Incorporating Personalized Medicine in Community Hospital Systems ��� Catholic Health Initiatives’���Center for Translational Research July 17, 2013

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

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

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  collec<on  across  CHI  network  -­‐ CLIA  cer<fied  laboratory  for  personalized  medicine  -­‐ Research  Laboratory  for  IP  genera<on  

Center  for  Transla4onal  Research  (CTR)  

Biosta<s<cs/Data  Analy<cs  -­‐  Electronic  Medical  Record  links  

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

Best Practices: Biospecimen Collection Overview

Cloud-based Informatics: Network Strength

Data  Warehouse  

CCR   CTR  

Research  Data  

Analysis  

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

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  Genera<on  

Hypothesis  Development    

Transla<onal    Research    Laboratory  

Specimen  and  

Data  Access  

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

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

Personalized Report

§  Personalized report generated from the exome sequencing of our patient

§  Can be tailored to individual physician preferences

Clinical Trial #1 Eligibility

Patients Like Me

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

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

Therapies targeting the EGFR pathway

17

EGFR = Epidermal Growth Factor Receptor

Selected QIAGEN partners:

therascreen KRAS test

BKM120

Afatinib

Zelboraf

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

Thank you.