Services

With 20+ years of industry experience serving as department head in nonclinical pharmaceutical research and development for small biotech companies, we can offer the following services:

Vendor management:

Whether you have academic collaborations, contract research organizations (CROs), or other consultants specializing in sub-areas of nonclinical development in place or are starting from scratch: we can vet and negotiate contracts with CROs, monitor study conduct, and can consolidate feedback across all areas of nonclinical development.

In vitro and In vivo pharmacology/pharmacokinetics/pharmacodynamics:

We can design efficacy and early PK/PD studies to aid in the final selection of a development candidate (DC) with “go/no go” endpoints, look for potential off-target binding/activation, and position a DC to go into IND-enabling studies with submission-ready reports.

nonGLP/GLP toxicology and safety pharmacology:

Once a DC has been selected, we can develop, implement, and execute a strategic plan tailored to the program to get to first-in-human (FIH) clinical trials as quickly and efficiently as possible while mitigating risks in the process.  We can prepare the nonclinical sections of regulatory documents.

Other Items:

Nonclinical development covers a vast area, so let’s chat about your needs/goals.  We can support you in more ways than can be listed here.

We understand budgets are tight in small biotech. Whether you want a contract/fractional employee to keep monthly spend consistent, you would like to pay by the hour, or be creative, we can be flexible to your needs.