Taiho Oncology, a Carnegie Center-based pharmaceutical company, is gearing up for a major expansion in anticipation of bringing a new cancer drug to market. Taiho Oncology is the American division of Taiho Pharmaceuticals, a Japanese company that in 2013 employed more than 2,500 people and took in more than $1 billion in revenue. The company recently completed an international clinical trial of a new chemotherapy drug called TAS-102 and is preparing to apply to the FDA for approval to use it in the U.S.

If TAS-102 is approved, it will be Taiho’s first drug to hit the U.S. market, and Taiho is preparing to dramatically expand its staff of 50 American employees. It has also hired Tim Whitten as CCO of the American branch. Whitten, an experienced pharmaceutical executive, is best known for leading Bristol-Myers Squibb’s commercialization of Taxol Injection.

“Tim’s extensive commercial experience, which includes having launched the highly successful chemotherapy, Taxol, as well as other oncology compounds, makes him particularly well suited to build our commercial organization in the USA and a critical addition to our executive leadership team,” said Eric Benn, CEO of Taiho Oncology, in a statement.

Whitten says Taiho plans to add 25 to 30 people over the next year to help launch TAS-102. Its commercialization team currently has only four people, he says. “Employees who come here have the opportunity to build a commercial program from scratch,” he says. “Everybody will need to roll up their sleeves, check their ego at the door, and just do a whole lot of very important work that needs to be done in order for us to be ready to launch TAS-102 in the U.S.”

Today Taiho’s office is located at 202 Carnegie Center. Whitten says the new employees — the commercial and medical affairs divisions — will require adding another office elsewhere in Carnegie Center, but that in about a year and a half the company plans to move to a larger location where they can all be under the same roof. Whitten says he hopes to remain in the Princeton area, but is also looking in Pennsylvania and elsewhere in New Jersey for a suitable site.

The expansion is being driven by an experimental drug that has recently undergone a clinical trial of about 800 patients, mostly in Japan. Taiho plans to announce the detailed results of the trial at an upcoming conference. TAS-102 is an oral combination anti-cancer drug. Whitten says the results have not been published yet, but that patients who got the experimental drug in the trial “showed improved overall survival compared to a placebo” in patients with metastatic colorectal cancer whose disease had progressed after they received standard therapies.

Whitten says if TAS-102 is approved, it will be a turning point for Taiho. The company was founded in 1963 and began importing Soviet-designed anti-cancer drugs to Japan. It has since become a research and development company in its own right and focuses on developing anti-cancer drugs. In 2002 Taiho opened its American branch in Carnegie Center. That division has, until now, run clinical trials and helped with R&D work. Bringing a drug to market for the first time would be a major shift. “It would be the fruit of the company’s long-term effort to globalize Taiho and become a fully integrated company, not just in Japan, but in the pharmaceutical market all over the world,” Whitten says.

Whitten says he learned a number of lessons from the Taxol launch that he is now applying to his work at Taiho. “You have to be very detail-oriented to have a successful launch,” he says. “It involved so many departments in an organization, and they all needed to learn their role. Everyone needed to execute the plan. You need manufacturing, sales, public relations, human resources, finance, accounting, and legal. They all have to operate in unison in order to have a successful launch.”

One nuance of TAS-102 is that Taiho is a Japanese company with a different management style from that found in the United States. Decision making in Japan tends to be collaborative, while the process in America is less democratic. “In Japan, making decisions almost always involves a significant discussion among team members and often requires a consensus before a decision is made,” Whitten says. “Here in the U.S., the boss often makes that decision more quickly and with less input.”

Whitten says he prefers to take a hybrid approach with his small team, sometimes making decisions quickly but allowing his subordinates to challenge him on anything, and he sometimes finds himself changing his mind based on their input.

Whitten grew up in West Virginia, where his father was a railroad clerk and his mother was a stay-at-home mom who did laundry on the side for 50 cents a basket. “My parents never graduated from high school or college, but they ingrained it in my sister and me that it was something that was required from the time we were toddlers. They had me saving my dimes and quarters from the time I can remember.”

Whitten graduated from West Virginia University in 1980 with a degree in pharmacy, and then earned an MBA at the University of Virginia in 1985. He worked for Bristol-Myers Squibb for 17 years in various sales, marketing, and planning roles. He worked for Pharmacyclics and Insmed before joining Taiho in 2013.

Whitten says the company will be actively recruiting over the next few months to build up its team. “We are looking for experienced employees,” Whitten says. He noted that Taiho is a large company with great resources, but its American presence is relatively small. “We can be very nimble and get things done very quickly. If you want to work in an entrepreneurial environment, we can provide that.”

Taiho Pharma U.S.A. Inc., 202 Carnegie Center, Suite 100, Princeton 08540; 609-750-5300; fax, 609-750-7450. Eric Benn, CEO. www.taihooncology.com.

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