Patricia Richards – Principal
More than 30 years experience as leader of pharmaceutical research and development
Dr. Richards is a globally recognized expert in pain management and central nervous system drug development. Her long-term interest in pain and central nervous system pharmacology has led to leadership roles in R&D and as the Chief Medical Officer for several pharmaceutical companies. Working with both small and large pharmaceutical companies, Dr. Richards has considerable experience in all stages of clinical drug development, including protocol development, due diligence, clinical strategy, and IND/NDA preparation (U.S., EU and Asia regulatory interactions and submissions). As a consultant, she specializes in clinical development strategy and protocol design for the pharmaceutical and medical device industry.
Her prestigious background includes inventor of Brisdelle® (paroxetine, Sebella Pharmaceuticals, Inc.) a compound for post-menopausal hot flashes; lead scientist and medical director for completion of two successful Phase III pediatric pain studies, in which patients were enrolled in less than half the projected timeline and that led to FDA approvals of products for pediatric pain; lead scientist and director of a Phase II program for an injectable pain product that involved six concurrent studies in various pain models; director of multidisciplinary teams of scientists, statisticians, health economists, project managers, clinical trial managers, clinical research associates and other research personnel; director of post-marketing drug safety programs; created concept and developed an innovative clinical research study on oxygen desaturations; and contributor of late-stage drug development for a first-in-class compound for opioid induced constipation. Dr. Richards is board certified in Internal Medicine, Anesthesiology and received Special Certification in Pain Management.
- Pain management and CNS drug development
- US, EU and Asia clinical trial design
- Due diligence, regulatory strategies and communications
