Stephen Fecho, Jr

Leading up to its official publication date later this summer I will share a brief summary of each chapter within my new book, "Supply Chain Planning for Clinical Trials". The intent here is to provide readers insight into the book's structure and content. To kick things off, please find the Table of Contents listed below: PART 1 - CLINICAL SUPPLY CHAIN FOUNDATIONS Chapter 1 - Supply Chain Management Chapter 2 - Introduction to Clinical Trials Chapter 3 - Introduction to the Clinical Trial Supply Chain Chapter 4 - Quality Considerations Chapter 5 - Regulatory Considerations Chapter 6 - RTSM and its Role in the Clinical Supply Chain PART 2 - SUPPLY CHAIN PLANNING FOR CLINICAL TRIALS Chapter 7 - Supply Chain Planning for Clinical Trials Chapter 8 - Finished Product Demand Planning: Basic Concepts Chapter 9 - Finished Product Supply Planning: The Production Plan Chapter 10 - Finished Product Expiry Planning Chapter 11 - Finished Product Supply Planning: The Distribution Plan Chapter 12 - Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance Chapter 13 - Advanced Concepts in Demand and Supply Planning Chapter 14 - Clinical Supply Chain Reports, Budgets, and Metrics Chapter 15 - Clinical Supply Chain Planning Processes Chapter 16 - A Week in the Life of a Clinical Planner PART 3 - ADDITIONAL CLINICAL SUPPLY CHAIN CONSIDERATIONS Chapter 17 - Comparator and Ancillary Planning Chapter 18 - Make-to-Order and Just-in-Time Supply Chains in Clinical Trials Chapter 19 - Direct-to-Patient Supply Chain Management Chapter 20 - Contract Organization Management and Oversight Chapter 21 - International Logistics for Clinical Biopharmaceutical Products Chapter 22 - Clinical Supply Chain Planning Tools and Technology Chapter 23 - Integrating the Clinical Supply Chain into a Commercial Launch Looking forward to hearing your feedback, and don't forget to pre-order a copy of the book on Amazon now! #ClinicalTrials #ClinicalTrialSupplyChain #SupplyChainManagement #SupplyChainStrategy #ClinicalSupplyChain #DemandPlanning #SupplyPlanning #SupplyChainProfessionals #PharmaceuticalSupplyChains #BiotechnologySupplyChains #InventoryManagement #CellandGeneTherapy #RegulatoryCompliance #GMPCompliance #DistributionManagement #HealthcareInnovation #NewBookRelease #AuthorAnnouncement https://lnkd.in/gT4uCz5F

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 1 Summary 📚 Chapter 1 – Supply Chain Management (SCM) uses the Supply Chain Operations Reference (SCOR) model as a framework for understanding how a global supply chain operates. Topics covered include demand and supply planning, sourcing and procurement, manufacturing, and logistics. This chapter also discusses how data serves as the backbone for modern supply chain management and how people, business processes, and technology interact within this discipline. At the conclusion of the chapter, the reader should understand the basic components of SCM, how these components are related to and reinforce each other, and the vocabulary used in SCM and throughout the book. The content in this chapter creates a foundation of knowledge for the reader to build upon when the nuances of clinical trial supply chain management are introduced in later chapters. This chapter is ideal for readers who do not have a formal background in SCM. Pre-order your copy today! (Credit to the Association for Supply Chain Management (ASCM) for use of the SCOR Model) #ClinicalTrials #ClinicalTrialSupplyChainManagement #SupplyChainManagement #DemandPlanning #SupplyPlanning #Sourcing #Procurement #Manufacturing #Inventory #BillofMaterials #Yields #ManufacturingResourcePlanning #CapacityPlanning #Logistics #Delivery #Returns #SupplyChainData #Metrics #SupplyChainWaste #SupplyChainTechnology #BusinessProcessManagement

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 9 Finished Product Supply Planning: The Production Plan 📚 Chapter 9 shows the reader how to translate the Finished Product demand forecast into a dynamic production plan that accounts for changes in demand and supply over time. The chapter begins with a conceptual introduction to the min-max inventory management model and how creating inventory targets enable the plan to react to changes in demand. Then the most important inventory health metric is covered, weeks-of-supply. The production plan table brings together the key production planning inputs: demand, inventory targets, and weeks-of-supply into a single, consolidated view of the plan. Multiple example production plans are shown to reinforce individual concepts and how the inputs work together to output a recommended production strategy. Other topics include adjusting inventory targets and translating recommended production orders into actual orders. The chapter concludes with the production plan summary and a discussion of production order readiness to ensure the plan is successfully operationalized. At the completion of this chapter, the reader will understand the most basic elements of demand and supply planning for clinical trials. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #ClinicalTrialEnrollment #ClinicalSupplyChain #DemandPlanning #SupplyPlanning #Inventory #InventoryTargets #InventoryManagement #SupplyChainMetrics #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-order your copy now! https://lnkd.in/gUhy3xwN

