• From Concept to Medicine - A Comprehensive Drug Development Journey

  • De: Jim Mitchell
  • Podcast

From Concept to Medicine - A Comprehensive Drug Development Journey

De: Jim Mitchell
  • Resumen

  • 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 transforms a promising compound into a fully approved, market-ready medicine. Each episode is a deep dive into the critical stages of drug development, including:

    🔬 Drug Discovery: Where innovation begins—exploring cutting-edge research, target identification, and the quest for the next medical breakthrough.

    🧪 Preclinical Testing: Investigating safety, efficacy, and mechanisms of action before a drug ever reaches human trials.

    👩‍⚕️ Clinical Trials: The rigorous, high-stakes world of human testing—what works, what fails, and what it takes to get to the finish line.

    📜 Regulatory Approval: Understanding the intricate web of global regulatory agencies, FDA submissions, and the make-or-break moments for new drugs.

    🏭 Manufacturing & Scale-Up: From lab to large-scale production—how pharmaceutical companies tackle formulation, stability, and distribution challenges.

    💰 Market Access & Commercialization: The economics of drug development—pricing, market dynamics, and the delicate balance between innovation and accessibility.

    Whether you're a scientist, industry professional, investor, or simply fascinated by the inner workings of the pharmaceutical world, this podcast brings you expert insights, real-world case studies, and in-depth discussions on the past, present, and future of drug development.

    Join us as we demystify the science, strategy, and business behind the medicines that change lives. Subscribe now and be part of the journey!

    04/28/25 - Public Beta for early access to the cGXP regulatory training module is open now here: https://firstpenguinproductions.notion.site/From-Concept-to-Medicine-A-Complete-Drug-Development-Journey-with-cGXP-Guidance-and-Training-Mod-1c1fcd6a5f5880e9b689f1f8c5b5fc09

    Jim Mitchell 2025
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Episodios
  • 105 – Season 7 Recap & Future Directions (S7E15)
    Apr 27 2025

    This episode recaps the key formulation and drug delivery advancements covered throughout Season 7, connecting the major takeaways to future regulatory and post-marketing challenges. It discusses how lessons learned from past experiences are shaping the next wave of innovation in drug product design. The episode previews upcoming topics, including compliance, real-world effectiveness, and evolving industry trends, fostering a forward-looking discussion that links past insights to future opportunities.

    Beyond simply summarizing the season's content, this episode provides a comprehensive overview of the advancements and challenges in drug formulation and delivery. The discussion emphasizes the importance of understanding drug properties, such as solid-state properties and polymorphism, for optimizing drug performance and ensuring consistency. Furthermore, the episode highlights the crucial role of liposomes and other advanced delivery systems in enhancing drug bioavailability and enabling targeted therapy. The regulatory landscape is also revisited, emphasizing the importance of bioequivalence studies and stability testing for ensuring drug quality and safety. Finally, the episode looks ahead to the future of drug development, exploring the potential of personalized medicine, continuous manufacturing, and modeling and simulation to transform how we design and deliver drugs.

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    24 m
  • 104 – Advanced Drug Delivery Systems (S7E14)
    Apr 27 2025

    This episode explores next-generation drug delivery technologies, including nanocarriers, liposomes, and implantable devices. It delves into the science behind these innovations, highlighting their advantages over conventional methods and showcasing their real-world clinical applications. The discussion emphasizes how these advanced systems improve drug efficacy, reduce side effects, and enable targeted therapies, providing practical examples.

    Beyond simply administering medication, advanced drug delivery systems aim to optimize drug distribution and efficacy within the body. The episode highlights the enhanced permeation and retention (EPR) effect of nanocarriers in targeting diseased tissues and the versatility of liposomes in improving drug solubility and protecting drugs from degradation. Furthermore, the discussion explores the benefits of implantable devices for delivering medication over extended periods, reducing the frequency of dosing and maintaining consistent drug levels. The episode also touches on the regulatory challenges and safety considerations associated with these advanced systems, emphasizing the need for rigorous testing and careful monitoring. Finally, the episode explores the broader applications of these technologies beyond cancer and inflammatory diseases, including their potential use in treating infectious diseases and neurological disorders.

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    17 m
  • 103 - Patient-Centric Design in Drug Delivery (S7E13)
    Apr 27 2025

    This episode examines how patient-focused formulation strategies can enhance treatment adherence and improve therapeutic outcomes. It explores innovations in user-friendly dosage forms, delivery devices, and personalized medicine, highlighting their real-world clinical applications. The discussion emphasizes the impact of factors like ease of use, dosing convenience, and patient preferences on treatment success, providing practical examples of how design choices improve patient experience and health outcomes.

    Beyond simply developing effective drugs, patient-centric design focuses on making treatments easier and more convenient for patients to use. The episode highlights the importance of considering factors like the physical form of the drug, its solubility, and its stability when designing dosage forms. Furthermore, the discussion explores the role of advanced technologies like cryo-probe NMR spectroscopy and process analytical technology (PAT) in optimizing drug formulations and ensuring consistency. The episode also touches on the importance of considering the route of administration and the use of targeted drug delivery systems to enhance efficacy and reduce side effects. Finally, the episode delves into the exciting field of personalized medicine, exploring how artificial intelligence and an understanding of patient-specific factors like genetics and metabolism can be used to tailor treatments and improve outcomes.

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    16 m
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