Developing and

Implementing a PMO
for a Gene Therapy
Focused CMO
By:
Sreelakshmi Chandrasekharan,
Quyen Thach, Kaleana Plares,
and EC Schneider

1
 ● INTRODUCTION
● SCOPE
● OBJECTIVE
● VALUE PROPOSITION
Table of ●
●
PROCESS
TIME
Contents ●
●
COSTS
RISKS
● EXECUTIVE
SUMMARY

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 Introduction

● Non-US Public Company

● Over 10,000 full-time employees
● Yearly revenue over $10B
● Specializes in viral vector-based gene therapy
● Global clients
○ Major pharmaceutical and biotechnology-based companies
● No centralized project management department

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Scope Statement
Setting up a Project Management Office (PMO) for a Contract Manufacturing
Organization (CMO)

In-Scope:
Clinical and commercial scale manufacturing
Consistent final product for client companies
Project management for viral vector-based gene therapy

Out-of-Scope:
Pre-clinical research
Marketing and commercialization

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Objective

Establish a PMO that will increase the project management

maturity level from Level 1 (no PMO) to Level 4
(Implementation) within 1 year
Immediate: Level 2 - Mobilize
Within 6 months: Level 3 - Design
Within 1 year: Level 4 - Implement

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Objective-Performance Metrics
Level 2 - Mobilize Level 3 - Design Level 4 - Implement

● Project Manager ● Project timeline ● Employees be able

and Project Lead/ established to perform their
Assistant ● Training sessions assigned tasks with
established and meetings little to no troubles
● 10 employees established ● Documents are
established ● Divide and train traceable
● Determined employees based on ● Project continue
products their specialties moving forward with
● Documentation ● Documentation for little to no problem
storage (i.e cloud, traceability ● Communication are
drive, hardcopy) established clear and concise
● Communication
means established
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Value Proposition

For a large-scale public company specializing

in viral vector-based gene therapy, our group
will implement a PMO which focuses on
improving stakeholder satisfaction, resource
management, and meeting proposed
timelines by establishing standard processes
to be implemented in each project.

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 Process and Key Activities
Phase 1:
Move from Level 1 (Ad
Hoc) PM Maturity to Level
2 (Mobilize)
Current state analysis
PMO defined and recognized
in initial meeting
Common goals established
Products well explained
Stakeholders recognized
Identify who needs to be
involved in PM trainings/
meetings
Consistent documentation
Phase 2: Phase 3:
Move from Level 2 PM Move from Level 3 PM
Maturity to Level 3 Maturity to Level 4
(Design) (Implement)
PM training meetings Roll out of designed
Design and document core processes in all projects
processes, methodology, & Build relevant
governance framework
communities in and out
Establish project risk of PMO
management, goals, and
metric based guideline Promote metrics based
performance
Determine project timelines
Establish risk
Integrate PM through PM
management culture
software
Define product success
Perform Risk
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Management
Deliverables

Phase 1 Phase 2 Phase 3

2 A: Training & 2 B : Design ● Implement the
● Research
Timeline ● Core process designed
● Feasibility Study
● PM training & methodology process for all
● Recognize
for the ● Risk the projects
stakeholders
members establishment ● Evaluation of
● Well documented
● Establish the ● Integration of the established
processes
Project PM software process
timeline

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 Critical Path
Determine goals,
products,
PM Training Meeting Roll out designed project
meetings,
personnel,
stakeholders

Current state
Design/document core processes
analysis, define
methodology, gov framework
PMO

Built relevant
Consistent communities
documentation Integrate Project in and out of
PMO
through PM software

Establish Risk
Management, Perform Risk Management
timeline, goal, metric Promote Metric based
based guideline, product Performance
success criteria 10
 Milestones

Phase 1: Phase 2: Phase 3:

Move from Level 1 (Ad Move from Level 2 PM Move from Level 3 PM
Hoc) PM Maturity to Level Maturity to Level 3 Maturity to Level 4
2 (Mobilize) (Design) (Implement)

★ PMO is well ★ Project timeline is ★ Core processes are

defined and established and core implemented and
understood by processes are projects are
those involved in designed completed within
the project timelines
★ Project risk
★ Current state management is ★ Risk management
analysis has been designed culture is 11
 Decision Making Process
Phase 1 Phase 2 Phase 3

