Biopharmaceuticals - Pharmaceutical Development and
Safety Assessment
The commercial and scientific prominence of biopharmaceuticals is beyond dispute. This course provides an interdisciplinary introduction to the new advances in our ability to develop macromolecules into effective biopharmaceuticals.
At first sight, development of biopharmaceuticals appears straightforward since the biology of endogenous compounds, such as proteins or peptides, and clinical proof of concept and safety profile often are given beforehand (e.g. insulin, growth hormone, coagulation factors). However, given by tremendous recent advances in genetic understanding, biotechnology, and knowledge of protein function in the biology of diseases, an explosion of novel opportunities for development of biopharmaceuticals has occurred. Even though discovery of novel biopharmaceuticals may be void of typical small molecule pitfalls, the complexity of pharmaceutical development and safety assessment phases may still pose large challenges in the overall development of novel biopharmaceuticals.
What you will learn
After the course, you will be able to:
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Proactively identify and assess potential major issues during development of biopharmaceuticals regarding pharmaceutical development, safety and efficacy testing
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Design and develop novel interdisciplinary approaches within the field of expertise thereby improving current practice in the development of biopharmaceuticals
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Communicate field specific issues and solutions regarding development of biopharmaceuticals to other specialists, and project stake-holders
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Cooperate within a multi-disciplinary development project team
Course content
The course will teach the specific characteristics and procedures within the development of biopharmaceuticals. Morning lectures held by experts touch upon basic concepts and specific issues related to biopharmaceuticals within their fields of expertise. Emphasis is put on issues and complexities related to development of biopharmaceuticals. There will be focus on project initiation, discovery phase, including pharmacology and protein engineering. Particular emphasis will be given to pharmaceutical development and safety assessment of biopharmaceuticals. Regulatory aspects will be taught as well. Afternoon group sessions are allocated to design a project plan, discuss potential issues and their solutions and present these to illustrate project team handling of deviations from project plans due to common or unexpected issues related specifically to biopharmaceuticals.
Participants
The course is for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for development of biopharmaceuticals.
Participants should:
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Hold a relevant bachelor degree or equivalent
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Have a minimum of 2 years of relevant job experience within drug development
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Have proficiency in English
Course dates
5 days, 13 - 17 August 2012, 9.00 - 17.00 at the University of Copenhagen, Frederiksberg Campus.
Coure directorship
Harrie Boonen, Associate Professor, Department of Pharmacology and Pharmacotherapy, University of Copenhagen
Bente Steffansen, Associate Professor, Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen
The course directors will be present throughout the course to ensure coordination of topics.
Other course teachers
List of lecturers may be subject to change
Kirsten Dreyer, Symphogen A/S, Are Bogsnes, Novo Nordisk A/S, Carsten Boye Knudsen, Zealand Pharma, Camilla Foged, Assoc. Professor, University of Copenhagen, Lars Hovgaard, Novo Nordisk A/S, Adjunct Professor Faculty of Pharmaceutical Sciences, Steen Hvass Ingwersen, Novo Nordisk A/S, Lars Iversen, Novo Nordisk A/S, Claus Kristensen, Novo Nordisk A/S, Rikke Lindecrona, Novo Nordisk A/S, Kasper Møller, CMC Biologics A/S, Hanne Mørck Nielsen, Assoc. Professor, University of Copenhagen (t.b.c.), Henrik Duelund Petersen, Novo Nordisk A/S, Peter Thygesen, Novo Nordisk A/S, Henrik Tang Vestergaard, Danish Medicines Agency (t.b.c.), Joris Wilms, KLIFO A/S.
Course fee
DKK 18,500/EUR 2,500. Fee includes teaching, course materials, all meals during the course and examination. Participants already enrolled in a Master's programme at the Faculty of Pharmaceutical Sciences, University of Copenhagen will get a 15% discount on the course fee.
Examination
An optional examination is provided (3 ECTS credits at Master's level) if a written report (case story), based on an extended literature list, is handed in before 10th September 2012. The course has been preapproved as an elective on the MIND and MPRA programmes at the University of Copenhagen. Read more
