ATHENA Breast Health Network

1. ATHENA Breast Health Network Laura Esserman, MD, MBA Kathy Hajopoulos, MPH August 18, 2009

2. Approach has to change Progress in technology and the power of biomedical research will not realize its potential until we create delivery systems that enable us to: Track interventions and outcomes, routinely Support feedback on performance and quality improvement Provide a platform to apply and test emerging molecular tests and other research tools that enable tailored care Integrate the process of clinical care and clinical research

3. The problem and opportunity How to advance the field? How to get the most updated information to patients and providers? How to learn faster and better from what we do to care from our patients? How to integrate research findings into clinical care?

4. Despite advances, better options for breast cancer care and prevention needed Women are still dying of the disease (44,000 per year) Highest risk, curable patients (Stage 2-3) need access to trials with novel agents in the neoadjuvant setting Screening has not had a major impact on mortality Burden of low risk disease has increased significantly Highest risk disease presents in the interval between screens Recall and biopsies are common and often unnecessary Tools to identify low and high risk disease exist, but are not uniformly available nor has their effectiveness been evaluated Women at high risk not identified by primary care providers Prevention Co-morbidities

6. The Impact of Screening on Molecular Subtypes

7. Total invasive cancer Total invasive cancer

9. Systems should enable improvement in both the present and the future The data we collect today should: Improve the services we deliver Enable comparative effectiveness studies Provide feedback on performance Set the stage to improve care and continuously improve the standard of care

10. ATHENA: breast cancer is a model Advance and accelerate practice of personalized medicine: Reduce morbidity and mortality by gaining a molecular understanding of breast cancer and factors that drive breast cancer risk Improve our understanding of who is at risk for what kind of cancer Generate the evidence base for developing more cost-effective, innovations for prevention, diagnosis and treatment Implement a comprehensive informatics infrastructure to integrate clinical care and research Innovate and integrate tools to collect, analyze, and distribute data in real time amongst all stakeholders Change the way patients and providers interact to prevent and manage the disease

11. ATHENA is a collaborative effort The University of California System: Five UC Cancer Centers: UCSF, UC Davis, UC Irvine, UCLA, UCSD UC Berkeley School of Public Health UCSF Phillip Lee Institute for Health Policy Studies BIG Health Consortium (NIH) Quantum Leap Healthcare Collaborative Northern California Cancer Center (NCCC) Center for Medical Technology Policy (CMTP) Biotechnology, Pharmaceutical & Information Technology Companies Advocates Healthcare Payers

12. ATHENA Addresses issues critical to the population at large Harness researchers, clinicians, patients, health care payers, biotechnology, pharmaceutical and technology companies Pool resources to reduce cost of discovery, care Tests a new model for health care delivery where: Clinical care and research are seamlessly integrated Improvements based on science and routine analysis are an integral part of clinical care Evidence based management is used to sustain change Comparative effectiveness studies can be conducted to evaluate use of emerging technologies to tailor care

13. Silos of information

14. Creating Connections

16. ATHENA AT A GLANCE

17. ATHENA Specific Aims Identify patients at high risk for recurrence and death based on tumor biology, response to therapy, co-morbidities and lifestyle factors to develop and offer tailored interventions to reduce mortality. Identify low risk patients at the time of diagnosis and offer more tailored options for treatment thereby reducing unnecessary morbidity from overtreatment. Build better models to predict risk and outcomes for low and high risk breast cancer to drive the development of tailored screening and prevention strategies. Create a repository of clinical and biological information, specimens and a set of analytic tools to conduct comparative effectiveness studies that will provide feedback and opportunities to accelerate learning and continuously improve treatment and intervention options.

18. ATHENA Core Projects/Components While ATHENA will require long-term planning and development, certain evidence-based practices can be implemented immediately, including: Identify women at high risk for breast cancer and offer a web-based prevention tool for patients and primary care providers Implement models for coordinating diagnostic evaluation, likely to safely eliminate 25% of biopsies (e.g., for women with BIRADS 4A lesions) Conduct molecular profiling at the time of diagnosis to safely reduce interventions for very low risk cancers Identify women with the highest risk cancer diagnoses, offer them risk-based treatment interventions, and refer them to cutting edge adaptive design trials. For those women with significant co-morbidities, provide lifestyle interventions (e.g., WHEL study) likely to improve cause-specific and overall survival Profile women with metastatic cancer and offer novel therapies (SU2C)

19. ATHENA Learning Economy: Better Care Today Better Care in the Future Prevention: Systematically identify those at risk using available tools Improve tools to identify poor risk cancers Screening: Over-diagnosis - use today�s molecular tools to reduce the consequence of finding good prognosis cancers Improve tools for risk assessment to tailor screening Diagnosis: Reduce excess biopsies (follow BIRADS 4A) Anticipate need to profile tumors, use better fixatives Treatment: Reduce interventions for good prognosis cancers Tailored trials, based on molecular profiles in poor prognosis cancers Target co-morbid conditions to improve outcomes (HTN, NIDDM, Obesity)

20. ATHENA: a 21st Century Knowledge Economy

21. Process for getting started Learn what we do across the 5 UC medical centers Clinical, science, research, IT, infrastructure Identify information, feedback clinicians and researchers want, need Leverage successful tools and processes: Existing tools and best practices to meet ATHENA goals Cohorts and registries already in place Identify opportunities to improve care, share resources, leverage purchasing power Identify barriers to change

22. Opportunities to work together in new ways Shared infrastructure Patient surveys Capture of structured data Data and biospecimen repositories Project Management Purchasing power for common equipment Economy of scale in providing services Hereditary and high risk counseling Patient education, coaching, and resources desk Survivorship services Data analysis, feedback

23. Challenges The UC medical centers have everything and nothing in common � this is a strength and a challenge. UC has invested in bringing amazing faculty members to their campuses, many with innovative ideas and programs Relative underinvestment in infrastructure to link innovations and to bring them to clinical practice No common infrastructure across the medical campuses EMR: EPIC, GE, others CTMS: ONCOR, VELOS, others Clinical care, clinical research, and translational research are conducted in silos There is no mechanism to share data

24. Progress to date ATHENA Project Office established at UCSF Site visits to all 5 medical centers completed Completed detailed assessments at all sites: Technical Radiology & Pathology Clinical Research PI�s at each site identified and Working Groups across all sites initiated Initial funding ($10 million): Safeway Foundation � June 2009 UC Office of the President MRPI Grant - January 2010 effective date ATHENA proposed as a BIG Health Initiative UC�s collaborating on the submission of other grants

25. Seeking Matching Funds $20 Million needed for infrastructure investment: Patient data acquisition (electronic surveys for patient reported intake & outcomes) Development of interoperable/semantic infrastructure to enable data and information exchange Integrated, system-wide data and bio-specimen repository Development of multiple EMR and PHR interfaces Development of decision services tools and dashboard Analytics to support comparative effectiveness and feedback Hardware & software support