Benefits of Bayesian Dose Escalation Designs for Oncology Studies
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]
Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks
Risk assessment is a complex process intended to protect human health by identifying drug-related hazards, determining dose-response relations for a product within relevant biological systems, and assessing exposure levels to characterize potential risks. These assessments may be conducted via traditional frameworks using data from in vitro and in vivo studies, as well as novel frameworks using pharmacokinetic and pharmacodynamic model-based […]
A Snapshot of Gap Analysis
When building a successful regulatory strategy, it is critical to keep the end objectives in mind and design a process that is tailored to your specific product. Planning for regulatory requirements can help you avoid non-compliant practices from the very beginning, but how do you make sure your strategy is comprehensive? The answer may be […]
3 Tips for IMPD Success
The Investigational Medicinal Product Dossier or IMPD contains summaries of information related to the quality, manufacture, and control of any IMP, along with data from non-clinical and clinical studies, including the overall benefit and risk assessment. The IMPD is a critical part of the European clinical trial application, as the clinical trial may not be […]
The Essential Role of the CMC Expert in Drug Development
The Chemistry, Manufacturing, and Controls (CMC) expert plays a critical role in the drug development process, supporting sponsors in their ultimate goal of marketing authorization approvals to bring life-changing products to the patients who need them. CMC applies to the entire drug product development lifecycle, beginning during drug candidate selection and continuing through post-approval and […]
A Regulatory Perspective on Cell and Gene Therapy in Oncology
By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy The past decade has produced many promising innovative cell and gene therapies (CGTs) to treat human diseases. CGT products, which use genetic material to modify cells in vitro or in vivo to treat, prevent, or potentially cure diseases, have great potential to address unmet medical needs. […]
Inspection Readiness: What is it, why it matters, and what you need to know to be prepared
Organizations must have inspection readiness since inspections can be unannounced or come at any time. Good Clinical Practice (GCP) inspectors use different approaches depending on the regulatory authorities for which they represent; however, all of them will verify the compliance status on GCP and other applicable regulations during the inspection. Planning ahead to anticipate all processes are compliant means an organization […]
Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection
The International Conference on Harmonization/Good Clinical Practice E6 (ICH GCP) lays out clear expectations for both the sponsor and investigators for compliant trial conduct. These guidelines cover compliance with GCP and with the applicable regulatory requirements to ensure that procedures related to clinical trials are followed. The guidelines encompass data recording and processing to ascertain if […]
The Potential of Biosimilars – for Drug Makers and Patients
The production of biosimilar drugs remains at a rapid pace and represents not only an advantage for patients but also a remarkable profit opportunity for drug makers. And for patients, the approval of biosimilars may represent the only alternative of treatment due to the extremely high cost of many original biologic drugs. That said, in […]
The Multifaceted Role of the Nonclinical Expert at the Center of Drug Development Teams
Product development teams getting started on preclinical exploration of a potential treatment need a certain set of specialists on board. Key roles include scientists, clinical strategist, project manager, regulatory affairs director, and a nonclinical expert, a primary authority on product safety. In fact, inclusion of a nonclinical expert is mandated by regulatory authorities to ensure […]