{"id":null,"code":"DRUG0012","name":{"valueFi":"Drug Development Learning Project","valueEn":"Drug Development Learning Project","valueSv":"Drug Development Learning Project"},"credits":10.0,"minCredits":10,"maxCredits":10,"tags":[],"createdAt":1790534698004,"contentList":[{"title":{"valueFi":"Osaamistavoitteet","valueEn":"Learning outcomes","valueSv":""},"content":{"valueFi":"On this course students apply all aspects of drug development they have learned in a virtual drug discovery and development project. Students use their drug development project skills and knowledge starting from an evaluation of the biological target and its possible involvement in the pathophysiology of a disease to design a full development program of a drug molecule. Students improve their expert communication, presentation skills and peer feedback as well as justification of their decisions to a sponsor in simulated steering meetings. This course has the focus on working life skills, professional life relevance and creative problem solving individually and as a member of a team.","valueEn":"On this course students apply all aspects of drug development they have learned in a virtual drug discovery and development project. Students use their drug development project skills and knowledge starting from an evaluation of the biological target and its possible involvement in the pathophysiology of a disease to design a full development program of a drug molecule. Students improve their expert communication, presentation skills and peer feedback as well as justification of their decisions to a sponsor in simulated steering meetings. This course has the focus on working life skills, professional life relevance and creative problem solving individually and as a member of a team.","valueSv":"On this course students apply all aspects of drug development they have learned in a virtual drug discovery and development project. Students use their drug development project skills and knowledge starting from an evaluation of the biological target and its possible involvement in the pathophysiology of a disease to design a full development program of a drug molecule. Students improve their expert communication, presentation skills and peer feedback as well as justification of their decisions to a sponsor in simulated steering meetings. This course has the focus on working life skills, professional life relevance and creative problem solving individually and as a member of a team."}},{"title":{"valueFi":"Sisältö","valueEn":"Content","valueSv":""},"content":{"valueFi":"The drug discovery and development learning project is done as a simulated Project Team work in 3 phases. It starts with an overview of the target and its possible involvement in diseases, search in patent databases to learn of the IPR status of the target, and finally analyse the financial/economical feasibility of the new development program. Teams design a program for the drug discovery by analysing methodological possibilities to find a lead compound and to optimise it for further development. In the next phase, Teams design an entire non-clinical development program for the drug candidate during which they plan all studies to demonstrate the mechanism of action of the drug molecule, its ADME properties, its efficacy in animal disease models and the toxicological and safety experiments that are required to demonstrate the safety of the candidate molecule. Finally, Teams design a clinical development program for the study drug, from first-to-man dosing studies in healthy volunteers to phase 2 and 3 clinical trials in patients. Finally the marketing access Strategy is presented.","valueEn":"The drug discovery and development learning project is done as a simulated Project Team work in 3 phases. It starts with an overview of the target and its possible involvement in diseases, search in patent databases to learn of the IPR status of the target, and finally analyse the financial/economical feasibility of the new development program. Teams design a program for the drug discovery by analysing methodological possibilities to find a lead compound and to optimise it for further development. In the next phase, Teams design an entire non-clinical development program for the drug candidate during which they plan all studies to demonstrate the mechanism of action of the drug molecule, its ADME properties, its efficacy in animal disease models and the toxicological and safety experiments that are required to demonstrate the safety of the candidate molecule. Finally, Teams design a clinical development program for the study drug, from first-to-man dosing studies in healthy volunteers to phase 2 and 3 clinical trials in patients. Finally the marketing access Strategy is presented.","valueSv":"The drug discovery and development learning project is done as a simulated Project Team work in 3 phases. It starts with an overview of the target and its possible involvement in diseases, search in patent databases to learn of the IPR status of the target, and finally analyse the financial/economical feasibility of the new development program. Teams design a program for the drug discovery by analysing methodological possibilities to find a lead compound and to optimise it for further development. In the next phase, Teams design an entire non-clinical development program for the drug candidate during which they plan all studies to demonstrate the mechanism of action of the drug molecule, its ADME properties, its efficacy in animal disease models and the toxicological and safety experiments that are required to demonstrate the safety of the candidate molecule. Finally, Teams design a clinical development program for the study drug, from first-to-man dosing studies in healthy volunteers to phase 2 and 3 clinical trials in patients. Finally the marketing access Strategy is presented."