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Currently accounting for approximately 43 percent of the global prescription drug market by revenue, the U.S. market is too large and too important to be ignored by foreign life sciences companies. Whether they are planning to establish a business presence in the U.S. market this year, next year, or at some point in the future, it is critical that they develop a U.S. Market Entry Strategy and Commercial Plan for their company. Even if foreign-based life sciences companies do not intend on having a business presence in the U.S., they will need to consider and plan for the commercialization of their product(s) in this important global market.

Deciding to expand operations to other countries and specifically the United States brings with it a number of opportunities and a number of challenges like where to locate the subsidiary business, how to find qualified people for hire, and how to address domestic legal and tax consequences of a U.S. market entry. It will be time consuming and expensive for companies to resolve these issues on their own; therefore, with the assistance of trained professionals who have current knowledge of the U.S. healthcare market, this process will be more cost-effective.

BioPortUSA was formed to assist non-U.S. based life sciences companies (pharmaceutical, biotech, diagnostic, and medical device) with their entry to the United States market. A key benefit to clients that choose to work with BioPortUSA is the aggregation of all those essential services required to address the U.S. market strategic planning requirements. BioPortUSA partner companies provide support where and when it is needed, enabling client companies to draw on short-term U.S. market industry experts and avoid long term commitment and overhead.

It is difficult for foreign-based companies to understand and easily navigate through the complexities of the key considerations for U.S. market entry. BioPortUSA makes this task easier by aligning the services of its professional partner companies to assist clients with the following critical considerations:

• Legal services (i.e. intellectual property, immigration law, corporate structure and governance, etc.)- provided by Morgan Lewis and Bockius, LLC.
  
• Accounting and tax (i.e. Sarbanes-Oxley, federal and state filing requirements, tax mitigation, transfer pricing, and government tax incentives)- provided by Amper, Politziner & Mattia.
  
• Human capital acquisition (i.e. executive recruiting, use of experienced “interim” executives, formation of a permanent employee hiring plan, compensation and benefit programs, etc.)- provided by Ashton Tweed.
  
• Commercial real estate (i.e. geographic location, office space requirements, warehousing, and product distribution)- provided by Cushman & Wakefield.
  
• Clinical drug development and regulatory consulting (i.e. CRO requirements for Phase III and IV, FDA interface and product regulatory submissions)- provided by PharmaNet Development Group.
  
• Risk management consulting and insurance services (i.e. clinical trial insurance, director & officer insurance, property and casualty, and employee healthcare benefits)- provided by Marsh.

Senior industry executives, who have successfully built or managed similar organizations, work with each BioPortUSA client to aid in successful U.S. market entry. This executive can function as the “interim” head of the U.S. business unit until such time as it is appropriate to establish a permanent executive team. This process allows the client companies of BioPortUSA to function initially as a virtual business with lower operational expenses and a reduced time-to-market for product commercialization.

BioPortUSA is sensitive to the need to integrate U.S. activities with the cultural needs of the home office, to evaluate risks and to assist in the development of an organization’s structure and strategies that allow foreign-based companies to make the most of the commercial and financial opportunities in the U.S. market. The international reach of each partner company allows BioPortUSA to uniquely support client company management in making these decisions.

For more information about BioPortUSA, visit www.BioPortUSA.com.
Contact James Laird at 610-299-8181.