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Partner in Clinical Development
          ASCO 2012
Cancer Product Development

                                                                     CTNeT
         The Problem                   Opportunity
                                                                    Response

• Diagnosis and               • Molecular biomarker testing   • Biorepository and registry to
  treatment by anatomical       coming into mainstream –        identify patients for trials
  location and histology        personalized medicine (PM)      based on prospective
  with limited molecular      • FDA addressing challenges       molecular characterization
  characterization              of new agent development      • Streamline processes for
• Difficulty defining           in era of PM                    efficient study start-up,
  subsets likely to benefit   • Consensus that old clinical     execution, and completion
• Broad applications of         trial model must be            leading to
  treatments                    transformed                   • Greater outcome gains in
• Lengthy, costly drug        • CTNeT has funding to            patient subsets
  development with              create a new clinical trial   • Fewer negative Phase 3
  incremental gains             operating model – no legacy     studies
• Large number of               programs
                                                              • More effective personalized
  negative Phase 3                                              medicine tailored to the
  studies                                                       needs of the patient

                                                                                          2
Mission Statement

To transform cancer research and care by
 combining the innovative science of our
  cancer centers with the expertise and
 resources of academic and community
       oncologists throughout Texas




                                           3
Genesis of CTNeT
• 2007: Texas voters approved a 10-year, $3 billion bond fund to
  create the Cancer Prevention and Research Institute of Texas
  (CPRIT)
• 2010: CPRIT funded a grant to establish CTNeT as a 501(c)(3)
  organization to conduct statewide clinical cancer trials. CTNeT’s
  main tenets are to:
       • Conduct statewide, tissue-based, and biomarker-driven
         clinical trials focused on making substantive advances in
         personalized care for cancer
       • Collaborate closely with the CPRIT-funded Texas Cancer
         Research Biorepository (TCRB)
       • Implement a highly effective, cancer clinical trials model to
         improve the design, activation and conduct of clinical trials


                                                                         4
Clinical Site Network
               UT HEALTH SCIENCE CENTER HOUSTON / MEMORIAL HERMANN CANCER CENTER


UT HEALTH SCIENCE CENTER at SAN ANTONIO                     MARY CROWLEY CANCER RESEARCH CENTER


UT MD ANDERSON CANCER CENTER                                        THE METHODIST HOSPITAL SYSTEM


BAYLOR COLLEGE of MEDICINE                                               SCOTT & WHITE HEALTHCARE


TEXAS CHILDREN’S CANCER CENTER                                            TEXAS ONCOLOGY


   UT MEDICAL BRANCH at GALVESTON                                UT SOUTHWESTERN MEDICAL CENTER


     CENTER for CANCER and BLOOD DISORDERS                      ONCOLOGY CONSULTANTS, PA


                       TEXAS TECH HEALTH SCIENCES CENTER / COVENANT HEALTH SYSTEM

                             SOUTH TEXAS ONCOLOGY HEMATOLOGY AT START CENTER




                                                                                             5
Biorepository and Registry
• Collection of research-quality biospecimens on standing tissue
  procurement protocols with costs covered by CTNeT
• Broad molecular characterization on all specimens to
  prospectively identify subsets of patients for clinical trials
• Characterization in central CLIA-certified lab - Cancer Genetics
  Laboratory (CGL) at Baylor College of Medicine (BCM)
• Collaboration with the Texas Cancer Research Biobank in the
  Human Genome Sequencing Center at BCM
  (1 of 3 NCI-designated whole genome sequencing centers)
• Biospecimen registry with annotated clinical information for
  investigator notification of future studies




                                                                     6
Cancer Genetics Lab Tests
Over 140 cancer genetic tests:
   • FISH: Individual probes and disease-specific panels
   • Mutation Analysis
        • Gene amplification, deletions, insertions, base-pair mutations
        • e.g. AKT, BRAF, BCR/ABL, C-KIT, EGFR, KRAS, P53…
   • Next-Generation Sequencing (Ion Torrent)
         • Cancer mutation panel (“actionable mutations”)
                 • 46 cancer-related genes, up to 739 mutations
                 • Sensitivity up to 5% for certain mutations
   • Chromosomal Microarray Analysis (CMA)
         • Whole genomic analysis: 1800 cancer-related genes
         • 400-probe microarray (Agilent), looking for SNPs,
           heterozygosity

                                                                   7
Biorepository and Registry

                            Tissue             Results
Patient        Patient      submitted          reported
                                                                    Study Site
Consent      Registration


                      Tissue stored for   All test results stored
                      future research     in data warehouse

