Due to changing regulatory standards and guidelines, the pathway from discovery to commercialization for a drug, biologic or cell-based therapy can be unclear and complex.
Examine the facts
- For every success, 30,000 compounds are screened
- FDA approval rate for drugs that enter clinical trials is < 10%
- Cancer drugs have the lowest approval rate (5.1%) and orphan rare diseases the highest (25%)
- Less than 31% of drugs that enter Phase 2 studies go on to Phase 3
- Less than 58% of drugs that enter Phase 3 trials are submitted to the FDA
- 85% of drugs submitted to the FDA are approved
- Mean time from FDA filing and approval is 1.6 years
- Cancer drugs have the shortest time to approval at 1.1 years, while neurology drugs have the longest at 2 years
- 95% of all research, development and clinical trial costs go toward Phase 3 trials
- *June, 2016 BIO Conference.
Most drugs fail due to the process. CSSi LifeSciences™ has proven processes that can increase your chances for success!
ROAD MAP TO SUCCESS FOR DRUGS AND BIOLOGICS
The pathway from discovery to commercialization for a new drug, biologic or cell
based therapy can be unclear and complex, with ever changing regulatory guidelines.
Regulations and requirements vary by regulatory agency (i.e., CDER, CBER, EMA
CHMP) and the new guidance requirements for Special Designations are ambiguous
and are often subject to a re-viewer's discretion. We can help you gain a deep
understanding of the applicable regulations and requirements, often beyond what is
available in published guidance documents and other initiatives, that could influence
your regulatory pathway and profitability.
We will work with you to design and implement a competitive, cost-effective regulatory strategy, prepare and submit a marketing application, and serve as your liaison from start to end, helping you to negotiate with US FDA, EMA, and international regulatory agencies quickly and effectively.
Our team possess the skills and resources to successfully develop your product.