How to Build Effective CDMO partnership?
Two decades ago, the CDMO sector was a whirlwind of activity and innovation. There has been an increase in the importance of CDMOs in the drug development strategy of corporations of all sizes. There has been an increase in the number of mergers and acquisitions as CDMOs seek to extend their services and recruit new clients in response to this boom in demand.
In addition to identifying potential CDMO partners, pharmaceutical and biopharmaceutical businesses must create mutually trusting CDMO relationships. Clear communication is vital in this situation. A CDMO relationship can enable both parties to work through misconceptions and overcome unexpected obstacles. Here is how to do that:
Be Specific About What You Expect From a CDMO
Knowing what you want from a CDMO collaboration is the first step towards obtaining it. When a company approaches a CDMO like Scorpion Bio with a request for proposal (RFP), it’s surprising how often they don’t know exactly what they want from the partnership and how they want to work together.
An assessment of your in-house capabilities and identifying gaps in skills, knowledge, and resources are recommended before employing a CDMO to help fill them. The more intangible traits that contribute to a successful working partnership should also be considered. A potential spouse’s responsiveness, flexibility, and support expectations are all examples of intangible attributes that you might look for in a mate.
The most critical thing to ask a CDMO is, “Are the quality systems adequate?” The use of ISO-type contractors is unnecessary if you require cGMP manufacturing. In the same way, why pay more for cGMP production if you’re looking at potential regulatory starting materials? Investigate prior quality issues by searching the FDA’s warning letter archive.
Intellectual Property Knowledge
The ownership of patents, trade secrets, and specialized procedures employed in creating pharmaceutical products is a controversial subject. In particular, this is true during the last stages of product development, when the final procedures and product attributes are constantly changing. A few essential points:
Typically, the product firm owns and maintains all intellectual property specific to the product.
As far as manufacturing process patents and trade secrets go, there are several options. A CDMO can own intellectual property yet license it to a firm for their product if they have established appropriate processes.
For every scenario, the contract language must be unambiguous to safeguard the product development while also allowing the CDMO to execute work and utilize capacity for several clients at once
When Your CDMO Is Bringing You on Board, Pay Close Attention to Their Approach
For your project, you need a partner eager to take on substantial challenges”a partner committed to discovering the most cost-effective and efficient path forward, even if that path doesn’t appear as it did at first glance.
Of course, this extends beyond the scope of your initial in-person meetings. A good partner will encourage open communication about the project’s quality, timeliness, and cost from the beginning to the end. They will put their efforts into creating a strategy that can be used throughout your program’s life cycle, which necessitates weighing the risks and benefits of each new step.
Put another way, this isn’t a “one and done” dialogue but rather an ongoing exchange of information and a shared commitment to the end outcome.