Bringing a Strong Regulatory Law Background to Life Sciences Clients

Get to know Axiom lawyer Nancy at a glance:

• 20+ years combined experience in the life sciences and insurance regulatory industries
• 10+ years as a lawyer at Clinical Technology Transfer Group, serving major biotechnology clients
• Engaged through Axiom as a project lead and subject matter expert in clinical development at F500 pharmaceutical companies and a major research university

With over 20 years of combined experience in the life sciences and insurance regulatory industries, Axiom lawyer Nancy brings a seasoned perspective to her work with global pharmaceutical companies.

At Nancy’s current engagement, she serves both as the project lead and subject matter expert, responsible for ensuring that the project is properly scoped, and that both the clinical operations and legal department are satisfied. This engagement requires adaptability and quick thinking, which Nancy credits partly to the fact that she has over 10 years of experience in insurance regulation before pivoting to the life sciences industry.“Because of that experience, I’m able to bring an additional perspective to any project I engage in,” she explains. “My expertise is varied and includes the 10 years I spent working in the biopharma industry in a private firm. At Axiom, I’ve been working with small, medium, and large clients to assist them in developing the tools they need, and providing them the negotiation expertise I have from my regulatory background and my 10 years at the law firm.”

A grounding in insurance regulatory law

Nancy began her law career in the insurance industry, where she worked for over a decade, including in a senior counsel role at the American Insurance Association. There, she developed a deep understanding of the regulatory context in which a wide variety of industries in the United States operate.  

“I became very interested in insurance law from a regulatory perspective – how the insurance industry is regulated at the state level,” Nancy explains.

She began a position as a law clerk with the American Insurance Association while she was still in law school. The role served as a springboard, and Nancy became regulatory counsel to the Association after she graduated law school. For 10 years, as she worked her way up to Senior Counsel, she worked side by side with state and federal lobbyists, provided legal analysis of existing regulations and statutes affecting the industry, drafted new laws and regulations, and provided testimony in regulatory hearings.

“I have a regulatory background, and I think that’s really important in the legal profession generally, because every industry has some sort of regulatory backdrop and component to it. Knowing how the process works really helps you in any field you go into.”

Expanding into the life sciences industry

In 2007, Nancy decided to pursue a new direction – clinical technology. She began working at a small law firm outside of Washington, DC, that focused exclusively in this area. Nancy helped major biotech companies draft and negotiate transactional agreements and regulatory documents related to clinical trials.

After 10 years working in the law firm, Nancy again felt the pull to carve out a new path and try something different. She sought varied work that would help her grow and further develop within the legal profession.

“At the firm, I engaged somewhat with various clients, but once I negotiated various types of agreements over and over again for a lengthy period of time, I felt less challenged. I knew I wanted to work on a project basis and also be able to develop a deeper relationship with the client.”

In other words, she was looking to go beyond representing clients – she wanted to feel like she was part of their team and doing the work with them.

Working toward bringing novel drug therapies to life

Nancy joined Axiom in November 2016, initially taking an engagement assisting a large multinational pharmaceutical company revamp all of its contract templates. From there, she worked on projects within life sciences that involved developing and negotiating clinical technology agreements for various pharmaceutical companies. Nancy also had the opportunity to do something she’d never done before – work with a large academic institution negotiating its performance and responsibilities in hundreds of clinical trials.

Nancy started her current engagement earlier this year and has been able to make more of an impact as she’s working closely with multiple departments, from clinical operations to legal to finance.

“I’m providing the multiple components of a major pharmaceutical company with legal advice, and I feel like I have more of a vested interest in the project, and I find that really satisfying,” she shares.

It is her deep and varied experience that provides Nancy with a unique perspective for the legal teams with whom she works. At Axiom, a true highlight of her current engagement has been having the ability to cultivate a working relationship with the client’s entire team – working with them to bring large, global, key trials with promising drug therapies to fruition.

“The project I’m working on now is the most fulfilling project I’ve worked on,” she says. “I’ve been able to have an impact on the studies’ development at an earlier point than in past projects, and it’s exciting to see the process happen in support of promising drug development.”

Staying resilient moving through the pandemic and beyond

As we feel our way through the coronavirus pandemic, Nancy recognizes that the rest of 2020 will likely have no shortage of challenges for her practice area.

“I think that the clinical development industry is facing what will hopefully be a short-term stall due to the overwhelming need right now to focus on COVID-19,” she says. “Unfortunately, I think the overall result of that is going to be a slowdown in non-COVID-related clinical research. That’s really a tragedy, because there is so much life-saving research and clinical development in many essential therapeutic areas that has been forced on temporary hold.”

Nancy expects this impact on clinical research to make itself felt for the next year or two while COVID vaccines are being developed, at which point the general focus will hopefully broaden once again. When that happens, Nancy predicts a wave of legal work in the life sciences field as the industry resets its goals.

Towards a more flexible legal industry to better serve clients and lawyers

The legal industry in general will need to evolve in order to remain resilient in the face of uncertainty. Now more than ever, lawyers are juggling family needs and work demands all at once, which could be a recipe for burnout. To remedy this, Nancy believes the industry itself will need to present more flexible options for routine remote work.

“The pandemic has caused a lot of changes in our work habits, and in our work in general, that I don’t think are going to disappear after this is all over,” she says. “Employers may need to adjust as people come to expect greater flexibility as they balance work and family.”

To work with experienced lawyers like Nancy and bring unique perspective and world-class expertise to your team, get in touch with us at Axiom.