Protein Polymer Technologies, Inc. has announced the addition of Stephen Reitzler as Vice President, Clinical and Regulatory Affairs, effective October 3, 2005.
Reitzler’s responsibilities will include strategic and executional oversight for all U.S. clinical and regulatory matters, including filings and interaction with regulatory authorities.
Reitzler joins PPTI with twenty-five years of experience in the strategic management of regulatory, compliance and clinical research.
Prior to joining the company, Mr. Reitzler served as V.P. Regulatory Affairs and Quality Assurance for INNERCOOL therapies and previously was V.P. Regulatory Affairs and Quality Assurance for NuVasive Incorporated.
He has broad experience in both 510 (k) and PMA applications, and ISO/FDA GMP audits.
"Stephen brings exceptional clinical and regulatory expertise to PPTI and we welcome him to our executive team," said William N. Plamondon III, PPTI’s Chief Executive Officer.
"His impressive background will prove to be extremely valuable and further strengthen our leadership in clinical and regulatory affairs as we advance toward the important product development milestones that we have set for the company."
Mr. Reitzler played an important role at United States Surgical Corporation that took a creative and cutting edge approach to the Food and Drug Administration process.
He also helped start a highly successful and large consulting practice in San Diego, Advanced Bioresearch Associates, where he was head of regulatory affairs and worked on a variety of projects such as an implantable heart, an artificial liver and a chemotherapy drug.
"I am excited to join PPTI at this point in its transformation and am confident that my experience can add value as we go forward and execute our development and commercialization strategies," commented Mr. Reitzler.
"I am impressed by the current product pipeline and the value that it will provide."