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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

14:53

180 - Season 12 Recap & Closing the Journey (S12E15)

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

2025/06/02

This episode recaps the entire series, summarizing key lessons and insights while looking forward to ongoing innovation. Final reflections by Host and SME, celebrating the learning journey and setting visions for the future are shared. Analysis of the major moments and topics of the year are featured, bringing the season full circle.The discussion highlights pre-clinical testing, the ADME, and GLP, then moves to covering each of the stages of a clinical trial, and regulatory requirements and ethics

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9:56

179 - Preparing for the Unknown (S12E14)

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

2025/06/02

This episode discusses strategic risk management and flexible design to prepare for future uncertainties in drug development. Dialogue on contingency planning, scenario analysis, and adaptive strategies with real-world examples is presented. Analysis is focused on building adaptability into the process and thinking ahead.Various techniques for managing strategic risk, including contingency planning and flexible design, are analyzed. The role of regulatory requirements and the role of pharmaceutical

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12:15

178 - Future Manufacturing Technologies (S12E13)

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

2025/06/02

This episode looks ahead at emerging manufacturing innovations—such as modular and continuous systems—that promise efficiency gains. Conversation on technology trends, projected industry impacts, and documented case studies are analyzed. Discussion around the traditional methods are compared to these new technologies, such as 3-D printing and modular systems.The various processes and technologies, like modeling, simulation, and automation, that support the development of pharmaceutical products are

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12:19

177 - Policy Changes Shaping the Future (S12E12)

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

2025/06/02

This episode analyzed how anticipated policy changes and regulatory reforms may impact the drug development landscape. Discussion on current debates, potential shifts, and strategic responses backed by recent examples were presented. Discussions on current policy standards are included and discussions about proposed regulatory shifts are also provided.Among the areas covered are dietary supplements with new dietary ingredients. Rules for conducting clinical trials, and the Orphan Drug designation

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13:05

176 - Next-Gen Clinical Trial Designs (S12E11)

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

2025/06/02

This episode explores novel clinical trial designs (basket, umbrella trials) aimed at increasing efficiency and patient benefit. Dialogue on design principles, adaptive features, and case studies from current literature are provided. Discussions around adaptive designs and the benefits as they relate to the future of drug development are analyzed.The efficiency gains of umbrella trials as compared to traditional development of cancer-treating pharmaceuticals are highlighted in detail. OPR&D and

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12:08

175 - Balancing Innovation and Safety (S12E10)

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

2025/06/02

This episode discusses the challenge of balancing rapid innovation with rigorous safety standards in modern drug development. Conversation on risk management, ethical considerations, and regulatory requirements are presented with detailed examples. Discussions start with how a drug process happens and why pre-clinical phases of research exist. The importance of the FDA and ICH guidelines is highlighted.Conversations on the need for innovation versus the ethical need to make drugs and medical

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10:39

174 - Global Collaboration & Open Innovation (S12E9)

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

2025/06/02

This episode explored models of global collaboration and open innovation that are transforming drug development worldwide. Dialogue on partnerships, data sharing, and collaborative research with real-world case references is provided. Discussions on global collaboration and why it is a growing necessity are included. There are also many OPR&D examples to show the many forms of collaboration.Specific examples of global collaboration are highlighted. The discussion on the International Council for

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12:15

173 - The Evolving Role of Al in R&D (S12E8)

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

2025/06/02

This episode dives deep into how Al continues to influence every stage of drug research, from discovery to clinical trials. Discussion on new algorithms, data integration, and future potentials are backed by literature examples. The conversation includes what drives the need for Al, such as cost or speed, and the safety surrounding the use of Al.The integration of Al into many areas of drug development is highlighted, for example, with Inoplexus, Adamwise, and Biomotive. The integration of Al into

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12:32

172 - Sustainability & Green Chemistry in Pharma (S12E7)

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

2025/06/02

This episode discusses the move toward sustainable practices and green chemistry in drug development and manufacturing. Dialogue on environmental initiatives, innovative chemistry approaches, and documented case studies is provided. There is much discussion on pollution, waste, resource depletion, and economics.The episode also explores the 12 core principles and some of the most important, including waste prevention and atom economy. The conversation goes into detail about examples, like safer

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10:05

171 - Patient Data & Digital Health Records (S12E6)

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

2025/06/02

This episode examined the role of big data and digital health records in shaping future drug development decisions. A conversation on data analytics, privacy concerns, and clinical applications with detailed real-world insights is offered. There's talk about how Al and machine learning tools can find patterns and connections within the massive amounts of data.The conversation covers not only target finding and clinical trials but also real-world impacts of drug use, discussing PKPD and the

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13:39

170 - Emerging Trends in Personalized Development...

