Strategic Consulting Services

Leadership Team

DAVA Oncology, LP Four Forest Plaza

12222 Merit Drive, Suite 820 Dallas, TX 75251 Annemieke DeMaggio, PhD VP, Scientific Affairs [email protected] Mobile: 972.310.3282 John Eckardt, MD Chief Medical Officer

[email protected] Mobile: 314.614.5124 Mark Levonyak President [email protected] Mobile: 214.460.5051 Nora Ku, MD Sr. Medical Director [email protected] Mobile: 305.283.5896 Martin W. Lee, MD EVP, Clinical Trial Services

[email protected] Mobile: 952.373.1405 Nicolas Kuehl VP, Business Development [email protected] Mobile: 314.304.2823

Gregory Pynes, MPA, CMP Executive Director, Meetings,

Branding, and Partnerships

Strategic Consulting

DAVA Scientific Services

Strategic Validation Strategic Toolbox DAVA’s medical oncology expertise provides a unique perspective in drug development. Click one

of our services on the left to start.



Tumor Compass

 Reference Guide

 Pathway Navigator

 Clinical & Competitive Landscapes

 Congress Coverage

Tumor Compass

• Collects prioritized information from publicly available resources • Organizes relevant data into

interactive format to allow for intuitive navigation

• Highlights clinical and

competitive insights based on historical perspective and

Tumor Compass

• LOT- Key clinical trials are organized on a timeline to reflect changes in regulatory and clinical standards over time

• MOA- Each competitor profile includes key preclinical and clinical data; detailed

summaries of ongoing trials include

milestone estimates and impact analyses • Patient Subsets- Reviews impact of risk

stratification and histology on the treatment paradigm

Explore the current standard of care including Line of Therapy, Key Competitors, Patient Subsets or Optimal Sequencing of Agents

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Standard of Care Reference Guides

• Tumor-specific reference guides highlight pivotal trials that have shaped standard of care and practice patterns

• Examination of the objective impact and authors’ conclusions

• Customizable for all audiences

– Medical, marketing, training

• User friendly, clickable PDF, platform neutral

– iPad, Windows/PC, web-portal

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Pathway Navigator

• Comprehensive overview including mutations, activation, downstream signaling

• Patients selection, molecular subsets and inhibition by tumor type

• Pathway inhibitors, clinical

development and competitive

landscape by company and patient segment

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Clinical & Competitive Landscape

• To create the clinical landscape, we focus on:

– The current and future treatment paradigms – Clinical and molecular patient segmentation – Epidemiology

– Tumor biology

– Role of biomarkers

• Highlight regulatory strategies

• Provide developmental timelines of key competitors

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Congress Coverage

• Congress coverage is a key tool to stay one step ahead of the competition

• This process begins with a pre-meeting

benchmark analysis and congress road map of relevant data being presented

• The next step is comprehensive congress coverage to provide you with post-meeting analysis, commentary, and insight by DAVA’s medical oncology professionals

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 Disease Strategy & Portfolio Planning

 Clinical Development Strategies

 Life Cycle Management

DAVA Strategic Consulting Process

Our process begins with a clinical and competitive landscape analysis, which is validated by external

opinion leaders and DAVA medical experts and aligned with your key internal stakeholders. We leverage our unique strengths, oncology expertise and proprietary strategic toolbox to achieve your goals.

Each project is customized to the sponsor’s requests by utilizing the DAVA strategic tools outlined in the above sections.

Disease Strategy & Portfolio Planning

• Identify and validate relevant clinical and commercial development

opportunities and competitive threats

• Optimize assets in development to maximize the entire disease or

product portfolio

• Provide insight for the pipeline

development & clinical trial design

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Clinical Development Strategies

• Create a strategy to optimize clinical potential while limiting competitor impact; create product profile for key competitors

• Clinical development strategies address critical issues in:

– Trial design & feasibility – Patient segmentation – Unmet needs

• Identify key risks in the study designs and provide a strategy for their mitigation

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Life Cycle Management

• Provide strategic insight and

tactical recommendations around the design of clinical development programs to support future growth • Validate the life cycle management plan with key internal stakeholders to obtain views on clinical,

 Advisory Feedback

 War Games

 Qualitative Insights

Advisory Feedback

• Recruit academic and community experts to define treatment

patterns

– Access to DAVA’s physician database

• Pressure test strategies and tactics

• Provide clinical insight and

recommendations for short and long term strategies

War Games

• Anticipate and react to competitors’ actions

• Respond to competitive new product entries

• Define competitors’ potential messaging and positioning

• Develop strategies and tactical objections to competitors

Qualitative Insights

• Gain a deeper understanding beyond a traditional

moderator

• Identify strengths and

weaknesses of the clinical data • Learn how to best

communicate data and key messaging

1 on 1 in depth interviews moderated by DAVA Medical Oncologists on key clinical and regulatory events

Anticipating competitors’ actions and reactions to your moves may be the key determinant of success for any marketing strategy. One competitor loses exclusivity eroding category pricing, undermining your pricing strategy. Another may decide to offer new products that have the potential to completely undermine your existing strategy.

 Could you have anticipated such moves?  How do you respond?

Case Study:

Strategies for Achieving Advantage

Situational Analysis

Company A preparing for new product launch A1 into highly competitive and crowded market. The existing agents enjoy high physician satisfaction due to their innovator status. Company A’s drug A1 offers improved mechanism of action with a higher affinity for the therapeutic target resulting in moderate efficacy improvement and significant toxicity & convenience advantage.

DAVA Approach & Tools

Validation • War Games

Internal Stakeholder Alignment • Tumor Compass MSL Training • Strategy Development Execution

DAVA has developed a

clinical landscape

overview that includes trials that define the standard of care and the emerging competitors, including development

DAVA Tumor Compass provided a reservoir and quick-reference guide of up-to-date clinical information to chart the course DAVA validated & pressure tested key

assumptions, clinical data, and strategies with medical experts providing internal alignment.

Why DAVA Oncology?

• Since inception, DAVA has worked with over 30 companies, from big pharma to small biotech, on over 160 projects

• Our people are led by five seasoned medical oncologists with decades of clinical oncology experience, two PhDs with extensive training in oncology and two pharmaceutically-trained executives with many years of experience in the oncology space

• We provide strategic intelligence that is customized to fit your needs

• Our services can be tailored to clinical development, new product planning, or the commercial setting of your drug development

• We offer a wide range of services to meet your unmet needs

Our Promise