Project proposals are among the first steps in the partnership between a pharmaceutical company and a CDMO. The project proposal is critical to defining project scope and goals. Most of the information in the proposal is based on a questionnaire from the CDMO but can also be obtained from a formal Request for Proposal (RFP) generated by the prospective client.
While project proposals can be written to assume unknown factors (given the unknowns associated with working with preclinical/early-phase materials), this can lead to scope creep and delays as revisions or amendments to the project proposal become necessary at different stages of the project (i.e., adding or removing studies). Accordingly, proposal questionnaires are created by CDMOs to provide the details they need to know about a project — not only to determine whether they are able to assist with the project’s requirements, but to empower the CDMO to make appropriate recommendations about how to prevent delays and facilitate smooth project progress.
Role of the Questionnaire
To receive the most comprehensive project proposal possible for an intended scope of work, it is important to fill out any questionnaire as accurately and completely as possible. Questionnaire segments are likely to vary by CDMO because every organization operates a little differently. Ultimately, though, all CDMOs seek the same “big picture” information: presentation, end goal for the material, etc.
In an ideal scenario, a prospective client fills out the questionnaire in its entirety, up to and including the required in-process and release testing. However, as noted above, there is some leeway to include must-have items in the proposal’s first iteration and then add less critical information as it becomes available. At the top of the must-have list is a safety data sheet (SDS) which helps the CDMO understand whether it has the knowledge, equipment, personnel, etc. to safely handle a client’s material. Following closely behind on the priority list is formulation information.
The next must-have is storage condition data, because a CDMO must be able to store the API or DS material before they can manufacture the final drug product. Additionally, given the long lead times for many components (especially if they are a special class), clarity on component sizes and types should be understood up front. That said, pharmaceutical companies have options. At Singota, if you know you need a vial, but you don’t know exactly which size, options are available and can be pursued.
Stability data falls into the category of “nice to have up front but can wait until a little later.” The key advantage of knowing this information early is planning for the cost of that testing or those lab services. So, early questionnaire segments focus on information vital to the manufacture of the product — like formulation and storage conditions — while about half the questionnaire focuses solely on testing. For example, quality control (QC) testing changes are a common amendment based on client or regulatory agency insight throughout the project. The point is, companies should strive to complete questionnaires, but some items that are not understood early can be added via an amendment or separate project proposal at a later date.
Try to never leave a blank space on a questionnaire. That space is a question mark for the CDMO: was the question overlooked, do they think it is not important, or did they simply not know? Instead, be specific about why the question is not/cannot be answered. Write “I don’t know,” or “I’ll understand this at a later time,” or “We need to talk to so-and-so to understand this and we’ll answer in two weeks.” These types of answers give the proposal writer(s) more room to work, so to speak, when adding contingencies to the project proposal.
A Typical Proposal Process
At Singota, the proposal process begins with our business development (BD) team fielding inquiries, and then sending out questionnaires to facilitate further conversations. Once a questionnaire is returned, we review it to make sure we can accommodate what the client is asking for: can we handle the material, the quantity, etc.? The BD team is supported by people from the manufacturing team, QA, and our lab to discuss with the client any questionnaire responses for which they require more information. This ensures we understand each request and can accurately include it in the proposal.
Large project proposals can take weeks to assemble due to additional team meetings between Singota and the client to ensure everyone is on the same page (i.e., the revision process outlined above). A client may be unclear on formulation details, methods may not be fully developed, or they are unsure how many units they need. At the other end of the spectrum, some clients specify every detail all the way down to, for example, how much volume will be released for various testing. Whatever the case, both parties need to work together and identify any product or process knowledge gaps and make sure that appropriate studies are included in the proposal to ensure the project results are successful.
Even after the questionnaire has been submitted to the CDMO and its proposal tendered to the prospective client, work remains to be done. Most proposals go through several stages of revision before finalization and signing. Sometimes, one or both parties think different of some element or another once they see it in writing. For example, the CDMO may make some assumptions that the client realizes, under review, do not reflect what they meant to convey.
Proposals often are reviewed by both companies’ legal departments/representation, as well. And, sometimes the proposal simply has to be changed for clarification of terms, or because a client experiences sticker shock after seeing the pricing for all the services they requested, so they whittle down the list until the cost is more palatable.
Notably, the more people and departments involved, the more cumbersome it is to progress through revisions. Different reviewers may make conflicting requests based on their individual viewpoints. Ideally, the same people who filled out the questionnaire are those attending meetings relevant to the proposal and working on revisions.
Singota’s Support System
Singota often works with small, virtual companies that excel in the science of their product but may lack the experience or know-how to map out and execute what is needed for a successful manufacturing campaign. These needs span a number of factors, including full characterization of the product’s attributes, test methods to properly identify the drug substance, methods to determine the product’s properties, product stability over time, formulation do’s and don’ts, what the material will be used for, how the material will “act” during manufacturing batches larger than those used in a laboratory setting, etc.
In an effort to be responsive and remain agile in the face of this uncertainty, Singota continually updates its questionnaire, ensuring it reflects what we need to understand about prospective client needs. Singota is initiating another round of improvements to our process of gathering information about the project and product to be manufactured. Through an improved questionnaire, a checklist of important questions, and in-depth person-to-person discussions with the clients, we conduct pre-proposal gap assessments that aim to identify necessary activities during the project to close the gaps and ensure success.
Some of the items Singota needs to understand include the following:
- Material development phase and the intended outcomes of all work performed with Singota (i.e., purpose of the testing performed, clinical trial use, etc.)
- The product (i.e., formulation, product stability, formulation scale, etc.)
- The process (i.e., a flow diagram for a clinical process based on the formulation, readiness vs. unit operation required to formulate and manufacture the product with suitable release and stability at scale)
- Any intricacies with the formulation and/or product that may require special considerations in Singota’s manufacturing process
- Information around any manufacturing-related studies that may or may not have been previously conducted (i.e., hydrogen peroxide degradation, pump studies, mixing studies, stoppering studies, etc.)
- Any analytical methods required for in-process and/or release testing, and information around method availability, validation, etc.
This increased focus on upfront disclosure signals the importance of thinking about each question; nothing is extraneous. It should be interpreted as, “You don’t have to necessarily need to have all this information right now, but at some point, you’re going to need to know these answers,” and we will incorporate these activities into the proposal.
We do this because smaller organizations are a priority for us, not just convenient filler for our production lines. If you have a project need that is a good fit with Singota’s capabilities and have the information required, we’re not going to bump you because somebody bigger came along. Moreover, through specializing in small batch sizes, our technicians have amassed deep experience in working through specific issues, determining the solutions or studies necessary to help mitigate those problems forward.
About The Author
Malorie Meyer is a proposal writer at Singota Solutions. Malorie received her BA in biotechnology from Indiana University – Bloomington and her MBA in data analytics from the University of Southern Indiana. She has 9 years of experience in the pharmaceutical industry, with past roles including analytical chemistry laboratory testing, stability study development, and stability data trending at Cook Pharmica, LLC d/b/a Catalent Indiana, LLC. She has two and a half years of project management experience at Singota Solutions, overseeing projects ranging from supply chain services to laboratory analytical projects. For the past year, Malorie has focused on drafting proposals for new and existing scopes of work.
Singota Solutions is a contract development and manufacturing organization (CDMO) focused on helping clients in the pharmaceutical and biotechnology industries move their products through the drug development pipeline faster by being agile, accountable, and transparent.