}},{"title":{"valueFi":"Suoritustavat","valueEn":"Study methods","valueSv":""},"content":{"valueFi":"The course is based on team work in a virtual drug discovery and development project. Teams will be given the name of a target protein and start working to produce both written project reports and to give oral presentation separately in every phase.\r\nStudents have lectures on the general outlines of project work. Teams keep notes on the project meetings and project workbook which includes peer feedback to other members of their team. Teams give scientific feedback to other Teams. Project Teams use Microsoft Teams for their communication and project management. \r\nAll students have mandatory attendance full time in every course session.","valueEn":"The course is based on team work in a virtual drug discovery and development project. Teams will be given the name of a target protein and start working to produce both written project reports and to give oral presentation separately in every phase.\r\nStudents have lectures on the general outlines of project work. Teams keep notes on the project meetings and project workbook which includes peer feedback to other members of their team. Teams give scientific feedback to other Teams. Project Teams use Microsoft Teams for their communication and project management. \r\nAll students have mandatory attendance full time in every course session.","valueSv":""}},{"title":{"valueFi":"Toteutustavat","valueEn":"Course unit methods","valueSv":""},"content":{"valueFi":"Lectures (6 h) - mandatory presence\r\nSeminars (24 h) - mandatory presence\r\nIndependent Project work in teams (240 h)","valueEn":"Lectures (6 h) - mandatory presence\r\nSeminars (24 h) - mandatory presence\r\nIndependent Project work in teams (240 h)","valueSv":""}},{"title":{"valueFi":"Oppimateriaalit","valueEn":"Learning material","valueSv":""},"content":{"valueFi":"Given material on the project and team work shared on Moodle site. Students are encouraged to seek information on relevant regulatory guidelines concerning drug discovery and development available on the web pages of EMA, FDA and ICH, and to utilize IPR (patent) databases, PubMed, Clinical Trials Registers etc.\r\nMicrosoft Teams is available for UTU students as part of the Microsoft 365 package license.","valueEn":"Given material on the project and team work shared on Moodle site. Students are encouraged to seek information on relevant regulatory guidelines concerning drug discovery and development available on the web pages of EMA, FDA and ICH, and to utilize IPR (patent) databases, PubMed, Clinical Trials Registers etc.\r\nMicrosoft Teams is available for UTU students as part of the Microsoft 365 package license.","valueSv":""}},{"title":{"valueFi":"Lisätiedot","valueEn":"Further information","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Kurssikirjallisuus","valueEn":"Literature","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Esitietovaatimukset","valueEn":"Qualifications","valueSv":""},"content":{"valueFi":"Student has passed DRUG0005 Principles of Drug Discovery and Development, 8 ECTS before enrolling to this course.","valueEn":"Student has passed DRUG0005 Principles of Drug Discovery and Development, 8 ECTS before enrolling to this course.","valueSv":""}},{"title":{"valueFi":"Arviointiasteikko","valueEn":"Assessment scale","valueSv":""},"content":{"valueFi":"0-5","valueEn":"0-5","valueSv":"0-5"}},{"title":{"valueFi":"Arviointikriteerit","valueEn":"Assessment criteria","valueSv":""},"content":{"valueFi":"Evaluation criteria are based on the outcome of the project work. For this, both written project reports as well as oral presentations are evaluated. Scientific quality and reasoning of approaches used during different phases of the project, innovative ideas, knowledge of regulatory requirements of drug development processes and presentation skills and performance are taken into account in the evaluation. The evaluation of oral presentations is done by peer teams and teachers.","valueEn":"Evaluation criteria are based on the outcome of the project work. For this, both written project reports as well as oral presentations are evaluated. Scientific quality and reasoning of approaches used during different phases of the project, innovative ideas, knowledge of regulatory requirements of drug development processes and presentation skills and performance are taken into account in the evaluation. The evaluation of oral presentations is done by peer teams and teachers.","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 2","valueEn":"Assessment criteria 2","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 3","valueEn":"Assessment criteria 3","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 4","valueEn":"Assessment criteria 4","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Kielet","valueEn":"Languages","valueSv":""},"content":{"valueFi":"englanti","valueEn":"English","valueSv":"engelska"}},{"title":{"valueFi":"Taso","valueEn":"Level","valueSv":""},"content":{"valueFi":"Syventävät opinnot","valueEn":"Advanced Studies","valueSv":""}},{"title":{"valueFi":"Oppiaine","valueEn":"Subject","valueSv":""},"content":{"valueFi":"Drug Discovery and Development","valueEn":"Drug Discovery and Development","valueSv":"Drug Discovery and Development"}},{"title":{"valueFi":"Vastuuhenkilöt","valueEn":"Person in charge","valueSv":""},"content":{"valueFi":"Ullamari Pesonen, Sanna Soini","valueEn":"Ullamari Pesonen, Sanna Soini","valueSv":"Ullamari Pesonen, Sanna Soini"}},{"title":{"valueFi":"Luokittelu","valueEn":"Classification","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Linkit","valueEn":"Links","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}}]}