Consulting Services for Companies of All Sizes
ProPharma Services supports and partners with small to mid-sized biotechnology/pharmaceutical companies. Our expertise can assist in early discovery, preclinical and clinical stages of drug development, as well as due diligence for potential in-licensing opportunities. We have broad experience in both small and large molecule drugs including:
- Small molecule metabolism (ADME, CYP reaction phenotyping, enzyme kinetics, induction, extrapolation of in vitro/in vivo data to projected human pharmacokinetics)
- Provide input into early drug discovery strategy
- Pharmacokinetics/toxicokinetics analysis (PK/PD and pharmacokinetic modeling)
- Extensive experience with small molecule drug-drug interactions
- Assessment of compound liabilities both in the context of drug discovery/development, and in-licensing opportunities
- Experienced writers of project reports, IND/NDA enabling documents and IND/CTD/NDA submission
Experience with all facets of large molecule discovery/development
- Immune mediated clearance (clearing, neutralizing and sustaining antibodies) and effects on PK and PD
- Receptor mediated clearance and nonlinearity
- Immunoassays – cross reactivity, interference from binding proteins
- Assays for anti-drug antibodies
- Use of surrogate molecules
