Demonstrating product value to improve licensing opportunities
The thousands of smaller, research-based biopharmaceutical companies performing much of today’s cutting-edge research face substantial challenges navigating the early stages of development to demonstrate the value of their novel therapies for potential licensing partners or purchasers. They need to provide key efficacy and safety data as quickly as possible, yet most of these companies lack the infrastructure and resources to undertake an extensive early-phase testing program.
PAREXEL is right where you need us to help meet those challenges and keep your early-phase products moving forward quickly and efficiently. We have the experience and resources to guide you through every aspect of early phase development, including performing designing robust trials, overcoming regulatory hurdles, managing data, and overseeing the entire early phase process. Utilizing our strategic network of early phase clinical units in the US, Europe, and South Africa, PAREXEL can provide individually tailored Phase I/IIa development programs across a wide spectrum of therapeutic areas.
We also have extensive experience conducting Proof of Concept (PoC) studies, which offer a faster, less-expensive way to test the therapeutic potential of a new product. A typical PoC study is designed to find signals of a product’s efficacy against a targeted indication as soon as possible in the development process. For smaller companies with limited resources, a PoC study can be the best approach to quickly answer key efficacy questions and demonstrate the value of their product to increase licensing opportunities.
PAREXEL’s other early-stage capabilities include:
- Global database of healthy volunteers and patients
- Highly qualified investigators and sites
- Comprehensive technology resources
- Market analysis and product classification/positioning
- Strategic product development planning
- Regulatory liaison and pre-IND agency meetings
- Bioanalytical analysis
- IND preparation and submission
- Manufacturing process development and GMP auditing