In the pharmaceutical industry, a wide range of sponsors is pursuing drug development. On one end of the spectrum are emerging biotechs whose knowledge about the process is limited to the drug itself. These organizations typically have limited time or personnel to spare for anything beyond the early development phases. On the other end are the big players who have very in-depth knowledge of both the drug and the development process. They also likely have access to a vast supply of resources but simply just want to transfer their product to another manufacturing site. Between these extremes lie other varying levels of drug development knowledge and experience. As a result, the requests for proposal (RFPs) submitted by sponsors often reflect this diversity. Some RFPs provide an extensive amount of detail about every aspect and expectation of the project while others contain only what the writer thought were the most pertinent bullet points. 

For a CDMO to create a proposal that offers an accurate projection of the scope, costs, and timelines for a project, each RFP submitted by a sponsor must provide the same basic but important information. The goal is to offer a complete understanding of the status of your project and the activities leading to the major project deliverables. It creates a strong foundation for the project, and it also establishes a relationship of open and clear communication between the sponsor and the CDMO. 

RFP Must-Haves

Investing the time to build a structured RFP template that outlines specific details of the project eliminates any assumptions and ultimately ensures the budget and scopes are aligned correctly from the beginning. RFPs that lack the information necessary to create an accurate proposal lead to additional requests for information that can stretch over multiple emails, phone calls, and waiting periods. Beyond the quote team, several of a CDMO’s subject matter experts are typically involved in the process, from R&D to Operations and even Finance.

 Below are 10 categories that must be included in an RFP template. If a sponsor is able to provide the information required for each of these sections, a CDMO and its in-house experts can provide a complete and accurate proposal that leaves little room for surprises.

1. Scope — This is a high-level summary that provides insight into what the nature and status of the project is as well as the sponsor’s overall objectives.

    

2. Responsibilities —This section outlines the expected responsibilities of the sponsor and the CDMO. While it may not seem necessary, it is good to state this information upfront so everyone is on the same page going forward.

3. Drug Candidate —The name of the drug candidate, its physical/chemical properties, its functions, classification, and most importantly, its level of toxicity are included in this section. The material safety data sheet (MSDS) alone may not suffice. The sponsor should also provide the information relative to the occupational exposure level or any other information that would help categorize the level of toxicity of the drug. That would allow the CDMO to determine if the drug can be handled safely in its facility.

4. Formulation — This includes the drug’s master formula, which is a list of ingredients, the amount of each ingredient per batch, and the ingredients per single unit dosage form. The current manufacturing process and equipment train should also be outlined, preferably in a flowchart diagram.

If a formulation has to be developed, this section can list the type of dosage forms, the dosage strengths, and the physical attributes of the tablet, such as size, weight, color, etc. For more complex dosage forms, such as an extended-release formulation, the targeted in vitro release profile will help define the technology and level of expertise that needs to be involved. 

5. Analytical Development — The quality of the data provided in this section will often directly impact the achievement of the initial milestones. Raw materials and product specifications, analytical methods validation reports, and product stability data are all crucial elements that need to be tackled right from the beginning in order to open the path for the manufacturing activities. 

6. Process Development — This section defines the strategy to ensure the manufacturing process is scalable and generates products that meet all of the quality attributes defined in the product target profile. The scale of the batches should be defined here as they are usually smaller than the anticipated commercial batch, especially when API cost is an issue. 

7. Manufacturing — This is usually the main deliverable. Whether it be clinical phase I/II/III or process validation, the scale and number of batches are clearly detailed. When multiple strengths are involved, the strategy to leverage the number of batches between the strengths is explained.

8. Packaging Strategy —When multiple packaging configurations are part of the scope, the sponsor should specify how the batches would be split among the configurations and the dosage strengths. For example, the plan could be to use the same packaging configuration for each strength or to use different packaging sizes for different strengths. 

9. Stability Strategy — Product stability studies could be conducted at the different phases of development, but in all cases, the pull dates, the packaging configurations and the environmental conditions should be clearly stated in this section.

10. Commercial Forecast — Depending on the type of project, a sponsor may have a commercial forecast, which determines the batch size needed for commercial production. This is an important piece of information for any project as it would allow the CDMO to determine how this product would fit in its commercial capacity and if capital investment would be needed.

Key Questions To Ask In An RFP

In addition to the information above, there are key questions from the sponsor that a CDMO should address in its proposal. By providing these answers, a CDMO is committing to its ability to meet the requirements of the project and to successfully carry it through to completion. For example, a sponsor can use specific questions to gauge how much of its project a CDMO is equipped to handle, how much can be completed at the CDMO’s facility, and if the CDMO has the equipment and materials necessary to get started. These include: 

• Do you have the capacity for this project?
• Can you meet my timeline?
• Will any parts of the scope need to be outsourced?
• Do you have the raw materials on hand to begin this project?

Another area where additional questions should be asked is regarding a CDMO’s project management team. In the pharmaceutical industry, some sponsors have had bad experiences with CDMOs who over-promise and under-deliver. A strong project management team can foster communication and manage the sponsor’s expectations by maintaining a good level of trust between both parties. Here are some specific questions a sponsor may want to ask about a CDMO’s project management team:

• How many dedicated project managers do you have?
• How many projects does each project manager currently have, and what is the maximum number of projects they will manage at any time?

If the CDMO indicated in the first set of questions that its facility has the capacity for a project, but these questions reveal its project management team may not, this could be a red flag for the sponsor.

Final Steps For Your RFP

 As already stated, a CDMO should consult each stakeholder involved in a project before providing a proposal to the sponsor. Returning an accurate and complete proposal requires a well-organized internal communication process to facilitate the transfer of information between all teams involved in building the proposals.

 Once the RFP is sent, a sponsor should provide an appropriate amount of time for completion. This is typically between 10 and 15 business days. In the RFP, the sponsor should also provide a target date for when a decision will be made. It is also good business practice to inform the CDMO if it is not selected for the project. Sponsors should also be aware that once the proposal is agreed upon and signed, a manufacturer’s supply agreement (MSA) will need to be created. This is a legal binding agreement between the two parties that involves coordination and agreement from both company’s legal teams. Depending on negotiations, this could delay the start of the project.

 Overall, when it comes to the design of an RFP, there is nothing required by law and the “rules” are up to the sponsor. However, a properly crafted RFP template using the guidelines above not only helps a CDMO provide the sponsor with the information it needs to make an informed decision, but it also improves efficiency and response time in a sponsor’s RFP process.

Article by: Francois Chouinard, Ph.D.