1

How Startups Are Using Informatics

for Creating Innovation

2

Remarks

• Addressing you as a ‘user’ of informatics, not as a

data scientist

• Will highlight needs/’drivers’, types of

data/information, structure and analysis and the

tools we use

3

Seventh Sense BioSystems ‘Snapshot’

• VC funded medical technology company

• Devices that enable diagnostics to be performed wherever needed

• Blocking IP

• Large established & growing markets

• Enabling platform technology

Nanoparticle Technology

May’09

Integrated TAP Design

Apr’11

4

What Makes VC Backed Device

Company Like 7SBio Different

Investors: Short Window to Invest and Create a Huge Exit

‘Drives’ much of what’s needed and resourced

Partners & Potential Acquirers: Go Big or Go Home - Show

value of technology in potential partner’s hands

The Challenge: Leverage informatics to meet these needs but

not be paralyzed or handcuffed

5

Supporting Product & Business

Development and Commercialization

>50 Data Sources

Market Research

Clinical Advisory

Board

Subject Matter

Experts

+ = Decision

Support (ie.

Monitoring and

predictive)

Strategic Analysis

6

Segments of Information

Product Development & Innovation

• Pre-clinical info

• Competitive intelligence

• Procedure data • User Requirements

Operational

• Manufacturing and supply chain metrics and planning

Financial

• Planning and modeling

• Trends

• M&A

Clinical

• Disease trends

• Technology trends

• Evidence

• Clinical studies

• Outcomes research

• Reimbursment

>50 Government and Independent Data Sources

Modeling, Planning and Reporting

7

Market Analysis Government

1. SEC &

2. Medicare part B physician / supplier national data CY 2011 - Top 100 lab procedures

3. Healthcare Cost and Utilization Project (HCUP) http://hcupnet.ahrq.gov/

4. CDC Stats 2008 - Chronic Liver Disease and Cirrhosis

5. CDC Reports – CLIA Update - http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0311/Addendum_E_WALSH.pdf

Independent Research, Reports & Associations

6. Analysis performed by outside Market Research firm

7. Frost & Sullivan - U.S. POC Market Report 2009

8. Mintel Survey - Home Diagnostics 2010

9. IMS Health Presentation - The Global Use of Medicines: Outlook Through 2016

10. Investor Reports from key industry players (Becton Dickinson, Alere, Siemens, Roche, JNJ, Axis Shield [now Alere])

11. The National Ambulatory Medical Care Survey (2012)

12. National Health and Nutrition Examination Survey (nhanes 2009)

13. Laboratory Medicine: A National Status Report 2007

14. Global Industry Analysts Report 2008

15. Organ Procurement and Transplantation Network

16. SEER Data, 1973-2010

17. Burden of liver disease in the United States: Summary of a workshop

18. 2005 Clinical Chemistry Report - http://www.clinchem.org/cgi/content/full/51/3/483

19. CEO of IncellDx estimates U.S. market between $300 M - $400 M and World Market $2 B -

http://www.genomeweb.com/dxpgx/incelldx-advancing-toward-filing-fda-clearance-hpv-test

20. Director of Laboratories - HPV Market $500 M, 6.2 M new cases -

http://www.aacc.org/events/expert_access/2009/may/Documents/May2009ExpertAccess.pdf”

21. GenProbe Presentation - biotechnology.georgetown.edu/509%20Powerpoints/GenProbe.pdf

22. Bayer & Roche Presentations (2008)

8

Market Analysis

1. ADA Data http://www.diabetes.org/

2. Consumer Genetics Presentation http://www.amerturk.com/consumergenetics/data/slide.pdf

3. Forbes Article http://www.forbes.com/2008/10/29/cholesterol-pharmacuticals-statins-biz-cx_mh_1030cholesterol.html

4. Pharmaceutic Research and Manufacturers of America, PhRMA Annual Membership Survey 2013

5. Tufts Center for the Study of Drug Development Reports

6. K.A. Getz, et al., Variability of Protocol Design Complexity by Phase & THerapeutic Area.

7. Article: Clinical Trials costs are rising rapidly- http://www.pharmalive.com/clinical-trial-costs-are-rising-rapidly

8. Analysis Group: "Innovation in the Biopharmaceutical Pipeline: A Multidiemnisonal View" Boston MA 2013

9. Center for Information and Study on Clinical Research Participation (CISCRP) - https://www.ciscrp.org/

10. Medicare Report - The National Market for Medicare Clinical Laboratory Testing: Implications for Payment Reform

11. Chembio Investor Presentation 2010

12. Coagusense article http://www.forbes.com/feeds/businesswire/2010/06/01/businesswire140489735.html

13. New scripts for statins - 800,000/yr in 2004 http://www.smartmoney.com/investing/economy/the-state-of-statins-15936/

14. Bayer Presentation http://www.viva.vita.bayerhealthcare.com/fileadmin/user_upload/Presentation_Parotelli.pdf

15. Update to Reimbursement Rates for Clinical Laboratory Procedure Codes Will Change on April 1, 2010

https://www.tmhp.com/Homepage%20File%20Library/Update%20to%20Clinical%20Lab%20Reimbursement.pdf

16. GenProbe http://phx.corporate-

ir.net/External.File?item=UGFyZW50SUQ9NTEzNDR8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1

17. AHA Website http://www.americanheart.org/presenter.jhtml?identifier=4478

18. "Presentation given by Denise L. Uettwiller-Geiger, PhD

9

Financial Analysis

1. The National Ambulatory Medical Care Survey (2012)

2. Laboratory Medicine: A National Status Report 2007

3. SI, JNJ, RHHBY, ALR Other Diagnostic Companies http://www.wikiwealth.com/

4. SI, JNJ, RHHBY, ALR Other Diagnostic Companies

https://www.google.com/finance

5. Analyst reports

6. Investor call transcripts (Motley Fool)

7. Mulit-country physician survey data (2011)

8. US consumer survey data (2011)

9. Discussion with Industry Insiders

10

Product Development

1. Qualitative interviews with numerous

stakeholders (lab managers, physicians, end

users, etc)

2. Internet survey research (physicians, diabetics,

mothers, etc)

3. User focus groups

4. Discussion with internal advisors (technical,

clinical & market)

5. Bench & clinical testing results

11

Integrated Models for Planning,

Tracking, BizDev and Commercialization

Product

Launch

Global market &

segment potential

Product

unit/pricing

projections by

Partner

FTE expense

plans

Product

unit/pricing

projections

P&L by quarter

P&L Scenario

Planning &

Ratios

Graphs

COGS

CAPEX

12

In Closing….

“Never let the facts get in the way of a good story” Mark Twain