PROGRAMME OF THE 4th ANNUAL BIOSIMILARS FORUM (17-18 OCT, 2019)

This 2-day series of events consists of a professional COURSE DAY and a SYMPOSIUM DAY, comprising burning issues in Biosimilar development with a dedicated focus on the statistical and regulatory aspects of follow-on biologics.

During these two interactive days the forum ensures maximum knowledge transfer among professionals, regulators and leading subject matter experts in biosimilar development to exchange and elaborate on the best practices and debate the evolving landscape, pitfalls and current perspectives of biosimilars.

COURSE DAY

17 OCT, 2019

professional course in advanced biostatistics and robust methods in assessing biosimilarity, will be delivered by prominent biosimilar research expert scientists.

SYMPOSIUM DAY

18 OCT, 2019

professional presentations and round table sessions, focusing on statistical and regulatory perspectives in biosimilar development (presented by leading experts from the fields of regulatory, academic and clinical research).

 SYMPOSIUM DAY PROGRAMME 18 OCT

As in previous years, visitors can take part in the event with world-prominent subject matter experts from the fields of regulatory, academic and clinical research, who will be providing a detailed overview of current development issues of follow-on biologics and guidance for their handling.

Agenda of the Symposium day

 8:30 – 9:00 | 2nd day Registration

9:00 – 10:40 | THEORETICAL CONSIDERATIONS

  • Symposium opening

Session Chair: 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

  • Multiplicity issues in biosimilar development programs

Franz KÖNIG
Associate Professor,
Section for Medical Statistics, Medical University of Vienna, Austria

  • 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

  • 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

  • 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

10:40 – 11:15 | Coffee break and networking

11:15 – 13:00 | 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

13:00 – 14:00 | Lunch break and networking

14:00 – 15:30 | CHALLENGE THE REGULATOR

This extended Regulatory Panel Discussion and Q&A type of interaction replies 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 will look 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

15:30 – 16:00 | Coffee break and networking

16:00 – 17:00 | ROUND TABLE DISCUSSION

an open, structured discussion within a round table framework. This session provides 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

  • Discussants:

Industry perspective: Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars,
Analytics group, Novartis, Germany

Regulatory perspective: 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

  • Panel members:

Ildikó ARADI
Former Vice-Chair, Medicines for Europe, Biosimilar Medicines Group,
Hungary

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

Franz KÖNIG
Associate Professor,
Section for Medical Statistics, Medical University of Vienna, Austria

Discover more about the Forum:
COURSE DAY PROGRAMME

Join us for discovery, inspiration and meet leading biosimilar development experts at our Forum!

The last modular tickets are available with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium programme for free.