My presentation on 21 SP's Genetic-based Clinical Decision Support System given in September 2012 and May 2013 in San Francisco at two health technology meetings.

1. Jeff Shomaker
Founder and President
5-9-13
Proprietary & Confidential
21 SP, Inc.
Better Dosing = Better Outcomes
Warfarin Example

2. 21 SP, Inc.
INR Levels and Serious Adverse Events
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RR = Relative Risk compared to INR Range of 2-3. For oral anticoagulation therapy, excluding antiplateletes, for all indications
(eg, AF, MI, Heart Valves, etc.). Thromboembolisms = strokes, MI, or systemic emboli. Hemorrhages = events requiring
hospitalization, blood transfusion, or surgery.
Source: Oake, N, et al (2008 Jul 29). Anticoagulation intensity and outcomes among patients prescribed oral anticoagulant
therapy: a systematic review and meta analysis. CMAJ, 179(3): 235-244.
Key: Patients are always safer when INR = 2-3. If INR < 2, increased risk
of disability and death. If INR > 3, increased risk of disability and death.

3. 21 SP, Inc. 3
Pharmacogenomics (PhGx) and Warfarin
• PhGx: how genes influence response to drugs
• Warfarin a good example 1), 2):
– Atrial fibrillation increases stoke risk 4 – 5x
– Warfarin reduces this risk by 2/3
– 2MM US patients start Warfarin each year
– However, during first 6 months, serious adverse events are high
– Proper dosing is critical
– Patient’s genetic makeup key determinant of proper dose
• 21 SP provides MDs a tool, which is patent pending, for
dosing based on PhGx
(1) Kitzmiller JP, et al (2011 Apr). Pharmacogenomic Testing: Relevance in Clinical Practice. Cleveland Clinic J of Medicine,
78(4): 243-257 and (2) Melamed OC, et al (2011 Mar). Quality of Anticoagulation Control Among Patients With Atrial Fibrillation.
American J Managed Care, 17(3): 232-237.

4. 21 SP, Inc.
21 SP’s First Product Demo
• A clinical DSS to improve warfarin dosing
• Demo w/ David Ewing Duncan’s genetics
Author of Experimental Man:
What one man's body reveals
about his future, your health,
and our toxic world (2009:
John Wiley & Sons)
• David E. Duncan’s proper dose = 2.5 mg/day (1/3 of
standard dose of 7.5 mg/day)
• Standard dose = overdose and increased bleeding risk
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5. 21 SP, Inc. 5
PhGx saves lives. 21 SP puts PhGx in MDs’ hands
• PhGx-based dosing “… highly superior to standard dosing
in the comparative effectiveness study in achieving and
maintaining therapeutic INRs, a well-validated measure of
clinical effectiveness and safety, and in reducing bleeding
and thromboembolic events and death.” 1)
• 21 SP enables MDs to use PhGx at bedside
• 21 SP’s app including associated mobile access to
validated research, will increase role of PhGx in dosing
• Patient outcomes will improve
(1) Anderson, JL, et al (2012 Mar 16). Randomized and Clinical Effectiveness Trial Comparing Two Pharmacogenetic Algorithms
and Standard Care for Individualizing Warfarin Dosing: CoumaGen-II. Circulation, CIRCULATIONAHA. 111.070920. Online
ahead of print.

6. 21 SP, Inc. 6
21 SP Contact Information
• 21 SP in located in the SF Bay area and its
website is at www.21spinc.com
• Please contact Jeff Shomaker, the founder and
president, at jshomaker@21spinc.com or 650-346-
9890 for further information.