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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

9:20

130 - Automation in Analytical Labs (S9E10)

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

2025/05/10

Explore how automation, robotics, and AI are transforming routine and complex analytical workflows within analytical labs. Uncover the various methods this all comes about and the means for automating it all. Hear the impact of what can come about and why those initial steps are important. Touch upon the technology aspect that can automate liquid processes with mass spectrometry.Examine the many different technologies with automated systems that can come about with a more complete metabolic profile

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13:04

129 - Case Study: Tackling Complex Impurities (S9E9)

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

2025/05/10

Delve into a case study that walks through identifying, characterizing, and mitigating complex impurities with advanced analytical tools. Take a look at collaborative methods, and the importance of this collaborative work to ensure effectiveness. Hear how teams use chemistry, data, analysis, and more to understand exactly what is happening and what, if any, dangers they may pose to a consumer. Explore the processes used by analytical chemists to be impurity detectives as they test new medicines.Gain

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15:24

128 - Data Integrity in QC (S9E8)

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

2025/05/10

Uncover the high importance of data integrity in analytical labs, focusing on ALCOA+ principles and secure electronic systems. Learn what is meant by all of the above, the framework for quality and reliability, starting with attributable. Examine how it needs to be as trustworthy in systems, as it is to get it on paper, by securing controls. Gain insight into the purpose of audits, and look at how they prepare those responsible, along with reviewing potential consequences that would result from not

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8:30

127 - Process Analytical Technology (PAT) (S9E7)

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

2025/05/10

Examine Process Analytical Technology (PAT) and its significant function in monitoring crucial attributes of quality during the manufacturing process. Highlight the use of spectroscopic probes and how these high tech instruments use light in a clever way. Look at real-time sensors and their power as indicators, along with a host of factors, and highlight how Multivariate data analysis is used. Discuss PAT and how it improves effectiveness, reduces failures, improves quality, and leads to streamlined

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16:27

126 - Stability Testing & Forced Degradation (S9E6)

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

2025/05/10

Learn how forced degradation studies guide stability indicating method development and inform formulation design. Examine the purpose behind "torturing" the ingredients and subjecting them to all sorts of conditions. Hear how stresses from temperature and light actually impact a drug and lead to water. Walk through the ways these changes come about, and their impact, such as a product becoming hydrolyzed when exposed to water.The exploration then examines real world applications, such as controlling

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11:52

125 - Dissolution Testing & Bioequivalence (S9E5)

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

2025/05/10

Explore dissolution testing's vital role in predicting in vivo drug performance and supporting bioequivalence, especially for generic drugs. Uncover how it uses a variety of specialized apparatus to replicate various stomach and intestinal environments, and then simulates digestion. The analysis highlights the significance of carefully choosing the right liquid medium and apparatus to truly capture dissolution dynamics. Discuss how it helps ensure generic and brand name versions release the drug in

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21:19

124 - Spectroscopy & Quality Control (S9E4)

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

2025/05/10

Explore key spectroscopic techniques, such as UV-Vis, IR, Raman, and NMR, while focusing on their critical roles in identifying compounds, verifying purity, and characterizing formulations. The discussion underscores how molecules interact with electromagnetic radiation to enable the techniques for structural and compositional insight. These techniques help determine what a product's ingredients actually are, and provide the necessary quality control. Dive into common uses for the tools and their

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11:23

123 - Mass Spectrometry in Drug Analysis (S9E3)

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

2025/05/10

Examine how mass spectrometry (MS) helps to generate a super detailed molecular profile in drug analysis, and in effect offers that unique fingerprint for that batch of a drug. Explore ways to identify and deal with impurities in drugs, to help ensure medication safety. Gain insight into resolution and sensitivity as it applies to the detective work in MS testing. Learn about various mass spectrometers, and how they are specially designed to solve complex analytical challenges.Learn how

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11:43

122 - Innovations in Chromatography (S9E2)

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

2025/05/10

Explore the cutting-edge innovations revolutionizing chromatography, especially in techniques like HPLC, UPLC, and SFC. Discuss the continuous improvements in speed, resolution, and sensitivity that are making lab work more efficient, particularly in drug discovery and development. See how new medicines benefit from the advantages of speed and accuracy, critical factors in drug development processes. Delve into the science behind these advancements, understanding both their implementation and

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18:34

121 – Advanced Analytical Techniques Overview (S9E1)

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

2025/05/10

Delve into the fascinating world of advanced analytical techniques that underpin drug development and quality control. This episode illuminates the science ensuring the medicines we rely on are safe, effective, and of consistent quality. Gain insights into the mountain of sources driving this field, spanning pharmacokinetics (how drugs move through the body), drug interactions, and the latest in high-throughput screening for new drug candidates. Explore the crucial role of automation, robotics, and

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24:31

120 – Season 8 Recap & Future Outlook (S8E15)

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

2025/05/04

Recap and reflection over the regulatory affairs, post-marketing surveillance and pharmacovigilance season. Looping back around on the key points and concerns with a forward looking attitude toward future directions and trending.

