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Aldo Vidinha: “The European market is evolving at a slower pace than expected”

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CEO and founder of Stepwise Pharma & Engineering, Aldo Vidinha is one of the main organizers of the conference Medical Cannabis Europe, which takes place next week in Lisbon. With a career in the pharmaceutical industry, Aldo started working in the field of medical cannabis in Australia in 2016, having worked at Holigen, in Sintra, and later founded his own company, Stepwise.

We spoke with Aldo Vidinha to get to know his cannabis journey a little better and preview the main highlights of the Medical Cannabis Europe conference, which promises to be a space for deepening technical knowledge but also networking, on the 15th and 16th of September, at the National Association of Pharmacies, in Lisbon.

How long have you been working with cannabis and how did your career in this area begin?
I started my collaboration in the field of medical cannabis in 2016, through an investor contact to participate in a project in Australia, at which time concrete steps were being taken towards the legalization of medical cannabis in this country. This project was concluded with the obtaining of a GMP manufacturing, distribution, import and export license for a facility in Sydney. Subsequently, we decided to proceed with the Holigen project (RPK Biopharma) in Portugal, in 2017. As COO of this company, I led the processes of licensing, engineering and management of the construction of the facilities, implementation of the quality processes, production, cultivation and validation, and inspections to obtain applicable permits to carry out GMP dried flower cultivation and manufacturing operations, as well as distribution, import and export. The facilities in Sintra, with capacity for indoor cultivation, were successfully completed by obtaining GMP cultivation and manufacturing licenses, while the facilities in Aljustrel obtained outdoor cultivation, distribution, import and export licenses.

When did you decide to found Stepwise and what is your main area of ​​activity?
In 2020, I decided to embrace a new challenge, as I felt that I could contribute in another way, not only to the success of the medical cannabis industry in Portugal, but also to the pharmaceutical industry in general. To that end, I founded Stepwise Pharma & Engineering, a pharmaceutical consulting company with a comprehensive portfolio of services, especially designed for the pharmaceutical and life sciences industry, including medical cannabis. Our services focus on providing a complete service to existing companies or investors who want to start a project from scratch. Our services range from developing an initial idea, carrying out a market analysis and strategic definition of the business, going through the search for a suitable location, executing the engineering project, ensuring compliance with the applicable GACP and GMP requirements, preparing the Management Systems of Quality or evaluation of existing systems, preparation of the validation strategy (facilities, equipment, systems, processes, cleaning, analytical methods and transport) as well as the execution of the defined validation strategy. Finally, support for the preparation and during Infarmed inspections to obtain licenses. In fact, we have some projects in which we are working on a turnkey model, in order to provide full support to the customer and ensure the success of the business implementation phase and obtaining licenses. On the other hand, we have a specialized Regulatory Affairs department, which provides product registration services, including Marketing Authorizations (AIM) and Marketing Authorizations (ACM).

Next week the second edition of Medical Cannabis Europe will take place in Lisbon. How did the idea of ​​creating this conference come about and what was the main objective?
The idea for the conference grew out of a drive to create value for the medical cannabis industry and help drive its success. In this sense, our objective was to organize a conference focused on the technical part, promoting excellence in the cultivation and manufacture of products based on the cannabis plant for medicinal purposes in Portugal. We also intend to provide an opportunity for discussion between the various operators and other stakeholders of the industry, through moments of networking and not only, so that they can share experiences, thus promoting the creation of synergies and partnership opportunities.

Who is it for and what can attendees of this event expect?
This event is intended for those who are part of the industry, be they operators, suppliers, service providers and others. stakeholders or persons wishing to invest in and/or work in the industry. All participants can expect a conference with a technical focus, with the participation of national and international experts, who will talk about best practices worldwide in terms of cultivation, manufacturing, distribution, market, product registration, among others. . On the other hand, they can also talk to suppliers and reference service providers, who will have exhibitors to present their services. Finally, we will have several moments of networking to promote the creation of synergies and opportunities between participants, sponsors and guests.

What are the main highlights of the conference, particularly in terms of lectures and speakers?
All topics are current and important to the industry, making it difficult to choose the highlights. I can, however, perhaps highlight three: the update of the state of the medical cannabis market in several countries, such as Germany and Switzerland, with German and Swiss speakers; a panel discussion on “The challenges of developing medicinal cannabis products and their registration and placing on the market” in which we will have a panel moderated by Luc Richner, from Cannavigia, and with speakers such as Michael Sassano, CEO of Somaí Pharmaceuticals , Manuel Oliveira, general director of the Iberfar laboratory, and António Vieira, CEO of Cannexporpharma. I also highlight a presentation on the main methods of extracting cannabinoids (CO2 and Ethanol) with speakers from Tilray and Holistic Industries in the USA.

What analysis do you make of the cannabis situation in Portugal? And at an international level?Currently, there are 20 companies authorized to grow the cannabis plant for medicinal purposes and 6 companies authorized to manufacture pharmaceuticals (dry flower, extracts/oils or both). There are some challenges in cultivation, mostly related to the consistency of the product obtained. Factors such as, for example, the genetics used (from seeds instead of clones or tissue culture), the cultivation methods applied and the control of environmental conditions during cultivation, contribute to the delay in developing and providing products with the consistency and required quality. Another barrier to market growth is related to the fact that most operators in Portugal are focused on cultivation operations and do not include pharmaceutical operations (GMP). That is, the product that is produced in facilities authorized for cultivation only has a classification as an initial raw material (often called “GACP certification”), requiring further processing of this product (post-harvest operations) in facilities licensed for pharmaceutical manufacturing. (GMP) of medical cannabis, this being one of the requirements for the product to be registered, placed on the market and sold in pharmacies. On the other hand, the European market is evolving at a slower pace than initially expected for two reasons, in my opinion: the difficulty of access to the product by patients, availability of suitable products and the availability of consistent and quality product required to be registered as a pharmaceutical product.

 

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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages ​​using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]
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