Mark Staples, Ph.D.
Click here for Dr. Staples' CV.
Mark Staples received his BA in 1975 and his Ph.D. in 1979, both in Biochemistry from the University of Kansas. He was a Postdoctoral Fellow at Harvard Medical School 1979-1980 and held a part-time Research Appointment there 1982-1986.
For more than 20 years Dr. Staples has helped transform scientifically interesting projects into commercial products serving unmet medical needs. His product development activities include pharmaceutical development of proteins and peptides and project management of the technical (CMC) portion of regulatory submissions. He has participated in five early stage companies. His titles have been at the Director and Vice President levels since 1997.
Highlights of projects Dr. Staples has worked on include:
- MicroCHIPS, Inc., 2003-2007: led Pharmaceutical Technology research leading to highly concentrated leuprolide and PTH(1-34) formulations suitable for delivery from an implantable MEMS-based device.
- GlycoGenesys, Inc., 2002-2003: re-engineered the manufacturing process for the polysaccharide anti-cancer agent GCS-100, enabling clinical trials to resume.
- Praecis Pharmaceuticals Inc., 1997-2002: compiled the CMC section for Plenaxis(TM), an extended release prostate cancer therapeutic (launched in 2004).
- Biogen (1988-1997): played critical roles developing and launching the MS drug, AVONEX®, and led analytical and formulation development for the ANGIOMAX® anticlotting peptide.
Dr. Staples continues to hold volunteer leadership positions within the American Association of Pharmaceutical Scientists (AAPS), including Chair of the BIOTEC Section (2006). He has also held positions on the Board of the Parenteral Drug Association New England Chapter (1993-2006), was President of the Chapter in 2003-2004, and in March received the PDA Chapter Volunteer Award.
