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PODCAST

From Concept to Medicine - A Comprehensive Drug Development Journey

Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientist’s vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventure—filled with scientific breakthroughs, regulatory twists, and the relentless pursuit of innovation.In this podcast, we take you behind the scenes of pharmaceutical research and development, unraveling the complex and fascinating process that

science chemistry

All Episodes

16:41

90 – Season 6 Recap & Integration (S6E15)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode revisits the major themes and concepts covered throughout Season 6. The primary focus is on pharmaceutical manufacturing and process development. We will consolidate key learnings, highlighting the interconnectedness of various topics. Such as process optimization, quality by design, analytical methods, and regulatory requirements.The discussion synthesizes the core principles of process development, emphasizing how a deep understanding of chemistry and engineering is essential for

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15:10

89 – Environmental & Safety Considerations (S6E14)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode discusses how environmental and safety concerns have changed the design and operation of pharmaceutical manufacturing plants. Discussion topics include, waste, worker safety, handling of hazardous materials, and risk minimization.The episode will draw parallels with the scientific literature. It will be focused on optimizing reaction conditions, waste reduction, and safety considerations. Examples will be presented highlighting the concepts of green chemistry, the design of closed

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16:02

88 – Risk Management in Process Scale-Up (S6E13)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode delves into the critical aspect of risk management during the scale-up of pharmaceutical manufacturing processes. We'll explore strategies for identifying and mitigating potential risks. These risks can range from unexpected side reactions and impurity formation to equipment failures and safety hazards.The conversation centers on proactive risk assessment. This includes techniques like process hazard analysis and failure mode and effects analysis. We'll discuss contingency planning,

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8:54

87 – Continuous Manufacturing & Emerging Trends (S6E12)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode introduces continuous manufacturing as a transformative approach in pharmaceutical production. This represents a significant departure from traditional batch processing. We'll explore the potential advantages of continuous manufacturing. Including increased efficiency, reduced waste, smaller facility footprints, and enhanced process control.The discussion will cover the regulatory perspective on continuous manufacturing, highlighting the FDA's support and guidance for this emerging

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11:42

86 - Technology Transfer from Lab to Plant (S6E11)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

Explore the pivotal process of technology transfer in the pharmaceutical industry. This episode covers, transferring a manufacturing process from the controlled environment of a development lab to the complexities of a commercial production plant. It's not just about scaling up; it's about ensuring that the quality and consistency achieved in the lab are maintained at a much larger scale.Discover the core elements of successful technology transfer. Including, thorough training of personnel,

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14:40

85 – Process Validation & Regulatory Requirements...

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

Process validation is the cornerstone of pharmaceutical manufacturing, a systematic endeavor to demonstrate that a production process consistently yields a product meeting its predetermined specifications. This episode provides a comprehensive overview of this crucial process and its associated regulatory landscape.We delve into the key stages of process validation, from meticulously defining the process and crafting validation protocols to rigorous documentation and real-world testing. By examining

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11:14

84 – Case Study: Manufacturing a Complex Molecule (S6E9)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode presents a detailed case study from OPR&D, showcasing the challenges and triumphs of scaling up the manufacturing process for a complex pharmaceutical molecule. The narrative follows the journey from initial lab synthesis to large-scale production, highlighting the iterative process of optimization and troubleshooting.The discussion will cover the specific hurdles encountered, such as unexpected side reactions, low yields, and difficulties in purification. We'll explore how the

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13:12

83 – Analytical Methods in Process Development (S6E8)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode explores the vital role of analytical methods in supporting process development and ensuring the consistency of pharmaceutical manufacturing. The conversation centers on key techniques like HPLC, spectroscopy (NMR, UV-Vis), and how these tools are used to monitor reactions in real-time, troubleshoot problems, and optimize process parameters.We'll discuss how analytical data provides critical insights into reaction kinetics, impurity formation, and the impact of scale-up on product

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15:28

82 – Impurity Profiling & Control Strategies (S6E7)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode focuses on the crucial aspect of identifying and controlling impurities during pharmaceutical manufacturing. The conversation explores the various analytical techniques used to detect and quantify even trace amounts of unwanted substances in drug products. We'll delve into methods like HPLC, NMR, mass spectrometry, and ICP-MS, highlighting their strengths and limitations.The discussion will also cover the strategies manufacturers employ to minimize impurity formation during the

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11:55

81 – Crystallization and Solid Form Selection (S6E6)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode delves into the critical importance of crystallization in defining a drug's solid-state properties and its impact on overall performance. The conversation centers on polymorphism – the ability of a drug substance to exist in multiple crystal forms – and how these different forms can have vastly different properties, such as solubility, stability, and bioavailability.We'll explore how scientists carefully control the crystallization process to obtain the desired polymorph with optimal

