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 not only be offered as a traditional course but also as a distance course. Those who choose to attend online will have access to all streamed lectures for 1 month. Traditional participants also have the opportunity to add lectures online. 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.

Lecturer

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

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

Program

Preliminary Program

Preliminary schedule:
day 1 ca 8:30-17:00
day 2 ca 9:00-17:00
day 3 ca 9:00-16:00

Distance course

Those who register for the online course will get access to a login link before the course starts and will have access to all streamed lectures for 1 month. Traditional participant also have the opportunity to add lectures online.

Registration Fee

All prices are in SEK excl VAT.

Program Committee

Tuulikki Lindmark, Disruptive Materials
Olga Björklund, NDA Group
Björn Ursing, SwedenBio
Lisa Bandholtz, Apotekarsocieteten

Venue for course on-site

The course is held at Apotekarsocieteten, Wallingatan 26A, Stockholm