Precision medicine, and the associated integrative approach to healthcare, has been critical in providing a comprehensive understanding of the physiology and pathophysiology that ultimately leads to effective diagnostic, prognostic, and intervention strategies. While laboratory tests have been used to stratify risk and guide medical decision support for decades, the growing ability to select – and continue administering – the right drug for the right patient through novel diagnostic technologies is creating a new standard for healthcare, especially for high-risk therapies.

Our clients’ interest in precision healthcare emphasizes the critical importance of matching the right therapy to the right patient. Thus, we focus on the use of pharmacoepidemiologic and pharmacogenomics strategies for research on drug efficacy and safety, biomarker-based companion diagnostics (CDx), immuno-oncology, medication adherence, and clinical-decision support algorithms.

Our experts bring value to our clients across the entire process of research, development, and commercialization. We provide expert guidance and research leadership on the determinants of drug efficacy and safety to improve the quality of healthcare.

Areas of focus within our Precision Medicine specialty include:

Research and development
Independent, expert third-party review of biomarker program and strategy
Evaluation of scientific literature for biological and clinical value
Analysis and integration of multi-omic data

Optimization of study design and execution
Selection of appropriate sample types
Analytical platforms, including NGS
Biostatistical support

Clinical and regulatory strategy
Evaluation for accuracy and robustness for clinical translation
Development of CDx-related safety strategy and studies
Development of reimbursement strategies for CDx
Safety and regulatory guidance

Commercialization strategy
Review of market potential, current standard of care and competition
Product development risk assessment, strategy, and guidance

Representative Projects Include:

Conducted proteomic, metabolomic, genomic, epigenomic, transcriptomic, and first ever phenomic analysis of smokers with and without COPD for biomarker discovery.

Reviewed biomarker strategy and discovery/validation pipeline to support clinical trials for a major oncology immunobiologic.

What Our Clients Say:

Venebio provided impressive and timely scientific leadership and regulatory guidance for a major initiative at MWV Healthcare. Venebio and its team of experts planned and spearheaded a remarkable research effort to establish the scientific evidence behind our regulatory approach. Their strategy culminated in the publication of two papers in a leading scientific journal, and a successful ongoing engagement with officials at the highest levels of the FDA regarding the exciting role of innovative pharmaceutical packaging in addressing the huge public health problems of medication non-adherence and medication errors. We are extremely pleased with our collaboration with such a creative and forward-thinking research organization.

Elizabeth Whalley Buono, Esq., VP, Global Quality, External and Regulatory Affairs, WestRock, Inc.


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