Although small molecules represent the majority of compounds in development as drug candidates, there is an increasing tendency to more complex molecular structures to address unmet molecular needs. This has been reflected in the…

There has been an increasing focus on large molecule therapeutics and pharmaceutical companies have increasingly aligned their development pipelines in that direction. This has resulted in more biological therapeutics coming to market.  Last year,…

Biomarkers can be defined and utilized for many purposes.  There are disease biomarkers as well as mechanistic or pharmacological biomarkers.  To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to…

How will your background in science play a role in your new Senior Scientific Advisor position? I feel that my skill set has evolved consistently since my graduate degrees where I’ve learned different yet complimentary lessons about data presentation, data interpretation, marketing, customer partnering, optimizing operational processes, customer management and…

At KCAS, we work with Director, VP, and C-level pharmaceutical and biotech executives that need to measure their drug or the effect of their drug in biological matrix. Many of our customers rely on…

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer under patent…

Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative to the known stability of…