Mark Staples, Ph.D. provides pharmaceutical technology consulting services to biotechnology and pharmaceutical companies.
For more than 25 years Dr. Staples has helped transform scientifically interesting projects into commercial products intended to serve unmet medical needs. His product development activities include pharmaceutical development of proteins, peptides and small organic molecules. He has extensive experience with project management and compilation of the technical (CMC) portion of regulatory submissions.
From 1984 to 2007, Dr. Staples played critical operating and leadership roles in five early stage companies, in addition to founding and leading the Biogen Formulation and Analytical Development Group from 1988-1997. During 1997-2007, his titles were various levels of Director or Vice President at several early stage companies.
Dr. Staples received his BA (Chemistry, Biochemistry, English) and Ph.D. (Biochemistry, 1979) from the University of Kansas (Lawrence, KS). He was a Postdoctoral Fellow in the Biological Chemistry Department at Harvard Medical School 1979-1980 (Boston, MA) and held a part-time Research Appointment there 1982-1986 in Dr. Elkan Blout’s laboratory. He also received an MBA (1985) at Northeastern Unniversity (Boston, MA). His research emphasized structure-function relationships of peptides and proteins. In 2006, Dr. Staples chaired the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section. He Also chaired numerous AAPS Committees 2001-2008. He was served on the Board of the Parenteral Drug Association (PDA) New England Chapter (2005-2006), was President of the Chapter in 2003-2004 and Treasurer 1993-2002, and in March 2007 he received the PDA Chapter Volunteer Award. He remains active in PDA and AAPS.
Mark can be reached at: