The Promise of Personalized Medicine A Breast Cancer Survivor Perspective Mary Lou Smith, JD

1. The Promise of Personalized Medicine A Breast Cancer Survivor Perspective Mary Lou Smith, JD

2. Why Are We Here? • It’s all about the patient And • The future So our daughter’s and our daughter’s daughters will not have to deal with breast cancer as a life-threatening disease

3. Personalized Medicine • Definition - personalized medicine (PER-suh-nuh-LIZED MEH-dih-sin)A form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease.

4. Patient Dilemma with Words and Decisions… Personalized medicine? Biospecimen? Biopsy? 2nd pass? Targeted Therapies? EGFR Inhibitor? Proteomics? Invasive ? Non-invasive? Academic Center ? Local ? Informed Consent? How to pick treatment? Do my kids need genetic testing? Where is my tissue? Eligible ? Insurance ? Am I Going to Live?

5. My Breast Cancer Experience 1986 21 yrs ago 2007 9 mo ago Diagnosis • Low grade DCIS • One breast • 1 cm • Clear margins Diagnosis • Low grade DCIS • Both breasts • 7mm, 3mm • Clear margins • Treatment Options • Lumpectomy vs mastectomy • Radiation therapy vs no radiation therapy • Anti-estrogen • Treatment Options • Lumpectomy vs mastectomy • Radiation therapy vs no radiation therapy

6. What I Found Out • I had • The same diagnosis • The same treatment options • The same decisions • For the same reason • There is no evidence

7. What I Wanted • I wanted research-based answers that addressed my tumor and my body • Without that I was forced to make a decision in the absence of evidence • I developed a chart to reflect my options and my concerns about my future health

9. I Wanted Personalized Medicine • I still want it • My hope is that in the next 5 years, you will find the answers for the 60,000 women diagnosed with DCIS each • My belief is the answers will be found through genomics

10. Physicians may be comfortable with a “good” prognosis Women are not – The diagnosis is life-changing Women want certainty not a gamble with their lives Patients Want Certainty

11. Your role in helping patients… “ Nothing in life is to be feared. It is only to be understood.” -Marie Curie

12. The Promise • Personal Targeted Therapies • Seek and Control instead of Search and Destroy • Genetic Testing • Reduced Toxicities • Predictive/Preventive Capability • Reduced drug failure rates • A CURE

13. The Problems • Insurability and employability • Cost • Will the markets be big enough to attract industry? • How will we design the research? • How will we conduct the research? • How do we break the silos of cancers at academic medical centers?

14. Where We Go From Here…. • “The important thing in science • is not so much to obtain new facts • as to discover new ways of • thinking about them” • Sir William BraggBritish physicist (1862 - 1942)

15. Organizations Today

16. Organizations Tomorrow

17. Questions Advocates Can Help Answer • Which clinical outcomes are most important to individuals with disease? Are they being incorporated into clinical trials? • Will patients understand the implications of donating tissue and will the results be provided to donors and the public? • What sorts of validation should be required of genomic tests? • How can we maximize the information gained from tissue samples while protecting the individual with disease?

18. Questions Advocates Can Help Answer (Continued) • How can research results best be accepted into clinical practice? • How can we expand the adoption of genomics into clinical trials? • How can we network with a diverse group of medical professionals and organizations such as pathologists, biospecimen repositories, IRBs, and others?

19. Let Us Help You • Educate patients and the public • Problem-solve • Support genomic-friendly policies • Reduce regulations • Encourage standards and “best practices” • Increase funding

20. HOPE Physical Behavioral Social Cultural Economic Political Spiritual Technological

21. Thank You