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Woman of the Week: Marinus’ Christy Shafer

Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here.

Christy Shafer stepped into the role of chief commercial officer at Marinus Pharmaceuticals at a critical time in the company’s evolution — it was prepping for the approval and eventual launch of Ztalmy for patients with CDKL5 deficiency disorder, a rare form of genetic epilepsy that predominantly affects children.

“It’s a little-known fact that 90% of drug candidates fail and they’re never brought to market,” Shafer said. “It’s a daunting number when you’re in the clinical stage of identifying where your drug is going to be placed in the marketplace. So that was step No. 1 for us to beat the odds to bring this drug to market.”

Ztalmy represents the first and only approved treatment for a disorder that affects about one in 40,000 live births, which classifies it as an ultra-rare disease.

“Not only do these children beat the odds, if you will, but bringing a drug to market for a disease that has never ever been treated before is beating the odds again,” Shafer added.

The industry veteran, who had spent time at Alexion Pharmaceuticals and Pacira Pharmaceuticals before joining the rare disease-focused Marinus in November 2020, now has her eyes on the road ahead and launching Ztalmy globally with partners in Europe, EMEA, China and Russia.

“We’re all grown up,” she said. “Now, it’s about expanding awareness … and access.”

Shafer, who spent more than 20 years in the operating room with “biologics, pharmaceuticals, and devices,” was open to a new avenue when the opportunity presented itself to move into the rare disease space.

“I thought day in and day out that we were making a difference,” she said. “It felt wonderful to be able to change the progression of medicine with a new device or a new biologic and treat patients differently. But rare disease brought me that and then so much more. I was able to launch drugs in the rare neurology space that affected me personally more than I could have ever imagined. When I was asked to come to Marinus and build out the commercial team, I will say I was daunted at first, but I thought what an amazing opportunity. What other company could I marry not only my skills in the hospital setting with a potential launch of our IV product with my rare disease passion. It really felt like serendipity. I couldn’t have imagined bringing together those two bridges that have been so good to me over the years.”

Here, Shafer shares how her experience as a competitive swimmer guides her leadership philosophy, how she built a team and commercial blueprint to launch Ztalmy, and why being focused on patients is key to success.

Welcome to WoW, the Woman of the Week podcast by PharmaVoice powered by Industry Dive.

In this episode, Taren Grom, editor-in-chief emeritus at PharmaVoice, meets with Christy Shafer, chief commercial officer, Marinus Pharmaceuticals.

Taren: Christy, welcome to the WoW podcast program.

Christy: Thank you, Taren. It’s a pleasure to be here with you today.

Taren: Let’s dig right in and talk about how you and Marinus beat the odds, as they say, to bring the first ever treatment approved for patients with CDKL5 deficiency disorder. And it’s a rare form of genetic epilepsy that really predominantly affects children. How did you all bring this to market?

Christy: Taren, I think you really hit the nail on the head with the ‘beat the odds’ statement there, which for any drug candidate right now is super difficult. It’s a little known fact that 90% of drug candidates fail and they’re never even brought to market. It’s a daunting number when you’re in the clinical stage of identifying where your drug is going to be placed in the marketplace. So that was step number one for us is to really beat the odds to bring this to market.

But I think that from my position as running the commercial team, we’ve really beat the odds continually throughout the last year, and we’ve just been super proud of it. This is the first and only approved indication for children and their families living with CDD or CDKL5 deficiency disorder. You did mention that it’s in a rare pediatric population, I’ll give you a couple statistics here. CDKL5 is affecting in about 1 in 40,000 live births. So this is a very ultra-rare disease, not only do these children kind of beat the odds, if you will, we’ve tried to follow their path and really bringing a drug to market that has just never ever been treated before is in and of itself beating the odds. So we’ve been very, very pleased not only to be able to present our data to the FDA in a manner that was palatable, we were able to work with them to really address what was needed for these children get an approval and then effectively bring it to market with our very, very small team.

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