Dr. Richard Paul is an actively licensed Internal Medicine M.D. with more than two decades of experience in drug development, regulatory affairs and clinical research. He has worked as a practicing physician, a pharmaceutical company development executive and CRO executive. Rich’s experience spans medical safety, clinical research, and regulatory strategy. In addition to his generalized drug development knowledge, Dr. Paul has experience in metabolic, hematology, oncology, CNS disease including Pain, Parkinson’s Disease and Alzheimer’s dementia, respectively.
Dr. Paul started his career after securing his Medical Degree with post graduate work at Albert Einstein College of Medicine, NY, Rutgers University’s Internal Medicine Residency program and a Fellowship tenure at Harvard Medical School/Joslin Diabetes Center. Following the postgraduate work, Rich enjoyed private clinical practice treating adults and juveniles with diabetes and metabolic diseases for over 9 years before transitioning into pharmaceutical research with Pfizer. He has also held executive leadership positions in clinical research, regulatory and medical safety departments with Ergo Science, Grünenthal USA, Shionogi USA and Schering Plough Corporation. Notably, Dr. Paul was the founding Managing Director of Grünenthal USA, establishing the subsidiary for Grunenthal GmbH of Germany.
Through the course of his accomplished career, Rich has served many clients and employers in the areas of scientific and regulatory consultation. Dr. Paul has multi-divisional FDA experience having represented and participated with a number of Biotech and Pharmaceutical sponsors supporting Investigational and New Drug Applications with the US FDA and other international regulatory agencies. Further, Dr. Paul has led global regulatory groups for two CROs and one biotech organization.
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Officers
G. Alexander Fleming, MD
Executive Chairman
Thomas Seoh
President and Chief Executive Officer
Clinical Development
Regulatory Affairs
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Pre-Clinical
CMC, Formulation/Process Development & Sourcing
Medical Device
QA/QC
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Medical Writing/Electronic Submissions
Process & Innovation Management
Elizabeth Whalley Buono, BSN, RN, MBA, JD
Commercializing and Business & Corporate Strategy
Founders