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A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

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Lessons learnt to transition from Horizon 2020 to the new FP10

February 19, 2024 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020.

The report identifies several areas of possible improvement, which may be taken into account in the definition of the new FP10 (2028-2034) that will follow the current programme Horizon Europe (FP9). Among these are a broader participation, further simplification and reduction of the administrative burden, reinforcement of the dissemination, exploitation and deployment of results, support for the participation of women and enhancement of synergies with other initiatives at EU, national and regional level.

With a overall budget of € 75.6 billion, the main goal of H2020 was to support EU’s economic growth and excellence in science, industrial leadership and societal challenges. We summarise the main features of the report.

Key numbers of Horizon 2020
Calls under H2020 collected more than a million individual applications from 177 countries. Funded projects were more than 35,000, involving more than 40,000 organisations. The true impact of the programme cannot yet be fully appreciated, as 41% of projects were still active at the time of the final evaluation and are expected to yield further results.

Many new technologies in various domains of science were developed thanks to H2020 funding, i.e. mRNA vaccines, photonics and micro- and nanoelectronics, and novel hydrogen-fuelled transports. Sustainable development benefited from investments equal to 64.4% of H2020’s budget.

Activities run under FP8 led to almost 4,000 applications for protection of intellectual property (¾ patents and 12% trademarks). Peer-reviewed publications were over 276,000. Horizon 2020 had a significant effect in boosting employment (+20%) and increasing the turnover and total assets for participating companies (+30%). The mobility of approx. 50,000 researchers across countries and sectors was also supported. The programme allowed to improve the access to newly created or upgraded research infrastructures for more than 24,000 researchers and organisations.

According to the final report, some additional € 159 billion would have been needed to fund all the high-quality proposals submitted. Despite this, the long term impact of the programme is estimated to contribute an average annual increase of €15.9 billion to EU GDP (€429 billion for the period 2014-2040), and a net gain in employment levels of around 220,000 employees at its peak.

Co-investment led to a wide development of public-private partnerships and joint undertakings, with private partners contributing resources (in cash or in kind) two-three times the volume of EU funding. The development of the venture capital ecosystems and networks was also improved.

Key scientific and societal achievements
Medical sciences, quantum mechanics, chemical engineering and composite materials were among the main scientific domains targeted by actions run under Horizon 2020, together with climate change, health and food security and other societal challenges.

The relevance of scientific publications is acknowledged by the citation frequency, that according to the report is twice the global average. A significant number of papers (4%) are among the most cited worldwide, while more than 25% covered emerging and rapidly evolving R&I sectors. The great majority of publications (82%) were published as open access papers, thus greatly supporting the circulation of knowledge.

Emerging health crises were among the main research priorities related to improvement of public health, together with rare diseases and personalised medicine. Ebola and Zika epidemics were the first targeted emergencies, but the real test case was the Covid-19 pandemic: the final report indicates H2020 and the previous FP7 are recognised as the third most frequently acknowledged funding sources for Covid-19 related research in the world.

As for climate change, this field of research received 32% of H2020 funding to support, among others, the development of alternative and low-emission fuels. Other relevant lines of R&I included the development of a smart European electricity grid, automation, energy storage integration and the adoption of renewable energy sources.

As for the ongoing digital transformation, H2020 supported for example the development of safe and user-friendly robotics. Over 20% of the overall budget was dedicated to research in social sciences and humanities disciplines.

Elements to be improved
Horizon 2020 allowed to greatly expand the European network of research infrastructures. According to the final evaluation, access to these facilities may be further improved by enabling greater synergies between EU, national and regional programmes for research infrastructure. Despite H2020 saw improvements in the presence of women in evaluation panels (42%), the fixed target of 50% share of women in scientific advisory panels and as researchers in projects was not yet achieved (43% and 23% respectively).

As for financial aspects, the interim evaluation identified a notable gap in venture and growth capital in the EU to scale up innovations. The issue was addressed through the launch, in the last three years of H2020, of a pilot to run the European Innovation Council (EIC), which according to the report showed positive preliminary results both on the turnover and staffing levels of its beneficiaries, and in tackling the critical funding gap in high-risk areas where limited alternatives are available at national and regional levels.

Preparing for the next FP10
With Horizon Europe framework programme coming to an end in 2027, the final report on results achieved by H2020 represents a first basis to reason on new research targets and financial support to be part of the new FP10 2028-2034 (you can find comments here and here).

While some members of the European Parliament already called for a FP10 budget of at least € 200 billion (see here more), several academic and scientific organisations published their proposals to be considered in the drafting of the new programme.

The European University Association (EUA), Science Europe and the European Association of Research and Technology Organisations (EARTO) sent a joint open letter to EU Commissioner Iliana Ivanova, asking for a doubling of the FP10 budget to €200 billion. A higher budget stability and protection of funding from being shifted to non-R&I purposes are among other requests, together with rebalancing support across various stages of R&I (i.e. bottom-up basic research, applied research, development, and innovation). Sufficient national investments in R&I are also deemed important.

The European universities of science and technology represented by Cesaer also published a note to advance their suggestions, in line with the EU Commission’s goals of a more elaborate EU industrial policy, and the move towards EU-30+. Key elements should include the leadership in deep tech, clean-tech and biotech based on the full knowledge value chain, the use of open and competitive calls to select researchers and innovators and award funding across all parts of FP10, a stable financial environment with at least €200 billion investments and enacting the 3% GDP target to R&I agreed by the EU Council in 2002. An annual review mechanism of current performance and a ring-fence to protect the budget allocated to R&I are among the suggested actions.

Guiding principles proposed by EU-LIFE (the Alliance of research institutes advocating for excellent research in Europe) also address investments in the European Research Council, the bridging role of the European Innovation Council, the need to avoid additional pillars and fragmentation, and the development of a coherent impact approach by reducing the size of consortia and monitoring the impact of initiatives in Pillar 2.


Commission establishes portfolio of 10 most promising treatments for Covid-19

November 19, 2021 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The second phase in the development of new medicines to treat Covid-19 – a part of the EU Strategy on Covid-19 Therapeutics launched in May 2021 – has reached a cornerstone with the announcement made by the European Commission of a first portfolio list of ten potential Covid-19 therapeutic candidates likely to be authorised by the European Medicines Agency (EMA). The only medicine authorised up to now at EU-level to treat Covid-19 is remdesivir.

The choice of the molecules to be included in the list was based on independent scientific advice by an expert group, and it is aimed to offer new treatment opportunities for patients affected by the disease in a way complementary to the preventive action of the already available vaccines. The strategy shall contribute to the achievement of the European Health Union, and it has been modelled on the example of the EU Vaccines Strategy.

Once available in the European market, the new medicines are expected to contribute to the reduction of hospitalisations and deaths from Covid-19. “We have already signed four joint procurement contracts for different Covid-19 treatments and we stand ready to negotiate more. Our goal is to authorise at least three therapeutics in the coming weeks and possibly two more by the end of the year and help Member States gain access to them as soon as possible.”, said the Commissioner for Health and Food Safety, Stella Kyriakides.

Three different categories of therapeutics

The initial list of ten candidates includes three different categories of therapeutics, and it may evolve in future according to the emerging of new scientific evidence.

Antiviral monoclonal antibodies have been identified as the most efficacious approach to be used in the earliest stages of infection. This category includes the following medicinal products under development:

  • Ronapreve, a combination of two monocolonal antibodies casirivimab and imdevimab from Regeneron Pharmaceuticals and Roche.
  • Xevudy (sotrovimab) from Vir Biotechnology and GlaxoSmithKline.
  • Evusheld, a combination of two monoclonal antibodies tixagevimab and cilgavimab from Astra-Zeneca.

The second category refers to oral antivirals, in this case too for early treatment; it includes the following candidates:

  • Molnupiravir from Ridgeback Biotherapeutics and MSD.
  • PF-07321332 from Pfizer.
  • AT-527 from Atea Pharmaceuticals and Roche.

Hospitalised patients may also benefit from the use of immunomodulators; four different possible candidates have been selected within this category:

  • Actemra (tocilizumab) from Roche Holding.
  • Kineret (anakinra) from Swedish Orphan Biovitrum.
  • Olumiant (baricitinib) from Eli Lilly.
  • Lenzilumab from Humanigen.

The scrutiny and selection of the most promising therapeutic options took into consideration 82 different molecules in late-stage clinical development. The analysis assumed that different types of products are needed for different patient populations and at different stages and severity of the disease. This scrutiny exercise was completely separate from the standard scientific assessment of the regulatory dossiers submitted for the candidates, that will be performed by EMA in order to issue the recommendation for final marketing authorisation by the EU Commission.

Steps towards the approval of the selected candidates

As announced by Commissioner Stella Kyriakides, half of the selected candidate therapeutics may reach approval by EMA by the end of 2021. These include products for which the rolling review is already ongoing or that have applied for marketing authorisation to the European Medicines Agency. Pre-requisite for the approval is the final demonstration of their quality, safety, and efficacy; there is still the possibility some of the products in the list shall not be authorized should the scientific evidence provided to EMA be considered not enough robust to meet the regulatory requirements.

Four other candidates are still in early phase of development and have already received scientific advice from the Agency; their rolling review shall begin as soon as enough clinical data will be available. The further development of these products will benefit by an innovation booster to support development activities.

As said, this is just a first list of promising therapeutics to treat Covid-19; some other approaches are expected to be identified as a consequence of the activation of several new initiatives by the EU Commission. Among these are the setting up of the interactive mapping platform for promising therapeutics which represents one of the first targets of action for the newly created Health Emergency Preparedness and Response Authority (HERA) (we wrote about this in October’s newsletter). The Commission also announced the activation within few weeks of the HERA website, where contact details and practical guidance for interested companies shall be found.

A pan-European matchmaking event for therapeutics industrial production has been also announced; this effort will focus on the development of new and repurposed Covid-19 therapeutics and it is aimed to mobilise the EU’s pharmaceutical manufacturing capacity.

The criteria used to select the candidate therapeutics

The European Commission published also a Q&A note to better explain the process that led to the selection of the ten promising therapeutics to be included in the list.

The portfolio of the selected products (authorised and under development) has been established by the expert sub-group on Covid-19 therapeutics (part of the expert group on SARS-CoV-2 variants) upon request of the Commission. The criteria used to run the analysis were approved by Member States in the Human Pharmaceutical Committee.

They include the evaluation of the pharmacological rationale on the basis of the available evidence of the potential role played by the single medicinal product in the treatment of Covid-19, its stage of development and availability of relevant data from clinical trials, the absence of (new) major identified safety issues, and the ability to answer to unmet clinical need and/or bring therapeutic added value. For some product categories, the efficacy against new SARSCoV-2 variants has been also evaluated.

Other points included in the assessment refer to the route of administration, treatment regimen, and formulation, and the company’s intention to access EMA’s early stage scientific advice procedures. The analysis run by the expert group did not focused on more industrial aspects, i.e. manufacturing, production volumes, prices and access conditions; these will be part of the considerations made by the Commission in order to activate its support instruments.

As for the three different categories of selected products, antiviral monoclonal antibodies are intended to mimic the action of natural antibodies generated by the immune system against coronavirus. They can exert both a curative and a preventive action against the infection, in particular in the earliest stages of the disease. They are usually administered by injection.

Oral antivirals are small molecules aimed to block the activity and replication of the virus. These too are early interventions targeted to prevent damage in tissues and organs and offer the advantage of administration as tablets or capsules, thus favouring compliance. Other plus identified by the expert group are a higher resistance to variants, and the therapeutic action maintained also in vaccinated patients.

Immunomodulators aim to regulate the excessive reaction of the immune systems against the virus, thus preventing the risk of hospitalisation. They represent a symptomatic treatment option for patients at severe stage of progression of the disease despite vaccination and antiviral therapy.