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MarkArnoldBionodhDeSilvaBinodh DeSilva, Ph.D., is the Executive Director of Immunochemistry and Biomarker Development at Bristol-Myer Squibb Company in Lawrenceville,NJ.
Mark E. Arnold, Ph.D. is Executive Director of the Bioanalytical Sciences & Selective Integration Department of the Bristol-Myers Squibb Co. located in Princeton, NJ.

In September, the draft revision to the U.S. Food and Drug Administration (FDA) Guidance on Bioanalytical Method Validation was released.  It has the potential to significantly alter the manner in which pharmacokinetic (PK) and biomarker measurements are conducted. Thus, the bioanalytical community in pharmaceutical and biotechnology companies, contract research organizations (CROs) and quality assurance groups are studying and commenting on the revision.

Four previous and successful Crystal City (CC) Workshops (1990, 2000, 2006, and 2007) have been held by the American Association of Pharmaceutical Scientists (AAPS) and FDA to discuss current issues in bioanalysis. In those workshops, the bioanalytical and scientific needs that intersected with regulatory compliance and patient safety were freely discussed and debated to produce best practices.  The 2000 Workshop provided input into the first BMV Guidance (2001) and the subsequent AAPS/FDA meetings resulted in white papers that have served as a de facto guidance to the industry until the EMA issued its Guideline in 2011.  The upcoming CCV meeting, while not occurring in Crystal City, but bearing that proud heritage, will again provide a forum for the regulatory and industry community to meet and discuss bioanalytical practices that provide the robust data the FDA needs to enable decisions on new and efficacious drugs.

While the agency welcomes written comments to its draft guidance, this two and a half day meeting is expected to have the largest cross-section of industry participants from around the globe participating in direct conversations with the FDA.  Key to the meeting is the opportunity for the FDA to present reasoning behind the revisions and new aspects of the guidance so that the attendees can understand the rationale and the implications to their work.  More than 12 hours of open audience participation discussion with Agency and industry experts has been included within the agenda.  A robust dialogue is expected with recognition that some topics may be contentious. That, however, is not only expected, but is essential to enable agreement around best practices for drug development.

The Crystal City V Workshop: Quantitative Bioanalytical Methods Validation and Implementation will be held in the Hilton Baltimore, Baltimore, MD from December 3-5, 2013.


More about the Authors

Dr. DeSilva has been an active member of AAPS since 1997. Currently, she is a Member-at-Large on the AAPS Executive committee, the past-chair of the Biotech section of the AAPS, member of the Steering Committee of the Global Bioanalytical Consortium representing North America.  She is co-chairing the Crystal City V conference with Drs. Brian Booth, Sam Haidar and Mark Arnold.

Mark Arnold is actively involved as a Steering Committee member of the Bioanalytical Focus Group American (past-Chair) of the AAPS and several other bioanalytical groups/meeting, and will co-chair the Crystal City V meeting. Dr. Arnold has over 60 peer-reviewed publications, and 50 posters and podium presentations.