Publications by authors named "Abbas Bandukwala"

Article Synopsis
  • The 17th Workshop on Recent Issues in Bioanalysis (17 WRIB) occurred in Orlando from June 19-23, 2023, gathering over 1000 professionals from pharma, biotech, and regulatory agencies to discuss current bioanalysis topics.
  • The event featured 3 Main Workshops and 7 Specialized Workshops covering key issues like biomarkers, immunogenicity, and evolving regulations including the EU IVDR and US FDA remote assessments.
  • The outcomes of the workshop led to a comprehensive White Paper offering recommendations for improving bioanalytical practices and regulatory compliance, divided into three parts focusing on different aspects of bioanalysis.
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The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on 19-23 June 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

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The US FDA convened a virtual public workshop with the goals of obtaining feedback on the terminology needed for effective communication of multicomponent biomarkers and discussing the diverse use of biomarkers observed across the FDA and identifying common issues. The workshop included keynote and background presentations addressing the stated goals, followed by a series of case studies highlighting FDA-wide and external experience regarding the use of multicomponent biomarkers, which provided context for panel discussions focused on common themes, challenges and preferred terminology. The final panel discussion integrated the main concepts from the keynote, background presentations and case studies, laying a preliminary foundation to build consensus around the use and terminology of multicomponent biomarkers.

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The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

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The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

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The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

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Article Synopsis
  • * The workshop featured three Main Workshops and seven Specialized Workshops covering a range of subjects, including biomarker development, mass spectrometry, and innovations in cytometry and reagent generation.
  • * The resulting 2021 White Paper provides recommendations based on workshop discussions to aid the bioanalytical community in enhancing scientific quality and regulatory compliance, with the publication divided into three parts for clarity.
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Article Synopsis
  • The 14th Workshop on Recent Issues in Bioanalysis (14 WRIB) took place virtually from June 15-29, 2020, attracting over 1000 participants from various sectors in the pharmaceutical and biotech industries, as well as regulatory agencies globally.
  • The event featured three main workshops and seven specialized workshops over 11 days, focusing on critical topics such as bioanalysis, biomarkers, immunogenicity, gene therapy, and vaccine development.
  • The associated 2020 White Paper offers recommendations based on discussions from the workshop and is divided into three parts, covering various aspects of bioanalytical practices and regulatory compliance, with some sections published in previous volumes of the journal Bioanalysis.
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Article Synopsis
  • The 2019 Workshop on Recent Issues in Bioanalysis (WRIB) was held in New Orleans from April 1-5, with over 1000 attendees from various sectors, focused on topics like bioanalysis and gene therapy.
  • The event spanned five days, providing a platform for discussing current challenges in bioanalysis methods such as LCMS and qPCR.
  • The resulting White Paper, divided into three parts, offers key recommendations based on discussions, covering FDA guidance, ICH draft guidelines, and various topics in biomarker and gene therapy analysis.
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We describe here the agreed upon first development steps and priority objectives of a community engagement effort to address current challenges in quality assurance (QA) and quality control (QC) in untargeted metabolomic studies. This has included (1) a QA and QC questionnaire responded to by the metabolomics community in 2015 which recommended education of the metabolomics community, development of appropriate standard reference materials and providing incentives for laboratories to apply QA and QC; (2) a 2-day 'Think Tank on Quality Assurance and Quality Control for Untargeted Metabolomic Studies' held at the National Cancer Institute's Shady Grove Campus and (3) establishment of the Metabolomics Quality Assurance and Quality Control Consortium (mQACC) to drive forward developments in a coordinated manner.

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