Shows
The VirtualPharmTen CMC Questions for Emerging Biotechs in 2025This podcast presents ten crucial questions for emerging biotech companies to consider when reviewing their Chemistry, Manufacturing, and Controls (CMC) strategies at year-end. The questions cover various aspects, including regulatory milestones, data analytics, risk management, quality assurance, and future goals. Each question includes examples illustrating its importance for successful drug development. The ultimate aim is to ensure a robust CMC strategy aligned with regulatory expectations and industry best practices, thereby minimizing delays and maximizing the chances of successful submissions. Failing to address these questions could result in significant setbacks. Support the show2024-12-1923 minThe VirtualPharmCMC Regulatory for Early Drug Development SuccessCracking the Code CMC Regulatory Compliance in Early Drug Development Summary This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Manufacturing, and Controls (CMC) regulatory compliance during drug development. It emphasizes the importance of strategic CMC planning, risk assessment, and early engagement with regulatory authorities from Phase 1 through Phase 3 clinical trials. The series stresses the critical role of CMC in ensuring product quality and safety, highlighting the benefits of prior initiatives such as the Quality by Design (QbD) approach. The first par...2024-12-1721 minThe VirtualPharmSetting Drug Specifications in Data-Limited ScenariosThis Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory compliance, and Quality by Design principles. Cross-functional collaboration and thorough documentation are crucial for ensuring product quality, manufacturability, and regulatory success. Ultimately, the guide provides a roadmap for navigating the complexities of specification setting in data-scarce pharmaceutical development. Support the show2024-12-1220 minThe VirtualPharmMastering CMC Quality Module 3 & QOS for NDA SubmissionsThis guide explains how to create a high-quality CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the FDA. It emphasizes the importance of these documents for regulatory compliance, accelerated approval, and demonstrating product quality. The guide provides a step-by-step process, including best practices and common pitfalls to avoid, and highlights the strategic role of the QOS in communicating with regulatory authorities. Ultimately, the text advocates for meticulous preparation and expert consultation to ensure a successful NDA submission. The target audience includes regulatory affairs professionals, CMC scientists, and pharmace...2024-12-1020 minThe VirtualPharmPlaying Monopoly in Real Life – The Game of Regulatory CMC in Drug DevelopmentThe podcast explains the complexities of the Regulatory Chemistry, Manufacturing, and Controls (CMC) process in drug development by drawing an analogy to the popular board game Monopoly. The author compares various aspects of the CMC process, like pre-IND planning, formulation development, and regulatory interactions, to actions taken while playing Monopoly. The text also highlights the crucial importance of risk management and emphasizes the need for thorough planning and execution in order to achieve success in bringing a drug to market. Support the show2024-12-0515 minThe VirtualPharmThe Role of API Process Development in CMC Drug DevelopmentThis Podcast discusses the critical role of API process development in the Chemistry, Manufacturing, and Controls (CMC) drug development process. This process focuses on ensuring the drug substance or API (Active Pharmaceutical Ingredient) can be manufactured consistently and safely at scale. The text explains the different stages of API process development, from the early preclinical phase where synthetic routes are developed, to later stages where these routes are optimized for scalability and cost-effectiveness. The text then explores challenges in API process development, such as the complexity of chemical reactions involved in drug synthesis...2024-12-0315 minThe VirtualPharmEnhancing CMC Efficiency with Augmented Intelligence for BiotechsThe Podcast focuses on how technology, specifically augmented intelligence (AI), can improve the efficiency and compliance of drug development. The article emphasizes the importance of technology in streamlining back-office operations and supporting the regulatory aspects of Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical companies. The text highlights how AI-powered solutions can automate processes, enhance collaboration, and provide data-driven insights to help companies navigate complex regulatory submissions. The article showcases Enkrisi, a company utilizing AI-powered solutions to revolutionize regulatory CMC, and presents their platform, EnkrisiGPT, as a cutting-edge solution for navigating the complexities of drug development.Support the...2024-11-2714 minThe VirtualPharmMastering Stability Studies: The Blueprint for Drug Substance & Product SuccessThe podcast provides an overview of drug substance and product stability testing. They describe the importance of stability testing for ensuring product quality and safety. The texts highlight the complexity of FDA stability guidelines, which are intended to provide general principles for conducting stability testing. The sources then outline the specific guidelines for stability testing established by the International Conference on Harmonisation (ICH) and provide a step-by-step process