Patient Cloud. Future of Clinical Trials. and the. PhUSE Conference. Christopher Temme. October Product Management, Director

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1 Patient Cloud and the Future of Clinical Trials PhUSE Conference Christopher Temme Product Management, Director October Medidata Solutions, Inc. 1

2 Agenda Introduction Recruitment and Sites Patient Cloud Device Trial Patient Engagement Clinical Trials of the Future 2013 Medidata Solutions, Inc. 2

3 Problems Questionable Data Quality Delayed Start Patient Satisfaction 2013 Medidata Solutions, Inc. 3

4 Poor Recruiting 80% of Studies are Delayed 70% are because of poor Recruitment Engage More Sites? 2013 Medidata Solutions, Inc. 4

5 Can t Simply Add Sites $60,000 Site Monitoring & Maintenance Costs as a function of Patients Recruited $50,000 $40,000 $30,000 $20,000 Site Monitoring and Maintenance Costs per 100 Patients $10,000 $ Medidata Solutions, Inc. 5

6 Improving Site Performance Recruitment as a function of Indicators Section 1 Section 2 Section 3 Section 4 Division 1 Division 2 Division 3 Division Medidata Solutions, Inc. 6

7 Today: Clinical Trials are Site-Centric 2013 Medidata Medidata Solutions, Inc. 7

8 Inversion: Clinical trials are Patient-Centric (Really) 2013 Medidata Medidata Solutions, Inc. 8

9 Current: Data is captured at visit-based time points 6-minute walk test data Meters walked Patient 1 Patient 2 Increased morbidity / mortality risk Visit 1 Visit 2 Visit 3 Visit 4 Source: American Journal of Respiratory and Critical Care Medicine, 2011; The 6MWT has been found to be useful to stage severity of disease, provide information on efficacy of treatment, and predict morbidity and mortality in congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF) 2013 Medidata Solutions, Inc. 9

Future: Data is captured continually 6-minute walk test data Meters walked 700 600 500 400 300 200 Patient 1 Patient 2 Increased morbidity / mortality risk 100 0 Visit 1 Visit 2 Visit 3 Visit 4

10 Future: Data is captured continually 6-minute walk test data Meters walked Patient 1 Patient 2 Increased morbidity / mortality risk Visit 1 Visit 2 Visit 3 Visit 4 Source: American Journal of Respiratory and Critical Care Medicine, 2011; The 6MWT has been found to be useful to stage severity of disease, provide information on efficacy of treatment, and predict morbidity and mortality in congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF) 2013 Medidata Solutions, Inc. 10

11 The Medidata Patient Cloud is an ios App ipod Touch ipad ipad Mini ipad iphone iphone 2013 Medidata Solutions, Inc. 11

12 The Medidata Patient Cloud is an ios App API Calls RWS 2013 Medidata Solutions, Inc. 12

13 Evolution of Patient Engagement Many / constant Patient Cloud Patient Interactio ns IVR Specialpurpose Device IWR Few / infrequent Paper Time 2013 Medidata Solutions, Inc. 13

14 Evolution of PRO Many/ Constant Patient Interactions IVR Specialpurpose Device Patient Engagement IWR Patient Cloud Few/ Infrequent Paper Time 2013 Medidata Solutions, Inc. 14

15 New Patient Experience New software delivery models (SaaS/apps) More engaged & better informed patients Consumerization of IT Better patient outcomes Ubiquitous connectivity Better data Patients desire to be engaged Innovation opportunities (e.g., crowdsourcing) Key Drivers Key Results 2013 Medidata Solutions, Inc. 15

16 My Entertainment Experience 2013 Medidata Solutions, Inc. 16

17 My Social Experience 2013 Medidata Solutions, Inc. 17

18 My Banking Experience 2013 Medidata Solutions, Inc. 18

19 Future: is now 2013 Medidata Solutions, Inc. 19

Trials of the future will have better design, be more patient-centric, and have far less reliance on sites Today Future Design Studies grow larger and

trials are site-centric Clinical trials are patient-centric (continuous data capture, reduced patient burden) Depth of subject data decreases as

incorporation of new sources Embrace real-world complications in clinical trials through better data / analytical techniques Sites High fixed cost to

20 Trials of the future will have better design, be more patient-centric, and have far less reliance on sites Today Future Design Studies grow larger and more expensive as they progress through phase III Adaptive trial designs will enable small, targeted phase III trials Patient management Clinical trials are site-centric Clinical trials are patient-centric (continuous data capture, reduced patient burden) Depth of subject data decreases as therapy progresses through trial stages Limit real-world encroachment on clinical trials Depth of subject data expands through all phases due to incorporation of new sources Embrace real-world complications in clinical trials through better data / analytical techniques Sites High fixed cost to initiate sites Zero incremental cost to initiate sites that have run trials in the past; enables vast site expansion and faster recruitment 2013 Medidata Solutions, Inc. 20

21 New Patient Experience Patient Cloud Old World Ability to share experiences at will Periodic, prescriptive touch points Sense of community w/ PI, peers Powerful, technology-enabled interactions Holistic experience across treatment, feedback & behavior A real sense of purpose Limited role/value Limited technology investment / commitment Feedback only Limited ability to contribute 2013 Medidata Solutions, Inc. 21

22 Benefits of Engagement What we know about a Patient With Continued Engagement Added Value Without Continued Engagement Trial Duration Time 2013 Medidata Solutions, Inc. 22

23 Patient Centric Studies Patient Diaries Quality of Life Assessments Direct-to-Patient Studies Patient Engagement (Dosing, Retention, Compliance) 2013 Medidata Solutions, Inc. 23

24 2013 Medidata Solutions, Inc. 24 Thank you!

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