Biologics Drug Development-3 day 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 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.
If you prefer to register to the course on-site at Läkemedelsakademin, please visit https://www.lakemedelsakademin.se/produkt/biologics-drug-development-3-day-course-8/?lang=en

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.

Agenda

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

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

Program committee

Olga Björklund, BioInvent, Tuulikki Lindmark, TuuLife Science, Frida Lawenius, 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.
Traditional participant SwedenBio member, early fee until April 29, 8 500 SEK
Traditional participant SwedenBio member, late fee from April 30, 11 200 SEK
Traditional participant, early fee until April 29, 11 200 SEK
Traditional participant, late fee from April 30, 13 700 SEK
All prices excludes VAT.