Consulting Services

How I Can Help

I offer comprehensive consulting services tailored to the unique needs of your drug development programs. My expertise is focused on creating and implementing actionable strategies that yield clear, interpretable results for informed decision-making.

  1. Translational & Clinical Biomarker Strategy

    I provide end-to-end guidance on developing and executing biomarker strategies that support every stage of the drug development pipeline.

    • Strategy Design: Designing comprehensive translational plans for all phases, from research and Phase 1/2 through Phase 3 and post-marketing studies.

    • Regulatory Support:Deep experience in authoring and reviewing biomarker sections for regulatory documents, including study protocols, clinical study reports, and global BLA filings.

    • Risk Mitigation: Proactively identifying scientific and technical risks and developing effective mitigation strategies to ensure programs stay on track.

    • Cross-Functional Leadership Coaching: Expertise in leading matrixed, cross-functional teams to ensure alignment and execution of complex biomarker plans.

  2. Clinical Proteomics & Mass Spectrometry

    Leveraging my experience as the Director of a leading clinical proteomics lab, I offer specialized support for your 'omics initiatives.

    • Technology & Platform Guidance: Advising on the use of cutting-edge mass spectrometry-based approaches as well as complementary platforms like Olink and SomaScan.

    • Development: Support for developing novel small and large molecule multiplexed mass spectrometry panels to measure critical biomarkers.

    • CRO Management: Guidance on evaluating and partnering with CROs for proteomic, lipidomic, and metabolomic services to increase efficiency and bandwidth.

  3. Therapeutic Area Expertise

    My direct, hands-on experience allows me to provide immediate, context-specific contributions to programs in several key therapeutic areas.

    • Neuroscience: Including Alzheimer's Disease and Multiple Sclerosis.

    • Immunology & Autoimmune Disorders: Including Neuromyelitis Optica Spectrum Disorder (NMO), Lupus, and other rare autoimmune diseases.

    • Rare Diseases: Deep familiarity with the unique challenges of developing therapeutics and biomarker strategies for rare disease indications.