We had a successful and professionally fruitful event together in this year at our 4th professional event in a row, where we focused on the statistical and regulatory aspects of biosimilar development with leading experts from the fields of regulatory, academic and clinical research. 

The specialty of the series is that it brings the regulators, industry leaders, clinical researchers as well as medical scientists together from around the world and provides an opportunity for a constructive dialogue between them about the burning issues and challenges of biosimilars and as in previously, this year’s event also provided a detailed overview of current development issues of follow-on biologics and guidance for their handling.

Scientific Programme Committee

Bernd JILMA 
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

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

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

Stephan LEHR 
Statistician, Austrian Medicines and Medical Devices Agency

Júlia SINGER 
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics

Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis

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:

 

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

This 2-day series of events consisted of a professional short COURSE in advanced biostatistics (on October 17th) and a SYMPOSIUM DAY with invited presentations, posters and round table session (scheduled for October 18th) 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 ensured 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 short course in advanced biostatistics:

Robust methods for assessment of average and scaled average bioequivalence

Presenters:

Robert SCHALL
Professor, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa

in cooperation with

Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria, South Africa

Discover more details:
COURSE DAY PROGRAMME

SYMPOSIUM DAY

18 OCT, 2019

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.

Regulatory Keynote Speaker: Andrea LASLOP
Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES), Austria

Some topics from the programme:

  • Challenge the Regulator – special Q&A session on hot topics
  • Scientific factors in biosimilar product development
  • Recent developments and best practices in assessing biosimilarity
  • Clinical study designs
  • and much more with constructive professional exchanges about the current prespectives, development trends, burning issues and challenges of biosimilars
Discover more:
SYMPOSIUM DAY PROGRAMME

Speakers and invited professional guests of the 4th Annual Biosimilars Forum

Academic and clinical researchers, regulatory representatives and industry leaders gathered together from around the world to share with each other their perspectives on the most important issues and challenges of biosimilar research. Some speakers who have accepted our invitation:

Andrea LASLOP 
Head of Scientific Office, Austrian Medicines and Medical Devices Agency (AGES); Member of the Scientific Advice Working Party (SAWP) of the EMA; Austria

Robert SCHALL
Professor, Statistical Consultation Unit, Department of Mathematical Statistics and Actuarial Science, University of the Free State,
South Africa

Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria, South Africa

László TÓTHFALUSI
Associate Professor, Faculty of Pharmacology, Semmelweis Medical University, Hungary

Arne RING
Professor of Statistics, University of the Free State, South Africa; Head of Biometrics and Statistical Programming, medac GmbH, Germany

Júlia SINGER 
Chief Scientific Officer, Accelsiors CRO Ltd.; President of the Hungarian Society for Clinical Biostatistics, Hungary


Andreas BRANDT 
Statistical assessor, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Stephan LEHR 
Biostatistician, Austrian Medicines and Medical Devices Agency (AGES); former President of the Viennese Section of IBS, Austria

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 and EMA Paediatric Committee; Unit Head at National Institute of Pharmacy and Nutrition, Hungary

Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria

Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany


We had 4 very successful and professionally fruitful events in the previous years in a row, please read more about our former forums!

The summary page about our previous events is available in:

LEARN MORE ABOUT THE PREVIOUS EVENTS!

At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research.
Click on the button below and take a look at the professional lectures of our events, short video interviews with the key speakers, photo galleries and more.

SOME SPEAKERS FROM OUR PREVIOUS FORUMS

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada

Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna, Austria

Andrea LASLOP  
Unit Head, Austrian Medicines and Medical Devices Agency, Austria

Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Hungary

TESTIMONIALS

  • Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.

    –Bernd JILMA | Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

  • I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!

    –Ildikó ARADI | Vice-Chair, Medicines for Europe, Biosimilar Medicines Group

  • These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …

    –László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto

  • The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.

    –Shein-Chung CHOW | Professor, Duke University School of Medicine

  • These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.

    –János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University