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.

For more information, photo gallery, short video interviews with the key lecturers please, scroll down.

We had a successful and professionally fruitful event together last year.
Learn more about the programme of the 2nd Annual Biosimilars Forum!


GALLERY

Video interviews

Please watch these short video interviews with the key lecturers and industry representatives of the 2nd Annual Biosimolars Forum about their current research interests, general views on biosimilars drug product development and about the perspectives of this professional conference series.

 

 

Account of experiences about the 2nd Annual Biosimilars Forum

World’s prominent biosimilar development experts have returned to Budapest to the 2nd Annual Biosimilars Forum on 5 – 6 October, 2017.

Accelsiors CRO has partnered with the Viennese Section of the International Biometric Society and the Hungarian Society for Clinical Biostatistics once again to deliver this unique professional forum for research management, leadership and support teams working in and for biosimilar drug development.

The professionally very fruitful 2nd Biosimilars Forum was hosted in Budapest, 5 – 6 October, 2017 by Accelsiors CRO with participation of internationally renowned experts of biosimilar drug development such as Prof. Dr. László Endrényi (Professor Emeritus of University of Toronto), Andrea Laslop (Head of Scientific Office, Austrian Medicines and Medical Devices Agency), Helmut Schütz (Owner at BEBAC – Consultancy Services), and clinical researchers, biostatisticians, regulatory professionals and sponsors from around the world.

This year’s two-day forum covered important issues and specific areas of debate facing clinical development teams specialized on biosimilars. The program of the event was very comprehensive and integrated multiple perspectives on current biosimilar research.

Focused on statistical and regulatory perspectives of biosimilar development

The 2nd Annual Biosimilars Forum welcomed László Endrényi Professor Emeritus from the University of Toronto who presented a lecture about Scientific factors in biosimilar product development. A very substantial course was delivered by Helmut Schütz, owner at BEBAC – Consultancy Services, who gave a detailed overview about open issues in the assessment of bioequivalence and biosimilarity.

The EMA regulatory expert Andrea Laslop showcased her keynote presentation about the 12 years of biosimilars in Europe and provided an essential understanding of the European regulatory framework. The regulatory part of the forum was further strengthened by Ina-Christine Rondak’s lecture (Seconded National Expert from Technische Universität München to EMA), she presented a useful overview of regulatory perspective on comparison of quality attributes in drug development.

As a very interesting novelty in this year’s program Prof. Janos Szebeni, Director of the Nanomedicine Research and Education Center delivered a keynote presentation about the immune side effects and unsolved issues in bio- and nanosimilar development.

The program of the event gave deep insight into the statistical perspective of biosimilar research. The prominent lecturers such as László Tóthfalusi (Associate Professor of Semmelweis Medical University), Bernd Jilma (Vice Chair, Department Clinical Pharmacology, Medical University of Vienna) and Johanna Mielke (Biostatistician at Novartis Pharma AG) provided an overview about scientific principles and methodologies used in the design and analysis of biosimilar studies as well as their recent industry experiences.

The members of the round table section from industry, regulatory and academic site had a really fruitful and constructive discussion both on actual challenges and open issues of biosimilar development. The participants of this open discussion such as Stephan Lehr (Biostatistician, Austrian Medicines and Medical Devices Agency and President of Viennese Section of IBS), Heike Wöhling (Head of Biostatistics, Sandoz Biopharmaceuticals), Ildikó ARADI (Head of Clinical Development of Biologics, Gedeon Richter Plc., Vice-Chair, European Generic medicines Association – European Biosimilars Group), Franz KÖNIG (Associate Professor at Medical Unversity of Vienna, Section for Medical Statistics), Vid STANULOVIC (Consultant, Clinical Development and Pharmacovigilance) had a highly constructive conversation about regulatory and industry perspectives of biosimilars, recent developments, as well as about essential statistical methods and high-level research.

