OnePlan Life Sciences Boston Strategy Presentation

OnePlan's Strategic Portfolio Solutions for Life Sciences

1. Transforming Strategy into Execution
Life Sciences Portfolio Success
with
OnePlan
Robert Happy
[email protected]
Phil Zack
[email protected]
Shawn Kim
[email protected]

2. OnePlan is an AI-enabled Strategic Portfolio & Program/Work Management
platform that enable organizations to streamline their R&D programs & Tech
Ops/GPS, optimize their investments & resources, while driving growth.
Connect Strategy to
Execution
We bridge the gap between strategic goals
and on-the-ground work, ensuring alignment
across portfolios, programs, and projects.
Deliver Real-Time
Visibility & Insights
Gain a unified view across all work with real-
time dashboards and analytics that support
faster, data-driven decision-making.
Unify Tools and
Teams
Integrate with Microsoft Project, Smartsheet
Planner, Azure DevOps, Jira, and more—
breaking down silos and improving
collaboration.
Optimize Resource &
Capacity Planning
Model capacity, demand, and resource
allocation to ensure the right teams are
focused on the right work at the right time.
Centralize Financial
Management
Plan, track, and forecast budgets and actuals
to improve investment performance and
financial governance.
Support Hybrid Work
Delivery Models
Enable Stage Gate Development/Waterfall,
Agile and Hybrid work execution—all within a
single platform that provides leadership with
a consolidated view.
Plan Strategically. Execute Effectively. Deliver Value.
for Life Sciences

3. Industry Recognitions
Life Science/Biotech-Pharma Focus and Other Major Industries
Private Equity Partner
Secured Platform
Strategic Partnership
at a Glance

4. Portfolio Managers
Resource Planning
Financial Planning
Work Plan
Visualizations
Dashboards
Status Reports
Plan Managers
Agile Plan
Ideation / Requests
Artificial Intelligence – Sofia GPT
Demand
TimesheetsMy Work
Stakeholders
Team Members
Executives
Portfolio Planning
Planning
Do the right work Do the work right
Resource Negotiation
Resource Managers
Products, Applications, etc.
Execution Analysis
What-if Scenario Modeling
•Products
•Services
•Applications
Capacity Planning
IssuesRisksChanges
•Business Value
•Benefits
Realization
Strategy
End-to-End Capabilities

5. Who Is Philip M. Zack DVM, PhD, DACVP, Executive Life Sciences Advisor?
[email protected] [phone]
Education
•DVM, PhD
•Experimental Pathologist
•Diplomate Am College of
Veterinary Pathologists
Research
Background
•Retroviral pathogenesis
•Hemorrhagic Diseases
•Hematology
•50+ Articles/abstracts
Modalities
Experience
•Small Molecules
•Biologics
•Liposomes
•Aptamers
•Fixed Dose Combos
•Peptibodies
Experience
o 25+ years experience in
Program/Portfolio/Allianc
e Mgmt
oLed Portfolio
Committees, Program
Management
Departments and
Therapeutic Areas in
multiple companies
•Gilead
•Amgen
•Vertex
•Myovant
oEstablished and Managed
as Dept Head or a
consultant
• Governance Bodies
• Portfolio Strategy
• Program Strategies
• PMO Departments
• Team Charters
• High-Performance
Teams
oImplemented Integrated
Portfolio and Program
Management Systems in
multiple companies

6. Life Sciences
Framework for
Successful Portfolio
Management
1. Formulate and Align Strategy across
the organization
2. Link strategic objectives/imperatives,
goals, operational deliverables, and
resources
3. Conduct Portfolio Reviews to ensure
Strategic and Operational Adaptability
and ensure Financial/Resource
Flexibility
4. Utilize Disciplined Portfolio
Governance to ensure optimized
decision matrix
5. Employ “Best Practices” Portfolio
Management Processes

7. Corporate – Ensure Portfolio and Program Strategies fully Support
Corporate Goals
Strategy for the Portfolio and its Assets/Programs Must be
Formulated and Aligned across the Organization
Portfolio Strategy is Driven by the Key Strategic Imperatives from all the
Programs
Program Strategies are structured to meet the requirements for Asset
Development Plans and include the Asset Strategic Imperatives and their
Rationale linked to key operational outcomes impacting strategy

