17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Reg
The 17th GCC Closed Forum was held in San Antonio, TX, USA, on 10<sup>th</sup> May 2024. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The topics discussed at the meeting included integrative bioanalysis, patient-centric sampling, emerging technologies, data integrity, sample reconciliation efforts, discrepancies of ELISpot data, cross-validation harmonization, ultrasensitive platforms for immunogenicity assays, remote regulatory assessments, shedding assays by qPCR/dPCR, and biomarker assays. Conclusions and consensus from discussions of these topics are included in this article.
Authors
- Allan Xu
- Tracy Iles
- Mark Odell (ORCID: https://orcid.org/0000-0001-5464-9882)
- Stephen E. Rundlett
- Cheikh Kane
- Nathan Riccitelli
- Ritankar Majumdar (ORCID: https://orcid.org/0000-0001-6624-0187)
- Joseph Bower
- Weihua Gu (ORCID: https://orcid.org/0000-0003-3848-4840)
- Danielle Salha
- Corbyn Lamy
- Manisha R. Diaz
- Katherine R. O’Brien (ORCID: https://orcid.org/0000-0001-8972-9161)
- Steve Lowes
- John Pirro
- Doug Johnson (ORCID: https://orcid.org/0000-0002-4331-8508)
- Annika Carlsson
- Xinping Fang
- Wei Garofolo
- Shane Karnik (ORCID: https://orcid.org/0000-0001-7019-7724)
- Dawn Dufield
- G. Reynolds (ORCID: https://orcid.org/0000-0003-2813-568X)
- Mathilde Yu
- Troy Voelker
- Magdalena Tary‐Lehmann
- Mitesh Sanghvi
- Kevin Malone (ORCID: https://orcid.org/0000-0001-5665-4706)
- Jerome Bergeron
- Katie Matys
- Rathna Veeramachaneni
- Adriane Spytko
- Sankeetha Nadarajah (ORCID: https://orcid.org/0009-0002-9122-9822)
- Jennifer Zimmer
- Jia‐Bao Liu (ORCID: https://orcid.org/0000-0002-9620-7692)
- Amanda Hays (ORCID: https://orcid.org/0000-0002-3429-4727)
- Agostinho G. Rocha (ORCID: https://orcid.org/0000-0001-7134-7376)
- Mario Pellerin
- Shashank Gorityala
- Elizabeth Hyer
- Aihua Liu (ORCID: https://orcid.org/0000-0003-0309-114X)
- Vivek Kumar Dwivedi (ORCID: https://orcid.org/0009-0005-8603-3640)
- Moucun Yuan (ORCID: https://orcid.org/0000-0001-7532-1296)
- Tao Xu
- Annelies W. Turksma
- Daniel J. Sikkema
- Amanda Leskovar
- Elizabeth Dompkowski
Institutions
- Xihua University (CN)
- Universidad de La Frontera (CL)
- Natural Sciences and Engineering Research Council of Canada (CA)
- IDEXX Laboratories (France) (FR)
- Charles River Laboratories (Netherlands) (NL)
- Donghua University (CN)
- Allama Iqbal Medical College (PK)
- Altera (United States) (US)
- Franklin Institute (US)
- LabCorp (United States) (US)
- United Services Automobile Association (US)
- IQVIA (United Kingdom) (GB)
- Sanquin (NL)
- Alibaba Group (Cayman Islands) (KY)
- Blackrock Microsystems (United States) (US)
- Bioanalytica (Switzerland) (CH)
- Springhouse (US)
- Pharmaron (United Kingdom) (GB)
- White Plains Hospital (US)
- Reaction Biology Corporation (United States) (US)
- MSD (Sweden) (SE)
- Syneos Health (United States) (US)
- Altasciences (Canada) (CA)
- IQVIA (United States) (US)
- Ultra Electronics 3 Phoenix (United States) (US)
- Precision for Medicine (United States) (US)
- Grand Challenges Canada (CA)
- Humacyte (United States) (US)
- Shaker Heights Public Library (US)
- Bioanalytical Systems (United States) (US)
- Charles River Laboratories (Germany) (DE)
- Charles River Laboratories (United States) (US)
- Kansas Bioscience Authority (US)
- Olathe Public Schools (US)
- Harrogate District Hospital (GB)
- Navidea Biopharmaceuticals (United States) (US)
- Hua Medicine (China) (CN)
- The White House (US)
- Stord hospital (NO)
- Thermo Fisher Scientific (United States) (US)
- Intralytix (United States) (US)
- Smiths Detection (Canada) (CA)
- Apex School of Theology (US)
- BioPharm (United Kingdom) (GB)
- Senseonics (United States) (US)
- Olathe Medical Center (US)
- Thermo Fisher Scientific (Israel) (IL)
Publication Details
- Journal
- Bioanalysis
- Published
- 2025-06-18
- DOI
- https://doi.org/10.1080/17576180.2025.2529119
- Citations
- 1
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.80