Our team is committed to exploring the human possibilities that relate to synthetic biology, with a focus on also addressing the social issues related to cannabidiol (CBD) and its impacts on society.
CBDynamics is designed to address multifaceted challenges affecting the research, development and use of CBD, a compound proven to be valuable for the treatment of various medical conditions. However, due to legal obstacles, social stigmatization and regulatory issues, access to and production of CBD can be problematic in many countries, including Brazil.
Our project spans two years, and in this first year, we have dedicated significant efforts to gaining a profound understanding of how society impacts our project. This endeavor is particularly crucial given the inherent complexity of our project, which revolves around the contentious topic of Cannabidiol (CBD) in a country where the subject remains heavily stigmatized. In light of these challenges, we recognize that a high-quality Human Practices (HP) project demands a comprehension of our surroundings and the social dynamics at play. To this end, we have engaged in extensive theoretical research and fieldwork to expand our knowledge base. This multifaceted approach not only broadens our perspectives but also equips us to navigate the intricate web of social, cultural, and political factors that influence our project. By delving into both theoretical studies and practical data collection, we have strived to bridge the gap between our project and the society it aims to serve.
This year, we have actively initiated direct engagements with key sectors within our local community and academia. By doing so, we have successfully started building a foundation for constructive dialogue and collaboration. Our strategic approach involves segmenting society into distinct sectors to ensure a comprehensive understanding of how various perspectives and interests intersect with our project. In the upcoming year, we are determined to further broaden our reach by establishing connections with the remaining sectors we have delineated.
In order to get to know these sectors, we have drawn up two questionnaires, which are simple to understand, to collect data from the local community and academia. They were done in different locations - as the main square from our city (Figure 1) and our university campus (Figure 2) - and searches for different people. These results are compiled in the following sections, based on our reading from this data obtained.
Figure 1. Data collection in our city's central square.
Source: 2023, Authors.
Figure 2. Data collection at our university campus.
Source: 2023, Authors.
We know very well that you can't change the world with a questionnaire, but you can develop a social impact project by asking society what they think about the project. It was with this questionnaire that we were able to orient ourselves in all the activities we set out to do, because it was in this way that we were able to establish which approaches would be appropriate for our work. These approaches were used throughout the planning of the "Women in Engineering" event and "Educa SynBio" (Education).
In order to establish the link between our project and society, we asked ourselves the question of how those different social entities interfere and collaborate with our research and to better assess the wide-ranging impacts of the CBDynamics project on society, we chose to segment it into distinct sectors, namely: Academia, Government, Healthcare, Industry, Local Community and Public Organizations. Each of these sectors plays a critical role in the CBD-related landscape, and our project seeks to address specific issues affecting each of them.
Academia stands to benefit from the CBDynamics project, as it promotes the research and development of new techniques and approaches in synthetic biology. This could boost the growth of synthetic biology as a field of study and lead to significant advances in the understanding of CBD and its potential uses.
The government could benefit from reducing the bureaucracy and costs related to regulating CBD when produced synthetically. This could make it easier for patients to access quality treatments and reduce public spending on the import of CBD-based products. In addition, the CBDynamics project can influence health policies by promoting more favorable regulation of medicinal CBD.
The health sector is directly affected by the potential of CBDynamics. With the development of synthetic CBD production, a significant improvement in treatment options is expected for a range of medical conditions, such as epilepsy, multiple sclerosis, cancer and neurological disorders. Access to safer and more effective treatments could improve patients' quality of life and reduce dependence on more aggressive pharmaceutical drugs, having a direct impact on public health.
The pharmaceutical industry is influenced by the potential for the synthetic production of CBD on an industrial scale. This could result in a reduction in production costs, making CBD-based products more affordable for patients. In addition, synthetic production could open up space for the creation of customized formulations and the combination of CBD with other active ingredients, allowing for the creation of more specific drugs for different medical conditions.
