According to the FDA, New Chemical Entities (NCEs) are drugs that contains no active moiety which has previously been approved by the FDA in any other application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act. A NCE is granted exclusivity by the FDA, which gives the license holder limited protection from new competition in the marketplace.
It’s important to note the difference between an NCE and a New Molecular Entity (NME). While an NCE has no active moiety, an NME contains an active moiety that has not yet been approved by the FDA or marketed in the U.S.
NCEs begin life as chemical molecules and ultimately emerge as key ingredients in life-saving drugs. Yet, despite their urgency in treating disease, nearly one-third of drug candidates fail in preclinical studies – and often this can be attributed to compromised NCEs. Added to that, identifying an NCE and developing it as a new drug can take upwards of 15 years, at costs in the hundreds of millions of dollars.
Why are there so many challenges when manufacturing NCEs? The key reason is uncertainty. As with anything new, the pathway to their creation is completely unchartered territory. No one can be quite sure of how the NCE molecule will react under different conditions, how long it may take to achieve the desired outcome or what problems could arise in raw materials.
For these reasons, most NCE development and manufacturing is outsourced to Contract Development and Manufacturing Organizations (CDMO)s who can leverage their expertise, experience and library of best practices. Since successfully navigating FDA regulations can be challenging, it’s advisable to carefully scrutinize the CDMO’s track record of adherence to the highest cGMP standards. Contaminants, hazards and quality control in manufacturing are key issues that could result in the FDA’s delaying the trial. With time pressures always at the forefront, setbacks can be devastating and costly – yet many could have been avoided.
Below are four other key challenges in developing NCEs and how your CDMO can help to assuage them.
While there are endless curveballs that are thrown in the NCE development process, perhaps one of the most important strategies is to work with an experienced CDMO, that is equipped to handle the surprises that can arise. This means a CDMO with cGMP-level labs, plants, equipment and scientists who recognize that while each molecule is unique, there are standard best practices that can applied to enable the best outcome.
Given the volatile nature of NCEs, another key best practice is collaboration and communication. CDMOs and their sponsors must work together to quickly address issues proactively.
New Chemical Entities are just that – new. Working with a trusted CDMO to bring your NCE to the market can save valuable time, save costs and successfully deliver a critical ingredient to the populations that need it the most.