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 5 Regulatory Considerations 📚 Chapter 5 takes the reader through another foundational aspect of the clinical trial supply chain, obtaining approval from the Competent Health Authority (CHA) of the country where the trial takes place and ensuring compliance with the regulatory application. This chapter begins with an overview of the regulatory filing, the Investigational New Drug (IND) application in the United States and the Clinical Trial Application (CTA) in other countries. Regulatory application content is covered as are interactions with the Competent Health Authority. Then the authoring, submission, and approval process is discussed. Amendments to INDs and CTAs are common and must be successfully navigated to ensure compliance when importing drug to a country so this topic is also covered thoroughly. The chapter concludes by laying out a business process, Process Version Management, for regulatory status tracking and managing change through the regulatory lifecycle. This is done by linking batch-specific information with the regulatory relevant attributes contained within each IND or CTA. At the end of this chapter the reader will have a firm understanding of an oft neglected space within the clinical trial supply chain. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #RegulatoryAffairs #RegulatoryApplications #InvestigationalNewDrugApplication #ClinicalTrialApplication #RegulatoryAmendments #InvestigationalProduct #ProductLifecycleManagement #ChangeControl #ChangeManagement #ProcessVersionManagement Pre-Order your copy now! https://lnkd.in/gUhy3xwN

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📚 New Book Announcement: "Supply Chain Planning for Clinical Trials: A Practical Guide" 📚 I am so excited to finally unveil a project I've been working on for the last 3+ years, my new book: "Supply Chain Planning for Clinical Trials: A Practical guide"! Published by Wiley, this is the first book of its kind specifically dedicated to the planning and execution of clinical trial supply chains. Key highlights include: 🔍 In-depth analysis of supply chain challenges unique to clinical trials including small molecule, large molecule, and cell and gene therapy modalities. 📝 Practical tools and frameworks to enhance supply chain efficiency and resilience. 📊 Strategies for optimizing inventory management and distribution logistics. 🌐 Exploration of global regulatory requirements and compliance considerations. 📈 Case studies and real-world examples illustrating best practices and innovative approaches. Order your copy of "Supply Chain Planning for Clinical Trials" today, and please like, share, and leave your comments below to help this announcement reach the widest audience possible. Thank you for your engagement, and special thanks to my editors Wiley and my colleagues at Denali Therapeutics for their incredible support on this journey. #ClinicalTrials #SupplyChainManagement #SupplyChainStrategy #ClinicalSupplyChain #DemandPlanning #SupplyPlanning #SupplyChainProfessionals #PharmaceuticalSupplyChains #BiotechnologySupplyChains #InventoryManagement #CellandGeneTherapy #RegulatoryCompliance #GMPCompliance #DistributionManagement #HealthcareInnovation #NewBookRelease #AuthorAnnouncement https://lnkd.in/gT4uCz5F

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 8 Finished Product Demand Planning: Basic Concepts 📚 Chapter 8 teaches the reader how to build a demand forecast for a clinical trial. The chapter begins by laying out a framework for demand forecast creation: the what – the Stockkeeping Unit (SKU); the where – depot and/or site; and the temporal – weeks or months. This culminates in the demand forecast table. Then the chapter pivots to a detailed step-by-step approach for translating the clinical protocol into a forecast for individual subject demand. Examples are given for both small molecule and large molecule modalities to illustrate the nuances involved with each product type. Once individual enrollment is complete, the focus shifts to forecasting subject enrollment, a notoriously difficult challenge for clinical trials. Similar to individual subject demand, the chapter walks the reader through both how to build an enrollment curve and how to think about forecasting enrollment to reduce waste. Other demand-related topics including overage, site stocking demand, and total SKU demand are also touched on before the chapter closes with the challenge of forecasting clinical trial demand accurately. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #ClinicalTrialEnrollment #ClinicalSupplyChain #DemandPlanning #ClinicalTrialForecasting #ForecastAccuracy #ForecastOverage #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-Order your copy now! https://lnkd.in/gUhy3xwN

