Dr Michael Silverman talks about some of the clinical experiences of BioStrategics Consulting Ltd and what he describes as his ideal business clients.
BioStrategics Consulting Ltd provides its services through its President and Senior Clinical Development Consultant, Michael H Silverman, MD, FACP. Since 1999, BioStrategics Consulting Ltd has been providing strategic, management-level clinical development consulting services to companies around the world, including North America, Europe, Asia, and New Zealand. This experience has included virtually all types of therapeutic products across almost every therapeutic area. BioStrategics Consulting Ltd has been an active partner and peer-level advisor to CEOs, COOs, and CSOs in the development of small molecule pharmaceuticals, biological agents, immunotherapeutic agents, novel drug delivery formulations, and medical devices. Therapeutic fields of particular concentration include oncology/hematology, autoimmune/inflammatory disease, infectious disease, rheumatology, dermatology, and ophthalmology. Furthermore, BioStrategics Consulting Ltd has often been able to assist client companies achieve their goals through its global network of experienced drug development professionals (such as biostatisticians, medical writers, clinical operations personnel, and clinical contractors) as well as academic thought leaders and clinical investigators.
Dr Silverman has found that the ideal candidate company for BioStrategics’ consulting services is a small, development-stage pharmaceutical or biotechnology company that does not have senior clinical research personnel or clinical operations infrastructure. He has also found that BioStrategics Consulting Ltd is often able to provide the most leverage to new clinical programs by becoming involved 6-12 months prior to IND filing and serving as an active member of the development team. This timing is optimal for contributing to overall clinical strategy, clinical protocol design, and thought leader/investigator cultivation and selection; and participating in pre-IND meetings and related regulatory interactions. As a result, BioStrategics Consulting Ltd has particular interest and experience in first-in-man and related Phase 1 clinical trials in both healthy volunteer and patient populations, including Phase 1 oncology trials, and in the clinical strategy and the design of later stage clinical studies.
BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries. The goal of this blog is to provide a forum to discuss the challenges and intricacies of clinical development, as well as the testing of pharmaceutical, biotechnology and medical device products in man.
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