Steering Committee Meeting Highlights: Next-Gen Supply Chain in Life Sciences
Explore insights from the recent Clinical and Commercial Supply Chain Steering Committee Meeting on building resilient supply chains in the life sciences industry post-COVID-19. Topics include clinical forecasting, real-time inventory management, and challenges in direct patient solutions.
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Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 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 May 20, 2021 Agenda Introductions New Members 2021 Events BSMA Steering Committee Website and Chat Room GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Clinical Forecast Panel Discussion Follow-Up Integration of Inventory Across Clinical Trials Network ( Real Time Inventory Management ) Update CTSM Consortium Update Open Forum (What challenges or problems are you working on?) Next Meeting Any Other Business
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 2021 Events Steering Committee Meetings Impact of Annex 13 Changes - April 15 (repeat?) Future topics tbd (1-2 per steering committee meeting) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Webinars or Panel Discussions Clinical Forecasting April 7 Real Time Inventory Management June 29 or 30? Annual Conference October 20 Real Time Inventory Visibility (Integrated systems) Clinical Forecasting Levels of Maturity for Planning Clinical Trials Drug Supplies (How and when does a company go from an excel-based solution to more complex technology solutions?) Direct to Patients Challenges & Solution
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 Steering Committee Website 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) Includes steering committee mission, members, meeting slides and recordings, webinar content and recordings Coming Soon: Chat room for sharing challenges and solutions Future: White papers (i.e. Industry Best Practices)
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 Clinical Forecasting Panel Follow-Up Dan Silva Title: Challenges and Opportunities in Clinical Trial Supply Forecasting Topics: Lingering Challenges, Sources of Truth, Improving interactions with GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC clinical development Date: Wednesday, April 7 at 8 am PT Facilitator: Dan Silva, Tenthpin Panelists: Luke Moyer, Incyte Derek Thornton, Amgen Marc Trombella, BioMarin
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 Real Time Inventory Management Panel Update Advisory Team Almac Group Rob Cascone GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC BeiGene Rutesh Desai Denali Therapeutics Ryan Mills 4G Clinical Jan Pieter Kappelle Genentech David Volk GenPro Research Arun Sivandam Schrocken Yogi Chordia, Alec Parsons Tenthpin Dan Silva
Real Time Inventory Management Meeting May 13, 2021 Pain Points The lack of integration between manufacturers, service providers and intermediate companies results in the inability to obtain critical real-time information such as the quantity, status and location of inventory at CMO s, 3rd party warehouses, distributors, GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC etc. which creates the following problems Increased risk of patient stock outs (putting the patient s life and clinical study at risk) Excess inventory, safety stock and expired/obsolete inventory Increased shipping and expediting costs Increased time tracking and updating information from multiple systems with outdated information Increased risk of using incorrect information for demand planning, supply planning and inventory management
Real Time Inventory Management Meeting May 13, 2021 Vision Via a common process and data model, align the pharma and biotech clinical supply industry to achieve seamless collaboration and GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC 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.
Real Time Inventory Management Meeting May 13, 2021 Next Steps Identify how BSMA can achieve its objective Potential options . GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC Round Table/Panel Discussion BSMA Conference Partner with SAP Consortium and other industry associations Other ideas?
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 CTSM Consortium Update Dan Silva GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 Next Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OFEMIC Thursday, June 17 Next Steering Committee Meeting
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Any Other Business?
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 2021 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Thank you!
Clinical and Commercial Supply Chain Steering Committee Meeting May 20, 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
Set an Flexibility Industry Standard Higher flexibility in the business process to fulfill future clinical supplies business needs Determine best practices and avoid costly one-offs CTSM Goals Enabling the Network End-to-End Visibility Increased collaboration between all CTSM stakeholders Transparency and insights into the clinical supplies process from source to site/patient
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
Input Input: Consortium is near complete with membership Company (23) Roche Amgen Daiichi Sankyo Gilead JNJ Merck/MSD Novartis 4G Clinical Almac Amicus TherpeuticsSilver member AstraZeneca BMS Boehringer BSMA Lilly McKesson Myonex Sharp Symetric UCB Beigene BioNTech CSL Behring Consortium level 1-6-13 Platinum member Gold member Gold member Gold member Gold member Gold member Gold member Silver member Silver member Total of 23 companies onboarded 18 companies onboarded in 2021Q1 In summary 128 participants Silver member Silver member Silver member Silver member Silver member Silver member Silver member Silver member Silver member Silver member Pending pending Pending Masked Different companies: Pharma & Biotech Large & small Service providers, Contractors & industry SAP clients & non-SAP clients Legacy CTSM users & other system users
Throughput Process: Workshop model is maturing Average of 3 workshops per month Enablement session#1 Enablement session#2 Enablement session#3 Explore sessions: Explaining the different generations of operating, how all make sense and how that relates to systems Process overview of demand planning Next: business scenarios #1 is Adaptive trials PLAN MAKE DELIVER Explore session #2 Explore session#1 Explore session#3 Operating models 25-Mar-2021 Demand forecast Discover session#2 Discover session#1 Discover session#3 Discover sessions: Started with process overviews per workstream and as-is and challenges of some participating companies Next: process scenarios #1 is expiry management PLAN MAKE DELIVER
