Contents ARCI basics What does ARCI mean? How to read an ARCI chart Understanding the context and integration of an example ARCI (using an R&D function) with an overall (all functions) Innovation Process (IP) Tasks and decisions on ARCI follow Stage Gate steps on an IP process flow Specific R&D function ARCI is integrated with IP overall (all functions) ARCI Overall IP ARCI for all functions must be synchronized with product development project R&D team ARCIs Understanding that individual ARCI charts may have to be customized down to the channel and brand level in some cases Example Pharma IP organization breakdown Depicting how R&D PD teams may need custom ARCI charts down to brand levels

What Does “ARCI” Mean? ARCI CHART OF ROLES & RESPONSIBILITIES A = PERSON ACCOUNTABLE (ONLY ONE PERSON) R = PERSON(S) RESPONSIBLE (CAN BE MORE ONE PERSON) C = TO BE CONSULTED BEFORE A TASK OR DECISION I = TO BE INFORMED AFTER A TASK OR DECISION ARCI Charts Often called roles and responsibility charting. It means determining for each task or decision who is going to accountable (“A”), who will be responsible (“R”), who needs to be consulted before (“C”), and who needs to be informed after (“I”). Only one person can be accountable for any task or decision (“the buck stops here”), whereas one or more people may be responsible. We often say someone has the “A” for something, meaning it is the person who will be held accountable. The “A” role (accountable role) also means that person has the authority to get the task done or to make the decision. The person with the “A” role is obligated to use that authority to get the job done.

How To Read An ARCI Chart ROWS DESCRIBE TASKS & DECISIONS COLUMNS DEPICT ROLES RESPONSIBILITIES (As, Rs, Cs, Is, OR NONE) ARE SHOWN AT THE INTERSECTIONS

Pharma Example Explained The following slides demonstrate how a typical Pharma product development project might be executed through a stage gate process, including development and integration of ARCI charts at the appropriate levels. There is no significance to either the functional example (an innovation process) or the industry (pharma); ARCI charting is used universally in all industries and functional processes. These slides exemplify how custom ARCI charts must be developed in detail, in some cases down to the brand level. However, there is no boilerplate rule for how many ARCI charts are needed; ARCIs must be developed for each business process down to the appropriate level; each client circumstance and environment will require a custom solution; what is appropriate for one situation may differ from another.

Typical Three Innovation Process (IP) Components (Pharma) IP Stage Gate Process 1. PROCESS FLOW 3. PROJECT CORE TEAM 2. OVERALL ARCI CHART

Typical Pharma IP Stage Gate Process Flow Stage 1 - Ideation R&D 1 R&D Accountability This step will require a detailed R&D ARCI Prelim. Technical Assess. Ops 1.05 Strategy Ideation Catalog Prioritize (Informal) Consumer/ Customer Evaluation Volume Estimate Screen Estimate Resource Needs Stage Gate Prep SG I 1.01 1.02 1.03 1.04 1.06 1.08 1.09 1.10 Legal SWOT Sales 1.07 Mktg. QA Finance External Legal Sales Marketing R&D Operations Process QA Finance

Typical Pharma IP Stage Gate Process Flow Stage 2 – Concept Development Initial PTS Feasibility Study Capital Need Assess. COGS Assess. Final PTS 2.04 2.07 2.09 2.11 2.14 Mfg. Site Select. 2.10 Turn Idea into Concept Working VPM Initial GTM Patent Strat. Review Charter Team Quant. Volum-etric Initial P&L Stage Gate Prep SG II 2.01 2.02 2.03 2.05 2.08 2.13 2.15 2.18 SMLR Review Design Clinical (if needed) 2.06 2.16 Customer Input/ Forecast Develop Detailed Project Plan 2.12 5 R&D Accountabilities Each step will require a detailed R&D ARCI 2.17 Sales Marketing R&D Operations Process QA Finance

