Educational course: 3 day course in Biological Drug Development

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 be held in Stockholm, but live streamed to Oslo Cancer Cluster Incubator for a smaller audience where there will be possibilities to ask questions to the lecturers, as well as having discussions within the local group. Participants will also have access to all streamed lectures for 1 month, in addition to receiving all slides used during the course. Refreshments through out the day, and lunch is included. 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.

Lecturers

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

Patent/IP

Day 2

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

Financing

Day 3

Health economics and reimbursement

Clinical trials

Medical Products Agency

Business Development

Licensing Strategies among Big Pharma

Pharmacovigilance

Market, phase IV & post reg. Phase

 

Time and venue

The course is held at Apotekarsocieteten in Stockholm, and  live streamed at Oslo Cancer Cluster Incubator, Oslo.

 

Registration: Please contact Project Administrator, Jenny Hagberg at: jenny.hagberg@lakemedelsakademin.se

Questions: Please contact Ania Johansen at: ania@occincubator.com

 

Oslo Cancer Cluster will be collaborating with the Swedish Academy of Pharmaceutical Sciences (SAPS) and Innovation Norway, to offer you educational courses of high quality in different fields related to drug development. The courses will be held in Stockholm, but will be live streamed to OCC Incubator with a moderator and with interactive functions to participate in the course. Refreshments and lunch is also included.

The aim for the live streaming is to create an attractive, cost- and time effective alternative based upon these educational courses. The audience will be a smaller/medium sized group, which will have the possibility to discuss and share between them, as well as asking questions to the lecturers in real time. The entire course will also be available to all participants for 30 days, through a video of the stream and the slides used.