The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
Episodes
24 episodes
Ten CMC Questions for Emerging Biotechs in 2025
This 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 milestone...
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23:05
CMC Regulatory for Early Drug Development Success
Cracking 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, Man...
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Season 1
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Episode 23
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21:15
Setting Drug Specifications in Data-Limited Scenarios
This 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. T...
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Season 1
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Episode 22
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20:44
Mastering CMC Quality Module 3 & QOS for NDA Submissions
This 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, accele...
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Season 1
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Episode 21
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20:03
Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development
The 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 pro...
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Season 1
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Episode 20
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15:25
The Role of API Process Development in CMC Drug Development
This 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...
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Season 1
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Episode 19
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15:37
Enhancing CMC Efficiency with Augmented Intelligence for Biotechs
The 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 suppo...
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Season 1
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Episode 18
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14:23
Mastering Stability Studies: The Blueprint for Drug Substance & Product Success
The 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 a...
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Season 1
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Episode 17
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27:50
A Comprehensive CMC Strategy Document – Quick Guide
The 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...
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Season 1
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Episode 16
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18:20
Rules for Writing the Common Technical Document Quality Module 3
The 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 pr...
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Season 1
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Episode 15
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17:53
2024 ICH Guideline Reveals: Essential CMC and Drug Development Insights
The 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 vali...
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Season 1
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Episode 14
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26:31
Integrating 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, em...
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Season 1
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Episode 13
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29:55
Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide
This 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 docume...
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Season 1
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Episode 12
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11:53
6 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...
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Season 1
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Episode 11
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18:17
Robust 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 sta...
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Season 1
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Episode 10
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2:30
Strategic 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 ...
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Season 1
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Episode 9
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3:33
What 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...
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Season 1
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Episode 8
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18:23
Strategic Outsourcing: A New Era in Drug Development
This 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, incr...
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Season 1
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Episode 7
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7:57
Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance
In 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,...
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Season 1
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Episode 6
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20:35
Mastering Process Design: Your Roadmap to Success in Drug Development
This 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 improvemen...
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Season 1
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Episode 5
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11:14
Critical 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 th...
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Season 1
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Episode 4
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14:28
Building 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 c...
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Season 1
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Episode 3
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16:15
A 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...
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Season 1
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Episode 2
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10:18