Pearl Pathways has hired Mark Slisz as a senior advisor serving biopharmaceutical, medical device and diagnostic life science companies. He has more than 35 years of experience in the pharmaceutical industry. Slisz’s experience includes protein purification and characterization, recombinant DNA technology, large scale biotechnology purification and development, active ingredient and drug product manufacturing including sterile manufacturing and regulatory affairs. He has spent the past 22 years in Regulatory Affairs leading the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules.
Prior to joining Pearl Pathways, Slisz directed the CMC regulatory strategy and risk assessment for Endocyte Inc., a small biopharmaceutical company that pairs companion imaging agents with small molecule drug conjugates for cancer treatment. Prior to Endocyte, he held roles in regulatory, manufacturing, process development and research at Eli Lilly and Co.
Slisz has earned the Regulatory Affairs Society regulatory affairs certification for both the US (2000) and EU (2003), and has spoken at numerous national and international conferences on regulatory issues. He holds a Bachelor’s Degree of Science in Biology and Chemistry from Saint Joseph’s College.