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White Paper

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)

Matt Szapacs1 Abbvie, Philadelphia, PA, USA

Wenying Jian5 Janssen, Spring House, PA, USA

Daniel Spellman2 Merck, West Point, PA, USA

Jennifer Cunliffe4 Novartis, Cambridge, MA, USA

Elizabeth Verburg3 Lilly, Indianapolis, IN, USA

Surinder Kaur6 Genentech, South San Francisco, CA, USA

John Kellie7 GlaxoSmithKline, Collegeville, PA, USA

Wenkui Li8 Novartis, East Hanover, NJ, USA

John Mehl7 GlaxoSmithKline, Collegeville, PA, USA

Mark Qian9 Takeda, Cambridge, MA, USA

Xiazi Qiu10 WRIB, Montreal, QC, Canada

Federico Riccardi Sirtori11 EMD Serono, Ivrea, TO, Italy

Anton I. Rosenbaum12 AstraZeneca, South San Francisco, CA, USA

Tim Sikorski7 GlaxoSmithKline, Collegeville, PA, USA

Sekhar Surapaneni13 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Jian Wang14 Crinetics, San Diego, CA, USA

Amanda Wilson15 AstraZeneca, Cambridge, UK

Jinhui Zhang16 US FDA, Silver Spring, MD, USA

Yongjun Xue13 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Noah Post17 Ionis, Carlsbad, CA, USA

Yue Huang12 AstraZeneca, South San Francisco, CA, USA

Dina Goykhman2 Merck, West Point, PA, USA

Long Yuan25 Biogen, Cambridge, MA, USA

Kasie Fang7 GlaxoSmithKline, Collegeville, PA, USA

Ellen Casavant6 Genentech, South San Francisco, CA, USA

Linzhi Chen18 Boehringer Ingelheim, Ridgefield, CT, USA

Yunlin Fu8 Novartis, East Hanover, NJ, USA

Ming Huang19 Regeneron, Tarrytown, NY, USA

Allena Ji20 Chiesi, Boston, MA, USA

Jay Johnson21 Pfizer, Andover, MA, USA

Michael Lassman2 Merck, West Point, PA, USA

Jing Li22 Alnylam, Cambridge, MA, USA

Ola Saad6 Genentech, South San Francisco, CA, USA

Hetal Sarvaiya23 Abbvie, San Mateo, CA, USA

Lin Tao24 Sanofi, Framingham, MA, USA

Yuting Wang10 WRIB, Montreal, QC, Canada

Naiyu Zheng13 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Arindam Dasgupta16 US FDA, Silver Spring, MD, USA

Mohsen Rajabi Abhari16 US FDA, Silver Spring, MD, USA

Akiko Ishii-Watabe26 Japan MHLW, Tokyo, Japan

Yoshiro Saito26 Japan MHLW, Tokyo, Japan

Dulcyane Neiva Mendes Fernandes27 Brazil ANVISA, Brasilia, Brazil

Joseph Bower28 Precision for Medicine, Chantilly, VA, USA

Chris Burns29 UK MHRA, London, UK

Kevin Carleton5 Janssen, Spring House, PA, USA

Seongeun (Julia) Cho16 US FDA, Silver Spring, MD, USA

Xiulian Du16 US FDA, Silver Spring, MD, USA

Marianne Fjording30 EWG ICH M10, Copenhagen, Denmark

Fabio Garofolo31 BRI Frontage, Vancouver, BC, CanadaCorrespondence[email protected]

Sumit Kar10 WRIB, Montreal, QC, Canada

Olga Kavetska32 Pfizer, Groton, CT, USA

Elham Kossary33 WHO, Geneva, Switzerland

Yang Lu16 US FDA, Silver Spring, MD, USA

Andrew Mayer7 GlaxoSmithKline, Collegeville, PA, USA

Nisha Palackal19 Regeneron, Tarrytown, NY, USA

Danielle Salha34 Altasciences, Laval, QC, Canada

Eric Thomas35 Labcorp, Indianapolis, IN, USA

Tom Verhaeghe36 Janssen, Beerse, Belgium

Stephen Vinter29 UK MHRA, London, UK

Katty Wan37 Pfizer, San Diego, CA, USA

Yow-Ming Wang16 US FDA, Silver Spring, MD, USA

Kathi Williams6 Genentech, South San Francisco, CA, USA

Eric Woolf2 Merck, West Point, PA, USA

Li Yang16 US FDA, Silver Spring, MD, USA

Eric Yang7 GlaxoSmithKline, Collegeville, PA, USA

Abbas Bandukwala16 US FDA, Silver Spring, MD, USA

Shirley Hopper29 UK MHRA, London, UK

Kevin Maher16 US FDA, Silver Spring, MD, USA

Joshua Xu38 US FDA, Jefferson, AR, USA

Eric Brodsky16 US FDA, Silver Spring, MD, USA

Isabelle Cludts29 UK MHRA, London, UK

Chad Irwin39 Health Canada, Ottawa, ON, Canada

Julie Joseph39 Health Canada, Ottawa, ON, Canada

Susan Kirshner16 US FDA, Silver Spring, MD, USA

Mohanraj Manangeeswaran16 US FDA, Silver Spring, MD, USA

Kimberly Maxfield16 US FDA, Silver Spring, MD, USA

Joao Pedras-Vasconcelos16 US FDA, Silver Spring, MD, USA

Therese Solstad40 Norway NoMA, Oslo, Norway

Seth Thacker16 US FDA, Silver Spring, MD, USA

Omar Tounekti39 Health Canada, Ottawa, ON, Canada

Daniela Verthelyi16 US FDA, Silver Spring, MD, USA

Meenu Wadhwa29 UK MHRA, London, UK

Leslie Wagner16 US FDA, Silver Spring, MD, USA

Takenori Yamamoto26 Japan MHLW, Tokyo, Japan

Lucia Zhang39 Health Canada, Ottawa, ON, Canada

Lin Zhou16 US FDA, Silver Spring, MD, USA

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