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Mediterranean Nutrition Science: pioneering the future of nutraceuticals

Companies

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13 May 2025

<strong>Mediterranean Nutrition Science: pioneering the future of nutraceuticals</strong>

The pharmaceutical and nutraceutical industries are rapidly evolving, with growing demand for science-backed, sustainable solutions. Professionals in clinical research, regulatory affairs, quality control, and supply chain management seek innovative formulations that align with both patient needs and market trends. At the forefront of this transformation is Esserre, a leader in Mediterranean Nutrition Science, committed to developing clinically validated nutraceuticals. Thanks to its R&D center in Formello, Italy, and an open research network, Esserre creates solutions that blend Mediterranean extracts with pharmaceutical-grade ingredients. Recognized as the most effective strategy to prevent chronic diseases, the Mediterranean diet promotes longevity, holistic wellness and sustainability. Esserre enhances this approach by integrating advanced extraction techniques, phytocomplex characterization and a green supply chain, ensuring high-quality and science-backed formulations. Esserre’s nutraceutical portfolio addresses key health concerns with ready-to-market products, including:

Cardiometabolic Health: based on Brumex, a bergamot-derived extract clinically proven to support cholesterol and triglyceride reduction, backed by one clinical trial.
Immune & Energy Support: formulated with PunicaPLUS™, a pomegranate-derived extract with antioxidant activity.
Gut Health & Microbiota Balance: soluble fibers to support intestinal health.
Mental Wellness & Stress Reduction: a formula inspired by the principles of the Mediterranean diet, designed to support stress relief and cognitive function.

Esserre follows a pharma-inspired development model, ensuring scientific validation, regulatory compliance and market-readiness:

In-House R&D & Open Research Network – Proprietary scientific studies with leading universities.
Advanced Extraction & Formulation – Optimizing bioavailability.
Regulatory & Clinical Validation – Conducting preclinical and clinical trials under EU standards.
Sustainable Supply Chain – Traceable, clean-label production from botanical sourcing to final product.

As longevity and preventive healthcare gain global relevance, Esserre bridges the gap between pharma and nutraceuticals, delivering trusted, science-backed solutions.

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AUDA-NEPAD is the new PIC/S associated partner

Regulatory

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17 April 2025

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AUDA-NEPAD is the new PIC/S associated partner

The ongoing initiative to strengthen regulatory capacity across the African continent took a significant step forward with the formal integration of the African Union Development Agency–New Partnership for Africa’s Development (AUDA-NEPAD) into the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This milestone reflects a broader commitment to enhancing the quality and safety standards of pharmaceuticals manufactured and distributed across Africa.

In January 2025, the PIC/S Committee officially granted AUDA-NEPAD the status of Associated Partner Organisation, recognizing its strategic role in supporting the development of the African Medicines Agency (AMA). The newly established partnership is underpinned by a cooperation agreement focused on aligning GMP (Good Manufacturing Practice) standards and quality systems for both finished pharmaceutical products and active pharmaceutical ingredients (APIs).

This agreement is designed to streamline the pre-accession and accession pathways to PIC/S for National Regulatory Authorities (NRAs) that are part of the AMA framework. It also aims to provide structured training programs for GMP inspectors, fostering the technical competence and regulatory oversight capabilities of national agencies across the continent.

Moreover, the collaboration is expected to serve as a catalyst for confidence-building measures among African NRAs, reinforcing their capacity to ultimately become full PIC/S Participating Authorities. In the long term, this alignment with international GMP standards will not only improve the regulatory harmonization across Africa but also bolster the global competitiveness and safety of medicines produced within the region.

This development marks a pivotal moment in Africa’s pharmaceutical sovereignty journey, signaling a deeper integration into the international regulatory community and a renewed focus on building resilient, quality-focused supply chains across the continent.

The Warsaw Declaration on the future of framework programmes

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27 March 2025

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<strong>The Warsaw Declaration on the future of framework programmes</strong>

The Warsaw Declaration, released during the informal meeting of research ministers held on 10 and 11 March 2025 under the Polish presidency of the Council, contains the recommendations for the negotiations of the post-2027 Multiannual Financial Framework. Key points include the recognition of the long-standing importance of framework programmes as tools for fostering excellent science, technological development and innovation in the EU. The last two programmes also worked to expand transnational science and innovation cooperation within Europe and with like-minded countries.

