LUCC: Drug development and clinical trials course

PhD level, postdocs welcome, elective course (3 hp)

September / October 2024

Course coordinators: marcus [dot] jaras [at] med [dot] lu [dot] se (Marcus Järås) and Fredrik Ek.

The course covers the general process for development of a new drug from pre-clinical discovery via pre-clinical development and clinical trials. This course will prepare you for future work in the pharmaceutical industry as well as work in academia regarding innovations, early drug development and entrepreneurship.

Seminar series and case studies lead by expertise in the field mainly from local biotech companies. An excellent opportunity to network with senior managers/researchers in the companies.

• possible to sign-up only for a topic / topics of your interest (0 hp)

On completion of the course, the students shall be able to:

• give an account of drug development from discovery to registration of a new drug and describe commonly occurring methods associated with drug development
• give an account of important breakpoints in the drug development process
• give an account of different types of patents that occur in drug development
• describe the laws and rules that control the development of a new drug in the pre-clinical and clinical phase
• describe the different phases of the clinical development
• give an account of different possibilities for funding drug development in the preclinical and clinical phase
• participate in teamwork to provide theoretical and practical solutions for assignments related to drug development and clinical trials
• behave with a professional approach, respect others' opinions in discussions of drug development and clinical trials and meet set deadlines
• reflect on ethical considerations during the drug development process
• reflect on different strategies to achieve scientific, market-related and regulatory goals during drug development.

Course content

The course covers the general process for development of a new drug from preclinical discovery via pre-clinical development and clinical trials. The course will address scientific, strategic and regulatory challenges from discovery to approval of a new drug and also includes key methods and terminology. It also covers the importance of the professional groups that are involved in the different phases of the development of a new drug. This course will prepare the students for future work in the pharmaceutical industry as well as work in academia regarding innovations, early drug development and entrepreneurship.

Course design

The fundament in the course is seminars by experts mainly from the Life science industry, but also from Region Skåne and Lund University. In addition to seminars, the students will carry out team-based activities. The working methods in the course mostly involve active learning, requiring the students to prepare before each teaching component. The students are expected to behave professionally and, just as in a future work situation, participate constructively in team-based activities.

Master students:

Within the master’s program of the biomedicine programme, it is possible to choose the Life science track (second year). This consists of two courses, BIMM04: Drug development and clinical trials (7,5 credits), and BIMM82 (project course: 45 credits). For more details, contact marcus [dot] jaras [at] med [dot] lu [dot] se (Marcus Järås) or Fredrik Ek.