Moffitt Cancer Center, M2Gen and ConvergeHEALTH Collaboration
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1 Moffitt Cancer Center, M2Gen and ConvergeHEALTH Collaboration Eric Padron, M.D., Section Head, Personalized Medicine and Genomics, Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute Asif Dhar, M.D., Executive Vice President Solutions, ConvergeHEALTH by Deloitte
2 Global Healthcare and Life Sciences Practice Deloitte Healthcare Consulting is world-class and serves leading organizations across the healthcare value chain with an unparalleled ecosystem view "Deloitte is deep and strong in all four healthcare sub-segments: life sciences, provider, payer, and government healthcare." "Deloitte brings deep and broad capabilities to healthcare clients; its balance of financial, technical, and industry consultants allows the firm to respond to more complex and comprehensive engagements. Source: "Healthcare Consulting Marketplace "; Kennedy Information; used with permission Life Sciences Health Plans Providers Government Health 10 of the 10 largest pharmaceutical manufacturers 10 of the 10 largest biotechnology companies 10 of the 10 largest medical equipment manufacturers 85% of Fortune 1000 HCLS companies >70% of US Blue Cross Blue Shield Plans 24 of the top 25 largest managed care organizations (as ranked by AIS's Directory of Health Plans) Nearly 90% of managed care organizations (as ranked by HealthLeaders - Interstudy 2007) 10 of the 10 largest health care systems >80% of the US News and World Honor Roll hospitals 7 of the 9 largest For- Profit Health Care Systems 9 of the 10 largest Secular Not-for-Profit Health Care Systems US Federal Health agencies: CMS, CDC, FDA, MHS, NIH, VA, DoD >30 US state government Health & Human Services agencies Largest departments and ministries in all of the leading 25 nations as ranked by World Economic Forum 1 Copyright 2014 Deloitte Development LLC. All rights reserved.
3 ConvergeHEALTH by Deloitte Deloitte announces the launch of ConvergeHEALTH ConvergeHEALTH is part of a $ million investment Deloitte is making in life sciences and health care analytics including new analytics platforms, informatics services and talent NEW YORK, Feb. 20, 2014 Today Deloitte Consulting LLP announces the launch of ConvergeHEALTH by Deloitte, a business unit that supports the data-driven transformation of health care through the application of insights derived from new data, analytics, transformational services and collaborative business models. Intermountain Healthcare understands best care and how to achieve it on a consistent basis; higher quality means significant elimination of waste and significant reduction in the cost of care delivery. Intermountain had the data. Deloitte had the consulting services and the distribution network to make that better care widely available. Brent James, M.D. Chief Quality Officer, Intermountain Healthcare 2 Copyright 2014 Deloitte Development LLC. All rights reserved.
4 Value Expertise Commitment Accelerating Healthcare Transformation Deloitte is investing significantly to support the data driven transformation of healthcare $ M committed in investments in healthcare analytics, collaborations & partnerships over 3 years Acquisitions of Intrasphere and Recombinant Data Corp. Industry leading healthcare data warehousing & analytics solutions with over 30 implementations Deep view into longitudinal, process level, & comparative clinical data working with market leader, Intermountain #1 Healthcare and Life Sciences consultancy in the US: 600+ domain experts supported by 10,000+ IT practitioners Partnerships with market leaders such as Intermountain Healthcare, M2Gen, Northern New England Accountable Care Collaborative, and Regenstrief Institute Leverage existing technology partnerships and solutions To support the data driven transformation of healthcare to a personalized, value based paradigm 3 Copyright 2014 Deloitte Development LLC. All rights reserved.
5 However, Life Sciences decision makers are confronted with data and analytics issues High Costs Significant costs to reliably access necessary data sets Incomplete Insights Available data often does not reflect the full span of clinical observations Business Models Ethically gain access to data from multiple stakeholders and ability to collaborate efficiently Inability to Recognize Associations Technology and privacy challenges related developing associations across disparate datasets Resource Constraints Lack of expertise, resources and time needed to effectively interrogate data Successful use of data often requires: 1) widespread and easy accessibility to existing data and evidence assets, 2) clinical nuances and background to derive insights from data, 3) near real-time connectivity to health systems to further build on that evidence, and 4) appropriately skilled resources to do the same 4 Copyright 2014 Deloitte Development LLC. All rights reserved.
6 Clinical Trial Data and Real-world Evidence when leveraged independently can have tremendous value Adequate usage of clinical trial data and real-world evidence can have transformational impact on multiple life sciences activities Clinical Trial & Biomarker Data Real-World Evidence Target identification Comparative effectiveness Target validation Unmet health system needs Indication expansion Discontinuation risk Cross-study analysis Patient stratification Biomarker discovery Safety signal sensitivity 5 Copyright 2014 Deloitte Development LLC. All rights reserved.
