Priv-Doz. Dr. Wolf S. Richter
founded pharmtrace in September 2006 to provide expertise and advice to drug developers in the integration and application of medical imaging and biomarkers to the drug development process.
He has a distinguished background, encompassing almost 20 years’ experience in clinical practice, academic and industrial research. Prior to establishing pharmtrace, he was Head and Executive Director, Global Medical Development Diagnostic Imaging / Radiopharmaceuticals and acting Head Digital Image Management in Schering AG, Berlin. His expertise includes the identification and critical assessment of medical needs, the preparation of clinical development plans, first in man studies, clinical phase II and III programs, the design of centralized image analyses (blinded reads).
Wolf S. Richter is associate member of the faculty of Charité Medical School. He is specialized and board-certified as a nuclear medicine physician. During his clinical career, he was part the radiological and nuclear medicine services of Charité Medical School. He had the role of a senior physician for cardiovascular imaging. In addition, he established a small animal research lab and successfully studied isolated rat hearts using radiopharmaceutical methods. Wolf S. Richter is a strong team player with deep understanding of senior management expectations. Dr Richter published in excess of 40 original articles and more than 100 abstracts in addition to making regular conference contributions as an invited speaker.
Jay Wiggins, Ph.D.
His career spans both academic medicine and industry. He has more than 30 years experience in the pharmaceutical industry, encompassing bench research, drug discovery and clinical development in the US and Europe. In the course of his career, he has managed pre-clinical discovery efforts from identification of lead compounds and associated patents through IND filings with the FDA and other regulatory authorities.
Jay Wiggins is an expert in the use of imaging and biomarkers in clinical strategies. He directed global clinical programs through NDAs and post-marketing efforts, including management of multifunctional team, CROs and international trials. Jay Wiggins has also served as medical liaison and clinical lead for marketing and clinical operations providing guidance for worldwide pharmaceutical development. He believes strongly in timely and efficient clinical development. In what he considers one of the highlights of his career, he and his clinical team designed, implemented and completed 5 clinical trials (Phases 1-2) for a single project in a 2-year period. On another project, he and Wolf S. Richter drove a proof-of-concept project from initial concept to last patient out in less than 9 months.
He has more than 40 publications, largely in the field of cardiovascular biology and medicine.
Dr. Carsten Schwenke
Carsten Schwenke studied statistics including biometry at the universities of Dortmund (Germany) and Sheffield (UK). He worked for more than 9 years in pharmaceutical industry. During this time he acted as a study- and project-statistician in global development teams with main emphasis on diagnostic imaging, radiopharmaceuticals for imaging and therapy, and the preclinical and clinical development of vaccines. Carsten Schwenke has the relevant expertise and track record in the specific requirements of clinical trials where biomarkers and/or medical imaging are key end points.
In addition, Carsten Schwenke is an expert in pharmacoeconomics and outcomes research. He directed global health economics and outcomes research teams to support NDAs and post-marketing efforts. This included patient reported outcomes as supportive parameters in the approval process, cost-effectiveness analyses and submissions of health economic dossiers to reimbursement authorities (e.g., NICE).
Carsten Schwenke has contact with the Regulatory Authorities in Europe and the US on a regular basis. He is the author of several original articles in statistics and medical journals in addition to presentations at conferences on a regular basis.