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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

45:55

50 – Phase 1 Case Study & Lessons Learned (S4E5)

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

2025/04/06

This episode delves into a real-world case study of a Phase 1 clinical trial, focusing on the challenges and key takeaways from the experience. We follow the journey of a new drug designed to treat a neurological condition, highlighting the complexities of oral drug delivery and the unexpected safety signals encountered during the trial, such as gastrointestinal problems and elevated liver enzymes. The discussion emphasizes the importance of adaptive trial protocols, which allow researchers to make

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17:30

49 – Dose Escalation & Determining MTD (S4E4)

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

2025/04/06

This episode focuses on dose escalation, a critical process in early-phase clinical trials used to determine the Maximum Tolerated Dose (MTD) of a new drug. We explain how researchers gradually increase the dosage given to small groups of patients (cohorts) while carefully monitoring for any adverse effects. The discussion explores the specific decision criteria used to determine when to escalate the dose and when to stop, based on the severity and frequency of side effects. Real-world case studies,

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13:41

48 – PK/PD in Phase 1 (S4E3)

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

2025/04/06

This episode explores the simultaneous evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) in early human trials, also known as Phase 1 studies. We discuss how these two concepts work together to help researchers understand a new drug's behavior in the human body, including its absorption, distribution, metabolism, and excretion (ADME), as well as its effects on cells, tissues, and organs. The discussion uses illustrative examples, such as the development of blood pressure medications and

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16:04

47 - Designing Phase 1 Safety Trials (S4E2)

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

2025/04/06

This episode delves into the intricate design of Phase 1 safety trials, emphasizing the paramount importance of volunteer safety. We explore dosing regimens, ethical considerations, and the specific procedures used to ensure the well-being of participants. The discussion covers the structure of trial protocols, including informed consent procedures, and adaptive safety measures that allow for adjustments during the trial based on emerging safety data. The role of regulatory bodies like the

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13:58

46 – Phase 1: First-in-Human Studies Overview (S4E1)

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

2025/04/06

This episode introduces the crucial first stage of clinical trials where a new drug is administered to humans for the very first time. We explore the primary objectives of Phase 1 trials, which are to assess safety, determine safe dosage ranges, and understand how the drug is processed in the human body (pharmacokinetics). The discussion also covers the importance of ethical considerations, particularly informed consent, and the selection of participants, often healthy volunteers. Real-world

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30:27

45 - Season 3 Recap & Transition to Clinical Trials...

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

2025/03/30

This episode provides a comprehensive recap of the key concepts covered in Season 3, focusing on preclinical pharmacokinetics and setting the stage for the exciting transition to human testing in clinical trials. We'll revisit essential terms like volume of distribution, elimination half-life, clearance, and absorption, reinforcing their importance in understanding how drugs behave in the body. We'll also review the crucial role of ethical considerations and regulatory guidelines from the FDA and

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12:14

44 - Risk Management in Preclinical Phase (S3E14)

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

2025/03/30

Dive into the essential world of risk management in the preclinical phase of drug development. This episode explores how scientists identify, assess, and mitigate risks before a new drug is even tested in humans. We'll discuss the use of risk matrices and decision frameworks, highlighting their strengths and limitations in visualizing and prioritizing risks. Using real-world case studies, including challenges in developing new delivery systems and absorption issues, we'll demonstrate how proactive

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18:54

43 - Integrating Preclinical Data for IND (S3E13)

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

2025/03/30

This episode explores the crucial process of integrating preclinical data to create a compelling IND application, the gateway to human clinical trials. We delve into how toxicology, PK, and efficacy data are synthesized into a cohesive narrative that tells the complete story of a drug. We'll discuss the importance of data integration, highlighting how different pieces of the puzzle fit together to make a strong argument for testing the drug in people. Using real-world examples, including the

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31:14

42 - Case Study: Preclinical Success Story (S3E12)

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

2025/03/30

Dive into a real-world success story of a drug that navigated the challenging preclinical phase and achieved the milestone of a successful IND submission. This episode offers an inside look at the strategies that helped this drug overcome obstacles, highlighting the power of scientific ingenuity, meticulous research, and collaboration. We'll explore the crucial role of pharmacokinetics in drug development, focusing on how researchers overcame bioavailability issues and optimized the drug's journey

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12:57

41 - Preclinical Regulatory Interactions (S3E11)

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

2025/03/30

Explore the crucial, often unseen world of preclinical regulatory interactions, where communication between drug developers and regulatory agencies like the FDA and ICH can make or break a new drug's success. This episode focuses on how early meetings with regulators shape study design, data requirements, and ultimately, the entire drug development process. We'll discuss the importance of seeking guidance from experts at the FDA and other regulatory bodies, using real-world examples to demonstrate