In the next year, our plans involve a study of laboratory-scale production techniques for synthetic CBD. We are also committed to exploring the challenges and opportunities involved in the scaling-up process to bring laboratory-produced CBD to an industrial level. This transition represents a significant milestone in realizing the full potential of synthetic CBD for the benefit of patients and the pharmaceutical industry as a whole.
The CBDynamics project has a profound positive impact on the local community, particularly in regions where CBD faces stigma and restrictive regulations. Offering a synthetic CBD solution ensures that local healthcare professionals and patients gain access to treatments that are not only more reliable but also standardized. This not only enhances the quality of life but also significantly raises awareness about the medicinal advantages of CBD.
Non-governmental organizations and other public entities dedicated to research and the well-being of society can find opportunities to collaborate with researchers, doctors and patients in the study and responsible use of CBD. The CBDynamics project can highlight the work of these organizations and increase support from the community, the private sector and government institutions.
During the reading of our HP project, you’ll see us examine how our project addresses critical issues such as the production of CBD in synthetic form, combating the stigma surrounding Cannabis, access to quality medical treatments and influencing health policies. In the following sections, we will cover each of these areas in detail, highlighting the challenges faced and the innovative solutions proposed by CBDynamics. In addition, we’ll also outline our mission, vision and values, which guide us on this journey of discovery and innovation.
In doing so, we hope to convey the importance and transformative potential of our project in the field of synthetic biology and, more importantly, in improving the quality of life of individuals facing challenging medical conditions. Join us in exploring the possibilities of synthetic biology and CBD to build a healthier and more accessible future for all.
First of all, to start thinking about what could be developed during the project, we brainstormed all the first ideas, thinking about how we could relate parts of our research to each sector that could potentially be involved in our project. Each sector has a fundamental part to play in understanding the impact of our project on society, so we thought about developing these ideas one by one:
Patients who benefit from CBD treatment, along with the medical community, are intrinsically linked to the CBDynamics project. Patients depend on the research and production of high-quality CBD, while healthcare professionals prescribe and administer these treatments. This interaction aims to improve patients' well-being and offer safer therapeutic options.
The pharmaceutical industry is involved in the production and distribution of medicines based on CBD. The CBDynamics project can influence the market by making production more efficient and accessible, opening up opportunities for new products and partnerships.
CBDynamics presents an innovative approach to the production of CBD, which could potentially be revolutionary for countries with high bureaucracy in obtaining CBD-based medicines, as well as its purity, which will benefit various research projects in the area. In addition, the modeling developed could be useful for future researchers who want to develop research on CBD and the enzymes that make up the secondary metabolic pathway of Cannabis.
As far as the government is concerned, our project would be a way of improving the population's access to cannabidiol, so various public health policies could be implemented to make CBD more accessible to patients, thanks to the possibility of producing the drug without using Cannabis.
NGOs such as "CANNAB" and "ABRACE" have objectives related to research and access to quality treatments using CBD. In this way, the CBDynamics project could make a significant contribution to these NGOs by bringing all these important discussions about the need for the use of CBD to be more accessible to the population and how this drug is a great ally in the treatment of diseases such as epilepsy.
CBDynamics was shaped and designed to serve our community. Throughout the development of the project, we tried to communicate and, above all, understand the main problems that people who depend on CBD suffer from. This was done through opinion polls, conversations and participation in lectures to understand all these pains. As a result, we were able to identify a less bureaucratic and high quality alternative for all those who need this type of medicine, since CBDynamics will be able to obtain high purity CBD. As a result, there will be less noise in the treatment from other compounds that may not be removed in the traditional CBD production process, thus guaranteeing adequate and dignified treatment for our community.
Figure 4. Board of Stakeholders.
Source: 2023, Authors.
Each of these stakeholders is relevant to the CBDynamics project for particular reasons such as: Engagement, directly involvement with the project, whether as beneficiaries of the treatments, research partners, regulators, or patient advocates; purpose, to improve access to CBD-based treatments, reduce stigma, advance scientific research and influence policies to benefit society; and Core Values, shared values include innovation, responsibility, accessibility, ethics and social impact. Each stakeholder seeks to promote these values in their involvement with the project.
