Our 2nd annual event with the participation of scientific experts and prominent professionals from the field of clinical research

This unique forum – as a continuation of the very successful 1st Annual Biosimilars Forum in Budapest from last year – covered important issues and specific areas of debate facing clinical development teams. It is particularly useful for those who are interested in constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate.

About the 2nd Annual Biosimilars Forum (OCT, 2017)

The 2nd Annual Biosimilars Forum was hosted in Budapest, on October, 2017 by Accelsiors Ltd., clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this hot topic of research in lectures and informal discussions.

Please watch this short video with the key lecturers and the organizers of the forum summarizing their thoughts about the topic and sharing their experiences of this two days forum as an insight into the spirit of active brainstorming during the event.

SCIENTIFIC PROGRAMME COMMITTEE

Ildikó ARADI 
Head of Clinical Development of Biologics, Gedeon Richter Plc.; Vice-Chair, Medicines for Europe, Biosimilar Medicines Group

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

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

Stephan LEHR 
Statistician, Austrian Medicines and Medical Devices Agency; President, Viennese Section of IBS

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

Vid STANULOVIC
Consultant, Clinical Development and Pharmacovigilance

KEYNOTE PRESENTATIONS

12 years of biosimilars in Europe: 

What is the exposure and response
in our learning curve?

Andrea LASLOP
Unit Head, Austrian Medicines and Medical Devices Agency

Immune side effects of biologicals and nanomedicines:

unsolved issues in bio- and nanosimilar development.

János SZEBENI
Director of the Nanomedicine Research and Education Center at Semmelweis Medical University, Budapest and Professor at University of Miskolc, Department of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine

SHORT AGENDA

This two-day series of events consists of a COURSE DAY (October 5th) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 6th) comprising hot topics related to the development of biosimilars with a strong FOCUS ON Statistical and Regulatory perspectives.

5th October, 2017 | COURSE with special lecturer

6th October, 2017 | SYMPOSIUM and ROUND TABLE

Planned topics for presentations and discussions:

EMA “Statistics for quality comparison” reflection paper is out for public consultation (problem statement, and feedback from industry received)

  • Recent developments in assessing biosimilarity
  • Clinical study designs
  • Update on the last year review of the development program of registered Biosimilars in the EU (based on the EPARs)

SPEAKERS AND LECTURES 

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

Title of lecture:

Scientific factors in biosimilar product development

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

Title of course:

Open issues in the assessment of bioequivalence and biosimilarity

Andrea LASLOP
Unit Head,

Austrian Medicines and Medical Devices Agency

Title of keynote presentation:

12 years of biosimilars in Europe:
What is the exposure and response in our learning curve?

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

Title of lecture:

Investigating PK/PD in the steep ascending part of the dose response curve

Stephan LEHR
Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS

Title of lecture:

Statistical considerations in the biosimilarity assessment of quality attributes

Johanna MIELKE

Biostatistician,
Novartis Pharma AG
 

Title of lecture:

Clinical trials for biosimilars in Europe: an updated systematic comparison of the
clinical development programs

Ina-Christine RONDAK
Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA

Title of lecture:

Regulatory perspective on comparison of quality attributes in drug development

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine

Title of lecture:

Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar development

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

Title of lecture:

Algorithms for evaluating reference scaled average bioequivalence: Power, bias and consumer risk

(co-author and lecturer: László Endrényi)

REGISTRATION INFORMATION

Places are limited in number. Please fill out and send us the Registration Form as soon as possible.

Registration deadline: 30th September, 2017

PRICES

Two-day event: € 300
1st day course only: € 250
2nd day only: € 100

    WBS and ISCB members can attend the 2nd day symposium for free