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.

Spotlight

Today, many critical, life-saving medicines go through a complex global supply chain before ever reaching the patient. USP’s public standards play important roles throughout that supply chain. These range from standards that ensure the quality of raw materials used to make ingredients that go into drugs to healthcare quality practice standards that ensure that pharmacists, physicians and nurses are delivering high-quality care to patients.

Spotlight

Today, many critical, life-saving medicines go through a complex global supply chain before ever reaching the patient. USP’s public standards play important roles throughout that supply chain. These range from standards that ensure the quality of raw materials used to make ingredients that go into drugs to healthcare quality practice standards that ensure that pharmacists, physicians and nurses are delivering high-quality care to patients.

Related News

BUSINESS INSIGHTS

Xeris Pharmaceuticals Strengthens Its Patent Estate

XERIS PHARMACEUTICALS, INC. | August 20, 2021

Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has recently been granted three new patents relating to its formulation technology platforms. The U.S. Patent and Trademark Office granted U.S. Patent Nos. 10,987,399 and 11,020,403 to Xeris, and the China Intellectual Property Office granted Chinese Patent No. ZL201580042185.5 to Xeris. The US ‘399 patent covers storage-stable formulations of pramlintide, and the US ‘403 patent covers storage-stable formulations of benzodiazepines, both using Xeris’ proprietary XeriSol™ formulation technology. The Chinese ’185.5 patent covers pre-filled syringes containing a variety of active pharmaceutical ingredients, using Xeris’ proprietary XeriJect™ technology. These patents, and related patent applications that are pending in these and other patent offices around the world, also cover the uses of such products in treating a variety of diseases and disorders including diabetes. “Our strategy as a platform company is to patent early and often to continue to strengthen our position as a product development and formulation company. These new patent grants represent a significant expansion of Xeris’ intellectual property portfolio and help us to continue to invest in our innovation into life-saving therapies that can benefit patients worldwide,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “With the recent opening of our Research & Development center in Chicago, led by our Chief Scientific Officer and Xeris co-founder Dr. Steve Prestrelski, we anticipate that we will continue to develop and bring to the market novel solutions for treating and preventing a variety of human diseases and disorders, improving the quality of life for our patients and their families.” The granting of these patents expands the size of Xeris growing patent portfolio, bringing the total number of patents granted to Xeris worldwide to 121 (16 of which have been granted in the US). In addition to these new patent grants, Xeris has 120 patent applications pending worldwide, and expects to receive patent grants on several of those pending applications within the next several months. These patent grants, which provide Xeris the right to exclude others from making, selling, and using its proprietary technologies, will provide patent protection to Xeris on its proprietary pharmaceutical products for at least the next decade. All patents are owned by Xeris. About Xeris Pharmaceuticals, Inc. Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug products, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Read More

Lilly Launches Digital Health Open Innovation Challenge to Help Transform Atopic Dermatitis Care

Eli Lilly and Company | September 16, 2020

Eli Lilly and Company has launched an open innovation challenge for individuals and teams across the United States to submit inspiring digital health solutions that can help make life better for people living with atopic dermatitis. The challenge, "Transforming Atopic Dermatitis Care: Enhancing Quality of Life and Patient Care for People Living with Inflammatory Skin Diseases," focuses on leveraging digital technologies to enhance care and improve health and well-being for people with inflammatory skin diseases. The submission site, including additional details about the challenge's criteria, eligibility and requirements, is available at www.lilly.com/atopicdermchallenge.

Read More

PHARMA TECH

Iktos Announces Deployment of their AI for Drug Design Software Makya™ by Chiesi Group

Iktos and Chiesi Group | December 03, 2021

ktos, a company specialized in Artificial Intelligence for new drug design today announced collaboration agreement in AI for new drug design with Chiesi Group, the international research-focused pharmaceutical and healthcare. Under the agreement, Iktos’s de novo generative design software Makya™ will be used by Chiesi scientists to facilitate rapid and cost-effective design of novel compounds and accelerate hit-to-lead/lead optimisation for undisclosed Chiesi’s drug discovery programmes. Iktos has released Makya™, a generative AI-driven de novo design software for Multi-Parametric Optimization available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud. Makya’s user-friendly interface enables it to be used by medicinal or computational chemists. Makya™ can also be operated as a Python package through a Jupyter notebook interface. Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process, by automatically designing virtual novel molecules that have desired activities for treating a given disease. This tackles one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple bioactivity and drug-like criteria for drug discovery and development. “Licensing Makya is another step Chiesi wanted to complete in digitalization of R&D and in particular in drug discovery. The possibility of applying cutting edge AI technology relying on our internal expertise and historical data to drug design is very appealing. We think this emerging technology will become soon part of the compound design toolkit for all medicinal chemists, to facilitate their work aimed at identifying the right molecule”. Maurizio Civelli, Head of Global Research and Pre-Clinical Development Area of Chiesi Group “We are proud to work with Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, and to have their scientists use our software in their early discovery programs”, said Yann Gaston-Mathé, Co-founder and CEO of Iktos. “It is our ultimate goal to put our technology in the hands of drug discovery scientists, who have deep knowledge and understanding of their discovery programs. By combining their drug discovery expertise with our algorithmic and data science know-how and experience derived from the many collaborations we have established to date, we believe that the promise of AI to dramatically improve drug discovery will have a better chance to be realized and impact therapeutic development”. About Iktos Incorporated in October 2016, Iktos is a start-up company specializing in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, the design of molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. About Chiesi Group Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees. To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative therapeutic solutions in its three focus areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE and CARE. The Group’s Research and Development centre is based in Parma and works alongside six other important research and development hubs in France, the U.S., Canada, China, the UK and Sweden to pursue its pre-clinical, clinical and regulatory programmes. In 2018 Chiesi changed its legal status to Benefit Corporation, according to the law in Italy, the USA and, more recently, in France, by incorporating common benefit objectives into its bylaws, to generate value for its business, for the society and the environment. Since 2019, Chiesi has been the world’s largest B Corp certified pharmaceutical group. B Corps are global leaders committed to using business as a force for good. Moreover, as a Benefit Corporation, Chiesi Farmaceutici S.p.A. is required by law to report annually in a transparent way about its progress in achieving the common benefits objectives it has incorporated. The Group is committed to becoming carbon neutral by the end of 2035.

Read More