Camargo Pharmaceutical Services is pleased to announce the new Vice President of CMC Services, Lynn Gold, PhD. Dr. Gold will oversee API synthesis, delivery of CTM (formulation, manufacturing, analytical testing, packaging, stability) and coordination of chemistry, manufacturing and controls (CMC) information into regulatory filings.
Dr. Gold joins Camargo with an extensive pharmaceutical background in defining regulatory strategies to achieve corporate goals and moving early stage drug development programs to global regulatory submission and commercial launch. With over 18 years of experience in the pharmaceutical industry, she will be a tremendous asset to the growing list of Camargo clientele across the globe.
"Lynn is a truly talented individual with an impressive background in pharmaceutical development; her extensive experience within the industry is an asset to Camargo. I am confident that she will lead, build and expand the CMC capabilities within our organization," stated Camargo President and CEO, Ken Phelps. "The 505(b)(2) pathway is more than just regulatory activity. Formulation activities and timelines are different than traditional development pathways and we look forward to providing our clients with Lynn's expertise in this area."
Prior to joining Camargo, Dr. Gold held the position of vice president of research and process development at Sonus Pharmaceuticals located in Seattle, Washington, and was formerly the senior manager of pharmaceutics at Warner Chilcott Laboratories, a division of Galen Holdings, Inc., in Rockaway, New Jersey. She holds a PhD in physical organic chemistry from the University of Rochester and held a postdoctoral position at Duke University's Department of Chemistry studying the hydrophobic control of stereochemistry.
"The Camargo story is a true success. They make a real and valuable impact on drug development programs—it goes way beyond drug repositioning. The difference between a 505(b)(1) submission and the requirements of a 505(b)(2) submission are substantial. I am eager to join the Camargo team and start collaborating with the CMC division," stated Dr. Lynn Gold. "With my experience in the pharmaceutical industry I feel that I can successfully build the CMC business."
Camargo Pharmaceutical Services is a full-service CRO for the continuum of drug development. With more than 150 FDA approvals, Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulation and testing the drug product, conducting clinical studies and FDA application submissions. Visit www.camargopharma.com for more information.
SOURCE: Camargo Pharmaceutical Services