Challenges and Opportunities
Connelly just celebrated her one-year anniversary with GSK—a tough year in which the world's fourth-biggest drugmaker has
faced more than its share of disappointments and controversies. The FDA rejected restless leg syndrome drug Horizant (gabapentin
enacarbil) in February for safety reasons. Meanwhile, antidepressant Paxil (paroxetine) lawsuits in the US and Canada continue
to plague the company
The biggest thorn in the company's side, however, is the resurgence of "Avandiagate." The first iteration of this problem
took place in the summer of 2007, long before Connelly set foot on GSK's corporate campus, when FDA medical reviewer David
Graham investigated evidence of an increased incidence of heart attacks among Avandia (rosiglitazone) patients. GSK claimed
the evidence was inconclusive. The situation threatened to become another Vioxx situation—a potential disaster for GSK and
its reputation for clinical integrity. FDA ended the tussle by slapping a black box warning on the diabetes blockbuster and
making the company conduct another study of the potential link between the drug and cardiac incidents.
Flash forward to February 2010 and the Senate Finance Committee's 342-page airing of grievances against GSK—grievances that
include alleged "researcher-bullying" and study ghostwriting. The company has since been smacked around by the Senate and
the media over allegations of "misrepresented" data on Avandia. This is a big test for Connelly's "patient first" philosophy.
The company has struck back with a detailed 30-page rebuttal covering sponsored clinical trial evidence on ischemic heart
risk dating back to 2000.
"It's not uncommon for politicians to give pharma bad press—it gets them a few points when they're running their campaigns,"
Connelly says. "And that's okay. But people need to trust us. They need to know we are developing those medicines and approaching
our mission with the greatest respect for them as patients."
Compounding the effect of these legal problems is the patent cliff facing the entire industry. GSK lost Valtrex (valaciclovir)
and antiepileptic/mood stabilizer Lamictal (lamotrigine) in 2009. It'll also lose the Seretide/Advair (fluticasone propionate/salmeterol
xinafoate) combo after this year; antiviral combo Combivir (lamivudine and zidovudine) expires during or after 2012; and around
2013, two more antivirals and Zyban's (burproprion) formulation patents will go generic.
Connelly sees these challenges as opportunities for GSK to prove its R&D mettle. The structure of the company's R&D division,
headed by Moncef Slaoui, has undergone some drastic changes. The department now operates as a sort of miniature, centralized
galaxy of biotechs—called Discovery Performance Units (DPUs)—each working on a particular project. The scientists are more
like the first Apple employees than research machines: the atmosphere in these mini-biotechs is one of collaborating in a
high-tech garage. "One of the buzz phrases we use is 'repersonalizing R&D,'" says Kevin Colgan, GSK's vp of External Communications.
R&D doesn't just rely on internal discoveries. Like other companies, GSK is branching out through licensing deals and partnerships
with academic institutions and those smaller biotechs they're mimicking in-house. Currently, the company has 47 outside partnerships,
and that number will only grow going forward.
While her background is in sales, Connelly prides herself—though somehow in a self-deprecating way—on being well-versed in
the scientific complexities of GSK's drugs, both in the pipeline and on the market. She co-chairs an internal forum that decides
which R&D projects to fund, which necessitates more than just a working knowledge of drug development. While she's not a scientist,
she's more than happy to study up. "It's a lot of homework, but it's fascinating. I'm not afraid to say, 'I don't know—teach
me,'" she says. "That's what I've always done before and will continue to do now."
She advises all pharma up-and-comers—men as well as women—to adopt this philosophy. Other tips: "Take what you do very seriously,
but don't take yourself too seriously. Be genuine and transparent and sincere. Work hard and do your job."