investments Archives - European Industrial Pharmacists Group (EIPG)

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

Trends for the future of the pharmaceutical manufacturing

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By Giuliana Miglierini

The technological evolution of pharmaceutical manufacturing towards the full implementation of the Industry 4.0 paradigm is rapidly advancing. Digitalisation of productions is supported by the wide spread of automation, devices connected to the Internet of Things, and machine learning algorithms able to keep entire processes under control. Looking at pharmaceutical development, new types of treatments are emerging, also requiring a retuning of current approaches. Results from a survey among experts and industry insiders (56 respondents from 13 different countries) run by Connect in Pharma show new challenges are to be faced in the incoming years by the pharmaceutical industry in order to maintain its market position.

The combined value of the global pharmaceutical market in 2022 is estimated to be approx $650 billion. The main component reflects pharmaceutical manufacturing (US$ 526 billion in 2022, data Insight Slice), while the global pharmaceutical packaging market value is roughly US$131 billion (data Fact.MR).

Many different factors supporting the transformation of pharmaceutical manufacturing have been identified by Connect in Pharma, ranging from ageing of population to Covid19 and Ukraine crisis, to climate change and pressures on energy costs, up to the shortage of healthcare professionals. The final conclusions and opportunities identified by the report indicate new partnerships and collaborations (mainly with startups, and small and medium-sized companies) will remain fundamental to support competitiveness, together with growing investments in tech-driven innovations. Involvement of patients and healthcare professionals in identifying unmet needs and optimal solutions is another item to be considered in order to increase adherence to therapy, suggests the report.

Digitalisation still waiting to full exploit its potential

Innovation in automation and digitalisation of processes has been introduced in the pharmaceutical sector at a slower pace compared to other industrial sectors, due to its higher regulatory barriers. About one third (28%) of respondents to the survey indicated their companies are developing artificial intelligence (AI) or other digital tools for application in the manufacturing and packaging process. The main drivers towards the implementation of such systems are more efficient data collection, reduction of manufacturing down times and human errors, and the use of machine learning to support continuous manufacturing. Better workflow integration and anticounterfeiting, and the ability to share supply chain data with regulators are also relevant. These are all objectives that would need to provide new specific training to the workforce, e.g. on AI or tools for augmented reality.

One of the main barriers that, according to the report, is still slowing down the full potential of AI and digitalisation in the pharmaceutical industry is represented by the need to comply to regulations, including data integrity and security. The human factor may also prove relevant, as many people (including top management) may be reluctant to accept this change in technology. The availability of data scientists with a deep knowledge of the pharmaceutical sector is another critical point to be addressed.

Advances in drug delivery technologies

Connect in Pharma’s report also shed light on some drug delivery technologies that, despite not being an absolute novelty, are gaining relevance for the development of new products and treatments.

The moving of pharmaceutical pipelines towards a continuously increasing number of new biologic / biosimilar products, including mRNA-based and gene therapies, requires the availability of manufacturing and packaging capacities able to accommodate the specific needs of such often very unstable macromolecules. New drug delivery systems have been developed in recent years to provide answers to this need, among which is inhalation technology.

Dry powder inhalers and nasal delivery devices are the preferred formulations for the 50% of respondents to the survey that indicated actions are ongoing to develop new products using inhalation technologies. According to the report, these devices might prove particularly useful to deliver drugs that need to rapidly pass the blood-brain barrier in order to become effective, as well as for the delivery of vaccines. Fast absorption and higher bioavailability compared to other routes of administration are other elements of interest for inhalation technologies, which is also believed to be able to contribute to the reduction of carbon footprint.

Once again, the regulatory environment resulting from the entry into force of the EU Medical Devices Regulation (especially for drug-device combination products), together with the need to demonstrate patient safety and satisfactory bioavailability of these devices, are among the main barriers to their development, says the report. Inhalation technologies may also give rise to a new generation of delivery devices connected to the Internet of Medical Things (IoMT).

