Pharmaceutical Compliance Congress

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1 Pharmaceutical Compliance Congress October 29, 2013 Changes to the Commercial Business Model and the Implications to the Compliance: SMAC!

2 SMAC is transforming all industries, forcing the creation of new operating models 2

3 SMAC is changing the rules in healthcare forcing new business models and threatening survival Social Volume Value New value propositions Mobile Places Spaces New care delivery models Analytics General Individual More customized solutions Cloud Analog Digital Greater portability, security, access Agent Institutional Consumer More freedom, transparency, choice 3

4 Social volume to value We demand the same value experience in healthcare as elsewhere 4

5 Mobile places to spaces 90% reduction in price creating business model disruption Societal Technology Economic Political 3 rd Party Pay Consumer Pay $199 $2,999 $9,999 $14,999 Hospital Ambulatory Surgery Center $99 Physician Office Product Disruption Physician Pocket Consumer Business Model Disruption 5

6 Analytic general to individual Shortage of critical talent for Big Data and personalized medicine 6

7 Cloud analog to digital Enabling and demanding new business models Cloud Apps/ HIE Peripherals Health Insurance Exchange Remote Patient Monitoring Telehealth Patient portals Digital Radiology ACRIS Patient Throughput and Logistics Mgmt Care Management Workflow Apps Computer-assisted coding Electronic Health Records Revenue Cycle Management HIE (i.e. interface, portal, clinical messaging exchange, analytics) Infrastructure (e.g. network, storage, security, billing, device mgmt) Videoconferencing Middleware/ Platforms Software, Hardware and Services 7

8 Agent institution to consumer All business models must address a new customer, the consumers Patient drivers to adopt mhealth Access to a greater choice of applications Reduce own healthcare costs 60.00% 50.00% 1 Convenient access to provider % Access better quality healthcare 30.00% 20.00% Ability to obtain information % China 0.00% India U.S. Manage a particular medical condition Encouragement from my healthcare provider Manage aspects of my life from my mobile phone Encouragement from my healthcare payer Greater control over own health 4 8

9 Football is sensing a SMAC future 9

10 Social networks are leveraging analytics, cloud and mobile to revolutionize Fantasy Football 10

11 Football is beginning to measure everything about the game using mobile sensors 11

12 Measuring the biometrics of the athletes through mobile sensors to improve performance Heart Rate Heart Rate Variability Heart Rate Recovery Respiration Rate Accelerometry Intensity & Load Live Training Zones Estimated Core Temperature 12

13 These measures enable more precise and effective training through high powered analytics 13

14 NFL has even moved to integrated and interoperable health data in the cloud 14

15 SMAC for the rest of us 15

16 Most of us are already social self trackers, technology just make is easier, better, and fun 16

17 An ecosystems of mobile sensors, devices and apps are enabling us to track everything x 17

18 Form and function become integrated into fashion moving us toward ubiquitous mobile sensors 18

19 Major brands are leading this SMAC revolution in connected consumer health 19

20 Startups are also leading the way in novel sensors and measures Mood and emotion Time, heart rate, temperature, and more 20

21 Sensors are becoming implantable, printable, ingestible, and smellable Flexible Electronic Chips Tattoos for Glucometers Chips on a Pill Smelling Chips 21

22 Has SMAC created a pedometer bubble? 22

23 SMAC is following Moore s Law driving the Internet of Everything (IoE) 23

24 SMAC is THE mega trend creating chaotic new opportunities, requiring a new view on healthcare 24

25 How are companies using SMAC to change their business models? Owning the Disease 25

26 Business Model Innovation Owning the Disease Case Study 1 Innovation in the new healthcare paradigm Molecular Dx screening IDs patients who would benefit from treatment Wireless Easypod injection device records dosage data and transmits to clinicians Personalized Nurse call center intervenes when notified by device of patient noncompliance System-based Results: Sales growth in a declining, off-patent brand Sales force reduction Smaller administrative costs; improved margin Clinical nurses in physician s office assist in treating patient EHR Integrates patient information Value-based reporting to NHS demonstrates compliance and improved outcomes Value driven Enhanced patient outcomes at lower cost Better clinical integration More care provided in home settings at lower cost

