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