Jim Calarese

For many of us in leadership positions it's the time of the year to undertake a thorough check in on ours and our direct reports business objectives, i.e. mid-year reviews. But, do you actually also have personal development goals outside your professional career? Here are mine for 2024: I wanted to hit the gym 100-times this year; creating at least 25 new podcast episodes, preferably with more guests. Attend a handful of networking events. Find something new to replace my ended engagement at the Startup Netzwerk Bodensee and progress a bit further with the Supply Chain College. Not missing a sports tournament of our kids. On most elements I am tracking well: Just out of the 44x visiting the gym. Counting in my basement evening workouts, I am on track. Podcasts on track as well with several great guests hosted. One new product of the Supply Chain College in market (Icebreakers). New side hustle also signed last week - to be announced soon separately. Kids happy so far 😉 What about you?

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🚀 Strengthening the Pharmaceutical Supply Chain Globally 🌍 Facing worldwide adversities, it's imperative to keep the pharmaceutical supply chain robust. The piece "SUPPLY CHAIN SOLUTIONS - From Lab to Life" featured in Drug Development & Delivery outlines vital tactics for the uninterrupted flow of medical treatments. At Alcami, we're in step with these tactics through our cutting-edge pharmaceutical storage options. Our modern facilities offer environments with controlled temperatures to preserve the integrity of products sensitive to temperature changes, a worldwide presence to aid in regionalization and decrease risks, and live tracking to boost transparency and enable proactive oversight. By working together, we can make sure that essential treatments are consistently delivered to those in need. Discover more about these crucial tactics here 👉 (https://gag.gl/DqZTC6). #Pharma #SupplyChain #ClinicalTrials #Alcami #Resilience

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The FDA's latest draft guidance outlines key steps for companies seeking designations for platform technologies, potentially expediting cell or gene therapy approvals. The 15-page document details how utilizing prior platform data could streamline regulatory processes. This move is especially advantageous for gene therapies sharing common technology foundations. #FDA #biopharma #regulatory #genetherapy #innovation https://lnkd.in/eEEz-NYR

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Solid article on teamwork and key elements which drive success.

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 13 Advanced Concepts in Demand and Supply Planning 📚 Chapter 13 helps the reader address more complex planning scenarios from both the demand and supply sides of the equation. On the demand side, the chapter begins with a discussion of accuracy or conservatism in demand planning before moving on to the concept of aggregate forecasting which is holding all subject demand at a single SKU-Depot location. Then strategies for managing subject attrition and subject replacement are tackled. On the supply side, holistic end-to-end supply planning strategies are introduced before the chapter moves on to providing strategies for variable durations of treatment, dose titrations, dose reductions, SKU switching, and complex study extension scenarios. Additional topics covered include segregation of site and depot inventory, inventory pooling, and when to leverage deterministic or stochastic planning models. The chapter concludes by introducing low case – high case demand and supply planning as a highly useful scenario planning technique. At the completion of this chapter, the reader will be ready to tackle more challenging clinical trial supply chain planning issues. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #ClinicalSupplyChain #SupplyChainVisibility #DemandPlanning #DemandForecasting #SupplyPlanning #ScenarioPlanning #InventoryManagement #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-Order your copy now! https://lnkd.in/gUhy3xwN

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The true success of any life sciences therapy is its ability to reach the patient, which medical publications can enhance with the right technology and measurement practices in place. As new technology becomes available, manufacturers must use it and enhanced data collection and communication methods to improve medical publications’ effectiveness and couple it with improved data collection and communication. When these practices are paired with human expertise, the ability to give patients and providers information they can use skyrockets, improving health outcomes and the product’s success. 

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Continuous manufacturing, whether of the active pharmaceutical ingredient or drug product, continues to make inroads as companies advance select projects. https://lnkd.in/g7yhhGkp #pharma #biotech #innovation #continuousmanufacturing #ATMP

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#First90Days 💫*Organizational design* is the fundamental element in supply chain to be addressed within new team, to synergise central/decentral operating models-clears ambiguity within responsibilities of team member ✨Establishing *performance review* mechanisms (daily/weekly/monthly) to keep the focus on results and operations KPIs ⚡️*Talent building* - cross train team members with core competency based on the future needs & interests as SUPPLY Chain is nothing without people and their engagement After mindfully understanding the team, gaining certain trust, addressed low hanging fruits, aligning expectations with supervisor, time to pull out FY25 roadmap to create ANTI-Fragile supply chain and achieve industry standard QCD targets… #Leadership #SCM #Planning

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My trusted colleague Chris Della Rocca recently spoke on a panel with Kate Magill of Supply Chain Dive and Manufacturing Dive. He discussed AI in Supply Chain Management and shared Johnson & Johnson’s perspective on the rapid evolution of intelligent automation and advanced technology in crucial parts of our business. Automating low-level alerts while allowing us to focus on high-impact areas will undoubtedly enhance our efficiency and responsiveness. It's always great to see those in #MyCompany having insightful conversations that touch every industry! #SupplyChain #Manufacturing #AI

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Is packaging part of your sustainability objectives?

