Aeris Therapeutics Strengthens Management Team.May Orfali, MD is Vice President for Clinical Research and Medical Affairs WOBURN, Mass. -- Aeris Therapeutics, Inc. (www.aerist.com), a privately-held company, today announced that May Orfali, MD has been appointed Vice President for Clinical Research and Medical Affairs. In this newly created position, Dr. Orfali will be responsible for the leadership and management of Aeris' clinical research programs. Dr. Orfali comes to Aeris Therapeutics with more than 12 years of experience working in the pharmaceutical and medical device industries, providing clinical leadership in a broad range of therapeutic areas. Most recently Senior Medical Director in Clinical Development and Medical Affairs at Cubist Pharmaceuticals, she has also served in leadership positions at the Women's Health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. Group at Boston Scientific Corporation and Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. Transnational Corporation Any corporation that is registered and operates in more than one country at a time; also called a multinational corporation. A transnational, or multinational, corporation has its headquarters in one country and operates wholly or partially owned subsidiaries in one or more . "Dr. May Orfali brings a wealth of talent, leadership and proven program management experience to Aeris' clinical research and development efforts. She also complements and adds new breadth and depth to our internal medical resources," said David Dove, M.D., Aeris' President and Chief Executive Officer. "May's prior work with both pharmaceutical and device programs sets her apart, and is particularly important for a combination product like Aeris' Biologic Lung Volume Reduction (BLVR BLVR Believer BLVR Bronchoscopic Lung Volume Reduction BLVR Bovine Leukemia Virus Receptor BLVR Block Last Version Reference ) System. We are very pleased to have her as a member of our team." "I am excited to join the very talented team at Aeris Therapeutics at such a critical time in the company's development," Dr. Orfali said. "I look forward to helping move the company's product pipeline, most immediately the BLVR System, forward to regulatory approval and commercialization." A graduate of the Baghdad University School of Medicine, Dr. Orfali trained in pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. oncology at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world and Children's Hospital, Boston, and served on the research staff of the Dana Farber Cancer Center. She has also held research positions with UNICEF UNICEF (y  `nĭsĕf'), the United Nations Children's Fund, an affiliated agency of the United Nations. and the World Health Organization.
About Aeris Therapeutics, Inc. Aeris Therapeutics, Inc. is a specialty bio-pharmaceutical company dedicated to the development and commercialization of innovative therapies that improve the lives of patients with lung disease lung disease Pulmonary disease Pulmonology Any condition causing or indicating impaired lung function Types of LD Obstructive lung disease–↓ in air flow caused by a narrowing or blockage of airways–eg, asthma, emphysema, chronic bronchitis; . The company possesses a fundamental core clinical competence in pulmonary medicine with substantial internal capabilities in basic sciences, preclinical and clinical research, drug delivery, product development, and regulatory affairs. Aeris' research and product development efforts currently encompass the areas of interventional pulmonology pul·mo·nol·o·gy n. The branch of medicine that deals with diseases of the respiratory system. pulmonology The study of the lungs and respiratory function and targeted delivery of drugs and biologics. Aeris' lead product is the Biologic Lung Volume Reduction (BLVR) System, a non-surgical treatment for patients with advanced heterogeneous emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly . Founded in 2000, Aeris Therapeutics Inc. is privately held, with corporate offices in Woburn, MA. About The Biologic Lung Volume Reduction System. Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality Morbidity and Mortality can refer to:
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope bronchoscope (brŏng`kəskōp'), long, tubular instrument with a light at the tip that is inserted through the windpipe and bronchial tubes to examine these structures. to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable gel. The gel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better. Aeris' BLVR development program has been granted Fast Track designation by the U.S. 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 is presently in Phase II clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation for a clinical program provides a number of procedural benefits designed to facilitate the development and expedite the review of the investigational product. |
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