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.
Useful to get an overview and some of the considerations in this area.
What I learnt will help me understand cross functional discussions better at work.
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 drug development and most have worked with or in small drug development companies.
Contact us
Upcoming course
Date to be announced. Register your interest, and we’ll notify you as soon as registration opens!