The U.S. Food and Drug Administration has sought to address its lack of resources and accelerate the speed with which it reviews applications for new drugs and biologics through fees imposed on the pharmaceutical and biotechnology companies whose products it reviews. The fourth incarnation of the so-called Prescription Drug User Fee Act or PDUFA, which first passed in 1992, expires at the end of September 2012. Its reauthorization is moving toward the top of the industry’s policy agenda. PDUFA fees have more than doubled since fiscal 2007 to $667 million and now account for two-thirds of the total spent on human drug reviews. Recent data suggest that despite improvements credited to PDUFA, performance under the program has been slipping. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA, about reauthorization of the act, how to view the agency’s performance, and whether the industry is getting the intended benefits from the fees it pays.

As the economy emerges from what’s been described as the longest and deepest downturn since the Great Depression, work is returning to the life sciences, just not jobs in the conventional sense. Instead, some say companies are balancing their needs to bolster their ranks while controlling labor costs through the use of contingent workers. While such efforts are not new, some argue that the life sciences industry is starting to tap into a growing pool of highly skilled workers. They say that we are witnessing the start of a major transformation in the way the industry works with specialized teams of workers assembled for specific projects and then disbanded. We spoke to Alan Edwards, science product leader for the Americas Products Group of temporary staffing firm Kelly Services, about this trend, how the workforce is changing, and why life sciences companies may be well suited for working in this way.  

Sanofi-Aventis is searching for an edge. Like other big pharmas, the company is increasingly looking outside its own walls for breakthrough ideas. At the BIO International Convention in Chicago at the start of May, the Paris-Based pharmaceutical company announced it had joined the Massachusetts Life Sciences Center’s Corporate Consortium Program. The Center, a quasi-public agency, is charged with implementing a ten-year, $1 billion Life Sciences Initiative for the state. Under the agreement, Sanofi is paying $500,000 for a two-year, non-voting membership. The funds will be used in the center’s Accelerator Program, which makes loans to early-stage Massachusetts life sciences companies performing translational science and research. What Sanofi gets in return is an early peek at these promising companies and their technologies. We spoke to Paul Chew, U.S. chief medical officer for Sanofi, about the agreement, changes to the company’s R&D structure, and why Big Pharma is increasingly looking beyond its own walls for innovation.

The BIO International Convention that just concluded in Chicago can be described in many ways. On one hand it was a gathering of nearly 15,000 industry leaders looking to discuss evolving business models, ongoing policy issues, and the changing financial landscape. On the other hand, it was a bit like a continuous speed dating session spread over four days, an oversized convention facility, a few dozen hotels, as well as busses, bars, and parties. This week we’re departing from our usual format to give our listeners a taste of the convention with the voices from a few of the folks we met during our stay in the Windy City. What you’ll hear is a diverse group of people who are excited by innovative ideas, optimistic about the future, and ready to find partners with which to work.

When the biotechnology industry gathers in Chicago this year for the BIO International Convention, its largest annual meeting, the mood will be quite different from a year ago. Healthcare reform legislation has since passed, the economy continues to improve, and stability has returned to financial markets. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about this year’s conference, how the industry is addressing some of the ongoing challenges it faces, and what will be on the top of the agenda for those in attendance.

When President Obama signed healthcare reform legislation it contained a provision that opens the doorway to biosimilars—copycat versions of biologics that are no longer protected by patents. The legislation was viewed as a big victory for the biotech industry because it provides for a 12-year period of protection from biosimilar competition for these expensive therapies, but big questions remain as to how the U.S. Food and Drug Administration will construct a pathway for biosimilar approvals. We spoke to Erika Lietzan, a partner with Covington & Burling in the lawfirm’s food and drug group and government affairs group. She discussed the significance of the legislation, the challenges ahead for the FDA, and what points of controversy remain to be resolved.

It’s been nearly 40 years since Richard Nixon signed the National Cancer Act and launched what has become known as “the war on cancer.” But since that time, despite massive investment in research, cancer has remained one of the leading causes of death in the United States. Susan Gapstur, an epidemiologist with the American Cancer Society, authored a commentary in the cancer-themed March 17 issue of JAMA. We talked to Gapstur about what progress has been made on the war on cancer, the tension between the high cost of new treatments and the benefits they provide, and whether or not we need a better metaphor than war for the ongoing efforts to prevent and halt the disease.

