Project Description

Pharmaceutical formulation
expert for patent litigation

The need

Defense attorneys requested an expert for an ANDA case involving a drug for treating a particular metabolic disease. The expert needed to have drug formulation experience, including experience with salt selection for an active pharmaceutical ingredient.

Our approach

We focused our efforts on finding an expert with hands-on industry experience in drug formulations and an advanced degree in organic chemistry or medical chemistry. Experience with the specific drug or class of compounds would be ideal, however we balanced this consideration against the likelihood the expert would have a conflict if the experience was too specifically aligned with this molecule.

The expert

We identified a PhD pharmaceutical professional with more than 30 years of industry experience in solid state chemistry, formulation development, API synthesis, analytical method development, and bioanalytical assays. He has expertise with polymorphs and salt selection for formulation development of APIs. He authored articles on related topics in the Journal of Organic Chemistry, Current Opinion in Drug Discovery & Development, and the Journal of Pharmaceutical and Biomedical Analysis. He is also a named inventor on multiple US patents.