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Meeting Co-chairs: Prof. Johannes Löwer and John Purves

Day 1, Thursday, 07 February 2013

08.30 - 09.00  Registration and Welcome Coffee 
09.00 - 09.15  Welcome to the meeting
Session 1: Roundup of the last year
09.15 - 10.00  Regulatory activities relevant to biopharmaceuticals in Europe – from updates on clinical trial regulations to recent regulatory decisions to new guideline initiatives

Ilona Reischl  (AGES)

10.15 - 10.45  An update on CAT activities during the last year and what to expect in the future Christian Schneider (CAT Chairman, Danish Health and Medicines Authority)  
10.45 – 11.15

Coffee Break

11.15 – 11.45 Trends, decisions and new guidelines in the past year – CMC requirements for antibody-drug conjugates, QbD experience, substantial amendments and variations, clonality requirements, batch release and more Steffen Gross (Paul-Ehrlich-Institut)
11.45 - 12.15 News and trends: Session 1 panel discussion Chaired by meeting co-chairs Featuring: Ilona Reischl (AGES), Christian Schneider (CAT Chairman, Danish Health and Medicines Authority), Steffen Gross (Paul-Ehrlich-Institut)
12.15 - 13.15 Lunch
Session 2: Biosimilar monoclonal antibodies in the EU and the US  
13.15 - 13.45 The EU framework on biosimilar monoclonal antibodies: Where have we come from? Where are we going? Christian Schneider (BMWP Chairman, Danish Health and Medicines Authority)<
13.45 - 14.15 The FDA draft guidance on biosimilar product development Steven Kozlowski (FDA) 
14.15 - 15.00 Determining the indication for a biosimilar monoclonal antibody – when is extrapolation an option for obtaining all of the indications of the reference product? How is the selection of the reference product justified?  - The analytical experience for functional characterisation. Cornelius Fritsch (Novartis) - How much can we extrapolate immunogenicity data? Thomas Schreitmüller (Roche) 
15.00 – 16.00 Session 2 panel discussion Chaired by meeting co-chairs Featuring: Christian Schneider (BMWP Chairman, Danish Health and Medicines Authority), Steven Kozlowski (FDA), Cornelius Fritsch (Novartis), Thomas Schreitmüller and Frank Scappaticci (Roche), Genevieve Michaux (Covington & Burling LLP)
16.00 – 16.30 Coffee Break
Session 3: Drug-diagnostic companion development
16.30 - 17.00 Where do we stand with EU and US requirements for drug-diagnostic companion developments? Sylvie le Gledic (Voisin Consulting)
17.00 – 17.30 Session 3 panel discussion Chaired by meeting co-chairs Featuring: Sylvie le Gledic (Voisin Consulting),  Genevieve Michaux (Covington & Burling LLP)
17.30  Close of day one and reception before departure to the evening event
18.45  Ascent by coach to the Henslers Hof – a rustic and charming Black Forest farm house

DAY 2: Friday, 08 February 2013

08.00 - 08.30  Welcome Coffee with snacks
Session 4: The new Pharmacovigilance system
08.30 - 09.15  The new PRAC: six months after inauguration Sabine Straus (CBG-MEB)
09.15 - 09.45  Session 4 panel discussion Chaired by meeting co-chairs Featuring: Sabine Straus (CBG-MEB), Monika Pietrek (Pietrek Associates)
09.45 – 10.15 Coffee Break
Session 5: Looking at other regions: Brazil   
10.15 - 11.15  Authorising biopharmaceuticals in Brazil – pathways for biotech products, biologicals, vaccines, biosimilars and ATMPsLaura Gomes Castanheira (ANVISA) 
11.15 - 12.00  Industry experience with authorisations of biopharmaceuticals in Brazil Tatiana Gaban, Roche Thomas Kirchlechner, Sandoz


Session 6: Science and strategy of development   
12.00 - 12.30 Essentials to know in 2013 on immunogenicity of therapeutic proteins. An update on most recent occurrences, regulatory activities and scientific progress Paul Chamberlain (NDA Advisory Board) 


12.45 - 13.30  Lunch   
13.30 - 14.00 The storm has cleared: RESTORE as a new in vitro system for understanding the TeGenero trial Thomas Hünig (University of Würzburg) 


Session 7: Bridging the regulatory-HTA gap – considerations during development
14.15 - 15.00 

How to incorporate HTA considerations into clinical development – strategy, company structure, stakeholders involved, scientific considerations for future clinical developments of incorporating criteria to determine additional benefit

Jan Müller-Berghaus (CHMP Member, Paul-Ehrlich-Institut)

A case study for the indication multiple sclerosis

Markku Toivonen (NDA Advisory Board) 

15.00 - 15.30

The German AMNOG 

Meriem Bouslouk (G-BA)

15.30 - 16.00 

Session 7 panel discussion

Chaired by meeting co-chairs

Featuring: Jan Müller-Berghaus (CHMP Member, Paul-Ehrlich-Institut), Markku Toivonen (NDA Advisory Board), Meriem Bouslouk (G-BA)


Wrap up and concluding remarks 


16.15  Close of meeting