Strengthening team with extensive experience in product and process development and scale-up from bench to commercial process
PRINCETON, NJ -- (Marketwired) -- 10/19/16 -- Adgero Biopharmaceuticals Holdings, Inc. ("Adgero" or the "Company"), a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy ("PDT") platform for the treatment of serious oncology indications, announced today that it has strengthened its management team with the appointment of Laura Edgerly-Pflug as Vice President, Manufacturing Operations and Quality Control.
Ms. Edgerly-Pflug has over 25 years' experience in manufacturing and quality control in the biotechnology-pharmaceutical industry. Over this time, she has worked on the development and commercialization of a number of complex pharmaceuticals and biologicals with a wide range of formulations and routes of administration. She has extensive experience in product and process development and scale-up from bench to commercial process, all areas of good manufacturing practice (GMP) compliance, and has developed and implemented quality management systems and improved pre-existing quality systems.
Frank Pilkiewicz, Ph.D., Chief Executive Officer and Chairman of the Board of Adgero, stated "We are very pleased to have Laura join the Adgero team. As a well experienced leader in product and process development with expertise in scale-up, contract manufacturing, quality assurance and control and product management, we look forward to the capabilities she brings in driving the REM-001 Therapy development towards commercialization. This key strategic appointment is another step forward for Adgero in bringing our proprietary late-stage technology to market."
Laura joins the Adgero team from her most recent role as an independent consultant at Pflug BioPharm Solutions, where she provided strategic direction and implementation to clients in the areas of quality assurance, new technologies, new products and life cycle initiatives. Prior to that, Ms. Edgerly-Pflug served at Insmed Incorporated, formerly Transave Inc., as VP of Technical Operations and Chemistry, Manufacturing and Controls. While at Insmed, Ms. Edgerly-Pflug was responsible for product development and manufacturing of sterile liposomal products from preclinical development through commercialization. In addition, Ms. Edgerly-Pflug has served as the Director of Manufacturing at Ovation Pharmaceuticals Inc., currently Recordati Rare Diseases, and was responsible for continuity of supply of three commercial sterile injectable products from contract manufacturing organizations in accordance with commercial supply and quality agreements. Earlier in her career, Laura served as Senior Director of Global Pharmaceutical Development at Biomira, where she was accountable for all staff and activities focused on the development of liposome-based cancer vaccines, proteins and peptides in support of pre-clinical and clinical studies. Following her initial industrial position as a chemist at Colgate Palmolive, Laura rose to the rank of Scientist at The Liposome Company where she developed the validation process for the company's lead commercial product Abelcet®.
"Adgero's late stage photodynamic therapy shows real promise as a treatment for patients suffering from cutaneous metastatic breast cancer. I believe that REM-001 Therapy has the potential to provide opportunities as an effective therapy in a range of serious oncology indications. I look forward to working with the Company to further advance this innovative technology to its next stage of growth," commented Ms. Edgerly-Pflug.
Adgero Biopharmaceuticals Holdings, Inc. is a privately-held biopharmaceutical company focused on building a pipeline by advancing its proprietary late stage photodynamic therapy ("PDT") platform with broad utility for the treatment of serious oncology indications. Its lead product candidate, REM-001 Therapy, has demonstrated promising safety and efficacy in four Phase 2/3 clinical studies in patients with cutaneous metastatic breast cancer ("CMBC") who have failed radiation therapy. Use of Adgero's existing data or the completion of a Phase 3 trial in individuals with CMBC could lead to approval of REM-001 Therapy.
For more information, please visit www.AdgeroBiopharm.com.
This press release contains certain forward-looking statements, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company's actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source: Adgero Biopharmaceuticals Holdings, Inc.
Released October 19, 2016