David Epstein - Novartis

Banking on innovation and leading with determination

Name: David Epstein
Title: Division Head, Novartis Pharmaceuticals

After an FDA advisory committee snubbed Novartis' ($NVS) panobinostat 5-2 over concerns about safety and the way Novartis interpreted data, the Swiss drugmaker quickly responded with supporting data that convinced the agency to approve it. It was the kind of determination that Novartis Pharma Head David Epstein often preaches and that will be needed time and again for the Swiss drugmaker to realize its goals.

Epstein leads the largest division in one of the world's largest pharma companies, with pharma sales making up about 55% of Novartis' total last year. His division of the company takes on even greater prominence after the Swiss drugmaker's M&A acrobatics last year to get more focused, sculpted into fighting shape. Novartis unloaded its animal health and vaccine units and put its consumer health unit into a JV with GlaxoSmithKline ($GSK), which GSK will run. It also has taken over most of GSK's oncology drugs, giving a bit more heft to Novartis' oncology business.

When the shaping by Chairman Joerg Reinhardt and CEO Joe Jimenez was complete, pharma stood out as the muscle that will bear the burden for growth. Its ambitious oncology division has said it will launch 10 pipeline treatments, including panobinostat, by 2017, and the company is on record saying that it will develop 14 blockbusters by 2018.

But if Epstein is feeling under pressure, he is not showing it. In written responses, Epstein tells FierceBiotech his formula to move the pharma division forward is to concentrate on patient needs, innovate and recruit and develop good people. That may initially sound like so much corporate speak, but he and his people have the deliverables that make it mean something.

"We have one of the most cutting-edge pipelines in the industry," Epstein said, and there are plenty who would agree.

The drugmaker's CTL019 is seen as a leader in a new class of personalized cancer therapies known as CAR-Ts. Its recently approved Cosentyx is the first-in-class psoriasis drug that works by blocking the interleukin-17 (IL-17) protein. Although a recent report threw a bit of cold water on the anticipated heart failure drug LCZ696, Epstein has said that its launch "will possibly be the most exciting" the company has ever had. There certainly is a lot riding on it. It took center stage in the pharma giant's cardio drug development strategy after both the FDA and EU regulators snubbed its heart failure drug serelaxin, which was to be the foundation of its cardio franchise. LCZ696 has been forecast to be a megablockbuster, bringing in billions of dollars in sales.

Clearly Epstein has lots to work with.

An experienced leader, he has headed the pharma division since 2010, a job he was given after a 10-year stint in which he essentially built the Novartis oncology division from scratch to number two in the world behind Roche ($RHHBY). His diverse team, assembled from around the world, won 6 cancer drug approvals and 10 indication expansions in 10 years. One of those was the 2001 approval of Glivec/Gleevec, the blood cancer wonder drug that remains one of the best-selling cancer drugs in the world, racking up $4.75 billion last year.

"At one point I thought the launch of Glivec was a once-in-a-lifetime experience," Epstein said. "We knew we were about to make a shift in how cancer patients with CML and GIST were being treated, but the monumental change that in fact resulted was not only awe-inspiring but truly humbling." Now, he says, he has the same anticipation for the launch of Cosentyx and potential regulatory approvals of LCZ696, which he believes will have an even greater impact on patients than Glivec.

It is not that there aren't challenges that face the industry and his division. He has had to repeatedly apologize to regulators and the public in Japan after a series of missteps that culminated in the first-ever two-week suspension of a company in Japan for failing to report a boatload of adverse events.

He also recognizes there are challenges even for those drugmakers who get it right. Payers and governments are doing more due diligence on the price-to-benefit calculations of the drugs they consider for approval. Still, Epstein says he believes they will recognize, and so reward, "true innovation."

Innovation, like determination, is another term that regularly surfaces as Epstein discusses his work, not surprising from a man who considers Apple ($AAPL) founder Steve Jobs a role model. Epstein tries to be what he calls an "all in" leader, and anyone who aspires to that must do a number of things well, he said: "Listen. Be curious. Take smart business risks. Paint a compelling vision of the future and always remain humble."

Humble perhaps, but not beyond boasting on behalf of his team--which, by the way, he says he regularly takes to the Swiss mountains for a little inspiration and staff development.

"Our commitment for example to cell and gene therapy, which includes CTL019," Epstein says, "will truly change how cancer can be treated, shows the determination of Novartis Pharma to not accept the status quo and our work to truly revolutionize the research, development and manufacturing of innovative medicines that help people live longer and better lives so they can spend more time doing what matters most to them."

-- Eric Palmer (email | Twitter)

For more:
Special Report: Top 10 best-selling cancer drugs of 2013 - Gleevec
Novartis bags a surprise approval for the blood cancer-treating panobinostat
Novartis sees 'most exciting launch' ever with megablockbuster-to-be heart drug
FDA rejects Novartis' 'breakthrough' cardio drug serelaxin

David Epstein - Novartis
Read more on

Suggested Articles

UCB’s bispecific antibody recently beat Johnson & Johnson’s Stelara at clearing psoriasis symptoms, and now it has bested AbbVie’s Humira, too.

FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.

The CTAD presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate.