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•The Cusp PharmaTech Consulting LLC (CUSP) name and logo reference the radical transformation of the pharmaceutical industry due to the advent of biotechnology.
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•Advances have not just involved the creation of leading edge technologies, but diverse fields that have been converging for years (in other words, a cusp of multidisciplinary technological advances).
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•The prospects for industry innovation promise to extend our capability to reduce unmet medical needs and improve the quality, not just the duration, of life.
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•CUSP commits to helping its client companies fulfill their goals: one definition of a cusp is “An important moment when a decision is made that will determine future events.”
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•CUSP was founded by Mark A. Staples, Ph.D. in 2007 and is based in Cambridge, MA. Dr. Staples has worked in drug development for over 25 years. His specialties include:
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•Development: process, analytical methods, formulation and dosage form design; technology transfer to GMP operations (manufacturing and quality laboratories)
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•Product types: drugs (small organic molecules, peptides and proteins), biologics, and combination products
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•Project management: compilation of data for regulatory submissions
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•Outsourcing: selection, collaboration and direction of additional consultants, contract laboratories (CROs) and manufacturers (CMOs)
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•Target clients are biotechnology and pharmaceutical companies that wish to leverage internal resources by enlisting CUSP for consulting assistance.
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•CUSP enables the collection and compilation of data for the Chemistry, Manufacturing and Controls (CMC) section of Regulatory submissions: Investigational New Drug (IND) and New Drug Applications (NDA).
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•Successful INDs and NDAs authorize, respectively, clinical trials and marketing of human therapeutic products; CUSP tailors support for each client to make this effort as cost effective as possible.