Michael Benedict, PharmD Vice President, Research Moffitt Cancer Center

1. Affiliate NetworksComprehensive Cancer Center Perspective Michael Benedict, PharmD Vice President, Research Moffitt Cancer Center

2. Today • Brief overview of Moffitt History with Affiliates • Successes and Challenges • Total Cancer Care Initiative • Partnering with NCCCP sites

3. External Research Sites : 2010 Cancer Centers of Florida Mayo Clinic, Jacksonville Ocala Oncology Univ. of Florida - Gainesville Project Type Bethesda Memorial Hosp. Duke University Broward General Med. Ctr. Ponce School of Med. FIQCC North Broward Med. Ctr. James A. Haley VA Martin Memorial Hospital Jefferson Medical College CCC&R/Watson Clinic Johns Hopkins Univ. MCC Non Intervention Tallahassee Memorial Klinik Lowenstein, Germany Space Coast Med. Assoc. Cleveland Clinic St. Joe’s Candler, Savannah Overton Brooks VA MCC Clinical Intervention Women’s Cancer Assoc. Louisiana State Univ. Southeast Nebraska Cancer Ctr. Univ. of FL - Jacksonville Leesburg Regional Med. Ctr. Minneapolis VA MCC Prevention Morton Plant Mease Medical Univ. of SC Sarasota Memorial Hospital National Cancer Institute Florida GYN Oncology Fox Chase Cancer Center St. Joseph’s Hospital - Tampa Cooperative Group Emory University Baptist Hospital of Miami Univ. of North Carolina Billings Cancer Center Vanderbilt University Boca Raton Com. Hosp. Virginia Commonwealth Univ. SEP2C Carolinas Medical Center Univ. of Maryland Greenville Hospital System Univ. of Chicago Hartford Hospital Cornell University Total Cancer Care Our Lady of the Lake Montefiore Medical Ctr. St. Vincents of Indiana Univ. of Louisville

4. The Situation • Only 2-4% of adult cancer patients enrolled in clinical trials Klabunde CN etal JNCI 2011 • 85% of cancer patients are treated in their local community • Lack of practice standards and quality measurements • Patient centered outcomes research requires community participation • Access to clinical trials, esp. underserved populations is a challenge • Molecularly directed medicine requires new approaches, infrastructure, and connections

5. Benefits • Expands treatment options for the patient in the community • Patients can be treated close to home decreasing costs of travel and time • Collaboration of institutions may increase referrals for both institutions • Increase market advantage for community

6. Barriers • Cost - inadequate funding • Lack of interesting trials • Trial characteristics that may be difficult to implement in community • Extra-biopsy • Advanced Imaging • Increased regulatory burden • IRB availability or funding • Monitoring and oversight

7. Moffitt History with Affiliates • Program began in 1998 • Part of Moffitt State Mandate Instrumentality of the State • Designate “Partner Hospitals” • Export trials • Educational opportunities, use of name/logo: Branding • Referrals, marketing advantage • Focus cooperative group trials

8. Moffitt Clinical Research Network - 2006 • Office created to provide oversight and centralization • Protocol review and preparation • Site approval/credentialing • Liaison between Moffitt & site staff • Regulatory, contracting, budget, payment • Assisted with data entry & monitoring • Training resource

9. Moffitt Clinical Research Network • Re-invigoration of the program • Identified physician champion • Concerted effort to place Investigator Initiated Trials (IIT) in the community • Lot of Interest • Limited success • Accrual inconsistent • Funding poor • Complicated, difficult to implement • Emergence of academic affiliations • Project Sunshine • N01 – Southeast Phase II Consortium • Total Cancer Care Consortium – M2Gen

10. Personalized Approach to a Patient’s Cancer Journey Intervention Populations at Risk Diagnosis Survivorship Prognosis Relapsed Disease Treatment – Behavioral Research – Psychosocial & Palliative Care – Family Needs – Health Outcomes – Risk Factors – Genetics – Early Detection – Health Disparities – Recurrence Therapy – Drug Discovery – Adaptive Trial Design – Prevention – Lifestyle/Nutrition – Education – Genomics/Proteomics – Imaging Modalities – Nanotechnology – Primary Therapy • Multimodality • Target Based – Post Therapy • Surveillance – Clinical Trials Matching – Molecular Oncology – Biomarker Analysis (http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243)

11. The Purpose • Identify the needs of individual patients; • Identify markers that would predict needs and risks so that interventions could become preemptive; • Identify molecular signatures for patients who are not likely to respond to standard of care; • Utilize clinical characteristics and molecular profiling techniques to match the right patient to the right treatment at the right time the first time; • Raise the standard of care for all patients by integrating new technologies in an evidenced based approach to maximize benefits and reduce costs.

