Best Ethan at Enkrisi Podcasts (2025)

1
Ten CMC Questions for Emerging Biotechs in 2025 23:05

6M ago23:05

23:05

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 i…

1
CMC Regulatory for Early Drug Development Success 21:15

6M ago21:15

21:15

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 e…

1
Setting Drug Specifications in Data-Limited Scenarios 20:44

6M ago20:44

20:44

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. Cros…

1
Mastering CMC Quality Module 3 & QOS for NDA Submissions 20:03

6M ago20:03

20:03

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 …

1
Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development 15:25

6M ago15:25

15:25

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…

1
The Role of API Process Development in CMC Drug Development 15:37

6M ago15:37

15:37

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 de…

1
Enhancing CMC Efficiency with Augmented Intelligence for Biotechs 14:23

6M ago14:23

14:23

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.…

1
Mastering Stability Studies: The Blueprint for Drug Substance & Product Success 27:50

6M ago27:50

27:50

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 s…

1
A Comprehensive CMC Strategy Document – Quick Guide 18:20

7M ago18:20

18:20

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 developme…

1
Rules for Writing the Common Technical Document Quality Module 3 17:53

7M ago17:53

17:53

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 M…

1
2024 ICH Guideline Reveals: Essential CMC and Drug Development Insights 26:31

7M ago26:31

26:31

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…

1
Integrating Knowledge into Risk-Based Decision-Making with ICH Q9(R1) 29:55

7M ago29:55

29:55

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 enco…

1
Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide 11:53

7M ago11:53

11:53

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 …

1
6 Haunting Regulatory CMC Challenges on Halloween (and How to Survive Them!) 18:17

7M ago18:17

18:17

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 fo…

1
Robust Stability Protocol for CMC Submissions 2:30

7M ago2:30

2:30

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…

1
Strategic Timing for Defining Regulatory Starting Materials (RSMs) 3:33

7M ago3:33

3:33

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-s…

1
What Does CMC Regulatory Affairs Do? 18:23

7M ago18:23

18:23

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 develop…

1
Strategic Outsourcing: A New Era in Drug Development 7:57

8M ago7:57

7:57

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 …

1
Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance 20:35

8M ago20:35

20:35

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 ar…

1
Mastering Process Design: Your Roadmap to Success in Drug Development 11:14

8M ago11:14

11:14

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 pr…

1
Critical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance) 14:28

8M ago14:28

14:28

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 …

1
Building a Robust NDA/BLA Strategy: Ethan and Desi Discuss 5 Strategic Steps in Regulatory CMC for Approval 16:15

8M ago16:15

16:15

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’l…

1
A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval 10:18

8M ago10:18

10:18

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, …

1
Bringing Regulatory CMC to Life 10:22

8M ago10:22

10:22

We 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 n…

Podcasts Worth a Listen

Ethan At Enkrisi Podcasts

Podcasts Worth a Listen

1
The VirtualPharm

Despina & Ethan at Enkrisi

1
Ten CMC Questions for Emerging Biotechs in 2025 23:05

1
CMC Regulatory for Early Drug Development Success 21:15

1
Setting Drug Specifications in Data-Limited Scenarios 20:44

1
Mastering CMC Quality Module 3 & QOS for NDA Submissions 20:03

1
Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development 15:25

1
The Role of API Process Development in CMC Drug Development 15:37

1
Enhancing CMC Efficiency with Augmented Intelligence for Biotechs 14:23

1
Mastering Stability Studies: The Blueprint for Drug Substance & Product Success 27:50

1
A Comprehensive CMC Strategy Document – Quick Guide 18:20

1
Rules for Writing the Common Technical Document Quality Module 3 17:53

1
2024 ICH Guideline Reveals: Essential CMC and Drug Development Insights 26:31

1
Integrating Knowledge into Risk-Based Decision-Making with ICH Q9(R1) 29:55

1
Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide 11:53

1
6 Haunting Regulatory CMC Challenges on Halloween (and How to Survive Them!) 18:17

1
Robust Stability Protocol for CMC Submissions 2:30

1
Strategic Timing for Defining Regulatory Starting Materials (RSMs) 3:33

1
What Does CMC Regulatory Affairs Do? 18:23

1
Strategic Outsourcing: A New Era in Drug Development 7:57

1
Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance 20:35

1
Mastering Process Design: Your Roadmap to Success in Drug Development 11:14

1
Critical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance) 14:28

1
Building a Robust NDA/BLA Strategy: Ethan and Desi Discuss 5 Strategic Steps in Regulatory CMC for Approval 16:15

1
A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval 10:18

1
Bringing Regulatory CMC to Life 10:22