Fátima Carvalho: “From an analytical point of view, cannabis is a particularly complex and challenging matrix”

Fátima Godinho Carvalho, executive director of the LEF - Laboratory of Pharmaceutical Studies since 2018, states that “From an analytical point of view, cannabis is a particularly complex and challenging matrix, especially when compared to chemical entities of synthetic origin”. Working in the cannabis sector since 2014, when the first cannabis company, Terra Verde, set up in Portugal, Fátima worked at MSD and Iberfar, before joining LEF – INFOSAÚDE, in 2006.

With over 25 years of experience in the pharmaceutical industry, essentially in Quality Assurance and Control positions, Fátima holds a Master's degree in Pharmaceutical Sciences from the Faculty of Pharmacy of the University of Lisbon and has a postgraduate degree in Management from Católica Lisbon School of Business & Economics.

In addition to being a certified trainer and having been involved in various educational activities, namely master's and postgraduate courses, Fátima Godinho is also a co-organizer of the conference Medical Cannabis Europe, which takes place this Thursday and Friday at National Association of Pharmacies, in Lisbon. Last year, Fatima wrote a chronicle on the state of the art of cannabis in Portugal, in partnership with Aldo Vidinha, with whom she co-organizes the second edition of this conference.

The event is already sold out and registration is closed. We spoke with Fátima Godinho to learn more about her professional career and what she has been doing in the cannabis sector in Portugal.

Since when have you been working in the pharmaceutical industry and what exactly do you do?
I started my career in 1993 as a supervisor in the Microbiology laboratory at MSD. At the Iberfar Group, at the now extinct CFP (Companhia Farmacêutica Portuguesa), I integrated the management of the FQ and Microbiological Quality Control teams and, in 2002, I combined the management of the Quality Control of Iberfar, SA., with that of deputy of the Technical Directorate. In 2006 I joined the LEF team, as head of the Quality department, in 2014 I took over the technical direction and in 2018 the executive direction of the LEF.

How and when did cannabis appear in your professional career?
In 2014 LEF had its first project in this area. We collaborated in an innovative project, which involved Terra Verde and GW Pharmaceuticals, supporting them both in terms of Quality consultancy and by carrying out Analytical Control. Since then, LEF has played a very relevant role in this area, in an absolutely transversal way in the cycle of this product, from quality consultancy, regulatory and analytical areas, among many others.

When you started working with cannabis, what did you know about the plant? Did you already know about any of the cannabis research or did it surprise you that it might also have a medicinal side?
Until 2014, knowledge about the therapeutic potential of this plant was relatively small. However, within the scope of international partnerships established within the ANF group, I was already aware that, in countries such as Canada and some more liberal states in the United States, the use of this plant for medicinal purposes was on the rise, so it was expectable that this type of therapeutic approach would eventually reach Europe. Therefore, we began to deepen the knowledge that today we replicate with our customers and partners, in order to add value to the chain.

Bearing in mind that your training and experience were essentially in conventional pharmacy, what main differences and challenges have you encountered when working with cannabis?
From an analytical point of view, cannabis is a particularly complex and challenging matrix, especially when compared to chemical entities of synthetic origin. It contains more than 550 compounds with potential therapeutic effect, of which more than 150 have been identified as cannabinoids. On the other hand, the regulatory frameworks of several European countries have different requirements, which implies that companies must have a good capacity to adapt to the demanding and constant changes imposed by health authorities and their potential customers.

Since 2019, LEF has obtained three different cannabis-related manufacturing authorizations from Infarmed. What specific work have you developed in this area and who are your main customers?
LEF, as a CRO / CMO with 30 years of experience, has the ability to offer companies in the medical cannabis sector a solution one-stop shop. We have a variety of services that include the development of formulations and production of experimental batches on a pilot scale, support in the preparation of the technical documentation necessary for the submission of the MA or ACM application, quality consultancy in the context of obtaining cultivation licenses and /or manufacturing, development of qualification and validation programs, training and audits. On the other hand, LEF is the national reference in the analytical area, in the development and validation of methods, in quality control, in the execution of stability studies and in the support of cultivation and manufacturing activities, such as environmental monitoring, water analysis , etc. We work with most Portuguese companies operating in this sector and we collaborate with several international operators, who find in the LEF a service provider with GMP certification, which allows them to enter the European market.

If we look at the regulator, at the companies in the industry and at the patients who use cannabis for medical purposes, we find very different perspectives or opinions. How do you analyze the current situation of medical cannabis in Portugal and Europe?
The medical cannabis market will be the main driver of growth in the European market, as the decision to liberalize its use for recreational purposes is not consensual and, perhaps, controversial in many countries. Some sources in the sector point to a forecast of sustainable growth and a valuation of the market in the order of 3 billion euros in 2025. However, it is expected that operators in this industry will have to prepare themselves to face some challenges, such as a dynamic regulatory framework with increasing demands, the need to train the health system, namely to invest in more information, training and qualification of professionals. of health. Priority will be given to improving access to medical cannabis products and the need to monitor health outcomes and promote pharmacovigilance as a result of increased use.

Most countries are getting ready to regulate adult cannabis use and it has already been realized that “cannabis sells”. In Portugal there are already more than 100 cannabis stores and in supermarkets it is increasingly common to find various cannabis products, essentially cosmetics. What is your opinion on the full legalization of the use of this plant?
My role and that of LEF are exclusively focused on the medicinal reach and impact of using this plant.