IMMUNOGENICITY OF PROTEIN DRUGS: CAUSES, MONITORING, AND CONSEQUENCES

Friday, March 17th, 2006 at 11:30 in Auditorium 3

The Danish University of Pharmaceutical Sciences Universitetsparken 2, 2100 Copenhagen O

Proteins - the miracle drugs. Or are they really?

Recombinant technology has allowed the production of many potential protein drugs at an acceptable cost, allowing the treatment of severe, chronic and life-threatening diseases, such as cancer, diabetes, rheumatoid arthritis, hepatitis, etc. Currently, over 160 protein drugs are available on the world market, and several hundreds more are in clinical trials. The total protein drug market already exceeds 30 billion, and is expected to rise by at least 10% a year.

This does not mean that developing and using protein drugs is easy. In general, protein drugs need to be administered by injection or infusion. However, perhaps the single most important hurdle for a protein drug is the potential to develop an immune response. That is, the immune system of the patient marks the protein as foreign, and attacks it. This may occur even when the protein is, essentially, structurally equal to the endogenous protein. An immune response is often difficult to predict, but may have serious, potentially lethal consequences.

European experts will discuss in this seminar the current state-of-the art regarding the factors that may cause an immune response to protein drugs, monitoring and early detection of an immune response in the clinic, and clinical implications of an immune response. Finally, the current view of the regulatory agencies will be discussed. This seminar is, therefore, a must-attend for anyone working in the field of protein drug development, immunogenicity, and pharmacology of protein drugs.

Program

11:30 - 12:00 Welcome
Sandwiches available
12:00 - 12:10 Introduction
Marco van de Weert/Eva Horn Møller
12:10 - 12:50 General aspects of an immune response to protein drugs
Erwin Roggen, Novozymes A/S
12:50 - 13:30 Factors causing an immune response to protein drugs
Huub Schellekens, Utrecht University
13:30 - 14:00 break
14:00 - 14:40 Monitoring the development of an immune response
Klaus Bendtzen, National University Hospital Copenhagen / BioMonitor ApS
14:40 - 15:20 Clinical aspects of immunogenicity of protein drugs
Antonio Bertolotto, University Hospital S. Luigi Gonzaga
15:20 - 16:00 Regulatory aspects of immunogenicity to protein drugs
Nanna Aaby Kruse, Danish Medicines Agency
   

the program as pdf can be found here


the speakers

Dr. Marco van de Weert and Dr. Eva Horn Møller are Assistant Professors in the Biomacromolecules Group at the Department of Pharmaceutics and Analytical Chemistry at the Danish University of Pharmaceutical Sciences. They both work in the field of protein drug formulation.

 

Dr. Erwin Roggen obtained a degree in Biochemistry at the University of Antwerp. After several university positions in Belgium he joined Novozymes A/S, where he is Science Manager for Immunology.

 

Prof. Huub Schellekens is a physician and microbiologist. He is currently the director for the Central Laboratory Animal Institute of Utrecht University.

 

Prof. Klaus Bendtzen is a physician and Head of the Institute for Inflammation Research of the National University Hospital in Copenhagen. He is also Founder and Chief Scientific Officer of BioMonitor ApS, Symbion Science Park, Copenhagen.

 

Prof. Antonio Bertolotto is a physician, neurologist, and Head of the Multiple Sclerosis Center and Clinical Neurobiology Laboratory at the University Hospital S. Luigi Gonzaga in Orbassano (Turin, Italy).

 

Dr. Nanna Aaby Kruse is a pharmacist at the Danish Medicines Agency.

 


Organised by: Eva Horn Møller and Marco van de Weert, the Danish University of Pharmaceutical Sciences, and is open for attendance by all interested parties.

The participation is free of charge, and includes tea/coffee in the break. However, you are requested to sign up for the meeting by sending an e-mail to mvdw(at)dfuni.dk, before March 10th, 2006. Participation is limited to 240 people, and the selection will be on a first come, first served basis.

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Last update: 06.06.2006

University of Copenhagen
Faculty of Pharmaceutical Sciences
Universitetsparken 2
2100 Copenhagen
Denmark

Phone +45 35 33 60 00
Fax +45 35 33 60 01
Mail farma@farma.ku.dk
Web www.farma.ku.dk