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From Concept to Medicine - A Comprehensive Drug Development Journey

Jim Mitchell

EN270 episodes
sciencechemistryeducationcourses

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...

Episodes (270)

171 - Patient Data & Digital Health Records (S12E6)

From Concept to Medicine - A Comprehensive Drug Development Journey

Jun 2, 202510:05pending

169 - Regulatory Science of the Future (S12E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

Jun 2, 202514:06pending

168 - Advances in Biotechnology & Gene Therapy (S12E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

Jun 2, 202515:21pending

167 - Precision Medicine & Genomic Innovations (S12E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

Jun 2, 202510:11pending

166 - Future of Drug Discovery (S12E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

Jun 2, 202511:19pending

64 - FDA 2025 Inspection Operations Manual - What to Expect When You’re Expectin...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 26, 202516:14pending

49 – Audit Readiness and Advanced Topics (S20E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202517:15pending

48 - Documentation, Lab Practices & Quality Systems (S20E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202516:18pending

47 - Operational Excellence Validation, Equipment & Processes (S20E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202516:04pending

46 – cGMP Fundamentals and Regulatory Overview (S20E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202528:05pending

45 - Current Trends and Future Directions in GMP (S19E7)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202517:08pending

44 - Preparing for Regulatory Inspections (S19E6)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202525:56pending

43 - Case Study 2 Example of Successful GMP Implementation (S19E5)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202516:15pending

42 - Case Study 1 Illustrative GMP Failure (S19E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202513:10pending

41 - Complaint Handling and Product Recalls Protecting Patients (S19E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202519:45pending

40 - Handling Deviations and Non-Conformances (S19E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 20258:55pending

39 - Stability Programs and Shelf Life Determination (S19E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202515:52pending

38 – FDA Form 483 Implications and Impact (S18E6)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202524:12pending

37 – Establishing and Maintaining a GMP Quality Management System (QMS) (S18E5)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202517:07pending

36 – Audit Findings and Corrective and Preventive Actions (CAPA) (S18E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202515:05pending

35 – Conducting the GMP Audit Best Practices (S18E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202517:34pending

34 - Planning and Preparing for a GMP Audit (S18E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202513:50pending

33 – The Role of GMP Audits in Ensuring Compliance (S18E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202520:28pending

165 - From Lab Bench to Pilot Plant: Navigating the Challenges of Chemical Proce...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202517:16pending

164 - Strategic Approaches to Impurity Control in Multi-Step Organic Syntheses (...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202520:11pending

163 - Implementing Continuous Flow Reactors for Enhanced Process Safety and Effi...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202512:45pending

162 - The Art and Science of Crystallization in Pharmaceutical Development (S11E...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202513:59pending

161 - Optimizing Reaction Conditions Through Design of Experiments (DoE) (S11E11...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 20259:22pending

160 - Addressing Impurities and By-Products in Pharmaceutical Process Developmen...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202510:03pending

159 - Innovations in Crystallization Techniques for Active Pharmaceutical Ingred...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 20259:02pending

158 - Special Feature Sections in Organic Process Research & Development: Hot To...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202510:08pending

157 - The Role of Quality by Design (QbD) in Pharmaceutical Development and Manu...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202510:17pending

156 - Overcoming Scale-Up Challenges in Pharmaceutical Process Development (S11E...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202510:41pending

155 - Applications of Flow Chemistry in Modern Drug Development (S11E5)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 20259:41pending

154 - Regulatory Considerations for Starting Materials in Drug Substance Develop...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202512:16pending

153 - The Evolving Landscape of Continuous Processing in Pharmaceutical Manufact...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202513:20pending

152 - Challenges and Strategies in Peptide Drug Synthesis and Manufacturing (S11...

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 202514:38pending

151 - Rapid Process Development and Scale-Up Using Multiple Reactors (S11E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 24, 20259:15pending

21 - Principles of Good Documentation Practices (GDP) (S16E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 18, 202521:23pending

32 - Data Management, Records, and Reporting in GLP (S17E6)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202520:04pending

31 - GLP Protocols and Standard Operating Procedures (S17E5)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202519:57pending

30 - Test Systems and Test and Reference Items in GLP (S17E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202516:54pending

28 – Key Elements of GLP Organization and Personnel (S17E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202510:32pending

29 – GLP Requirements for Facilities and Equipment (S17E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202514:14pending

27 - Introduction to Good Laboratory Practices (GLP) (S17E1)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202511:49pending

26 – Electronic Records and Signatures Navigating 21 CFR Part 11 (S16E6)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202517:15pending

24 - Batch Records The History of a Batch (S16E4)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202512:33pending

25 - Laboratory Notebooks and Data Recording (S16E5)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202521:00pending

23 - Standard Operating Procedures (SOPs) Your GMP Blueprints (S16E3)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202523:07pending

22 – The ALCOA+ Principles Ensuring Data Integrity (S16E2)

From Concept to Medicine - A Comprehensive Drug Development Journey

May 17, 202521:02pending