But now that the bubble has burst, pharma can expect what Russell predicted a decade ago: a more competitive industry, with greater focus on pharmacoeconomic data, ROI, and less tolerance for me-too drugs. “The economic miracle is over—there will be a struggle to survive in this industry,” he says.

Russell, a speaker at the Reuters healthcare conference today, breakfasted with Pharm Exec at the W Hotel, and offered a preview before tomorrow’s main event, the business update for its Human Genetic Therapies (HGT) business. The meeting will take place in HGT’s new Lexington, MA, headquarters, and with more than 1,000 employees (up from 300 in 2005), it will also provide a visual reminder of how this business is a growth engine for Shire.

Over the last three years, this specialty pharma company has grown and diversified both its product portfolio and geographic reach. A few years back, Adderall XR accounted for the lion’s share of Shire’s sales. But recently announced Q3 earnings show that the company has succeeded in bringing along its newest drugs—and for the first time, new product sales exceeded those of Adderall XR (and not a moment too soon, as generic Adderall arrives on the market in just six months). With almost two dozen potential launches planned for 2008-2015, Russell says the company is in “the best shape it’s ever been.” He attributes this to strong IP (even for its next-stage ADHD drug Vyvanse), a heavy focus on orphan drugs, and Shire’s litany of productive deals including Jerini.

On Tuesday, Russell will address HGT and outline Shire’s seven-year plan. (“Five years was too short, 10 too long,” says Russell.) It includes expansion into China and  a reorganization along patient lines; drugs for diseases that serve more than 50,000 patients will fall under specialty pharma head Mike Cola; smaller drugs will fit within Shire HGT, presided over by Sylvie Grégoire. Russell says this paradigm best capitalizes on the different commercialization models, enabling smaller orphan drugs to fully leverage the “advocacy-based selling model.”

But it’s not all roses for Shire. In the short-term, the company will experience a dip in sales in 2009, and possibly 2010, as it fully transitions away from Adderall XR. Perhaps a bigger issue is the biogenerics bill that’s shaping up among legislators. Russell plans to visit Washington, DC, several times over the next few months to conduct what he characterizes as much-needed education on the interaction between intellectual property and biosimilars. Right now, small molecules have 20 years of patent life, but biologics only have seven. “Without 12 or 14 years of exclusivity, it just might not warrant the investment,” says Russell. “You see the reaction when I tell people that—their eyes light up and you can tell they are beginning to understand.”