We also focused on a condition that could be treated with CBD so that we could understand how our project was linked to society and how we could positively impact it. We, therefore, chose to address epilepsy.
Epilepsy is a neurological disease with a high occurrence in the world population, affecting about 1% of people. The prevalence is higher in developing countries, reaching 1.5% to 2.0% more cases compared to developed countries. The incidence varies according to factors such as age, gender, race, type of epileptic syndrome and socioeconomic conditions. (Maranhão; Gomes; Carvalho, 2011).
In developed countries, epilepsy is more prevalent in childhood, especially idiopathic epilepsies and those associated with developmental disorders. In the elderly population, cases resulting from degenerative and vascular processes prevail. In developing countries, most cases are related to infectious and parasitic causes and head trauma. (Maranhão; Gomes; Carvalho, 2011).
Approximately 340,000 cases of epilepsy are diagnosed each year in Brazil, with around 1.8 million patients with active epilepsy, and around 9 million people have had an epileptic seizure at some point in their lives. (Marchetti, R., p. 170–182, 2005).
Epilepsy can be classified into different types of seizures, epilepsies and epileptic syndromes. Seizures can be focal, generalized or of unknown onset. Focal seizures can be subdivided into perceptual and perceptually impaired. Generalized seizures can be motor or non-motor. Epilepsies includes idiopathic generalized epilepsies, self-limited focal epilepsies, and combined focal and generalized epilepsies. Epileptic syndromes are grouped by age of onset and remission, and may be electroclinical or associated with structural, metabolic, immunological, and other causes.
The classification of epilepsy is essential to determine the appropriate treatment and establish the patient's prognosis. The etiology of epilepsy can be structural, genetic, metabolic, infectious, immunological or unknown. Correct identification of the etiology aids in treatment decisions and genetic counseling when necessary. (Maranhão; Gomes; Carvalho, 2011).
In summary, epilepsy is a neurological disease with a high global incidence, and its classification into seizure types, epilepsies and epileptic syndromes is fundamental for proper treatment and patient prognosis. The etiology of epilepsy can vary, with structural, genetic and other causes, which impact on therapeutic approaches.
CBD has been the subject of clinical studies that evidence its beneficial effects against seizures in patients with epilepsy. Several research studies show that many patients experienced either total or partial improvement after using CBD, with no significant reports of adverse effects or toxicity. Moreover, there is no evidence to suggest that prolonged use leads to tolerance or dependence.(MARANHÃO; GOMES; CARVALHO, 2011).
The antiepileptic benefits of CBD were first observed in a study (Zuardi, A. W., 2008) with rodents conducted by Brazilian researchers in 1970. In this research, CBD was added to the medication that patients were already using, resulting in significant improvement for four out of eight treated patients, partial improvement for three of them, and only one patient showed no improvement.
In 2013, a study involving 19 children suffering from treatment-resistant epilepsy demonstrated that a CBD-rich Cannabis extract reduced seizures in 83% of the cases (Ben-Zeev, B, Medical Cannabis for Intractable Epilepsy in Childhood v.11, 2020).
Although the results of these studies are promising, the use of CBD for epilepsy treatment outside experimental contexts still requires more scientific data obtained within international standards and clinical studies to ensure its safety and effectiveness.
Epilepsy is one of the major neurological diseases worldwide. According to the World Health Organization, it affects about 2% of the Brazilian population and approximately 50 million people globally, being more common in developing countries, children, and adolescents.
Conventional pharmacological treatment with anticonvulsant drugs has limitations, proving ineffective in about 30% of patients (Carvalho, Franco, Eidt, Hoeller and Walz, 2017). Therefore, there is a growing demand for more effective alternative treatments.
CBD has stood out in this scenario, particularly in cases of epilepsy refractory to conventional pharmacotherapy. Anecdotal evidence shows that cannabis extracts with high levels of CBD have been effective in reducing seizures, especially in children with rare types of epilepsy that are resistant to conventional treatments.(Maranhão; Gomes; Carvalho, 2011).
