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With over 20 years in the pharmaceutical industry. Dr. Cowley has extensive experience in the development, filing and commercialization of a wide range of synthetic and biological molecules including biosimilars. In addition, Dr. Cowley has experience with the development and approval of several types of combination products such as auto-injectors and on body injectors. Dr. Cowley has personal experience in the writing and review of multiple CTA and BLA/MAA regulatory filings. I am responsible for leading and developing the strategic direction of the R&D/Clinical Quality Operations organization.
Dr. Cowley has significant experience in external engagements interacting with regulators and influencing based on the strategic direction of AstraZeneca/Medimmune. Dr. Cowley has been an invited speaker and have presented at several local and international conferences. With a focus on operational excellence and new technologies, I am a strong advocate for modernization of processes, analytical methods where appropriate and specification setting based on QbD principles that can allow acceptance criteria to extend beyond clinical experience and eliminates specifications designed to only monitor process constancy. The understanding and use of prior knowledge is critical during the process of setting commercially relevant specification leading to the establishment of clinical and commercial specifications that focuses attention on attribute criticality based on a risk-assessments and attribute knowledge.