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A growing issue in many walks of life: Our tendency to make decisions, pick sides and spread narratives before evaluating information objectively. Within the realms of global supply chains, this issue is particularly prevalent in the development of the make vs. buy strategy, the manufacturing foot print strategy and supply switching programs to name a few. We #Procurement and #Supplychain professionals are responsible for protecting the long term interests of our shareholders so, we must avoid making decisions before evaluating all options/information objectively.

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👣 How Parents Influence Their Kids’ Career Choices: A Personal Perspective As parents, we often wonder how much our career choices and passions influence our children. This question hit home recently when my 9-year-old daughter brought home attached drawing from school, depicting her future career aspirations. On one side, she envisions herself as a "Kommissarin" (a detective), and on the other, a "Supply Chain Managerin." The latter made me smile, as I could see my career subtly influencing her dreams. Seeing her consider a role in supply chain management made me reflect on why this field might be appealing to her: ✔ Problem-Solving: Supply chain management is all about solving complex puzzles, which can be very engaging and satisfying for curious minds. ✔ Technology and Innovation: Kids today are tech-savvy and interested in how technology shapes the world. Supply chain management offers a front-row seat to the latest tech and innovation. ✔ Global Perspective: Understanding and managing supply chains requires a global outlook, something that can be incredibly exciting and educational for young minds interested in the world. It's satisfying to see her interests develop, and it reminds me of the importance of sharing our work and passions with our children. By doing so, we open their eyes to a world of possibilities, helping them discover what excites them and where they might want to focus their energies in the future. I believe that we cannot leave a lasting legacy based solely on material things. Instead, the lessons and values we impart to our children are what truly matter. Whether it's encouraging them to invest in stocks of Apple rather than just buying the latest iPhone, hitting the gym instead of sitting on the couch (which is also fine sometimes!), or seeing them mimic us by trying to write a book or develop a game, our actions and choices shape their worldviews. By living our values and sharing our passions, we teach them the importance of curiosity, hard work, and making thoughtful decisions. These lessons are the real legacy we leave behind. Let’s continue to inspire and guide our kids, not by pushing them towards a particular path, but by sharing our journeys and encouraging them to explore their own. Btw: Most of the above can also be applied to our workplaces and the impressions with leave behind on our co-workers etc.

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📚 Supply Chain Planning for Clinical Trials: A Practical Guide - Chapter 7 Supply Chain Planning for Clinical Trials 📚 Chapter 7 shifts the focus from foundational elements to a broad introduction of supply chain planning. The chapter begins with supply chain planning objectives: ensuring uninterrupted supply of trials, meeting program requirements, and minimizing cost are discussed. Then an overview of clinical planning activities – Build the Plan, Refresh the Plan, Communicate the Plan – is given, and the Visibility-Control-Flexibility framework is introduced. Example supply chains show how the various elements of the plan including demand planning, supply planning, distribution planning, expiry planning, and upstream planning integrate with one another. Quality, Regulatory, and RTSM elements are also woven into the story here. The chapter also covers the business processes required to support supply chain planning and discusses the role of the Clinical Supply Chain function from tactical to strategic activities that impact the overall CMC strategy. This chapter sets the stage for the remainder of the book and gives the reader necessary context for what’s ahead. #SupplyChainPlanningforClinicalTrials #SupplyChainManagement #ClinicalTrialSupplyChainManagement #ClinicalSupplyChain #DemandPlanning #SupplyPlanning #DistributionPlanning #ExpiryPlanning #SupplyChainControl #SupplyChainVisibility #BusinessProcessManagement #AnalyticalPlanning #StrategicPlanning #SupplyChainRisk #RiskManagement Pre-Order your copy now! https://lnkd.in/gUhy3xwN

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So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/gJFCNEyA Way to go, #TeamFTI!

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Insightful article regarding FDA on Switching Studies to Demonstrate Interchangeability: Thanks for putting this together Stan! #Biosimilar #PCMA #AMCP #Marketaccess

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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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Converge Consulting, LLC Consultant, Ulpiano Flores, provides a nice summary of the valuable insights presented at this year's TraceLink FutureLink conference. If you weren't able to attend, or even if you were there, It's worth the quick read understand how end-to-end pharmaceutical supply chain orchestration is evolving. Thanks Ulpiano!! #lifesciences #supplychain #DSCSA

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https://lnkd.in/gre8mUg8 If one is to look at a common denominator among these five FDA historical cases. We would see time, the time that transpired before the FDA system reacted to the risk. In the FDA business time is risk exposure and by default many times, loss of life. Fast forward to today and cases like the CPAP Phillips device and we see not much has changed in the agency’s timed reaction protecting the consumer to large scale risk. One can play the devils advocate and claim that many other cases were prevented to develop to this national impact. True, but if we are to apply the quality concepts the agency applies on its clients, validation, CAPA, and the rest of GMPs to lessons learned to its own operations what happens? What did the agency learned from all these historical cases that it applied to the Phillips case for example? This week we had one of the largest bottled water recalls in the history of bottled water. If you look at the causes of the recall it is time again. The conditions are time related negligence of company quality control and time related failure of the agency to inspect. Negligence, time after time in reacting to risk, much like most national cases. What are the primary factors that cause this reaction time issues? Maybe we need time to think about it?

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