PsicoMedica Research Group

1. PsicoMedicaResearch Group Institutional Presentation Sergio Gloger M.D. sergio.gloger@psicomedica.cl www.psicomedica.com June 2005 June 2005

2. Mission • To perform research activities based on GCP/ICH and fulfilling FDA/EMEA/local regulations standards • To provide clinical services for the general public trough specialized programs • To provide continuing education for professionals, patients and the public in general June 2005

3. Research Activities International Multicenter Clinical Trials • 15 studies since 1999 (extension studies not included) • Sponsors • Servier, Johnson & Johnson , Astra-Zeneca, Wyeth, Merck (MSD), Pfizer, Novartis, Lilly, Sanofi-Aventis • CROs • Covance, Quintiles, PPD, ICON • Central Labs • Covance, MRL, Biomedical Systems, Quest Diagnostics June 2005

4. Table 1. Protocols by diagnosis, 1999 to June 2005 *Recruitment ended prematurely by the sponsor in one MDD and one BD study **Extension studies not included ***Actual recruitment 22% over assigned number of patients to the site DROP-OUT RATE: 18% Research Activities June 2005

5. Research Activities Table 2. Major Depressive Disorder Simultaneous Protocols 2003-2004* *Extension studies not included **Recruitment ended prematurely by the sponsor June 2005

6. Academic Research Activities (current) • Identification of peripheral resistance to thyroid hormone in a refractory to treatment mood disorder population • The use of the Refetoff Protocol (progressive high doses of T3) to revert refractory to treatment mood disorder patients • Validation of a screening depression rating scale in Parkinson disease and other medical illnesses June 2005

7. Professional Staff June 2005

8. Headquarters • 280 square meter facility • Medical neighborhood • Easy access and parking • Facilities specially designed for clinical protocols • Fax and photocopy machines available • Broad-band internet access • Comfortable waiting room • Specific areas for monitor visits • Eleven consultation offices • Independent research and administrative areas • Fully equipped laboratory procedures room • Independent drug and CRF storage facility: temperature and access controlled • Access to a clinically integrated 16 bed in-patient clinic June 2005

9. Recruitment Strategies • General and specific strategies according to study characteristics • Access to a high number of patients consulting in PsicoMedica (100 new patients and 750 visits per month by June 2005) • Patient visits expected to increase in the near future • Easy access to own database (over 2500 files by june 2005) • All medical staff involved in research allows in-house referrals • Medical staff working in other institutions allows network referrals June 2005

10. Recruitment Strategies • Staff involved in educational activities in diverse settings, such as universities, academic meetings, schools and the general public • Frequent media interviews for educational purposes increases consultation (no need to promote trials favors recruiting “non-biased” patients) • Waiting rooms check-list leaflets and other educational materials for identification of pathologies • Telephone screening interviews are offered for those who call to PsicoMedica and do not reserve an appointment • The above strategies allowed in the past 22% excess recruitment over contract June 2005

11. Quality of work • Strict GCP/ICH based procedures (i.e. Informed Consent process) • PI available and involved in study procedures • Full-time trained study coordinator (R.N.) • Back-up study coordinators (R.N.) • Experienced and work stable co-investigators staff • Same investigator/rater in charge of the patient along the study • Main rating scales administered solely by physicians June 2005

12. Quality of work • Structured patient records and other source documents properly stored • Routine registration of pre-screened subjects not complying with entry criteria • Rating scales used in routine clinical work • Regulatory procedures and data handling are accurate and fast processed • IRB “Comité Etico Científico - Servicio de Salud Metropolitano Oriente” does a good quality work with a fairly brief response time (average 3-4 weeks ) • Site has been successfully audited by sponsors and CROs Quality Control Division in four separate studies June 2005

13. Summary • PsicoMedica is an institution devoted primarily to medical research and clinical trials • Neuroscience has been our main research focus and we are actively looking forward to be involved in additional medical areas June 2005

14. Summary • PsicoMedica has successfully carried- out 13 phase II and III, and two phase IV, international multicenter clinical trials, involving 300 patients in 8 different medical conditions • PsicoMedica has been successfully audited in four different studies June 2005

15. Summary • PsicoMedica is in a privileged position for expanding its research activities do to its organizational structure, management strategies and qualified human resources June 2005

16. Summary Chile is a privileged place to carry-out clinical trials considering the following : • Access to an educated patient population willing to volunteer for medical trials • Very low rate geographical mobility • Generally no need to advertise for recruitment • Well trained medical and nurse professionals June 2005

17. Summary • Tradition in academic research • Critical research activities performed by physicians • High standards in communication and technological facilities • Honesty and probity are attitudes toward work deeply rooted in Chilean society • Economic and political stability June 2005