Global Leaders Address Building the Next-Gen Supply Chain of Life Sciences
Steering committee meeting agenda for the Clinical and Commercial Supply Chain on November 9, 2023, focusing on challenges, future meetings, updates, workstreams, and upcoming conferences in the wake of the COVID-19 pandemic. Discussions include clinical demand and supply planning, best practices, innovation in trial packaging strategies, and more.
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Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 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 November 9, 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 Group Discussion: What are your top challenges? Future Meeting Dates Introductions from First Time Callers (Name and Company)
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 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 Brussels, Belgium: October 19-20, 2023 Future Conferences Foster City, CA: March 20-21, 2024 Kigali, Rwanda, Africa: May 27-28, 2024
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 2023 Work Stream Clinical Supply & Demand Planning Co-Chairs: Ryan Mills (Denali) and Sebastien Coppe (formerly N-Side) Member Companies: Aligos, Amgen, Arrowhead, Bayer, BioMarin, Dermavant, Exelixis*, Gilead, Helix, HiBio, Novartis, SK Pharmateco*, Illumina, Incyte, Wugen, Tenaya Therapeutics, Almac Group (IRT), Almac Clinical Services, Catalent, Clarkston Consulting, Inceptua, Signant Health, Slalom Consulting, Genpact, Keck Graduate Institute Waiting for person to be identified Scope: Clinical Demand and Supply Planning, CD&OP, Inventory Optimization GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC 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 Shiera (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 Conference: Upstream Supply Planning (Drug Product/Drug Substance from large and small companies)
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 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 Scope: ERP, IRT, Digitalization, Analytics, Master Data GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Last Webinar (September, 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) Next Webinar December 13, 2023: The Power of Data Driven Clinical Supply Chain : Beth Walkenbach (Keck), Antonio Tramontano (Genpact), Ed Arnheither (Keck) Workstream Group Discussions March 20-21, 2024 Conference: Topics In review: Clinical Supply Waste, IRT/GS1, Clinical Study Close-Out
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 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, Inceptua, Catalent, Clarkston Consulting, Kinaxis, Keck Graduate Institute ? Scope: Process changes & Tech Transfers, Regulatory challenges, CMO selection, Batch sizes, Organizational structure, People & culture Co-Chairs: Mike Dallmann (Avidity BioScience) and Aparna Seksaria (SAP) Next Webinar -Q2, 2024 Workstream Group Discussions Process changes for tech transfers, Batch/scale sizes, Organizational structure/Infrastructure, S&OP timing March 8-9, 2024 Conference: A Debate Should a Company Have 1 Combined or 2 Separate Supply Chain Departments for Supporting Commercial and Clinical Products?
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 2023 Work Stream Global Logistics & Trade Compliance Chairman Emeritus: Matt Burns (Gilead) Co-Chairs: Jeff Bernia (Bayer), Christopher Jacks (Catalent), Deep Sengupta (DSG Global Academy) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Member Companies: September s Kick-Off Meeting had 25 companies represented Open to all Manufacturing & Service Providers who participate in global logistics, imports/exports and trade compliance Scope: Clinical up through and including Commercial Launch Next Meeting: Tuesday, November 14 at 8 am PT (2nd Tuesday of month) 1st Webinar: Mid-January, 2024 (tentative) Topics for first webinar and March 8-9, 2024 Conference: Valuation, Classification, Country of Origin
Clinical and Commercial Supply Chain Steering Committee Meeting November 9, 2023 What Are Your Top Challenges? GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC b) CMO capacity/CMO on-time delivery c) Inaccurate forecasts d) Lack of Tools & Technology e) Inadequate Processes f) Lack of Data for making informed decisions 1. What are your top challenges (pick 3) a) Raw Material and/or Comparator availability? 2. What is your greatest staffing challenge? (pick 1) a) Filling open positions/Finding the right person for the job b) Employee retention c) Finding appropriate Training & Development offerings
Clinical and Commercial Supply Chain Steering Committee Meeting September 7, 2023 Next Meetings - Thursdays, 8 am PT 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 November 9, 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 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 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 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 Drug Mfg. 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)