                                                                      Communication with
                                                                      site for future
                                                 CTNeT                potential studies
                                              Biorepository
                                               Operations




                                                                                  8
Operating Model
                   Simple – Streamlined – Scalable

• Master clinical trial agreement with each site; study-specific work orders

• Reliance agreements for AAHRPP-accredited central IRB (Chesapeake)

• Reliance agreements for single scientific review

• Centrally negotiated single study budget

• Single Data Safety Monitoring Board

• Risk-based data monitoring

• Metrics to assess, refine and support decisions

• Stipend supported site-based research champions (PI / SPOC)



                                                                         9
Informatics Platform
• Medidata® : 21 CFR Part 11-Compliant EDC platform
   • CTMS™: Study planning and management
          • Milestones, recruitment tracking, subject visits, tracking
             queries, exemptions, deviations, SAEs, alerts
      • Financial management
      • Site monitoring
      • Regulatory compliance
      • Integration with Rave®, any EDC, IVRS, CTMS, financial or
        data-mart/OLAP system, MS Project/Excel
      • AS2, SFTP and CDISC ODM-compliant data sharing
    • BALANCE™: Randomization and trial supply management




                                                                     10
Informatics Platform Cont.
• Medidata Rave®:
      • Single platform supporting EDC and CDMS through
         industry standards-based architecture (CDISC)
      • Flexibility to interface with legacy systems with
         limited integration options, e.g., via ASCII file import
         and export
      • Plug-in architecture that facilitates the addition of
         new interfaces and functionality
      • Open, documented application programming
         interface (API)
• ARISg™: Drug safety and pharmacovigilance
• SAS®: Statistical analysis




                                                                    11
Services

                                   Business
                                 Development          Budgets,
              Medical
                                                      Contracts
              Writing

                                                                   Quality
    Site                                                          Assurance
 Operations


 Clinical                                                         Tissue Testing,
Operations                                                        Biorepository


          Clinical                                         Data
        Development                                     Management,
                                                        Biostatistics
                         Drug            Regulatory
                        Safety             Affairs




                                                                                    12
Governance
Independent Committees                                  CTNeT Committees

  Central Institutional        CTNeT 501 (c)(3)        Scientific Steering
    Review Board              Board of Directors            Committee
      Chair: TBD             Chair: W. Butler, MD     Chair: D. Johnson, MD

     Data Safety
   Monitoring Board          President and CMO       Tumor Biology Committee
     Chair: TBD               C. Geyer, Jr. MD       Chair: R. DuBois, MD, PhD


                                                        Council of Principal
                                                          Investigators


                            Vice President and COO
                                   P. Winger

SVP, Clinical Development                              Head of Biostatistics
 L. Paradiso, DVM, MBA                                 A. Razmpour, Ph.D.



                                                                               13
Executive Leadership
Charles E. Geyer, Jr., MD                                  Patricia A. Winger
President and Chief Medical Officer                        Vice President and Chief Operations Officer
Former Director of Medical Affairs                         Former VP of Research Operations
- National Surgical Adjuvant Breast                        - US Oncology
and Bowel Project                                          Former VP, Business Integration
                                                           - Sarah Cannon Research Institute
Linda J. Paradiso, DVM, MBA
Sr. Vice President of Clinical Development                 Dean J. Ferrigno, CPA, MBA
Former Head, Global Oncology Regulatory Affairs            Vice President, Finance
- Amgen                                                    Former VP, CFO
Former Head, Oncology Clinical Development                 - Sarah Cannon Research Institute
- Pfizer La Jolla                                          Former Head of Development Finance
Former Head, Clinical Research                             - Daiichi Sankyo
- Agouron Pharma
Former Senior VP, Clinical and Regulatory Affairs          Paul Papagni, JD, CIP
- Salmedix                                                 Vice President of Research Admin, Compliance
                                                           Former Executive Director for Clinical Research
Neera Bhansali, PhD*                                       - MD Anderson Cancer Center
Head of Bioinformatics
Faculty Director, MS Health Informatics
                                                           Ahmad Razmpour, PhD
and Management Systems                                     Vice President, Biostatistics
- Florida International University, Miami                  Former Head, Immunology Statistics
Former Director, Data Quality & Standards,                 - Abbott Global Statistics and Data Management
-    H. Lee Moffitt Cancer Center                          Former Sr. Director II, Biostatistics
                                                           - Wyeth Global Biostatistics & Programming
Holly Powers, JD                                           Former Head, Biostatistics & Data Management
                                             *Consultant   - Cytogen Corporation
Legal Counsel
- Jameson and Powers, PC

                                                                                                             14
Board of Directors
William T. Butler, MD, Chairman                             Alfred G. Gilman, MD, PhD (Ex-officio, voting)
Chancellor Emeritus                                         Chief Scientific Officer
- Baylor College of Medicine                                - CPRIT

Bruce A. Chabner, MD                                        William H. Gimson, III, MBA (Ex-officio, voting)
Professor of Medicine, Harvard Medical School               Executive Director
Director of Clinical Research, MGH Cancer Center            - CPRIT
- Massachusetts General Hospital
                                                            Sandra J. Horning, MD
John D. Cullen                                              Senior VP, Global Head, Clinical Development
Chief Executive Officer                                     Hematology/Oncology
- DMX, Inc.                                                 - Genentech/Roche

Carolyn Dickson                                             Patrick J. Loehrer, Sr., MD
Executive Director                                          Director, Indiana University Simon Cancer Center
- The O’Donnell Foundation                                  Associate Dean of Cancer Research
                                                            H. H. Gregg Professor of Oncology,
James H. Doroshow, MD (Govt. Liaison, non-voting)           - Indiana University School of Medicine
Director, Division of Cancer Treatment and Diagnosis
Senior Investigator, Laboratory of Molecular Pharmacology   Richard L. Schilsky, MD
- National Cancer Institute                                 Professor of Medicine, Chief, Section of Hematology-Oncology
                                                            Deputy Director, Comprehensive Cancer Center
Richard B. Gaynor, MD                                       - University of Chicago, Biological Sciences Division
VP, Clinical Development and Medical Affairs, Oncology
- Eli Lilly and Company                                     Robert C. Young, MD
                                                            President
                                                            - RCY Medicine


                                                                                                               15
Scientific Steering Committee

David H. Johnson, MD, FACP        Richard A. Gibbs, PhD            Dipti Ranganathan
Committee Chair                   Baylor College of Medicine       UT Southwestern Medical Center
UT Southwestern Medical Center
                                  Alfred G. Gilman, MD, PhD        Christopher O. Ruud, MD
Arthur L. Beaudet, MD             CPRIT                            Scott and White Healthcare
Baylor College of Medicine
                                  William H. Gimson, III, MBA      Joseph O. Schmelz, PhD, RN, CIP, FAAN
Donald A. Berry, PhD              CPRIT                            UT Health Science Center San Antonio
UT MD Anderson Cancer Center
                                  Beth A. Hellerstedt, MD          Ian M. Thompson, Jr., MD
Hak Choy, MD                      Texas Oncology                   UT Health Science Center San Antonio
UT Southwestern Medical Center
                                  Susan G. Hilsenbeck, PhD         Daniel D. Von Hoff, MD, FACP
Raymond N. DuBois, MD, PhD        Baylor College of Medicine       Translational Genomics Research Institute,
UT MD Anderson Cancer Center                                       (TGEN)
                                  David G. Poplack, MD
Charles E. Geyer, Jr., MD, FACP   Texas Children’s Cancer Center   Patricia A. Winger
CTNeT                                                              CTNeT
                                  Elda Railey
                                  Research Advocacy Network




