AGENDA

This two-day series of events consists of a COURSE DAY with two professional lecture sessions (October 25th) and a SYMPOSIUM DAY (invited presentations, posters and round table session, scheduled for October 26th) comprising issues in biosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.

The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling. This unique forum will cover specific areas of controversy facing clinical development teams. The Annual Biosimilars Forum event series examines the actual challenges of biosimilar drug development with for research management, leadership and support teams working in and for biosimilars.

Quick-links:    |    SPEAKERS    |     COURSE DAY    |     SYMPOSIUM DAY    |

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

SPEAKERS, LECTURERS, SPECIAL GUESTS

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:


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


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


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


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


Phillip PALLMANN
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK


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


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


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


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


The list will be expanded soon

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!

PROGRAMME OF THE 3rd ANNUAL BIOSIMILARS FORUM

25th OCTOBER, 2018 | 1st day: COURSES with special lecturers

MORNING COURSE SESSION

Uni- and multivariate Bioequivalence of
PK parameters

Lecturers of the Morning Course Session:

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

Abstract:

Testing for the equivalence of the pharmacokinetic behaviour of compounds is an indispensable task in biosimilar and generic development. In many cases this is done on the basis of pharmacokinetic (PK) parameters that summarize how the compound is absorbed, distributed, metabolised and excreted.

In this course we will briefly discuss how different PK parameters can be estimated using a non-compartmental approach and then show how bioequivalence can be assessed on the basis of a single as well as multiple PK parameters.

The R packages PK and jocre will be presented.

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

Abstract:
  • Multiple endpoints are common, and they are not necessarily equally distributed.
  • Equivalence thresholds are, if ever, defined as ratios. Therefore, ratio-to-comparator tests and confidence intervals are needed.
  • Commonly log-normal distribution is assumed. Alternatives for normal distribution (including variance heterogeneity) or any distribution (rank statistics) will be discussed. Claiming equivalence for multiple correlated endpoints is challenging.
  • The pros and cons of multivariate tests and intersection-union tests are discussed.
  • Sometimes bioassays with multiple biosimilars with respect to a single comparator are considered.
  • The pros and cons of multiplicity adjustment will be discussed.
  • The three topics will be explained by means of real data examples using CRAN packages.

Early Bird Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number!

1st Lesson video (available now):

Unequal carry-over – “solved” in BE but still an issue in assessing biosimilarity?

EXCLUSIVE CONTENT – free video lecture series

Watch for free the presentations from the 2nd Biosimilars Forum

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

This video lecture series includes all of the professional courses & lectures delivered at the 2nd Biosimilars Forum relating to actual issues / challenges of follow-on biologics and guidance for their handling. The 1st lesson of the 3-part course about the ‘Open issues in the assessment of bioequivalence and biosimilarity’ lectured by Helmut SCHÜTZ is available now.

26th OCTOBER, 2018 | 2nd day: Professional SYMPOSIUM and ROUND TABLE

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!

Planned programme of the day with a strong

FOCUS on Statistical and Regulatory Perspectives in Bio- and Nanosimilar Development

As in previous years, visitors can take part in the event with world-prominent subject experts from the biosimilars and nanosimilars development areas who will be providing an overview of current regulatory requirements for assessing biosimilarity of biosimilar products and giving detailed guidance to handle differences between regulatory guideline recommendations and clinical research practice.
The detailed agenda and list of speakers of the Symposium day are under preparation, the program of the event will continue to expand until October with internationally renowned speakers from the biosimilars and nanosimilars area.
Some professional lectures from the programme of the Symposium day:

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

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

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

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, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine

Challenges with safety assessments in biosimilar studies

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

How the increase of assay sensitivity influences the immunogenicity assessment

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


This page is frequently being updated, the detailed program of the 2nd day will be available soon, so please come back to learn more. We recommend you to click here and read more about our previous forums!
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!

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.