Biologics Drug Development-3 day course

Preliminary program

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 will also be offered as an online course. Those who choose to attend online will have access to all streamed lectures for 1 month.

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.

During the course you will get insight on how to work in the different stages of development, what to think about and what pitfalls there are on the road. To get the most exchange of the course, it is an advantage to have a natural science background.

Subjects

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

For participants on site in Stockholm there is also plenty of networking opportunities.

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

Program Committe

Olga Björklund, BioArctic, Tuulikki Lindmark, TuuLife Science,  SwedenBio and Lisa Bandholtz, Apotekarsocieteten

Participation fees

Please notice, you must tick a box at the registration form to indicate one of the below participation fees.
SwedenBio member, early fee until August 31, 9 500 SEK
SwedenBio member, fee from September 1, 13 000 SEK
Regular fee until August 31, 13 000 SEK
Regular fee from September 1, 16 500 SEK
All prices excludes VAT.

Preliminary schedule

Day 1 ca 08:30-17:15
Day 2 ca 08:30-17:00
Day 3 ca 08:30-17:00

Venue

Apotekarsocieteten, Wallingatan 26A, in central Stockholm.