DJC Drug Development Consulting
Douglas Fuhrer is a strategic consultant for medical device, small molecule and biologic therapeutic programs and was a Director of Toxicology and Pharmacology in established Biotechnology companies. He has over fifteen years experience with hands-on applications including directing teams of scientists and technicians in CRO, Large Pharma and Biotech organizations. His training and experience also includes applied animal investigation skills as a study director of GLP toxicology and safety pharmacology studies. He has completed multiple successful INDs and non-clinical programs supporting clinical development and leading to strong regulatory submissions of preIND briefing packages, INDs, NDAs and global equivalents. He has advanced treatments in the therapeutic areas of anti-infectives, cancer, immune regulation, diabetes, CNS, prostate enlargement, and hepatitis C. Recently he provided critical support which led to the FDA advisory committee approval of an anti-fibrotic drug. He is also expert at writing risk assessment report in support of extractable leachable studies he received his Bachelor’s and Master’s of Science degrees in Biological Sciences from Northern Illinois University and his Ph.D. in Biochemistry from the University of Illinois at Urbana-Champaign. His academic work focused on signal transduction mechanisms and he is board certified in toxicology (DABT). Memberships he has include the Society of Toxicology, Safety Pharmacology Society, and American Association of Pharmaceutical Scientists. He is also a founder and manager of the LinkedIn Biopharma Interest Group (BIG).
Intracellular components of signal of transduction are both therapeutic targets and targets of toxicity. The translation of a plethora of activating and inhibiting signals by a cell signals a cumulative response which can help bring a body back to reach cellular and systemic homeostasis. Understanding cellular specific mechanisms of signal transduction allows the development of target focused pharmaceuticals and avoidance of off-target responses. Predictive toxicity programs, in vitro assays and animal therapeutic models can only provide limited clinical efficacy and safety information. A harmonization of all available signaling information allows the dissection of pathways to identify targets of limited cross-talk to other critical signaling cascades. When in the process of regulatory safety assessment studies, by understanding cellular signal transduction unexpected, an optimized therapeutic index with an immaculate report is possible. The ability to understand and distinguish similarities and differences between toxicity species and the clinic is also central to this application, leading to quick first in man studies and clean clinical trials.