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Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 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 September 7, 2023 Agenda GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Conference Updates Workstream Group Updates Global Logistics & Trade Compliance Workstream Group (New) Group Discussion on Artificial Intelligence (facilitated by Tony Ko from Slalom) Future Meeting Dates Introductions from First Time Callers (Name and Company)
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Conference Updates GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC See BSMA Website: https://biosupplyalliance.com/2023-summit-march-8-9/ Recording of most sessions available on-line Future Conferences Brussels, Belgium: October 19-20, 2023 S. San Francisco Area, US: March 20-21, 2024 Kigali, Rwanda, Africa: May 27-28, 2024
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Work Stream Clinical Supply & Demand Planning Co-Chairs: Ryan Mills (Denali) and Sebastien Coppe (formerly N-Side) Member Companies: Aligos, Amgen, Arrowhead, Avidity Bio, Bayer, BioMarin, Dermavant, Exelixis*, Gilead, Global Blood Therapeutics (Pfizer), Helix, Novartis, Pliant Therapeutics, SK Pharmateco*, Illumina, Incyte, Wugen, Tenaya Therapeutics, 4G Clinical, Almac Group (IRT), Almac Clinical Services, Catalent, Clarkston Consulting, Signant Health, Slalom Consulting, Genpact, Keck Graduate Institute Waiting for person to be identified GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Scope: Clinical Demand and Supply Planning, CD&OP, Inventory Optimization Last Webinar S&OP in the Clinical Planning Space : Stacey Erickson (Clarkston), Laura Shuga (Bayer), Jon Miller (Wugen), Eliano Russo (Novartis) Next Webinar November 15, 2023: Best Practices & Innovation in Clinical Trial Pkg Strategies : Hilary Ross and Darrell Sheira (Almac), Diane Schilling (Incyte), Rob Cascone (Signant Health), Moderated by Tony Stolis (Slalom) Workstream Group Discussions Comparators, Imports/Exports Oct 19-20 Brussels Conference: Various topics about Clinical Supply Planning (incl. analytics and commercial launch readiness) March 20-21, 2024 SSF Conference: Upstream Supply Planning (Drug Product/Drug Substance from large and small companies)
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Work Stream Moving Beyond Excel and Point Solutions Co-Chairs: Rutesh Desai (Beigene)/Antonio Tramontano (Genpact) and Dan Silva (Tenthpin) Member Companies: Allogene Therapeutics, Amgen, Avidity Bio, BioMarin, Dermavant, Eikon, Exelixis, Gilead, Novartis, SK Pharmateco, Tenaya Therapeutics, 4G Clinical, Almac Group (IRT), Catalent, Egnyte, Endpoint Clinical, Kinaxis, Signant Health, Keck Graduate Institute GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Scope: ERP, IRT, Digitalization, Analytics, Integration with CDMO s, etc. Last Webinar Novartis Clinical Supply Chain Digitalization Journey : Antonio Tramontano (Novartis) and Ryan Pedroni (Eikon) Next Webinars Thursday, September 28, 2023: IRT The Better Half : Ian Little (Tenthpin), Hilary Ross (Almac), Donna Lucero (Amgen), Bryan Clayton (Endpoint), Olivier Wagner (Centuit), Moderated by Danish Faraz (Novartis) Mid-December, 2023: Data Governance and Master Data (Title and Speakers tbd) Workstream Group Discussions ? March 20-21, 2024 SSF Conference: Two Topics: IRT and Clinical Systems & Technology
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Work Stream Transitioning from Clinical to Commercial: Ensuring a Successful Product Launch GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Member Companies: BioMarin, Dermavant, Novartis, Sk Pharmateco, 4G Clinical, Catalent, Clarkston Consulting, Kinaxis, Keck Graduate Institute Scope: Process changes & Tech Transfers, Regulatory challenges, CMO selection, Batch sizes, Organizational structure, People & culture, Logistics Co-Chairs: Mike Dallman (Avidity BioScience) and Aparna Seksaria (SAP) Next Webinar Mid Oct., 2023: Workstream Group Discussions ? March 8-9, 2024 SSF Conference: ?
