Strategic Product Development
Accelerating clinical development and regulatory approval through integrated strategy, science, and execution.
Collaborate. Implement. Launch.
Navigating Your Path to Product Development Success
We partner with biotechnology, pharmaceutical, and government organizations to design and execute integrated development strategies that accelerate product approval and reduce regulatory risk.
Discovery
- CCSA has developed databases containing more than 30,000 entries on potential cancer preventives
- We provide critical evaluation of nonclinical efficacy and toxicity testing models as well as potential uses for medical devices
- We develop and apply structure-activity relationships (SARs) and mechanism of action evaluations for drug modality and safety
Regulatory
- CCSA plans, organizes, and leads pre-submission and other planning meetings with regulatory agencies
- We have authored more than 50 CDPs for cancer prevention and treatment alone
- We leverage our expertise and experience to support development strategies for a wide range of products from targeted small molecules to immunotherapeutics and advanced technology platforms
Biomarkers and companion diagnostics
- CCSA developed the first Master IND approved by FDA
- We have designed large phase 2/3 adaptive and companion diagnostic investigational protocols
- We partner with pharmaceutical and biotechnology entities, NCI, FDA, academia, and non-profits in support of public-private partnerships such as the NCI Center for Strategic Scientific Initiatives and The Biomarkers Consortium