Pearl Pathways Hires Mark Slisz

Mark-Slisz

Experienced biopharma leader joins Pearl Pathways

INDIANAPOLIS, INDIANA – August 22, 2017 — Pearl Pathways announces the hiring of Mark Slisz as a Senior Advisor serving biopharmaceutical, medical device, and diagnostic life science companies.
Slisz brings over 35 years of experience in the pharmaceutical industry to Pearl Pathways. His 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. Mark 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, Mark 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, Mark held roles in regulatory, manufacturing, process development, and research at Eli Lilly and Company. As a Senior Advisor at Pearl Pathways, Mark is responsible for the development of the regulatory strategy for early through late stage regulatory filings of both large and small molecules, interactions with global regulatory agencies, and leading cross-functional CMC development teams.

Mark has earned the Regulatory Affairs Society regulatory affairs certification (RAC) for both the US (2000) and EU (2003), and has spoken at numerous national and international conferences on regulatory issues.  Mark holds a Bachelor’s Degree of Science in Biology and Chemistry from Saint Joseph’s College.Diana Caldwell, President and CEO shares, “Our clients will benefit from Mark’s extensive leadership experience navigating a variety of regulatory compliance challenges in large multi-national companies and small startups. Mark brings expert technical knowledge of developing regulatory strategies, quality systems, and manufacturing capabilities. His expertise in the areas of large scale development, process validation, new facility start-up, and global regulatory submissions will provide significant value to our clients. We are thrilled to have Mark join our team.”


About Pearl IRB

Pearl IRB is an independent institutional review board, fully accredited by the Association for the Accreditation of Human Research Protection Program Inc. (AAHRPP).  Pearl IRB manages the local and central IRB needs for large and small institutions, principal investigators, CROs, and sponsors. Our vision is to improve the clinical research process which will lead to delivering therapeutics and diagnostics to patients sooner. Whether the research is a small single site project or a complex multi-center study, we can help.

Pearl IRB is part of Pearl Pathways, a comprehensive life science product development services company. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Whether you are small startup, still in the pre-commercialization stage, or a large multinational company with several products on the market, Pearl Pathways is equipped to serve you. Learn more at www.pearlpathways.com.

To learn more, please visit us at www.pearlirb.com, call us at (317) 899-9341, or email contact@pearlirb.com. Pearl IRB is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlirb.com.


FOR IMMEDIATE RELEASE

Contact: Waylon Wright
Pearl IRB
Business: (317) 602-5479
Cell: (832) 942-4152
contact@pearlirb.com
www.pearlirb.com