Creating a Compelling Value Story by Integrating Oncology R&D and Market Needs.

1. Aligning R&D and Markets
for a Compelling Value Story
Steve Heller
© OncStrat LLC
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OncStrat LLC Approach

2. OncStrat LLC Commitment
 Real world market insight for development stage oncology assets.
 Maximize ROI: define value by developing compelling, evidence
based, strategies and brand stories.
 Flexibility and Value – Work the way you need it.
 Our goal is to become a trusted advisor.
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3. The Challenge of a Compelling Value Story
Success requires differentiation and value.
We help you find it.
Activity Efficacy
Efficacy Regulatory Approval
Regulatory Approval Access for Patients
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4/25/2017 © OncStrat LLC
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4. Aligning R&D and Markets
3
Development
Opportunities
(Where should we
go?)
Target Product
Profile
(What will we be?)
ValueStory
Asset
Readiness
Market
Readiness
Branding
(What should
stakeholders
perceive?)
Market Access
(What value
enables access and
reimbursement?)
Market Plan
(How to engage
customers and
stakeholders?)
Differentiation
(What do we have
and how is it
different?)
4/25/2017 © OncStrat LLC
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R&D strategy and value story drive commercial success.

5. 4
Differentiation
(What do we have
and how is it
different?)
Opportunity
Sequence
(Where should we
go?)
TPP
(What will we be?)
o Vs. MOA target class
o Vs. expected therapeutic competition
o Preclinical/clinical evidence needs for optimal story
o Early Positioning
o Settings (MD choices, combinations,
stratification, biomarkers, novel reg. paths)
o Competitive/Access implications
o Trade-offs and mitigations
o Market Potential
o Clinical hurdles
o Economic hurdles
o Endpoints and
Evidence
4/25/2017
Rigor and
Transparency
Matter
© OncStrat LLC
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Asset Readiness: Define Opportunities and GAPS

6. Market Readiness: Prepare Position and Promotion
5
Branding
(What should stakeholders
perceive?)
Market Access
(What value enables
access and
reimbursement?)
Market Plan
(How do we address
customers and
stakeholders?)
4/25/2017 © OncStrat LLC
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7. 6
Branding
(What should stakeholders
perceive?)
Market Access
(What value enables
access and
reimbursement?)
Market Plan
(How do we address
customers and
stakeholders?)
o Disease Positioning
o Brand Character
and Positioning
o Target Customers
o SWOT and Claims
o Market Mix
o Generic Name
o Trademark
o Value/Price analysis
o Economics,
Outcomes, Claims
o Pricing and
Reimbursement
Strategy
o Market Definition
and Segments
o Buying Process
o Competition
o Forecast / Financials
o Organization
o Launch Plan
o Metrics
4/25/2017 © OncStrat LLC
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Market Readiness: Prepare Position and Promotion

8. 74/25/2017
Asset Readiness Plan
o Differentiation(CI) & Early Positioning
o Opportunity Sequence
o Target Product Profile
©
Strategy
o BD: Commercial Diligence & Value
o Portfolio Analysis & Prioritization
Disease Maps
o Disease and Stratification
o Unmet Need & Market Drivers
o Benchmarks
Value Story
o Value Proposition & Positioning
o Access and Reimbursement
o Forecast Scenarios
OncStrat LLC
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OncStrat LLC: Actionable Deliverables

9. Recent OncStrat LLC Engagements
84/25/2017
DRUG AND MARKET DEVELOPMENT
• Disease landscape, TPP, and access horizon for conjugated mAb in micro-orphan cancer. Impacted
protocol design and early positioning. In pivotal trial.
• Partnered to define launch field structure for novel immunotherapy with touch points in surgery and
oncology. Client developed new customer facing teams. Drug launched.
• Pressure test forecast for P2 asset. Revealed critical uncertainties on pricing and differentation.
• Pre-launch PD-1 mAb competitive intelligence. Drug launched.
• Authored MSL disease training backgrounders: immuno-oncology agent, biosimilar.
BIOMARKERS
• Impact of evolving biomarkers on prostate cancer stratification. Aligned R&D and marketing on
portfolio prioritization and BD opportunities.
• Competiitve analysis of evolving PARP biomarkers.

10. OncStrat LLC: Creating A Compelling Value Story
 Rigorously assess asset and market readiness.
 Identify opportunities and uncertainties.
 Recommend actionable choices to address goals and GAPS.
 Challenge via internal and external experts.
94/25/2017
Aligning R&D and Markets for a Compelling Value Story
© OncStrat LLC
All Rights Reserved

11. Steve Heller is a Global Strategic Marketing Leader with results across the commercial spectrum at BMS, J&J
(Janssen Oncology), and OncStrat LLC. He has led successful Business, Therapeutic Area and Brand
Strategies. His leadership spans sales, sales management, product launch, training & development, marketing,
new product development and business development.
Steve’s depth in oncology includes small molecules, biologics, monoclonal antibodies, cell therapy,
immunotherapy, novel drug platforms, and biomarkers. He has worked in therapeutics and supportive care,
including co-development and regional assets. Steve has spoken at multiple cancer conferences and is the
only marketer (non-scientist) honored to be a contributing author to CANCER MEDICINE. (Personalized Medicine
in Oncology Drug Development, CANCER MEDICINE, Holland-Frei, 8th Edition – 2010)
Steve joined J&J on the management team at Ortho Biotech, a start-up division with $10MM in sales that
eventually grew to >$3B. As Oncology Global Marketing Leader, he integrated commercial imperatives into
oncology R&D portfolio decision making. Steve had integral roles in multiple acquisitions, was the commercial
lead in the Velcade license, and served as the first Velcade Global Commercial Leader. Velcade became J&J’s
first $1B oncology asset. As VP of Oncology/Virology Business Development, he served on the Management
Board of Tibotec Therapeutics.
Steve has a combination of deep market insight and the ability to integrate R&D and market imperatives into
portfolio and compound strategies. He is a critical thinker who gets to the root of complex issues.
Steve serves on the Board of Trustees of Hunterdon County, NJ, YMCA, is a volunteer Court Appointed
Special Advocate (CASA) for Foster Children, and coaches Special Olympics Swimming. Steve has a B.S.
from the Pennsylvania State University and M.A. from Villanova University.
http://www.linkedin.com/in/steveheller
Steve Heller, President OncStrat LLC
104/25/2017

12. To Learn More
Steve Heller
sheller@oncstrat.com
c 908 809 8051
4/25/2017

13. THANK YOU
OncStrat LLC
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