Colorobbia – Pilot Results
Basic Pilot Data
Type of company: Nanotechnology
Country: Italy
- Type of industry: nano-based products
- Focus of Pilot: Nanomedicine
Interview with Giovanni Baldi Director, Ce.Ri.Col – Colorobbia Consulting Research Centre
The videos below concern interviews with Giovanni Baldi (Director Research Centre).
“We consider pivotal to our R&D efforts an open and continuous dialogue with stakeholders, patients, in the first place, and regulators, health-care professionals, policy makers, media, the society at large. It is vital to improve functionalities, quality and reliability, acceptability, of the NanoMed technologies and products.
With PRISMA we learned the importance of focusing on the ethical and social impacts of NanoMed since the early phases of the development, to become responsive and trustworthy toward needs and requests from users and society. This experience has convinced us of the strategic value of RRI for NanoMed and our organization.”
The first video is about the company and challenges faced.
This video is about the Safe by Design approach.
Pilot Company
Gruppo Colorobbia, Italy is active in research and development, prototyping and production of nano-based products to be used in the industrial fields of pharmaceuticals, nano-medicine, coatings and environmental protection, as well as to provide services in term of research, chemical and chemical-physical analysis, compliance with environmental and safety regulations in force, IT and process plant engineering.
One of its main project – and the focus of the pilot – is NANOMED. This ia large research project based on in-house resources from the company and funding by different cooperative projects, aims to create a technology platform providing an integrated and modular system, for the diagnosis and treatment (theranostic) of cancer and nervous system diseases. It is a nanotechnology based system using a combination of targeted and controlled drug delivery, hyperthermia and radiofrequency and laser imaging methods. The technology platform will lead to different products, including a contrast agent, a formulation (drug), a cell therapy system and a portable and integrated medical device to produce the cell therapy system.
A dialogue on ethical and social impacts with actors along the value chain of the R&I project, including researcher, suppliers, hospitals, authorities, patients associations, ethical committees, has been started (also thanks to the Prisma project), and will need to continue in the future.
Regular monitoring of normative developments and early cooperation with EU and national authorities active on medicinal products, ATMP and nanomaterials is already part of the NanoMed activities.
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The Challenge
This was a pilot on nanomedicine.
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Results
The pilot started with a a reflection with the company and a dialogue with stakeholders to identify the most relevant values to pursue for NanoMed products. The key values identified were:
- Product efficacy
- Safety of the product, in particular regarding safe use of nanomaterials along the value chain
- Excellence in R&D
- Ethics (respect of patients’ rights) and patient-centric procedures for both clinical trials and cure (principles of precaution, beneficence, dignity, informed consent, data protection and data ownership)
- Transparency about the ways of production and use of nanomaterials, toward all actors along the R&I value chain and the product supply chain
- Affordability, accessibility of the treatment: ensuring the final system, delivering the personalized therapy at the point of care, will be affordable for health-care professionals (e.g. local hospital structures) and patients.
So, the next question was: how could these values be faced within the NanoMed Project? Part of the complexity is that the assessment of socio- economic impacts of medicinal products is a step usually performed once the product is close to the market phase. In the case of personalized and point of care therapies, this is complicated by the novelty of the approach, including issues related to the potential impact on the existing healthcare system and the type of business models suitable for these new therapies.
During the pilot we focused on a dialogue with stakeholders, in particular to plan and design protocols to ensure respect of patients’ rights, including appropriate procedure for data management and informed consent with regard to data collected during clinical trials and therapy. Specific recommendations are:
- NanoMed should plan specific activities for early analysis of cost-benefit impacts of the new therapies, and screening of potential novel (responsible) business models. This could be informed by dialogue and cooperation with risk managers and potential public and private investors, including the health-care system (e.g. local authorities and hospitals)
- Design an informed consent protocol together with health-care professionals, patients associations, and ethical committees, considering the peculiar aspects of personalised medicine and nanomaterials. Include information on uncertainties related to the new therapies.
- Create informative events targeted to health-care professionals and patients to raise awareness on opportunities and challenges of personalized therapies, in particular the use of nanomaterials and ATMPs
- Identify appropriate communication means and channels to inform the wider public on NanoMed technologies and products. Ensure an easily accessible and understandable communication of benefits and risks of the product. Consider engagement of scientific journalists and media experts to realize the communication strategy.
- Engage a multi-disciplinary panel of independent experts and end-users in order to assist the project regarding strategic choice on ethical, legal and social aspects (e.g. risk-benefit evaluation) taking into account also technical developments (e.g. safety of nanomaterials) and socio-economical aspects