Managing Clinical Investigator Site Inspections: Key Strategies for Success
By Nuno Pires (Director, GxP Strategy) and Ernesto Vera Sanchez, MD, MPH, PhD (VP, Department Head, GxP Strategy) In our previous blog, “Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection”, we explored the broader concept of inspection-readiness, emphasizing the importance of adhering to Good Clinical Practice (GCP) guidelines to ensure overall compliance […]
Paving the Way for Safer, More Effective Treatments for Children
By Jessica Roberts PhD, MSCI, Director and Head Quantitative Translational Pharmacology Developing safe and effective drugs for children has long been a challenge for drug developers. With the need to cater to a wide range of ages and sizes, pediatric drug development requires precise and innovative approaches. Our infographic highlights the transformative role of pharmacokinetic […]
Empowering Small Biotechs: Conquering Clinical Trial Challenges with Data Management Champions
By José Matamoros Luna, MSc (Senior Clinical Data Manager II) Small biotechnology companies continue to be a significant force in the drug development market comprising 77% of the active products in development by biotech today.1 Nonetheless, the rise of clinical trial costs, resource scarcity, and fierce competition, along with limited availability of financing, requires small […]
Evolving Advisory Committee Processes: Key Updates From ODAC
By Nadine Bouchard (VP, Regulatory Affairs, Head of Program Management) and Lisa Sanders, PhD (Sr. Director, Regulatory Affairs) Background To help in their decision-making, the US Food and Drug Administration (FDA) sometimes makes use of an Advisory Committee, as defined in various regulations. An Advisory Committee provides independent expert advice and makes non-binding recommendations to […]
Neurotoxic Risks in Therapeutics: Nonclinical Considerations
By Marcus Delatte, PhD (VP, Regulatory Strategy), Rachel Rozakis, PhD (Sr. Clinical Pharmacologist), Devin Welty, PhD (VP, Clinical Pharmacology), and Alison Wakeford, PhD (Nonclinical Scientist I) Introduction Central nervous system (CNS) toxicity is a major reason for failure of drugs developed to target this system and others. Therefore, the early detection of potential CNS toxicities […]
Achieving Operational Excellence in Clinical Research Organizations: A Catalyst for Biotech Success
By Diane Francisco, Senior Director, Operational Excellence, Global Clinical Operations In a 2023 quantitative survey from Industry Standard Research (ISR) of 239 Phase II/III pharma and biotech outsourcers “Operational excellence” ranked number two out of 24 categories, when asked “What were the top reasons for choosing to work with a CRO” (ISR Phase II/III CRO […]
EU Pharmaceutical Legislation Reform – Towards a Resolution
By John McIntyre, PhD (Director, Clinical Strategy) and Sugato De, MSc (Vice President, Regulatory Strategy) Introduction In April 2023, the European Commission adopted a proposal for a new Directive1 and a new Regulation2 which revise and replace the existing general pharmaceutical legislation in the EU. The proposed change represents the largest reform of the European pharmaceutical legislation […]
Strengthen Your Regulatory Submissions Through Strategic Storyboarding
By Young-Sil (Anna) Yim, Senior Director, Regulatory Affairs at Allucent Introduction A successful marketing authorization application is expected to convey the complete story of the drug in a clear, harmonized, and strategic manner. The process is rarely easy, as the authoring process requires distilling the full product development journey, starting from early activities including CMC […]
Crossover Designs in Oncology: Statistical Perspectives
By Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting) Introduction There are several factors to consider when adding a crossover design feature to an oncology study. These designs typically allow for patients to crossover from placebo or standard of care (SoC) to investigational product after disease progression on their randomized therapy. It is also […]
Optimizing Your Clinical Development Plan: Strategies for Biotech Success
By Sugato De (VP, Regulatory Strategy, Head of Medtech), Josh Taylor (Sr. Director, Regulatory Affairs), Lisa R. Sanders (Sr. Director, Regulatory Affairs), John McIntyre (Director, Clinical Strategy) Critical Importance of the Clinical Development Plan Imagine you walk onto a plot of land and decide it is the perfect place to build your next home. You […]