Mobilize Design Implement

Stage 1 - Scoping Stage 2 - Build Business Stage 3 - Development

Case
● What are the ● What types of
common goals of ● What are the needs of documentation are
the PMO, CMO, and the CMO? required?
stakeholders? ● How feasible is our plan ● Can personnel be
● What is the current for PMO trained in a realistic
state of PM? implementation on the time?
● How will our proposed timeline? ● Is there significant
processes improve ● What is standard set of buy-in?
the CMO? PM tools for our CMO? ● What PM Metrics are
used? 12
 Metrics to Determine Progress

● Established during stage 3

● Can quantify how the PMO is performing during later stages in SGP and
post-launch
● Employee satisfaction
○ How satisfied are employees with the efforts of the PMO?
● Actual cost
○ How much has been spent on the project?
● Cost variance
○ How does the planned budget compare to the actual cost?
● Schedule variance
○ Is the project ahead, behind or right on schedule?

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 Decision Making Process
Phase 1 Phase 2 Phase 3

Mobilize Design Implement

Stage 4 - Testing and Stage 5 - Launch Stage 6 - Post-Launch

Validation Review
● How has assumed ● Outside the scope
● What are the risks risk impacted of this project!
associated? launch?
● What are the ● What issues have
opinions of those we come across
involved? How can post-launch?
we adjust?
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 Time
Phase 1 Phase 2 Phase 3

Mobilize Design Implement

1-2 months 3-4 months 5-6 months

9 months-1 year
total
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 Costs
Phase 1 Phase 2 Phase 3

Mobilize Design Implement

Initial Hires, Training, Software Software

Research, Setup implementation,
Planning 700k continuous training
600k 200k

1-2
Million* *500k as buffer
 Resources

Phase 1: Mobilize Phase 2: Design Phase 3: Implement

Personnels Software Troubleshooting assistants

Raw materials and products Training sessions and Analyzer and software
meetings engineers

Facilities and Labs Documentations and Liaisons

Regulatory Affairs

Equipments Shipping (cargos and

vehicles)

Time

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 Key Risks
Risk Probabilit Impact Response
y

Employees hesitant to High High Prevent: Establish importance of PM in

accept PMO initial meetings

Lack of expertise/no Mid High Transfer: Outsource project managers

potential project
managers

Designed processes are Mid High Convert to opportunity: Design new

inefficient processes with knowledge of what didn’t
work

Proposed timelines are Mid Mid Contingency plans: Have an action plan
not met ready

Poor communication and Mid Mid Mitigate: Scheduled meetings (share

slow implementation necessary information/status reports)

“Scope creep” Low Mid Monitor: Make sure new projects are 18
 Summary

● Current PM maturity level is Level 1 (Ad Hoc) and we aim to reach Level 4
(Implementation) within 1 year
● Decisions made through SGP
○ Quantifying metrics established early on to mark progress through stages and
PM phases
● Investments in employees, PM infrastructure, and PM software will be initially costly
○ Estimate total costs to be $1.5M
● Risk management will be an integral part of PMO

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Thank you!

20
Backup Slides

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 Process

● Immediate: Level 2 - Mobilize

○ Current state analysis and PMO recognized
○ Common goals established
○ Consistent documentation
● Within 6 months: Level 3 - Design
○ Design and document core processes, methodology, and governance framework
○ Integrate project management through PM software
○ PM training meetings
● Within 1 year: Level 4 - Implement
○ Roll out of designed processes in all projects
○ Build relevant communities in and out of PMO
○ Promote metrics based performance
○ Establish risk management culture and PM core competency

Used Throughout: Time and task management, Resource management, Finance management, Risk and issue
management

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 Decision Making

● Utilize Stage-Gate Process

● focus team member energy and the timely delivery of the plan
○ determines if the project team should stop work or continue
○ Ensures strategic alignment
● Stages correlate to Phases
● Ask key questions at end of each stage to decide how/if to proceed

Phase 1 Phase 2 Phase 3

Mobilize Design Implement

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 Costs
Factors to Consider:
● 9 Month-1 Year timeline
● Large Company, 10B Yearly Revenue
● Need to hire new personnel - NO CENTRALIZED Project Management
Expertise, or Department
○ Internal hires are a priority (salary increases instead of new hire salary)
○ PMO director
○ project and program managers (current employees, not part of PMO
officially)
○ project controllers
○ other project support roles like administrative assistant
● Software Selection and Implementation
Phase 1 Phase 2 Phase 3

Mobilize Design Implement

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 KPI’s of CMO in PM

● Client Retention
● Profit Margin
● Revenue per client
● Internal Process Quality
● Overall operation Effectiveness

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