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🏳️‍🌈🌍 Embracing Diversity = Fueling Innovation 🚀  Diversity is a powerful force to propel scientific innovation and growth. Embracing diversity in the scientific community means honoring the richness of unique perspectives, experiences, and talents. When we embrace diversity, we open ourselves up to new ideas, approaches, and solutions. Diverse perspectives challenge the status quo, spark creativity, and drive us to think differently. In the end, this diversity of thought is the catalyst for innovation.    In celebration of #PrideMonth, I had the honor of raising the Pride flag at our @Novo Nordisk site in Måløv, Denmark this morning. Like many of my colleagues, I am committed to fostering an environment where diversity isn't just about representation; it's about building a culture where every voice is heard.     Together, let's build a more inclusive and innovative world.     Read more about diversity and inclusion at Novo Nordisk: (novonordisk.com)    #diversity #inclusion #innovation 

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 11 Finished Product Supply Planning: The Distribution Plan 📚 Chapter 11 layers in another key element of the clinical trial supply chain, regional depot stocking and restocking strategies. This process begins with mapping the clinical packaging and distribution network for a particular study, and then creating linkages between the relevant depots. Inventory management parameters are revisited from a distribution perspective. Then a detailed set of distribution planning strategies are provided including determination of initial depot stocking quantities, Finished Product allocation strategy, distribution plan adjustments, and incorporation of regulatory commitments into the plan. Additional weeks-of-supply metrics and distribution summary report templates are also provided within the chapter before it concludes with a discussion of distribution plan handover activities. At the completion of this chapter, the reader has all the tools necessary to build and manage a Finished Product demand and supply for a global clinical trial. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #ClinicalSupplyChain #SupplyChainVisibility #DemandPlanning #SupplyPlanning #DistributionPlanning #InventoryManagement #BusinessProcessManagement #SupplyChainMetrics #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-order your copy now! https://lnkd.in/gUhy3xwN

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 12 Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance 📚 Chapter 12 covers the upstream side of the clinical supply chain. These materials are fundamentally different because demand for them is dependent on the Finished Product and because they are typically much more expensive to manufacture than Finished Products. As such, the chapter begins with a general overview of demand planning and supply planning techniques for upstream materials. Then detailed supply planning strategies are provided including all the factors that influence the quantity and timing of upstream production orders. Small molecules, large molecules, Primary Packaging materials, Drug Products, and Drug Substances all have unique attributes that contribute to the desired strategy, so individual sections are devoted to modality-material (e.g. small molecule Drug Substance) combinations. The chapter concludes similarly to the Finished Product supply planning chapters with the upstream production plan summary and the upstream production order readiness process. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrials #ClinicalTrialSupplyChain #ClinicalSupplyChain #SupplyChainVisibility #DemandPlanning #SupplyPlanning #PrimaryPackaging #DrugProduct #DrugSubstance #InventoryManagement #BusinessProcessManagement #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-order your copy now! https://lnkd.in/gUhy3xwN

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How a more favorable route of administration (ROA) may shift a competitive landscape. In this news, two major pharma have oral formulations of an existing MOA used in the treatment and management of high cholesterol in development. AstraZeneca sharing PI data on its cholesterol-lowering oral PCSK9-inh drug (to the tune of 50% reduction in bad cholesterol). With Merck, as another oral PCSK9-inh contender, with a PIII CV outcomes study underway, puts the AZ asset slightly behind in development... Both will likely sell the sizzle of the advantages of 💊 vs. 💉 "Both entrants are trying to replace Amgen’s Repatha and Sanofi-Regeneron’s Praluent, which are approved injectables for the same condition." #AZ #Merck #EuropeanAtherosclerosisSociety #Cholesterol #Dyslipidemia #Hyperlipidemia #Pharma #Healthcare

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The 340B Drug Pricing Program has grown significantly in recent years. States have responded by passing additional legislation, creating a complex policy landscape that’s challenging for both manufacturers and providers. My colleagues explore pharma’s and states’ policy responses, analyze how successful these responses have been and offer recommendations for how pharma can adapt in a dynamic environment.  #healthcare #pharma #340B #drugpricing #publicpolicy https://lnkd.in/eJwm-NrN

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Supply Chain Risk Management can be challenging, but using established tools and strategies lets you focus your efforts where they can do the most good!

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Great things are underway at Clarity.

