Global Leaders Address Next-Gen Supply Chain Strategies in Life Sciences

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Discover the insights from the Clinical and Commercial Supply Chain Steering Committee meetings, focusing on enhancing supply chain practices in the life sciences industry post-COVID-19. Explore the challenges, achievements, and future plans discussed by global leaders to standardize processes, improve visibility, and prepare for real-time ERP solutions.

  • Supply Chain
  • Life Sciences
  • Steering Committee
  • Global Leaders

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  1. Clinical and Commercial Supply Chain Steering Committee Meeting January 27, 2022 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC Welcome !

  2. Clinical and Commercial Supply Chain Steering Committee Meeting January 27, 2022 Agenda Introductions New Members Year in Review BSMA Annual Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Open Forum What challenges or problems are you working on? Next Meeting

  3. Clinical and Commercial Supply Chain Steering Committee January 12, 2022 This is our Steering Committee s One Year Anniversary! Created Steering Committee Charter (see next slide) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Forged an alliance with Tenthpin/SAP Consortium to help small and medium companies standardize their processes to help prepare them for real-time E2E ERP solutions Identified and prioritized key challenges faced by our members Established two Advisory Teams (Clinical Forecasting and Inventory Visibility) Hosted two webinars and one in-person mini-conference Chat room ready for launch Annual Conference agenda identified Future Plans: Strategic Alliances, Global Expansion, etc

  4. 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

  5. Clinical and Commercial Supply Chain Steering Committee Meeting BSMA Annual Conference June 22-23, 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 Digital Transformation Another conference is being considered for late 2022 and will focus on specialized areas, possibly Cell & Gene Therapy and Cold Chain (Location tbd)

  6. Clinical and Commercial Supply Chain Steering Committee Meeting Proposed SCM Topics for June 22-23, 2022 Conference Lessons Learned During the Pandemic (Plenary Session) Clinical Supply Chain Workshop (3 hour workshop - Luke Moyer, Incyte) Afternoon of June 22 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Using Stochastic & Deterministic Planning to Optimize Clinical Forecasting & Replenishment (Dan Silva & Clinical Forecast Advisory Team) 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 (Hans Heesakkers or Dan Silva - TenthPin; David Volk? - Genentech; tbd Beigene; tbd*) Transitioning from Clinical to Commercial Operations Keys to Ensure a Successful Product Launch (Khal Shah? - Exelixis; Robert Wheeler? - BioMarin; Arvind Singh Genentech; Matt Donnelly? - Beigene; Paul Seaback? - Dermavant; Matt Blum? - Catalent) tbd* - Include one SME from IRT i.e. Almac Technologies, Suvoda, EndPoint, Bracket, IQVIA (Cenduit) and one Clinical Distribution Service Provider (Fisher or Almac). Possibly a niche provider such as ClinApps

  7. Clinical and Commercial Supply Chain Steering Committee Meeting Proposed SCM Topics for June 22-23, 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 (Brittney Elko - Tricida; Derek Thornton - Amgen; Jon Paras Yprime; tbd? Almac or Fisher; CLO/CRO SME? (i.e. PRA, PPD, Clintec, ICON, IQVIA, Parexel, Covance, Atlantis); Compliance/Regulatory SME? Use CRO?) Avoiding Mistakes You Are About to Make in a Clinical Study Lessons Learned (Ryan Mills - Denali; Amy Thompson - Eidos; Marc Trombella - BioMarin; Mike Dallman; Malou Berdan? - Beigene; Genentech?; Gilead?; tbd*) How to Successfully Implement Direct-to-Patients Clinical Studies (Jan Pieter Kappelle - 4G and Nicole Gray - Catalent) Clinical Drug Accountability & Reconciliation tbd* - Include one IRT Service Provider i.e. Almac Technologies, Suvoda, EndPoint, Bracket, IQVIA (Cenduit) and one Clinical Distribution Service Providers (Almac or Fisher)

  8. Clinical and Commercial Supply Chain Steering Committee Meeting January 27, 2022 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? Hiring challenges? Supply shortages? Longer raw material & CMO lead times?

  9. Clinical and Commercial Supply Chain Steering Committee Meeting January 27, 2022 Next Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OFEMIC Thursday, March 3, 2022 Next Steering Committee Meeting

  10. Clinical and Commercial Supply Chain Steering Committee Meeting January 27, 2022 Back-Up Slides GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN Ba

  11. Clinical and Commercial Supply Chain Steering Committee Meeting 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)

  12. 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 GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC 2nd Tier Technology Solutions for Clinical Labeling for Agility, Regulatory Compliance and Speed to Market across the Globe . 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 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. Combine with Forecasting Best Practices 4th Tier Artificial Intelligence (AI), Machine Learning and Blockchain Deployment in Drug Discovery and Development

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