GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES

GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES
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In the wake of the COVID-19 pandemic, global leaders are convening to steer the clinical and commercial supply chain towards the next generation in the life sciences industry. The steering committee meetings discuss strategies, successes, areas for improvement, and future vision, aiming to establish industry standardization and promote best practices. Events like the BSMA Annual Conference provide opportunities for networking, learning, and addressing key challenges faced by the supply chain stakeholders in the ever-evolving landscape.

  • Supply Chain
  • Life Sciences
  • COVID-19
  • Steering Committee
  • Global Leaders

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  1. Clinical and Commercial Supply Chain Steering Committee Meeting May 12, 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 March 24, 2022 Agenda GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC BSMA Annual Meeting Update Steering Committee Vision Where do we go from here? Next Meeting See you at the Conference! Introductions New Members

  3. Clinical and Commercial Supply Chain Steering Committee Meeting May 12, 2022 BSMA Annual Conference June 22-23, 2022 Location: Crowne Plaza, Foster City, CA 2022 Summit June 22-23 - BSMA (biosupplyalliance.com) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Clinical Supply Chain Workshop 8:30-noon Plenary Session (Includes Clinical, Transportation and Digital Topics) 12:30-5:00 Evening Social Event (Wine & Beer Tasting, Food, Live Music, Games) 6:00-10:00 June 22 June 23 (3 Tracks) Supply Chain Management (Clinical through Commercial Launch) 8:30-3:15 Transportation Digital Transformation Networking, Awards and Cocktail Reception 3:15-6:30

  4. Clinical and Commercial Supply Chain Steering Committee Meeting May 12, 2022 Group Discussion Steering Committee Vision Past 12 months GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Established Steering Committee Charter (see next slide) Identified and prioritized areas of interest (Survey conducted early 2020; See back-up slides) Organized 2-day Annual Conference (Topics determined by Steering Committee) Hosted day in-person event and 3 webinars Established 2 Advisory Teams (Clinical Forecasting and Improving E2E Visibility) Alliance with Tenthpin (To help identify and disseminate industry best practices) Set aside time at monthly meetings for members to discuss issues and challenges (i.e. Staffing and hiring concerns, Ukraine, Latin America) Successes and Areas for Improvement?

  5. 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

  6. Clinical and Commercial Supply Chain Steering Committee Meeting May 12, 2022 Group Discussion GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Expand Advisory Teams Include SME s from Steering Committee and Service Providers Allow anyone who is interested to join (i.e. Ask people to sign up at Conference? Invite members of your staff?) Enable through Webinars and BSMA s Chat room Steering Committee Vision Where do we go from here ? Steering Committee Meetings Same time and frequency? Dedicate most of the meeting to group discussions about topics of interest ? Any other thoughts?

  7. Clinical and Commercial Supply Chain Steering Committee Meeting March 24, 2022 Back-Up Slides GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN Ba

  8. Clinical and Commercial Supply Chain Steering Committee Meeting CLINICAL SUPPLY CHAIN WORKSHOP: AVOIDING CLINICAL SUPPLY CHAIN MISTAKES YOU ARE ABOUT TO MAKE GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC stressful job with many moving pieces and very few clear answers. Since Luke s first clinical supply chain job 25 years ago, he s learned a lot about what works and what doesn t, and continues to remind us that every day you work in clinical supplies is a school day. This workshop is designed to accelerate the learning process for novice supply chain managers, helping them to understand key fundamentals and avoid some of the pitfalls many of us learned the hard way. Join Luke Moyer, Head of Global Clinical Supply Chain at Incyte, as he leads a fun and interactive workshop targeted to BSMA attendees who are new to the Clinical Supply Chain Role, as well as experienced clinical supply chain professionals seeking to learn and share best practices. Being a newbie in a clinical supply chain role can be intimidating to say the least.It s an urgent and AGENDA Your forecast is wrong, and that s okay Building a simple but powerful forecast in Excel The difference between overage and safety stock Stability protocols and supply planning Preventing waste and rework using pull vs. push IRT set-up basics Luke Moyer, Head, Global Clinical Supply Chain, Incyte

  9. Clinical and Commercial Supply Chain Steering Committee Meeting Proposed SCM Topics for June 22-23, 2022 Conference GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC How to Reduce Clinical Study Timelines & Get to Market Sooner (Plenary Session) Afternoon of June 22 (Case Study about how to insure Supply Chain & Manufacturing are not the bottlenecks N-Side) Clinical Supply Chain Workshop (3-3 hour workshop - Luke Moyer, Incyte) Morning of June 22 Using Stochastic & Deterministic Planning to Optimize Clinical Forecasting & Replenishment (David Volk Genentech, Marc Trombella BioMarin, Jan Pieter Kappelle - 4G, Cyrille Lefevre N-Side, Moderator: Dan Silver - Tenthpin) Tools & Technologies Beyond Excel A System Evolution to Achieve ERP Readiness (Rutesh Desai - Beigene; Luke Moyer - Incyte; Aparna Seksaria SAP; Yogendra Chordia Schrocken; Moderator: Bob Lamont Clarkston Consulting) Transitioning from Clinical to Commercial Operations Keys to Ensure a Successful Product Launch (Arvind Singh SK Pharmateco, Karl Lovett Beigene, Paul Seaback Dermavant, Marc Trombella BioMarin, Ann McMahon Catalent, Dr. Chris Armstrong - ThermoFisher)

  10. 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 Lessons Learned In The Planning and Execution of Clinical Studies (Ryan Mills Denali, Malou Berdan Beigene, Scott Sabalvaro Amgen; Dan Hanson Thermo Fisher, Moderator Mike Dallman Avidity BioScience) How to Successfully Implement Direct-to-Patients Clinical Studies (Jan Pieter Kappelle - 4G and Nicole Gray - Catalent) A Novel Approach to IRT Vendor Oversight (Facilitator: Jon Paras yprime) Ensuring Clinical Drug Accountability & Reconciliation: A Critically Rewarding Mission (Brittney Elko Tricida, Derek Thornton Amgen, Kathleen Williams Almac, Moderator: Jon Paras Yprime)

  11. Clinical and Commercial Supply Chain Steering Committee Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC BSMA SCM Excellence Awards Reminder: BSMA SCM EXCELLENCE LIFE SCIENCES AWARDS! Is that time to send us your nominations. Are you ready? (constantcontact.com)

  12. 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)

  13. 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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