Editor’s note: This story is part of our 2022 PharmaVoice 100 feature.
Shanthi Ganeshan’s knack for regulatory affairs has been evident throughout her career.
“I first met [Ganeshan] in her capacity as the global regulatory leader for Sandostantin, one of the most important products in Novartis’ portfolio. [Ganeshan] effortlessly managed the regulatory issues, including the pediatric submission for this compound with minimal cross functional support,” a nominator and former manager says. “I immediately saw the raw talent in her.”
Ganeshan has been a regulatory pro for more than 25 years at a number of major companies including Novartis, GSK, Gilead and now Stemline Therapeutics, where she took over as the senior vice president and global head, regulatory affairs and safety, in July. She’s also handled a wide swath of therapeutics and modalities including small molecules, biologics and cell therapy. Along the way she’s racked up numerous wins including achieving fast track and breakthrough designations for several emerging drugs, and helping to guide the first approval of a cell therapy, Kymriah, in the U.S.
Throughout all of these pursuits, colleagues say Ganeshan’s innovative approach to navigating the regulatory landscape has stood out.
“She has a diverse experience in the development and implementation of innovative global regulatory strategies spanning all phases of drug development,” a nominator writes.
One colleague notes, for example, that when working on Farydak for multiple myeloma after a “negative” Oncologic Drugs Advisory Committee (ODAC) vote, Ganeshan demonstrate “more positive risk/benefit data in a subset of patients” and the drug was ultimately approved.
“I want to be a sounding board and safety net to provide a safe haven for discussions. When situations present themselves, I give opportunities to people based on agility, ability and a growth mindset rather than a matching resume — I imbibed this from one of my early managers who took a chance on me.”
Senior vice president and global head, regulatory affairs and safety, Stemline Therapeutics
Ganeshan has continually brought an ability to think on her toes and use her influence. While at GSK, a colleague notes that Ganeshan was instrumental in advancing the approval of Blenrep, a first-in-class antibody drug conjugate therapy for multiple myeloma patients who have exhausted their options. Because Blenrep targets an unmet medical need, Ganeshan pushed with determination to get the drug approved. Then the team hit several speed bumps.
“Not only did COVID-19 hit, but GSK was informed that Blenrep would be reviewed at an ODAC,” a nominator writes. “[Ganeshan] was able to get contracts signed and organize virtual ODAC prep meetings in record time, really exhibiting her leadership and influential skills with a sense of urgency.”
Blenrep was ultimately approved in 2020. And Ganeshan says that relying on relationships with her colleagues has been pivotal in her success.
“I cannot say enough about building trust in your stakeholders and becoming a valued partner,” she says. “Everyone will eventually have to develop their own leadership style, but I tell each person to invest the time in developing relationships with not only your superiors, but with your peers and direct reports. These interactions are key to building the foundation of every relationship, which turns them into successful collaborations.”