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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Biomarker program (oncology)

Clinical pharmacology project leader for a global pharmaceutical company

The services of BioVentures Consulting Limited were engaged to lead a cross-functional project team to deliver the clinical pharmacology package for a biomarker-based oncology development programme. First-into-man and multiple ascending dose clinical pharmacology studies were designed and conducted. Activities spanned translational science to key opinion leader interactions. This successful 11-month assignment resulted in successful IMPD and IND submissions.

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