8. Portfolio Strategy Is Driven by the Programs
▪Effective Portfolio Strategy balances value/risks/opportunity
oAcross Therapeutic Areas and/or Franchises
oAcross Programs within Therapeutic Areas
oWithin Programs
▪Key Program Strategic Imperatives and their rationale are Included
in the Portfolio Strategic Plan
▪Key Decisions impacting portfolio and program value and resources
▪Key Results driving portfolio and program decisions
Ready Access to Cross-Functional and Integrated Key Data is Critical
for making Effective Portfolio, Program, and Functional Decisions:
OnePlan is designed to fully integrate all the necessary information

9. The Connection Between Strategic and
Operational Plans and Decisions
Maintaining a Single Source of Truth
Strategic Imperatives
Program Strategic Plan
Strategic Imperatives and Rationale
Integrated Project Plan
Integrated Project Plan
Objectives (Goals) & Key Results
Functional Plans
Resource Planning
Project Risk Plan – both Strategic and Operational
•Changes to a component of either the strategic or operational plan can impact
resources, time, risk, and priorities at the functional, Project or portfolio levels
•Change Control is important to ensure plan alignment
•Governance approves changes and ensures decision alignment across teams/functions
OnePlan is designed to fully integrate all the necessary information

10. OnePlan Portfolio Roadmaps give you a clear, time-phased view of all initiatives across
the enterprise.
See the Big Picture with Portfolio Roadmaps
See OnePln in action!
Interactive, Time-Based Roadmaps
Visualize initiatives along timelines to
understand sequencing, durations, and key
milestones.
Connect Work Across Portfolios
See dependencies and relationships
between programs, projects, stages, assets,
and products in one unified view.
Multi-Level Planning
Drill up to view strategic themes or down
into detailed execution plans
Custom Views by Audience
Create roadmap views tailored to
executives, product teams, or PMOs using
filters and grouping.

11. OnePlan helps decision-makers monitor portfolio performance in real time. Interactive dashboards
deliver insights into KPIs, financials, resource status, and risks—tailored to each stakeholder.
Tracking Performance across Programs
Data Integration is a major challenge for Portfolio Management:
OnePlan is designed to fully link all the necessary information

12. Asset/Program Value Assessment
•Asset/Program Value is critically important to determine choices of
program investments and to ensure balance of both risks and
opportunities
•Programs may be valued both qualitatively and quantitatively
•Quantitative assessments include ROI, NPV, PTRS which produce
financial/numerical outcomes
•Qualitative assessments can be structured to evaluate a number of
different Development and Commercial criteria.
oCriteria may be constructed to include quantitative values
oCriteria definitions with weighted scoring options can be established
•Both qualitative and quantitative criteria may be included and tracked in
the Integrated Project Plan

13. Value Driver Examples
Market Potential
Commercial Assessment
HEOR Research
Development Assessment
Clinical Regulatory
Molecule Attributes
Evidence of
Targeting Pathway
Evidence of
Target
Impact on Clinical
Outcome
Differentiation per
Benefit-Risk
Development
Complexity
Trial Feasibility
Appropriate Risk/Benefit
Profile
Level of Regulatory
Hurdle
Fit With Regulatory
Landscape
Opportunities to Expedite
Development
Breadth of Access
Potential for Target
Pricing
Competitive
Intelligence
CMC
COGS
Alignment to Platform
NumRequiredber of
SKUs
Drug Product
Complexity
Unit Cost
Market Crowdedness
Market Share Potential
Estimated Annual
Peak Sales
Time Horizon From
First Indication to
Primary Indication
Addressable Patient
Population
Profit Sharing
Intellectual Property
Barriers
Commercial
Infrastructure,
Resources, Synergy
Projected NPV
Competitive Conviction

14. Development – Clinical Value Criteria
Criterion Criterion Definition Range Range Definitions
Synergy of
Pipeline and
Inline
Products
Molecules in development may
demonstrate synergistic
benefits when combined with
other pipeline or franchise
molecules (based on at least
pre-clinical data)
1 (Low) No synergy with inline or pipeline molecules or molecules of a
different class
2 Potential synergy (pre-clinical data) with pipeline molecules or
pipeline molecules of a different class
3 Potential synergy (pre-clinical data) with inline molecules or inline
molecules of a different class
4 Proven synergy (clinical data) with pipeline molecules or pipeline
molecules of a different class
5 (High) Proven synergy (clinical data) with inline molecules or inline
molecules of a different class
Probability
of Technical
Success
Likelihood that development
program can prove efficacy,
demonstrate safety, and
establish medical value
proposition for a given
indication
1 (Low) Low probability of success
2
3 Moderate probability of success
4
5 (High)
High probability of success
Quality of
Clinical Data
(Trial
Design)
Assess the robustness of
asset’s clinical trial design for a
given indication
1 (Low) Observational Data
2
3 Uncontrolled single arm data
4
5 (High) Randomized controlled data

15. Commercial – Market Potential Value Criteria
Criterion Criterion Definition Range Range Definitions
Market
Share
Potential
The patient share achieved by asset
across total treatable population for a
given indication
1 < 10%
2 < 20%
3 < 30%
4 < 40%
5 (High) ≥ 40%
Risk
Adjusted
Peak Sales
Calculated as estimated peak sales
per indication multiplied by its
respective probability of success in
getting that indication, all summed
together for an asset
1 (Low < $250M
2 $250M to $499.99M
3 $500M to $749.99M
4 $750M to $1B
5 (High) > $1B
Time
Horizon
From First
Indication
to Primary
Indication
The time between approval of the first
indication and the approval of the
primary indication for an asset
1 (Low) > 4+ years
2 3+ years to 4 years
3 2+ years to 3 years
4 1+ years to 2 years
5 (High)
≤ 1 year

16. OnePlan empowers organizations to drive innovation by managing the full lifecycle of
opportunities - from initial capture to strategic prioritization and execution.
Capture, Evaluate, and Advance the Best Opportunities
See OnePln in action! See OnePlan in
action!
Centralized Opportunity Capture
Collect opportunities from across the
organization using customizable intake forms and
portals.
Opportunity Scoring & Ranking
Use scoring models to evaluate opportunities
based on business value, feasibility, risk, and
strategic fit.
Stage-Gate Governance
Advance opportunities through configurable
workflows with approval gates and business case
development.
Pipeline Visibility
Visualize innovation pipelines, from opportunity
intake through execution, with dashboards and
roadmap views.

17. Linking Strategic Imperatives, Objectives/Goals,
Operational Deliverables, and Resources
•Portfolio and Program Decisions are optimized by linking strategy and operational
objectives for the Portfolio, Programs, and Functions
•Program Strategies should be structured to meet the requirements for the individual
Development Plans and each stage-gate and can include:
oStrategic Imperatives and their rationale with key operational outcomes impacting strategy
oThe Go/NoGo decision matrix for advancing to the next stage-gate with timing
oKey risks and/or opportunities and data drivers
oEndorsement by all impacted functions
oLong-range planning hinging on achieving one or more strategic imperatives
•Program strategies and Operational Plans (Integrated Project Plans – IPP) must be
aligned with Portfolio Strategy
•The IPP should link all key portfolio elements including alignment with functions

18. Early and Late Strategic Plan Timelines and Stage Gates
Late Strategic Plan
End of End of Phase 3 Registration
Phase
Initiate LSP Discussions
With PRC, DC KOL
Complete Initial LSP
Determine Issues
& Questions
Develop High-Level
Plan & Strategy
Final Approved
LSP
Early Strategic Plan
Initiate LCMP
Includes Detailed
Lifecycle Plan
Portfolio Governance Review and Approval
Update LSP
P2
Stage Gate
Go/NoGo
POC
Stage Gate
Go/NoGo
EOP2
Stage Gate
Go/NoGo
File
Stage Gate
Go/NoGo
Pre-Clinical IND End of End of
FIH Phase 1 Phase 2A
Start & Complete
Initial ESP
Final
Approved ESP
Update ESP
FIH
Stage Gate
Go/NoGo

19. Strategic Imperatives, Objectives, Key Results
Creating a complete outline of the strategy and its associated Operational
requirements is an extremely useful communication tool components include:
Strategic Imperatives (SI)
SI’s (or objectives) provide the high-level strategy for one or more stage gates of a
program. Changing an imperative will have significant impact for the portfolio
objectives
Objectives (Goals)
Each SI will have multiple goals which are tactical requirements to achieve the SI
Key Results (Deliverables and Metrics)
Each Objective will have one or more Key Results from various functions with
associated metrics
This outline can be created for both the portfolio and associated programs
Key SI’s are elevated to the portfolio view

20. Strategic Imperatives and Goals for a Phase 3 program
Strategic Imperative Objectives/Goals
Deliver the Label
Deliver a competitive launch data set, label &
positioning
•Optimize Product Profile & label
•Compelling positioning / launch promotions
•Address global clinical evidence gaps
•Required preclinical toxicology studies
Deliver the Product
Seamless delivery and uninterrupted supply to
customers
•Commercially-viable Cold Chain Distribution and Fulfillment
oStability of product at refrigerated temps
•Increase manufacturing capacity
•Successful Regulatory filings and inspections
Establish the Science
Characterize and educate on XXXXXX
•Preclinical and clinical translational research on XXXX
•Disease state education / communication
•HCP administration training
Secure Access
Ensureoptimal pricing and reimbursement
that supports the labeled indication
•Establish product value in light of XXXX comparator; establish
optimal price to compete effectively in the market
•Demonstrate strong value proposition that includes OS with cost
effectiveness, budget impact and net health benefit
Expand the Label
Collect data to maximize potential of
molecule
•Lifecycle Plan Development (combination data, additional
indications, new tumor types, etc.)

21. Strategic Imperative #1: Deliver the Label
Deliver a competitive launch data set, label and positioning
Completed
Ongoing; on track
Not met
No longer applicableN/
A
Objectives Key Results Metrics Status
Optimize
Product Profile
& label
1.Execute XXXXstudy and complete
data analyses
Flash Memo completed by
end of Q4-XX
Compelling
positioning /
launch
promotions
2.DevelopStrategic Launch Plan
Complete draft Global
Launch Plan and have plan
endorsed by end of Q2-XX
Address global
clinical
evidence gaps
3.Develop robust global evidence
strategy
Strategy endorsed by end of
Q1-XX

22. Portfolio Strategic Imperatives and Objectives
Rolled up from Programs
Grow Product XXX
▪ Prepare for Optimal Launch (1
st
& 2
nd
line XXX)
▪ Renew EU Conditional Approval
▪ Execute Key Clinical Trials
Deliver the Best Pipeline
▪ Execute Key Clinical Trials
▪ Advance Programs XXX, YYY, & ZZZ
▪ Determine XXXX Investment Options
Support Corporate Goals
▪Support Smart Globalization
▪Manage Risk in Supply
▪Optimize Critical Third-Party Business Relationships
Manage the Therapeutic Area
▪Enhance PST/PGT Effectiveness
▪Implement and Maintain Medical Investment Plan Processes and Deliverables

23. OnePlan ensures all work—assets, programs, projects, and team work are aligned with
your organization’s strategic goals.
.
Connect Every Investment to Strategy
See OnePln in action!
Define and Manage Strategic Objectives
Establish enterprise goals and strategic
themes to guide investment decisions.
Link Work to Strategy
Map initiatives, programs, and projects to
strategic priorities for continuous alignment.
Track Strategic Contribution
Monitor how work delivers value to the
business with KPI tracking and success
criteria.
Visualize Alignment Across the
Enterprise
Use heat maps, roadmaps, and dashboards
to understand how your entire portfolio
supports strategic goals.

24. .
Managing IPP’s, Risks, Resources and
Financial all in one place with OnePlan
See OnePln in action!

25. .
Resource Management/Capacity Planning
Across the Portfolio
See OnePln in action! See OnePlan in
action!

26. Conduct Portfolio Reviews to ensure Strategic and Operational
Adaptability and ensure Financial/Resource Flexibility
•Annual Review Cycle – Quarterly
❖Q1: Review to Update Strategy and Imperatives
❖Q2: Review to Update Integrated Project Plan IPP proposal
❖Q3: Review to Update Resource Requirements to fund IPP
❖Q4: Review to Update new Global Program Plan
•Event-driven – to ensure that there is flexibility to achieve maximum
value and reduce risk
❖Changes in program priority
❖Changes in resource requirements
❖Changes in risk/opportunities
•Structured in a Portfolio Planning Calendar to ensure coordination
with Executive Team and BoD

27. Brand Planning (Tactics)
27
Portfolio Planning Calendar Example
1QXX 2QXX 3QXX 4QXX
Event
-
Driven
Updates
Formal Planning Processes
Business Development Activity & Ad Hoc Analysis
J DF M A M J J A S O N
Board Mtgs.
20xx
Plan &
Goals
Lock
Earn
-
ings 25
th
26
th
26
th
25
th

