Challenges of CMC Development for Emerging Biotech Companies
Young Isaac Newton is sitting in his Garden!
It is one of the most famous anecdotes in the history of science. The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.
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 have to entrust such processes to a CMC contract manufacturing organization (CMO).
Potential complications with this setup?
There are a number of potential complications with this setup. For example, different CMOs have different CMC capabilities, meaning that smaller, leaner sponsors must exercise all possible care and consideration to make sure that they choose the one that’s best-suited to their particular needs and circumstances. Furthermore, small emerging biotech are under intense pressure to produce results for their partners, which in turn means that their CMOs are under intense pressure to rush through CMC development as soon as possible. It’s no coincidence that excessive cost-cutting is correlated with an increased chance for errors, meaning that this is something that can lead to catastrophic consequences with surprising ease.
However, smaller emerging biotech need to remember that these challenges can be overcome with insight, meaning they should put some serious thought into how they can outsource their CMC development in a successful manner while operating under their resource constraints.
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. For example, some of them will have a complete understanding of what they want as well as how they want to bring it into existence, meaning they should choose a CMO that specializes in carrying out their orders in the most efficient and effective manner possible. In contrast, the rest of them could benefit from some guidance on sorting through their options, meaning that they might do better with a CMO that can provide strategic consultation in addition to the rest of their services. Decision-makers for emerging biotech companies must be prepared to spend as much time with their candidates as they need to make sense of their true capabilities and capacities. However, they should also be prepared to confirm the truth of such claims by consulting other sources because sales language can be rather misleading.
- Emerging biotech have few advantages compared to their bigger and more traditionally-established counterparts, meaning they need to make use of what they have as much as possible. One such example is their responsiveness, which is the speed at which their representatives can respond to the expressed concerns of other stakeholders. To capitalize on this advantage, emerging biotech companies must be prepared to engage other stakeholders in open and transparent two-way communication, which is critical for building the mutual trust that is so fundamental to successful business partnerships. After all, mutual trust can be used to smooth over potential bumps, thus providing emerging biotech with a measure of protection from the unexpected contingencies that lie in wait for businesses of all sizes and all sectors.
- Finally, emerging biotech should not let themselves be pressured into rushing because the potential consequences are too great to be risked. For example, following up the proper procedures will enable even emerging biotech to anticipate the most probable issues when it comes to their products as well as come up with the right answers in advance, whereas more slipshod preparations can leave them floundering for a response, which can be devastating for their credibility in the eyes of others. This is particularly important when it comes to getting their products approved by the regulatory agencies, who often tend to be indirect when sponsors have to make sudden changes close to submission because it can suggest a lack of either capability or control.
Further Considerations
Summed up simply, emerging biotech sponsors have less resources than their bigger and better-established counterparts, which is why they must focus so much on choosing the right strategies in order to get the desired results without putting themselves at too much risk at the same time.
