Preclinical and Translational Development

We help clients design the experiments and development plans needed to establish biological activity, differentiation, and translational relevance. We can support individual studies or coordinate broader programs from discovery through translational and early regulatory studies.

Our support includes:

  • Experimental strategy and study design

  • Assay development and validation

  • Mechanism-of-action elucidation

  • In vitro and in vivo proof-of-concept studies

  • Pharmacology and translational planning

  • Biomarker development

  • Formulation and delivery strategy

  • Candidate selection planning

  • CMC and regulatory oversight

  • IND-enabling study planning

  • CRO selection and oversight

Relevant experience

We have led preclinical and translational programs from early discovery through phase-1 clinical studies. Our experience includes developing novel assays and experimental approaches, investigating mechanisms of action, establishing pharmacodynamic and translational studies and biomarkers, evaluating formulation strategies, and study coordination.

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