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From Science Europe a guideline for the alignment of research data

Caterina Lucchini
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From Science Europe a guideline for the alignment of research data

Research funding organisations, research organisations, and individual researchers
have different needs and requirements when it comes to research data management
(RDM). The core requirements for data management plans (DMPs) and criteria for the
selection of trustworthy repositories are collected in the guide proposed by Science Europe “The international alignment of research data management”. The aim of this guide is to provide organisations and communities with a common basis from which they can develop RDM policies. These should be considered as minimum requirements that can be supplemented with more specific ones according to the needs of the community or organisation in question.

Main topics

The guide is divided into three parts.

  1. Core Requirements for Data Management Plans: six aspects that every
    DMP should cover, with detailed guiding questions. Research funding organisations, research organisations, and research communities are encouraged to use the core requirements for data management plans as a basis to set up their own DMP templates. At a later stage, the core requirements can also serve as reference document for the evaluation of DMPs. 
  2. Criteria for the Selection of Trustworthy Repositories: four topics
    detailing criteria that every trusted repository should meet. The criteria for the selection of trustworthy repositories will help research funding organisations, research organisations, and individual researchers to identify repositories for storing and sharing data.
  3. Guidance: more detailed information and examples to support the
    implementation of the requirements and criteria into an organisation’s policies.

This guide was developed in a way that makes it useful for a large number of
organisations and researchers. It focuses on content-related questions and does
not refer to any procedural aspects of using DMPs and selecting a repository, as
those may differ significantly among organisations.

Packaging and green economy

Caterina Lucchini
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Packaging and green economy

There is an ongoing challenge for drug packaging. The green economy requires the use of recyclable and easily disposable materials and therefore the pharmaceutical packs must adapt and abandon the path so far. The policies decided at international level to reduce the pollution of the planet concern all sectors of life and human activities and therefore do not exclude the pharmaceutical sector. The main producers are adapting to new requirements and the packaging of pharmaceutical products are made using recyclable materials such us plastic, paper, glass and aluminum.

Requirements

The packaging for medicines must meet very specific and important requirements to ensure that the packaging:

  1. do not contaminate or alter the drug
  2. protect the content
  3. be easily manoeuvrable to access the medicine
  4. is hardly tampered with

Most used materials

According to the survey carried out by the Italian packaging institute and relative to 2017, the classification of the materials used for the primary packaging sees aluminum at the first place with 60.7% of the total, followed by glass (20.2%), plastic (18.8%) and paper (0.2%).

The secondary packaging is made of cardboard, those for transport are made of various materials (for example cardboard, plastic film). The liars, which are part of the packaging of the medicine, are made of paper.

Market data

In 2017, about 50,000 tons of primary packaging were produced in Italy for ethical and OTC drugs sold in pharmacies. Considering also the secondary packaging we reach a final total of about 90,000 tons. With respect to the previous year, 2016, there was a decline of 1%, but these are still very important figures considering the need for disposal and recycling of materials.

In the period 2000-2017 there was an average annual increase of about 1.4% of the number of packages produced.

The packaging of a drug must be able to adequately protect the content but at the same time must guarantee a simple and functional use by users. The drug market knows no crisis. According to the EvaluatePharma forecasts, the global value of the medicines will exceed the trillion dollars by 2024 with an annual growth rate of over 6%.

New members of the italian Higher Health Council

Caterina Lucchini
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New members of the italian Higher Health Council

The new thirty non-law members of the Italian Higher Health Council (Consiglio Superiore si Sanità – Css) were appointed at the beginning of February by the Minister of Health, Giulia Grillo; it will be the same Css, after the official settlement of the new members – which are added to the members by right – to appoint its new president.

The procedure

A blind based on competences procedure has been followed for the appointment of the new members of the Css. The result is a “top” team that also includes many Italian scientists operating abroad, selected transparently according to the number of publications and citations and the impact of these contributions on clinical progress.

In the new Css there will be represented new skills such as in Computer Science and Bioinformatics, Epidemiology, Immunology, Hygiene, Oncological Prevention and the study of  chronic diseases mainly related to the aging of the population, together with experts of global relevance in the field of innovative drugs and cell therapies (Car-T and stem cells).

