Diana Wood is the founder and CEO of KCST. Diana has over 30 years of pharmaceutical development with a special emphasis on the development of unique and orphan drugs. Since 2008 Diana has also been the VP, Corporate Development for Stason Pharmaceuticals, Inc.
Aidan Nuttall Ph.D. Vice President, Development. Aidan has over 35 years of pharmaceutical development with expertise in the oversight of preclinical and clinical evaluations.
KCST specializes in working with small start-up companies, and with large pharmaceutical companies outside the US to develop their drugs in the US. We offer a unique perspective on how to develop, difficult to develop drugs utilizing various regulatory strategies & platforms, such as
- Development of FDA Briefing Documents
- Orphan designation
- Orphan drug grants
- Patent and PCT filings
- Breakthrough designation
- Conditional Approval
- IND submissions
- NDA submissions
- Sponsor fee waivers
- Oversight of 3rd party vendors (IND/NDS enabling preclinical vendors, CRO, central lab, manufacturing, etc.)
KCST also provides strategic drug development, formulation and scale up through the parent company Stason Pharmaceuticals, Inc. www.stason.com