Sr. Mgmt. Reviews & Succession Planning
20xx Financial
Planning
Goals Assessments
Long-Range Planning
Ratify 20xx
Performance
16
th
& 17
th
7
th
& 8
th
19
th
& 20
th
3
rd
& 4
th
5
th
& 6
th

Key
Events
Key
Conferences
PGT Update
20xx 1Q
Performance
20xx 2Q
Performance
20xx 3Q
Performance
20xx
Goals
XXXX
2
nd
-4
th

20xx
Budget
Lock
Development
Prioritization
XXXX 7
th
-10
th

BIO 19
th
-22
th

JP Morgan
9
th
-12
th

MC
Review
Monthly Operating Reviews (2yr views)
Research
Prioritization
©2016 Vertex Pharmaceuticals Incorporated
UK Science Day 29
th

Boston
Science Day
17
th
& 18
st

xxxx
2-5yrs KRM
xxxx
Hh1KRM
Xxxx
Ph3 KRM
xxxxx
Ph2a KRM
XXXX
Science Day
25
th
& 26
th

xxxxx
Ph3 KRM
xxxx
Ph2a IA
xxxx
Ph2a IA
xxxx Ph1
CF KRM

28. .
Manage automated stage gate workflows
to align with governance to meet your exact
needs all in OnePlan.
See OnePln in action!

29. OnePlan helps you evaluate, prioritize, and model portfolios based on strategic
alignment, resource constraints, budgets, and other key criteria.
.
Prioritize & Select Programs with Confidence and Clarity
See OnePln in action!
Scoring Models for Prioritization
Score and rank initiatives using
customizable models based on business
value, risk, cost, and strategic fit.
What-If Scenario Planning
Create and compare multiple portfolio scenarios
to test trade-offs and funding options before
committing.
Constraint-Based Optimization
Model portfolios based on resource
availability, budget limits, or strategic
themes to make balanced decisions.
Executive Decision Support
Provide leadership with data-driven insights
to make informed go/no-go and funding
decisions.

30. Utilizing Disciplined Portfolio Governance is
Critical to Ensure Effective Decisions
•Must Balance Cross-functional and Functional
•Consider both Strategic vs Operational Decisions
•Governance Committees should be structured with
formal membership and charters
A significant challenge in most organizations is understanding
Cross-Functional (Shared) Leadership and how to balance it with
Functional (Authoritative) Leadership

31. Program Governance – Committees and Oversight
Portfolio
Governance
Committee
Executive
Committee
Data Access
Steering
Committee
Pricing
Committee
Development
Review
Committee
Program
Strategy
Team
Data
Generation
Committee
CMC Review
Committee
Commercial
Review
Committee
Development
Sub team
Commercial
Sub team
CMC Sub
team
Study Mgmt
Teams
Compassionate
Use Committee
Publication
Committee
Non-
Interventional.
Study Review
Committee
Grants Review
Committee
Safety Review
Committee
Program
Sub-Teams
Program
Governance Bodies
Product
Committees

32. Program Governance Organization
32
Portfolio Governance Committee
Oversees long-term portfolio strategy, program strategy and program planning
and execution
•Manages the Development and Commercial portfolio
•Oversees program strategy and program execution
•Ensures that key corporate portfolio goals are operationalized and on-track
•Reviews program progress and key planning deliverables
•Approves portfolio prioritization between programs, stage gate transition;
recommends changes to program budgets and resource allocation across
projects; oversees program risks/opportunities
•Provides guidance to the PSTs and assesses PST performance and effectiveness.

33. Employ “Best Practices” Portfolio Management
Processes
•Operate using an overall Portfolio Plan
•Conduct Performance assessment of the Portfolio Committees decisions with
focus on quality
•Ensure that a communication system and plan is implemented to ensure that
stakeholders for each decision are appropriately informed of Decisions,
Actions, Risks, and Issues
•Integrate Risk/Opportunity assessments and reviews into both Strategy and
Operational plans
•Utilize Powerful Software – OnePlan Platform- to facilitate data and information
management for optimal portfolio management

34. Next Steps
•Set-up Your Own Life Sciences Strategy
Workshop
•FREE - Trial & Support
•Personalized 1:1 demo for your organization

35. www.oneplan.ai