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 3 Summary 📚 Chapter 3 – Introduction to the Clinical Trial Supply Chain offers a complete overview of the clinical biopharmaceutical supply chain from raw material sourcing to Finished Product distribution. The chapter begins by introducing the three primary drug modalities in development today – small molecules, large molecules, and cell and gene-based therapies. From there, the chapter explores Drug Substance manufacturing, Drug Product manufacturing, analytical development and product characterization, and manufacturing process development activities. In the clinical development space, changes to the manufacturing and analytical landscape of Drug Substances and Drug Products are constant. Understanding how to incorporate these changes into the supply chain planning process is necessary for success. The Finished Product steps including packaging, labeling, and distribution are also covered in detail as Finished Product execution activities are often within the Supply Chain function’s scope of responsibility. This chapter also introduces the CMC strategy for a product’s development and the CMC team stakeholders that the Clinical Planner partners with to develop the demand and supply plan for the product. Finally, the chapter concludes with recent trends and risks that have impacted clinical trial supply chains around the world. Pre-order your copy now! #SupplyChainPlanningforClinicalTrials, #SupplyChainManagement, #ClinicalTrialSupplyChainManagement, #SmallMolecules, #LargeMolecules, #Biologics, #CellTherapySupplyChainManagement, #GeneTherapySupplyChainManagement, #SupplyChainPlanning, #Manufacturing, #Distribution, #BiopharmaceuticalProcessDevelopment, #ChangeManagement, #DrugSubstance, #DrugProduct, #FinishedProduct, #CMCStrategy, #CMCStakeholders https://lnkd.in/gUhy3xwN

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Today we fulfill the promise that began in 2012 when our company was founded. We have been purpose built, bringing together the best commercialization services and products the industry has to offer. And, today, we unite the Precision Value & Health family of brands as Precision AQ.   Our mission at Precision AQ is clear – to ensure patients have access to the life-changing therapies they need. Our 1200 experts represent the full commercialization continuum, bringing a comprehensive understanding of each individual and every unique need along the way. Our distinct and collaborative approach fuses scientific rigor with the deepest human empathy.   Where IQ meets EQ, we are Precision AQ. Precision Value & Health PRECISIONeffect PRECISIONvalue PRECISIONadvisors PRECISIONheor PRECISIONscientia Makara Health Communications PRECISIONxtract Across Health Precision AQ - Investor Relations & External Communications Precision AQ

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Reflecting on the dynamic shifts in the global pharmaceutical export market in 2023, it's evident that innovation, collaboration, and foresight are pivotal drivers. With the United States driving innovation, Europe serving as a hub for contract manufacturing organizations (CMOs), and India leading the way in exports, the landscape showcases the industry's resilience and adaptability. As these interconnected markets shape the future of healthcare, the emergence of new players signals a more globalized approach, ensuring broader access to essential medications. This interconnectedness underscores the importance of fostering collaboration across borders. By uniting efforts, we can accelerate innovation and expedite the delivery of life-saving treatments to patients worldwide. #pharmaceuticals #export #innovation #collaboration

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#deflateHAE is an educational resource for people living with hereditary angioedema (#HAE), many of whom may be making trade-offs among #efficacy, #convenience, and #tolerability. Learn more: https://deflatehae.com This content is not meant to replace a conversation with a healthcare provider. A healthcare provider can evaluate your symptoms and make the appropriate clinical decisions.

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🚀 Biopharma Market Expansion: Key Takeaways As biopharma companies explore new markets, it's crucial for leaders to tailor their approach to the unique nuances of each market. Here are some critical insights: 1️⃣ Revenue Potential: By 2028, markets outside the US are projected to generate US$120 billion in revenue, presenting substantial growth opportunities. 2️⃣ 2023 Revenues: Non-US markets accounted for 56% of global biopharma revenue in 2023, up from 52% in 2020. This trend underscores the growing importance of international markets. 3️⃣ Patent Cliff: The industry faces a $200 billion revenue risk from expiring patents by 2030, pushing companies to diversify globally. 4️⃣ Global Market Size: The global biopharma market was valued at US$1.4 trillion in 2023, highlighting the vast scale and potential of the industry. 5️⃣ Strategy Models: Large biopharmas (≥ US$20 billion annual revenue) prefer direct presence in significant markets, while smaller firms (≤ US$5 billion) often opt for distributor partnerships in complex regions. 6️⃣ Operational Challenges: Tailored entry strategies are essential due to varying regulatory, reimbursement, and tax considerations across different countries. 7️⃣ Strategic Focus: Companies should prioritize specific countries, develop tailored entry models, establish robust launch sequences, and build cross-functional capabilities to mitigate risks. Planning and executing a well-thought-out international expansion strategy can help biopharma companies maximize revenue potential and patient reach worldwide. 🌍💉 #Biopharma #MarketExpansion #GlobalGrowth #Biotech #Pharmaceuticals #Strategy #RevenueGrowth P.S. How is your company planning to navigate these market opportunities in 2024? Share your insights below.

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