Strategic Consulting Services

Transcription

1 Services 1

2 Leadership Team Mark Levonyak President Mobile: Martin W. Lee, MD EVP, Clinical Trial Services Mobile: John Eckardt, MD Chief Medical Officer Mobile: Nora Ku, MD Sr. Medical Director Mobile: Annemieke DeMaggio, PhD VP, Scientific Affairs Mobile: Gregory Pynes, MPA, CMP Executive Director, Meetings, Branding, and Partnerships Mobile: Nicolas Kuehl VP, Business Development Mobile: DAVA Oncology, LP Four Forest Plaza Merit Drive, Suite 820 Dallas, TX

3 DAVA Scientific Services DAVA s medical oncology expertise provides a unique perspective in drug development. Click one of our services on the left to start. Scenarios & Case Studies 3

4 Tumor Compass Reference Guide Pathway Navigator Clinical & Competitive Landscapes Congress Coverage 4

5 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 forward-looking analyses 5

6 Tumor Compass Explore the current standard of care including Line of Therapy, Key Competitors, Patient Subsets or Optimal Sequencing of Agents 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 Click Image 6

7 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 Click Image 7

8 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 Click Image 8

9 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 Click Image 9

10 Congress Coverage Click Image 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 Click for Example Click Image 10

11 Disease Strategy & Portfolio Planning Clinical Development Strategies Life Cycle Management 11

12 DAVA 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. 12

13 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 Click Image 13

14 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 Click Image 14

15 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, regulatory, and marketing aspects 15

16 Advisory Feedback War Games Qualitative Insights 16

17 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 17

18 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 messaging 18

19 Qualitative Insights 1 on 1 in depth interviews moderated by DAVA Medical Oncologists on key clinical and regulatory events 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 19

20 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 Studies & Scenarios 20

21 Challenging Market Scenarios 21

22 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. 22

23 DAVA Approach & Tools Clinical Landscape Competitor Analysis Market Overview External Validation Advisory Feedback War Games Internal Stakeholder Alignment MSL Training Tumor Compass 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 timelines 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. This process ensures launch readiness is in line with clinician expectations. 23

24 Why DAVA Oncology? Our Promise To improve patient care by realizing the full potential of oncology drug development 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 24