12. The Approach for Cancer • Can we follow you throughout your lifetime? • Can we study your tumor using molecular technology? • Can we recontact you? • Total Cancer Care Protocol

13. Unique Consenting Approach Electronic Consenting System Wireless touch- screen tablet Consists of IRB Approved: Introductory Video Consent Video by PI Informed Consent Signature Capture Demographics Survey Connects via secure interface and forwards HIPAA-compliant information to database

14. Partners in the Fight Against Cancer Billings Clinic Norton Cancer Institute, Louisville, KY Lehigh Valley

15. Total Cancer Care Research Protocol • TCC protocol active at 18 sites with over 69,871 (1) patients consented • Enrolling approx 500 patients/week • 9 sites in Florida and 9 sites in other states (NC, SC, NE, LA, IN, KY, CT, MI, GA) • Tissue biorepository continues to expand with 22,748 (1) tissue samples collected • 16,223 (1) tumors profiled • Longitudinal data collection (1) As of 2/4/11

16. Productivity TCC Consortium sites led to interests in capitalizing on this network

17. CCSG Administrative Supplement • Intended to build linkages w NCCCP sites • To better attain collaborative goals in relation to • accrual to trials • collection of quality biospecimens • outreach to underserved populations • Leverage the resources of both initiatives (CCSG – NCCCP) • Due June 2009

18. CCSG Administrative Supplement • Awarded September 2009 • Partners • Billings Clinic • Hartford Hospital • Aims • Dissemination novel trials – N01 • Participation in behavioral and outcomes research • Capitalize on the Biospecimen processes

19. NCCCP in Clinical Trial Participation • Hartford (3 trials) • Phase 2 trial in ovarian cancer • Multi-arm Phase 2 trial in OC, endometrial, HCC, islet cell and carcinoid tumors • Phase 1/2 trial in breast cancer • Billings (5 trials) • Phase 2 trial in SCC of H&N • Multi-arm Phase 2 trial in OC, endometrial, HCC, islet cell and carcinoid tumors • Phase 1/2 trial in breast cancer • Phase 2 trial in myeloma • Phase 1/2 trial of 1-MT/docetaxel in solid tumors (NCI CM-62208 N01 Contract: Southeast Phase 2 Consortium)

20. Clinical Trials Video Evaluation • Internally developed DVD about trials • English and Spanish (trans-created) • Send to new patients • Help to initiate the Dialog about trials • Prior to roll out - validation • Health Outcomes and Behavior Program • Paul Jacobsen, PhD • NCCCP partner participation • Completed - Data under review currently

21. NCCCP Partnering Lessons Learned • Eagerness to participate in research • Desire a seat at the table in designing and conducting research • Sophisticated infrastructure in place which is required to support trials • Focused Hub of trial support • (Clinical Trials Office) • Centralize Infusion • Critical mass of existing research

22. NCCCP Partnering Lessons Learned • Robust Health Information Management systems and willing to invest to linkages • Community practices have unique challenges in conducting Total Cancer Care Protocol • Surgical – Medical Oncology Links • Integrating protocol into high volume clinical operations • BUT it can be done and DONE WELL • One of the best partners to help us realize personalized cancer care (molecularly directed)

23. What’s Next • Trial Matching • TCC Data • 3 NCCCP sites and 2 FL based consortuim members • Identifying trial ready populations • Breast • Ovarian • Lung

24. What's Next • Capitalize on TCC Network • Patient Data Molecular Information New Type of Trial

25. Streamlining Clinical Trials ~Half the patients <Half the time >Response rates Traditional Clinical Trials Broad Patient Population “TurboTrial” Molecularly Defined Population 3-5 Years 10-12 Years

26. Thank you