Pfizer's keys to juggling 8 U.S. launches? Organization, accountability, clear goals

Pfizer
Pfizer scored four new drug approvals between late September and late November of last year. (Pfizer)

Think you’re busy? Take a look at Pfizer’s commercial team for oncology, which is currently launching four new drugs, three new indications for older drugs, and a biosimilar. And that’s just in the U.S.

It’s taken some serious internal organizing on Pfizer’s part, but so far managing the multiple rollouts has been “done very well,” according to Andy Schmeltz, global president and general manager of Pfizer’s oncology unit. 

“Certainly you can only have one top priority at a time, and I think we’ve tried to be thoughtful in making sure that we organize ourselves internally so that there can be key priorities,” Schmeltz said in a recent interview. “Division of labor, accountability and clear goals” are all vital pieces of the equation, he added.

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RELATED: On a roll with FDA approvals, Pfizer doubles down in AML with Daurismo nod

Pfizer went on a hot streak late last year in the new drug approvals department, notching go-aheads for EGFR lung cancer drug Vizimpro, PARP inhibitor Talzenna, ALK lung cancer-fighter Lorbrena and acute myeloid leukemia treatment Daurismo between late September and late November.

At that time, it was already working with partner Astellas on launching a blockbuster new indication for Xtandi in nonmetastatic prostate cancer. And early 2019 brought more green lights, with an April approval for quick-selling Ibrance in men and a kidney cancer OK for its Bavencio-Inlyta combo the following month.

Plus, Pfizer couldn’t just drop what it was working on before the wave of approvals hit: namely, building awareness around Ibrance and its CDK 4/6 class.

“While we’re doing all these things, certainly, we’re in the growth trajectory with Ibrance and CDK growth and still need to get the word out there,” Schmeltz said.

But while the approvals may have come rapid-fire in the U.S., outside Pfizer’s home country, the company has had some breathing room. “Reimbursement in countries around the world takes different amounts of time,” Schmeltz said, meaning the new drugs’ global debuts have been more staggered.

One thing’s for sure, though: The raft of regulatory success has been “very well-received by stakeholders,” he said.

“When we can come in and talk about Pfizer oncology and the broad portfolio of medicines that could have utility for patients, that enables a different conversation with cancer centers, with health plans, with reimbursement authorities,” Schmeltz pointed out. “Of course, you’re often discussing the merits for the individual medicine, but it’s in the context of broader medicine.”

He pointed to the breast cancer arena, where Pfizer has been fielding Ibrance since 2015 in the U.S., as an example. With the approval of Talzenna and of Pfizer’s biosimilar of Roche’s Herceptin—which has regulatory clearance but has yet to launch—“you can envision for women with metastatic breast cancer, we now have potential medicines that can offer benefit or utility across the full spectrum of patients,” Schmeltz said.

“That is super-exciting from our perspective, but also may provide some unique opportunities in access and reimbursement and partnership,” he added.

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