                                                                                                       16
www.ctnet.org
                17

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CTNeT Overview ASCO 2012

  • 1. Partner in Clinical Development ASCO 2012
  • 2. Cancer Product Development CTNeT The Problem Opportunity Response • Diagnosis and • Molecular biomarker testing • Biorepository and registry to treatment by anatomical coming into mainstream – identify patients for trials location and histology personalized medicine (PM) based on prospective with limited molecular • FDA addressing challenges molecular characterization characterization of new agent development • Streamline processes for • Difficulty defining in era of PM efficient study start-up, subsets likely to benefit • Consensus that old clinical execution, and completion • Broad applications of trial model must be leading to treatments transformed • Greater outcome gains in • Lengthy, costly drug • CTNeT has funding to patient subsets development with create a new clinical trial • Fewer negative Phase 3 incremental gains operating model – no legacy studies • Large number of programs • More effective personalized negative Phase 3 medicine tailored to the studies needs of the patient 2
  • 3. Mission Statement To transform cancer research and care by combining the innovative science of our cancer centers with the expertise and resources of academic and community oncologists throughout Texas 3
  • 4. Genesis of CTNeT • 2007: Texas voters approved a 10-year, $3 billion bond fund to create the Cancer Prevention and Research Institute of Texas (CPRIT) • 2010: CPRIT funded a grant to establish CTNeT as a 501(c)(3) organization to conduct statewide clinical cancer trials. CTNeT’s main tenets are to: • Conduct statewide, tissue-based, and biomarker-driven clinical trials focused on making substantive advances in personalized care for cancer • Collaborate closely with the CPRIT-funded Texas Cancer Research Biorepository (TCRB) • Implement a highly effective, cancer clinical trials model to improve the design, activation and conduct of clinical trials 4
  • 5. Clinical Site Network UT HEALTH SCIENCE CENTER HOUSTON / MEMORIAL HERMANN CANCER CENTER UT HEALTH SCIENCE CENTER at SAN ANTONIO MARY CROWLEY CANCER RESEARCH CENTER UT MD ANDERSON CANCER CENTER THE METHODIST HOSPITAL SYSTEM BAYLOR COLLEGE of MEDICINE SCOTT & WHITE HEALTHCARE TEXAS CHILDREN’S CANCER CENTER TEXAS ONCOLOGY UT MEDICAL BRANCH at GALVESTON UT SOUTHWESTERN MEDICAL CENTER CENTER for CANCER and BLOOD DISORDERS ONCOLOGY CONSULTANTS, PA TEXAS TECH HEALTH SCIENCES CENTER / COVENANT HEALTH SYSTEM SOUTH TEXAS ONCOLOGY HEMATOLOGY AT START CENTER 5
  • 6. Biorepository and Registry • Collection of research-quality biospecimens on standing tissue procurement protocols with costs covered by CTNeT • Broad molecular characterization on all specimens to prospectively identify subsets of patients for clinical trials • Characterization in central CLIA-certified lab - Cancer Genetics Laboratory (CGL) at Baylor College of Medicine (BCM) • Collaboration with the Texas Cancer Research Biobank in the Human Genome Sequencing Center at BCM (1 of 3 NCI-designated whole genome sequencing centers) • Biospecimen registry with annotated clinical information for investigator notification of future studies 6
  • 7. Cancer Genetics Lab Tests Over 140 cancer genetic tests: • FISH: Individual probes and disease-specific panels • Mutation Analysis • Gene amplification, deletions, insertions, base-pair mutations • e.g. AKT, BRAF, BCR/ABL, C-KIT, EGFR, KRAS, P53… • Next-Generation Sequencing (Ion Torrent) • Cancer mutation panel (“actionable mutations”) • 46 cancer-related genes, up to 739 mutations • Sensitivity up to 5% for certain mutations • Chromosomal Microarray Analysis (CMA) • Whole genomic analysis: 1800 cancer-related genes • 400-probe microarray (Agilent), looking for SNPs, heterozygosity 7
  • 8. Biorepository and Registry Tissue Results Patient Patient submitted reported Study Site Consent Registration Tissue stored for All test results stored future research in data warehouse Communication with site for future CTNeT potential studies Biorepository Operations 8
  • 9. Operating Model Simple – Streamlined – Scalable • Master clinical trial agreement with each site; study-specific work orders • Reliance agreements for AAHRPP-accredited central IRB (Chesapeake) • Reliance agreements for single scientific review • Centrally negotiated single study budget • Single Data Safety Monitoring Board • Risk-based data monitoring • Metrics to assess, refine and support decisions • Stipend supported site-based research champions (PI / SPOC) 9
  • 10. Informatics Platform • Medidata® : 21 CFR Part 11-Compliant EDC platform • CTMS™: Study planning and management • Milestones, recruitment tracking, subject visits, tracking queries, exemptions, deviations, SAEs, alerts • Financial management • Site monitoring • Regulatory compliance • Integration with Rave®, any EDC, IVRS, CTMS, financial or data-mart/OLAP system, MS Project/Excel • AS2, SFTP and CDISC ODM-compliant data sharing • BALANCE™: Randomization and trial supply management 10
