Binodh DeSilva, PhD, is AAPS past-president.

Binodh DeSilva

	The importance of pharmacokinetics characterization in evaluating the safety and efficacy of drugs has given rise to a need for guidance in ensuring the accuracy and reproducibility of the underlying bioanalytical data.

	For more than 25 years, bioanalytical scientists and practitioners have actively participated in defining bioanalysis procedures and standards-most notably through the joint American Association of Pharmaceutical Scientists (AAPS)/FDA ‘Crystal City’ workshops.

	During this time, various guidelines were issued on bioanalytical method validation (BMV) by FDA; the European Medicines Agency; Japanese Ministry of Health, Labour, and Welfare; Brazil’s Agencia Nacional de Vigilancia Sanitaria; and the China Food and Drug Administration. Although all regulatory guidance/guideline documents are similar in their requirement for producing accurate and reproducible standards, having multiple guidelines has resulted in variations in the substance or the interpretation of the standards, which in turn has bred ambiguity and perceived disharmony. As a result, when drug manufacturers submit their applications for drug approval globally, they struggle to address these differences in their bioanalytical application, causing delays in approval.

	The opportunity for the International Council for Harmonization (ICH) to take up this issue emerged in 2016. In the absence of a harmonized guideline for BMV, members of AAPS, the European Bioanalysis Forum (EBF), and the Japan Bioanalysis Forum (JBF) formed a three-region team in March 2016 and drafted a proposal for bioanalytical harmonization, which they then submitted to the European Federation of Pharmaceutical Industries and Associations (EFPIA) to be submitted to the ICH assembly in June 2016. A proposal was also raised and endorsed by the ICH assembly. Subsequently, an Informal Working Group was formed to draft a business plan (1) and a concept paper (2). Following the finalization of these two documents, the ICH Assembly endorsed BMV as a multidisciplinary new topic for harmonization (ICH M10) in October 2016.

	With the initiation of the multi-step ICH process, the three-region team proactively sought ways to understand the process; determine how each region/ group would be represented in the Expert Working Group (EWG); and identify next steps. The team recognized the importance of bringing industry together to provide current perspectives to the EWG, rather than waiting until after the draft ICH document is released for comment. This was particularly important for companies that supported regulated studies but did not have representation in ICH.

	The team facilitated open workshops with AAPS in the United States and Europe in September 2017 that attracted a global audience. Sessions were built around areas of expected consensus as well as current concerns that required harmonization. The US workshop focused on strategic discussion, and the EU workshop focused on sharing and discussing survey data on current industry practices/experience. With these sister workshops and sustained collaboration between AAPS, EBF, and JBF, we can continue to contribute to the objectives of the ICH harmonization process, which is to improve efficiency of the drug development process without compromising safety and efficacy evaluations.

	Editor’s Note: This article is excerpted from a May 2018 

 article. The following individuals contributed to this report: F. Vazvaei, Roche Innovation Center New York; L. Amaravadi, Shire Plc; L. King, Pfizer Inc.; P. Timmerman, European Bioanalysis Forum; Y. Ohtsu, Astellas Pharma Inc.; and E. Fluhler, Glenmark Pharmaceuticals.

Final Endorsed Business Plan, M10: Bioanalytical Method Validation

Final Endorsed Concept Paper, M10: Bioanalytical Method Validation


	Binodh DeSilva, PhD, is AAPS past-president.


	Vol. 42, No. 10
	October 2018
	Page: 10

	When referring to this article, please cite it as B. DeSilva, “AAPS Traces the Path to ICH M10,” 

Articles

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.