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PODCAST

The VirtualPharm

Despina & Ethan at Enkrisi

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

science chemistry

All Episodes

23:05

Ten CMC Questions for Emerging Biotechs in 2025

The VirtualPharm ·

2024/12/19

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 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 expectation...

en-us

21:15

CMC Regulatory for Early Drug Development Success

The VirtualPharm ·

2024/12/17

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, 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 C...

en-us

20:44

Setting Drug Specifications in Data-Limited Scenarios

The VirtualPharm ·

2024/12/12

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. 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. Ultimate...

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20:03

Mastering CMC Quality Module 3 & QOS for NDA Submissions

The VirtualPharm ·

2024/12/10

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, 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 ...

en-us

15:25

Playing Monopoly in Real Life – The Game of...

The VirtualPharm ·

2024/12/05

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 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 ...

en-us

15:37

The Role of API Process Development in CMC Drug...

The VirtualPharm ·

2024/12/03

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 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 ...

en-us

14:23

Enhancing CMC Efficiency with Augmented Intelligence...

The VirtualPharm ·

2024/11/27

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 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 nav...

en-us

27:50

Mastering Stability Studies: The Blueprint for Drug...

The VirtualPharm ·

2024/11/25

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 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 ...

en-us

18:20

A Comprehensive CMC Strategy Document – Quick Guide

The VirtualPharm ·

2024/11/21

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 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 ...

en-us

17:53

Rules for Writing the Common Technical Document...

The VirtualPharm ·

2024/11/19

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 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 tea...

en-us

26:31

2024 ICH Guideline Reveals: Essential CMC and Drug...

The VirtualPharm ·

2024/11/12

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 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 t...

en-us

29:55

Integrating Knowledge into Risk-Based Decision-Making...

The VirtualPharm ·

2024/11/07

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. T...

en-us

11:53

Mastering the Art of Authoring a CMC Quality Module 3...

The VirtualPharm ·

2024/11/05

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 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...

en-us

18:17

6 Haunting Regulatory CMC Challenges on Halloween...

The VirtualPharm ·

2024/10/31

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 impo...

en-us

2:30

Robust Stability Protocol for CMC Submissions

The VirtualPharm ·

2024/10/29

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 n...

en-us

3:33

Strategic Timing for Defining Regulatory Starting...

The VirtualPharm ·

2024/10/24

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 redu...

en-us

18:23

What Does CMC Regulatory Affairs Do?

The VirtualPharm ·

2024/10/22

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 a...

en-us

7:57

Strategic Outsourcing: A New Era in Drug Development

The VirtualPharm ·

2024/10/17

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, 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 regulator...

en-us

20:35

Developing a Regulatory CMC Strategy for Global...

The VirtualPharm ·

2024/10/15

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, 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 ...

en-us

11:14

Mastering Process Design: Your Roadmap to Success in...

The VirtualPharm ·

2024/10/10

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 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 t...

en-us

24 results

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