Who is not struck by the awe of a rocket launch? Did you ever consider how such a large object can be propelled into the sky with such speed from a standing start? The answer is thrust! Two opposing forces work against each other during launch: the downward weight of the rocket and upward thrust. For success, the push effect of the thrust must be greater than the downward force.
In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground.
Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. That’s a lot of downward pressure — so where’s the thrust?
Here are a few common complaints from drug sponsors: One, after contacting a CDMO they were subjected to several calls with different people from the same organization, sometimes over a period of weeks, reviewing the same information. Two, they did not receive an initial indication that the CDMO could take on their project until they received a proposal, which sometimes took months. Three, they had already done some initial vetting of the CDMOs capabilities and were ready to confirm their findings and talk about project specifics and timing.
But a few key practices by CDMOs in the initial stages of a relationship with a drug sponsor can deliver the thrust needed to get projects moving quickly.
Making the most of the first meeting
Once a drug developer contacts a CDMO who they think is a fit, it is time to schedule a formal meeting with a set agenda — an assessing capabilities and timing (ACT) meeting.
Focusing the first meeting on CDMO capabilities and capacity leads to the best outcome at this stage. To do this, CDMO attendees should include a scientific expert with a comprehensive understanding of the CDMO’s capabilities, a technical project manager with awareness of all current and planned CDMO projects, and a business development representative to serve as facilitator.
On the drug developer side, attendees should be able to speak about the services they need, dosage form specifics, method of delivery, specific stage(s) of development they are in and in need of support, and timing requirements.
ACT meeting deliverables
CDMOs should offer the following at the conclusion of an ACT meeting:
- Yes/no on whether the CDMO has the capabilities and timing for the project.
- If yes, the drug developer should hear from the CDMO in no more than a week following a formal project review.
- Next contact should include a high-level project estimate that details general project scope, a plan for tech transfer, work for any missing actions that have been identified via RFP, and an estimated cost range and timing.
- Provided the drug sponsor finds the high-level estimate acceptable, they should receive a proposal two weeks later.
The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients.
The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.