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4 results on '"John Stamatopoulos"'

1. GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

Author

Xinping Fang, Cheikh Kane, Valentine Barra, Dawn Dufield, Marsha Luna, Adriane Spytko, Jerome Bergeron, Corey Nehls, Robert MacNeill, Andrew Dinan, Esme Farley, Scott Reuschel, Hao Wang, Chantal DiMarco, Timothy Sangster, John Stamatopoulos, Shane Karnik, Nadine Boudreau, Kathie Lindley, Sarah Maasjo, Ariana Tudoroniu, Changming Yang, Jennifer Vance, Christina Satterwhite, Hao Feng, Ira DuBey, Jing Shi, Natasha Savoie, Brian K. Hoffpauir, Kurt J. Sales, Travis Harrison, Orlando Bravo, Jenifer Vija, Jason Ambrosius, Ardeshir Khadang, Chad Briscoe, Stephanie Cape, Edward Tabler, Philippe Couerbe, Adriana Iordachescu, Evgueni Fedorov, Jennifer Zimmer, Roger Hayes, Luca Matassa, Michael H. Buonarati, Franklin Spriggs, Stacie McCown, Michael E. Brown, Wei Garofolo, Jenny Lin, John Lindsay, Paul Rhyne, Shelby Anderson, Bruce Stouffer, Rafiq Islam, John Pirro, Edward Wells, Angie Underberg, Saadya Fatmi, Philip Joyce, Shaolian Zhou, Mohammed Bouhajib, Joseph Bower, Hanna Ritzén, and Liam Moran

Subjects
Engineering, Medical education, Validation study, Bioanalysis, business.industry, Event (computing), Clinical Biochemistry, Attendance, Reproducibility of Results, Guidelines as Topic, General Medicine, Guideline, Analytical Chemistry, Medical Laboratory Technology, Research Design, Humans, General Pharmacology, Toxicology and Pharmaceutics, business, Biomarkers
Abstract

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.

Published
2019

2. 12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

Author

Ira DuBey, Marc Moussallie, Nadia Kulagina, Dave Williams, Corey Nehls, Rabab Tayyem, Michael E. Brown, Wei Garofolo, Edward Tabler, Philippe Couerbe, Ardeshir Khadang, John Lindsay, Michele Malone, Paul Rhyne, Anahita Keyhani, Mark Warren, Jennifer Zimmer, John Stamatopoulos, Sian Estdale, Clark V. Williard, Bruce Stouffer, Eric Thomas, Mathilde Yu, Rafiq Islam, George Hristopoulos, Simona Rizea Savu, Robert MacNeill, Edward Wells, Jenny Lin, Hanna Ritzén, Iohann Boulay, Natasha Savoie, Kayode Awaiye, Vellalore Kakkanaiah, Shane Karnik, Christina Satterwhite, Curtis Sheldon, Amanda Hays, Chad Briscoe, Kathie Lindley, Colin Barry, Yi Qun Xiao, Andrew Dinan, Allan Xu, Luca Matassa, Arron Xu, Lawrence Goodwin, Steve Lowes, Jessica St Charles, Chantal Di Marco, Mohammed Bouhajib, Maria Cruz Caturla, Nicola Hughes, Patrick Bennett, Jenifer Vija, Stephanie Cape, Roger Hayes, Hao Wang, Xinping Fang, James Bourdage, Franklin Spriggs, and Chris Beaver

Subjects
Societies, Scientific, Bioanalysis, Certification, Immunogenicity, Clinical Biochemistry, Oligonucleotides, General Medicine, Computational biology, Flow Cytometry, Chemistry Techniques, Analytical, Mass Spectrometry, Analytical Chemistry, Social Control, Formal, Medical Laboratory Technology, Indicators and Reagents, Business, General Pharmacology, Toxicology and Pharmaceutics
Abstract