for conducting stability testing. Finally, the texts emphasize the importance of following regulatory guidance and using validated methods to ensure the accuracy and reliability of stability testing data. Support t...2024-11-2527 minThe VirtualPharmA Comprehensive CMC Strategy Document – Quick GuideThe provided text focuses on the complexities of regulatory drug development and emphasizes the importance of a comprehensive and dynamic strategy document, particularly in the area of chemistry, manufacturing, and controls (CMC). This document helps streamline the process by providing a visual representation of the various stages of drug development, allowing for effective communication, tracking of progress, identification of potential issues, and data-driven decision-making. The text then introduces Enkrisi, a company offering expertise and support in regulatory CMC, with their dynamic strategy document acting as a navigational tool for navigating the complexities of the drug development process. Enkrisi emphasizes...2024-11-2118 minThe VirtualPharmRules for Writing the Common Technical Document Quality Module 3The podcast provides guidance on creating a successful Common Technical Document (CTD) application for drug approval, specifically focusing on Quality Module 3. It emphasizes the importance of clarity, accuracy, and thorough documentation in presenting scientific data to regulators. The document highlights the need for a cohesive narrative within Module 3 to demonstrate the drug's quality and consistency from early development to commercialization. It also underscores the critical role of team leadership and collaboration in ensuring a comprehensive and compelling submission. The document emphasizes that a well-structured Module 3, coupled with a strong Quality Overall Summary (Module 2.3), can significantly increase the likelihood of...2024-11-1917 minThe VirtualPharm2024 ICH Guideline Reveals: Essential CMC and Drug Development InsightsThe podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)/Q14 for analytical validation, Q5(R2) for viral safety evaluation, and Q9(R1) for quality risk management. The text also examines the ICH's efforts to address emerging technologies in cell and gene therapy and real-world data utilization for safety assessments. Finally, the text discusses the impact of the ICH Biannual Assembly held in June 2024, including progress updates on current guidelines, the introduction of new proposals, and the harmonization...2024-11-1226 minThe VirtualPharmIntegrating Knowledge into Risk-Based Decision-Making with ICH Q9(R1)The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pharmaceutical industry, emphasizing reducing subjectivity and integrating knowledge into risk-based decision-making. The update encourages the use of digital tools and emerging technologies to control risks, and it aims to improve industry consistency and regulatory oversight. The updated guidelines promote a shift to more objective risk assessments, ultimately contributing to a safer and more reliable pharmaceutical industry by reducing quality defects and improving patient outcomes. S...2024-11-0729 minThe VirtualPharmMastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple GuideThis Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the importance of these documents for demonstrating a product's quality, navigating the regulatory review process, and achieving global market access. They also provides best practices for authoring these documents, common pitfalls to avoid, and strategic advice for optimizing their use. The discussion emphasizes the QOS as a critical component for communicating with regulatory authorities and justifying deviations from standard guidelines, thus streamlining the review...2024-11-0511 minThe VirtualPharm6 Haunting Regulatory CMC Challenges on Halloween (and How to Survive Them!)This podcast covers the common regulatory challenges faced by professionals working in the pharmaceutical and biotechnology industries. The authors provide seven scenarios, ranging from an unexpected clinical hold to difficulty obtaining budget approval for regulatory activities, and present solutions for each. These solutions include strategies for effective communication with regulatory agencies, proactive planning, and utilizing readily available resources. The document emphasizes the importance of preparation and a proactive approach to navigating the complex regulatory landscape. Support the show2024-10-3118 minThe VirtualPharmRobust Stability Protocol for CMC Submissions The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It emphasizes aligning stability protocols with regulatory guidelines from bodies like the FDA and EMA, focusing on key aspects like study design, storage conditions, analytical method validation, quality control, and forced degradation studies. The episode also highlights the need for data integrity, clear scope definition, and container compatibility, underscoring how a strong stability protocol ensures drug quality, safety, and efficacy throughout its shelf-life, supporting successful NDA/BLA submissions. Support the sh...2024-10-2902 minThe VirtualPharmStrategic Timing for Defining Regulatory Starting Materials (RSMs) The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-IND, Post-IND but pre-clinical trials, and late development before submission—each with its own advantages and challenges. Early-stage definitions offer flexibility but limited regulatory guidance, mid-stage definitions align