Former Deputy Office Director at the FDA, Elaine Morefield, PhD, also joins Aclaris
WAYNE, Pa., June 15, 2018 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology and immunology, announced the expansion of its executive leadership team with the appointment of David Gordon, MB ChB, as Chief Medical Officer. Dr. Gordon will report to President and Chief Executive Officer, Dr. Neal Walker, and will lead Aclaris’ clinical research and medical affairs functions. Christopher Powala, Chief Regulatory and Development Officer, has added Elaine Morefield, Ph.D to his team as Director, Product Quality. Product Quality was Dr. Morefield’s area of focus for more than eight years at the U.S. Food and Drug Administration (FDA).
“We are excited to have David join the leadership team at this critical time when we are expanding the number of clinical programs for our pipeline of JAK inhibitors and preparing to initiate a Phase 3 program for common warts,” said Dr. Walker. “David has a wealth of experience developing first-in-class treatments and drugs with stand-out clinical profiles,” he added.
Prior to joining Aclaris, Dr. Gordon was Senior Vice President and Head of Dermatology Research and Development at GlaxoSmithKline plc (GSK). Over eighteen years at GSK, he led teams responsible for all stages of research from drug discovery through development and post-approval. He served as Clinical Vice President and Medicine Development Leader in the Immuno-Inflammation and Biopharmaceutical groups at GSK. His experience includes successfully developing and obtaining regulatory approval for drugs in a range of therapeutic areas, including NUCALA® (mepolizumab)? and BENLYSTA® (belimumab). His British medical degree (MB ChB) was awarded from Aberdeen University. He is accredited as a specialist in Pharmaceutical Medicine by the Faculty of Pharmaceutical Medicine in London.
“The time I have spent in immuno-inflammation and dermatology has taught me about both the impact of dermatological diseases and how we can apply our knowledge of science to address the needs of these patients,” said Dr. Gordon. “I am pleased to be joining Aclaris, a company that is passionate about finding solutions for these patients by developing and commercializing new therapies for dermatologic conditions, including diseases for which no FDA-approved medications exist.”
Aclaris also welcomes the addition of Dr. Elaine Morefield. While at the FDA, Dr. Morefield managed the New Drug Application CMC review process and implementation of FDA’s quality by design (QbD) effort. Dr. Morefield’s 30 years of pharmaceutical product development experience also includes positions at Wyeth, Schering-Plough, DSM, and Vertex Pharmaceuticals. Dr. Morefield has had an instrumental role in the development of over one hundred pharmaceutical products.
“I share Dr. Gordon’s enthusiasm for contributing to the efforts of Aclaris to develop new treatments for underserved dermatologic diseases,” said Dr. Morefield.
“We are thrilled that Dr. Morefield has joined Aclaris and is contributing her considerable expertise in regulatory strategy and unique insight into FDA,” adds Christopher Powala.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology. Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ clinical development of its drug candidates, including the timing for initiation of planned clinical trials. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K filed for the year ended December 31, 2017, Aclaris’ Quarterly Report on Form 10-Q filed earlier for the quarter ended March 31, 2018 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “Financial Information” section of the Investors page of Aclaris’ website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Michael Tung, M.D.
Senior Vice President
Corporate Strategy/Investor Relations