Enabling more cost-effective and timely product and drug development programs
On average, it takes 10-15 years and costs $2.6 billion to develop one new medicine, including the cost of the many failures. And only 12% of new molecular entities that enter clinical trials eventually receive U.S. Food and Drug Administration (FDA) approval1.
In this environment, it is essential to have a strong and robust drug development strategy that allows for successful execution to deliver clear and high impact.
Building on a wealth of experience and specialized expertise, ICON enables sponsors to implement product development and drug development programs that are intelligently designed, cost effective and timely – while also taking into account the practical considerations of translating a plan into action.
ICON offers global, robust integrated asset development consulting, covering all phases of drug development, to virtual companies, start-ups, biotechs, pharmaceutical, and medical device sponsors.
Why work with us
Our drug development team has a broad array of experience ranging from preclinical through to full clinical development. We provide objective, asset-centric solutions which are designed to accelerate development and manage development risk.
Working with us will give you a deeper understanding of development options, with respect to scientific and regulatory risks, costs and timelines, to meet overall business objectives. It also means you gain access to in-depth scientific expertise across disciplines for ad hoc support.
We offer full development and lifecycle support, from helping clients to develop target product profiles, study synopses, protocols, integrated development plans and regulatory position pieces. Our innovative solutions, such as the use of novel statistical design can optimize development efficiency.
Our services include:
- Preparation of fully integrated asset development plans (CMC, preclinical, clinical, regulatory and commercial)
- Protocol development assistance: consultation on study designs, endpoints, objectives, measurements and statistical design
- Scientific and medical oversight
- Liaison with KOLs and patient advocacy groups
- Investigator relationships
- Development of academic advisory boards
- Due diligence to support asset acquisitions, divestment or investment
- Therapeutic area and protocol training
- Pipeline and portfolio review
- Preparation of regulatory dossiers and representation at formal regulatory meetings
- Gap analyses for regulatory submissions
To learn more or to speak with an expert, contact us today.Contact us
Asset development insights
The importance of formulation studies in drug development
Formulation studies require time, money and expertise, and the race to clinic and beyond may tempt drug companies, especially smaller ones, to take shortcuts that end up costing more later.
Regulatory agencies encourage use of adaptive designs
FDA and EMA thinking on adaptive designs has progressed significantly, and support for the approach has strengthened.
Clinical development of cell and gene therapies
ICON experts discuss the intricacies of CGT development, the solutions that will enable CGT development on a global basis, and the future of CGT clinical trials.