2013-07-17: Incorporating Personalized Medicine in Community Hospital Systems
- 1. Incorporating Personalized Medicine in Community Hospital Systems Catholic Health Initiatives’ Center for Translational Research July 17, 2013
- 2. CHI: 5th Largest Hospital Network in US Strength in Numbers § 5th largest US network § 86 acute care hospitals in 18 states § 40 LTC facilities § 85,000 employees § 2,900 physicians and midlevel providers § Diverse markets with 90% ranked #1 or #2 § $15B in assets, $12B in annual revenue § FY 2012 – provided $715M+ in charity care
- 3. Personalized Medicine § What is it? § Personalized medicine is the use of new methods of molecular analysis to better manage a patient’s disease or predisposition toward a disease… approaches may include genetic screening programs that more precisely diagnose diseases and their sub-types, or help physicians select the type and dose of medication best suited to a certain group of patients. – Personalized Medicine Coalition
- 4. CHI Institute for Research Innovation Center for Clinical Trials -‐ Clinical Trial recruitment and management across CHI Center for Healthcare Innova4on (CHCI) -‐ Next Gen healthcare delivery -‐ Mul-‐center Bio-‐Repository for specimen collecon across CHI network -‐ CLIA cerfied laboratory for personalized medicine -‐ Research Laboratory for IP generaon Center for Transla4onal Research (CTR) Biostascs/Data Analycs -‐ Electronic Medical Record links
- 5. Bio-Repository Network § Responsible for scientific oversight of collection process and storage, project specifications § Installation of full time employee at individual sites across the CHI § Responsible for patient recruitment and sample processing/storage § Uniform collection procedures § Regulatory Guidance - WIRB protocol approval § Dedicated staff to facilitate sample collection, storage and shipment § Annotated biospecimens with clinical and longitudinal data (up to 10 years) § Single software solution for: q Chain of custody tracking from consent to storage q Data capture from downstream molecular analyses q Querying capabilities to define cohorts 5
- 6. Best Practices: Biospecimen Collection Overview
- 7. Cloud-based Informatics: Network Strength Data Warehouse CCR CTR Research Data Analysis
- 8. Physician Engagement § CHI is a community based hospital system § Physician engagement includes: q education of local physicians in bio molecular assays, including next generation sequencing q Partnership to investigate clinically relevant questions from inside the CHI system q Proposed projects for grant/venture capital funding through a variety of mechanisms
- 9. CHI Discovery Research Network CTR working with Physicians in their communities § Hypothesis-driven Research § Research Partnering § Education Discovery Research Network Biospecimen Procurement Program Infrastructure Support IP Generaon Hypothesis Development Translaonal Research Laboratory Specimen and Data Access
- 10. Next Generation Sequencing (NGS) § Current generation of technology allows for sequencing of the whole genome of a patient, or a patient tumor sample § Derived from technology used to do the first human genome sequencing project § That project took years, and millions of dollars § Current turn around time is 6 to 8 weeks for an entire genome to be sequenced, turn around times continue to decrease as do costs
- 11. Data Tsunami § Data storage and subsequent analysis is rapidly becoming a bottleneck for most NGS labs § Single gene sequencing produces files of 10’s to 100 KB in size § Exome sequencing produces ~10 GB file size per run § Full genome sequencing produces file sizes on the order of ~100 GB § Accompanying data analysis is time consuming and requires specialized training and software
- 12. Personalized Report § Personalized report generated from the exome sequencing of our patient § Can be tailored to individual physician preferences
- 13. Clinical Trial #1 Eligibility
- 14. Patients Like Me
- 15. Challenges for NGS § Input requirements can be difficult to meet with FFPE, especially FNA § Physicians leery of what information they will get, quantity of information a problem § Clear, concise physician reports required § Current turn around times too long for full exome sequencing, better for targeted
- 16. Opportunities for NGS § True implementation of personalized treatment based on biology not phenotype or even histology § Preservation of precious tissue by integrating multiple tests into one assay § Longitudinal examination of a patients primary, recurrence and resistant disease § Becoming more necessary with additional targeted therapies and clinical trials
- 17. Therapies targeting the EGFR pathway 17 EGFR = Epidermal Growth Factor Receptor Selected QIAGEN partners: therascreen KRAS test BKM120 Afatinib Zelboraf
- 18. Patient Testing § First available test at CTR, for KRAS, codon 12,13,61 § Reporting clinical outcome for the use of EGFR inhibitors (panitumumab, cetuximab) § Predominantly used for colorectal cancers as per guidelines (National Comprehensive Cancer Network) § 30-35% of patients have KRAS mutation, predictive for lack of response to EGFR targeting § Cost of EGFR targeting: $30,000 for 8 weeks treatment § FFPE samples, typically from FNA § We also see lung cancer and metastatic samples
- 19. Thank you.