Partners required : No one goes it alone in ‘magic’ US market
Quickly and efficiently reaching the U.S. pharmaceutical market is a critical goal for most biotechnology and pharmaceutical companies.
Whether going it alone or finding a strategic partner to help navigate the road to U.S. commercialization, today’s biotechnology companies have never faced a tougher or longer trip. Tightened financial markets, increased FDA regulatory oversight, uncertain intellectual property protection, more, bigger and longer clinical trials, shortages in skilled workforces, and not least, the challenges in reimbursement are all part of today’s obstacles.
Raymond J. Briscuso, Chief Executive for the Life Sciences Conference Group led an Interactive Workshop at BIO-Europe 2007 built around the provocative title, “What You Wish You Knew Before Going to Market in the United States.”
Panelists included Jules A. Müsing the Vice President for Licensing and Business Development at Johnson & Johnson, Dr. Giorgio Mosconi the Founder and Chief Operating Officer for Acureon Pharma, Dr. Steve Bryant the Senior Director of Business Development at Genmab and Gwilym Attwell with Fish & Richardson.
Who you know, who you can recruit and who can help as a strategic partner were themes running through the responses of the panelists to the question, “What is the single biggest issue a company faces in approaching the US?”
Dr. Bryant said the key is to have partnerships.
“With very few exceptions, you can not do it yourself,” he said. “Who to partner with is the crucial component, and your choice of a partner is the single most important decision you will make because if you do it wrong you will delay your product for years. At the worst, you may kill your product.”
Dr. Mosconi said there is an absolute “magic in the US market and it was clear that to grow our company we had to think about the US market, to have access to the financing. But we needed to understand the market and we were intimidated by the size and complexity.
He said the company looked at several options before choosing what he called, “the third way where we merged with another company of the same size and with a complementary pipeline.”
“We recognized as a company in Europe looking at the US, we needed senior experienced people. An access to talent becomes extremely important.”
A second factor for success, he said, is “to have a dialogue with the FDA, to go to the agency at the end of Phase II and to discuss plans for the multi-million Phase III. This is not just about getting approval but for creating a marketable product, to be sure your plan meets the expectations.
“The FDA is not the enemy,” he said. They are open to talking, so you should work closely with them. Sometimes companies are working in new areas where even the FDA does not know yet what it thinks.
The best result, he said, is that “the FDA will respond in writing, which is more than nice. This document becomes a tool for you to plan, to know what is good and what you need to fix. And it is invaluable in helping to cool down the anxiety of investors.”
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