The new FP10 should be designed so to provide long-term orientation to address the Union’s key challenges, secure a stable and predictable framework for the R&I community and strengthen the European Research Area. The Declaration recalls the pivotal role played by the European Research Council (ERC) and the European Innovation Council (EIC) and calls upon the Commission to preserve their independence and expand their role. EU research ministries also recall the provisions of the Treaty on the Functioning of the European Union, highlighting that the FP shall establish the scientific and technological objectives to be achieved, fix the maximum overall amount, and establish the detailed rules for Union financial participation.

The Declaration also underlines that the future FP should support excellent and impactful R&I in an open and fair competition. The request to the Commission is for an adequate budget matching the programme’s strategic role. In particular, none of the future programmes or instruments should be funded at the expense of the FP. Furthermore, funds should be allocated solely to research and innovation to maintain programme continuity and efficiency.

EU Commission, how to design a monitoring framework of the EU One Health Action Plans against AMR

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20 March 2025

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<strong>EU Commission, how to design a monitoring framework of the EU One Health Action Plans against AMR</strong>

The One Health approach, which integrates human, animal, and environmental health, plays a fundamental role in shaping numerous initiatives aimed at combating Antimicrobial Resistance (AMR). Recognizing the importance of a coordinated strategy, the European Commission has recently released a report detailing the design of a monitoring framework for the EU’s 2017 One Health Action Plan against AMR, as well as the 2023 Council Recommendation on strengthening EU efforts to tackle antimicrobial resistance through a One Health perspective.

The primary objective of this framework is to systematically track the implementation, progress, and overall impact of One Health initiatives, ensuring that EU actions addressing AMR are approached in a comprehensive and integrated manner. It encompasses a wide range of legislative and non-legislative measures that span across all 27 EU member states, along with Iceland and Norway. The study underpinning this framework was developed through extensive consultations with relevant stakeholders, the identification of key indicators from pre-existing data collection initiatives, and the proposal of additional indicators where necessary to fill gaps in monitoring efforts.

Given the evolving nature of policies and actions in the fight against AMR, the framework is expected to be adaptable over time. Future updates and refinements may be introduced to ensure its continued relevance and effectiveness as new challenges and developments emerge in the field of antimicrobial resistance.

(Source: European Commission)

The new European Biotech and Biomanufacturing Hub

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13 March 2025

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The new European Biotech and Biomanufacturing Hub

The new Biotech and Biomanufacturing Hub, a key milestone in the European Commission’s Strategy to boost biotechnology and biomanufacturing in the EU, was officially launched on 30 January 2025. Designed as a central reference point, the Hub is accessible through the Your Europe web portal and aims to streamline the scale-up process while making it easier for businesses – particularly startups and SMEs – to navigate complex regulatory frameworks.

Companies looking to bring innovative biotech products to the EU market and enhance their competitiveness can access a comprehensive set of resources within the Hub. The platform provides essential information on regulatory pathways for human and veterinary medicines, biologicals, advanced therapy medicinal products (ATMPs), and feed and food ingredients. Additionally, it offers guidance on the authorisation process for different biotech products, intellectual property protection, and health technology assessments—all of which are crucial for ensuring market access and compliance.

Beyond regulatory insights, the Hub also serves as a gateway to EU funding opportunities, helping biotech and biomanufacturing companies identify financial support mechanisms tailored to their needs. A dedicated section highlights available research infrastructures, including pilot and testing facilities, networks, and collaborations that can support R&D and innovation activities. Moreover, companies can leverage market insights provided through the platform to make informed strategic decisions.

By consolidating all these resources into a single access point, the new Biotech and Biomanufacturing Hub represents a significant step toward fostering a more dynamic, competitive, and innovation-driven biotech sector in Europe.

Source: European Commission

A €200 billion initiative to fund AI gigafactories

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6 March 2025

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<strong>A €200 billion initiative to fund AI gigafactories</strong>

On 11 February 2025, European Commission President Ursula von der Leyen unveiled the new InvestAI initiative at the Artificial Intelligence (AI) Action Summit in Paris. This ambitious program aims to mobilize €200 billion in investments dedicated to advancing artificial intelligence across the European Union. A key component of the initiative is the EU’s InvestAI fund, which will allocate €20 billion to finance the construction of four new AI gigafactories across the continent. Each of these cutting-edge facilities will house around 100,000 next-generation AI chips and will be specialized in training the most advanced, large-scale AI models.

