The story is a common one. Your organization has just acquired a new asset and you are responsible for finding the custom development and manufacturing organization (CDMO) that is going to take you all the way to commercialization. If only it were that simple. Here are some questions that you should ask yourself before you even approach a CDMO, let alone begin a draft of that all important request for proposal (RFP).
First, how involved are you going to be with the project management? Be honest, are you going to be able to check on progress daily, weekly, biweekly? The less time you have, the more you will need to rely on the project management of the CDMO. Clear lines of communication and regular updates help develop the trust between the innovator and the CDMO that is needed for success. It is not an exaggeration to say that projects have failed, relationships have been destroyed and companies have folded due to poor communication.
Let’s consider some of the risk factors that could potentially derail your project. Risk factors often center around the following: time, budget and region.
Very often you face extreme pressure in order to maintain a timeline. You absolutely must have capsules by a certain date in order to start your clinical trial. Can you afford a delay if problems arise? Will a month-long delay be catastrophic to the program?
Think about your budget. Depending on where your organization is in the development cycle the questions are different. In the early stages, you want proof of concept as quickly and cheaply as possible. As your scale increases, spending some development dollars to make process improvements makes more sense. This is also important when crafting your RFP. Can you afford multiple scope changes if you put out an incomplete request? It may be better to take some time to get it right, but that timeline is forefront in your thoughts.
Next, you should also consider regional based risk factors. When your project is on the other side of the world you need to consider delays simply due to time zones. Your travel budget will need to be increased so that you can visit the CDMO prior to selection and then as the project continues. You should also consider language issues. All batch records need to be written in the native language of the operators, do you have the time and budget to account for that?
Now that you have decided how involved you can be and how much risk you can accept as an organization it is time to get serious about your project. After all, how can you create a short list of CDMO if you don’t match your project requirements against their strengths and weaknesses? When evaluating your project are there any special technologies required? Some examples of project-specific considerations may include low temperature, high pressure, energetic chemistry. Maybe you need to be able to measure out very small doses for formulation. Are there special safety concerns, such as high-potency or dust explosion hazard?
What is the scale of your project now? Are you willing to perform a tech transfer later if you outgrow your first CDMO or would you rather try to find a partner to take you from start to finish? Trick question! Even if you stick with the same partner, there are likely to be multiple tech transfers within the organization. A successful project will often hinge on your ability to anticipate problems BEFORE they happen, not just putting out fires as they occur.
Before you can craft a contingency plan to address adverse events that inevitably occur in your development program, you should have clear answers to most if not all of the questions above. You can event take it a step further by developing potential solutions to those surprises. Having a clear and focused direction for your project before you approach the CDMO, will pay dividends in the end. Keep these ideas in mind, and you are more likely to save time, focus your efforts most effectively and maximize your chances for a successful, smooth process.