Advisory, planning and operational oversight across all stages of development

We apply an insider’s perspective to inform strategy and provide functional oversight of outsourced biopharma development, optimizing the path to proof-of-concept and, ultimately, regulatory approval.

We provide sponsor-side, stage-centric skill sets to advance development with objectivity and integrity, whether as a strategic sounding board or variable extension of your internal team.

Development Strategy

Key Considerations

  • We are deeply and exclusively rooted in life sciences. We have assembled a team of the highest caliber, performing vitally important roles for which competition in the market is intense.
  • Our variable resources, engaged where and when needed, keep your fixed costs down and allow you to focus investment on de-risking the science and creating value.
  • We act solely in our clients’ best interests, taking an agnostic approach to selecting the right CRO or other providers.

How Danforth Can Help

Preclinical Advisory

We provide strategic guidance to help early-stage companies achieve a robust non-clinical package, ultimately leading to a successful IND filing and paving the way to enter clinical development. Our input and oversight of the preclinical plan are shaped by well-informed perspective across the entire development continuum, ensuring that clients begin with the end in mind. Click here to learn more.

Chief Medical Officer Advisory

The involvement of a seasoned interim or fractional Chief Medical Officer from the early preclinical stage through the later stages of clinical development can be a difference maker in successfully advancing a biopharmaceutical toward proof-of-concept and approval. We have aggregated a team of highly qualified clinicians with expertise in distinct therapeutic areas and technologies, able to guide preclinical and clinical programs, help build KOL relationships and support deal-making via deep understanding of due diligence requirements. Click here to learn more.

Clinical Development Operations

Elite BioPharma Consulting, a Danforth Advisors company, collaborates with pharmaceutical, biotechnology and medical device companies to support their product development process from initial application through final regulatory filing. The firm’s founders and consultants deliver broad experience in all areas of clinical research for both drug and device development. Click here to learn more.

Clinical Business Operations

Our CBO specialists have deep expertise in the planning and management of outsourcing across preclinical development, clinical studies and CMC. This includes outsourcing strategy, vendor selection and oversight, performance-based contracting and negotiation, investigator site agreements, and management of clinical finance to help clients improve study-level forecasting and accuracy of accruals. Click here to learn more.

How else can we help?

Learn about our additional capabilities