“Drug development is all about the patient,” says Lisa Campbell, Senior Consultant and Medical Advisor at NDA. She offers a patient-focused perspective of drug development from her diverse experience as a clinician, ex-regulator, and regulatory consultant.

“The passing of my brother due to cancer when I was 18 deeply impacted me. It led me to pursue a medical career, driven by a desire to care for patients as my brother had been in and out of hospitals. I decided that I would train to become a doctor, so I applied for a six-year medical degree where I explored various specialties. It was on this journey that I found my passion for obstetrics and gynaecology. The personal connection and intricate care involved resonated with me, aligning my personal experience with my professional path.”

Lisa completed her medical degree and practiced as an obstetrician/ gynaecologist for about 13 years. Whilst she enjoyed the patient-facing role, she made the difficult decision to set aside her career in clinical medicine to be able to spend more time with her young family. 

Lisa later started working as a regulator at the UK MHRA, where she took on senior leadership roles for almost 10 years. She chaired many scientific and regulatory advice meetings and was also involved in several innovative projects, contributing her skills and expertise to promote diversity and inclusivity in clinical trials. “I was heavily involved in encouraging and supporting the inclusion of pregnant women and women of childbearing potential in clinical trials, an area that some pharma companies are inexperienced in or feel uncomfortable delving into. Sadly, these groups of women are commonly excluded from clinical trials. I worked closely with the MHRA and FDA to organize a workshop, educating and promoting the use of a drug development in these areas,” Lisa commented. As a senior medical assessor in the clinical trials unit, she worked alongside the ethics committees to implement and develop the combined ways of working clinical trial application process in the UK.

When the COVID pandemic hit, Lisa was the lead assessor for developing and introducing a fit-for-purpose regulatory assessment/approval pathway to expedite the approval of safe trials for the treatment and prevention of COVID. Based on this experience, she actively participated in the development of the clinical trial pre-assessment ILAP tool. “Working at the agency gave me the opportunity to collaborate with pharma, CROs, and consultants,” Lisa recounted. “I also developed diverse interests, including learning to put the patient at the forefront as a regulator, and stressing its importance to drug developers.”

In 2022, Lisa joined NDA as a Senior Consultant and Medical Advisor, bringing a wealth of clinical and regulatory experience for providing solutions to NDA clients. Her role involves collaborating closely with the NDA Advisory Board members, providing regulatory and clinical strategy, and engaging in client-facing meetings.

While reflecting on her role, Lisa shared:

“The NDA family has a wealth of varied expertise that can assist our clients in many areas of regulatory affairs. I joined NDA to contribute my skill and expertise, explore new opportunities, and expand my knowledge. As a medic with extensive clinical experience, having also been an ex-regulator, I am in a unique privileged position to add value to clinical strategy by putting the patient at the forefront of decision-making. I value building lasting relationships with clients, understanding their needs and concerns and assisting them in their journey from conception to marketing and beyond. It's enlightening to be able to apply my expertise from a slightly different perspective and with different considerations.”

Lisa also buttresses the culture and values of NDA and how the NDA colleagues portray them. She says, “My colleagues are collaborative, supportive, and very approachable. This way of working brings a lot of added value to how we can support clients. I feel a sense of satisfaction and fulfilment whenever we work as a team to provide solutions for our clients.”

Lisa is passionate about helping patients, and this attribute reflects in her role. In her words, “I’m able to use my medical training, clinical experience, pharmaceutical regulatory experience, and continued professional development to make a difference in the lives of patients. Whether it’s a patient having a baby or a client at the verge of developing a new drug, I am passionate about helping make people’s lives better.”

With a background as a clinician, ex-regulator, and medical advisor/ senior consultant, Lisa provides some insight into what regulatory affairs is all about.

“I think regulatory affairs is about bringing something extra to drug development and bringing solutions to patients in the most effective and meaningful way. I see my role within regulatory affairs as helping drug developers discover how science and innovation can change the life of the patient. This is because drug development is about how patients feel and how their lives are being changed. If it isn't delivered in the right way and the patients are not involved in the process, the drugs that end up in the market may be less useful to the patients that need them. I believe that regulatory affairs helps drug developers to think outside the box, think on a global level, and think about the patient.”

She leaves these final thoughts for drug developers:

“When developing drugs, remember that they are for patients. Hold the patient’s hand and take the patient along on the drug development journey. The value patients bring to navigating the regulatory journey is priceless. If you always have the patient in mind from the early stages of drug development, the regulatory path will be clearer.”