Healthcare Industry News: Xolair
News Release - December 20, 2007
Pearl Therapeutics, Inc. Expands Its Senior Management Team With Top Talent in Clinical Development and Regulatory AffairsREDWOOD CITY, Calif., Dec. 20 (HSMN NewsFeed) -- Pearl Therapeutics, Inc., a biopharmaceutical company developing treatments for major respiratory diseases, today announced the appointment of Colin Reisner, MD, FCCP, FAAAAI to the position of Chief Medical Officer and Executive Vice President of Clinical Development and Medical Affairs, and Michael Golden to the position of Vice President, Regulatory Affairs and Quality.
"We are delighted to welcome Colin and Michael as we continue to build our team with experts in the development of respiratory products," said Adrian Smith, President, Pearl Therapeutics, Inc. "Both Colin and Michael have proven records of success in the pharmaceutical industry and are innovative leaders who have designed and managed the clinical and CMC development programs of many marketed products, from pre-clinical through NDA filing and commercialization."
Dr. Reisner joins Pearl from Novartis Pharmaceuticals where he was Executive Director and former Disease Area Section Head for Global Respiratory Development, a position focused on both clinical development leadership and shaping Novartis' global strategy for respiratory products. He led the clinical development activities of several programs in asthma, COPD, and cystic fibrosis, assessing single and combination therapies across a wide range of delivery systems and dosage forms. Earlier at Novartis, Dr. Reisner served as the Global Brand Medical Director for Xolair®, the first biologic agent approved for asthma. In this capacity, he oversaw all clinical activities ranging from design and implementation of the pediatric development program to the European approval for the treatment of severe persistent allergic asthma.
Prior to Novartis, Dr. Reisner served as Senior Director in the Respiratory Division at GlaxoSmithKline, and as the International Project Leader for beta agonists. Dr. Reisner played a diverse and integral role in the development of several key products including Advair® Diskus® and Serevent® Diskus® for COPD, Serevent® and Flovent® pediatric programs, Ventolin® HFA dose counter, and led the final stages of the cilomilast development program, including the NDA submission.
Dr. Reisner began his career in the pharmaceutical industry at Boehringer Ingelheim where he focused on drug development in the Respimat® device, as well as the development of reformulated products using alternative propellants. Additionally, he assisted in securing approval of Combivent® Inhalation Aerosol in several European countries and Australia, and led the clinical components of a large COPD disease management program in collaboration with Penn-State Geisinger Health System.
Dr. Reisner graduated from the University of Witwatersrand Medical School in South Africa and completed his residency in Internal Medicine at Danbury Hospital, Danbury, Connecticut, a Yale-affiliated training program. He completed his fellowship training in Allergy and Immunology at National Jewish, Denver, Colorado, and he is a Diplomat of the American Board of Internal Medicine and the American Board of Allergy and Immunology.
Michael Golden joins Pearl from GlaxoSmithKline where for 20 years, he played significant roles in the development, regulatory submission and approval of 8 marketed inhalation and nasally delivered drugs including Flovent®, Serevent®, Advair®, Ventolin®, and Veramyst® Nasal Spray. Most recently he was the Director, External Advocacy, Global CMC Submissions, Regulatory Affairs at GSK. In this position, he was the principal advocate and liaison between GSK and the FDA in support of Quality by Design for all products. Additionally, Mr. Golden was a board member of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), where he led the consortium to find common ground between the Industry and the FDA for many regulatory, quality, and scientific topics. Mr. Golden's leadership has earned him a reputation as one of the most experienced, innovative, and respected CMC regulatory experts in the inhalation field.
Mr. Golden began his career at GSK as a research investigator and helped to establish the Inhalation Product Development group. For almost a decade he specialized in analytical chemistry and led project teams for various inhaled products.
Prior to joining GSK, Mr. Golden was with The Upjohn Company where he developed novel laboratory and on-line analytical methods for solid and liquid dosage forms. He received his MS in Analytical Chemistry from the University of Georgia, Athens, and has presented and published extensively.
About Pearl Therapeutics, Inc.
Pearl Therapeutics is developing a pipeline of advanced respiratory products that will offer patients and their healthcare providers a choice of formulations and dosage strengths better suited to their needs. Pearl's products will afford multiple health benefits compared to current treatment options and will be available in familiar and widely used dosage forms to enhance compliance. The company has licensed advanced particle technology from Nektar Therapeutics for application in selected fields.
Founded in 2006, Pearl Therapeutics is privately held and backed by Clarus Ventures, New Leaf Ventures and 5AM Ventures.
Source: Pearl Therapeutics
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