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

3. June 2005 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

4. June 2005 Research Activities DIAGNOSIS STUDIES N o PATIENTS Randomized/Assigned to site Major depressive Disorder*7147 / 132 Bipolar Disorder (Acute/mixed mania) 122 /20 Bipolar disorder (Acute mania)*13 / 8 Post Traumatic Stress Disorder18 /8 Panic Disorder130 / 24 Borderline Personality Disorder19 / 6 Alzheimer Disease238 / 18 Schizophrenia143 / 30 Total15**300 *** / 246 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% DROP-OUT RATE: 18%

5. June 2005 Research Activities Table 2. Major Depressive Disorder Simultaneous Protocols 2003-2004* *Extension studies not included **Recruitment ended prematurely by the sponsor Study Recruitment Period (months) Screened Patients Screen Failures N o (%) MDD 1 1447 3,4 patients p/month 6 (12.7) MDD 2 941 4,5 patients p/month 5 (12.1) MDD 3 **1,511 7,3 patients p/month 3 (27.2) Total1599 6,6 patients p/month 14 %

6. June 2005 Academic Research Activities 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

7. June 2005 Professional Staff StaffNumber Psychiatrists adult child and adolescent 8484 Neurologists adult child and adolescent 4242 Nutriologist1 Study Coordinators (registered nurses)3 Nurse technician1 Psychologists adult child and adolescent 9292 Occupational Therapist2 Phonoaudiologist1 Administrative3

8. June 2005 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

9. June 2005 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

10. June 2005 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

11. June 2005 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

12. June 2005 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

13. June 2005 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

14. June 2005 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

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

16. June 2005 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

17. June 2005 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