Meeting brings together government, industry, and academia to outline strategies for strengthening national drug production

The event Integration, Good Practices and Technological Partnerships in the Pharmaceutical Inputs Sector, conceived by the Brazilian Association of the Pharmaceutical Inputs Industry (ABIQUIFI), EMBRAPII and CNPEM — with the participation of several EMBRAPII units, companies and institutions —, brought together on September 9th representatives from the pharmaceutical and pharmachemical industries, startups, regulatory bodies, and academia to discuss how to transform Brazil’s potential into reality and advance the national production of innovative pharmaceuticals.

For Claudia Caparelli, Innovation Manager at CNPEM, this meeting with pharmaceutical companies and startups developing disruptive technologies in drugs production, held at CNPEM, was a national milestone, as it not only allowed for discussion on Good Practices in Pharmaceutical Development in Brazil, but also for strengthening relationships between those who promote applied science and those who implement technologies for new drugs on the market. “We come out of this event with an action plan, with the aim of further enhancing the development and arrival of new medicines to the national market, with the certainty that we are on the right path to improve the quality and speed not only in identifying new potential molecules for new medicines, but also in assessing the industry interest in developing and producing these inputs nationally”, she says.

Challenges and opportunities

In this context, Iaralice Medeiros de Souza, from Fiocruz, highlights the importance of solid partnerships to accelerate development. “Cooperation is essential to facilitate and speed up processes that, on their own, would take much longer. This way we can transform research results into quality products for the population”, she observes.

Luciene Ballotin, representative of the Brazilian National Institute of Metrology, Quality and Technology, Inmetro, reinforces that certifications and good laboratory practices are essential to provide international credibility, but highlights that they must be applied proportionally to the maturity of each project, to avoid unnecessary costs in the initial phases.

Collaboration and regulation The meeting reinforced the importance of bringing together companies, science and technology institutes and regulatory bodies to reduce the gap between research and the market. This connection is already reflected in initiatives led by CNPEM with strategic partners. In the area of biodiversity and pharmaceuticals, the Iwasa’i Project, in partnership with UFPA, explores Amazonian soil bacteria with potential for new antibiotics and antitumor agents.

Other projects in collaboration with Nintx and funded by Embrapii use Brazilian natural products as the basis for innovative therapies against multifactorial diseases, including cancer and metabolic disorders. Among them, the “Aliança Dor” [Pain Alliance] initiative seeks alternatives for the treatment of neuropathic pain through modulation of the microbiota. These researches combine CNPEM’s natural products library, developed in partnership with Phytobios, with the use of Sirius and advanced algorithms.

The Center also participates in the development of open tools, such as NP3 MS Workflow, software built with USP and Unicamp that accelerates the identification of bioactive molecules, and is part of the Licuri Production Chain project (MCTI), which combines pharmacological investigation into licuri oil with training and good management practices for communities in the Brazilian Semiarid region.

For ABIQUIFI’s Executive-President, Norberto Prestes, the excellent scientific infrastructure already in place in Brazil needs to be used as a strategic asset. “Today, CNPEM is the country’s calling card for science and innovation. This international credibility has been opening doors to new projects with national and foreign pharmaceutical companies. Our mission now is to accelerate this process and position Brazil as a protagonist”, he highlights.

Biodiversity and radical innovation

The sustainable exploitation of Brazilian biodiversity was identified as one of the main opportunities for generating innovation. Tania Sawada, from Centroflora Group, recalled that the company is already developing projects in partnership with CNPEM for the discovery of new molecules in biomes such as the Amazon and Cerrado, associating radical innovation with family farming programs that ensure traceability and social return.

According to Germano Bassmann, head of Biotechnology R&D at Cristália, cooperation with CNPEM has been crucial in advancing research with lower risk. “The Center is a benchmark in research quality and delivers results that give us security, reducing risks and increasing the chances of project success”, he says.

The role of startups and EMBRAPII units

The meeting reinforced that around 70% of radical innovation in the world comes from startups, which reinforces the need to support these companies with access to cutting-edge infrastructure and strategic partnerships. For Fábio Cavalcante, Market Relations Coordinator at Embrapii, cooperation between units is essential. “The pharmaceutical sector requires complex projects that can rarely be handled by just one institution. The way forward is to combine skills to serve the industry cooperatively”, he explains.

Milena Soares, a researcher at Senai Cimatec and Fiocruz Bahia, highlights that collaboration is crucial to scaling the sector. “Science today is not done alone. It is essential to share infrastructure and optimize resources to expand development capacity”, she says.

Next steps

As a follow-up, the group decided to contribute to Anvisa’s regulatory agenda, develop guides and practical guidance for startups and universities, and conduct a detailed mapping of the capabilities and infrastructure available at EMBRAPII units. There was also consensus on the need to establish priorities for certifications and training in good laboratory practices, in addition to establishing partnerships that ensure the ongoing training of professionals. Another point considered essential is seeking joint solutions with development agencies to ensure the maintenance of strategic equipment.

Participants

Among the participants were representatives of the Ministry of Science, Technology and Innovation, Ministry of Health, Inmetro, IQ-USP, FMRP/USP, CEINFAR, ISI Biosynthetics, CIEnP, UFMG – FarmaVax, CQMED-UNICAMP, Cinatec, Fiocruz, Biotimize, Libbs, Bionovis, Nintx, Cristália, Aché, Microbiológica, Centroflora Group, Biominas Brasil e ISI São Paulo Advanced Materials.