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Tel Aviv Sourasky Medical Center (TASMC)

Tel Aviv Sourasky Medical Center (TASMC). Research and Development Division. Overview Tel Aviv Medical Center. 1000-Bed Capacity University-affiliated Serves a population of over 400,000 people All modern medical specialties State-of-the-art equipment

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Tel Aviv Sourasky Medical Center (TASMC)

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  1. Tel Aviv Sourasky Medical Center (TASMC) Research and Development Division

  2. Overview Tel Aviv Medical Center 1000-Bed Capacity University-affiliated Serves a population of over 400,000 people All modern medical specialties State-of-the-art equipment Extensively involved in medical research

  3. Capabilities All phases of clinical trials Basic research

  4. Capabilities…… Clinical Research Phase I Trials Phase IIa Trials Phase II Trials Phase III Trials TASMC Early Phase Research Center (EPRC) TASMC Clinical Trials Network Services (CTNS) EPRC EPRC

  5. EPRC Description • Established in 1997 • Operating under strict GCP standards • Phase I, Phase IIa and bioequivalence studies • Dedicated staff • Staff trained under GCP standards • Over 2000 healthy volunteer pool

  6. EPRC Layout • A 28-bed pharmacokinetic unit • Lab facility for processing biological samples • Ambulatory treatment facilities & office services for volunteers

  7. » Inflammatory conditions » Lipid metabolism » Oncology » Psychiatry » Pulmonology » Topical drug administration » Vaccines EPRC Experience Over 250 studies related to the following clinical areas: » Allergy » Bone metabolism » Cardiovascular » Central nervous system » Diabetes » Gastrointestinal » Urology » Infectious diseases

  8. EPRC Expertise • Study design, protocol development and conducting clinical trials • Flexibility in meeting individual client’s requirements • Competitive costs

  9. EPRC Location Within a Large Hospital Advantages • Provision of central services for EPRC maintenance: - Disposal of bio-hazard material - 24-hour freezer central alarm system - Power failure backup • Additional medical staff (available for study purposes) Physicians, nurses, lab technicians, others • Safety backup ICCU, crash team • Hospital pharmacy services • Clinical laboratories services • High standard auxiliary tests - Imaging - Pulmonary function tests - Psychiatric assessment

  10. EPRC Location Within a Large Hospital Advantages • Protocol approved through hospital’s IRB • Joint projects with various hospital departments - Oncology - Infectious diseases - Neurology - Cardiology - Gastroenterology - Psychiatry - Pulmonology - Intensive care • Phase IIa studies more accessible • Rapid recruitment of hospitalized and ambulatory patients through the hospital’s Clinical Trials Network Services • Public opinion more favorable to clinical trials carried out in the premises of a major hospital

  11. EPRC Location Within a Large Hospital

  12. EPRC Joint Operations • Central laboratories for safety screens • GLP bioanalytical laboratories • CROs for data management and monitoring on behalf of the Sponsor • Other medical institutes for recruitment of additional patients The EPRC operates in liaison with other bodies, local and international, according to the Sponsor’s requirements:

  13. EPRC Additional Services • Conducts bioequivalence, Phase I and Phase IIa trials as a subcontractor for CROs • Liaises between potential clients and CROs in matters concerning monitoring, data management, etc. • Participates in large scale studies in which the involvement of a dedicated clinical pharmacology unit is required (e.g., a PK drug-interaction sub-study) The EPRC also:

  14. EPRC Key Personnel Jacob Atsmon, M.D. graduated the Tel-Aviv University Sackler School of Medicine, specialized in Internal Medicine in Israel and Clinical Pharmacology at Vanderbilt University, USA. Since 1997 he has served as the Director of the EPRC and the Head of the Hospital's Clinical Pharmacology Unit. Dr. Atsmon is regarded as one of the leading experts in Israel in conducting early-phase clinical trials and has gained vast experience in this area. Dagiel Dagan, D.M.D, M.B.A, a graduate of Swiss and Israeli universities, is currently the Business Development Consultant of the EPRC, and has gained extensive experience in clinical development, marketing and sales in the areas of medical devices pharmaceuticals, and neutraceuticals. He served in executive positions with European and Israeli medical companies. Mrs. Kirsten Yakira Haim, RN.,B.S. studied in the United States and acquired extensive experience in nursing both in an emergency department and a cardiovascular telemetry monitored unit. She has acquired unique experience in managing clinical trials under GCP standards and is one of the first nurses in Israel to manage a dedicated clinical research center.

  15. EPRC Strategic Objectives EPRC is looking for strategic partners to form alliances with pharmaceutical and biotechnological companies as well as with CROs, to create long-range cooperation and key account relationships.

  16. EPRC Contact Information Tel Aviv Sourasky Medical Center Clinical Research Center 6 Weizmann St. Tel-Aviv 64239, Isreal Tel: +972-3-6974875, Fax: +972-3-6973935 E-mail:dagield@tasmc.health.gov.il www.tasmc.org.il

  17. EPRC hank ou

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