Mariam Koohdary’s Guide to Mastering FDA Approval

Mariam Koohdary helps AstraZeneca usher its pipeline of lifesaving pharmaceuticals through FDA approvals and beyond

Medical breakthroughs that were once thought of as impossible are becoming realities every day. At the same time, these breakthroughs are fundamentally changing the way professionals treat some of the world’s most devastating diseases.

For Mariam Koohdary, deputy general counsel at global pharmaceutical company AstraZeneca, this is a major aspect of what motivates her work-—not to mention the work of about 3,000 AstraZeneca researchers who work with a $1 billion annual budget, individuals whose work Koohdary and her legal team help support.

The company’s work focuses on respiratory and cardiovascular-metabolic conditions, as well as oncology, but AstraZeneca’s approach to fighting cancer also includes applications of immunotherapy. This falls under one of the ten recommendations to come out of former President Barack Obama’s Cancer Moonshot project (managed by the National Cancer Advisory Board, a federal agency in the Department of Health and Human Services).

“We are finding ways to use our own immune systems to attack cancer cells,” Koohdary says. Other approaches the company takes include developing therapies that target specific mutations to attack cancer cells, which block tumor cells’ DNA-encoded ability to reproduce, and using antibody-drug conjugates that direct cancer-killing agents to target specific tumors.

To hear Koohdary describe what the company is doing makes her sound less like a lawyer and more like a scientist. In fact, she is the daughter of now-retired medical professionals (her mother was a nurse and her father a physician), and she has a natural affinity for biology and chemistry. Koohdary even combined a political science major with premed studies in college, but her father encouraged her to choose law over medicine.

After graduating from law school at Temple University, Koohdary clerked for a federal judge at a time when the dockets happened to be filled with patent disputes that were coming to trial. She was intrigued not only by the legal nuances, but also by the novel scientific concepts that gave rise to disputes in the first place. “I saw the importance of science in advocacy,” she says. “And I loved the combination.”

At AstraZeneca, Koohdary supports teams across the three main phases of the pharmaceutical life cycle: the research and development, launch, and the postlaunch periods. Each has its own challenges, its own set of problems to solve, occasional disappointments, and some true success stories.

“Taking the time to say ‘thank youʼ for hard work and effort is something that not enough leaders prioritize.”

Generally, the legal team first engages with investigational products when they reach the human clinical trial phase. For example, the rules around informed consent for patients who participate in trials are stringent, so management of the legal-regulatory requirements must be similarly tight. When those trials prove a new compound to be safe and efficacious, a genuine excitement builds among Koohdary’s legal team as much as with scientists. “This is when we get more involved with our business teams and regulatory agencies around the world who ask questions about our data, which ultimately leads to the approved label in each respective country,” she says. As the medication gets closer to launch, Koohdary’s team goes to work with the marketing and communications teams at AstraZeneca to ensure messaging to medical professionals and patients is in keeping with the regulatory directives and the scientific characteristics of the medication.

The bulk of the third phase of her work, post-launch, is managing the company’s litigation, which can include product liability lawsuits. Koohdary had the sizable legal task of managing a large class action suit a few years ago. She says there were hundreds of lawyers, scientists, and other experts involved. More than 20,000 individual patients joined the mass tort, and aside from the huge financial exposure in the case, she had to make strategic decisions that sometimes overrode counsel that had more seniority than she did.

“From day one, I was often the youngest person in the room,” she recalls. The matter progressed over several years, a time in which she had to manage both the litigation itself and help educate internal stakeholders on how to navigate the business environment while it was pending. She says the litigation helped hone her leadership skills. “I have always preferred to be considered just one member of a broader team, and that litigation helped me learn a lot about the importance of having diverse views on issues, but ultimately to make a decision and stand by it,” Koohdary says. “While those decisions were ultimately mine, getting there together was important to me. I also learned the value of true collaboration. Fundamentally, all teams want to feel that they are part of something bigger than themselves and that every member is important and has something valuable to contribute.”

While Koohdary also respected and valued what she heard from outside counsel, she says that she frequently held different views. She explains that in-house lawyers generally have a better perspective of a company’s ultimate strategy as a whole and will come to different conclusions and decisions as a result. The case ultimately went to trial and AstraZeneca prevailed.

Koohdary is quick to credit her legal staff, some of whom work out of the United Kingdom, Sweden, and various other countries. Leading such a large and diverse team requires building trust. “Keeping my word is important to me, and taking the time to say ‘thank you’ for hard work and effort is something that not enough leaders prioritize,” she says. “Finally, being honest is critical, which includes providing real and meaningful feedback, both positive and constructive. Almost everyone wants to improve their skills, but most people don’t naturally take the time to seek feedback.”

She also tells young lawyers interested in healthcare and pharmaceutical law that this is as good as it gets.

“There are different, challenging legal issues in this industry. It’s highly regulated, with different rules everywhere in the world. But I feel like I am part of an important mission, one that constantly offers different puzzles to solve,” Koohdary says. “What I love most is being surrounded by incredibly smart people who challenge me and help make me a better lawyer and leader.”

Koohdary might be working with a lot of smart lawyers and PhDs, but ultimately, her task is about patients and advancing science. “I can’t wait to see what the future holds for both our approved medicines and those in our pipeline,” she says. “After all, it’s not really about the law, it’s about the science and the patient.”