As in previous years, visitors could take part in the event with world-prominent subject matter experts from the fields of regulatory, academic and clinical research, who provided 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 | 2^nd day Registration

9:00 – 10:20 | 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

• Balaam’s Design Revisited

• Measuring switchability using observational data

• Applications of the expected power (statistical assurance) for bioequivalence trials

10:20 – 10:45 | Coffee break and networking

10:45 – 12:30 | 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

12:30 – 13:30 | Lunch break and networking

13:30 – 15:00 | 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

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

15:30 – 16:30 | 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

• Discussants:

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