7 Potential synergistic impact as we integrate insights from both the data sources Multiple use cases and key activities can be influenced in a positive manner by a continuous application flow as we converge trial data and RWE Convergence of disparate data sources Clinical Trial & Biomarker Data Real World Evidence Convergence of disparate data sources Research & Development Commercial Planning Execution Effectiveness Safety Identifying new indications Meta-analysis across clinical trials Comparative Effectiveness Support/Augment safety signal detection Repositioning of drugs Biomarker Identification Dosage adjustment for phenotype / genotypes Amplify signals related to efficacy and safety Feasibility analysis Inform new trial design portfolio planning and gap analysis Validate conclusions on adverse events Hypothesis development & testing Improve trial recruitment Reduce redundant clinical studies Identify and publish new labelling changes 6 Copyright 2014 Deloitte Development LLC. All rights reserved.
8 Deloitte LS Analytics Solutions Omics analysis Extend open source Analysis archive Data delivery pipelines Insights Consortium Data models and analytics frameworks Cloud and on-premise deployment tools Informatics and statistical models Precision Miner Miner Platform transmart/ i2b2 Population Miner Outcomes Miner Visually explore large populations Identify signals Select cohorts to analyze Identify basic correlations Propensity-matched subsets Identify advanced correlations Compare treatment effectiveness Subscription access to reports 7 Copyright 2014 Deloitte Development LLC. All rights reserved.
9 Deloitte Portal ConvergeHEALTH s Insights OutcomesMiner Real World Evidence Platform Real World Consortium & Additional Data Analytics Platform Visualization Portal Follow-On Studies (access to real-word, deidentified EHR data) Health System Consortia EHR Data Sets CH s analytics engine aggregates and synthesizes patient-data Customers access the analytics results via a visualization portal SaaS, Hosted, or On-premises Tools & Visualization Customers collaborate on follow-on studies to understand causality of outcomes IMHC CH Moffitt A Intermountain Data Moffitt Cancer Center data Genomic EMR Lab Claims Regesnstrief Administrative Client Acquired Data Informatics tools deployed behind Consortium member firewalls eliminates PHI issues Analytics engine processes, synthesizes, and performs analytics de-identified data sources to power CH tools. Visualization portal allows users to interrogate outcomes to understand which treatments work for specific populations Customers can conduct follow-on retrospective and prospective studies to understand causality of outcomes 8 Copyright 2014 Deloitte Development LLC. All rights reserved.
10 Moffitt Cancer Center/M2Gen and ConvergeHEALTH Oncology Collaboration to Support a Rapid Oncology Learning Netwrok Moffitt Cancer Center's M2Gen Joins ConvergeHealth in Personalized Cancer Partnership April 01, 2014 M2Gen, ConvergeHealth, and Deloitte will work together in a consortium launched by Intermountain Healthcare to contribute to biomarker discovery and genetic clinical trial matching, and to generate evidence to support personalized medicine efforts. The partners will use ConvergeHealth's OutcomesMiner solution, informatics, and consulting services, along with M2Gen's and Moffitt's expertise to conduct personalized medicine studies. M2Gen is based on Moffitt Cancer Center's Total Cancer Care program. It analyzes patient tissue and information and deposits those clinical and molecular data into a repository that is used for biomarker studies and to support gene-based clinical trials. "Through our data on biomarkers and ConvergeHEALTH's analytics, this collaboration will help us work toward our goal of personalized cancer care for our patients," said Moffitt Cancer Center's President and CEO Alan List.
11 ConvergeHEALTH has formed a network of health system consortium partners to establish a rapid learning network Research Informatics Solutions Collaboration Across Healthcare Stakeholders Rapid Learning Environment Research Partnership with Health Systems Improved understanding of patient outcomes and health system value drivers through Outcomes Miner Engage with M2Gen Informatics Research in IRB-approved follow-on studies Develop further evidence to support comparative effectiveness research programs, new product planning activities, health economic and outcomes research and observational insights Leverage next generation analytics, near real time insights from real world evidence and collaborative research to better understand patient outcomes and critical success factors in healthcare 10 Copyright 2014 Deloitte Development LLC. All rights reserved.
12 ConvergeHEALTH s Landmark Collaboration with Moffitt / M2Gen ConvergeHEALTH, M2Gen and Deloitte will offer personalized medicine studies and realworld analytics services to life sciences organizations, study sponsors and cancer centers We are thrilled to team with Deloitte to extend our reach and bring our combined analytics and collaborative study services to clients around the world. This will expand the studies we will conduct, bringing more therapies to market and provide more studies to the health systems we serve. - Bill Dalton, Ph.D., M.D., CEO of M2Gen Real-World Evidence Collaboration Extends the ConvergeHEALTH Consortium s capabilities to contribute toward biomarker discovery, gene-based clinical trial matching, and real world evidence generation to support the shift to personalized medicine in oncology Combines ConvergeHEALTH s OutcomesMiner solution suite, informatics and consulting services with the experiences of M2Gen and Moffitt in conducting personalized medicine studies and M2Gen s rich source of oncology and personalized medicine insights drawn from its Total Cancer Care (TCC) program Together, ConvergeHEALTH, M2Gen and Deloitte will support LS and health care organizations worldwide in advancing effective learnings around translational research, realworld evidence and personalized medicine 11 Copyright 2014 Deloitte Development LLC. All rights reserved.