Another major trend identified by Connect in Pharma refers to the development of new drug delivery systems for injectable medicines (50% of respondents). This area is greatly impacted by the entry into force of the revised Annex 1 to GMPs, on 25 August 2023, that will increase the requirements for aseptic manufacturing. According to the report, main areas of innovation in this field may include new devices for injectable drug delivery, namely targeted to diabetes (the leading area of innovation), intravitreal ocular injection, autoimmune diseases, oncology, respiratory therapy, and pain management.

Connected devices

Diabetes is a highly relevant field of innovation also with respect to the implementation of connected devices, those embedded sensors and electronics allow for the real-time collection of data on self-administration of the therapy by patients, and their forwarding to health professionals. AI algorithms further enhance the potential of connected devices delivering diabetes treatments, as they support the real-time monitoring of insulin concentration in blood, and the consequent level of insulin delivered by the device. According to Connect in Pharma, other positive characteristics arising from the use of connected devices refer to the possible increase of patient adherence and compliance to treatment, resulting in improved patient outcomes and more personalised treatment.

Regulatory barriers are once again a main burden to the wider spread of connected devices, says the report, due for instance to the ultimate control over the sharing of data, and the choice if to implement single-use or reusable devices. Manufacturing costs, cybersecurity, and patient hesitancy are other hurdles identified by respondents to the survey.

The challenges for sustainability

The green policies put in place especially in the EU are calling industry to revise its processes and products to decrease their environmental impact, improve sustainability of manufacturing and packaging processes, so to eventually meet the climate targets fixed for 2050. According to the report, the global healthcare sector would be responsible for 4.4% of global net emissions. Connect in Pharma’s survey indicates 66% of involved companies are working to implement more sustainable practices. These may include for example the use of recycled materials in secondary packaging, the implementation of energy efficient technologies, and the development of more ecofriendly drug delivery systems. Costs have been identified as the main barrier to transition, together with the lack of common definitions. According to some of the experts, a wider use of data to monitor manufacturing systems and processes may help in improving the overall efficiency and in lowering the carbon footprint. Transport, for example, has a great impact on the sustainability of packaging.


EIC: challenges for the governance and opportunities for innovation

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by Giuliana Miglierini

The European Innovation Council (EIC) was launched in March 2021 by the EU Commission to support the growth of highly innovative startup companies. Since then, the programme experienced some difficulties to become fully operative, as delays occurred with companies requesting grant-only or grant-first support and with the decision-making procedures for companies requesting blended finance or equity-only investments.

According to the Commission, this situation is a result of the restructuring of the EIC Fund to better reflect Horizon Europe legislation and the outcomes of the pilot phase. Negotiations are also ongoing with an external fund manager of the EIC Fund and are expected to close by the end of June. Internal discussions in the European Commission and IT problems are among the possible causes of the delays, reported Politico. A situation that is highly impacting on the selected companies, that are hampered from proceeding with the timely development of their business.

The difficult governance of the EIC prompted the European Parliament to start an investigation, led by Horizon Europe’s rapporteur Christian Ehler, to better clarify the issues undermining the EIC functioning (see more on ScienceBusiness). Mr. Ehler asked the stakeholders to provide inputs by 14 June; the final outcomes of the investigation will be summarised in a non-legislative report on the implementation of the EIC.

The idea behind the report is to get the debate about the future of the EIC out in the open and provide the Parliament’s perspective on it. As co-legislator we have a duty to ensure the Commission implements the legislation we approved,” said Christian Ehler.

The EIC Accelerator

Available investments for startups and SMEs under the EIC Accelerator programme total €2.5 million for grants and €0.5 to €15 million equity investments through the EIC Fund. Higher investments are possible to support the development of technologies of strategic European interest.

A fast assessment procedure was introduced in 2021 to submit new projects at any time. A tailored business coaching support is available to successful candidates to draft the full applications, which are then evaluated at regular cut-off dates approximately every three months. The Commission announced it is finalising its decision-making procedure for the grant and equity components to companies selected for blended finance during the 2021 cut-offs. This is expected to allow the signature of contracts for the grant component of blended finance in a couple of days after the closure of the decision-making procedure, followed by the payment of a pre-financing of the grant one week later. A due diligence is needed to support the investment decision by the EIC Fund for the equity component, that will thus occur few weeks or months later.

