Pfizer Issues A Challenge – Cook Pharmica Delivers

By Ed Miseta, Chief Editor, Clinical Leader

When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.

“This test proved to be a cultural challenge for us,” says Frank Marchesani, business development executive at Cook and a co-presenter (along with Pfizer) of the Moving From Outsourcing To Partnersourcing session at the 2014 Biopharmaceutical Development & Production conference. “Generally, when a sponsor comes to you with a proposal, they will dictate the terms of the job and how to move forward. In this case, they left a lot of that up to us.”

Cook felt Pfizer was looking for a CMO that would be an extension of the company itself; one that could produce a product with an almost cookie-cutter like similarity. Finding such a partner would garner long-term benefits for both companies. But Pfizer also gave the CMO a lot of latitude to perform the production in a manner with which they were most comfortable. Generally the sponsor will dictate the terms of the project and how to develop the process,” says Marchesani. “In this case, we were able to develop the process from the ground up, with very little input from their scientists. That presented us with the opportunity to impress them with our abilities, or to fail if things didn’t go as planned. That approach to outsourcing is unusual in this business.”

Do It Our Way

Frank Marchesani, business development executive, Cook Pharmica

When working on projects, CMOs will sometimes have to accommodate the specific requests of a sponsor. Even though contract manufacturers will have good internal procedures in places, a sponsor will occasionally insist that a project be performed according to their own policies, procedures, and manufacturing practices. Although Cook is flexible enough to accommodate the requests of any sponsor, in this case the company was afforded the opportunity to complete the job according to its own internal policies. “It is possible to be adaptable to the wishes of the client without throwing out all of your own policies and systems to do so,” says Marchesani. “If you have the right practices in place, meeting quality, regulatory, and timeliness goals should not be an issue.”

CMOs will often find themselves competing with a sponsor’s own in-house capabilities. When deadlines are a concern, developing a process from scratch can be tricky, since timelines can add pressure to make quick decisions that may not serve the long-term interest of the project. In this case, Cook was not presented with strict deadlines that had to be met. At several points in the project, Cook scientists and engineers recognized opportunities that might enable them to improve the process. Without a strict deadline hanging over their heads, personnel were able to explore other options, and determine what path would lead to the best end result. This is a luxury generally not afforded to CMOs.

Be Flexible But Profitable

All CMOs have principles that are of utmost importance to them. Some are non-negotiable, such as quality and professionalism. Others are not easily differentiable, such as cost. But one area that is important to sponsors, and is one where CMOs can truly differentiate themselves, is flexibility. If not done correctly, it can also present a revenue conundrum for the CMO.

“Our GMP assets are the biggest revenue generator we have in the plant,” says Marchesani. “They are also our highest cost assets. For that reason, you want those assets to always be in operation. They are like the most expensive suites in a hotel. If they sit idle, the company is losing out on a lot of revenue as well as profit.”

Being as flexible as possible with clients is a something a CMO strives for, but is something that can also result in empty suites. A scheduling change from a sponsor will certainly disrupt the internal production schedule. Proper communication between the sponsor and CMO is the best way to ensure that last minute surprises happen rarely, and can be somewhat anticipated and mitigated when they do.

When asked for one suggestion on how sponsors and CMOs can better work together, Marchesani was quick to note communication. “Too often there seems to be silos surrounding the scientists and management in an organization,” he says. “Oftentimes management within pharma will make statements regarding their outsourcing strategy that their scientists are not aware of or are not on board with. This can present issues to both sides when the project begins and the two teams begin to work together toward the common goal. The management philosophy regarding outsourcing must be shared with the entire team and be faithfully followed.”

To make all meetings and interactions go more smoothly, Cook will actually train its employees on how to best interact with clients. The training is done internally and covers all aspects of communicating with sponsors, including how and when to engage when audit teams are in the facility and how to best communicate in partner personnel in conversation. The goal is to make everyone as comfortable as possible, so honesty and forthright dialogue can take place.

In the end Cook was able to deliver on the challenge. Both sides were able to learn about the other, which will help with future partnering opportunities. In this case, the communication and the trust the two teams had in each other clearly paid off for both companies.