According to the European Commission, these gigafactories will constitute the world’s most significant public-private partnership in the AI sector, positioning Europe as a leader in the development of trustworthy artificial intelligence. The initiative aligns with the EU’s cooperative and open innovation model, prioritizing complex industrial and mission-critical applications. This announcement follows the initial plan for seven AI factories, which was unveiled in December 2024, with an additional five expected to be introduced in the near future.

InvestAI will also establish a layered investment fund, offering different risk and return profiles to attract a diverse range of investors. The European Commission’s initial financial contributions will be drawn from existing EU funding programs that include a digital component, such as the Digital Europe Programme, Horizon Europe, and InvestEU.

In addition to these efforts, the Commission will launch a European AI Research Council to consolidate resources and explore innovative ways to leverage data for AI and other emerging technologies. Furthermore, 2025 will see the introduction of the “Apply AI” initiative, designed to accelerate the adoption of artificial intelligence across key industrial sectors, reinforcing Europe’s competitive position in the global AI landscape.

Switzerland to join EU’s research and innovation programmes

R&D
Research

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20 February 2025

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Switzerland to join EU’s research and innovation programmes

After years of negotiations, Switzerland and the European Union have reached a long-awaited agreement that will see the country participate in key EU research and innovation (R&I) initiatives. The discussions, which aimed to update trade relations across twelve different sectors, concluded on 20 December 2024. The formal signing of the agreements is expected in 2025, followed by a national consultation phase in Switzerland, with the Swiss Parliament set to express its opinion by 2026.

One of the most significant outcomes of this deal is the reintegration of Swiss researchers into EU R&D programmes, including Horizon Europe (all Pillars), Euratom Research & Training, and Digital Europe. Swiss institutions and researchers will be eligible to apply for most funding calls as early as 1 January 2025, thanks to a transitional arrangement established between the two parties. This development restores Switzerland’s role as a key player in European scientific collaboration, strengthening partnerships with institutions across the EU. Beyond research, the agreement also includes a financial contribution from Switzerland to the EU’s cohesion fund, amounting to CHF 130 million per year from 2025 to 2029. These funds will be directly allocated to programmes and projects in EU partner countries, reinforcing Switzerland’s commitment to European economic and scientific cooperation.

Additionally, the negotiations have resulted in an updated health agreement, expanding Switzerland’s involvement in European health security frameworks. The country is now set to participate in the EU’s health security mechanisms and the European Centre for Disease Prevention and Control (ECDC), ensuring closer collaboration in areas such as pandemic preparedness, disease monitoring, and crisis response. With these agreements, Switzerland is taking a crucial step towards deeper integration with the EU’s research, digital, and health ecosystems, fostering stronger ties with European partners and reinforcing its position as a hub for scientific and technological excellence.

From software updates to patient safety

Companies

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17 October 2024

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<strong>From software updates to patient safety</strong>

Digital trust is crucial in modern cybersecurity, defined as users’ confidence in the ability of people, technology, and processes to create a secure digital environment.^[1] It mirrors patients’ essential trust in pharmaceuticals; both scenarios involve an intrinsic relationship where the end user relies on a product’s safety, efficacy, and reliability. This parallel underscores a universal truth: trust is a vital currency in any sector where the consumer has limited visibility into the processes, whether it involves medications or technological services. In the pharmaceutical industry, trust is built over time through painstaking research, regulatory compliance, clinical trials, and ongoing evaluation through pharmacovigilance, all designed to assure patients and providers of a drug’s safety and effectiveness. Similarly, in IT services, particularly cybersecurity, trust hinges on best practices, transparent processes, and verifiable outcomes.

The CrowdStrike incident: a case study

The CrowdStrike incident on July 19, 2024, provides a poignant case study highlighting the crucial need for digital trust. An update to the Falcon sensor application led to widespread outages, impacting approximately 8.5 million Windows machines due to a substantial coding error. The responses post-incident unveiled vital factors that contributed to the outage: a flaw in a content validation process and the failure of specific testing protocols that could have identified the potential vulnerability.^[2] The dynamics of the events resembled the Swiss cheese model of accident causation.^[3] CrowdStrike’s response to the incident – committing to enhanced software testing and adopting a staggered deployment strategy – reflects approaches commonly employed in the pharmaceutical industry. As pharmaceutical manufacturers routinely revisit and refine their quality assurance processes, software vendors must continuously improve their development and release processes.

