Welcome

BioStrategics Consulting Ltd, through its Founder and President Michael Silverman, MD, FACP, provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries, including:

• Clinical development strategy and management, especially for development-stage companies
• IND planning and preparation
• Conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials
• FDA and other regulatory authority submissions and meetings
• Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas
• New technology assessment, due diligence, and clinical planning
• Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).

Since its founding in 1999, BioStrategics Consulting Ltd has provided clinical research leadership for:

• More than 25 Investigational New Drug applications, Clinical Trial Applications, or similar regulatory submissions
• Multiple pre-IND and milestone meetings with FDA
• Numerous first-in-man clinical trials, both in healthy volunteer and in target patient populations
• Proof-of-principle clinical trials in oncology, rheumatology, dermatology, ophthalmology, autoimmune disease, infectious disease, immunotherapy, endocrinology/metabolic disease, and hematology
• Clinical trials programs that align with business success, efficiently achieve value inflection points, and have (in some cases) enabled advantageous exit events
• Clinical trial operational teams on 4 continents
• Due diligence, business development, partnership, and corporate strategic analysis projects of preclinical-, clinical-, and commercial-stage projects.