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
Starting a development project/TPP
Target identification
Pharmacokinetics
Pharmacodynamics (In vivo pharmacology)
Nonclinical Safety Studies
Immunogenicity
Translational science/biomarkers
Day 2
Patent/IP
Regulatory strategies
Manufacturing of clinical material for biopharmaceuticals
Analysis and formulation of biologics
Virus validation
Manufacturing process of biologics , and medical device
Biosimilars – preclinical and clinical aspects
Advance Therapy Medicinal Products (ATMPs) overview
Day 3
Financing
Health economics and reimbursement
Clinical trials
Medical Products Agency
Business Development
Licensing Strategies among Big Pharma
Pharmacovigilance
Market, phase IV & post reg. phase
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, BioInvent, 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.
Inlägget Biologics Drug Development-3 day course dök först upp på Läkemedelsakademin.