CTNeT Overview ASCO 2012
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CTNeT Overview ASCO 2012

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An overview of the oncology clinical trials network (CTNeT) which is being implemented throughout Texas. ...

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

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

CTNeT Overview ASCO 2012 CTNeT Overview ASCO 2012 Presentation Transcript

  • 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 StatementTo 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 CENTERUT HEALTH SCIENCE CENTER at SAN ANTONIO MARY CROWLEY CANCER RESEARCH CENTERUT MD ANDERSON CANCER CENTER THE METHODIST HOSPITAL SYSTEMBAYLOR COLLEGE of MEDICINE SCOTT & WHITE HEALTHCARETEXAS 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 TestsOver 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 ResultsPatient Patient submitted reported Study SiteConsent 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
  • GovernanceIndependent 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. WingerSVP, Clinical Development Head of Biostatistics L. Paradiso, DVM, MBA A. Razmpour, Ph.D. 13
  • Executive LeadershipCharles E. Geyer, Jr., MD Patricia A. WingerPresident and Chief Medical Officer Vice President and Chief Operations OfficerFormer Director of Medical Affairs Former VP of Research Operations- National Surgical Adjuvant Breast - US Oncologyand Bowel Project Former VP, Business Integration - Sarah Cannon Research InstituteLinda J. Paradiso, DVM, MBASr. Vice President of Clinical Development Dean J. Ferrigno, CPA, MBAFormer Head, Global Oncology Regulatory Affairs Vice President, Finance- Amgen Former VP, CFOFormer Head, Oncology Clinical Development - Sarah Cannon Research Institute- Pfizer La Jolla Former Head of Development FinanceFormer Head, Clinical Research - Daiichi Sankyo- Agouron PharmaFormer Senior VP, Clinical and Regulatory Affairs Paul Papagni, JD, CIP- Salmedix Vice President of Research Admin, Compliance Former Executive Director for Clinical ResearchNeera Bhansali, PhD* - MD Anderson Cancer CenterHead of BioinformaticsFaculty Director, MS Health Informatics Ahmad Razmpour, PhDand Management Systems Vice President, Biostatistics- Florida International University, Miami Former Head, Immunology StatisticsFormer Director, Data Quality & Standards, - Abbott Global Statistics and Data Management- H. Lee Moffitt Cancer Center Former Sr. Director II, Biostatistics - Wyeth Global Biostatistics & ProgrammingHolly Powers, JD Former Head, Biostatistics & Data Management *Consultant - Cytogen CorporationLegal Counsel- Jameson and Powers, PC 14
  • Board of DirectorsWilliam T. Butler, MD, Chairman Alfred G. Gilman, MD, PhD (Ex-officio, voting)Chancellor Emeritus Chief Scientific Officer- Baylor College of Medicine - CPRITBruce A. Chabner, MD William H. Gimson, III, MBA (Ex-officio, voting)Professor of Medicine, Harvard Medical School Executive DirectorDirector of Clinical Research, MGH Cancer Center - CPRIT- Massachusetts General Hospital Sandra J. Horning, MDJohn D. Cullen Senior VP, Global Head, Clinical DevelopmentChief Executive Officer Hematology/Oncology- DMX, Inc. - Genentech/RocheCarolyn Dickson Patrick J. Loehrer, Sr., MDExecutive 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 MedicineDirector, Division of Cancer Treatment and DiagnosisSenior Investigator, Laboratory of Molecular Pharmacology Richard L. Schilsky, MD- National Cancer Institute Professor of Medicine, Chief, Section of Hematology-Oncology Deputy Director, Comprehensive Cancer CenterRichard B. Gaynor, MD - University of Chicago, Biological Sciences DivisionVP, Clinical Development and Medical Affairs, Oncology- Eli Lilly and Company Robert C. Young, MD President - RCY Medicine 15
  • Scientific Steering CommitteeDavid H. Johnson, MD, FACP Richard A. Gibbs, PhD Dipti RanganathanCommittee Chair Baylor College of Medicine UT Southwestern Medical CenterUT Southwestern Medical Center Alfred G. Gilman, MD, PhD Christopher O. Ruud, MDArthur L. Beaudet, MD CPRIT Scott and White HealthcareBaylor College of Medicine William H. Gimson, III, MBA Joseph O. Schmelz, PhD, RN, CIP, FAANDonald A. Berry, PhD CPRIT UT Health Science Center San AntonioUT MD Anderson Cancer Center Beth A. Hellerstedt, MD Ian M. Thompson, Jr., MDHak Choy, MD Texas Oncology UT Health Science Center San AntonioUT Southwestern Medical Center Susan G. Hilsenbeck, PhD Daniel D. Von Hoff, MD, FACPRaymond N. DuBois, MD, PhD Baylor College of Medicine Translational Genomics Research Institute,UT MD Anderson Cancer Center (TGEN) David G. Poplack, MDCharles E. Geyer, Jr., MD, FACP Texas Children’s Cancer Center Patricia A. WingerCTNeT CTNeT Elda Railey Research Advocacy Network 16
  • www.ctnet.org 17