Jeff R. Dudley
|
There are two aspects of technology transfer that are equally important—the science and technology behind technology transfer,
and the working relationships among the partners involved. Most people spend the bulk of their time and effort on the former.
However, whether your role is to deliver technology to another function, or to receive that technology, both facets are essential
to a smooth transition.
The real-life scenarios that follow illustrate what happens when interpersonal communication is ignored, and what results
when it is addressed up front.
TECHNICAL FOCUS
For contract manufacturing organizations in the pharmaceutical arena, like Dowpharma, Dow Chemical Company's business operations
unit, getting the technology exchange right is of paramount importance. During our initial face-to-face meeting for a project
with a new prospect, we decided to work together. We also agreed—at the partner's request—to use only one person from their
organization, and one from ours, as the central and only voice between the two companies. Our partner had transferred many
projects to CMOs successfully, and we had received them successfully in the past. They thought the single focal point was
a successful method; although we did not prefer this approach, we agreed. So, we began to transfer data and answers to questions
through these two focal points. We were working on an established product, and were confident in our ability to duplicate
it and become the second supplier of this product for our partner.
Shortly after our first meeting, we began to run demonstration batches in our pilot plant that met specifications, and to
scale up to the commercial plant for our validation campaign. Throughout the next eight months, we worked tirelessly to deliver
in-specification product to our partner. Whenever we had questions or concerns, we shared them with our contact, who consulted
an expert inside his company to get an answer. Our partners were very responsive.
It was soon time for the validation campaign. We were eager to get started and confident that we could produce in-spec batches
and become the second supplier of this product for our partner. Our partner's liaison visited our plant to ensure we were
ready to go. He reviewed our protocols and procedures and was also confident we could meet their needs.
The validation campaign could not have gone smoother. We made not three, but six consecutive batches that were not only in
specification, but were at very nominal values and close to the product our partner was already receiving. We shipped our
product to the partner with the "perfect" certificate of analysis.
As with many CMO contracts, we get paid for our work after we deliver the product in specification and it meets the partner's
needs. So after eight months of work and six consecutive, successful validation batches, we were anxious to get paid. Our
partner contact said it would take the company a few days to get back to us with confirmation of product quality. We were
anxious to hear and began to plan our celebration.
I was not in the office when our company contact heard from our partner's, but our employee later reported the following
conversation:
Partner: "Your product is not the right color yellow!"
Dowpharma: "What do you mean it is not the right color yellow! Your spec simply calls for it to be yellow."
Partner: "I am telling you, your product is not the right color yellow. We cannot use it."
Our company contact called an emergency meeting that I attended. What were we going to do? Our partner had said his company
could not use our product. We asked our partner to ship samples of their product to us and we compared them with our product.
Below is a sample of our yellow, and theirs:
