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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

19:40

Celecoxib (Celebrex) (S24E6)

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

2025/07/13

In this episode of From Concept to Medicine, we dive into the story of Celecoxib, the first blockbuster COX-2 selective NSAID, widely known by its brand name Celebrex. Designed to relieve pain and inflammation with fewer gastrointestinal side effects than traditional NSAIDs, Celecoxib emerged from decades of pharmaceutical research seeking the elusive “safer NSAID.” We explore how it fits into the broader evolution of pain relief—from aspirin to ibuprofen to diclofenac—and trace its development as a

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31:36

Diclofenac (S24E5)

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

2025/07/07

In this episode of The Deep Dive, we explore the complex and often surprising story of Diclofenac, a pain reliever that’s as powerful as it is controversial. From its origins in the labs of Ciba-Geigy in the late 1960s to its widespread use today in pills, gels, patches, and even eye drops, Diclofenac has become a global staple in pain management. But what sets it apart isn’t just its therapeutic power—it’s the intricate balance of its benefits and risks. We unpack the science behind how it works on

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20:47

Naproxen (S24E4)

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

2025/07/07

In this illuminating episode of The Deep Dive, we trace the remarkable journey of Naproxen—from its surprising roots in steroid chemistry using Mexican yams to its rise as one of the most familiar over-the-counter pain relievers on the market. We explore how Syntex, a pioneer in hormone synthesis, pivoted to pain relief innovation in the late 1960s, and how that pivot led to the development of a longer-lasting alternative to ibuprofen. Along the way, we uncover the brilliant scientists behind the

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29:40

Ibuprofen (S24E3)

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

2025/07/07

In this episode, we dive deep into ibuprofen, one of the most widely used non-steroidal anti-inflammatory drugs (NSAIDs) in the world. From its discovery in the 1960s to its current status as a household name, we explore the fascinating journey of this versatile medication. We'll examine its unique mechanism of action, comparing it to aspirin and other pain relievers, while discussing its role in managing various conditions from headaches to arthritis. The episode also delves into the groundbreaking

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28:51

Acetaminophen (S24E2)

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

2025/07/07

Join us as we explore acetaminophen, one of the most widely used pain relievers in the world. We'll dive into the fascinating journey of how this medication evolved from its discovery to becoming a household name as Tylenol. Through engaging discussions and real-world examples, we'll examine its mechanism of action, proper usage guidelines, and why it has become the go-to choice for fever and pain relief in many situations. Our conversation will also cover important safety considerations, including

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26:29

Aspirin (S24E1)

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

2025/07/07

Join us for a fascinating exploration of one of humanity's oldest and most influential medicines - aspirin. In this inaugural episode, we dive deep into the remarkable journey of acetylsalicylic acid, from its ancient origins in willow bark to its modern-day applications. Our expert guests will guide us through the pivotal moments in aspirin's history, including its groundbreaking synthesis at Bayer, the revolutionary discoveries about its mechanism of action, and its evolution from a simple pain

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19:23

63 - Audit Readiness and Continuous Improvement in...

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

2025/06/02

This episode offers listeners a chance to become more knowledgeable on how they can audit preparedness, by using internal audits. We will discuss corrective action processes and share strategies for ensuring ongoing quality improvement.Our goal is to help empower these organization with information on how to maintain compliance and risk management. The ultimate intention is to show how this can ensure that clinical operations stay strong, aligned with the most current cGCP regulations, transparent,

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16:38

62 - Documentation, Informed Consent, and Safety...

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

2025/06/02

This episode serves as a refreshing dive into the key aspects of documentation in clinical trials, making it much more than a dry overview. We'll journey through aspects of informed consent procedures, adverse event reporting, and the very best record-keeping practices.Ultimately, the intention of this exploration is to provide reliable guidance on how to maintain accurate audit trails. By the end, it will be much more clear that all documentation needs to not only meet regulatory standards but also

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20:30

61 - Operational Excellence in Clinical Trials...

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

2025/06/02

In this episode, we revisit the critical operational components that make up clinical research. This discussion will offer effective methods for monitoring the study process and the key quality assurance procedures that are necessary to support compliance.We have prepared some practical advice that will give insight into optimizing your processes and will include how to successfully manage risk and prepare for audits. The overall goal is to make these clinical processes as efficient as possible

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20:02

60 – cGCP Fundamentals and Regulatory Overview (S23E1)

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

2025/06/02

his episode recaps the essential principles of current Good Clinical Practice (cGCP) and provides a comprehensive overview of the regulatory framework governing clinical trials. We emphasize the key ethical, legal, and operational standards that underpin this framework. A core focus is on how these concepts work to protect participants involved in research and simultaneously ensure the delivery of high-quality research outcomes. Ultimately, our mission is to provide listeners with a clear and

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23:26

59- Data Integrity, Informed Consent, and...

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

2025/06/02

This episode explores the fundamental principles of data integrity and its importance in ensuring trial trustworthiness. It delves into the critical role of informed consent, which is the ethics and heart of clinical research, emphasizing the need for willingly and knowingly involved people in these trials. Finally, it explores the best practices in recordkeeping for clinical trials.Finally, the use of key terms like audit trails and source data verification, is discussed, and the practical

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14:28

57 - Protocol Design, Investigator Responsibilities,...

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

2025/06/02

This episode explores the fundamental components of clinical trial protocols, the roles assumed by investigators in these trials, and the essential nature of thorough documentation. It will focus on the importance of having well-defined objectives and how researchers need to be on the same page about how to collect data and how to analyze it. From there, the need for safety monitoring and appropriate protocols is examined.It also discusses how meticulously designed protocols, comprehensive training

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16:16

58 - Risk Management and Quality Assurance in...

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

2025/06/02

This episode explores the critical processes of risk management and quality assurance within the clinical research environment. It will focus on GMPs, premises, processes, products, and procedures, and how they impact quality. Beyond that, the episode discusses the physical space of equipment and how that impacts the final product.The episode details effective strategies for monitoring compliance, managing deviations from protocols, and implementing CAPA (Corrective and Preventative Action)

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11:45

56 - The Historical Evolution of cGCPs (S22E2)

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

2025/06/02

This episode traces the progression of cGCP standards, commencing from the foundational ethical principles of early clinical research through to the contemporary regulatory landscape. Key milestones are examined, accompanied by landmark cases and regulatory transitions that have significantly shaped current practices in the field. Understanding how these elements came to be what they are today will make the reasoning behind them more obvious.The episode further examines how these historical

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18:17

55 - What are cGCPs? Foundations and Ethical...

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

2025/06/02

This episode defines current Good Clinical Practices (cGCPs) and explores their pivotal role in safeguarding trial participants and ensuring the integrity of data. It delves into the ethical considerations inherent in clinical research, emphasizing the significance of informed consent as a cornerstone of ethical practice. The discussion also highlights the critical importance of meticulous protocol design in establishing a solid foundation for robust clinical research. Furthermore, the episode

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17:05

54- Compliance, Enforcement, and Audit Mechanisms...

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

2025/06/02

Details and explains the enforcement mechanisms that regulatory agencies employ to make sure cGCP compliance. Also explained is the role that audit procedures, risk-based inspections, and corrective actions have.This includes the ways that all of the previous measures drive continuous improvement and to safe guard participant safety in clinical research. Discussions on good documentation practices will take place, the types of audits are performed, and the role they take in maintaining GCP

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15:00

53 – ICH Guidelines and Global Harmonization (S21E4)

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

2025/06/02

This is a dive into ICH guidelines, specifically E6(R2), which is a corner stone of current Good Clinical Practices, that shapes cGCP worldwide. We discuss the reasoning behind harmonization efforts and the way these standards are influencing national regulations.This also discusses that ICH Guidelines, particularly the E6 R2 guideline, is about ensuring that clinical trials are conducted ethically. There is a focus on patient safety throughout every step. Practical implications for multinational

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18:44

52 - European and International Regulatory...

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

2025/06/02

Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences.Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This

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28:20

51 – In-Depth Analysis of FDA cGCP Regulations (S21E2)

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

2025/06/02

This episode dives into the complex world of U.S. regulations for clinical trials. Examine the detailed provisions within U.S. regulations for clinical trials as we explain how FDA guidance documents, relevant sections of 21 CFR, and associated Q&A documents shape current clinical practices. We will also break down enforcement strategies, such as inspection protocols, providing practical examples of regulatory interpretations to ensure adherence to cGCP requirements.We'll discuss how the

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22:40

50 – Overview of the cGCP Regulatory Landscape (S21E1)

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

2025/06/02

Delve into the expansive regulatory framework that governs clinical trials. Discover the critical roles played by key agencies such as the FDA, EMA, and WHO, and understand how ICH guidelines, like ICH E6(R2), fit into the overall picture. We'll also explore the history and evolution of these regulations, tracing their origins and how they've adapted over time. This episode will highlight the interconnectedness of these regulations, revealing how they form a global system dedicated to ethical

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270 results

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