The new members

Prof. Sergio ABRIGNANI
Ordinary of General Pathology – University of Milan
Prof. Adriano AGUZZI
Director of the Zurich Institute of Neuropathology
Prof. Mario BARBAGALLO
Ordinary of Geriatrics – University of Palermo
Prof. Mario Alberto BATTAGLIA
Ordinary of Hygiene and Public Health – University of Siena
Prof. Luca BENCI
Lecturer in Health Law – University of Florence
Prof. Renato BERNARDINI
Ordinary of Pharmacology – University of Catania
Prof. Giuseppe CAMPANILE
Ordinary of Animal Sciences and Technologies – “Federico II” University of Naples
Prof. Claudio COBELLI
Ordinary of Bioengineering – University of Padua
Prof. Giulio COSSU
Ordinary of Regenerative Medicine – University of Manchester
Prof. Giuseppe CURIGLIANO
Associate of Medical Oncology – University of Milan
Prof. Bruno DALLAPICCOLA
Scientific Director of the Bambino Gesù Pediatric Hospital
Prof. Domenico DE LEO
Ordinary of Legal Medicine – University of Verona
Prof. Paola DI GIULIO
Associate of Nursing Sciences – University of Turin
Prof. Marco FERRARI
Ordinary of Odontostomatological Diseases – University of Siena
Prof. Carlo FORESTA
Ordinary of Endocrinology – University of Padua
Prof. Silvia GIORDANO
Ordinary of Histology – University of Turin
Prof. Andrea GIUSTINA
Ordinary of Endocrinology and Metabolism Diseases – S. Raffaele University of Milan
Prof. Andrea LAGHI
Ordinary of Radiology – La Sapienza University of Rome
Prof. Franco LOCATELLI
Deputy Director of Onco – Pediatric Hematology of the Bambino Gesù Hospital
Prof. Francesco LONGO
Associate Dept. of Policy Analysis and Public Management – Bocconi University of Milan
Prof. Vito MARTELLA
Ordinary of Infectious Diseases of Pets – University of Bari
Prof. Maria G. MASUCCI
Ordinary of Virology – Karolinska Institute of Stockholm – Member of the Nobel Commission
Prof. Marco MONTORSI
Rector of the HUMANITAS University
Prof. Paolo PEDERZOLI
Ordinary of General Surgery – University of Padua
Prof. Giuseppe REMUZZI
Director of the Irccs “Mario Negri” of Milan
Prof. Camillo RICORDI
Surgery and Cell Transplantation Medicine – University of Miami (USA)
Prof. Massimo RUGGE
Professor of Pathological Anatomy and Oncology – University of Padua
Prof. Giovanni SCAMBIA
Scientific Director of the Policlinico Universitario Agostino Gemelli Irccs Univ. Cattolica
Prof. Fabrizio STARACE
Director of Mental Health Dept. and Pathological Dependencies – AUSL of Modena
Prof. Paolo VINEIS
Ordinary of Epidemiology – Imperial College of London

New rules on safety features

Caterina Lucchini
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New rules on safety features

On February 9th the new rules on safety features have start to prevent the counterfeiting of the packaging of medicines. Unique identifiers and anti-tampering devices must be present on the packaging placed on the European market after this date. The pharmacists are responsible for checking the authenticity at the end of the supply chain.

Italy and Greece are at the moment exempt from the introduction of the new measures, as they have already adopted similar systems of control.

A closed system at the base of the checks

Verification of authenticity requires access to the closed system by pharmacists specifically authorized for this purpose. Patients will also be able to verify that the online pharmacies they use to purchase medicines are authorized and operate legally (just by clicking on the appropriate European logo on the homepage of the pharmacy website).

Before the checks by pharmacists, pharmaceutical companies that produce the medicines have the task of inserting into the system all the information that compose the unique identifier of the single package of any drugs.

The European database is centrally managed by the European Medicines Verification Organization. In some cases, depending on the origin of the drugs, wholesalers could also be called upon to verify authenticity along the supply chain.

 

Excipients for Controlled Release

Caterina Lucchini
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Excipients for Controlled Release

Excipients are key ingredients in the pharmaceutical industry. Furthermore, the demand for controlled release formulations is expanding, considering the trend of greater comfort linked to the use of drugs. Extended-release products have reduced dosing frequencies, which are particularly beneficial for pediatric and geriatric patients, but are appreciated by most patients and in general lead to improved medication adherence. Reformulation of branded drugs in controlled-release formats is one of the most common methods for extending the product lifecycle. Generic drugs are also often formulated with controlled-release properties.

