How to keep your oncology program on target and on schedule
Precision medicine, personalized medicine and adaptive trial designs are the new normal. So much so that clinical trials have become an important care option for patients. The regulators (EMA in the EU and FDA in the US) are responding to this situation with innovation; providing numerous accelerated pathways to provide cancer patients early access to new therapies.
In the therapeutic area of oncology, Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), provides a framework for submission and review of oncology products allowing concurrent decisions in the countries involved. As one of the international partners in this collaboration, NDA provides expert knowledge to support the process which may allow patients with cancer to receive earlier access to therapy in several countries simultaneously.
Precision drugs requires personalized R&D
Drug development is an expensive, highly competitive, high-risk business, governed by strict legal standards. Getting drugs to the market is a thrilling but all-consuming challenge. Along the path to approval many regulatory milestones need to be met while you are holding your breath for the much-awaited clinical data that can make or break the company.
Moving your product from concept to commercialization requires a thorough understanding of the science and proactive planning for success right from the start. Preparing all the necessary steps to address the patient population, generate evidence and documentation to meet regulatory requirements can be overwhelming, but you don’t have to face it alone.
Making your organization stronger
By partnering with NDA, the journey towards your essential goals will be fully supported by our experts. We will integrate knowledge about industry standards and regulatory thinking into your organization and take your data as far as you intend throughout the process.
By asking the right questions, NDA will empower you to make the right decisions, to get regulatory approval and to support decisions of the cost/benefit value of the end product or recommendations for its future use.
Whether you are in the need of our full range of service or single activities, NDA offers tailored expertise and a designated person to help you gradually build solid evidence for the optimal outcome of your oncology product right from the beginning.