The organizers are delighted that they could establish an opportunity with this event series for a constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate and many interested people visited the event to learn and network. Visitors could take part in the experience with some of the world’s most prominent experts of this innovative field who gave a detailed overview in biosimilar product development and gave a guidance how to adjust clinical research practice to effective legislation or vice versa, raised ideas on how legislation could be developed further to meet the challenges this quickly developing field pose.

The organizers of the 2nd Annual Biosimilars Forum are proud that they once more had the chance to support biosimilar development professionals and they have assisted in sharing of recent scientific and practical knowledge aimed at increasing effectiveness of drug research.

SPEAKERS AND LECTURERS

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 TÓTFALUSI
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)

AGENDA OF THE 2nd ANNUAL BIOSIMILARS FORUM (OCT, 2017)

This two-day series of events consisted of a COURSE DAY (October 5th, 2017) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 6th, 2017) regarding hot topics related to the development of biosimilars with strong FOCUS ON Statistical and Regulatory Perspectives.
5th OCTOBER, 2017

1st day: COURSE with special lecturers

11:00 – 12:00 

1st Day Registration

12:00 – 13:00

Scientific factors in biosimilar product development

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

13:00 – 14:00 

Lunch break

14:00 – 17:40

Open issues in the assessment of bioequivalence and biosimilarity

The course is lectured by:
Helmut Schütz,
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
Main topics of the course:
  • Unequal carry-over – “solved” in BE but still an Issue in Assessing Biosimilarity?
  • Multi-Group and Multi-Site Studies. To pool or not to pool?
  • Group-Sequential and Two-Stage Designs.
  • Reference-scaling and Control of the Type I Error.
Schedule of the course:
14:00 – 15:00   |   1st part of COURSE
15:00 – 15:20   |   Coffee break: refreshments & networking
15:20 – 16:20   |   2nd part of COURSE
16:20 – 16:40   |   Coffee break: refreshments & networking
16:40 – 17:40   |   3rd part of COURSE

17:40 – 18:00

Discussion

6th OCTOBER, 2017

2nd day: SYMPOSIUM and ROUND TABLE SECTION

9:00 – 9:30 

2nd Day Registration (for those attending only day 2)

9:30 – 10:00

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

Johanna MIELKE,
Biostatistician,
Novartis Pharma AG

10:00 – 10:30

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

László TÓTHFALUSI,
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Budapest
László ENDRÉNYI,
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

10:30 – 11:00

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

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

11:00 – 11:30

Coffee Break

11:30 – 12:20

1st Keynote lecture: 12 years of biosimilars in Europe: what’s the exposure and response in our learning curve?

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

12:20 – 12:50

Regulatory perspective on comparison of quality attributes in drug development

Ina-Christine RONDAK,
Biostatistician,
Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA
Stephan LEHR,
Biostatistician, Austrian Medicines and Medical Devices Agency,
President, Viennese Section of IBS

12:50 – 13:45

Lunch Break

13:45 – 14:25

2nd Keynote lecture: Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar 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

14:25 – 14:45

Coffee Break

14:45 – 16:45

Round table discussion:

Moderator:
Júlia SINGER,
Chief Scientific Officer, Accelsiors CRO Ltd.;
President, Hungarian Society for Clinical Biostatistics
Discussants:
Regulatory perspective: Stephan LEHR,
Biostatistician, Austrian Medicines and Medical Devices Agency,
President, Viennese Section of IBS
Industry perspective: Heike WÖHLING,
Head of Biostatistics,
Sandoz Biopharmaceuticals
Panel members:
Ildikó ARADI ,
Head of Clinical Development of Biologics, Gedeon Richter Plc.,
Vice-Chair, European Generic medicines Association – European Biosimilars Group
Bernd JILMA,
Vice Chair,
Department Clinical Pharmacology, Medical University of Vienna
Franz KÖNIG,
Associate Professor,
Medical Unversity of Vienna, Section for Medical Statistics
Andrea LASLOP,
Unit Head,
Austrian Medicines and Medical Devices Agency
Johanna MIELKE,
Biostatistician,
Novartis Pharma AG
Vid STANULOVIC,
Consultant,
Clinical Development and Pharmacovigilance