PME: What was your career path to your current position?
Lorna Pender (LP): I was a hospital doctor in medicine for just over four years, during which time I worked my way through different medical specialties and treated many patients with rare diseases. I had always been interested in bringing more cutting-edge treatments and research opportunities to patients, so I decided to focus on medical writing for a while and how clinical trials operated from that side of things.
I then decided to fully immerse myself in industry and joined medical affairs to help drive a more cutting-edge medicines landscape for patients. This exposed me to Early Access Programmes (EAPs) and one of the most rewarding parts of my career was when I could see how a paediatric programme enabled children to go from not being able to play in the waiting room to running around. It was an impactful reminder of the benefits that EAPs can bring to patients and their families.
I worked in medical affairs for a number of years on different conditions, programmes and research, and I was loudly advocating the importance of incorporating the patient voice into the design of clinical trials and medical strategies. That’s why I decided to join Clinigen and work solely with patient organisations, experts and advocates to drive a patient-focused industry approach and bring medicines to more people.
PME: Do you feel that working as a doctor and then in medical affairs has given you a detailed overview of the different sides of the patient experience?
LP: It’s definitely a massive benefit to walk in the shoes of the rare community and be able to apply lived experience to my work, as I also identify as part of the rare community myself. I have a rare form of alopecia, and I had the experience of sitting in the chair as a patient and being told that there weren’t any treatment options available and that I was not going to be referred to a clinical trial. I definitely identify with a large part of the rare community and I do a lot of work as a patient expert, such as explaining to regulatory authorities what living with a rare condition is like and what matters to me as a patient.
PME: How do Early Access Programmes work and what role do they play in the treatment of rare diseases?
LP: In a nutshell, EAPs are a route or pathway for people to access unlicensed treatment. They are usually operated because there’s a population of patients with a life-threatening or seriously debilitating medical condition that have no available treatment options. In other cases, there are treatments available that have been attempted but not been successful, or there are treatments that have been approved in different countries but not the patients’ country.
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