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Published
2019

3. Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis

Author

Mathilde Yu, Michele Malone, John Stamatopoulos, Christina Satterwhite, George Hristopoulos, Simona Rizea Savu, Mohammed Bouhajib, Chad Briscoe, Edward Tabler, Philippe Couerbe, Edward Wells, Ardeshir Khadang, Ira DuBey, Sian Estdale, Mark Warren, Hanna Ritzén, Wei Garofolo, Franklin Spriggs, Arron Xu, Chris Beaver, Jennifer Zimmer, Iohann Boulay, Anahita Keyhani, Kayode Awaiye, Vellalore Kakkanaiah, Curtis Sheldon, Jessica St Charles, Roger Hayes, Patrick Bennett, James Bourdage, Yi Qun Xiao, Marc Moussallie, Sumit Kar, Shane Karnik, Rabab Tayyem, Maria Cruz Caturla, Clark V. Williard, Hao Wang, Nadia Kulagina, Nicola Hughes, Robert MacNeill, Luigi DiMarco, Andrew Dinan, Kathie Lindley, Natasha Savoie, Xinping Fang, Chantal DiMarco, Bruce Stouffer, Jenifer Vija, Corey Nehls, Stephanie Cape, Eric Thomas, John Lindsay, Paul Rhyne, Michael E. Brown, Jenny Lin, Amanda Hays, Allan Xu, Hao Feng, Lawrence Goodwin, Rafiq Islam, Colin Barry, and Dave Williams

Subjects
Quality Control, Bioanalysis, Societies, Pharmaceutical, Clinical Biochemistry, Commercial kit, Ligands, 030226 pharmacology & pharmacy, 01 natural sciences, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, White paper, Surveys and Questionnaires, Drug Discovery, Humans, General Pharmacology, Toxicology and Pharmaceutics, health care economics and organizations, End user, 010401 analytical chemistry, General Medicine, Reference Standards, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, ComputingMethodologies_PATTERNRECOGNITION, Contract research organization, Drug development, Pharmaceutical Preparations, Biomarker (medicine), Biological Assay, Business, Reagent Kits, Diagnostic, Biomarkers
Abstract

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members’ opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.

Published
2019

4. 11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation

Author

Franklin Spriggs, Chris Beaver, Ashley Brant, Daniel Sikkema, Susan Ohorodnik, John Lindsay, Wei Garofolo, Mike Buonarati, Jing Tu, Chad Briscoe, Scott Fountain, James Hulse, Andrew Dinan, Mark E. Arnold, Rafiq Islam, Saadya Fatmi, James Bourdage, Michael E. Brown, Jim Wilfahrt, Edward Tabler, Philippe Couerbe, Anahita Keyhani, Roger Hayes, Ariana Tudoroniu, Adriana Iordachescu, Kelly Colletti, Jennifer Zemo, Natasha Savoie, Jessica St Charles, John Stamatopoulos, Damon Papac, Colin Barry, Vimal Patel, Gene Ray, Bruce Stouffer, John Marcelletti, Jenny Lin, Jennifer Zimmer, Mark Warren, Mathilde Yu, Maria Cruz Caturla, Philip Joyce, Jenifer Vija, Christina Sanchez, Rachel Green, Xinping Fang, Clark V. Williard, Yansheng Liu, Mohammed Bouhajib, Stephanie Cape, Ira DuBey, Masood Khan, George Hristopoulos, Nicola Hughes, Nadine Boudreau, Barry van der Strate, Rabab Tayyem, Jim Datin, Michael Kennedy, Joanne Hayward-Sewell, Edward Wells, Joseph Bower, Christina Satterwhite, Yi Qun Xiao, Jim Yamashita, Corey Nehls, Curtis Sheldon, Dominic Warrino, Allan Xu, Shane Karnik, and Ardeshir Khadang

Subjects
Bioanalysis, China, Computer science, Matrix stability, 010401 analytical chemistry, Clinical Biochemistry, Biosimilar, General Medicine, 030226 pharmacology & pharmacy, 01 natural sciences, 0104 chemical sciences, Analytical Chemistry, Food and drug administration, 03 medical and health sciences, Medical Laboratory Technology, Engineering management, 0302 clinical medicine, Research Design, Humans, Biological Assay, Sample collection, General Pharmacology, Toxicology and Pharmaceutics, Laboratory Manuals, Biosimilar Pharmaceuticals, Biomarkers
Abstract

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO–Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives’ sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

Published
2018

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