Typical Pharma IP Stage Gate Process Flow Stage 3 – Product, Package, Process Process Design 3.01 12 R&D Accountabilities Each step will require a detailed R&D ARCI Thermal Process/ Microbial Capital/ Capacity Est. 3.17 3.19 3.02 3.09 Initial Qual. Rpt/ Draft Form. Scale Up/ Documen- tation Package Design 3.10 3.11 3.03 3.14 Replicate Meeting Charter Team SG III Formulate & Optimize Product Replicate Mfg. SLT Final P&L Stage Gate Prep Sensory CLT/HUT 3.00 3.04 3.16 3.20 3.27 3.30 Method Devel. & Optimize Method Devel. & Optimize RCE Label Info Packet Final BOM Finalize IP Strategy Kill/ Rework 3.05 3.21 3.24 3.28 RM/FG Sourcing Label Approval 3.06 3.25 Product Positioning Branding Graphics Concept & Product Volumetric Marketing Plan 3.07 3.12 3.15 3.22 3.26 TM Search Customer Input/ Forecast Finalize Project Plan 3.13 3.18 3.23 3.29 Finalize Clinical Design Execute Clinical 3.08 Legal Sales Marketing R&D Operations Process QA Finance

Typical Pharma IP Stage Gate Process Flow Stage 4 – Product Launch Qualify Package 4.02 2 R&D Accountabilities Each step will require a detailed R&D ARCI Qualify Label 4.03 Order Materials 4.04 Capitalize Produce Order Fill/Ship 4.05 4.12 4.19 Charter Team Transfer Techn. Track Product 4.06 4.15 4.01 FDA Filing 4.07 Creative Develop. Produce Materials Sales Launch Initial Sell HCP Detail 4.08 4.13 4.16 4.17 4.21 Execute Marketing Plan Develop. Sales Training 4.09 4.18 Transition Plan Customer Service 4.10 4.20 Pricing/ Contract Develop. Pre Sell 4.11 4.14 Sales Marketing R&D Operations Process QA Finance

responsibilities shown Project Roles & Responsibilities (Overall ARCI) For Typical Pharma IP (Only Stages 1-3 Shown) Top level R&D roles & responsibilities shown In yellow area

responsibilities for each R&D step in the stage gate process Integration of the 3 IP Components With Detailed R&D Function ARCI IP Stage Gate Process Detailed R&D roles & responsibilities for each R&D step in the stage gate process

Take Another Look at the Detailed R&D ARCI Chart and Note How It Correlates To the Overall IP Process The ARCI chart for R&D functions details every role & responsibility for every task & decision

Typical Pharma Product Development Project Core Team R&D R&D Project Manager Marketing Market Research Sales Finance Q.A. Operations TL P M

Typical Pharma IP Core Team, Showing Expanded R&D Project Team (All R&D Functions) . Sales Marketing Product Developer Package Developer Science/Med. SME Finance Technical Services R&D R&D Project Manager TL Research Services P M Regulatory Affairs Finance Q.A. Clinical Operations Market Research Label Coordinator Scientific Assess. Operations

Typical Core R&D PD Project Team CORE R&D PRODUCT DEVELOPMENT PROJECT TEAM Project Manager Principal Investigator Accountable for the outcome of the entire development project Product Developer(s) Package Developer(s) Science/medical expert(s)

Typical Organization of Pharma R&D Business Units CORE R&D PRODUCT DEVELOPMENT PROJECT TEAM Project Manager Principal Investigator Accountable for the outcome of the entire development project Product Developer(s) Package Developer(s) Science/medical expert(s) CHANNEL 1 CHANNEL 2 CHANNEL 3 Product Developers Package Developers Science/ Medical SME Product Developers Package Developers Science/ Medical SME Product Developers Package Developers Science/ Medical SME

Typical Breakdown of Pharma R&D Business Units CORE R&D PRODUCT DEVELOPMENT PROJECT TEAM Project Manager Principal Investigator Accountable for the outcome of the entire development project Product Developer(s) Package Developer(s) Science/medical expert(s) CHANNEL 1 CHANNEL 2 BRAND A BRAND B BRAND C CHANNEL 3 BRAND J BRAND K BRAND L BRAND R BRAND S BRAND T

In Some Cases, Individual ARCI Charts Will Have To Be Customized Down To the Channel and/or Brand Level

In Other Cases, Individual ARCI Charts Will Have To Be Customized Down Only To the Channel Level

In Rare Cases, A Single ARCI Chart For All R&D Will Be Sufficient To Guide All Channel & Brand Contributors