MANAGING CLINICAL TRIALS OUTSIDE OF THE US John Potthoff, PhD President & CEO

Theorem Clinical Research Global, full-service CRO employees Planning and execution of clinical trials and regulatory applications Focused business units: Medical Device and Diagnostics BioPharmaceutical Development Clinical Analytics Coverage of 44 countries Page 2

Why conduct trials outside of the US? Page 3 Gain registration in target company Support a global development effort Complex or rare diseases; incident rates may not be high enough in the US to enroll a trial Timelines for registration may be faster outside of the US to allow a company to begin sales while completing registration in the US Costs may be reduced for registration outside of the US Competitive landscape may be advantageous outside the US

Where are trials conducted? Page 4 Data as of 02 December 2012

Actively Recruiting Studies Non-U.S. Only (49%) U.S. Only (45%) Both U.S. & Non-U.S. (7%) Location Number of Recruiting Studies and Percentage of Total Non-U.S. Only14,193 (49%) U.S. Only13,010 (45%) Both U.S. & Non-U.S.1,898 (7%) Total29,101 (Data as of December 02, 2012) Page 5

Focus on Asia Pacific Page 6 Aging Population Increasing Life Expectancy Increasing Incidence of Major Disease Increasing Health Consciousness Higher Disposable Income Over 30% of new expenditures on healthcare worldwide are attributable to Asia.

Why Asia for Clinical trials? Page 7 Money Cost of clinical trials in Asia is much lower than in US/EU (30-50%) Time Start-up timelines have become more favorable (other than China) and are 4-6 months covering all applications, site selection, contract negotiations, etc. Resources Population exceeds 4 billion and is genetically diverse High incidence of some indications: Diabetes Mellitus (> 11%), Hepatitis B, etc. Ability to recruit patient naïve and advanced case patients Seasonality Southeast Asia: Advantage for seasonal indications (e.g. influenza)

Regulatory Authorities in Asia Pacific CountryAuthority ChinaSFDA Hong KongDoH AustraliaTGA IndiaDCGI JapanMHLW KoreaKFDA MalaysiaMoH New ZealandMedsafe PhilippinesBFAD SingaporeHSA & AVA TaiwanDoH Page 8

Asia Regulatory and Start-up Timelines *Note: China not to scale Complicated and risk of delays Page 9

Data Collection in Asia Pacific Page 10 Data Collection Most Trials conducted in accordance with global regulatory guidelines* Virtually all sites conduct clinical research in English Virtually all sites can work in electronic data capture (EDC) systems Most of the leading EDC tools now allow for multi-language data processing, allowing sites to add comments in their local language** *Some local trials conducted according to local minimal guidelines **Requires ability of CRO to process data in local languages

Focus on China and India Page 11 *1.3 billion people *537 active trials in oncology (cancer) *102 active medical device trials *1.2 billion people *124 active trials in oncology (cancer) *27 active medical device trials China India

Drug Controller General of India (DCGI) Page 12 Currently politicizing on policy issues relating to compensation for injury to or death of a participant in a clinical trial Currently left to the discretion of the Ethics Committee Indication under investigation/cause of injury or death may not be considered Example: Oncology trials often have survival as the outcome measure Unable to conduct first-in- man trials in India Only may conduct trials in India if registration in India is the goal

Conclusions Conducting clinical trials outside of the US is a necessary part of reaching a global audience Conducting clinical trials outside of the US can be highly complex without local knowledge and experience Several advantages to conducting trials outside of US: Registration in multiple regions Access to specific patient populations Strategy to seek registration in cost advantaged locations Page 13

John Potthoff, PhD President & CEO