Evan Siegel, MPhil, PhD
Ground Zero Pharmaceuticals, Inc.
Evan Siegel, MPhil, PhD, is the President and Chief Executive Officer at the Ground Zero Pharmaceuticals, Inc., a regulatory affairs and product development consulting firm in California. He provides services in the strategic, regulatory, preclinical, clinical CMC and compliance areas for firms developing pharmaceuticals, biologics, medical devices and combination products. Previously, Dr. Siegel has served as CEO at the Oxochemie, Inc.; as Vice President at the Regulatory Affairs and Bioethics for Medical Science Systems, Inc.; also as Director of Regulatory Consulting and Principal Regulatory Scientist for Quintiles, Inc. He has been a Toxicologist at the US FDA and California Department of Health Services and has also served as Chief of Special Services. Dr. Siegel has been a Director of Pharmacology and Toxicology at Astra and Syntex. Dr. Siegel is an Adjunct Professor at the University of Queensland in Brisbane, Australia. (This is me - Update Profile)
| Unspecified - present | President and Chief Executive Officer Ground Zero Pharmaceuticals, Inc. |
|---|---|
| Unspecified - present | Adjunct Professor University of Queensland |
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The issues associated with expensive therapeutics are multifaceted and involve personal, professional and societal components. Value related to medical treatment is uniquely assessed by each individual with respect to his/her financial burden, overall lifestyle and quality of life, societal role,...
1. Sponsors need to be "squeaky clean" with respect to their assessment of signals of toxicity in drug develpment programs. 2. This assessment should be made at the preclinical and early clinical stages of the process, irrespective of political and financial considerations. 3. The per cent of failures...
Overseas manufacturing controls for both APIs and finished drug products will need to be improved and the FDA will closely monitor compliance in an increased fashion. Drug regulation itself is not likely to change, but more inspections and more thorough review of DMFs and information submitted in...
1. The results are intriguing, but the clinical relevance for the large number of patients who could be exposed in the real-life clinical situation is uncertain. 2. The hypotheses for thsi program early-on seem to be supported by the phase 3 data to date, i.e., the nitro-comopounds may have actions...
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