ABOUT THE EVENT SERIES

The Annual Biosimilars Forum event series examines the actual challenges of biosimilar and nanotechnology formulated drug development for research management, leadership and support teams working in and for biosimilar drug development. The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling.

This year’s event will cover important issues and specific areas of debate facing clinical development teams specialized in bio- and nanosimilar development with a strong focus on statistical and regulatory perspectives. As in previous years, the program of the event will be supported and complemented by leading experts from the fields of regulatory, academic and clinical research.

CALL FOR ABSTRACT SUBMISSIONS

This year the Scientific Programme Committee plans to organize a Contributed Papers section and a Poster section within the Forum.

The organizers are pleased to invite authors to submit abstracts for poster and oral symposium presentations to be delivered at the 3rd Annual Biosimilars Forum.

Email us your Abstract, participate at our 3rd event with your professional work!

SHORT AGENDA

At this 3-day series of events we will be focusing on the most actual issues and challenges in bio- and nanosimilar drug development with a strong focus on STATISTICAL and REGULATORY perspectives.

25 OCT, 2018 | COURSES with special lecturers

26 OCT, 2018 | SYMPOSIUM DAY: invited presentations, posters and round table session

27 OCT, 2018 | SEMINAR DAY: Nanotechnology in drug development

SPEAKERS AND LECTURERS

As in previous years, the programme of the event will be supported and complemented by international specialists from the biosimilars and nanosimilars area. The agenda of the forum will continue to expand until October with internationally renowned experts. Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum (more speakers coming soon):


Raj BAWA
President of Bawa Biotech LLC; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA


László ENDRÉNYI
Professor Emeritus from the University of Toronto, Canada; Former President of Canadian Society for Pharmaceutical Scientists, Canada


Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany


Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK


Andrea LASLOP
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria


Gert STORM
Professor of Targeted Nanomedicine at the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands

Tickets are available now 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 for free.
Register before 25th of MAY, and get up to 25% EARLY BIRD DISCOUNT from the ticket price!

25 OCT – 1st day COURSES with special lecturers

MORNING COURSE SESSION

Uni- and multivariate Bioequivalence of
PK parameters

Lectured by: Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK

In cooperation with: Phillip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

AFTERNOON COURSE SESSION

Preclinical biosimilar assays consider both bioequivalence (PK) and equivalence (surrogate therapeutic endpoints)

Lecturer of the Afternoon Course Session:

Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany

26 OCT – 2nd day SYMPOSIUM – Some lectures from the programme of the day:

Regulatory Keynote Presentation: The biosimilar concept revisited – is there a need for change?

Andrea LASLOP
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria

Scientific Keynote Presentation: Bioequivalence of highly variable drug products – an update

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

Co-author: László TÓTHFALUSI
Associate Professor, Faculty of Pharmacology, Semmelweis Medical University, Budapest, Hungary

Biosimilars in paediatrics: extrapolation of totality of evidence, indications, and other possible challenges

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

Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals

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

Challenges with safety assessments in biosimilar studies

Emmanuelle VINCENT
Head of Biostatistics and Data Management,
Fresenius-Kabi, Switzerland

How the increase of assay sensitivity influences the immunogenicity assessment

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

27 OCT – 3rd day SEMINAR – Nanotechnology in drug development | Some lectures from the programme:  

Professional Seminar:
The Era of Biosimilars and Nanosimilars: Current Perspectives

Raj BAWA
President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA

The immunological characterization of nanotechnology-formulated drugs

Marina A. DOBROVOLSKAIA
Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA

Targeted Nanomedicine: State of Art and Future Developments

Gert STORM
Professor of Targeted Nanomedicine at the Department of Pharmaceuticst of the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands

SCIENTIFIC PROGRAMME COMMITTEE

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

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

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

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

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

 Video Lesson 3 (with 2 professional topics) | Available now

EXCLUSIVE CONTENT – free video lecture series

Sign up and watch all of the presentation videos recorded at the 2nd Biosimilars Forum for free. Learn from the World’s prominent biosimilar drug development experts.

This video lecture series includes the professional courses & lectures delivered at the previous Forum relating to actual issues and challenges of follow-on biologics and guidance for their handling. All the lessons of the 3-part course about the ‘Open issues in the assessment of bioequivalence and biosimilarity’ lectured by Helmut SCHÜTZ are available now.

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 | Head of Clinical Development of Biologics, Gedeon Richter Plc.

  • 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

The detailed programme of the event will be available soon, until then we recommend you read more about our previous 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