3RD ANNUAL BIOSIMILARS FORUM – HOSTED BY ACCELSIORS

Join us for discovery, networking and inspiration at our 3rd professional event, and focus on statistical and regulatory perspectives in biosimilar development with leading experts from the fields of regulatory, academic and clinical research.

Based on the success of the last years’ events the Viennese Section of the International Biometric Society and the Hungarian Society for Clinical Biostatistics have partnered with Accelsiors CRO once again to deliver the 3rd Annual Biosimilars Forum, to be held on 25th – 27th October, 2018 in Budapest for research management, leadership and support teams working in and for biosimilar drug development. This year’s event will cover important issues and specific areas of debate facing clinical development teams specialized on biosimilars with a strong focus on statistical and regulatory perspectives.

The event will provide a detailed overview of current development issues of follow-on biologics and guidance for their handling, additionally, the unique specialty of this professional forum is that it brings together regulators, medical scientists, clinical researchers and pharmaceutical development companies from around the world to provide an opportunity for a constructive dialogue related to the specific challenges of biosimilar development.

Leading biosimilar development experts from the fields of regulatory, academic and clinical research will return to Budapest in 2018 to the 3rd Biosimilars Forum. Some of them:

This 3-day series of events consists of a COURSE DAY with two professional lecture sessions (25th OCT), a SYMPOSIUM DAY (invited presentations and round table session, scheduled for 26th OCT) and a SEMINAR DAY (lectured by special experts from the field of nanotechnology-formulated drug development – 27th OCT) comprising issues in Bio- and Nanosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.

SHORT AGENDA

25th October, 2018 | Professional COURSES with special lecturers

• Thomas JAKI and Phillip PALLMANN: Uni- and multivariate Bioequivalence of PK parameters
• Ludwig A. HOTHORN: Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints

26th October, 2018 | SYMPOSIUM and ROUND TABLE – Clinical studies and regulatory questions

As in previous years, the programme of the event will be supported and complemented by leading experts from the fields of regulatory, academic and clinical research 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.

WBS and ISCB members can attend the 2nd day symposium for free. Please send us your registration as soon as possible because places are limited in number! We look forward to meeting you in Budapest!

Lectures from the programme of the Symposium day:

• László Endrényi and László Tóthfalusi: Bioequivalence of highly variable drug products – an update (Scientific Keynote Presentation)
• Andrea Laslop: The biosimilar concept revisited – is there a need for change? (Regulatory Keynote Presentation)
• Ágnes Gyurasics: Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars
• Johanna Mielke: An update on development strategies of recently approved biosimilars in Europe
• Emmanuelle Vincent: Opportunities and limitations of a blinded sample size reassessment in biosimilars development
• Johanna Mielke: Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach
• János Szebeni: Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals
• Heike Woehling: How the increase of assay sensitivity influences the immunogenicity assessment

NEW! 27th October, 2018 | Professional SEMINAR: Nanotechnology in drug development

The programme of the 3rd day is dedicated to professional Seminar sessions with a strong focus on current perspectives of Biosimilar and Nanosimilar drug development, will be delivered by special international experts from the field of nanotechnology-formulated drug development. Some seminar titles form the 3rd day programme:

• Raj BAWA: The Era of Biosimilars and Nanosimilars: Current Perspectives (Morning seminar session)
• Gert STORM: Targeted Nanomedicine: State of Art and Future Developments
• Marina A. DOBROVOLSKAIA: The immunological characterization of nanotechnology-formulated drugs

The list of speakers, Agenda, tickets with flexible terms and the registration details are available at the event’s official website: www.biosimsforum.com

Participation is particularly useful for those who are interested in constructive and open dialogue between regulatory professionals, medical statisticians, clinical researchers and sponsors with whom they collaborate. Tickets are available now with flexible terms at the event’s official website. Please send us your registration as soon as possible because places are limited in number.