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Key note session at Bangalore India BIO on

Actualizing Potential of Clinical TrialsJune 4th 2010

D A PrasannaFounder & Vice Chairman Ecron Acunova

Asia Europe Americas

Accelerating Pharma time-to-market, cost effectively

introduction

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EA combines domain knowledge, patient access & financial strength

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 forQuality, Revenue and Reputation

India in Clinical trial so far…

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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?

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Clinical Trial India‘s relative position

IN 1232PO 1714

30th November 2009, clinicaltrials.gov

No of sites 08 ROW (w/o US)DE 7825 16,9%

FR 6047 13,1%

UK 3762 8,1%

ES 3550 7,7%

IT 3300 7,1%

JP 2707 5,9%

PL 2328 5,0%

RU 2277 4,9%

AUS 1952 4,2%

BE 1900 4,1%

NL 1650 3,6%

SW 1440 3,1%

HU 1326 2,9%

CZ 1311 2,8%

AR 1310 2,8%

IN 1256 2,7%

BR 1256 2,7%

AT 1000 2,2%No of registered clinical trials

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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

Therapy area competence

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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

Graduate from Ph III

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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

Breadth of expertise

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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

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

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Building an ecosystem and qualifying improves quality

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

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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!

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As a country we can participate in larger programs

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

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Thanks

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

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Contact us www.ecronacunova.com We accelerate Pharma time-to-market cost effectively

ASIA EUROPE AMERICAS

SJR I Park, Mobius EPIP, Whitefield Bangalore – 560 066India

bd.asia@ecronacunova.com

+91 80 6691 5725

Hahnstrasse 70D-60528 FrankfurtGermany

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 ServiceCRO

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