european journal of pharmaceutical sc iences 30 (2007 ) 96–98

avai lab le a t www.sc iencedirect .com

journal homepage: www.elsev ier.com/ locate /e jps

doi:10.1016/S0928-0987(06)00357-5

EUFEPS Workshop on

Optimising Biotech Medicines:

Second-Generation Pharmaceutical Proteins

January 11–12 • 2007 • Hilton Munich City • Munich • Germany

A Discussion and Training Forum for Scientists from the Pharmaceutical Industry, Regulatory Agencies and AcademicInstitutions

Organised by the European Federation for Pharmaceutical Sciences (EUFEPS)

The Workshop opens on Thursday, January 11, 2007, at 09:00 (Pre-registration on Wednesday, January 10, 2007) and it closes on

Friday, January 12, 2007, at 15.30.

Scope and AimToday, a major fraction of NDA’s includes biologicals, i.e. biotech medicines. Part of those is second-generation biologicals. The

biologicals differ from low molecular weight drugs because of their complex production and purification process and a

different quality control paradigm, including different analytical and formulation approaches. In this Workshop the following

issues will be addressed:

• Production processes for biologicals: Optimisation of protein excretion and downstream processing protocols

• Second generation biologicals: Design and manufacture (e.g. epo-derivatives and pegylation approaches)

• Formulation of biologicals: Route of administration, characterisation and stability

Ample meeting time will be devoted to round-table discussions and break out sessions in addition to the invited state-of-the-art

lectures.

Sessions will include:• Advances in production approaches

• Second-generation proteins

• New formulation challenges

• Is there a future for pharmaceutical proteins?

Format and Preliminary ProgrammeKey segments of the processes are broken down into a number of sessions, each with lectures and discussions, as well as

general and break out discussion sessions for problem/solving, conclusions and recommendations.

Workshop Planning CommitteeDaan J.A. Crommelin, Leiden, NL (Co-Chair); Theo Dingermann, Frankfurt, DE; Wolfgang Friess, Munich, DE (Co-Chair); Ulrike Holzgrabe,

Würzburg, DE; Hans H. Lindén, Stockholm, SE; Christian R Noe, Vienna, AT; Ernst Wagner, Munich, DE; Angelika M Vollmar, Munich, DE.

Oral and poster contributionsScientific contributions relating to the scope and aim of the Workshop will be welcome and considered for poster presentations.

Abstracts should be submitted to the EUFEPS Secretariat, both as an email attachment and as a hard copy. For editorial

instructions, please visit the Workshop Website EUFEPS Online at: www.eufeps.org. Submission deadline is November 30, 2006.

Exhibition InformationCompanies are welcome to participate as an exhibitor at this Workshop. The Workshop delegates are academics, industrialists,

regulators and students which will give you a unique opportunity to meet experts in your field. The exhibition offers every

opportunity to promote and position your company, your products, your services, your expertise and your specialists,

facilitating your contact with them, predicting their needs and shaping future collaboration.

Preliminary Programme

Welcome, Introduction and Opening RemarksChristian R Noe, University of Vienna and EUFEPS President, Vienna AT

Daan JA Crommelin, Top Institute Pharma, Leiden NL

Ulrike Holzgrabe, University of Würzburg, Würzburg DE

Se ssion I: Advances in production approachesChairman: Daan JA Crommelin, Top Institute Pharma, Leiden NL

Alternative production systems for pharmaceutical proteins: Are they going to work?Joerg Knaeblein, Schering, Berlin DE

Improving protein production. Where does it end?Dorothee Ambrosius, Boehringer Ingelheim, Biberach an der Riss DE

PAT and biological production: The quality is in process?Stephen Flatman, Lonza Biologics, Berkshire UK

Session II: Second-generation proteinsChairman: Wofgang Friess, University of Munich, Munich DE

PEGylation: The basicsFrancesco M Veronese, University of Padua, Padua IT

PEGylation: Case study; Interfereon alfaKlaus Reichert, F Hoffmann – La Roche, Penzberg DE

Altering the glycosylation patternTara Arvedson, Amgen Inc, Thousand Oaks CA USA

Second-generation insulinThomas Kjeldsen, NovoNordisk, Bagsvaerd DK

Fusion proteinsTBA

Breakout SessionsI: Process Analytical Technology (PAT)Leader: Stephen Flatman, Lonza Biologics, Berkshire UK

II: Alternative Production SystemsLeaders: Joerg Knaeplein, Schering, Berlin DE

and Rainer Rudolph, University of Halle, Halle DE

european journal of pharmaceutical sc iences 30 (2007 ) 96–98 97

Thursday, January 11, 2007

III: Second-generation proteins:Pharmacokinetics and PharmacodynamicsLeader: Theo Dingermann, University of Frankfurt, Frankfurt DE

Welcome Buffet

Session III: New formulation challengesChairman: Theo Dingermann, University of Frankfurt, Frankfurt DE

Formulation challenges with second-generation protein pharmaceuticalsWolfgang Friess, University of Munich, Munich DE

ImmunogenicityWim Jiskoot, University of Leiden, Leiden NL

Analytical challenges addressedTudor Arvinte, University of Geneva, Geneva CH

New delivery systemsDaan JA Crommelin, Top Institute Pharma, Leiden NL

Breakout SessionsI: Immunogenicity: Biological aspectsLeader: Angelika M Vollmar, University of Munich, Munich DE

II: Pharmaceutical protein delivery and formulation aspectLeader: Daan JA Crommelin, Top Institute Pharma, Leiden NL

III: New Analytical ToolsLeader: Tudor Arvinte, University of Geneva, Geneva CH

Regulatory aspectsAjaz Hussain, Novartis, Princeton NJ USA

Session IV: Is there a future for pharmaceutical proteins?Chairman: Angelika M Vollmar, University of Munich, Munich DE

Anticalins: Therapeutic antibody surrogates with tailored properties derived from the lipocalin protein familyArne Skerra, Technical University of Munich, Munich DE

Artificial binding moleculesRainer Rudolph, University of Halle, Halle DE

Concluding remarksGerhard Winter, University of Munich, Munich DE

Additional InformationInformation on this Workshop will be posted on the EUFEPS Online (www.eufeps.org). Alternatively, contact the EUFEPS

Secretariat (address below) for copies of announcements, the preliminary programme, registration form and hotel reservation

form.

Useful addressEUFEPS secretariat

PO Box 1136,SE-111 81 Stockholm, Sweden

Tel.: +46 8 7235000, Fax: +46 8 4113217

Email: conferences@eufeps.org

98 european journal of pharmaceutical sc iences 30 (2007 ) 96–98

Friday, January 12, 2007