Former FDA regulatory scientist joins Pearl Pathways

January 23, 2018

 FOR IMMEDIATE RELEASE

Contact: Waylon Wright

Pearl Pathways

Business: (317) 602-5479

wwright@pearlpathways.com

www.pearlpathways.com

 

Former FDA regulatory scientist joins Pearl Pathways

 

INDIANAPOLIS, INDIANA – January 23, 2018— Pearl Pathways announces the hiring of Robert Seevers, PhD as Senior Advisor to serve biopharmaceutical companies.

Seevers brings over 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold chain shipping, setting global specifications, quality by design (QbD), global regulatory submissions, and interactions with global regulatory agencies. His knowledge spans all major therapeutic areas with specific expertise in CNS, Endocrine, Metabolism, Autoimmune, Oncology, Radiopharmaceuticals, and drug delivery systems. Seevers’ robust clinical research experience includes acting as a primary investigator, Vice-Chair of an Institutional Review Board, FDA Reviewer/Team Leader, and medical writer.

Seevers’ career includes eight years at the United States Food and Drug Administration (FDA). At FDA, Seevers served as a Team Leader responsible for managing a team of reviewers for the evaluation of CMC sections of INDs, NDAs and BLAs. Prior to joining Pearl Pathways, Seevers spent 16 years with Eli Lilly and Company in Regulatory Affairs, where he led 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.

 

As Senior Advisor at Pearl Pathways, Seevers 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, leading cross-functional CMC development teams, helping clients identify product development vendors (e.g. CROs, CMOs, contract laboratories), and will serve on Pearl IRB, an AAHRPP accredited Independent Review Board.

 

Seevers is a member of the United States Pharmacopeia Packaging, Storing, and Distribution Expert Committee, acts as a Stability Consultant for the World Health Organization (WHO), speaks regularly at nation and international life science conferences, and continues to be an active writer of industry publications.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Robert’s unique life science portfolio as an ex-FDA regulator coupled with extensive leadership experience within the biopharmaceutical industry. His dual-sided industry experience will be invaluable for our clients to navigate a variety of regulatory compliance challenges in both large multi-national companies and small startups. He brings expert technical knowledge of CMC development, drug substance synthetic processes, cold-chain shipping, radiopharmaceuticals, and global regulatory submissions including INDs, NDAs, and BLAs. We are thrilled to have Robert join our team.”

 

About Pearl Pathways

Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our AAHRPP accredited central IRB, Pearl IRB, supports all aspects of human research.

To learn more, please visit us at https://www.pearlpathways.com, call us at (317) 899-9341, or email contact@pearlpathways.com. Pearl Pathways is headquartered in Indianapolis, Indiana, with a regional office in Houston, Texas, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlpathways.com.