会前工作研讨会 - 分析开发、确认、试样分析之技术建言

课程主持者：

Boris Gorovits, Ph.D., Director, Bioanalytical R&D, Wyeth  and Michael G. Tovey, Director, Laboratory of Viral Oncology, Institute Andre Lwoff

关于免疫抗原性(immunogenicity)之议题，目前焦点置于准确的临床前评估及临床的意义。
专家提供建议的白皮书尽管有所帮助，但仍遗留下许多问题及不明白之处。其中最主要的问题，诸如在分析过程中，游离药物的处理，获得积极正面结果之困难，以及在没有明确规定下，要满足法令主管当局之困难。
这些问题将由来自相同领域之领导者，发表临床前期及临床案例之详细分析。
此外，为时半日的会前工作研讨会中，将探讨免疫抗原性测试协议之建议。

这个会议将报告降低或是除去免疫抗原性药剂之开发现况。检视有助于免疫抗原性之各种因子，包括赋形剂、团聚、不纯物、投药经路、T细胞・B细胞之抗原决定位(epitope)等。为了将免疫抗原性降至最低，将议论评估诸如灭杀除癌(Methotrexate)的角色与类PEG序列的优点。
在案例学习中，临床医师将从有害的折叠构造蛋白质，到T或B细胞抗原决定位，介绍测量及除去免疫抗原的技术。
此外，并报告制品作用、其对安定性之影响，以及临床案例学习结果。另外将针对非免疫原性生物制剂开发的应用，进行技术上的评估。

邀请演讲：

抗药物抗体之临床影响

Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec, Inc.

EU方针中，治疗用单株抗体的免疫原性风险评估之优先化

Paul Chamberlain, NDA Advisory Board

 免疫耐受性诱导(tolerance induction)之临床前案例研究及临床计画

Richard Garman Ph.D., Scientific Director, Immunology R&D, Genzyme Corp.

焦点演讲者：

• Susan Richard, Ph.D., Group Vice President, Clinical Laboratory Science, Genzyme Corporation
• Bonnie Rup, Ph.D., Assistant Vice President, Protein Bioanalytics, Drug Safety and Metabolism, Wyeth Research
• Michael G. Tovey, Ph.D., Director of Research, Laboratory of Viral Oncology, Institute Andre Lwoff, CNRS
• Susan Kirshner, Associate Chief, Laboratory of Immunology, Office of Biotechnology, FDA
• Boris Gorovits, Ph.D., Director, Drug Safety Metabolism, Bioanalytical R&D, Wyeth
• Matthew Baker, Ph.D., Chief Scientific Officer, Antitope Ltd.

列席者：

• Michele Fiscella, Ph.D., Associate Director, Clinical Immunology Department, Human Genome Sciences
• Dong Geng, Principal Scientist, Bioanalytical Sciences, Bristol-Myers Squibb Co.
• Bonnie Wu Ph.D., Senior Research Scientist, Clinical Pharmacology Sciences, Centocor Research & Development Inc.
• Meina Liang, Ph.D., Associate Director, PKPD & Bioanalysis, MedImmune, Inc.
• Joy Cavagnaro, Ph.D., D.A.B.T., R.A.C., President, Access BIO, LC
• Nadja S. Prang-Richard, Ph.D., M.B.A., Program Director Monoclonal Antibodies, LFB S.A.
• Jochem Gokemeijer, Principal Scientist, Pharmacology, Adnexus Therapeutics, a Bristol-Myers Squibb R&D Company
• Claire Dobson, Ph.D., Head of Display Technology - Neuroscience & CVGI, Lead Generation, MedImmune, Inc.
• Sally Fischer Ph.D., Senior Scientist / Group Leader, Bioanalytical Research and Development (BARD), Genentech, Inc.
• Erik D. Foehr, Ph.D., Director, BioAnalytical Research and Development, BioMarin Pharmaceuticals, Inc.
• Albert Torri, Ph.D., Senior Director, Pre-clinical Development, Regeneron Pharmaceuticals Inc.
• Steve Keller, Director, Pre-clinical and Clinical Development Sciences, Facet Biotech, Inc.
• Joël Richard Ph.D., Senior Director, Head of Drug Product Development, Pharmaceutical Development, IPSEN - Beaufour Ipsen Industrie
• Jack A. Ragheb, M.D., Ph.D., Senior Regulatory Research Officer, Laboratory of Immunology, Department of Therapeutic Proteins, CDER, FDA. (Tentative)
• Richard Garman Ph.D., Scientific Director, Immunology R&D, Genzyme
• Barend Bouma Ph.D., Chief Operating Officer, Head Research & Development, Crossbeta Biosciences BV
• Volker Schellenberger, Ph.D., Vice President, Drug Discovery, Amunix, Inc.
• Paul W.H.I. Parren Ph.D., Vice President, Research & Pre-clinical Development, Genmab
• Philippe Stas, MBA, CEO, Algonomics
• Fiona A. Harding, Ph.D., Associate Director, New Technologies, Facet Biotech, Inc.
• David Estell, Vice President, Innovation, Genencor International
• Tina Furebring Ph.D., Vice President, Research & Development, Alligator Bioscience