of the public-private partnership that is guiding further development of the DILIsym platform that will benefit many key stakeholders.” Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, added, “Given the effect of rising costs on providing vital healthcare, the use of novel simulation technologies to improve the efficiency of drug development is more critical than ever. An important first step is ensuring that regulatory agencies have the most advanced technology tools to fulfill their essential mission. We are delighted the FDA has opted to renew once again and will continue using DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.” DILIsym software results support crucial drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 13 years, DILIsym Services, a division of Simulations Plus, has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues. Companies interested in a free trial version of the DILIsym software can request it here. About Simulations Plus Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.

PHARMACY MARKET

Mednow Announces Partnership With Medcan Health Management Inc. to Deliver Collaborative, Interdisciplinary Healthcare

businesswire | May 18, 2023

Mednow Inc Canada’s on-demand virtual pharmacy has been named the preferred virtual pharmacy partner for Medcan Health Management Inc. and its valued clients. Mednow is focused on improving the delivery of pharmacy services in Canada through digitization to provide better patient access to pharmacists, doctors and other healthcare professionals. Mednow offers instant access to pharmacists in the Mednow app or on the phone and offers fast, free delivery of prescription medication. “At Medcan, we’re always striving to bring our valued clients the highest level of service and incredible level of care through integrated, comprehensive and convenient health and wellness services, including ensuring they have easy access to a premium pharmacy experience,” said Shaun Francis, CEO and Chair of Medcan. “By partnering with Mednow, our Medcan clients will not only have a new option to get their prescription medications, over the counter products or supplements, but also the added benefit of always-on access to knowledgeable pharmacists who can help ensure they’re taking medications correctly,” said Francis. “Mednow is proud to partner with Medcan, a pioneer in high quality healthcare in Canada and an ideal partner to work with to reduce care fragmentation and enhance collaboration between our two healthcare professions,” said Ali Reyhany, CEO and Co-Founder of Mednow. “Our proprietary technology provides seamless access to our pharmacy team, which deploys the latest health technologies and best practices in pharmacy to optimize patient care. Texting your pharmacist, automatic refill reminders and the availability of Pillsmart™ medication packs are just some of the ways Mednow can help Medcan’s mutual patients,” said Reyhany. About Mednow Mednow is a healthcare technology company offering virtual access with a high-standard of care. Designed with accessibility and quality of care in mind, Mednow provides virtual pharmacy and telemedicine services as well as doctor home visits through an interdisciplinary approach to healthcare that is focused on the patient experience. Mednow’s services include free at-home delivery of medications, doctor consultations, a user- friendly interface for easy upload, transfer, and refill of prescriptions, access to healthcare professionals through an intuitive chat experience and the specialized PillSmart™ system that packages prescriptions in easy-to-use daily dose packs, each labelled with the date and time of the next dose.

PHARMACY MARKET, PHARMA TECH

Merck & XtalPi Collaboration Optimizes Drug Formulations with AI-Powered Techniques

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." About XtalPi 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.