An overview of the oncology clinical trials network (CTNeT) which is being implemented throughout Texas. The non-profit network is a first of its kind and combines the innovative science of Texas cancer centers with the expertise and resources of both academic and community oncologists throughout the state. To learn more, visit www.ctnet.org

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
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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
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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
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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
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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
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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
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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
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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)
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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
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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
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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
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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.
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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
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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
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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
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17. www.ctnet.org
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