Simcyp Releases Version 13 of its Widely Used Simulator
New release further expands biologics capabilities and provides new tools for formulation scientists
Certara
™, provider of software and scientific consulting services that aim to improve productivity and decision-making from drug discovery through drug development, today announced that version 13 of its
Simcyp
™ Simulator has now been released, which permits the quantitative prediction of drug-drug-interactions and pharmacokinetic-pharmacodynamic outcomes in virtual populations. The latest platform strengthens Simcyp’s position as the leading provider of translation tools for connecting pre-clinical ADMET data to clinical outcomes using modeling and simulation.
Simcyp has extended its model repertoire for biologics by incorporating a full physiologically-based pharmacokinetic (PBPK) model for monoclonal antibodies and therapeutic proteins with significant practical applications. In addition, the inclusion of a non-linear plasma protein and red blood cell binding facility in version 13 addresses a level of complexity that is regularly needed for modeling in the oncology arena. The integration of a novel sophisticated IVIVC tool to handle in vitro - in vivo correlations of dissolution for various solid oral dosage forms enhances the scope of the simulator in the divisions of Formulation and Pharmaceutics.
Commenting on the new release, Professor Amin Rostami, vice president of research and development at Simcyp, said: “The expanding scientific expertise and diversity of specialties within Simcyp R&D over the last few years have enabled us to address many different areas that Consortium member companies were interested in. The latest release is a clear manifestation of the breadth and depth of knowledge within the team who fully complement each other.”
Reflecting on the expansion of the model repertoire for generic manufacturers and companies focusing on biologics, Dr Steve Toon, vice president of consulting services and technical sales support at Simcyp, commented: “Simcyp continues to enhance and evolve its products and services in line with the changing face of the pharmaceutical industry. With many of our Consortium member companies’ growing interest in biologics and increasing requests for consultancy support from the biotech and generics communities, the enhanced features within version 13 keep Simcyp at the forefront of PBPK modeling and simulation research, science, products and consultancy services.”
Version 13 of the Simcyp Simulator is now available to all Consortium members and academic associates with current not-for-profit license agreements.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