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Work Stream Global Logistics & Trade Compliance GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Co-Chairs: Jeff Bernia (Bayer), Christopher Jacks (Catalent), Deep Sengupta (DSG Global Academy) Member Companies: Open to all Manufacturing & Service Providers who participate in global logistics, imports/exports and trade compliance Scope (draft): Clinical up through and including Commercial Launch Kick-off Meeting: Tuesday, September 26 at 8 am PT Dates & Topics for 1st Webinar: tbd Topic for March 8-9, 2024 Annual Conference: tbd
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Artificial Intelligence in the Clinical Space Facilitated by Tony Ko, Slalom Consulting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC How do you envision AI impacting Clinical Trials? What is the timing for when we might see this happening? What are you doing to prepare for this? (Do you have a team or strategy in place?) What can Professional Associations such as BSMA do to help? What can our service providers, college and university affiliates do to help?
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Next Meetings - Thursdays, 8 am PT November 9, 2023 January 11, 2024 March 20 & 21, 2024 (Annual Conference) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN Ba
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 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 (through commercial launch) 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 Includes input from virtual, small and medium size members Identify, discuss and align to industry best practices that members and solution providers can incorporate into their design Share at BSMA webinars & conferences 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 Provide direction and support to Workstream Groups, ID topics for Conferences, Allocate time at meetings to discuss critical issues (i.e. Hiring challenges, Ukraine)
Clinical and Commercial Supply Chain Steering Committee Workstream Groups Charter GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Includes input from virtual, small and medium size members and from Service Providers Identify, discuss and align to industry best practices relating to their workstream Encourage collaboration during meetings and with EnterAkt for participants to ask and share information about challenges and solutions related to their workstream Identify topics and speakers for BSMA webinars & conferences Enable people to connect with their peers
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 EnterAkt Collaboration platform that allows participants to communicate, coordinate, and share challenges, solutions and best practices GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Pilot Program 2023 (Open to anyone) Used for posting Steering Committee Meeting and Webinar recordings, and Q&A s from Webinars Next Steps Expand use to allow All Users the ability to identify and connect with SME s and people with similar interests; Post questions and seek answers from peers and solution providers; Receive alerts when someone you choose to follow posts a topic of interest. Complete (see next slide) Promote world-wide throughout our Manufacturing and Service Provider community 30 minute training video: https://us06web.zoom.us/rec/share/GtNvyUe_EzVMLdPvuC7CLQPBtpO5rz_M4tMAGpRLc49r6cf3 BpoutYZi4T0hEQn1.uRCjMR9Za0gIlHwE?startTime=1683312908000 Passcode: B5vS9s^J Website: https://bsma.enterakt.com/login
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 EnterAkt If you have trouble gaining access Anyone who requests access should receives an email from info@qlhinc.com with a user-name and password and a subject line that reads "Welcome to Enterakt!". If your company uses an email quarantine system, it may be a couple of days before your junk/spam filter allows you to see it. If you do not log-in within 60 minutes, you GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC receive a message "This password token is invalid" error. It means the time to confirm your account expired for security reasons. You can still go the site at https://bsma.enterakt.com and click "Forgot Password?" to get a reset link. New software enhancement We just added the ability for a Follower to get a notification if a Followee creates a post and/or comments on a post. Remember, each user controls (via their profile settings) whether they want to receive such notifications by either text or email. By default those notifications are turned off.
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Membership Benefits and Costs* Integral part of a collaborative group of Biopharma Supply Chain professionals sharing common interests, challenges, solutions and best practices GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Membership in Steering Committees and/or Workstream Groups Complimentary registration for special events, such as Webinars and Round Tables Complimentary access to EnterAkt and ability to seek and share information 10 complimentary passes to BSMA conferences for members See Website: https://biosupplyalliance.com/fees-benefits/ * Applies to drug Research, Development and Manufacturing companies. There are separate benefits and fees for Service Providers, Suppliers, and Consulting Companies
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)
