Successful Technology Transfer Requires More Than Technical Know-How - Frequent and open communication is a necessity in successful technology transfer. - BioPharm International

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Successful Technology Transfer Requires More Than Technical Know-How
Frequent and open communication is a necessity in successful technology transfer.


BioPharm International
Volume 19, Issue 10

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,


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