Sanjay Narayan—division counsel, brand legal and compliance at the biopharmaceutical company AbbVie—found himself with opportunities to apply his experience and skills across several areas of the company when it spun off from Abbott Laboratories in 2013. But his talent for minding the details of product launches has helped AbbVie grow from the beginning.
Narayan joined Abbott Laboratories as counsel, legal, regulatory and compliance, in 2009 and earned a promotion to senior counsel, healthcare compliance, in 2012, when his focus became ensuring that AbbVie’s efforts aligned and complied with the various laws and regulations that apply to a large biopharmaceutical company and agreements with the US government.
“A large part of my focus was working hand-in-hand with our compliance teams and other business functions to make sure we stayed abreast of legal and compliance developments and designed and executed our policies and procedures accordingly,” Narayan says.
By then, Abbott had already announced its plan to separate into two publicly traded companies. While Abbott Laboratories now specializes in diversified products, including medical devices and nutrition products, the focus for AbbVie remains focused as a research-based biopharmaceutical manufacturer.
“I was part of a team that was making sure that, as we were splitting off, we were developing our own policies and processes as AbbVie. I focused on making sure those policies and processes were efficient and set us up for success as a standalone biopharmaceutical company,” Narayan says.
Narayan enjoyed the work because it gave him insight into every facet of the business at both Abbott Laboratories and AbbVie. His passion, however, is his involvement in new treatment launches. That’s part of the reason why, even with all his compliance work, Narayan kept his role advising the business on a new treatment for Parkinson’s disease that won FDA approval in January 2015.
Narayan sought opportunities to increase his subject matter expertise, lead other attorneys in his legal group, and honed his ability to prioritize tasks, which helped elevate him to his current role. He now has oversight over AbbVie’s neuroscience, metabolic, GI care, and women’s health treatments. And in October 2016, Narayan gained oversight of the company’s legal operations in Puerto Rico.
There are now a couple of key areas where he spends most of his time.
“Anytime you can see the impact our work has on patients, it’s pretty tremendous.”
“A large part is trying to anticipate the changes in the pharmaceutical industry and advising our internal teams,” he says. “I’m also keeping an eye on our peers to remain cognizant of what they’re doing.”
Narayan is also heavily involved in AbbVie’s medicine distribution efforts. As medicine formulations become more complex, so do the ways they must be delivered, stored, and administered.
“It took a lot of time to develop what our network would look like and then contract with specialty pharmacies to make sure they have the equipment to store the product and could distribute it in an appropriate manner,” he says. “At the end of the day, we need to be sure our patients can get their medication.”
Last year, AbbVie collaborated with another pharmaceutical company to launch a monthly, self-administered treatment for relapsing forms of multiple sclerosis. This provided another set of opportunities for Narayan.
“You had different companies approach contracting differently in terms of the kind of data they want, the patient services they provide, the key performance indicators, and their normal approach to contracting,” he says. “I had to make sure we were on the same page with our partners.”
In an effort to align with FDA regulations regarding distribution models, Narayan has spearheaded contracting with various pharmacies to ensure they receive certification and training to handle the medicine and supply the FDA with the required data.
Somehow, Narayan still finds time to advise AbbVie on products before and after a launch. At the prelaunch stage, his focus is mainly on labeling, developing draft promotional materials, ensuring that all the information is consistent and compliant with the FDA legal requirements, and contracting to enable patient access at time of launch.
During the prelaunch phase for AbbVie’s Parkinson’s product, Narayan traveled to Europe, where the treatment was already approved and being administered to patients. As a result, he was able to better understand the product, the patient experience, and apply what he learned to the US launch.
“Legal is a tremendous partner and asset to the business, and I’m at my best when I’m ingrained in the business, as well as the broader cross-functional team,” Narayan says. “This allows me to understand the objective behind their proposals and help them find solutions to ensure we are serving our patients in the best
Narayan collaborates with cross-functional brand teams on strategies, tactics, and campaigns. For instance, Narayan provides counsel on AbbVie’s partnership with The Michael J. Fox Foundation on a campaign to provide educational resources to patients and their caregivers to help them understand Parkinson’s disease.
“The program helps Parkinson’s patients learn about the progression through different stages of the diseases and what you should look for,” Narayan says. “Being able to reach out to patients was very cool. It’s always good to see how the work you’re doing can have a positive impact in the community.”
Narayan considers himself lucky to have overseen the launch of two treatments in his time at AbbVie. Working on AbbVie’s treatment for Parkinson’s disease was particularly rewarding because it was his first product launch that won FDA approval.
“As you work diligently on distribution network contracts and arrangements with specialty pharmacies to handle the medicine and the day-to-day counseling for the execution of our sales and marketing activities, it’s tough to step away from all of that and remember why we’re doing what we’re doing,” Narayan says. “Anytime you can see the impact our work has on patients, it’s pretty tremendous.”