Helping You Move Your Asset Forward

All drugs that intentionally or unintentionally enter the central nervous system (CNS) require a thorough assessment of CNS activity. This assessment begins with an understanding of which receptors may be involved, and to what extent the drug may interfere with normal behavior. Factoring in margins from projected therapeutic exposures lends context, but in general, a number of standard, in-vivo assays are employed to determine if further, specialized assays are needed for determining whether the drug may have the potential to disrupt cognition or may be a drug of abuse. 

Dr. Hudzik’s expertise is in both drug discovery and safety this area and advises on Therapeutic indications at the Scientific to Board level. Along with his extensive network of trusted advisors, ALA BioPharma helps companies (most large to most small) and Universities that may be unfamiliar with these processes as well as in communicating results to Regulators.  He also gives guidance on clinical design and testing for CNS activity.  Being a pharmacologist, toxicologist and program director and advisor in industry for many years positions him to show you the roadmap to getting your IND or NDA approved.

Your internet search for a consultant in this area leads you to the big CROs – which have high turnover of expertise, study directors, and handlers.  This can lead to high variability or uninterpretable advice or results, which will create later Regulatory issues for you.  Better to stick to experience.