Q&A with María Angeles, Quality and Regulatory Affairs Director
1. Can you tell us about your background and what led you to the pharmaceutical industry?
My first interest in healthcare came from reading leaflets about medicines as a child. I always liked science, particularly chemistry, but I did not know the types of careers this could offer me. During my career, my favorite topics have always been those related to the manufacturing of medicines. So, once I finished my degree, I decided to study a Technical Master in Pharmaceutical Industry where I learned about regulatory affairs, good manufacturing practice (GMP), qualifications and validation. Since then, I have worked in Regulatory and Quality departments in a variety of roles.
At the beginning of my career I worked in multinational companies such as Menarini and Novartis, but later I moved into consultancy roles where I learned all about the product life cycle; not only about medicines but also medical devices, food supplements, cosmetics and biocides. In consultancy I saw businesses closer than I have seen them before, with commercial and general management responsibilities internationally, giving me a huge overview of the sector and also great professional growth.
After this period, I joined a startup for five years to help its geographical expansion in emerging countries, and this experience gave me another point of view. To see a company born, with the difficulties, mistakes, strategy changes, successes and failures that come with it, has allowed me to face almost any project!
2. What made you want to transition to a company focused on the research, cultivation and supply of medicinal cannabis?
I chose Linneo as I like the challenge of working in emerging sectors, and I also prefer to work in the headquarters of a company, where they are focused on the strategy. Medicinal cannabis is a big emerging sector, but it still has a long way to go. Health authorities are becoming more and more open to regulate medicinal cannabis for the treatment of chronic and acute pain (arthritis or neuropathic pain), to reduce cancer-related symptoms (pain, nausea and reduced appetite) or even for treating anxiety or insomnia. It is not a cure, but represents a palliative treatment option that can improve the health-related quality of life of patients. My belief in the potential of medicinal cannabis is why I am working in this sector.
3. What have been your priorities since arriving at Linneo Health? What does your day-to-day role look like?
My first priority has been to learn about the medicinal cannabis product and its behavior during the manufacturing process and during its shelf-life. The product is much more complex than any chemical entity as it is a plant, so has agricultural difficulties in addition to the pharmaceutical ones, which is new for me.
Legislation is another issue, since you cannot simply follow the current legislation related to medicinal products or herbal ones. Each country has its own legislation, there is not any European harmonisation. For example, in Spain, where Linneo is headquartered, there is no legislation to sell medicinal cannabis yet, although it is being prepared, so while we are authorised to cultivate and produce our products, they cannot be sold in Spain.
4. Why are quality and regulation so important to both Linneo and the medicinal cannabis industry?
Quality is very important because, as mentioned before, medicinal cannabis is a complex product and due to it being a narcotic, there are strict standards. Every batch must be thoroughly controlled to prevent rejection which could negatively impact the business.
Regulation of medicinal cannabis is becoming more widespread, but this varies between countries. The relationship between Linneo and health authorities is very important, in order for them better understand our product. Ultimately, we are all pursuing the same thing: to help patients by providing them with high quality, safe and efficacious medicines.
5. What do you see as the biggest challenges in the medical cannabis space today?
In my opinion, the biggest challenge today is the stigma surrounding medicinal cannabis. The discovery of the endocannabinoid system in humans wasn’t until 1988, meaning that a lot of doctors were not trained in this system so it’s difficult for them to see cannabis as a medicine, and not as a recreational drug. If cannabis is going to be prescribed by doctors and dispensed by pharmacists, we need them to really believe in the product, and for that to happen, the pharmaceutical industry has to make an effort to train them and demonstrate the evidence.
6. What do you think the space will look like in five years? What are your hopes for the future of the industry?
I hope we will have a new picture where there is harmonised regulation in more European countries, we have a larger portfolio with even more products available for patients, and more people believing in medicinal cannabis. Perhaps the stigma will still be around in five years, but I hope that the doctor and pharmacist communities will consider cannabis as a medicinal product that can help patients to improve their quality of life.