Epizyme Appoints Pamela Strode as Vice President, Regulatory Affairs and Quality Assurance
September 29 2016 - 6:30AM
Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical
company creating novel epigenetic therapies for people with cancer,
today announced that it has appointed Pamela Strode to the position
of vice president of regulatory affairs and quality assurance.
Strode will report to Epizyme’s president and chief executive
officer, Robert Bazemore and will oversee all of the Company’s
activities related to global regulatory strategy, including
upcoming 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 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 currently being studied in Phase 2
programs in patients with non-Hodgkin lymphoma (NHL) and in
patients with genetically defined solid tumors. The Company plans
to present data on tazemetostat’s efficacy and safety from both
Phase 2 studies in the first half of 2017. In addition, dependent
upon the data, the Company plans to meet with regulatory
authorities, beginning with the U.S. Food and Drug Administration
(FDA), to review data from its Phase 2 genetically defined solid
tumor study and discuss registration strategies in mid-2017.
Epizyme also expects to meet with FDA to review Phase 2 NHL data
and discuss registration strategies in 2017.
“I’m delighted to be joining the Epizyme team during such an
exciting time,” said Strode. “I look forward to applying my
experience in oncology and expedited drug development to advance
the tazemetostat program and our pipeline, with the goal of
bringing new therapies to patients with few or no other treatment
options. Our strategic approach to developing tazemetostat may
offer multiple accelerated paths forward for the treatment of
genetically defined solid tumors and hematological cancers.”
A 35-year healthcare industry veteran, Strode most
recently served as vice president, regulatory affairs at
Cerulean Pharma, Inc. with a focus on oncology
nanoparticle drug conjugate development. Strode
previously held progressively senior regulatory positions,
supporting global development and U.S. marketed products in
oncology, immunology and virology at Boehringer Ingelheim
Pharmaceuticals, Inc. (BI), and oncology and infectious disease
development products at Bristol-Myers Squibb. She also led the U.S.
product labeling development and maintenance function at BI.
Strode received a B.S. in microbiology from Cook College at Rutgers
University and an M.S. in quality assurance and regulatory affairs
from Temple University.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company creating novel epigenetic
therapeutics for cancer patients. Epizyme has built a proprietary
product platform that the Company uses to create small molecule
inhibitors of chromatin modifying proteins (CMPs), such as histone
methyltransferases or HMTs. CMPs are part of the system of gene
regulation, referred to as epigenetics, that controls gene
expression. Genetic alterations can result in changes to the
activity of CMPs, making them oncogenic (cancer-causing). By
focusing on the genetic drivers of cancers, Epizyme's targeted
science seeks to match the right medicines with the right
patients.
For more information, visit www.epizyme.com and connect with us
on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking
StatementsAny statements in this press release about
future expectations, plans and prospects for Epizyme,
Inc. and other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
uncertainties inherent in the initiation of future clinical studies
and in the availability and timing of data from ongoing clinical
studies; whether interim results from a clinical trial will be
predictive of the final results of the trial; whether results from
preclinical studies or earlier clinical studies will be predictive
of the results of future trials; whether results from clinical
studies will warrant meetings with regulatory authorities or
submissions for regulatory approval; expectations for regulatory
approvals to conduct trials or to market products; whether the
Company’s cash resources will be sufficient to fund the Company's
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; other matters that could affect the
availability or commercial potential of the Company's therapeutic
candidates; and other factors discussed in the "Risk Factors"
section of the Company's most recent Form 10-Q filed with
the SEC and in the Company's other filings from time to time
with the SEC. In addition, the forward-looking statements
included in this press release represent the Company's views as of
the date hereof and should not be relied upon as representing the
Company's views as of any date subsequent to the date hereof. The
Company anticipates that subsequent events and developments will
cause the Company's views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so.
Epizyme Contact:
Julie DiCarlo, Epizyme, Inc.
jdicarlo@epizyme.com
(617) 401-0721
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