1. Choosing the Licensing Strategy for Every Stage of Drug Development
Dr. Brian W Tempest
EU Pharma Law- Geneva Switzerland
5 November 2008

3. Licensing Deals

4. Asia 2040

5. Indian & Chinese Strategies

6. The Possible Use of India & Asia in R&D
Early discovery leads from USA, Europe or Singapore
Molecular optimisation from India
Toxicology from China, Central Europe, Singapore
Electronic Data Capture India
API Manufacture India
Drug Formulation Manufacture India, USA
Phase 1 Clinical Trials Europe
Phase 2,3 heavy use of India
Corporate back office India

7. Speed of Clinical Trials in India
EU India
Patients
Sites
Time m 18m
Neck Cancer CT
In 2007 Pfizer carried out 44 CTs at 143 sites in India involving 1800 patients in oncology, infectious diseases, CVS, psychiatry, respiratory and metabolic diseases . On par with China.
Source Dr Mattina President R&D
No. of USA investigators:
26, ,000
300 patients, 30 sites
$5.6m EU/USA vs. $ 1.8m plus
30% faster at $800K per day savings
Sources: CT Outsourcing Conference, 24th July 2007, Mumbai

8. Electronic Data Capture in India
Accuracy
GSK Staff
- 2.2m Clinical Data sheets
Trials
- No data security issues
- Error rate <0.01 / 100k
Source: BCG report “Looking Eastward, Sept’2006”
% Trials in EDC
25% %
Savings
Paper EDC
$2.8m $ 0.5m
2004 data
Sources: CT Outsourcing Conference,
24th July 2007, Mumbai

9. Cost of Goods in India

10. M&A Deal Multiples

11. M&A impact on Innovation

12. Thank You