From Concept to Medicine - A Comprehensive Drug Development Journey Podcast Por Jim Mitchell arte de portada

From Concept to Medicine - A Comprehensive Drug Development Journey

From Concept to Medicine - A Comprehensive Drug Development Journey

De: Jim Mitchell
Escúchala gratis

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!

Access the Notion Template for cGXP Training Modules here: https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module

***Information in this podcast series is for education only and not meant to construe medical advice. For that, please consult your health care professional.***

Jim Mitchell 2025
Ciencia Educación Química
Episodios
  • Azithromycin (S24E10)
    Jul 13 2025

    Azithromycin may be the most recognizable “Z-Pak” in the pharmacy, but its journey from Eastern European innovation to global blockbuster is anything but ordinary. This episode follows its origins as a chemical upgrade to erythromycin, engineered for better stability, longer half-life, and deeper tissue penetration. That dual-action—antibacterial and immunomodulatory—helped it conquer a wide array of infections, from respiratory illnesses and STIs to chronic inflammation. Its ability to accumulate inside white blood cells made it a favorite for targeting hard-to-reach bacteria.

    However, that convenience has come at a price. We explore azithromycin’s blockbuster sales history, its generic boom, and the intense regulatory scrutiny following studies linking it to cardiac arrhythmias. We revisit its controversial use during the COVID-19 pandemic and its real-world impact through mass drug administration campaigns for trachoma and child mortality reduction. With resistance on the rise and regulatory agencies issuing warnings, azithromycin’s story is a microcosm of our antibiotic dilemma—miracle or menace, depending on how we use it.

    Más Menos
    19 m
  • Erythromycin (S24E9)
    Jul 13 2025

    Erythromycin has been punching above its weight for decades. In this episode, we chart its rise from a soil-derived discovery by Saccharopolyspora erythraea to its position as a foundational macrolide antibiotic. Known for jamming the protein production machinery in bacteria, erythromycin treats everything from strep throat and pneumonia to neonatal eye infections and even gastroparesis. Its ability to speed up gut motility gives it a unique niche outside of traditional antimicrobial roles.

    Yet erythromycin’s legacy isn’t just pharmacological—it’s deeply regulatory and economic, too. We dig into its FDA and EMA approval pathways, the importance of GMP, and how different salt forms cater to clinical needs across oral, topical, and injectable products. We also explore manufacturing via microbial fermentation, the market dynamics behind generics, and the global impact on access and affordability. But with widespread use comes resistance, and erythromycin’s story is increasingly tied to the cautionary tale of antimicrobial stewardship. It remains a crucial tool, but one with limitations that demand attention.

    Más Menos
    16 m
  • Amoxicillin (S24E8)
    Jul 13 2025

    Amoxicillin is everywhere—from pediatricians’ offices to disaster relief kits—and for good reason. In this episode, we dive into its 1970s debut as a more bioavailable cousin to ampicillin, crafted by Beecham Laboratories. We unpack its role as a semi-synthetic penicillin, its mechanism of action as a beta-lactam antibiotic, and why its oral absorption made it a clinical favorite. Whether it’s tackling strep throat, UTIs, skin infections, or part of a triple therapy for H. pylori ulcers, amoxicillin’s versatility and safety profile make it a first-line defense for millions.

    But its ubiquity belies a complex global story. We explore the economics of manufacturing, the regulatory hurdles around dispersible tablets for children, and its critical role in public health programs like UNICEF’s pneumonia treatment campaigns. Beyond the capsule, we confront issues of overprescription, allergy mislabeling, and antibiotic resistance—especially in low-resource settings. As a drug that’s both life-saving and overused, amoxicillin embodies the paradox of modern medicine: easy to take, but not always easy to preserve.

    Más Menos
    36 m
Todavía no hay opiniones