Successful Technology Transfer Requires More Than Technical Know-How

October 1, 2006
Jeff R. Dudley

BioPharm International, BioPharm International-10-01-2006, Volume 19, Issue 10

We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.

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.

Jeff R. Dudley

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:

In the next conversation between the two companies, our partner reiterated they would be unable to use the product.

Dowpharma: "But you never said what shade of yellow you wanted, and there isn't a color spec! Our product is a yellow particle."

Partner: "You never asked for a color spec and it is definitely not the color we can use. Nice try, though."

So, there we were, with nothing to show after eight months of arduous work except a few metric tons of very yellow "in-spec" product, and significant expense. The terms of our contract were payment upon delivery and acceptance of the product. We all knew what that meant.

Quick Recap

LESSONS LEARNED

Our business had just experienced a very costly lesson, and we were determined to learn from it and share our insights, to help others avoid the same mistakes.

Technical capability is critical, but not enough

The first thing we learned was that even though technical capability, which we certainly had, is of value, it cannot stand by itself. Most established manufacturing organizations have great technical capability and it is often the factor organizations have the most confidence in; it is also the most measurable.

The Importance of Trust

Relationships should include multiple points of contact

We reconfirmed the importance of relationships and the need to:

  • Establish many—not just one—points of contact

  • Communicate regularly

  • Clarify our partner's goals

  • Commit time to our partner and their success

  • Allow ample time for our experts to get to know theirs

Define and care about your partner's success

Often, we assume we know what success looks like for our partner, but we never really ask them or take the time to write down their response. It is important to do so, and to keep reminding ourselves of their vision for success. It is important to help partners articulate their vision of success by asking detailed questions about aspects they may not be considering.

What´s in a Word?

Commit time to them and their success

There is no better measure of your priorities than where you spend your time. Make time for your partner's questions and needs, and be sure they know how much time you are dedicating to their success.

Provide time for your organization's experts to get to know your partner's experts

One of the keys to really understanding the technology is to not filter technical discussions through second- or third-hand explanations. Once the project is under way, provide opportunities and forums for the technical experts of each partner to communicate directly. The best forum is a face-to-face meeting. If this is not feasible, provide other virtual means to accomplish this.

Assign several points of contacts at different levels

The fatal flaw in this project was that there was only one point of contact, at one level. When our relationship came to a standstill, there was no other recourse. Multiple points of contact at multiple levels are essential. The business relationship cannot hinge on just one technical or personal relationship. Now, at a minimum, we have at least one individual each from our quality, technical, manufacturing, and regulatory departments, along with a chemist, meet with their counterparts in the other company, as well as with the project focal points.

TRUST IN ACTION

While involved in the failed project discussed, we were also beginning a new project with another potential partner. This one recognized the importance of a relationship as well as technical capability. The partner was confident in our technical capability, and also willing to develop a relationship on multiple fronts, unlike our first partner who wanted only one point of contact. This was evident at the beginning. The second partner was quick to warm to the idea of multiple points of contact. When things went poorly in the first project, the entire project hinged on that one relationship. It was not strong enough to overcome the issue. With the second partner, I noticed something interesting when I was invited to a project review meeting. If I hadn't known our employees personally, I would have been hard pressed to tell who worked for which company. The project team members seemed like they all worked for one company. Conversely, with the first partner, the single contact in face-to-face meetings would take questions and retrieve answers from someone else his company. Our questions became filtered.

The second project progressed smoothly through preclinical, Phase 1, and Phase 2 trials. We began to prepare for Phase 3 clinical and validation batches. To be on the safe side, we ordered enough raw material for six batches so that we could make three consecutive in-spec batches for validation purposes.

The day came for batch one. At this point, technical capability was most important: knowing what to do, and being able to execute our capability.

Although we were confident, we were nervous, too. Unfortunately, we failed batches two and three, which tested our relationship for the first time. We also failed batch five. It appeared as though we lost all chance of completing the validation. Our relationship was put to the true test.

I thought of the "yellow" project with the single point of contact, and feared that the new project would have the same outcome. But an important difference between the two projects was that we had developed a relationship with this partner. Although our technical capability for the validation run was flawed, our partner believed we could help them be successful. So they gave us another chance. I am convinced that the reason we were granted this second opportunity was that we both had multiple points of contacts, at many levels, who were interested in the success of this project. This was in stark contrast to the situation at our first partner, where there was only one point of contact.

So, we ordered more raw materials, conducted extensive root-cause investigations, and tirelessly inspected and evaluated our processing steps, mode of control, and equipment. We convinced ourselves we had solutions to all of the problems. Our partner supported us at each step of the way. Looking back, I remember a meeting in which it seemed that our partner's technical folks were working for us. They offered suggestions, recommended ideas, and participated in our success.

Finally, it was time to attempt revalidation. We had succeeded with batch number three, and decided to produce batches four, five, and six for launch quantities.

Our approach worked and we were successful—we completed the revalidation flawlessly.

Rather than bask in our success, we decided to build on it by deepening our level of trust with our partner. We conducted a deep drill analysis, reviewing what had gone well and what had not. We learned together and we developed a robust partnership that has endured though approval and commercial launch. We are now involved in process optimization to meet capacity demand of their product.

I am confident that without trust we would not be here today. Our partner values and respects us.

How do we know that? We prove our worth to them every day—and they tell us.

Jeff R. Dudley is the business operations director at Dowpharma, The Dow Chemical Company, 547 Bldg, Midland, MI 48667, 989.638.0597, Fax 989.636.2844, jrdudley@dow.com