Project Management Institute

Sanofi-Aventis, Paris, France & The Institute for Oneworld Health, San Francisco, California, USA

A pharmaceutical giant joins forces with a not-for-profit partner to drive down the cost of malaria treatment.

PHOTO BY MATTHIEU DELUC

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Henri Farret, Sanofi-Aventis

Sometimes the prescription for global medical issues requires a double dose of assistance.

In 2007, the Institute for OneWorld Health launched a project aimed at developing a more affordable malaria treatment for use in the developing world.

The group knew it couldn't go it alone, but it also knew not just any partner would do.

As with all of its projects, OneWorld Health solicited proposals and then launched into a thorough vetting process.

“The more time spent planning the project and making sure the two partners are aligned, the better,” says Kay Monroe, director of project management for OneWorld Health's malaria project. “It saves a lot of time and money on the back end because everyone is focused on the same goals.”

After months of evaluation and face-to-face meetings with several potential partners, OneWorld Health chose Sanofi-Aventis in early 2008.

And while it's certainly noble for the research and pharmaceutical company to sign on to the project, it's also a core part of its business strategy.

Sanofi-Aventis regularly teams up with notfor-profits and government agencies on projects to address medical issues around the world, says Henri Farret, industrial affairs/chemistry projects director at the company.

“Sanofi-Aventis has a department called Access to Medicines, which has the objective of providing poor patients with low-cost medicines for 'killing diseases,’ like tuberculosis, malaria and leishmaniasis,” Mr. Farret says.

The team has a core focus, zeroing in on seven medical issues where the Sanofi-Aventis product portfolio and know-how can make a difference, explains Philippe Farabolini, the department's director of business development. “For each program, we cover three main areas: improvement of existing drugs, program of information, education and communication, and a preferential pricing policy to deliver a 'no profit-no loss’ scenario.”

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We benchmark every stage, and if we have a problem that we can't overcome or we don't meet our criteria, the steering committee has to decide whether to move forward or stop.

—Kay Monroe, Institute for OneWorld Health

The goal of the malaria project is to develop a process for large-scale production of a semi-synthetic form of artemisinin, which can currently be extracted only from the sweet wormwood plant. The method was initially discovered by teams at the University of California at Berkeley and renewable products company Amyris.

Now it was time to think big.

“Through our partnership with OneWorld Health, we are optimizing and scaling up this process in order to hopefully make this process usable at the industrial scale,” explains Mr. Farret.

The end-result would allow manufacturers to produce enough of the ingredient to treat up to 200 million of the more than 500 million people estimated to contract malaria annually.

The project would not only boost the availability of artemisinin derivatives to drug manufacturers, but also help stabilize the price of anti-malarials containing the ingredient, explains Ms. Monroe.

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NOT SO DIFFERENT

In many ways, the project is run like a typical for-profit effort. The OneWorld Health team includes Ms. Monroe, who handles the project's scope, budget, communication and team management, and a scientific leader who oversees product development issues. The Sanofi-Aventis team includes its own project manager along with experts in scientific oversight and regulatory issues, as well as people with in-country expertise.

To track communication and progress, the project management team meets every week, the technical committee convenes once every two weeks, and the core teams get together once a quarter or more often if needed.

The project also has a steering committee with executives from both Sanofi-Aventis and OneWorld Health who have expertise in malaria treatment. The group is tasked with governance of the project and making sure stakeholder needs are met as the project progresses.

“The project is set up like any other pharmaceutical project, with the same technical criteria and manufacturing controls,” says Ms. Monroe. “We benchmark every stage, and if we have a problem that we can't overcome or we don't meet our criteria, the steering committee has to decide whether to move forward or stop.”

And issues do arise.

“At the technical committee meetings, we present the results of the previous weeks, discuss all the problems we've encountered and try to identify solutions,” she says. “Then we go try them out and come back to the next meeting to report our results. It's a constant iteration.”

As of March 2009, the team had completed the first phase, which involved transitioning the technology from the lab to Sanofi-Aventis facilities. The next phase involves scaling up the process, with the goal of meeting industry quantity requirements by the first quarter of 2010.

PHOTO BY MATTHIEU DELUC

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THE RIGHT FIT

The steady flow of problems and discussions could easily become frustrating with the wrong team. That, of course, makes it all the more important for both partners to capitalize on shared strengths and find ways to work in sync.

“Sanofi-Aventis understands the market. They've worked in the developing world, and they have experience on the not-forprofit side of the industry,” she explains. “We all speak the same language.”

But it's not simply a matter of picking the company with the best product portfolio or expertise in industrial-scale production. It's also about the cultural fit, says Ms. Monroe.

“When choosing partners, you can't negate that soft stuff,” she says. “The Sanofi-Aventis team is a joy to work with and that's huge. Sometimes it's not easy for people who are new to this kind of project to handle the stress, but Sanofi-Aventis has done it enough times not to get frustrated.”

Ultimately, the process works because both sides invest a great deal of time building a true partnership.

“We manage the project hand in hand with OneWorld Health, and we are learning a lot from each other,” adds Mr. Farret.

Those close ties can help expedite project progress, a big plus when timelines are far more compressed, he says.

“We often must overpass the existing standard procedures in order to be as efficient as possible and provide the project output in the shortest time possible,” he says.

At Sanofi-Aventis, a standard project timeline to ramp up volume production is typically seven to 10 years. But for the artemisinin project, the company expects to move from academic to industrial quantities in under five.

“To be on time, the decision-making process must be simple and very rapid,” Mr. Farret says.

That can be difficult, though. Along with shorter timelines, partnership projects often have more complicated financial management criteria.

And sometimes teams must also contend with some cross-cultural issues. “Even though the Sanofi team speaks English, French is their first language,” Ms. Monroe says. “So it's easy for misunderstandings to arise.”

To prevent problems, she follows up every discussion with a written summary. The teams also make a point to spend time together—outside the office—to strengthen communication. “Because we've built a relationship, the Sanofi project manager isn't uncomfortable calling me with a question or a concern,” she says.

All of this adds up to a healthy partnership.

“These projects can be difficult, but they are also very fulfilling,” Ms. Monroe says. “The expertise and experience our partners bring to the table keeps us moving forward.” —Sarah Fister Gale PM

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For each program, we cover three main areas: improvement of existing drugs, program of information, education and communication, and a preferential pricing policy to deliver a “no profit-no loss” scenario.

—Philippe Farabolini, Sanofi-Aventis

This material has been reproduced with the permission of the copyright owner. Unauthorized reproduction of this material is strictly prohibited. For permission to reproduce this material, please contact PMI.

PM NETWORK AUGUST 2009 WWW.PMI.ORG

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