University of Wisconsin–Madison

Reference Standards in Pharmaceutical Development

When: June 11, 2018 11:00am CST

A Discussion Regarding Preparation, Use, and Management for Drugs


Obtaining reference standards is one of the primary considerations for new drugs. Standards are understood and handled in different ways and often become problematic when not given appropriate attention or care. Reasons for lack of diligence for reference standard care include: often primary drug development objectives are proof of concept and FIH submissions; focus on start of clinical studies and clinical supplies; standards management is not well defined or has lack of processes; lack of understanding of reference standard lifecycle.  In short, reference standards may appear to be an obstacle to project timelines especially when standard acquisition and continued maintenance are time consuming. We wish to avoid “Did you say my standards retest date is next Tuesday?” moments. This webinar will provide an overview of reference standards and activities such as synthesis, characterization, risk mitigation, retesting, management and compliance.

About the Speaker: Harley E. Wilcox

Harley is a Senior Scientific Advisor for EAG laboratories in Columbia MO and assists new client projects, proposals generation, and acts as an interface between business development and EAG operational teams. He primarily supports small molecule analytical projects including MD/MV and stability.

Oncology Drug Development—Harley’s pharmaceutical career has spanned 30 years beginning with Marion Laboratories and manufacture of API. He moved from manufacturing to NCE synthesis to support of chemical development and oncology drug discovery programs, eventually to Analytical development support of oncology drugs.  As part of a new CMC regulatory submissions group, he supported global CMC team submissions.

As a director of manufacturing with oncology start-up Taxolog Inc. in New Jersey, he supported three clinical NCE’s, thousands of research compounds and developed on internal analytical group.  The group developed expertise in impurity ID, method development, and in-vitro metabolism studies. He developed relationships with many CMO’s and CRO’s for DS and DP clinical trial manufacturing, supply chain management, as well as pharmacokinetics support.

Harley received his BS in chemistry from UMKC and his MBA in healthcare management (FIT-2011).  He continues with his pursuit of knowledge in science and business.

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