Japanese Regulatory Agency Licenses Certara’s Biosimulation Software
Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator.
Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator. PMDA joins FDA and several other global regulatory agencies in increasing its reliance on biosimulation for investigational new drug and new drug approval reviews.
PMDA is using PPK (population pharmacokinetic), PK/PD (pharmacokinetic/pharmacodynamic), and other modeling and biosimulation approaches for dosage, dose regimen and dose adjustment for special populations, including pediatrics. In addition, PKS Online will provide the technical infrastructure necessary to securely store and manage PK and PD study data, and the associated pharmacometric analyses, in a regulatory-compliant environment.
Read the full release here.
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.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.
