Dan Gingerich Email and Phone Number

Summary Biostatistical and regulatory consultant with extensive pharmaceutical, biotechnology and nutraceutical experience. Recent projects include construction of datasets and statistical analysis of clinical data on autologous stem cell therapy, radiological outcomes of spinal surgery, laser treatment of pelvic pain in women, and comparisons of clinical scoring questionnaires for osteoarthritis trials. Endpoints of projects include preparation of comprehensive reports for regulatory submission, manuscripts for publication in peer refereed scientific journals, and technical marketing materials. Experience Research and regulatory affairs director for traditional pharmaceutical companies (Johnson & Johnson, Bristol Myers, Wyeth), a dietary supplement company (Stolle Milk Biologics, Inc) and a start-up immunotherapeutic technology development company (Imulan BioTherapeutics, LLC).Specialties: Statistical work-up of clinical and pre-clinical data, regulatory affairs strategy and planning for FDA submissions, clinical trial protocol design and management, data analysis, manuscript preparation, scientific presentations.