In the 1988 film "Coming to America" Eddie Murphy's character Prince Akeem of Zamunda travels to America — Queens, New York, to be exact — on his 21st birthday in search of love. But being vastly na ve of American culture, the African prince instead finds himself in a series of humorous fish-out-of-water experiences.

When foreign life sciences companies decide to enter the U.S. market they too could end up feeling like a fish out of water if they are not completely ready for or familiar with the U.S. regulatory process.

Addressing that problem, BioPortUSA (Wayne, Pennsylvania) has launched a commercialization accelerator aimed at helping overseas companies establish a business presence in the U.S.

"BioPortUSA simplifies the U.S. market entry process and helps foreign companies navigate the changing FDA regulatory environment, as well as the legal, tax, immigration and commercialization requirements that they will face in establishing a U.S. business presence," said BioPortUSA CEO James Laird. "By engaging BioPortUSA, client companies access a menu of core professional services all in one place that will enable them to correctly determine their early investment and accelerate the commercialization process for their product lines."

Speaking from the BIO 2007 Convention being held this week at the Boston Convention and Exhibition Center, Laird told Medical Device Daily that it is common for foreign companies to realize the importance of being in the U.S. to be global, maximize the value of their products, and to find a big commercial partner, but that they don't always understand the complexity of the U.S. market. That's where the motivation to form BioPortUSA came from, he said.

"One of our services we offer is a readiness assessment because on one side it's easy for them to say 'yep, we're ready [to enter the U.S. market] when the reality is that until they actually have a third party to help evaluate their technology, find out where they're at in their clinical development, where they're at in the regulatory process, where they're at with funding, and where are they organizationally [they don't really know if they're ready]," Laird told MDD.

"So our services allow them to tap into our senior executive talent that's familiar with the U.S. market place that could provide a bridge and allow them to stay virtual for a longer period of time and maximize their investment."

Laird said the company's ideal clients are late-stage development companies that may have already introduced their device or product to their domestic market.

"We're not looking for those early-stage companies that are still going through preclinical or clinical development," Laird said.

Because many of the companies that BioPortUSA are interested in helping attend industry meetings like BIO 2007, Laird said the conference was an ideal place for the company to introduce its services. He said BioPortUSA also plans to attend various regional conferences around the world as well as another big one, BIO-Europe 2007 in Hamburg, Germany in November.

To become a success, Laird said the company is trying to offer clients a one-stop shop by partnering with different service providers to address the entire need requirements of foreign-based companies.

BioPortUSA's partners include: Morgan Lewis and Bockius legal services; Wachovia Insurance Services; PharmaNet Development Group; and Amper, Politziner and Mattia, Certified Public Accountants and Consultants.

Another partner, Ashton Tweed, provides executive talent and has built what it calls an "executive talent bank."

"They've capitalized on the baby boomers who have either elected early retirement or have been downsized but are not ready to retire," Laird said. These senior executives can help coach young first-time CEOs avoid costly mistakes that any new CEO in the industry would make, Laird said.

In addition to offering a comprehensive readiness assessment, BioPortUSA says it also helps its clients develop a highly customized commercialization plan and implement some or all of the plan recommendations to "assure efficient and effective market entry."

Sharing a title with Murphy's 1988 film, Laird will moderate a panel called "Coming to America: Establishing a Business Presence in the United States" today at the BIO International conference.

No Comments