1. The Cusp PharmaTech Consulting LLC (CUSP) name and logo reference the radical transformation of the pharmaceutical industry due to the advent of biotechnology.

  2. 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).

  3. 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.

  4. 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.”

  5. 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:

  6. Development: process, analytical methods, formulation and dosage form design; technology transfer to GMP operations (manufacturing and quality laboratories)

  7. Product types: drugs (small organic molecules, peptides and proteins), biologics, and combination products

  8. Project management: compilation of data for regulatory submissions

  9. Outsourcing: selection, collaboration and direction of additional consultants, contract laboratories (CROs) and manufacturers (CMOs)

  10. Target clients are biotechnology and pharmaceutical companies that wish to leverage internal resources by enlisting CUSP for consulting assistance.

  11. 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).

  12. 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.


A point made by the intersection of at least two curved lines.

Download Business Card: CUSP card.jpg

Download vCard: Mark Staples vCard.vcf

Email: m.a.staples@comcast.net

The Boston skyline, viewed from the Cambridge/MIT side of the Charles River.