  • 11. Informatics Platform Cont. • Medidata Rave®: • Single platform supporting EDC and CDMS through industry standards-based architecture (CDISC) • Flexibility to interface with legacy systems with limited integration options, e.g., via ASCII file import and export • Plug-in architecture that facilitates the addition of new interfaces and functionality • Open, documented application programming interface (API) • ARISg™: Drug safety and pharmacovigilance • SAS®: Statistical analysis 11
  • 12. Services Business Development Budgets, Medical Contracts Writing Quality Site Assurance Operations Clinical Tissue Testing, Operations Biorepository Clinical Data Development Management, Biostatistics Drug Regulatory Safety Affairs 12
  • 13. Governance Independent Committees CTNeT Committees Central Institutional CTNeT 501 (c)(3) Scientific Steering Review Board Board of Directors Committee Chair: TBD Chair: W. Butler, MD Chair: D. Johnson, MD Data Safety Monitoring Board President and CMO Tumor Biology Committee Chair: TBD C. Geyer, Jr. MD Chair: R. DuBois, MD, PhD Council of Principal Investigators Vice President and COO P. Winger SVP, Clinical Development Head of Biostatistics L. Paradiso, DVM, MBA A. Razmpour, Ph.D. 13
  • 14. Executive Leadership Charles E. Geyer, Jr., MD Patricia A. Winger President and Chief Medical Officer Vice President and Chief Operations Officer Former Director of Medical Affairs Former VP of Research Operations - National Surgical Adjuvant Breast - US Oncology and Bowel Project Former VP, Business Integration - Sarah Cannon Research Institute Linda J. Paradiso, DVM, MBA Sr. Vice President of Clinical Development Dean J. Ferrigno, CPA, MBA Former Head, Global Oncology Regulatory Affairs Vice President, Finance - Amgen Former VP, CFO Former Head, Oncology Clinical Development - Sarah Cannon Research Institute - Pfizer La Jolla Former Head of Development Finance Former Head, Clinical Research - Daiichi Sankyo - Agouron Pharma Former Senior VP, Clinical and Regulatory Affairs Paul Papagni, JD, CIP - Salmedix Vice President of Research Admin, Compliance Former Executive Director for Clinical Research Neera Bhansali, PhD* - MD Anderson Cancer Center Head of Bioinformatics Faculty Director, MS Health Informatics Ahmad Razmpour, PhD and Management Systems Vice President, Biostatistics - Florida International University, Miami Former Head, Immunology Statistics Former Director, Data Quality & Standards, - Abbott Global Statistics and Data Management - H. Lee Moffitt Cancer Center Former Sr. Director II, Biostatistics - Wyeth Global Biostatistics & Programming Holly Powers, JD Former Head, Biostatistics & Data Management *Consultant - Cytogen Corporation Legal Counsel - Jameson and Powers, PC 14
  • 15. Board of Directors William T. Butler, MD, Chairman Alfred G. Gilman, MD, PhD (Ex-officio, voting) Chancellor Emeritus Chief Scientific Officer - Baylor College of Medicine - CPRIT Bruce A. Chabner, MD William H. Gimson, III, MBA (Ex-officio, voting) Professor of Medicine, Harvard Medical School Executive Director Director of Clinical Research, MGH Cancer Center - CPRIT - Massachusetts General Hospital Sandra J. Horning, MD John D. Cullen Senior VP, Global Head, Clinical Development Chief Executive Officer Hematology/Oncology - DMX, Inc. - Genentech/Roche Carolyn Dickson Patrick J. Loehrer, Sr., MD Executive Director Director, Indiana University Simon Cancer Center - The O’Donnell Foundation Associate Dean of Cancer Research H. H. Gregg Professor of Oncology, James H. Doroshow, MD (Govt. Liaison, non-voting) - Indiana University School of Medicine Director, Division of Cancer Treatment and Diagnosis Senior Investigator, Laboratory of Molecular Pharmacology Richard L. Schilsky, MD - National Cancer Institute Professor of Medicine, Chief, Section of Hematology-Oncology Deputy Director, Comprehensive Cancer Center Richard B. Gaynor, MD - University of Chicago, Biological Sciences Division VP, Clinical Development and Medical Affairs, Oncology - Eli Lilly and Company Robert C. Young, MD President - RCY Medicine 15
  • 16. Scientific Steering Committee David H. Johnson, MD, FACP Richard A. Gibbs, PhD Dipti Ranganathan Committee Chair Baylor College of Medicine UT Southwestern Medical Center UT Southwestern Medical Center Alfred G. Gilman, MD, PhD Christopher O. Ruud, MD Arthur L. Beaudet, MD CPRIT Scott and White Healthcare Baylor College of Medicine William H. Gimson, III, MBA Joseph O. Schmelz, PhD, RN, CIP, FAAN Donald A. Berry, PhD CPRIT UT Health Science Center San Antonio UT MD Anderson Cancer Center Beth A. Hellerstedt, MD Ian M. Thompson, Jr., MD Hak Choy, MD Texas Oncology UT Health Science Center San Antonio UT Southwestern Medical Center Susan G. Hilsenbeck, PhD Daniel D. Von Hoff, MD, FACP Raymond N. DuBois, MD, PhD Baylor College of Medicine Translational Genomics Research Institute, UT MD Anderson Cancer Center (TGEN) David G. Poplack, MD Charles E. Geyer, Jr., MD, FACP Texas Children’s Cancer Center Patricia A. Winger CTNeT CTNeT Elda Railey Research Advocacy Network 16

Editor's Notes

  1. From concept to final reports, we are your partner in drug development