The convergence of technologies such as mobile phones, wireless monitors, and the Internet, have begun to forever change healthcare. Coupled with the increasing ability to identify people who carry genes that put them at risk for certain conditions, we are witnessing the start of a consumer digital health revolution that promises to change the way doctor diagnose, treat, and interact with patients. We spoke to Eric Topol, chief medical officer of the West Wireless Health Institute, about how the convergence of technologies is empowering patients, attacking the high cost of chronic diseases by allowing doctors to intervene before problems become serious, and making the long-sought promise of personalized medicine a reality.

 

Anthem Blue Cross, California’s biggest for profit health insurance company, has been on the hot seat lately. Its plan to raise premiums on policies for individuals by as much as 39 percent landed the CEO of its parent company, Wellpoint, in front of a Congressional committee and reignighted efforts in Washington to pass healthcare reform legislation. Now the advocacy group ConsumerWatchdog has filed a class-action lawsuit against Anthem over the rate increases saying they violate California law. We spoke to Jerry Flanagan, healthcare policy director for ConsumerWatchdog, about his group’s lawsuit, what Anthem’s actions mean for reform, and why the proposed healthcare legislation wouldn’t have prevented Anthem from instituting the rate increases in the first place.

 

In 2009, Genzyme stumbled as a viral contamination halted production at a key manufacturing plant, caused drug shortages for the company, and eventually financial disappointment to its investors. The missteps have left the smell of blood in the water and now activist investor Carl Ichan is seeking to win four board seats and wrest control of the company from its CEO Henri Termeer. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about Ichan’s efforts, what it means for Termeer and Genzyme, and how other biotechs that have fallen in the investor’s grasp have fared.

It would have seemed that the question over whether or not genes could be patented was settled long ago, but ongoing legal battles and a report earlier this month from an advisory committee to the U.S. Secretary of Health and Human Services threaten, in the words of one industry group, to “unravel” the foundation of life science innovation in this country. Opponents say gene patents impede critical research and make important new diagnostics unnecessarily expensive, but industry argues they fuel innovation and bring important breakthroughs to patients. We spoke to Ken Chahine, visiting professor of law at the University of Utah about the recent report, the ongoing legal battles, and what’s at stake for the biotech industry, as well as patients. 

Pharmaceutical companies will need to rethink their strategies as the world in which they operate undergoes dramatic changes. Patients, armed with unprecedented access to information, are being transformed from passive participants to superconsumers of healthcare services. Drugmakers will need to rethink not only how they approach them, but how to forge partnerships with nontraditional healthcare players that are helping to usher in this new era from telecommunications carriers to information technology device makers. We spoke to Carolyn Buck Luce, global pharmaceutical sector leader for Ernst & Young, about these changes, how pharmaceutical companies will need to alter their business models, and whether or not drugmakers are ready for what lies ahead.

As President Barack Obama delivered his State of the Union Address, healthcare reform legislation, as one Senator described, was on life support. The Democrats, losing their supermajority in the Senate, say they are not ready to pull the plug on the bill, but as of now the path forward is unclear. We spoke to Jim Greenwood, president and CEO of the Biotechnology Industry Organization, about the uncertainty surrounding healthcare reform, what it means for such issues as follow-on biologics, and what the industry’s policy agenda looks like for 2010.

Chris Starr has lived through biotech windows, cycles, and bubbles. An industry veteran, today he is CEO and co-founder of Raptor Pharmaceuticals, which works on improving existing drugs through its targeting platform and formulation expertise. Like many executives, Starr has had to prioritize his pipeline and find ways to raise money during tough times. We talked to Starr about the changing environment for biotechs, how he’s adapted, and as times improve, whether or not there’s a new normal.

The U.S. Food and Drug Administration approved 26 new drugs in 2009, besting 2008 by a hair, according to Washington Analysis, which provides research to institutional investors. The number of new approvals for small molecule drugs actually fell slightly, while the number of new biologics approved grew. We spoke to Ira Loss, senior health policy analyst with Washington Analysis, about the numbers, whether they reflect a push by Big Pharma into biologics, and whether the FDA under a new administration is faring any better.

The biotechnology industry is gearing up for the annual JPMorgan Healthcare conference, the key annual meeting that kicks off the New Year for the industry. Last year the dismal economy cast a long shadow at the normally upbeat conference, but much has changed since then. We spoke to the Adam Feuerstein, Senior Columnist TheStreet.com about how far the industry has come during the past year, what he’ll be looking for at this year’s conference and whether or not biotech executives will be in a celebratory mood once again.