How controlled release is achieved?

Controlled-release “behavior” can be achieved by using polymeric coatings on solid dosage forms or by incorporating various types of polymer matrix systems, enzyme-activated systems, or systems that respond to changes in physical conditions within of the formulation. Mechanisms include dissolution, diffusion, osmotic pressure, maintenance of a hydrological or hydrodynamic equilibrium and ion exchange. Newer approaches based on nanotechnologies and new matrix technologies are currently under development and include administration of retarded controlled release drugs, floating systems and mucoadhesive systems for the regulated release of antiviral drugs.

The role of the excipients in controlled release


Excipients are key ingredients in controlled release formulations. They contribute to the formation of the matrix in the systems that use it and act as polymeric membranes for powders and multi-particulate systems in the forms of oral solid dosage (OSD). In oral liquid products, the excipients can also provide taste masking and protection for the gastric mucosa. In other specific cases, the excipients can be a deterrent to abuse and help to avoid alcohol-induced dumping. The excipients that provide controlled-release characteristics to oral solid dosage forms not only allow control of the API release rate, but also target the district where the release occurs.

New options

Since the excipients are key ingredients in controlled release formulations, it may seem surprising that the choices are somewhat limited, particularly for some patient populations such as pediatric populations. Suppliers are developing “new” excipients that can provide solutions and support for moving existing formulations into new areas, but the excipients do not have their own approval path. For this reason, pharmaceutical companies are reluctant to take on the responsibility of toxicology and clinical trials with an untested material because they run the risk of endangering the approval of their new pharmaceutical applications. Therefore, most of the new excipients used derive from modifications or combinations of previously approved excipients.

Main legal barriers to the better use of health data for pharmaceutical innovation

Caterina Lucchini
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Main legal barriers to the better use of health data for pharmaceutical innovation

The proliferation of health data in our ever more digitalised world of health care creates opportunities for better research around – and delivery of – pharmaceutical innovation. However, these opportunities may be constrained around the legal barriers to the use of health data for these purposes, which are poorly understood, particularly in relation to the new General Data Protection Regulation (GDPR).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) summarises research evaluating the main legal barriers to the better use of health data for pharmaceutical innovation.

Six specific problems

The report took into consideration six specific problems that impact on the possibility of collecting, accessing and using data for research purposes in the pharmaceutical field, for which the main barriers that currently limit its potential have been identified.

     1. Epidemiology and pharmacoepidemiology: identifying unmet need
     2. Pharmacogenetics: targeting development
     3. Interventional studies
     4. Non-interventional studies
     5. Pharmacovigilance
     6. Managed entry agreements

Legal barriers

The report was commented on the Efpia blog by Amanda Cole, one of the authors of the report. The legal barriers that arise in the utilisation of data by pharmaceutical companies vary across a product’s lifecycle. However, the main issues can be described under eight main themes.

     1. Data subject rights are not absolute and may be more limited within the context of health research due to the scientific or public interest merits of the data use, along with the high level of safeguards in place to protect data.
     2. Data ceases to be personal once anonymisation has been achieved, in which case it does not fall under data protection legislation. Where anonymisation is not possible, processors must have a legal basis for processing data.
     3. One such basis is (informed) consent. However, a key challenge is in constructing consent that is broad enough to permit later research, but specific enough to meet legal standards, particularly within the heightened requirements of the GDPR. We argue that these requirements are not usually compatible with medical research, and whilst consent is critical for other reasons, it should not usually be the legal basis for data processing.
     4. However, as outlined already, uncertainty around the appropriate legal basis for processing data under the GDPR is currently a major issue for industry.
     5. There is a need for a shared and consistent understanding of the compatibility of primary and secondary (re-)use of data.
     6. This addresses the heterogeneity both within and between countries that arises from divergent interpretations.
     7. There is a need for clear guidance or minimum standards for industry in the emerging area of digital health.
     8. Promoting confidence and engendering trust is fundamental and is achieved through being transparent and sharing good practice. The public must be convinced of the benefits of data processing for pharmaceutical research, and of the high safeguarding standards employed in handling their sensitive information. 

