Keynote Speaker Gemma Moore Inspires Students at Focus Friday

On Friday, February 3, Keck Graduate Institute hosted a special edition of Focus Friday with keynote speaker Gemma Moore, vice president of international regulatory affairs, Edwards Lifesciences. While typically KGI holds four Focus Fridays a year, this event combined three foci into one event: clinical and regulatory affairs, medical devices and diagnostics, and pharmaceutical discovery and development.

Guest speakers and an alumni panel addressed professionally attired KGI student attendees. Afterwards, students were able to mingle with the guests and ask questions. “It’s a good networking opportunity for students to meet with experts in a field they are interested in,” said Jennifer Markovski, KGI administrative associate. Markovski and other staff members and faculty help coordinate these events.

An expert in the field of regulatory affairs, keynote speaker Moore shared advice and inspirational stories of her work in regulatory and clinical affairs. Her talk focused on four cornerstones.

The first was the corporate world. Moore urged students to know the vision and mission of companies they work for and make sure those align with their own values.

The second was globalization and the strategy behind, “staying compliant with the rules of the game,” while delivering excellence to ensure safe and effective products for patients. Moore also discussed the challenges of globalization and shared results from industry associate reports, which showed that 65% of executives polled saw the regulatory environment as the biggest threat they face. This shows the value of regulatory and clinical affairs.

The third cornerstone was human experience surrounding diversity, communication, and culture. It is Moore’s viewpoint that, “The workplace thrives through diversity, communication, and cultural inclusiveness.” This value is even more important in a global environment. “We must all be global citizens in order to deliver safe and effective products to patients around the world,” said Moore.

Lastly, the fourth cornerstone of Moore’s talk was about how the student fits in and what they can offer.

Moore achieved a degree in clinical research from the University of Sydney and later, a master’s degree in public health. She began her career in evidence-based medicine. She then moved to industry working in regulatory affairs in clinical research for medical device and pharmaceutical companies. While in clinical research, Moore found herself taking on more and more regulatory affairs duties.

Most of Moore’s career has been spent in Asia Pacific and emerging market regions. Moore has devoted a lot of her career to international markets. “Globalization requires strategic thinking, technical capability, depth of knowledge, and the commitment to life long learning,” said Moore.

There is a need to understand globalization from a regulatory and economic standpoint, but it’s not all technical; it’s about people, communication, etc., she explained.

A piece of advice Moore had for students is to, “Understand the company in which you work. Know its vision and mission and ensure these are aligned with your values.” One of the personal examples Moore gave was that Edwards Lifesciences provides free heart surgeries around the world.

One recipient, a rural farmer in Chiang Mai, Thailand, whose family relies heavily on him, received one of these free life-saving surgeries. Edwards LifeSciences asked him to speak to their employees once he had recovered from surgery, and he reported that he is now able to work harder than when he was a young man. “It is truly a company that puts patients first,” said Moore.

Edwards Lifesciences is the global leader in patient-focused innovation. It partners with clinicians to develop products to save and enhance patients’ lives. In 1958, the founders created the first heart valve. At Edwards Lifesciences, “We’re not just leading technology, we started it,” said Moore.

Moore speaks passionately about Edwards Lifesciences’ transcatheter heart valves: “This is the only option for certain patients. When they receive an Edwards heart valve, it’s done without open-heart surgery [often the only option for some patients].”

Results of her work are evident globally, as in the case of the rural farmer in Thailand, but Moore also tells stories of how people are positively affected by Edwards Lifesciences’ products right here in Southern California.

For example, one day, Moore decided to treat her team to a meal at a local restaurant. When the server validated their parking ticket, she asked if they worked at Edwards Lifesciences. The server told them that because her grandmother had breast cancer, she had not been a candidate for open-heart surgery, and an Edwards’ valve saved her life.

Later, when Moore went to pay the bill, she noticed the receipt from the restaurant had a handwritten note that read, “Thank you for saving my grandma.” Stories such as these and the passion Moore uses to describe her work in such a new field are truly an inspiration.