Biologics drug development

3-day Course

About the course

Drug development of various types of biologic products is a complex and multidisciplinary process. The development integrates knowledge of the underlying disease, target identification, principles on biologics safety, planning strategy for toxicology and clinical studies incorporating the key aspects of manufacturing and controls.

This three-day course provides insights into all parts that should be addressed to effectively develop new biologics, from discovery to product launch. The course is given in English.

The course is organized in cooperation with SwedenBIO.

Who should attend?

The course is aimed for those involved in drug development of biologics (eg in small and medium-sized companies), and need a comprehensive picture of the complex development chain. 

To get the most exchange of the course, it is an advantage to have a natural science background.

Learning objectives

During the course you will get insight into how to work in the different stages of development, what to think about and what pitfalls there are on the road.

Course outline

Day 1

• Biopharmaceuticals – an introduction
• Starting a development project/TPP
• Pharmacokinetics for biologicals
• In vivo pharmacology
• Nonclinical safety studies
• Immunogenicity
• Biosimilars – Non-Clinical and clinical aspects
• Translational science/biomarkers

Day 2

• Patent/IP
• Regulatory strategies
• Manufacturing of clinical material for biopharmaceuticals
• Analysis and formulation of biologics
• Safety Evaluation in manufacturing of biologics including virus validation
• The Regulatory Environment in EU and US for ATMP/RMAT
• Clinical Trials
• Medical Products Agency

Day 3

• Financing
• Health economics and reimbursement
• Business Development
• Partnering with Big Pharma
• Pharmacovigilance
• Taking a project from idea to a late stage clinical development

Lecturer

All lecturers have experience from biologics drug development and most have worked with or in small drug development companies.