For years, in Brazil, the regulation of compassionate use of CBD for refractory cases, such as epilepsy and schizophrenia, has been conducted discreetly by the Federal Medical Council, due to the lack of conclusive studies at the time. However, this issue has now been overturned.
CBD represents a promising hope for patients with epilepsy who do not achieve satisfactory results with currently available treatments, and research on its use as epilepsy treatment continues to progress. Meanwhile, the search for other effective treatments continues, aiming to improve the quality of life for patients with pharmacoresistant epilepsy and their families.
The MVV (acronym for mission, vision and values) is the key element of the identity and purpose of a project, company or organization. From our MVV, the public can understand the objectives and principles of our project in a clear and simple way. Our mission statement gives the fundamental reason why the project exists, our purpose and how we can meet the needs of our target audience. The Vision sets out our long- and medium-term goals, as well as the direction we hope the project will take. To finalize the MVV, we present our Values, which demonstrate our ethics and cultural base, and are responsible for guiding our actions and decisions during the course of the project.
Our mission is to develop and produce CBD through synthetic biology, using recombinant gene technology, in order to provide an innovative and safe alternative for the treatment of epilepsy, and in the future other chronic diseases. We seek to facilitate access to high-quality medicinal therapies, contributing to improving the quality of life of patients in Brazil and around the world.
Our vision is to be recognized as an example in the production of cannabidiol via synthetic biology, driving the research and development of innovative therapies for epilepsy. We aim to be a benchmark in pharmaceutical technology, providing affordable and effective treatment for patients who need it.
With a commitment to these values, we aim to achieve our goal of producing synthetic cannabidiol efficiently and safely, providing a promising and viable alternative for the treatment of epilepsy. We seek to contribute to a future in which access to this type of treatment is facilitated, helping to improve patients' quality of life and well-being.
As with much of the Human Practices research, in which we sought to relate our project to the sectors affected, in the topic of MVV we also delved into the correlation of general MVV with each of the sectors. Brainstorming was again carried out using Miro, so that we could bring in as many different views as possible.
Figure 5. Board of our MVV for selected sectors.
Source: 2023, Authors.
"We acknowledge the profound impact of our project on various sectors, but it's equally important to consider how these sectors, and society as a whole, influence our project."
Through the Data Collection from Human Practices activities, we recognized the need to reevaluate our initial project ideas based on the feedback from the study sectors. Initially, we were apprehensive about collecting data from the local community, given our traditionalist society and the current delicate political climate regarding conservative issues in our country. To navigate this, we approached the topic with subtlety, using neutral terms rather than directly addressing Cannabis. Surprisingly, the public responded positively to our project. Despite most having little knowledge of the subject, when we explained our research's foundation and social motivation, many expressed support for this progressive step. This experience highlighted that prejudice often stems from misinformation, but open-mindedness, understanding, and dialogue can dispel doubts and reduce initial rejection.
Our initial expectations were pleasantly surpassed during the Data Collection. People demonstrated a remarkable willingness to discuss cannabidiol and advocate for its expanded medicinal use. This shattered our preconceived notions, emphasizing the crucial role of open dialogue and education in dispelling misconceptions about this topic. This experience underscored the importance of approaching these conversations with an open mind, as it has the potential to bring about profound shifts in societal perceptions and attitudes.
Another vital realization was that, from the outset of our research within the health sector, we were unaware that the impact of cannabidiol extends beyond the individual patient to their social circle. This magnifies our project's significance, as the social network of patients can be extensive. When viewing cannabidiol as a medicine, it becomes evident that we must not only address the patient's suffering but also consider the distress, worry, and anguish experienced by their relatives and friends. Our goal is to alleviate not only the patient's pain but also the emotional burden carried by those in their immediate support system.
Figure 6. Board of our Reflections on Selected Sectors.
Source: 2023, Authors.
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