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)

Author:

Kholmanskikh Olga1,Wang Yow-Ming2,Hersey Sarah3,Wadhwa Meenu4,Block Katherine5,Bandukwala Abbas2,Szapacs Matthew6,Weiner Russell7,Awwad Khader8,Dessy Francis910,Downing Sean7,Du Xiulian2,Garofolo Fabio11,Harris Shannon12,Hou Victor13,Jones Jennifer3,Kar Sumit14,Kinhikar Arvind15,Li Ming16,Mathews Joel17,Meissen John18,Sumner Giane Oliveira19,Pan Luying7,Sanderink Gerard20,Scully Ingrid21,Stanta Johannes22,Tanaka Yoichi23,Vauleon Stephanie24,Wagner Leslie2,Wang Kai25,Zhu Liang13,Eck Steven26,Lin Yi-Dong7,Azadeh Mitra27,Decman Vilma25,Diebold Sandra4,Du Xiulian2,Goihberg Polina28,Alcaide Enrique Gomez24,Gonneau Christele29,Hedrick Michael Nathan3,Hopkins Gregory30,Kar Sumit14,Loschko Jakob21,McCausland Megan31,Mendez Luis32,Sehra Sarita33,Stevens Erin34,Sun Yongliang Steve3,Tangri Shabnam35,Trampont Paul C13,Cludts Isabelle4,Dysinger Mark36,Kavita Uma37,Sugimoto Hiroshi7,Chilewski Shannon3,Grimaldi Christine19,Jiang Yong25,Kamerud John28,Liu Susana38,Owen Carolina34,Palackal Nisha19,Petit-frere Corinne39,Pine Samuel40,Abhari Mohsen Rajabi2,Scheibner Kara2,Williams LaKenya3,Xu Tao41,Zhang Guodong42

Affiliation:

1. Belgium FAMHP, Brussels, Belgium

2. US FDA, Silver Spring, MD, USA

3. Bristol Myers Squibb, Lawrenceville, NJ, USA

4. UK MHRA, London, UK

5. Genentech, South San Francisco, CA, USA

6. Abbvie, Philadelphia, PA, USA

7. Takeda, Cambridge, MA, USA

8. Abbvie, Ludwigshafen, Germany

9. GlaxoSmithKline, Rixensart, Belgium

10. Takeda, Cambridge, MA, USA

11. BRI Frontage, Vancouver, BC, Canada

12. HilleVax, Cambridge, MA, USA

13. Moderna, Cambridge, MA, USA

14. WRIB, Toronto, ON, Canada

15. Novartis, Cambridge, MA, USA

16. Stoke, Cambridge, MA, USA

17. Ionis, Carlsbad, CA, USA

18. AstraZeneca, South San Francisco, CA, USA

19. Regeneron, Tarrytown, NY, USA

20. Sanofi Pasteur, Swiftwater, PA, USA

21. Pfizer, Pearl River, NY, USA

22. Celerion, Stevenage, UK

23. Japan MHLW, Tokyo, Japan

24. F. Hoffmann-La Roche Ltd, Basel, Switzerland

25. GlaxoSmithKline, Collegeville, PA, USA

26. AstraZeneca, Gaithersburg, MD, USA

27. Ultragenyx, Cambridge, MA, USA

28. Pfizer, Andover, MA, USA

29. Labcorp, Meyrin, Switzerland

30. 2seventy Bio, Cambridge, MA, USA

31. Q2 Solutions, Atlanta. GA, USA

32. Merck, Kenilworth, NJ, USA

33. Incyte, Wilmington, DE, USA

34. Pfizer, Groton, CT, USA

35. Navigate, a Novartis Subsidiary, San Diego, CA, USA

36. Alexion, New Haven, CT, USA

37. Spark Therapeutics, Plainsboro, NJ, USA

38. Pfizer, Kirkland, QC, Canada

39. Fresenius Kabi, Bad Homburg, Germany

40. Sanofi, Ghent, Belgium

41. Frontage, Exton, PA, USA

42. Alnylam, Cambridge, MA, USA

Publisher

Informa UK Limited

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