16 th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

Author:

Zimmer Jennifer1,Hays Amanda2,Lester Todd2,Diaz Manisha3,Thomas Eric4,O'Dell Mark4,Hyer Elizabeth5,Tangri Shabnam6,Dakappagari Naveen6,Yuan Moucun7,Lavelle Amy7,Karnik Shane8,Liu Aihua9,Xu Bin10,Sales Kurt11,Gorityala Shashank2,Reynolds Gregory12,Sangster Tim13,Franckaert Dean14,Love Iain15,Patel Vimal16,Roberge Martin17,Lin Jenny18,Jerks Erik19,Xu Tao20,Garofolo Wei21,Nadarajah Sankeetha21,Kernstock Robert22,Dufield Dawn23,Ambrose David23,Warrino Dominic23,Luna Marsha23,Marco Chantal Di24,Tudoroniu Ariana25,Iordachescu Adriana25,Sanghvi Mitesh26,Barton Hollie7,Brown Michael27,Hoffpauir Brian28,Rocha Agostinho29,Dong Kelly30,Yamashita Jim31

Affiliation:

1. Alturas Analytics, Moscow, Idaho, USA

2. BioAgilytix, Durham, North Carolina, USA

3. Eurofins Viracor, BioPharma Services, Lenexa, Kansas, USA

4. Labcorp, Indianapolis, Indiana, USA

5. Labcorp, Madison, Wisconsin, USA

6. Navigate Biopharma, San Diego, California, USA

7. PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA

8. Aliri Bioanalysis, Colorado Springs, Colorado, USA

9. Resolian (Formally Alliance Pharma), Malvern, Pennsylvania, USA

10. Accurant Biotech, Cranbury, New Jersey, USA

11. Agilex Biolabs, Adelaide, Australia

12. BioAgilytix, San Diego, California, USA

13. Celerion, Lincoln, Nebraska, USA

14. CellCarta Biosciences, Montreal, Canada

15. Charles River Laboratories, Edinburgh, Tranent, UK

16. Charles River Laboratories, Reno, Nevada, USA

17. CIRION BioPharma Research (a Cerba Research Company), Laval, Quebec, Canada

18. CMIC, Hoffman Estates, Illinois, USA

19. Eurofins Pharma Bioanalytics, Lake St. Louis, Missouri, USA

20. Frontage Laboratory, Exton, Pennsylvania, USA

21. GCC, Toronto, Ontario, Canada

22. ICON plc, Whitesboro, New York, USA

23. KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA

24. Pharma Medica Research, Mississauga, Ontario, Canada

25. Pharma Serv International, Bucharest, Romania

26. Pharmaron, Germantown, Maryland, USA

27. Q2 Solutions Durham, North Carolina, USA

28. Smithers, Gaithersburg, Maryland, USA

29. Smithers, Ewing, New Jersey, USA

30. United-Power Pharma Tech Co., Beijing, China

31. WuXi AppTec, Plainsboro, NJ, USA

Publisher

Informa UK Limited

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