09.29.16
Pamela Strode has been promoted to vice president of regulatory affairs and quality assurance at Epizyme, Inc., a clinical stage biopharma company developing epigenetic therapies for cancer. Ms. Strode will report to Epizyme’s president and chief executive officer, Robert Bazemore and will oversee all activities related to global regulatory strategy, including interactions with regulatory authorities regarding tazemetostat and global filings.
“This next year will be transformational for Epizyme as we advance the clinical development of tazemetostat and aim to engage with regulators in 2017,” said Mr. Bazemore. “Pam’s extensive regulatory and oncology experience will be essential to our success, guiding our path to registration for tazemetostat and driving forward our pipeline in the years ahead.”
Epizyme’s lead product candidate, tazemetostat, is a first-in-class EZH2 inhibitor in Phase II pdevelopment in non-Hodgkin lymphoma (NHL) and patients with genetically defined solid tumors. The Company plans to meet with regulatory authorities, beginning with the U.S. FDA, to review data and discuss registration strategies in mid-2017. Epizyme also expects to meet with FDA to review Phase II NHL data and discuss registration strategies in 2017.
Ms. Strode has 35 years of healthcare experience and most recently served as vice president, regulatory affairs at Cerulean Pharma, Inc. with a focus on oncology nanoparticle drug conjugate development. Previously she held senior regulatory positions supporting global development and U.S. marketed products in oncology, immunology and virology at Boehringer Ingelheim, and oncology and infectious disease development products at Bristol-Myers Squibb.
“This next year will be transformational for Epizyme as we advance the clinical development of tazemetostat and aim to engage with regulators in 2017,” said Mr. Bazemore. “Pam’s extensive regulatory and oncology experience will be essential to our success, guiding our path to registration for tazemetostat and driving forward our pipeline in the years ahead.”
Epizyme’s lead product candidate, tazemetostat, is a first-in-class EZH2 inhibitor in Phase II pdevelopment in non-Hodgkin lymphoma (NHL) and patients with genetically defined solid tumors. The Company plans to meet with regulatory authorities, beginning with the U.S. FDA, to review data and discuss registration strategies in mid-2017. Epizyme also expects to meet with FDA to review Phase II NHL data and discuss registration strategies in 2017.
Ms. Strode has 35 years of healthcare experience and most recently served as vice president, regulatory affairs at Cerulean Pharma, Inc. with a focus on oncology nanoparticle drug conjugate development. Previously she held senior regulatory positions supporting global development and U.S. marketed products in oncology, immunology and virology at Boehringer Ingelheim, and oncology and infectious disease development products at Bristol-Myers Squibb.