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Edward Narke


Edward Narke is a seasoned biotech industry veteran with over 25 years of experience in all phases of drug development, from pre-clinical to post-marketing, in both biologics and small molecules. He has been involved in numerous first-in-man drugs and biologics approvals and has become an expert in Chemistry, Manufacturing, and Controls (CMC) and Regulatory Sciences (RS).

Ed’s career in the biotech industry has been defined by his commitment to innovation and excellence in drug development. He has a passion for driving change in the industry and has been involved in some of the most significant drug approvals of recent years. Ed’s journey in the industry began at Lonza, where he worked in chemical process development and technology transfer. He gained valuable experience in these areas, which laid the foundation for his future work in regulatory affairs.

Ed’s next step was at Pfizer (formerly Wyeth), where he managed the preparation of IND, NDA, and BLA submissions for Enbrel® and Rapamune® Sirolimus, among others. This experience gave Ed a deep understanding of the regulatory processes involved in drug development and helped him develop expertise in Chemistry, Manufacturing, and Controls (CMC) and Regulatory Sciences (RS).

Ed’s experience includes regulatory strategy and submission preparation for numerous first-in-man drugs and biologics before drug regulatory affairs with numerous successful emerging biotech firms. His expertise in this area has been invaluable to the industry, particularly for startups and emerging biotech firms looking to navigate the complex regulatory landscape.

In 2007, Ed founded DSI, which he built into the industry leader for regulatory drug development, focusing on CMC. As head of Regulatory Sciences for 14 years, Ed provided a full range of regulatory and CMC operational services to the industry, focusing on meeting the significant demand for FDA liaison, regulatory submission content authoring, CMC active management, and interpretation of new regulatory guidance. Ed’s work at DSI has driven innovation and change in the biotech landscape.
Throughout his career, Ed has been involved in numerous drug approvals, both in biologics and small molecules. His expertise has been critical to the success of these approvals, and his involvement has helped to bring life-saving drugs to market. Ed’s extensive experience in all phases of drug development, from pre-clinical to post-marketing, has made him a sought-after advisor and growth investor for emerging biotech sponsors and startups.

Ed’s commitment to excellence in the biotech industry extends beyond his Strategic work. He has served as a past Chair for the AAPS CMC Focus Group, the RAPS Philadelphia Chapter, and the RS section Content Advisory Committee for AAPS magazine. He is a co-instructor for several courses on the CTD Module 3 at significant conferences and has taught many on authoring CTD submissions.

As Chief Innovator at Enkrisi, Ed is on a mission to revolutionize the regulatory drug development industry by building the first Hybrid CMC Regulatory firm. Enkrisi is blending augmented intelligence and machine learning with the expertise of seasoned subject matter experts to assist emerging biotech companies in navigating the complex regulatory landscape.

By leveraging cutting-edge technology and tapping into our SME’s extensive industry expertise, Enkrisi is well-positioned to lead the way in regulatory drug development for the next generation of biotech companies. With a commitment to innovation, excellence, and delivering results, Ed is dedicated to driving growth and success in the biotech industry and helping bring life-saving therapies to needy patients.

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