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Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC Welcome !
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Agenda Introductions New Members BSMA Annual Meeting Overview GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Proposed Agenda 1 or 2 Days? Open Forum What challenges or problems are you working on? Next Meeting
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 BSMA Annual Conference March 24, 2022 Location: Foster City, CA GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Focus Areas Supply Chain Management (Clinical through Commercial Launch) Transportation (Steering Committee) Digital Transformation(Steering Committee) Another conference is being planned for late 2022 and will focus on specialized areas, possibly Cell & Gene Therapy and Cold Chain (Location tbd)
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Proposed SCM Topics for March 24, 2022 Conference GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Clinical Supply Chain Workshop (3 hour workshop - Luke Moyer, Incyte) Using Stochastic & Deterministic Planning to Optimize Clinical Forecasting & Replenishment (Dan Silva & Clinical Forecast Advisory Team) Lessons Learned During the Pandemic (Plenary Session) Using a Systematic Approach With Critical Clinical Inputs & Outputs to Eliminate Stock-Outs (Yogendra Chordia, Schrocken and Steve Clarke, BioSupply Consulting) Tools & Technologies Beyond Excel A System Evolution to Achieve ERP Readiness (TenthPin, tbd*.) Transitioning from Clinical to Commercial Operations Keys to Ensure a Successful Product Launch (Supply Chain or PSCO SME s)
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Proposed SCM Topics for March 24, 2022 Conference Page 2 of 2 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Clinical Drug Accountability & Reconciliation (Brittney Elko, Tricida; Derek Thornton, Amgen; Jon Paras, YPrime, & tbd*) Avoiding Mistakes You Are About to Make in a Clinical Study Lessons Learned (tbd*) How to Successfully Implement JIT Labeling and/or Direct-to-Patients Clinical Studies (tbd*) tbd* - Include SME s from Supply Chain and from Service Providers Do you want a One or Two day Conference?
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Group Discussion What challenges, issues, or initiatives are you working on?
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Next Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OFEMIC Thursday, January 20, 2022 Next Steering Committee Meeting
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Back-Up Slides GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN Ba
Clinical and Commercial Supply Chain Steering Committee Steering Committee Charter Educate BSMA community on current and future state of clinical and commercial supply chain to promote industry standardization GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC conferences Identify, discuss and align to industry best practices that members and solution providers can incorporate into their design Share at BSMA events webinars & Includes input from virtual, small and medium size members Improve connectivity with internal and external customers and suppliers, and hand offs between clinical and commercial Understand cost drivers and enable members to measure and manage these in meaningful segments Help members educate their executives around the need and value of ERP solutions, and what technologies are available Enable people to connect with their peers
Clinical and Commercial Supply Chain Steering Committee Survey Results Comments Top Tier Best practices for Clinical Forecasting and Demand Planning for Dynamic Enrollment - Making it patient-centric requires a pull versus push supply chain. Consider combining parts of IRT and EDC into this topic Integrating the Clinical Trials Network for Real Time Inventory Management in the Ecosystem of Drug Developer, CRO s, Patient sites, CMOs and Distributors Who should we include? GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Technology Solutions for Clinical Labeling for Agility, Regulatory Compliance and Speed to Market across the Globe . 2nd Tier Include Annex 13 changes requiring expiry on primary packaging. Impacts IXRS Include Distribution Supply Chain Challenges of Direct-to-Patient therapies People, Processes and Technologies to Integrate Clinical Operations with Commercialization Technology Maturity Curve for Enterprises from Small to Medium to Large Drug Companies Focus on clinical to commercial launch? 3rd Tier The Economics of Clinical Trials Management for C Suite Cycle Time, Working Capital, and Assets Required for Achieving Return on Investment (ROI) in Technology Normalizing the Lessons Learned from Operation Warp Speed Which Developed Vaccines in 10 Months VS. 10 Years in the Past. Optimal Configuration of the ERP System and its Economic Justification Optimal Services for Clinical Trials Design, IXRS and EDC with Data Analytics. Include Distribution Combine with Forecasting Best Practices? 4th Tier Artificial Intelligence (AI), Machine Learning and Blockchain Deployment in Drug Discovery and Development
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Steering Committee Website Includes steering committee mission, members, meeting slides and recordings, webinar content and recordings GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Clinical & Commercial Supply Chain Steering Committee - BSMA (biosupplyalliance.com) https://bsmaforum.startdots.com/community/ Chat room for sharing challenges and solutions Future: White papers (i.e. Industry Best Practices)
Clinical and Commercial Supply Chain Steering Committee Meeting December 16, 2021 Clinical Forecasting Advisory Team Scope: Lingering Challenges, Sources of Truth, Improving interactions with clinical development, Push vs Pull, Stochastic (simulation/scenarios), Study reconciliation Advisory Team: GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Dan Silva, Tenthpin Luke Moyer, Incyte Derek Thornton, Amgen Marc Trombella, BioMarin Jan Pieter Kappelle, 4G Clinical Next steps: Currently preparing a panel discussion for 2021 BSMA Annual Conference Team has decided to provide an overview of the two major types of clinical forecasting; stochastic (simulation) planning vs deterministic (calculation) planning. This event will be 90% educational, and include a sharing of situations of use for each method.
Real Time Inventory Management Meeting August 19, 2021 Improving Visibility & Access to Information Across the Clinical Trials Network Vision Via a common process and data model, align the pharma and biotech clinical supply industry to achieve seamless collaboration and information exchange throughout the supply network BSMA Objective: Help move the industry towards achieving the desired end-state (vision) by educating its members and their supplier base about the vision, including its benefits and the problems it solves, and creating a call to action that motivates them to support and act on achieving this vision. GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC
Real Time Inventory Management Meeting December 16, 2021 Current Status Collecting data that will enable us to quantify problems relating to lack of real-time visibility. (Primarily focusing on areas that supply chain can impact, such as COGM, cycle times, service levels, etc.) E.g. 90% of drugs produced gets packaged, 74% of drugs packaged gets shipped to clinical sites, 67.8% of drug shipped to sites was dispensed. Net Result: Only 45% of drug produced for clinical studies gets dispensed, GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC which means 55% of drug produced for clinical studies is wasted! Identifying relevant examples about initiatives which improved company s clinical capabilities and/or costs, while tying this back to our objective of educating and motivating people to support and act on achieving visibility to real-time information Working with industry SME s on E2E clinical trial process map, including inputs and outputs, to help supply chain and clinical operations professionals recognize the importance of tracking and using information for making better informed decisions and optimizing clinical trials Share this information with BSMA members and their providers at BSMA Annual Conference
