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White Paper

2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

Olga Kholmanskikhn Belgium FAMHP, Brussels, Belgium

,

Yow-Ming Wangg US FDA, Silver Spring, MD, USA

,

Sarah Herseyb Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Meenu Wadhwad UK MHRA, London, UK

,

Katherine Blocka Genentech, South San Francisco, CA, USA

,

Abbas Bandukwalag US FDA, Silver Spring, MD, USA

,

Matthew Szapacsc Abbvie, Philadelphia, PA, USA

,

Russell Weinere Takeda, Cambridge, MA, USA

,

Khader Awwadf Abbvie, Ludwigshafen, Germany

,

Francis Dessyh GlaxoSmithKline, Rixensart, Belgium;i Takeda, Cambridge, MA, USA

,

Sean Downinge Takeda, Cambridge, MA, USA

,

Xiulian Dug US FDA, Silver Spring, MD, USA

,

Fabio Garofoloj BRI Frontage, Vancouver, BC, CanadaCorrespondence[email protected]

,

Shannon Harrisk HilleVax, Cambridge, MA, USA

,

Victor Houl Moderna, Cambridge, MA, USA

,

Jennifer Jonesb Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Sumit Karm WRIB, Toronto, ON, Canada

,

Arvind Kinhikaro Novartis, Cambridge, MA, USA

,

Ming Lip Stoke, Cambridge, MA, USA

,

Joel Mathewsq Ionis, Carlsbad, CA, USA

,

John Meissenr AstraZeneca, South San Francisco, CA, USA

,

Giane Oliveira Sumners Regeneron, Tarrytown, NY, USA

,

Luying Pane Takeda, Cambridge, MA, USA

,

Gerard Sanderinkt Sanofi Pasteur, Swiftwater, PA, USA

,

Ingrid Scullyu Pfizer, Pearl River, NY, USA

,

Johannes Stantav Celerion, Stevenage, UK

,

Yoichi Tanakaw Japan MHLW, Tokyo, Japan

,

Stephanie Vauleonx F. Hoffmann-La Roche Ltd, Basel, Switzerland

,

Leslie Wagnerg US FDA, Silver Spring, MD, USA

,

Kai Wangy GlaxoSmithKline, Collegeville, PA, USA

,

Liang Zhul Moderna, Cambridge, MA, USA

,

Steven Eckaa AstraZeneca, Gaithersburg, MD, USA

,

Yi-Dong Line Takeda, Cambridge, MA, USA

,

Mitra Azadehz Ultragenyx, Cambridge, MA, USA

,

Vilma Decmany GlaxoSmithKline, Collegeville, PA, USA

,

Sandra Dieboldd UK MHRA, London, UK

,

Xiulian Dug US FDA, Silver Spring, MD, USA

,

Polina Goihbergab Pfizer, Andover, MA, USA

,

Enrique Gomez Alcaidex F. Hoffmann-La Roche Ltd, Basel, Switzerland

,

Christele Gonneauac Labcorp, Meyrin, Switzerland

,

Michael Nathan Hedrickb Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Gregory Hopkinsad 2seventy Bio, Cambridge, MA, USA

,

Sumit Karm WRIB, Toronto, ON, Canada

,

Jakob Loschkou Pfizer, Pearl River, NY, USA

,

Megan McCauslandae Q2 Solutions, Atlanta. GA, USA

,

Luis Mendezaf Merck, Kenilworth, NJ, USA

,

Sarita Sehraag Incyte, Wilmington, DE, USA

,

Erin Stevensah Pfizer, Groton, CT, USA

,

Yongliang Steve Sunb Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Shabnam Tangriai Navigate, a Novartis Subsidiary, San Diego, CA, USA

,

Paul C Trampontl Moderna, Cambridge, MA, USA

,

Isabelle Cludtsd UK MHRA, London, UK

,

Mark Dysingeraj Alexion, New Haven, CT, USA

,

Uma Kavitaak Spark Therapeutics, Plainsboro, NJ, USA

,

Hiroshi Sugimotoe Takeda, Cambridge, MA, USA

,

Shannon Chilewskib Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Christine Grimaldis Regeneron, Tarrytown, NY, USA

,

Yong Jiangy GlaxoSmithKline, Collegeville, PA, USA

,

John Kamerudab Pfizer, Andover, MA, USA

,

Susana Liual Pfizer, Kirkland, QC, Canada

,

Carolina Owenah Pfizer, Groton, CT, USA

,

Nisha Palackals Regeneron, Tarrytown, NY, USA

,

Corinne Petit-freream Fresenius Kabi, Bad Homburg, Germany

,

Samuel Pinean Sanofi, Ghent, Belgium

,

Mohsen Rajabi Abharig US FDA, Silver Spring, MD, USA

,

Kara Scheibnerg US FDA, Silver Spring, MD, USA

,

LaKenya Williamsb Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Tao Xuao Frontage, Exton, PA, USA

&

Guodong Zhangap Alnylam, Cambridge, MA, USA

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