Headliner: Jim Daly of Amgen

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Asked for his take on things now that Amgen is launching its first-ever cancer therapeutic, Jim Daly responds cheerfully.

“This organization is over the top right now with excitement to be in the therapeutics area,” he says. “We would always be incomplete as an oncology company until we were actually into therapeutics.”

Rounding out Amgen's oncology prowess is Vectibix (panitumumab), a drug approved in September for shrinking colorectal tumors that have spread in patients who have failed certain chemotherapies. Vectibix is new to the company's portfolio, having been acquired in April when Amgen bought Abgenix for $2.2 billion. The biotech needs a strong showing from new drugs like Vectibix to help soften the impending blow several years from now when blockbuster anti-anemia drug Epogen goes off patent in the US, as it has in Europe. Fundamental changes to Amgen's go-to-market tactics may also be in store.

According to Daly—who is responsible for leading all of Amgen's commercial activities in the US and Canada—spearheading the Vectibix rollout presents a different challenge than the launches of products Aranesp (anti-anemia) and Neulasta (anti-infection), both of which he led.
For one, Erbitux (cetuximab)—the Bristol-Myers Squibb/Imclone drug—threatens to contain Daly's enthusiasm. Erbitux, approved in 2004, is also indicated for treating refractory metastatic colorectal cancer.

Daly, a Buffalo native who trained as a pharmacist, remains unbowed. “Our immediate goal is to take market share from Erbitux,” he says. Adding to the challenge is the scrutiny over cancer drug pricing. Amgen has priced Vectibix about 20% lower than Erbitux, at roughly $8,000/month. It also sets a cap so that no patient pays more than 5% of their adjusted gross income on Vectibix.
But any victory would be incomplete without actually having Vectibix used in earlier lines of colorectal cancer and in new tumor types, like head and neck. (Erbitux has a head start there, already approved for head and neck cancer.) “Thematically we're in a smaller position of patients who've failed other therapies, but we'd like to move up,” Daly says.

Amgen uses a relatively small, 400-person field force to get the word out—“more finesse than muscle,” Daly explains. This highly trained force comprises hospital reps, oncology nurses as well as regional medical liaisons—MDs, PhDs and PharmDs who speak at a scientific level with customers. While Amgen does DTC advertising for some of its supportive products like Neulasta, “The physician is the key decision-maker for oncology therapeutics,” he says.

Certain investigational drugs, if approved, could pull the biotech further from specialists into primary care. One such candidate is denosumab, a monoclonal antibody in phase 3 trials for postmenopausal osteoporosis. If it can demonstrate a reduction in bone fracture, “We will be going to primary care but not in a Big Pharma way, with 3,000-4,000 reps,” says Daly. “We anticipate launching with well below 1,000 reps. We want to bring the biotech model to primary care.”

If anyone appreciates the difference, he does. After brief stints as a hospital and retail pharmacist, Daly spent 17 years with GlaxoSmithKline and GlaxoWellcome, starting as a rep and moving through the sales and marketing ranks. “We'd like to elevate the role of the rep as being a resource for physicians,” with clinical, medical and reimbursement expertise, he says.

Riding the industry wave away from small molecules toward biologics, Daly left GSK in 2002 for Amgen. “Time goes much faster in biotech as far as competitive pressures,” he says. “There's tremendous urgency on all fronts.”

But one never forgets being part of the healthcare system. “You have a huge responsibility to put the patient first. That's the single most important benefit of being a pharmacist,” notes Daly. “We need more healthcare professionals to go into the pharma/biotech industry.”

Daly is married with three children, ages 12, 11 and 4. “I'm a big Buffalo (NHL) Sabres fan,” he says, “the only Sabres fan in Thousand Oaks.”

HEADLINER STATISTICS:
Jim Daly
SVP, North America
Commercial Operations, Amgen

2002-2006
Amgen—VP/GM, oncology  

1985-2002
GlaxoWellcome/GSK—From sales rep to VP/GM, resp.

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