2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)

Author:

Baratta Mike1,Jian Wenying2,Hengel Shawna3,Kaur Surinder4,Cunliffe Jennifer5,Boer Jason6,Hughes Nicki7,Kar Sumit8,Kellie John9,Kim Yeoun Jin10,Lassman Michael11,Mehl John9,Morgan Ling12,Palandra Joe1,Sarvaiya Hetal13,Zeng Jianing14,Zheng Naiyu14,Wang Jian15,Yuan Long16,Ji Allena17,Kochansky Christopher18,Tao Lin19,Huang Yue20,Maes Estelle21,Barbero Luca22,Contrepois Kevin20,Ferrari Luca23,Fu Yunlin24,Johnson Jay25,Jones Barry15,Kansal Monika4,Lu Yang26,Post Noah27,Shen Honglue (Holly)11,Xue Yongjun (Y-J)14,Zhang Yiyue (Cynthia)26,Biswas Gopa26,Cho Seongeun (Julia)26,Edmison Anna28,Benson Kimberly26,Abberley Lee9,Azadeh Mitra29,Francis Jennifer30,Garofolo Fabio31,Gupta Shalini32,Ivanova Iordanka (Dany)28,Ishii-Watabe Akiko33,Karnik Shane34,Kassim Sean26,Kavetska Olga35,Keller Steve36,Kossary Elham37,Li Wenkui24,McCush Fred35,Mendes Dulcyane Neiva38,Abhari Mohsen Rajabi26,Scheibner Kara26,Sikorski Timothy9,Staack Roland F39,Tabler Edward40,Tang Huaping9,Wan Katty41,Wang Yow-Ming26,Whale Emma42,Yang Li26,Zimmer Jennifer43,Bandukwala Abbas26,Du Xiulian26,Kholmanskikh Olga44,Gijsel Sonja Kwadijk-de45,Wadhwa Meenu42,Xu Joshua46,Buoninfante Alessandra47,Cludts Isabelle42,Diebold Sandra42,Maxfield Kimberly26,Mayer Christian48,Pedras-Vasconcelos Joao26,Abhari Mohsen Rajabi26,Shubow Sophie26,Tanaka Yoichi33,Tounekti Omar28,Verthelyi Daniela26,Wagner Leslie26

Affiliation:

1. Takeda, Cambridge, MA, USA

2. Johnson & Johnson Innovative Medicine, Spring House, PA, USA

3. Seattle Genetics, Bothell, WA, USA

4. Genentech, South San Francisco, CA, USA

5. Novartis, Cambridge, MA, USA

6. Incyte, Wilmington, DE, USA

7. Biopharma, Toronto, ON, Canada

8. WRIB, Toronto, ON, Canada

9. GlaxoSmithKline, Collegeville, PA, USA

10. AstraZeneca, Gaithersburg, MD, USA

11. Merck & Co., Inc., Rahway, NJ, USA

12. Moderna, Mystic, CT, USA

13. Abbvie, San Mateo, CA, USA

14. Bristol-Myers Squibb, Lawrenceville, NJ, USA

15. Crinetics, San Diego, CA, USA

16. Biogen, Cambridge, MA, USA

17. Chiesi, Boston, MA, USA

18. Exelixis, Alameda, CA, USA

19. Sanofi, Framingham, MA, USA

20. AstraZeneca, South San Francisco, CA, USA

21. Abbvie, Chicago, IL, USA

22. EMD Serono, Ivrea, TO, Italy

23. F. Hoffmann-La Roche Ltd, Roche Pharma Research & Early Development (pRED), Basel, Switzerland

24. Novartis, East Hanover, NJ, USA

25. Pfizer, Andover, MA, USA

26. US FDA, Silver Spring, MD, USA

27. Ionis, Carlsbad, CA, USA

28. Health Canada, Ottawa, ON, Canada

29. Ultragenyx, Cambridge, MA, USA

30. Regeneron, Tarrytown, NY, USA

31. BRI Frontage, Vancouver, BC, Canada

32. Amgen, Thousand Oaks, CA, USA

33. Japan MHLW, Tokyo, Japan

34. Aliri, Colorado Springs, CO, USA

35. Pfizer, Groton, CT, USA

36. AbbVie, South San Francisco, CA, USA

37. WHO, Geneva, Switzerland

38. Brazil ANVISA, Brasilia, Brazil

39. Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany

40. PPD Thermo Fisher Scientific, Richmond, VA, USA

41. Pfizer, San Diego, CA, USA

42. UK MHRA, London, UK

43. Alturas Analytics, Moscow, ID, USA

44. Belgium FAMHP, Brussels, Belgium

45. Dutch IGJ, Randstad, Netherlands

46. US FDA, Jefferson, AR, USA

47. EU EMA, Amsterdam, Netherlands

48. Austria AGES, Vienna, Austria

Publisher

Informa UK Limited

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