CONFERENCE REPORT WITH FREE DOWNLOADS
A summary article and the presentation materials of the professionally very fruitful 4th Annual Biosimilars Forum are available now as a courtesy of the event series:
PHOTO GALLERY
Professional short course in advanced biostatistics:
- Robust methods for assessment of average and scaled average bioequivalence
Presenters:
Robert SCHALL
Professor, Statistical Consultation Unit, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa
Co-author:
Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria, South Africa
18 OCT, 2019 | 2nd DAY SYMPOSIUM: Clinical Research and Regulatory
THEORETICAL CONSIDERATIONS
- Balaam’s Design Revisited
Júlia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd.;
President of the Hungarian Society for Clinical Biostatistics, Hungary
Co-author: Joëlle MONNET GAUD
Director, Biostatistics,
Fresenius-Kabi SwissBioSim GmbH, Switzerland
- Measuring switchability using observational data
László TÓTHFALUSI,
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Hungary
Co-author: László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists, Canada
- Applications of the expected power (statistical assurance) for bioequivalence trials
Arne RING
Professor of Statistics, University of the Free State, South Africa;
Head of Biometrics and Statistical Programming, medac GmbH, Germany
REGULATORY QUESTIONS
- Regulatory Keynote:
Current challenges in the development of biosimilars
Andrea LASLOP
Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria;
Member of the Scientific Advice Working Party (SAWP) of the European Medicines Agency; Austrian delegate in the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency
- Regulatory reflections on biosimilar development and statistical methods used at quality level
Ina-Christine RONDAK
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA, Germany
- Quality and statistics: bringing two worlds together
Andreas BRANDT
Statistical assessor,
Federal Institute for Drugs and Medical Devices (BfArM), Germany
- Is similarity different? – Recent developments from the regulatory perspective
Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES);
Assessor, EMA Biostatistics Working Party; Alternate Member, EMA Scientific Advice Working Party;
Former President of the Viennese Section of the International Biometric Society, Austria
CHALLENGE THE REGULATOR
This extended Regulatory Panel Discussion and Q&A type of interaction replied to critical questions from the audience with a focus on the current regulatory requirements, approval process and also on the burning issues of debate facing clinical development teams specialized on biosimilars. During this discussion we were looking for answers also to that how to handle differences between regulatory guideline recommendations and clinical research practice and how to adjust clinical development practice to effective legislation, or vice versa.
- Moderator:
Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES);
Assessor, EMA Biostatistics Working Party; Alternate Member, EMA Scientific Advice Working Party;
Former President of the Viennese Section of the International Biometric Society, Austria
- Panel members:
Andrea LASLOP
Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria;
Member of the Scientific Advice Working Party (SAWP) of the European Medicines Agency; Austrian delegate in the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency
Andreas BRANDT
Statistical assessor,
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Ina-Christine RONDAK
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA, Germany
Ágnes GYURASICS,
Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition, Hungary
ROUND TABLE DISCUSSION
an open, structured discussion within a round table framework. This session provided an opportunity for a constructive dialogue between regulators, sponsors, academic and clinical researchers to elaborate and exchange their ideas on the current development issues an challenges of follow-on biologics.
- Moderator:
Helmut SCHÜTZ
Owner
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria
- Discussant:
Industry perspective: Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars,
Analytics group, Novartis, Germany
- Panel members:
Júlia SINGER
Chief Scientific Officer, Accelsiors CRO Ltd.;
President of the Hungarian Society for Clinical Biostatistics, Hungary
Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES);
Assessor, EMA Biostatistics Working Party; Alternate Member, EMA Scientific Advice Working Party;
Former President of the Viennese Section of the International Biometric Society, Austria
