The key to bioskin’s success is our team of highly motivated and skilled professionals. Team members with clinical, statistical and data management expertise interact closely to efficiently move projects from project planning through implementation to statistical analysis and reporting.
The staff based in our Hamburg and Berlin offices includes full-time dermatologists and physicians in both clinical units, clinical trial managers and medical writers (M.S., Ph.D. scientists), monitors, quality managers, data managers, statisticians, study nurses, recruiters and administrative support.
Walter Wigger-Alberti, M.D.
A dermatologist by training, Dr. Wigger-Alberti obtained his M.D. from the University of Kiel, Germany. Following residencies in dermatology in Westerland, Germany and the University Hospital in Zurich, Switzerland, he assumed a position in 1997 as attending physician and Head of the Skin Research Laboratory in the Department of Dermatology and Dermatological Allergology at the University of Jena, Germany. In 2001 Dr. Wigger-Alberti joined a dermatological CRO as Director of Clinical Research where he remained until joining bioskin®
in April 2009. Dr. Wigger-Alberti also holds a position as lecturer in the Department of Dermatology at the University of Osnabrück.
Betsy J. Hughes-Formella, Ph.D.
Director Business Development and Consulting
Dr. Hughes-Formella has been with bioskin®
since its opening in 1992. In her present position she oversees business development activities and serves as a consultant for early development programs and clinical trial designs. After completion of her M.S. and Ph.D. in Physiology from the College of Veterinary Medicine at the University of Georgia, Dr. Hughes-Formella moved to Hamburg in 1983 to join a research team in steroid research in the Department of Clinical Chemistry at the University Medical Center. After several years she shifted her area of interest to melanoma research and accepted a position as scientific assistant in the Department of Dermatology, where she remained until joining bioskin®
AJ Acker, RAC
Director Global Regulatory and Clinical Affairs
AJ Acker is a certified regulatory affairs professional (RAC) with more than 15 years of experience in the pharmaceutical industry and has a deep understanding of global clinical trial regulations and product approval requirements. A large part of his professional career has been spent in leadership roles for development of strategies ranging from preclinic to post-marketing for dermatology products. Mr. Acker has been responsible for global filings of clinical trial applications e.g. INDs and CTAs in the dermatology and other therapeutic areas. In addition, he has also taken on leadership roles for multiple marketing applications that have received approval by regulatory authorities. He has considerable experience with interaction and negotiation with the FDA, EMA and other regulatory authorities. Mr. Acker joined bioskin®
in February 2013.
Andrea Schmidt, Ph.D.
Director of Clinical Trial Operations
Dr. Schmidt, at bioskin®
since 1999, oversees the clinical trial management which includes trial organization of single and multi-center studies, medical writing and monitoring as well as the proposal and contract management at bioskin. She is also responsible for study allocation and capacity control of the two bioskin®
centers. Dr. Schmidt holds a Ph.D. in Pharmaceutical Biology and an M.S. in Microbiology both from the University of Hamburg, and gained experience in the fields of essential oils, disinfectants and microbiological stability testing during that time.
Amelie Spieser, M.S.
Director Data Management and Statistics
Amelie Spieser is responsible for the oversight of all data management and statistics activities at bioskin®
. She began her career in data management in Quintiles. Before joining bioskin®
in July 2012 she worked as Data Manager Operation Leader for Parexel. Mrs. Spieser holds an M.S. in molecular biology from University Louis Pasteur in Strasbourg, France.
Andrej Pischkow, M.A.
Director Quality Management
Andrej Pischkow began his career in Data Management at Astra Zeneca in 2001. In October 2005 he joined bioskin®
as a clinical monitor (CRA) and was Lead Monitor from August 2008 to May 2009 when he moved into his current position as Head of Quality Management. Mr. Pischkow holds an M.A. in German and Slavic philology from the Ernst-Moritz-Arndt-University in Greifswald, Germany.
Thomas Frase, M.S.
Head Information Technology/Facility Management
Thomas Frase joined bioskin®
in 1995 to add data management and statistics services to the bioskin®
in-house services. In his present position he heads up information technology. Mr. Frase holds an M.S. in computer science from the University in Kiel, Germany. Before joining bioskin®
Mr. Frase worked as a statistician for research programs on the genetics of psoriasis at the Department of Dermatology of the University of Kiel.