1. 1 Key note session at Bangalore India BIO on Actualizing Potential of Clinical Trials June 4 th 2010 D A Prasanna Founder & Vice Chairman Ecron Acunova AsiaEuropeAmericas Accelerating Pharma time-to-market, cost effectively

2. introduction 2 EA combines domain knowledge, patient access & financial strength Manipal GroupAcuNova Life SciencesWorld’s largest healthcare fund Leveraging India, Central & Eastern Europe for speed & cost Highlights Recruited 17,000+ patients last 5 years Full service I-IV, CDM, Central Lab, PK/PD Oncology, CV, Metabolic, Respiratory Lead in stem cell & diagnostic agent trails Studies found compliant by US FDA, HC, WHO, DCGI etc. Ranks amongst top 3 Indian Clinical Research Organization for Quality, Revenue and Reputation

3. India in Clinical trial so far… 3 India is engaged in clinical research for the last 15 years. Starting with size of population English in communication disease burden naïve patient advantage western medical education We have coveted a position of interest in the minds of clinical development community. Yet India’s share has not become significant. What are some steps required to get a higher leverage of our potential?

4. 4 Clinical Trial India‘s relative position IN 1232 PO 1714 30th November 2009, clinicaltrials.gov No of sites 08 ROW (w/o US) DE782516,9% FR604713,1% UK37628,1% ES35507,7% IT33007,1% JP27075,9% PL23285,0% RU22774,9% AUS19524,2% BE19004,1% NL16503,6% SW14403,1% HU13262,9% CZ13112,8% AR13102,8% IN12562,7% BR12562,7% AT10002,2% No of registered clinical trials

5. 5 Foreign data acceptance by US, EU FDA’s acceptance of foreign clinical trial data: GCP compliance Investigators of recognized competence Valid Scientific evidence Applicable to US population / medical practice ICH E5 and 21 CFR 312.120 articulate the principles

6. Therapy area competence 6 Special experiences and knowledge in clinical studies in oncology field:  Special in- and exclusion criteria, histological results  TNM Staging (Tumor, Lymph nodes, Metastasis)  Special physical examinations, e.g. ECOG / Karnofsky-Index  Tumor evaluation (RECIST)  Cooperation with radiologists  Preparation of infusion  Cooperation with pharmacists  Evaluation of laboratory results that are specially influenced by chemotherapy (hematological values)  Assessment of special tumor markers  Side effects of chemotherapy / new chemotherapies  Side effects with other medication  AEs of special interests (drug related)  SD check  Special documentation of source data Expertise contributes to data quality

7. Graduate from Ph III 7 Early years: Registration trials Ph IV Last decade: Ph III global trials This decade: Add Ph Ib to Ph II Early development for top 20 Pharma calls for new Competency PK/PD studies (insulin clamp study for eg) cadre of drug safety specialists. Sites with safety preparedness Doing a Ph II improves likelihood of Ph III

8. Breadth of expertise 8 In a therapy area, research breadth from drug delivery devices Co-morbidity nutritional research life style management Devices Helps to leverage same sites and bring perspectives

9. Qualify & support infrastructure A. Conventional infrastructure –Trained investigators –Accredited study coordinators –Investigator networks B. Special infrastructure –Drug labeling in stem cells –Stem cell EC –Core lab in spirometry for respiratory –Special biomarker testing –Trials involving PET agent with less than one day half life –Blinded readers 9 Building an ecosystem and qualifying improves quality

10. Credible regulatory bodies Investigator meeting coming under MCI scanner for inducement of Physicians Ph IV trials seeding a new variant or collection of new scientific data? Requirement of clinical trial a qualitative trade barrier? DCGI ‘s collaboration with US FDA and Health Canada is a great step 10

11. From National to Regional CRO Last decade National expert CRO’s in demand This decade many sponsors are reducing number of service providers Service providers also need to align –Regional or transnational –Follow disease burden map in geography expansion! 11 As a country we can participate in larger programs

12. In summary Foreign patient inclusion – understand to get the right trial to India Build therapy area competence in CRO’s Extend to early development studies Cover the breadth of a therapy area & leverage sites Build an eco system for clinical trials Credibility of regulatory bodies Align with changing sourcing strategy of sponsors 12

13. Thanks Ecron Acunova team in educating me for this talk India BIO for the platform Attendees for your attention 13

14. Contact us www.ecronacunova.com www.ecronacunova.com We accelerate Pharma time-to-market cost effectively ASIAEUROPEAMERICAS SJR I Park, Mobius EPIP, Whitefield Bangalore – 560 066 India bd.asia@ecronacunova.com +91 80 6691 5725 Hahnstrasse 70 D-60528 Frankfurt Germany bd.europe@ecronacunova.com +49 69 6680300 502 Carnegie Center Suite # 100 Princeton NJ 08540, USA bd.americas@ecronacunova.com +1 973 396 2742 Full Service CRO 20+ Y E A R S Track Record