Altus Pharmaceuticals Names Don G. Burstyn, Ph.D. Vice President, Regulatory Affairs.CAMBRIDGE, Mass. -- Altus(R) Pharmaceuticals Inc., a leader in the development of novel protein therapies to treat chronic gastrointestinal and metabolic diseases, announced today that Don G. Burstyn, Ph.D. has been appointed Vice President, Regulatory Affairs. In this role, Dr. Burstyn will oversee global regulatory affairs activities for the company's portfolio of products and will report to Peter Lanciano, President and Chief Executive Officer of Altus. Mr. Lanciano said, "Don brings extensive pharmaceutical, regulatory and product development experience to Altus, having worked both in industry and at the Food and Drug Administration. His broad background in a variety of regulatory affairs capacities will allow him to serve as Altus' strategic liaison with both the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. , which is of critical importance to the company's product development success. Don will play an important role in fostering Altus' growth as a multi-product company and his arrival continues to expand the Altus team with additional product development and commercialization experience." Dr. Burstyn will be responsible for managing discussions with the U.S. Food and Drug Administration and the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA) for Altus' portfolio of products, which is led by TheraCLEC(TM), a novel enzyme replacement therapy Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. Usually this is done by giving the patient an intravenous (IV) infusion containing the enzyme. to treat malabsorption malabsorption /mal·ab·sorp·tion/ (mal?ab-sorp´shun) impaired intestinal absorption of nutrients. mal·ab·sorp·tion n. Defective or inadequate absorption of nutrients from the intestinal tract. as a result of pancreatic insufficiency. TheraCLEC is currently in Phase 2 clinical trials and has received Orphan Drug Designation and Fast Track status from the U.S. Food and Drug Administration. Before joining Altus, Dr. Burstyn served as Vice President of Regulatory Affairs for Alkermes, Inc, where he was responsible for leading the company's activities related to the approvals of Nutropin Depot(TM) and Risperdal Consta(TM). Prior to Alkermes, Dr. Burstyn held a number of positions at Biogen, Inc. and with the U.S. Food and Drug Administration. Dr. Burstyn has also served on various committees for both the Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States. (PhRMA) and the Biotechnology Industry Organization Biotechnology Industry Organization or BIO was founded 1993 in Washington, DC. James C. Greenwood is BIO's current President. External links
About Altus Pharmaceuticals Inc. Altus Pharmaceuticals is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases. Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally delivered and injectable protein replacement products. As a company, Altus is committed to improving the quality of life of patients. More information about Altus and its clinical development programs can be found at www.altus.com. |
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