Lessons learned and recommendations

A key takeaway from the CrowdStrike incident is the risk associated with automated updates, which, although crucial for efficiency and maximum protection, can result in widespread failures. Cybersecurity solutions vendors should prioritize software testing processes to mitigate future incidents, emphasizing the importance of extensive and exhaustive code testing before deployment. Moreover, effective communication strategies are vital to maintain transparency during IT incidents. The CrowdStrike outage spotlighted organizations’ need to provide clear directions regarding the incident’s cause, immediate remediation actions, and preventive measures moving forward. Drawing parallels with the pharmaceutical industry, organizations must also foster a culture of accountability, demand adherence to ethical practices, and demonstrate a proactive stance toward the quality of processes and products. Building digital trust through more effective software testing or responsive communications is imperative for long-term success in today’s digital-centric marketplace.

References

Digital Trust – CIO Wiki. https://cio-wiki.org/wiki/Digital_Trust
https://www.crowdstrike.com/falcon-content-update-remediation-and-guidance-hub/
https://en.wikipedia.org/wiki/Swiss_cheese_model

MedTech Europe’s proposals for improving the AI Act

European Union

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3 October 2024

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MedTech Europe’s proposals for improving the AI Act

In a post published on the association’s blog and signed by Alexander Olbrechts, director Digital Health, MedTech Europe turned the spotlight back on the possible impact of the AI Act, the new European legislation that aims to regulate the safety and quality aspects of artificial intelligence applications. An area that is presented to offer numerous opportunities in the field of medical technologies as well, side by side with just as many challenges in how to implement them.

First and foremost is the need to integrate the new provisions of the AI Act with what is provided by existing industry legislation, most notably the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). MedTech Europe’s goal here is to continue the dialogue with European legislators to ensure that the two strands of legislation actually complement each other, avoiding duplication of activities or conflict with procedures already in place.

One of the main goals of the AI Act, moreover, is to arrive at a smoothly flowing compliance process for AI-enabled medical technologies. A goal that, according to Olbrecht, should involve aligning compliance assessment with what is already in place in the MDR and IVDR regulations. The suggestion here is to maintain the existing technology codes for notifications to authorities and notified bodies, to which is added the possibility of assisting sectoral notified bodies with designation procedures under the AI Act, avoiding delays.

The MDR and IVDR regulations also introduced a strong component of clinical investigations and studies on device performance to support their efficacy and safety. According to Medtech Europe, the AI Act should serve as a facilitator in this regard, and a specific priority clause should be provided for the MDR and IVDR regulations in case of conflict with the provisions of the new AI legislation. MedTech Europe’s request is that it be definitively clarified that clinical and performance evaluations should be considered exempt from any requirement for CE certification under the AI Act, and thus continue to follow the pre-market testing rationale established of two medical device and in vitro diagnostic regulations.

Finally, there is no shortage of mention of the development of new digital therapies, in which AI models and data analytics play a key role in the development, for example, of innovative diagnostic solutions that can reduce the need for hospitalization.

VTE, increased risk with chlormadinone and ethinylestradiol

Pharmacovigilance

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26 September 2024

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VTE, increased risk with chlormadinone and ethinylestradiol

An information note agreed between the European regulatory authorities and AIFA (the Italian medicines agency) reports the results of a retrospective study,
according to which the risk of venous thromboembolism (VTE) is slightly increased in women using combined hormonal contraceptives based on chlormadinone acetate and ethinylestradiol.

The conclusion comes from the retrospective cohort study RIVETRCS, according to which the risk of venous thromboembolism increases 1.25-fold with this type of contraceptive compared to women taking combined hormonal contraceptives containing levonorgestrel. Based on these results, the annual risk of VTE in women taking chlormadinone acetate with ethinylestradiol is estimated at 6-9 cases of VTE per 10,000 women.

These data are compared with an annual incidence of 5-7 VTE cases per 10,000 women using low risk combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate, and with 2 VTE cases per 10,000 women not using a combined hormonal contraceptive.

The decision to prescribe a combined hormonal contraceptive must therefore take into account the individual woman’s risk factors for VTE and be based on a comparison with the VTE risk of other combined hormonal contraceptives. AIFA also points out that the risk is highest during the first year of use of any combined hormonal contraceptive or upon resumption of treatment with combined hormonal contraceptives after a break of 4 weeks or more.

staff

The CrowdStrike incident: a case study

Lessons learned and recommendations

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