with initial regulatory interactions but reduce flexibility, while late-stage definitions are data-backed but difficult to adjust. The episode emphasizes balancing flexibility and regulatory alignment, advocating for a collaborative, data-driven approach to ensure efficient development and compliance. Support the show2024-10-2403 minThe VirtualPharmWhat Does CMC Regulatory Affairs Do?The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, and marketing comply with regulatory standards. The source details the key functions of CMC RA, such as regulatory strategy development, submission management, and compliance monitoring, and highlights the importance of collaboration with various departments, such as research and development, manufacturing, and quality assurance. Additionally, it provides insights into the day-to-day work of CMC RA professionals, emphasizing the need for clear communication, detailed documentation, and a deep...2024-10-2218 minThe VirtualPharmStrategic Outsourcing: A New Era in Drug DevelopmentThis article argues that strategic outsourcing, particularly for Small Molecule APIs, is a key component of successful drug development. It outlines the benefits of outsourcing for pharmaceutical companies, including cost reduction, increased focus on R&D, and faster time-to-market. The article also emphasizes the importance of regulatory strategy and highlights how Enkrisi, a company specializing in drug development consulting, can help pharmaceutical companies navigate complex regulatory requirements. The article concludes by presenting case studies demonstrating the successful implementation of outsourcing strategies for various pharmaceutical companies. Support the show2024-10-1707 minThe VirtualPharmDeveloping a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH GuidanceIn this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing regulatory requirements and supporting a cohesive approach to CMC globally. Support the show2024-10-1520 minThe VirtualPharmMastering Process Design: Your Roadmap to Success in Drug DevelopmentThis excerpt from "Robust CMC Process for Small Molecules" is a guide to designing robust manufacturing processes in the pharmaceutical industry. It highlights the importance of comprehensive planning, rigorous design, and continuous improvement in the development of small molecules, biologics, and dosage forms. The author stresses that a robust process development strategy is critical for ensuring that pharmaceutical products are safe, effective, and meet the highest quality standards. Key themes include proactive quality planning, risk management, process validation, and continuous improvement as crucial elements for success in the pharmaceutical development process. The article emphasizes the need to understand the...2024-10-1011 minThe VirtualPharmCritical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance)Podcast Description:In this episode, we explore the essential components of a robust Chemistry, Manufacturing, and Controls (CMC) due diligence framework, with a special focus on drug substance evaluation. Join us as we break down the comprehensive steps involved in conducting due diligence during pharmaceutical acquisitions or in-licensing. From regulatory compliance to technical assessments, we discuss how to mitigate risks, enhance regulatory readiness, and ensure the quality of drug substances. This episode highlights the importance of aligning CMC due diligence with international guidelines, like the ICH’s CTD Module 3, and emphasizes the role of multidisciplinary teams in...2024-10-0814 minThe VirtualPharmBuilding a Robust NDA/BLA Strategy: Ethan and Desi Discuss 5 Strategic Steps in Regulatory CMC for Approval Welcome to "Accelerating the Path to Approval", hosted by Ethan and Despina from Enkrisi. In this podcast, we explore the critical steps in developing a robust Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy that can make or break a successful New Drug Application (NDA) or Biologics License Application (BLA) submission. Today, we’ll be diving into the 5 Strategic Steps that ensure your CMC foundation is strong, well-structured, and aligned with regulatory expectations, significantly enhancing your chances of approval. From early regulatory engagement to continuous risk mitigation, we’ll walk you through real-world examples and case studie...2024-10-0316 minThe VirtualPharmA Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, and facility readiness can lead to costly delays or rejections. The episode is packed with actionable advice on how to streamline the submission process, collaborate effectively with Contract Manufacturing Organizations (CMOs), and ensure regulatory compliance to expedite drug approval. Whether you're navigating the NDA or BLA submission p...2024-10-0110 minThe VirtualPharmBringing Regulatory CMC to LifeWe are excited to announce the launch of our brand-new podcast, The VirtualPharm: The Regulatory Intelligence Podcast—where we bring Regulatory CMC to life! 🎉Hosted by industry veterans with decades of experience, The VirtualPharm dives deep into the most pressing and complex topics in Chemistry, Manufacturing, and Controls (CMC). Whether you're navigating the latest FDA regulations, preparing submissions, or tackling intricate compliance challenges, this podcast is your go-to resource for actionable insights and expert guidance.Why Listen?In-Depth Episodes: Explore the latest trends, challenges, and strategies in Regulatory CMC.Exper...2024-09-2610 min