What Information Does a CDMO Need to Deliver a Good Proposal?
Richard Sidwell, Ph.D., Senior Vice President and Chief Scientific Officer
When you are looking for a CDMO to help you with your pharmaceutical formulation development and clinical supply manufacturing project, you’ll need to give them a lot of information. This information will help the CDMO understand your needs and provide you with a proposal that correctly captures what you need them to do, is priced fairly, and predicts, as closely as possible, how long it will take.
Before you begin, first, make sure that you trust the people and organization you’re talking to. Second, have a legal-reviewed confidentiality and non-disclosure agreement (NDA or CDA) signed by authorized individuals from both companies. Always remember that an NDA doesn’t prevent the misuse of your confidential information; it just gives you leverage for legal recourse after the fact. Trust is crucial.
Once you trust the team you’re talking to and have a valid NDA, it’s time to talk details. There’s a lot you’ll need to share with your CDMO. Generally, the information will help answer 6 questions:
- Can they safely and compliantly handle your project?
- Do they have the required capabilities (expertise, equipment, capacity)?
- How much support do you need vs how much control do you want?
- Where is your project now?
- How far do you want to go (and how fast)?
- Do you have funding available to cover the cost of the program?
Hopefully, you can divulge enough information before the detailed RFP process begins to confidently answer “yes” to the first two questions. Otherwise, you may be wasting your time. Even if you’re confident at first, you can run into snags in the details. For example, a last-minute reveal that part of the process has to be run under an inert atmosphere or low humidity conditions has derailed more than one otherwise promising discussion.
With those caveats in mind, let’s get into it.
- What is your active pharmaceutical ingredient (API)? This includes the API’s structure, physical properties, and stability data.
- What is your API’s safety profile? What therapeutic category is it? Do you have toxicology studies or other information? Do you have an established Occupational Exposure Limit (OEL)?
- What is your ideal target product profile (TPP)? This includes things like the route of administration, the type of dosage form, the total daily dose, and the dosing frequency.
- What phase of development are you in? Pre-IND? Phase 1? Phase 3?
- Where do you intend to conduct your clinical trials? US? EU? Australia?
- Where do you intend to file? US? EU? Anywhere else?
- How much API is available? When? Of what quality standard?
- If the API is being manufactured outside the US, do you have an IND to import the material for clinical use?
- Can you provide the necessary API and impurity reference standards?
- Do you have any methods already developed? To what level? Are they validated?
- If you already know it, what is your product’s formulation? This includes the excipients, the dosage form, and the target release profile.
- If you already know it, what are your product’s ideal specifications? This includes the physical, chemical, and biological specifications for your product.
- If you already know it, what is your product’s manufacturing process? This includes the steps involved in manufacturing your product and the equipment and facilities that will be needed.
- Will you need a matching placebo?
- Are you open to the CDMO changing materials, formulation, process, or methods?
- Do you have any specific storage and distribution requirements?
- Do you have any specific packaging requirements?
- Is your trial going to be an open trial or will it be blinded?
- Is there any specific IP the CDMO needs to know to either work within or avoid infringing?
- What is your project’s timeline and budget? This will help the CDMO determine if they can meet your needs and provide a competitive price.
- Are you fully funded, or do you need quotes to help raise funding?
As you can see, there’s a lot to be considered. Depending on the stage of your project, you may not know some of these things and that’s OK. Just err on the side of sharing as much information as possible. If there are gaps, the CDMO will have to make assumptions, which to some degree, there always are. If you provide them with as much information as possible from the start, you are much more likely to get a proposal tailored to your specific project that meets your needs.
A few final points:
- Be as clear and concise as possible.
- Provide all of the information that is requested.
- If you are unsure about something, ask for clarification.
- Be prepared to answer questions from the CDMO. Remember that getting detailed questions is a good sign that the team is thinking carefully about your project.
By following these tips, you can greatly increase the likelihood that you will get a good proposal.