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19:38

80 – Purification & Isolation Techniques (S6E5)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode provides an overview of the essential purification and isolation techniques used in pharmaceutical manufacturing to obtain drug substances of the required purity. We'll explore three core methods: crystallization, filtration, and chromatography. The discussion will explain the fundamental principles behind each technique and how they're applied to separate the desired drug molecule from unwanted impurities or byproducts.The conversation will also delve into the challenges of scaling up

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18:57

79 – Reactor Design & Scale-Up Challenges (S6E4)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode examines the critical role of reactor design in scaling up chemical reactions from small laboratory flasks to large industrial reactors. We'll explore the fundamental differences between various reactor types, including batch reactors and continuous flow reactors. The discussion will focus on how these differences impact key process parameters like heat transfer, mixing, and reaction kinetics.The conversation will center on the challenges that arise when scaling up, such as temperature

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16:21

78 – Process Optimization & QbD Principles (S6E3)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode explains the core principles of Quality by Design (QbD) in pharmaceutical manufacturing, emphasizing its role in creating robust and reproducible processes. The conversation centers on identifying critical process parameters (CPPs) – those key variables that directly impact the critical quality attributes (CQAs) of the final drug product. We'll explore how manufacturers use techniques like design of experiments (DOE) to systematically understand the relationship between CPPs and

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19:01

77 – Process Chemistry: From Bench to Plant (S6E2)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

Dive into the world of process chemistry, the critical discipline that bridges the gap between laboratory discoveries and commercial drug production. This episode unpacks how process chemists take reactions that work beautifully on a small scale and adapt them to the vastly different demands of industrial manufacturing. We'll explore the nuances of optimizing reaction conditions, such as temperature, pressure, and mixing, and how these factors behave differently at large scales.The discussion will

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10:36

76 – Introduction to Drug Manufacturing & Scale-Up...

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/20

This episode provides a broad overview of the fascinating and complex journey a drug takes from initial lab discovery to large-scale industrial manufacturing. We'll discuss the fundamental differences between creating milligram quantities of a new chemical entity (NCE) in a research setting versus producing kilograms or even tons in a factory. The discussion will cover the vital role of "Process Chemistry". Key concepts like yield, purity, and safety will be explained, emphasizing how they become

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17:50

75 – Season 5 Recap & Lessons Learned (S5E15)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/14

This episode provides a comprehensive recap of the key insights from Season 5, focusing on Phase 3 clinical trials and the drug approval process. We revisit the critical lessons learned, highlighting the importance of robust trial design, meticulous data collection, and rigorous statistical analysis. We connect the dots between successful trial outcomes, regulatory achievements, and ultimately, the launch of new medicines into the market. We also discuss the challenges and complexities of this

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19:04

74 - Global Regulatory Harmonization (S5E14)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/14

This episode explores the ongoing efforts to align regulatory standards for drug approvals globally and their significant impact on the pharmaceutical landscape. We discuss the challenges posed by diverse regulatory requirements across different countries and the historical context that led to the formation of the International Council for Harmonization (ICH). We examine the roles of key regulatory agencies, including the FDA, EMA, and PMDA, and how the ICH facilitates collaboration and

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10:01

73 - Handling Regulatory Feedback & Resubmissions...

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/14

This episode provides strategies for effectively addressing regulatory feedback and navigating the resubmission process when needed. We emphasize the importance of clear, concise, and data-driven responses to regulatory inquiries, and how to respectfully address disagreements or conflicting information. We discuss the various types of FDA meetings (Type A, B, and C) and their strategic use in proactively engaging with regulators throughout the drug development process. We also explain how

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14:38

71 - Accelerated Approval & Breakthrough Therapies...

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/14

This episode explores alternative approval pathways for drugs addressing serious conditions, focusing on accelerated approval and breakthrough therapy designation. We discuss the criteria for these pathways, emphasizing the role of surrogate endpoints in accelerated approval and the requirement for confirmatory post-marketing studies. We explain how breakthrough therapy designation can significantly expedite drug development and review for serious or life-threatening conditions based on promising

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13:19

72 - Post-Approval Commitments and Phase IV (S5E12)

From Concept to Medicine - A Comprehensive Drug... ·

2025/04/14

This episode focuses on the critical phase of post-market drug surveillance, including post-approval commitments and Phase 4 studies. We discuss the shift in focus from early-phase clinical trials, which prioritize safety and initial efficacy, to long-term safety and effectiveness in a much wider patient population. We explain the concept of surrogate endpoints and how they can be used to support accelerated approvals, emphasizing the importance of post-marketing studies to confirm clinical benefit

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