Main Workshop DAY 3Thursday September 29, 2022: 7am - 6:30pm - Discussion Topic List

"Mass Spectrometry, Chromatography and Sample Preparation"

Part 1: Innovation in Mass Spectrometry & Novel Challenges & Solutions

  • Topic 1:

    Bioanalysis of Radio Ligand Therapy (RLT) Molecules by Mass Spectrometry from Discovery to Regulated Bioanalysis:

    • "Thinking outside the box" approaches for Detection of Parent Drug and Metal Containing Metabolites in Various Matrices - Topic 1a
    • Understanding the unique Method development and BMV of RLT molecules which are structurally different from all other traditional analytes - Topic 1b
  • Topic 2:

    Native Protein Mass Spectrometry Applications in Bioanalysis - Past, Present, Future

Part 2: Hybrid Assays (IA-MS)

  • Topic 3:

    New Strategies in Protein Digestion beyond Traditional Trypsin

  • Topic 4:

    Is Microflow really needed in Bioanalysis? - Myths & Realities, Advantages & Disadvantages after several years of accumulated experience

  • Topic 5:

    The Power of Hybrid Assay for Biomarker Quantification: Replacing not working a LBA with a Hybrid Assay in support of Clinical Trials

  • Topic 6:

    Recent Developments in Hybrid Assay (IA-MS) for Routine Immunogenicity Applications

Part 3: High Resolution Mass Spectrometry Assays (HRMS)

  • Topic 7:

    Advanced Applications of Mass Spectrometry & stem-loop qPCR for Complicated Bioanalysis of Novel Oligonucleotides

  • Topic 8:

    Mass Spec-based bioanalysis GalNAc-conjugated siRNAs as major bioanalytical platform replacing traditional hybridization assays in non-clinical and clinical studies

Part 4: Regulatory Challenges in Mass Spectrometry Bioanalysis

  • Topic 9:

    Are Biotransformation Studies for Biotherapeutics needed to know what we are measuring?

  • Topic 10:

    What is the Need to measure prodrug PK in addition to active drug? - Industry standards and recommendations in Mass Spectrometry Bioanalysis

  • Topic 11:

    Special Matrices/Patient-centric Sampling in Regulated Bioanalysis - Innovative development related to nasal sampling for biotherapeutics

Part 5: White Paper in Bioanalysis

  • 2022 White Paper on Mass Spectrometry, Chromatography and Sample Preparation:

    Consensus & Conclusions on Mass Spectrometry, Chromatography and Sample Preparation for 2022 White Paper

Agenda at a Glance Agenda at a Glance