Regulatory Challenges of CMC Drug Development for Emerging Biotech Companies
How a Falling Apple Inspired the Understanding of Gravitational Force.
Have you ever heard of the famous anecdote about Isaac Newton and an Apple? Although the details of this story have been embellished over time, it is said that a falling apple inspired Newton's understanding of gravitational force.
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Young Isaac Newton is sitting in his Garden!
Today, in more and more cases, the earliest stages of drug development are being handled by smaller emerging biotech sponsors, which have different resources and thus different challenges compared to their bigger and traditionally-established counterparts.
For example, these emerging biotech companies often lack the expertise, experience, and equipment needed to handle their CMC development on their own, which is why they must entrust such processes to a CMC contract manufacturing organization (CMO).
Potential Complications with this Setup?
Despite the advantages offered by CMC contract manufacturing organizations, there are a few potential complications for smaller emerging biotech sponsors.
For one, different CMOs have different capabilities, so sponsors must be careful to choose the best suited for their needs.
Furthermore, the pressure to produce results quickly and cost-effectively can lead to an increased chance of errors - which could have disastrous consequences if not appropriately addressed.
The good news is that this pressure can be overcome with insight and thoughtful considerations for outsourcing CMC development while still operating under limited resources.
Quick and Dirty CMC Scenarios for Emerging Biotech?
Here are some examples of potential strategies:
For emerging biotech companies, choosing the right CMO starts with understanding their particular needs and circumstances.
Some sponsors will know exactly what they want and how they want to achieve it, so they should look for a CMO who can carry out their orders efficiently and effectively.
Others may need guidance when sorting through their options; these companies may benefit from a CMO that also provides strategic consultation services.
Decision-makers should take their time when assessing potential candidates to make sure they have a full understanding of the CMO's capabilities and capacities.
It is also important to confirm the truth of claims made by sales language by consulting other sources.
Emerging biotech companies can capitalize on their advantage of responsiveness by engaging other stakeholders in open and transparent two-way communication.
This is essential for building mutual trust, which can help to protect the companies from unexpected contingencies that may arise.
Mutual trust helps to smooth out potential bumps, giving emerging biotechs a measure of protection no matter the size or sector they are in.
Finally, emerging biotech should not let themselves be rushed into making decisions.
Following the proper protocols will allow them to anticipate potential issues with their products and come up with the answers before they are asked, whereas hastily made decisions can leave them struggling for an answer.
This is especially important when dealing with regulatory agencies, who may have suspicions if there are sudden changes close to submission, which could suggest a lack of capability or control.
Further Considerations
Summed up simply, emerging biotech sponsors have fewer resources than their bigger and better-established counterparts, which is why they must focus so much on choosing the right strategies to get the desired results without putting themselves at too much risk at the same time.
Read More Insights Around Regulatory Drug Development visit our Blog or Watch our latest Video Navigating the New Regulatory Normal with Enkrisi on our YouTube Channel. Also, watch the YouTube version of How a Falling Apple Inspired the Understanding of Gravitational Force Now.