27 Business Model Innovation Owning the Disease Case Study 2 Business Model Innovation Diagnosis Treatment Myriad RBM molecular Dx screening IDs patients who would benefit from treatment Sanofi insulin drugs Engagement Support Data AgaMatrix iphone app shows patient relationship between insulin, glucose, and other factors to drive effective management Partnership with Healthy Interactions to foster greater dialogue between patient and provider AgaMatrix ibgstar glucose meter syncs data with app; glucose / insulin data can be ed to providers Analysis App provides individualized glucose pattern charts that can analyzed by providers Sanofi drove 15% growth in insulin sales by becoming a 360 partner delivering best-in-class and integrated solutions to diabetic patients 27

28 Business Model Innovation Owning the Disease Case Study 3 Business Model Innovation Diagnosis Claims data and other demographic information to identify people at risk of developing diabetes Treatment Healthy diet and exercise regimen Engagement Support Electronic scale to -YMCA staff track weight provides education on healthy diet and Engagement exercise platform drives - On-Demand video adherence program provides ongoing guidance - Personalized counseling by pharmacists and NPs Data Data from electronic scale and engagement platform aggregated centrally United Healthcare has been collaborating with partners to develop programs for diabetes and obesity Analysis Outcomes analyzed to determine efficacy of intervention 28

29 Business Model Innovation Owning the Disease Case Study 4 Business Model Innovation Diagnosis Treatment Medtronic s Insertable Cardiac Monitor helps doctors identify whether unexplained fainting is related to an irregular heartbeat or other cardiac related problems. Medtronic s cardiac resynchronization therapy devices help the heart beat in a more coordinated fashion Engagement Support Cardiocom s telescale and other telemonitoring devices will help it provides instant feedback to patients and can reduce readmissions Medtronic s CareLink Network helps doctors check a patient s condition and device status remotely when the patient is traveling Data CardioSight Reader can be used to obtain important details on a patient; a Heart Failure Management Report or Cardica Compass Trends Report is quickly sent to the doctor. Analysis Data allows doctors to see how well device and medications are working together and how heart function may change over time Medtronic s acquisition of Cardiocom helps it offer more comprehensive heart failure treatment value to hospitals under cost-cutting pressure 29

30 Conclusion and Questions 30

31 Brian Williams, Global Healthcare Strategy +1 (317) BACKGROUND As a member of 's Global Healthcare Strategy team, Brian advises healthcare executives on strategy, innovation and corporate and entrepreneurial ventures. He has nearly twenty years of investment, business development and strategy expertise within health care. Brian s work at provides senior executives with insights on market entry strategies, business model innovation and mhealth and ehealth strategy development and implementation Prior to joining, Brian served as an executive for two health care firms, including one early stage company where he quadrupled revenues in three years, leading to a sale of the company returning 10x invested capital. Brian also drove industry acceptance and market growth of a venture backed, Silicon Valley based SaaS deployed pharmaceutical data management and performance analytics firm. Prior to these management roles, he spent a decade as an investor and entrepreneur. As an investor, Brian co-founded two top decile performing private equity funds as ranked by 's MoneyTree report, whose investments included devices and diagnostics. Prior to his business ventures, Brian served as a speechwriter to a former two-term Governor of Indiana. INDUSTRY FOCUS Brian works within the life sciences industry for medical device and bio-pharmaceutical companies, as well as new entrants to healthcare where he provides senior executives with insights on: Entry strategies for new markets, adjacencies or new geographic territories Business model innovation that supports access to care, higher adherence rates or improved outcomes mhealth and ehealth strategy development and implementation PUBLICATIONS Co-author, The New Gold Rush, non-traditional entrants to healthcare Co-author, Owning the Disease, InVivo, December 2011, new business models in healthcare Co-author, Owning the Disease, Strategy and Tactics, InVivo, April 2013 Contributor, Medtech Innovation Scorecard: The race for global leadership Contributor, Medtech Innovation Scorecard; The imperative for innovation Contributor, Global Healthcare Heatlhcare M&A, trends and analysis

32 leads the industry in defining the issues affecting all facets of the healthcare industry A sample of our Healthcare Thought Leadership Owning the Disease: Adapting strategy into successful business tactics IN VIVO Magazine, April 2013 Owning the Disease: A new business model IN VIVO Magazine, December 2011 Medical Technology Innovation Scorecard: The race for global leadership Top health industry issues of 2013 Build and Beyond: The (r)evolution of healthcare PPPs Workplace wellness in Australia Personalized medicine You get what you pay for Biotech reinvented: Where do you go from here? Emerging Trends in Chinese Healthcare Behind the numbers: Medical cost trends 2013 Health Reform: Prospering in a postreform world To download any of the above reports, please go to: 32

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