Harnessing Clinical Research Management Systems and EHRs for clinical research Clinical Research Forum IT Roundtable John S. McIlwain, CEO Velos,

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1 Harnessing Clinical Research Management Systems and EHRs for clinical research Clinical Research Forum IT Roundtable John S. McIlwain, CEO Velos, Inc. November 17, 2016

2 Topics Velos Background Clinical Research IT Strategy Operations and Tactics Opportunities

3 Velos Background Parent business launched in 1991 Novel idea of leveraging low cost, welleducated software developers in India Software product focus Have developed a few dozen products in a variety of industries Holding company is 121 st Street Partners The holding company has equity stakes in a half dozen companies Velos and Aithent, our off shore company, employ about 350 people

4 Velos Founders John S Mcllwain Chairman, President, & Co Founder Amar P. S. Chahal, MD EVP &Co Founder N. Venu Gopal Co Founder 25+ years experience in the software industry with expertise in management, sales, marketing and finance. Chairman and President from September 1996 to June 2000 and from July 2001 to present. President of Aithent, Inc. from 1991 to Prior to Velos and Aithent, held a variety of executive management, consulting, finance and sales positions for companies such as Sun Microsystems and Price Waterhouse. John also served as Adjunct Professor of Management and Operations Science at Columbia University GSB. MBA from the Columbia University and a BA in English and Economics from Middlebury College. 30+ years experience in surgery, healthcare informatics and clinical research strategies. Held several key roles since 1996, including Executive Vice President of both Operations and R&D, and CTO. Past accomplishments include, Director of Health Services for Software Services International, Inc., Consultant to Merck & Company, Resident and then practicing orthopedic/vascular surgeon in NHS, London, England. MBA from Columbia University, Fellowship exams in Surgery from Royal College of Surgeons, Edinburgh, Scotland, and an MD from Armed Forces Medical College, Pune, India. 25+ years experience in the software industry with specialization in object technology, pattern recognition and artificial intelligence. Co founded and currently serves as CEO of Aithent, Inc., and is a member of Board of Directors of CareNet International in Japan. Worked with Fuji Xerox and Stanford Research International, and also as an Adjunct Professor at Columbia University GSB. MBA from Columbia University, and a Bachelor s and Master s in Engineering from Tokyo Institute of Technology, Tokyo, Japan.

5 121 st Street Companies Aithent Velos Pagoda Health Data Insights Offshore software product development; financial service industry, software products Clinical research and specialty medicine Knowledge management Healthcare claims (founding investors and advisors) BayaTree Rhoads Online Comaiba Stafa CT Offshore healthcare IT services Insurance industry compliance and education Operational Excellence Cell therapy operations

6 Velos History Founded in 1996, focused on medical records Pivoted to clinical research in 2004 Launched Velos eresearch in 2006 A few metrics: About 70 customers Velos customers receive roughly half of NIH funding among the 100 largest such funding recipients About a third of the CTSA use one or more Velos products 10,000 studies with active status across the Velos customer base 550,000 patients 400,000 samples 35,000 users 2,000 sites Employ about 100 people 45 in the U.S., 55 off shore Focused on clinical research and cell therapy

7 StafaCT unit StafaCT is an integrated, configurable, and comprehensive cellular therapy software solution.

8 8

9 StafaCT Solution Workflow 9

10 Clinical Research IT Strategy The Drivers Need for cost and time efficiency Precision Medicine opportunities, challenges Data standards and lack thereof Playing to core competencies Data utility and the learning organization Sponsor challenges and opportunities are largely the same

11 New product launches substantially increased R&D investment starting around Comaiba 2014 Volunteer 2015 Stafa IDS ecompliance 2006 eresearch

12 The Protocol Lifecycle Can be complex, siloed and inefficient

13 CTMS versus CRMS: The ideal is a unified, integrated CRMS approach

14 High level view of an integrated CRMS in large site settings Institutional Review Board (IRB) System Hospital Billing System Protocols/ Patients/Subjects/ Drugs/Samples CRMS Research Billing Office Electronic Health Record (EHR) Data Warehouse(s) Laboratory Information (LIMS) Partial List IRB Click InfoEd Pro IRB imedris Proprietary EHR/ ADT Epic Cerner GE Meditech Siemens Allscript Warehouse Proprietary LIMS IDX Proprietary Warehouse Billing Peoplesoft Lawson Other HR Security

15 CRMS Operations and Tactics To mandate or not Centralized versus decentralized approaches and operations Out of the box versus tailored implementations Incremental and targeted approaches to implementation and SOPs Targeted and continuum approaches to data Grabbing the lower lying fruit Staffing and organizational change

16 Lower lying Opportunities Opportunity Centralize and mandate protocol administration, study calendars, coverage analysis, and budgeting. Relative difficulty Medium Impact High Consolidate and standardize sponsor contracting, budgeting, Medium High and IRB reviews where feasible. Leverage existing data sets. Low Medium to High Extend regional, national, international alliances. Medium High Focus on high pay off areas such as integration, calendar creation, charge capture and data harvesting. Low to Medium Medium to High Leverage vendor out of the box systems and implementation guidance, then improve incrementally. Low Medium to High

17 Other noteworthy opportunities Data provisioning Data standards Connecting the clinical research supply chain Research networks Sponsors Consolidating disparate systems and processes

18 National Cancer Center South Korea

19 Type Rand. Phase NCC Closed Trials # of participated organization Sample Size Enrolled 1. Cervical Cancer Y N/A Head & Neck Cancer Y II Lung Cancer N II Gastric Cancer Y II Breast Cancer Y III Colorectal Cancer Y III Head & Neck Cancer Y II Gastric Cancer Y II Cervical Cancer N N/A Hospice N N/A Vocal Cancer Y II Lung Cancer N I/II Lung Cancer Y III Brain Tumor N II Dementia Y N/A Gastric Cancer Y III Cardiovascular disease Y III Year

20 NCC Closed Trials Type Rand. Phase # of participated organization Sample Size Enrolled 18. Lung Cancer Y II Breast Cancer N I/II Breast Cancer N I Colorectal Cancer N II Liver Cancer N II Gastric Cancer Y N/A Pediatric ALL (VHR) N N/A Pediatric ALL (Relapse) N N/A Breast and Prostate Cancer Y III Lung Cancer Y III Breast Cancer N I/II Liver Cancer N II Rectal Cancer Y III Colorectal Cancer N N/A Hospice N N/A Gastric Cancer Y II Pediatric & Adolescent N N/A Year

21 Type Rand. Phase NCC Closed Trials # of participated organization Sample Size Enrolled 35. ovarian, fallopian tube, and primary peritoneal cancer Y II Breast Cancer Y II Liver Cancer N II Cancer Pain Management N N/A Lung Cancer Y II Hospice N N/A Gastric Cancer N N/A Lung Cancer Y II Gastric Cancer N N/A Breast Cancer Y III Hospice N N/A Rectal Cancer Y II Colon Cancer Y II Hospice N N/A Pediatric N N/A N/A N/A N/A 2013 Year

22 In Summary Exciting times in Clinical Research IT EHR systems and related data have created considerable opportunity Sponsors are more aligned than ever The information technology is largely there Recognition of the need for investment, systems and systemic approaches is there Awareness of the need for data standards is nearly universal The importance of collaboration seems nearly universal Considerable opportunity lies ahead much done, much to do

23 Thank You!