The current status of the EIC Accelerator

According to the European Commission, 65 companies were selected for funding under the EIC Accelerator programme for the June 2021 cut-off, following the evaluation of their full application. Of these, 29 companies requested grant-only or grant-first support and 31 requested blended finance, including a grant component and equity investment. Contracts for six grant-only or grant-first companies were still to be signed as of 13 May 2022. The grant component is expected to close by early June 2022, while for the equity investment component and equity-only closure of the investment agreement is expected after June.

Some other 99 companies were selected for support in the October 2021 cut-off. Only one contract of the overall 34 companies that requested grant-only or grant-first support has been signed. Signature of the grant component for companies that selected blended finance is planned in July 2022, followed by the equity component and equity-only projects from the summer up to the end of the year.

The third cut-off round of March 2022 saw the selection of some other 74 companies, over a total of more than 1000 applications. Selected companies will each receive grants and/or equity investments up to €17.5 million. The next cut-offs for full applications is 15 June and 7 October.

Deep-tech training needed

A report published in April 2022 by the EIC Pilot Expert Group suggests the creation of two new deep-tech training programmes to better support the development of human entrepreneurial talent while fostering technological solutions. “We argue that EIC can’t succeed without including in its mandate the objective of proactively realising the entrepreneurial talent of Europe’s brilliant scientists”, write the members of the Expert Group in the foreword of the document.

The EIC Trailblazer Programme and the Pioneer Programme are the tools identified to reach this challenging goal. Both of the programmes should be implemented in a phased manner using pilot projects to allow for experimentation and learning, according to the recommendations set forth in the report. A main expected outcome is the creation of a new generation of deep-tech entrepreneurs, the EIC Innovators, able to better evaluate how their technologies are fitting into the world for commercialisation and impact.

The EIC Trailblazer Programme is targeted to support talented PhD candidates and postdocs that are part of projects funded by the EIC Pathfinder and EIC Transition. These EIC Trailblazer Fellows may receive a deep tech training programme, aimed to work as an internal accelerator and an elite programme targeting proto-entrepreneurs. A special prize and/or grant may also be considered to recognise scientific and entrepreneurial talents.

The Pioneer programme would allow for deep-tech add-on modules sponsored by the EIC to complement existing programmes delivered at the local level, in member states and potentially EU associated countries. Beneficiaries would include talented scientists that one day may apply for EIC funding, the “proto-EIC Innovators”.

Comments from research-intensive universities

The Guild of European research-intensive universities published a statement to contribute to MEP Christian Ehler’s initiative of a report on the implementation of the EIC. A better recognition of the role of universities’ Technology transfer offices (TTOs) as key actors in enabling researchers to develop their results for commercial and societal purposes is the key message of the Guild. To this instance, duplication of activities of the TTOs in terms of project management and support services should be avoided. Concerns are also highlighted with reference to the standard Intellectual Property (IP) provisions in the EIC Pathfinder and Transition schemes, as they might negatively affect the functioning of already well-performing TTOs without strengthening the capacities of weaker TTOs.

A positive experience is also acknowledged as for the EIC Transition scheme, that supports universities and their spin-offs with appropriate financial support for proof-of-concept projects. The Guild asks for the extension of this funding scheme to support an higher number of innovative projects.

An example of funded project

Swedish company Bico (formerly Cellink) is an example of EIC-funded project which saw a very rapid growth of its business, achieving $ 1 billion in market valuation in the first five years of activity. Founded in 2016, the company is now leader in the bioink sector and is developing new bio-printing technologies to be used for 3D printing of organs and tissues, so to overcome the lack of donors, reduce shortages and improve drug development.

Bioprinting is only one of the technologies included in Bico’s portfolio; gene therapy, gene editing, CRISPR, diagnostics are also investigated. The company built up from the first universal bioink created by Professor Paul Gatenholm (Chalmers University), a special biomaterial that enables human cells to grow outside the body and perform all the vital functions.