13 M2Gen: Capabilities in Real World Evidence
14 The TCC Protocol The Total Cancer Care Protocol May we follow you throughout your lifetime? May we study your tumor using molecular technology? May we re-contact you? The Total Cancer Care Protocol is a unique approach to Personalized Medicine, and is the foundation upon which M2Gen is built. 13 Copyright 2014 Deloitte Development LLC. All rights reserved.
15 The TCC Protocol: Patient Tissue, Clinical and Molecular Data The success of TCC to date has been a result of the harmonization of tissue and data SOPs across many different sites. For each patient collect: Tissue Specimens Molecular Data SOPs harmonized across all participating sites Longitudinal Clinical Data 14 Copyright 2014 Deloitte Development LLC. All rights reserved.
16 The TCC Consortium M2Gen currently partners with several Consortium Sites to reflect Real World experience Hartford Hospital, Hartford, CT St. Joseph s Candler Health System, Savannah, GA Moffitt Cancer Center, Tampa, FL Martin Health System, Stuart, FL Sarasota Memorial Health Care, Sarasota, FL Watson Clinic Center for Research, Lakeland, FL Baptist Health South, Miami, FL Morton Plant Hospital, Clearwater, FL Norton Healthcare, Louisville, KY Lehigh Valley Health Network, Allentown, PA Billings Clinic, Billings, MT 15 Copyright 2014 Deloitte Development LLC. All rights reserved.
17 Total Cancer Care to Date Community Sites and Moffitt 105,716 Consented Patients MCC (65%) Sites (35%) 35,679 Tumors Collected MCC (43%) Sites (57%) 16,279 Gene Expression Profiles As of May 14, 2014 Data Generated from Specimens CEL Files (Gene Expression Data) Targeted Exome Sequencing Whole Exome Sequencing (Ovary, Lung, Colon, Myeloma) Whole Genome Sequencing (Melanoma) SNP/CNV (Lung, Breast, Colon) RNA Sequencing (Breast, Myeloma) 16,279 files 4,016 samples 574 samples 13 samples with normal pairs 559 samples 430 samples Copyright 2014 Deloitte Development LLC. All rights reserved.
18 M2Gen: Enabling Rapid Learning The ability to identify patients using both genotypic and phenotypic data is at the core of M2Gen s solutions for Real World Evidence Genotype Identification of Patient Cohorts of Interest Phenotype 17 Copyright 2014 Deloitte Development LLC. All rights reserved.
19 Real World Evidence Case Study: Background Hypothesized Frequency Hypothesized Response to Approved Drug Populations of greatest interest Global biopharmaceutical company was interested in learning why certain patients did very well on approved therapy, while others did not respond Duration of Response to Therapy 18 Copyright 2014 Deloitte Development LLC. All rights reserved.
20 Real World Evidence Case Study: Query of the TCC Data Warehouse # of Patients M2Gen was able to quickly identify patients who received the drug, and stratify them based on response Patients with Confirmed Duration of Treatment mos <3 mos >24 mos 24 mos Duration of Treatment 19 Copyright 2014 Deloitte Development LLC. All rights reserved.
21 Real World Evidence Case Study: M2Gen Approach Using the TCC System, M2Gen was able to take a unique approach to addressing why some patients do or do not respond. Phenotypic Query Molecular Testing of Specimens Bio statistical Analysis M2Gen queried for patients who received the drug Patients at the extremes placed into long-duration and short-duration of response cohorts Paraffinembedded tumor specimen accessed for patients in both cohorts Specimens were sent to third party lab for sequencing and gene expression analysis Biostatistical analysis was performed to compare the two groups in order to identify markers of response/nonresponse (including markers from literature) 20 Copyright 2014 Deloitte Development LLC. All rights reserved.
22 Real World Evidence Case Study: Enabling Future Research The approach enabled a number of follow-on projects which capitalized on the findings from the project. Development of CDx for Next-generation Therapy Signal can be validated and used to select patients for next-gen therapy Rationale for Combination Therapy Combinations with other drugs targeting markers associated with non-response/resistance Prospective Studies to Evaluate Changes in Marker Over Time Studies could inform optimal sequence of drugs to ultimately improve efficacy Novel Clinical Trial Design Marker can be featured in adaptive trial or one that employs alternating therapies 21 Copyright 2014 Deloitte Development LLC. All rights reserved.
23 Unique Capabilities in Real World Evidence + 22 Copyright 2014 Deloitte Development LLC. All rights reserved.
24 This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this publication. As used in this document, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting. Copyright 2014 Deloitte Development LLC. All rights reserved.
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