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

2025/06/02

This episode explores how personalized development strategies (biomarker-driven trials, patient-centric design) are changing the field. Dialogue on integrating patient data and customizing treatment strategies with concrete examples is provided. This includes personalized medicine and its integration with today's society.A significant amount of time in the conversation is spent discussing biomarkers and their importance in creating specific drugs. Patient-centric design, the analysis of data with

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14:06

169 - Regulatory Science of the Future (S12E4)

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

2025/06/02

This episode is devoted to regulatory science. Discussions analyze how evolving regulatory science is adapting to innovative therapies and new technologies. Discussions on adaptive guidelines, flexible pathways, and global harmonization efforts using detailed case studies are also provided.In the world of regulatory science, challenges in AI, medical devices, and continuous manufacturing are analyzed. The regulatory side's evolution, the importance of global collaboration, and discussions from

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15:21

168 - Advances in Biotechnology & Gene Therapy (S12E3)

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

2025/06/02

This episode offers an overview of cutting-edge biotechnologies and gene therapies revolutionizing treatment options. It provides a narrative on breakthrough therapies, mechanisms, and regulatory challenges with real-world data. It further explores the origin of ideas that lead to amazing therapies, target selection, preclinical evaluation, and toxicology studies in animals.The conversation analyzes the FDA and the steps involved in pharmaceutical development. Discussing clinical trials, it explores

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10:11

167 - Precision Medicine & Genomic Innovations (S12E2)

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

2025/06/02

This episode explores advances in genomics and precision medicine that enable personalized therapies. Dialogue on genetic profiling, biomarkers, and tailored treatment approaches are presented with detailed literature examples. The conversation notes the foundation of personalized medicine starts with the human genome, our complete set of DNA instructions.The conversation explores how, while we share something like 99% of our DNA, it's that tiny bit of variation that makes us unique and how

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11:19

166 - Future of Drug Discovery (S12E1)

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

2025/06/02

This episode introduces emerging trends and innovative methodologies that promise to reshape drug discovery. The conversation dives into forward-looking ideas, paradigm shifts, and cutting-edge research highlighted in OPR&D studies. Al's role in finding new uses for drugs that we already have is discussed, especially how it can be efficient in the underfunded areas of neglected tropical diseases.The episode looks at how Pharma research generates vast amounts of data and the use of Al to manage

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16:14

64 - FDA 2025 Inspection Operations Manual - What to...

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

2025/05/26

In this episode of our advanced cGMP case study series, we take a detailed, practical journey through the FDA’s Investigations Operations Manual—the IOM. Often overlooked outside of regulatory circles, the IOM is in fact the FDA’s own blueprint for how inspections are prepared, conducted, and assessed. We unpack key sections, especially Chapters 5 and 8, revealing how investigators assess risk, structure inspections, and make observations that lead to Form 483s and, potentially, warning letters

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17:15

49 – Audit Readiness and Advanced Topics (S20E4)

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

2025/05/24

Summarize best practices for audit preparation, execution, and follow-up, integrating lessons from recent case studies and industry trends. Comprehend the CAPA process, risk management strategies, and emerging regulatory expectations that shape audit outcomes. Understand the importance of data integrity, GMP, and risk management to produce higher-quality products.The main point of audit readiness is to emphasize a proactive approach to ensure that manufacturing operations remain robust, transparent,

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16:18

48 - Documentation, Lab Practices & Quality Systems...

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

2025/05/24

Reinforce the critical importance of good documentation practices, laboratory controls, and an effective quality management system. Learn how standardized SOPs, comprehensive recordkeeping, and rigorous training contribute to data integrity and product consistency. Understand the interplay between laboratory practices and overall quality systems.Highlight the need for continual improvement and readiness for audits and regulatory inspections in a highly regulated industry. Examine FDA regulations for

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16:04

47 - Operational Excellence Validation, Equipment &...

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

2025/05/24

Refresh your knowledge of essential operational topics, including process validation, cleaning protocols, equipment qualification, and change control procedures. Understand the best practices and documentation requirements for each element. Emphasizing systematic approaches and risk-based strategies to maintain manufacturing integrity is key. Discuss how proactive management of operational processes leads to enhanced quality outcomes and sustained compliance within a dynamic production

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28:05

46 – cGMP Fundamentals and Regulatory Overview (S20E1)

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

2025/05/24

Explore the foundational principles of current Good Manufacturing Practices (cGMP) and the regulatory landscape governing pharmaceutical manufacturing. Delve into essential concepts derived from FDA 21 CFR and ICH guidelines, highlighting how quality standards have evolved over time and the critical role of fostering a robust quality culture. Emphasis will be placed on fundamental aspects such as facility controls, process validations, and meticulous documentation practices.Understand how these

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270 results

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