Last week, we detailed some of the inward questions that should be covered as you begin outsourcing your project to a CDMO. Now we will focus on some of the best practices for crafting your Request for Proposal (RFP). Miscommunication and problems that could be avoided are often directly attributable to a poorly crafted RFP. An effective RFP will convey clearly the scope of the project,
Scope of the Project and Deliverables
The scope of the project is arguably one of the most critical pieces of information you can communicate to a potential CDMO. The scope of your project is WHAT you want and needs to be both comprehensive and clear. After all, if you don’t communicate your needs, how can you expect the CDMO to fulfill them?
A common area of confusion in crafting an RFP is often the difference between the scope and deliverables. You can think of the scope as your order at a restaurant: a salad and a steak; the deliverables are the
In this case, the maxim is “ask, and you shall receive.”
Components of an RFP
The components of an RFP should be familiar. Remember all those lab reports you wrote in high school and college chemistry labs? Well, they are coming back to haunt you now. Every RFP should contain the following basic parts: cover page, introduction and background, objectives, deadline, technical information, proposal outline and any additional information.
Your RFP should begin with a cover page including a simple title and a top-level description of the project. The title should be simple and direct, creating a clear picture of the requirements. Your company name and contact details should be prominently featured; make it easy for the CDMO to contact you with questions or concerns. Finally, include the deadline to respond.
Introduction and Background
This section is all about cultivating a partnership with the CDMO. Introduce your company and product to help the CDMO align with your project goals. Projects evolve and can be convoluted, it is helpful to provide background on the road that has been traveled so far. Once the CDMO has read this section they should be developing an idea of who you are and where you are at.
Objective and Deadline
In this section, clarity is king. Explicitly spell out what you are trying to achieve; bullet points are useful. Some examples of common objectives include:
- Transfer process from current site
- Transfer and validate phase appropriate analytical methods
- cGMP demonstration batch on 10 kg scale
- 36-month ICH stability program
This section begins to break out your RFP into the line items that you want to see quoted in the proposal. You should also indicate if your company will be responsible for any related parts of the project.
Every RFP should have a deadline for submission. Deadlines can sometimes be negotiated, but a concrete expectation should ALWAYS be included. In addition,
A sense of balance is key in this section. For some, this is the most difficult section. Even though a confidentiality agreement is in place, you don’t want to throw everything over the fence, nor do you want to share too little. A general rule of thumb is to provide information consistent with an IND or IMPD. If there are details about your process that are known to be tricky or hazardous, please elaborate. Regardless, every RFP should include safety information, a process schematic or synthetic scheme, representative process descriptions and special considerations.
Proposal Outline and Additional Information
In order to make fair and informed decisions on the proposals you receive, you need to tell the CDMO exactly how you want the information presented. Most likely you will request a timeline for all activities; if it is critical for your analysis include it here.
Finally, just like a present, wrap it up. Outline your expectations on reporting. How often will the teams have a teleconference? Who will lead the call and prepare the minutes? Ask the CDMO to provide additional information about their site. When was the last PAI? How is waste handled?
A good RFP deftly balances clarity and brevity, and clearly communicates the expectations and responsibilities on both sides. Keep the previous principles in mind and in no time, you will be crafting the perfect RFP and ultimately save yourself time and headaches.