PR Newswire | January 24, 2024
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US.
Performance Validation is an industry leader with over 30 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries. The company provides environmental mapping, commissioning, qualification, computer system validation, and quality system consulting services.
ValGenesis is the industry innovator of digitized validation. The company's platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software.
In this partnership, Performance Validation will implement and manage next-generation digital validation tools developed by ValGenesis, including ValGenesis VLMS and VLMS Express, a simplified cloud-based digital validation solution for startups and midsized companies. ValGenesis and Performance Validation are providing an integrated governance approach to further strengthen risk and compliance across their customers' manufacturing processes.
"We are excited to partner with Performance Validation. Their extensive experience and our industry benchmarked digital validation platform can help life sciences companies implement their digitization plans efficiently according to Industry 4.0 standards," says Bo Olsen, ValGenesis' SVP of Partners. "By establishing a clear strategy that addresses their risk and compliance implications upfront, we can assure them of true business transformation."
"Performance Validation is thrilled to embark on this collaborative journey with ValGenesis, leveraging our extensive experience and knowledge of digital validation solutions. It's a powerful combination – our hands-on validation experience and their innovative digital tools. For our clients in the life sciences, this means more efficient, streamlined, and compliant solutions. We're not just adapting to Pharma 4.0; we're helping our clients lead the way in digital transformation," says Brad Henry, Vice President of Service Lines at Performance Validation.
ABOUT PERFORMANCE VALIDATION
Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward.
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences 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.
PR Newswire | January 09, 2024
Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine.
Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies.
Key Highlights of the Collaboration:
Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies.
Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry.
"This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care."
"This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market."
About Flagship Pioneering:
Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions.
About Samsung C&T:
Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.
PR Newswire | January 03, 2024
Frontage Laboratories, Inc. today announced that, through its wholly-owned subsidiary Frontage Europe S.r.l., it has completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (Accelera).
Accelera is a premier Contract Research Organization located in Nerviano, within the Lombardy region of Italy, part of the well-established NMS Group S.p.A. which has positioned itself as a global niche player in delivering discovery & preclinical studies and clinical bioanalysis to pharma and biotechnology companies, academic institutions, and other healthcare stakeholders.
"Today marks a very significant achievement in the 23-year history of Frontage Laboratories, as we establish a base of operations in continental Europe. Accelera has developed a tremendous reputation for high quality R&D services and we look forward to welcoming their Bioanalytical and Drug Metabolism & Pharmacokinetics teams to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "We envision this strategic acquisition as a first step in establishing Frontage's footprint in Europe, with the intent of adding other service areas in the continent. We believe both existing Frontage and Accelera clients stand to benefit greatly by leveraging Frontage's increasingly global platform. In addition, we are looking forward to partnering with the remaining Accelera business on exciting opportunities to service clients across our organizations."
According to Dr. Song Li, Founder and Chairman of Frontage: "It has been a long-standing goal of Frontage to expand our operations in Europe. We consider ourselves fortunate to capitalize on our outstanding relationship with the Accelera team, which has enabled us to bring our plans to fruition. We are very enthusiastic about working together as we further develop the Frontage platform in Europe, starting from a footprint in the Biopark in Nerviano Lombardy, where Accelera and Nerviano Medical Sciences Srl have already established a long-standing and efficient value chain. As always, our ongoing focus will remain on delivering the highest levels of quality, technology and expertise to our clients."
"We are thrilled to join forces with Frontage as part of this strategic acquisition that marks a significant milestone in Accelera's journey," said Luca Leone, CEO of Accelera. "Accelera has built a strong reputation for delivering high-quality R&D services through all phases of drug research and development with extensive experience in oncology. This unique occasion opens up new horizons for collaboration and growth. On one hand, we will further focus on offering top-notch In-vivo (end-to-end services) for multiple emerging modalities. At the same time, we look forward to exploring exciting opportunities to serve our clients across continents through our ongoing collaboration. This partnership reflects our commitment to advancing research and providing innovative solutions in the European market and beyond," said Luca Leone, CEO of Accelera S.r.l.
"Having Frontage as part of the growing partners operating from our Biopark is a landmark moment for us. In addition to the endless potential of the Accelera-Frontage collaboration, Nerviano Medical Sciences can leverage Frontage's world-class capabilities to drive breakthrough advancements in our drug discovery and development process. By uniting our strengths, we believe we can accelerate the pace of innovation and make a lasting difference in the field where all companies of this strong alliance operate and thrive here in Nerviano," said Hugues Dolgos, CEO of NMS Group S.p.A and Nerviano Medical Sciences Srl.
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.
About NMS Group
NMS Group is the largest oncological R&D company in Italy with more than 400 employees, of whom more than half are highly educated individuals dedicated to innovative research, development and manufacturing. The NMS kinase inhibitor discovery platform as well as the antibody-conjugating payload platform are the driving forces of the group's innovation, securing global recognition of NMS in personalized therapy. Recently entrectinib, originally discovered by NMS, which is a targeted kinase inhibitor used to treat NTRK1/2/3 and ROS1 dependent solid tumors that was licensed to Ignyta, now a member of the Roche Group, gained approvals for commercialization in all major markets. This is further evidence of the competitiveness of the drug discovery platform of NMS Group. NMS Group has three subsidiaries. NMS S.r.l. is a FIC / BIC focused drug research and development company with a robust pipeline of more than a dozen anti-cancer projects, and three of the projects are currently in early clinical development.