2018年度 臨床統計家育成 専門セミナー 第1回

2018年度 臨床統計家育成 専門セミナー (第1回)

主催  国立循環器病研究センター・データサイエンス部
共催：京都大学医学研究科・医療統計学，京都大学医学研究科・臨床統計学

日本医療研究開発機構(AMED)・生物統計家育成支援事業(京都大学×京都大学病院×国立循環器病研究センター)の一環として，国循・臨床統計家育成 専門セミナーを企画しました．医薬品・医療機器開発，臨床試験に参画する統計家としての専門性を高めるためのセミナーです．演者としてByron Jones先生を招へいし，"Design and Analysis of Biosimilarity Studies"(｢生物学的類似性試験のデザインと解析｣)について講演いただきます．

申し込みは下記のURLから，参加申し込みをお願いします．定員は35名で，定員に達したところで申し込み受け付けを終了します．参加費は無料です．同時通訳の提供はありません．皆様の奮ってのご参加をお待ちしています．

【 日　時 】2018年6月8日　午後1時30分～4時 (開場 午後1時～)
【 場　所 】大阪市北区鶴野町1番5号　関西大学梅田キャンパス 7階 701
【 参加費 】無料
【参加登録】http://www.kokuchpro.com/event/ncvcds1806BJ
【 講　師 】Professor Dr. Byron Jones (Novartis)
【 演　題 】Design and Analysis of Biosimilarity Studies
【講演要旨】A biosimilar is meant to be a cheaper copy of a marketed biologic that is produced after the patent on the original biologic has expired. Most biologics are very large, complex molecules or mixtures of molecules and are manufactured in living systems such as microorganisms, or plant or animal cells. Biologics have revolutionised the treatment of patients in important areas like cancer, diabetes and inflammatory diseases. Unlike generics, which are exact copies of small molecule drugs, and therefore can be considered as equivalent to the original drug, biosimilars can only be considered as “similar” to the originator biologic because of the complex processes needed to manufacture them. This talk will consider the statistical aspects of the guidance given by the USA Food and Drug Administration (the FDA) to sponsors who wish to develop a biosimilar. The guidance recommends a stepwise approach where similarity is shown first at the functional and structural (molecular) level, then at the non-clinical and PK/PD level and then finally at the clinical level. A key principle in this approach is that regulatory decisions will be based on the “totality of the evidence”, which is an integration of all the evidence from all of the steps.

We will briefly illustrate the statistical testing required at each of the steps in the FDA’s stepwise approach and make some comments on the properties possessed by the various tests.

It is possible, under the FDA approval process, for a biosimilar to be authorized for use as an interchangeable biosimilar, which means a patient can switch back and forth between the original biologic and the biosimilar without any loss of efficacy or increased safety risk. How to test if switching can be allowed is still open for debate. In this talk, we will propose several statistical approaches to test if a biosimilar and the original biologic are interchangeable and compare their properties and illustrate their use.

Professor Dr. Byron Jones is a Senior Biometrical Fellow and Executive Director in the Statistical Methodology and Consulting Group at Novartis Pharma AG in Basel Switzerland. Prior to joining Novartis in 2011 he was a Senior Statistical Consultant and Senior Director at Pfizer Inc for the previous seven years. Before that he was a Senior Director and UK Head of the Research Statistics Unit at GSK. He is a Visiting Professor in the Department of Health Sciences, University of Leicester and a Visiting Professorial Fellow in the School of Mathematics at Queen Mary College, University of London. He is a Fellow of the American Statistical Association. He was a PSI Board of Directors member and in 2016 led the successful campaign to save PSI. For the twenty-five years previous to joining the pharmaceutical industry he worked in academia, ultimately holding the position of Professor of Medical Statistics at De Montfort University. He was the Founder and Managing Director of CliniStat, the De Montfort University external consulting company. He is the joint author of four statistical text books (three in second editions and one in a third edition) and over 110 peer-reviewed publications. He is a Series Editor for Chapman and Hall/CRC Press' Biostatistics book series. He is a Founding Editor-in-Chief of the journal Pharmaceutical Statistics and formerly an Associate Editor of JRSS Series B and a Regional Editor of the Journal of Biopharmaceutical Statistics. He serves on several University Advisory Boards including Oxford University's Department of Statistics.