Case Studies & Experience
Former Director, Chemistry, Small Pharma Company
"When CSTI joined our pharma start-up to manage our drug development effort, we had several drug candidates, lots of energy and scientific expertise, but only a textbook plan of how to advance our compounds through IND and early stage clinical trials. CSTI provided the direction we needed to move from plans to implementation. With CSTI’s experience, skill, attention to detail, and by augmenting our team of technical experts, CSTI helped us to identify essential objectives and key milestones and managed our drug development programs to tight timelines and within budget targets. CSTI personnel were great professionals to work with!""
Head, Pharmacology, Large Pharma
"By preparing development plans from IND through commercialization for each of our assets, CSTI formed a comprehensive, seamless framework to manage our entire development portfolio. This provided transparency to each member of the development and management teams. For my department in particular, this framework allowed us to ensure that we had appropriate staff and equipment to generate quality data, and adequate time to interpret and report data to meet critical project milestones. CSTI exceeded expectations and kept our development efforts on pace to meet and exceed critical timelines. Most notably, under the direction of CSTI we advanced two of our assets to IND filing within 8 months; a commendable achievement for our small biotech organization!"
Director - QA, Small Biotech Company
"CSTI is a wise choice for product development management when companies are in need of expert advice and resources. We worked closely with CSIT for over a year and during that time, regulatory risks were identified and resolved, experts in the field were identified and hired, vendors were selected and effectively managed. Overall, the development process was greatly enhanced because issues were elucidated and managed to ensure that key milestones were achieved."
Chief Financial Officer, Contract Development and Manufacturing Company
"We hired CSTI to course-correct several development projects for one of our largest and key customers. The team quickly became a seamless extension of Company leadership, acting as a bridge between the scientists, management and the Customer. CSTI identified areas of improvement associated with quality and timeliness of deliverables, defined process improvement practices, and successfully implemented these practices. The team kept us informed of key decision points, major milestone progress and forecasted customer revenue and development costs. As a result, our delivery timelines, quality of our deliverables and customer satisfaction were significantly improved and resulted in repeat and continued business. I couldn’t have been more pleased."
Director Regulatory Affairs, Small Biotech Company
"Under CSTI’s direction we were able to evaluate the development and regulatory hurdles for our project and determined that continued development would not be advisable. Prior to CSTI’s involvement the development efforts were led by internal personnel, and we had questionable data and an unclear direction for the product. CSTI worked with internal and external technical professionals to define gaps and identify essential data required to decide if further development was warranted. Under CSTI’s management, within months, key data was available and analyzed. Together with the management team, the decision was made to terminate development of this product and to reallocate resources to the remaining projects under development. As an independent contractor, CSTI objectively led the team through the process of gathering additional data and toward the ultimate decision to discontinue development."
Scope and Therapeutic Experience
- Type of Assets: drugs, biologics, devices, and diagnostics
- Stage of development: research through post-marketing
- Therapeutic Area Experience:
Women’s health and wound healing