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8:41

119 – Emerging Trends in Regulatory Science (S8E14)

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

2025/05/04

This episode explores the innovations that are transforming regulatory science, including adaptive pathways, AI-driven analytics, and real-time monitoring. We discuss how these technologies are accelerating drug approvals, enhancing safety assessments, and streamlining compliance processes. The conversation highlights the shift towards a more flexible, data-driven, and patient-centered approach to drug regulation.Recent literature and real-world case studies are used to illustrate the advancements

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11:44

118 – Digital Tools in Surveillance (S8E13)

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

2025/05/04

This episode explores how digital technologies and data analytics are transforming pharmacovigilance and post-market surveillance. We discuss the use of mobile apps, wearables, AI-driven analytics, and big data integration in detecting adverse events and improving patient safety.The conversation highlights real-world applications, such as the FDA's Sentinel Initiative, AI signal detection, and real-time patient monitoring tools. Case studies are used to illustrate the impact and challenges of these

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15:36

117 – Patient Registries & Long-Term Studies (S8E12)

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

2025/05/04

This episode examines how patient registries support long-term safety and outcome studies in the pharmaceutical industry. We discuss the design, data collection, and analytical methods used in these registries. The conversation highlights their role in tracking rare adverse events, assessing treatment effectiveness over time, and understanding disease progression.Real-world examples from chronic disease registries, post-market drug monitoring programs, and biologics safety studies are used to

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11:42

116 – Real-World Evidence Impact (S8E11)

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

2025/05/04

This episode delves into the increasing importance of real-world evidence (RWE) in informing post-approval drug safety and effectiveness assessments. We discuss key data sources, including electronic health records (EHRs), insurance claims data, patient registries, and even social media. Analytical platforms, such as AI-driven signal detection and machine learning models, are explored.The conversation highlights how RWE influences regulatory decisions, label updates, and the development of risk

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16:28

115 – Labeling Changes & Post-Market Commitments (S8E10)

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

2025/05/04

This episode explores how drug labels evolve after a medication has been approved, including safety updates, new indications, and the addition of black box warnings. We discuss the regulatory commitments that companies must meet, such as post-market studies and REMS (Risk Evaluation and Mitigation Strategies) requirements. Examples of communicating with healthcare professionals and examples are shared.The conversation highlights communication strategies for informing healthcare providers and

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24:57

114 – Case Study: Navigating a Regulatory Challenge...

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

2025/05/04

This episode presents a case study of a pharmaceutical company overcoming a post-approval regulatory hurdle. The discussion focuses on the strategies employed, including negotiation with regulatory agencies, problem-solving approaches, and the ultimate resolution of the challenge. The importance of being dynamic, and the historical context of drug regulation are highlighted.Real-world examples, such as Vioxx (market withdrawal due to cardiovascular risks) and Thalidomide (birth defects leading to

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11:59

113 – Regulatory Inspections & Audits (S8E8)

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

2025/05/04

This episode outlines the inspection and audit processes used by regulatory agencies, such as the FDA, to ensure compliance with regulations in drug manufacturing and clinical trials. The conversation covers preparation for inspections, the conduct of audits, and follow-up steps. Documented examples highlight key aspects of the process.We highlight real-world examples of enforcement actions, including Form 483 observations, warning letters, and consent decrees, to illustrate the consequences of

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16:08

112 – Global Regulatory Variations (S8E7)

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

2025/05/04

This episode examines the key differences in regulatory requirements across major global markets, including the US (FDA), Europe (EMA), Japan (PMDA), and China (NMPA). We explore efforts towards global harmonization through the ICH (International Council for Harmonization) and discuss the challenges of aligning standards across different regions. We touch on pre-clinical data, clinical trials, bioavailability, and bioequivalence studies.The conversation highlights the impact of these variations on

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9:49

111 – REMS and Risk Mitigation Strategies (S8E6)

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

2025/05/04

This episode focuses on Risk Evaluation and Mitigation Strategies (REMS) and their crucial role in ensuring drug safety post-approval. We explore how REMS programs are developed, implemented, and monitored, highlighting key components such as ETASU (Elements to Assure Safe Use), communication plans, and monitoring requirements. The discussion emphasizes the collaborative effort between regulators and industry in designing and executing these programs.Real-world cases are used to illustrate the

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270 results

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