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 […]
The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
This informative webinar is aimed to be forward-looking, discuss the potential promises of emerging technological tools in expediting and radically changing submission preparation, pinpoint potential challenges and brainstorm resolutions. The current landscape of regulatory submissions is weighed down by the sheer volume of documentation required, complex guidelines and repetitive information across documents. It also involves the painstaking, cumbersome writing styles […]
Podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials
AI is increasingly being integrated across various industries, demonstrating its versatility and potential. In the biotech sector, it is important to consider how the use of AI might impact integral factors such as GCP compliance and inspection readiness. The incorporation of AI in the clinical trial process brings about a transformative influence on GCP compliance […]
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 […]
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 […]
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 […]
Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval
Case Study Zachary Swan, PhD (Director, Regulatory Affairs) Background and Challenge Allucent was approached by a commercial-stage biopharmaceutical company focused on infectious diseases to provide writing and strategy support for their unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies in […]
Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?
By Sugato De (VP, Regulatory Strategy, Head of Medtech) and Michelle Hoffner O’Connor (Clinical Strategy Scientist II) On December 21, 2023, the Food and Drug Administration (FDA) issued a draft guidance entitled “Master Protocols for Drug and Biological Product Development.” Master protocols originated as an efficient mechanism to determine which therapies may drive the most […]
Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting
Risk assessment is a complex process intended to protect human health. In drug development, this process includes identifying drug candidate-related hazards in relationship to dose and exposure via traditional in vitro and in vivo frameworks. Nonclinical studies in pharmacology, pharmacokinetics and toxicology are designed and conducted under conditions that closely mimic the clinical setting to facilitate proper risk assessment. The introduction of […]
Balancing Act in Preclinical Development: Strategies for Assessing and Managing Neurotoxic Risks in CNS Therapeutics
By Marcus Delatte (VP, Regulatory Strategy), Alison Wakeford (Scientist), Devin Welty (VP, Clinical Pharmacology), and Rachel Rozakis (Sr. Clinical Pharmacologist) Background Central Nervous System (CNS) disorders are typically severe and may produce various behavioral, anatomical, and physiological changes in millions of patients, which complicates developing effective therapeutics and managing product-related neurotoxicity. Therefore, careful attention should […]