Research collaboration in CF

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Research collaboration in CF Center for Cystic Fibrosis, University Children’s Clinic, Skopje R.Macedonia (Prof. Stojka Fustik)

Research collaboration in CF - our experiences in the past Research on cystic fibrosis in Macedonia (US-funded project, Principal Investigator Prof. G. Efremov, 1990-94) Genetic Modifiers in Cystic Fibrosis Liver Disease (international research project, Principal Investigator Dr. Michael Knowles) Clinical and Functional Translation of CFTR (CFTR2) project (Project Director Dr. Garry Cutting, Dr. Carlo Castellani)

Clinical studies Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (Arikace™), in Cystic Fibrosis Patients with Chronic Infections due to Pseudomonas Aeruginosa - main study (international multicenter clinical study, Principal Investigator for Macedonia Prof. Dr. S.Fustik) Safety and Tolerability Study of Single Dose Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients with Chronic Infections of Pseudomonas Аeruginosa - open-label extension sdudy (international multicenter clinical study, Principal Investigator for Macedonia Prof. Dr. S.Fustik)

Problems and Perspectives The legal regulations regarding the clinical studies (from 2012) discouraged some Clinical Research Organizations (CRO) to cooperate with partners from Macedonia in the research In the time of the previous government, Macedonia was defined as a captive state - some CRO were privileged We now have a much more democratic and open cooperative government, and we believe that more CROs will come back to Macedonia to do research studies