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10:01

40 – Immunogenicity Assessment in Biologics (S3E10)

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

2025/03/30

Dive into the complex world of immunogenicity assessment in biologics, exploring how our immune systems interact with these advanced medications derived from living organisms. This episode focuses on the challenges of immunogenicity, where our bodies can react to biologics as foreign substances, potentially impacting treatment effectiveness and causing unwanted side effects. We'll explore the sophisticated tools scientists use to detect and measure these immune responses, including ELISA and flow

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6:28

39 - Stability Testing in Preclinical Phase (S3E9)

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

2025/03/30

This episode focuses on the crucial role of stability testing in the preclinical phase of drug development, ensuring a drug candidate's integrity throughout its journey from the lab to the patient. We explore how drugs are subjected to various stress tests, mimicking real-world conditions like temperature swings, humidity, and light exposure, and how these tests help determine the drug's shelf life and appropriate storage conditions. We'll also discuss how stability data guides formulation

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12:34

38 - Bioanalytical Method Development (S3E8)

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

2025/03/30

Explore the fascinating world of bioanalytical method development, where scientists devise incredibly precise methods to measure drug levels in biological samples. This episode focuses on developing highly sensitive assays for PK and safety studies, enabling researchers to track a drug's journey through the body and monitor its safety profile. We'll discuss key concepts like accuracy, precision, sensitivity, and specificity, highlighting the importance of rigorous validation to ensure reliable

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44:45

37 - CMC Considerations in Preclinical Stage (S3E7)

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

2025/03/30

Venture behind the scenes of early-stage drug development and explore the often-overlooked but critical world of Chemistry, Manufacturing, and Controls (CMC). This episode focuses on the preclinical CMC work that ensures a drug candidate not only works but can be consistently manufactured at scale. We delve into the challenges of lab-scale synthesis, such as the availability and cost of starting materials and the complexity of scaling up production while maintaining quality. We'll discuss strategies

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12:42

36 - IND-Enabling Studies Overview (S3E6)

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

2025/03/30

This episode provides a comprehensive overview of the studies required to support an Investigational New Drug (IND) application, the crucial step that takes a new drug from the lab to human trials. We focus on the three main pillars: toxicology, pharmacokinetics (PK), and efficacy. Toxicology studies ensure the drug's safety, PK studies track its journey through the body, and efficacy studies demonstrate its effectiveness. We'll explore how these studies are meticulously designed and conducted,

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21:27

35 - Preclinical Efficacy Models (S3E5)

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

2025/03/30

Uncover the crucial role of preclinical efficacy models in demonstrating a drug candidate's potential before human trials even begin. This episode explores both in vivo (animal) and in vitro (laboratory) models, highlighting the strengths and limitations of each approach. We delve into the complexities of model selection, considering factors like the disease being targeted and the drug's mechanism of action. We also discuss the concept of predictive power, which assesses how accurately a model's

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13:46

34 - Dose Range Finding Studies (S3E4)

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

2025/03/30

This episode explores the critical process of determining the right dose for a new drug, a delicate balance between effectiveness and safety. We focus on dose-range finding studies in animal models, where researchers seek that "sweet spot"—a dose that works without causing harmful side effects. We'll discuss various dosing schedules, from single-dose studies for initial understanding to repeated-dose studies for long-term effects, and examine how different routes of administration impact dosing

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9:53

33 - Safety Pharmacology & Off-Target Screening (S3E3)

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

2025/03/30

Dive into the critical realm of early safety testing in drug development, focusing on safety pharmacology and off-target screening. This episode explores how scientists identify and mitigate potential risks associated with new drugs before they even reach human trials. We'll discuss essential safety assays like the hERG assay for heart risks and liver enzyme assays for liver toxicity. We'll also explore the broader concept of off-target effects, where a drug interacts with unintended targets in the

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8:33

32 - Pharmacokinetics in Preclinical Testing (S3E2)

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

2025/03/30

Explore the fascinating world of pharmacokinetics (PK) in preclinical testing, where scientists unravel the mysteries of a drug's journey through the body. We focus on ADME studies—absorption, distribution, metabolism, and excretion—conducted in animal models, providing crucial insights for predicting human doses. This episode delves into the experimental techniques used to track a drug's movement and transformation within the body, and how this data is interpreted to project safe and effective

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23:20

31 - Preclinical Toxicology Studies (S3E1)

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

2025/03/30

Delve into the critical world of preclinical toxicology studies, the essential stepping stone before a new drug can even be considered for human trials. These studies, encompassing acute, subchronic, and chronic designs, are the bedrock of ensuring drug safety, identifying potential hazards early on. We'll explore how scientists use these studies to evaluate a drug's safety profile, examining the different study designs and their specific focuses. We'll also unpack the crucial endpoints examined in

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270 results

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