PsicoMedica: Leading Clinical Research and Services

1. PsicoMedicaResearch Group Institutional Presentation Sergio Gloger M.D. sergio.gloger@psicomedica.cl www.psicomedica.cl November 2007

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 through specialized programs • To provide continuing education for professionals, patients and the public in general November 2007

3. Research Activities International Multicenter Clinical Trials • 43+ studies since 1999 (extension studies not included) • Sponsors • Astra-Zeneca, Bial, GSK, Forest, Johnson & Johnson, Lilly, Merck (MSD), Novartis, Pfizer, Sanofi-Aventis, Servier, Solvay, Wyeth • CROs • Covance, ICON, Quintiles, PPD, PRA, Parexel • Central Labs • Biomedical Systems, Covance, MRL, CRL, Quest Diagnostics, Quintiles November 2007

4. Research Activities by DiagnosisPhase II, III and IV • Alzheimer Disease: mild to moderate and severe • Bipolar Disorder: acute, mixed and depressed • Borderline Personality Disorder • Epilepsia • General Anxiety Disorder • Insomnia • Major Depressive Disorder • Multiple Sclerosis • Panic Disorder • Parkinson Disease • Post Traumatic Stress Disorder • Social Anxiety Disorder November 2007

5. Research Activities According to phase November 2007

6. Research Activities according to Phase and Diagnosis

7. Research Activities Example Major Depressive Disorder Simultaneous Protocols 2003-2004* *Extension studies not included **Recruitment ended prematurely by the sponsor November 2007

8. 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 November 2007

9. Professional Staff November 2007

10. Headquarters • 300+ 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 • Twelve consultation offices • Independent research and administrative areas • Fully equipped laboratory procedures room • Independent drug and CRF storage facilities: temperature and access controlled • Access to a clinically integrated 16 bed in-patient clinic November 2007

11. Recruitment Strategies • General and specific strategies according to study characteristics • Access to a high number of patients consulting in PsicoMedica (250+ new patients and 2500+ visits per month by November 2007) • Patient visits expected to increase in the near future • Easy access to own database (over 9000 files by November 2007) • All medical staff involved in research allows in-house referrals • Medical staff working in other institutions allows network referrals November 2007

12. 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 for an appointment • The above strategies allowed in the past 22% excess recruitment over contract November 2007

13. 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 November 2007

14. 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 six separate studies November 2007

15. 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 November 2007

16. Summary • PsicoMedica has successfully carried- out 38 phase II and III, and two phase IV, international multicenter clinical trials, involving hundreds of patients in 12 different medical conditions • PsicoMedica has been successfully audited in six different studies November 2007

17. Summary • PsicoMedica is in a privileged position for expanding its research activities do to its organizational structure, management strategies and qualified human resources November 2007

18. 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 November 2007

19. 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 November 2007