Programme
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| 13.45 - 14.15 | The FDA draft guidance on biosimilar product development Steven Kozlowski (FDA) |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
Q&A |
| 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)
Q&A |
| 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)
Q&A |
| 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) |
| 16.00 |
Wrap up and concluding remarks Co-chairmen |
| 16.15 | Close of meeting |