Global Leaders Address Building the Next Gen Supply Chain of Life Sciences in the Wake of Covid-19 Pandemic

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 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 August 19, 2021 Agenda Introductions New Members Calendar of 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 Advisory Team Update CTSM Consortium Update Improving Visibility & Access to Information Across the Clinical Trials Network Update Open Forum (What challenges or problems are you working on?) Next Meeting

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 Calendar of Events Steering Committee Meetings 3rd Thursday of each month Will include Open Forums for members to discuss challenges and solutions GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Webinars and Panel Discussions Clinical Forecasting April 7, May 11 (4G) and August 25 (4G) Check BSMA calendar for additional events Annual Conference Topics (draft) October 20 March, 2021 Clinical Supply Chain Workshop (demand & supply planning) Clinical Forecasting Improving Visibility & Access to Information to Optimize Clinical Trials 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 August 19, 2021 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)

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 Chat Room Forums - Please test & provide feedback Clinical supply forecasting & demand planning o In many companies the clinical study team provides a patient forecast which includes number of patients, enrollment rates and patient sites. Besides actual vs forecast , what other metrics do people measure to improve the integrity of this forecast? IXRS o GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC What % of studies in your organization use IXRS and what % of these are integrated with your distributor? Clinical systems & technology solutions o What systems should I evaluate that would enable me to plan, make and distribute both clinical and commercial drug requirements? Clinical processes & best practices o What are the top metrics I use to optimize the costs and service levels of my clinical studies? Blinded studies o Are unblinded members of your clinical supply chain allowed to participate on clinical study teams? If so, how do you insure confidentiality? Direct-to-patient challenges & solutions o What are some of the changes companies have made to address direct-to-patient challenges? Clinical packaging & labeling o What do I need to consider before determining if a study is a good candidate for JIT labeling? Clinical drug accountability & reconciliation o How does clinical supply chain reconcile drug stored and shipped from distributors to sites with the drug dispensed or left-over at the patient sites if the study did not have IXRS? Clinical cold chain & logistics o How many perishable shipments per month warrant having a depot in a Latin America country versus doing direct shipments from the US?

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 Clinical Forecasting Update Scope: Lingering Challenges, Sources of Truth, Improving interactions with clinical development, Push vs Pull, Stochastic (simulation/scenarios), Study reconciliation Advisory Team: GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Dan Silva, Tenthpin Luke Moyer, Incyte Derek Thornton, Amgen Marc Trombella, BioMarin Jan Pieter Kappelle, 4G Clinical Next steps: Currently preparing a panel discussion for 2021 BSMA Annual Conference Team has decided to provide an overview of the two major types of clinical forecasting; stochastic (simulation) planning vs deterministic (calculation) planning. This event will be 90% educational, and include a sharing of situations of use for each method.

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 CTSM Consortium Update o Continuing to onboard new members: BeiGene, AbbVie, Astellas, others are all in process or being final cleared to join in GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN demo environment is being built to address a growing demand for demos. o Demonstration of ICSM capabilities was conducted recently for Boehringer. A more formal o There continues to be separate reach-outs, as needed, to consortium members for inputs related to design decisions, e.g. GS1, serialization, clinical labeling, integration & validation, packaging batch allocation, umbrella trials, adaptive trials, blinding scenarios, etc. o On target for first commercial release of ICSM in April 2022

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 Improving Visibility & Access to Information Across the Clinical Trials Network Update Advisory Team GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OF COVID 19 PANDEMIC Almac Group Rob Cascone BeiGene Rutesh Desai BioMarin Marc Trombella Denali Therapeutics Ryan Mills 4G Clinical Jan Pieter Kappelle Genentech David Volk GenPro Research Arun Sivandam Schrocken Yogendra Chordia, Alec Parsons Tenthpin Dan Silva

Real Time Inventory Management Meeting August 19, 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 August 19, 2021 Current Status Collecting data that will enable us to quantify problems relating to lack of real-time visibility. (Primarily focusing on areas that supply chain can impact, such as COGM, cycle times, service levels, etc.) E.g. 90% of drugs produced gets packaged, 74% of drugs packaged gets shipped to clinical sites, 67.8% of drug shipped to sites was dispensed. Net Result: Only 45% of drug produced for clinical studies gets dispensed, GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC which means 55% of drug produced for clinical studies is wasted! Identifying relevant examples about initiatives which improved company s clinical capabilities and/or costs, while tying this back to our objective of educating and motivating people to support and act on achieving visibility to real-time information Working with Schrocken on E2E clinical trial process map, including inputs and outputs, to help supply chain and clinical operations professionals recognize the importance of tracking and sharing information for optimizing clinical trials Share this information with BSMA members and their providers at BSMA Annual Conference Other strategies and events tbd

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 Next Meeting GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN THE WAKE OFEMIC Thursday, October 21 Next Steering Committee Meeting

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 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

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

Real Time Inventory Management Meeting August 19, 2021 Problem Statement (Clinical) Supply Chain does not have real-time visibility to demand, supply and inventories throughout the end-to-end (clinical) supply chain due to GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCI!ENCES IN THE WAKE OF COVID 19 PANDEMIC disconnected systems, or lack of using specialized systems. As a result, decisions around producing drug, and triggers to manufacturers and distributors about supplies through the supply chain may come too late or worst-case not at all, causing excess/insufficient inventories and scrap, and putting patients and clinical studies at risk.

Clinical and Commercial Supply Chain Steering Committee Meeting August 19, 2021 E2E KPI s Monitoring the inputs and outputs that impact your E2E supply chain will enable you to make better decisions about how much and when to produce, where to store it, and when to ship it Service Patient Service Levels (OTIF; Patient holidays; Actual vs requested date; Actual vs promised date; Backorders) Production Service Levels (Actual vs planned dates for Manufacturing, QC & QA; # Time fence crashes Supplier Service Levels (Supplier OTD; Actual vs planned dates; Ave. lead times) Cost & Efficiency Logistics and Distribution Costs (# Shipments per site & patient; Cost/shipment; # Rush shipments; Storage costs) GLOBAL LEADERS ADDRESS BUILDING THE NEXT GEN SUPPLY CHAIN OF LIFE SCIENCES IN Supply Chain and Mfg/QA/QC Costs (Staffing as a % of COGM; # staff/sku) Inventory (Days and $ on hand; Inventory as a % COGM; Scrap; # Turns; % DS/DP/FG within min/max targets) Capabilities Forecast Accuracy (Actual vs forecast # patients, # sites, patients per site, enrollment rates, etc.; FPI/LPI/ LPO dates; Screen failure rates, etc.) Responsiveness, Flexibility, Stability (FG delivery lead times; Customs clearance performance; Cycle times; # Deviations/lot; # Change Orders; # Rejects; Capacity Utilization; MPS attainment; Temperature deviations; Inventory cycle count accuracy) Improving E2E Visibility will enable you to optimize your clinical trials

Real Time Inventory Management Meeting 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