 

Job market in Life Science sector

Caterina Lucchini
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Job market in Life Science sector

Job is increasingly flexible also in the Life sciences sector, where fixed-term contracts of various types (administered, interim, freelance, etc.) are taking an important role. A sample of Italian workers have been involved in the research “Talents in the Life Science 2018” of Kelly Services, according to which about two thirds (67%) of the respondents work with contractual forms different from the permanent one. The research involved one thousand four hundred people working in the pharmaceutical, biotechnology, medical devices and health services sectors in seven different countries (Italy, France, Switzerland, United Kingdom, Ireland, Germany and Holland). UK (66%), Ireland (61%) and Germany (49%) are the countries that according to the survey still show the largest share of permanent staff. The dynamics underlying the phenomenon would be attributable to the ever-increasing role played by artificial intelligence, which has driven the search for human personnel towards ever more specific skills. According to the majority of respondents at the European level (72%), the role they currently play will be progressively automated over the next five years. Despite this, according to Kelly Services, the prevailing sentiment is that of experiencing this change as an opportunity rather than an obstacle, an evolution towards the optimization of its results through increasingly innovative technologies.

The opportunities for flexible work

Greater freedom in planning private life (24%), the possibility of expanding knowledge / experience (17%) and the opportunity to change roles and places of work (14%). The possibility of verifying how much you really feel “suited” to a certain role or company culture and that of being able to easily change towards different figures or companies are other forces that emerge from the results that help to make fixed-term positions acceptable. On the other hand, the aspects related to the remuneration, mentioned only by 2% of the interviewed sample, are the tail light.

Medical liason officer

At the moment the figure of the Medical liason officer is the most remunerated on the Italian market (ral € 62 thousand, Kelly Services data); a figure that can aspire to even richer contracts in other countries, such as Germany (€ 77 thousand) or Switzerland (€ 94 thousand).

Formulation development: which is the direction?

Caterina Lucchini
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Formulation development: which is the direction?

We are in the era of controlled release formulations, but new emerging technologies are coming, such as fixed dose combinations or those with dual release profile.

The former use multiparticolates with variable coating or two- or three-layer tablets, while in the latter case two or more active ingredients are formulated in the same dosage form. According to Blessed Vladovicova, R & D manager of Saneca Pharma, also the solution of the solubility problems that characterize many new active ingredients will be at the center of the formulators’ priorities in the new year.

The advantages of controlled release formulations

Less risk of dose changes, constant concentrations in the blood and lower toxicity are, for Vladovicova, the main benefits of controlled release formulations. Formulation development is often outsourced – explained Vladovicova – and it is important that the chosen supplier has proven experience and technological ability in the development of this type of complex products. One of the emerging technologies in this sense is the pelletization, which often allows to solve the problems related to the formulation of active ingredients that are not stable or that have compatibility problems.

Formulate the opiates

Another hot topic reported by Vladovicova, especially in the United States where FDA has issued last year a new guideline dedicated to the development of generic abuse-deterrents, is the formulation of opiate drugs used to treat pain. A double-edged sword, because the abuse or misuse of this category of drugs can lead to dependence, and this kind of effect is the basis of the “opium epidemic” which currently represents a health emergency in the US. The abuse-deterrent formulations, explained Vladovicova, contain physical barriers that prevent breaking the tablets to extract the active ingredient. Another approach involves the use of opioid antagonists that are activated in case of wrong use of the medicine by inhibiting the action on the central nervous system, or substances that are unwelcome to the user who tries to alter the dosage form.

Serialization: impact of FMD on CMOs

Caterina Lucchini
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Serialization: impact of FMD on CMOs

The legislation and the European organization model require CMOs (Contract Manufacturing Organizations) great versatility in the implementation of FMD (Falsidied Medicine Directive).

In summary:
1. The responsibility of the connection to the European Hub is always of the AIC Holder;
2. For companies without a head-quarter in Europe, the connection contract to the European Hub must be signed by the national AIC Holder, who is responsible for it;
3. The connection contract to the European Hub must be signed by the European head-quarter, for the national AIC holders with a European OBP;
4. In the case of multiple social reasons existing in Europe for a given company, it will be only and exclusively the European head-quarter to connect;
5. In the case of AIC holders with multiple CMOs, the latter will not have direct access to the Hub European: they will have to send the data to the AIC Holder who in turn will upload it to the system of European archives.
The CMO can send serialization data, subject to agreement with its client / Owner of the AIC to the European hub through a gateway provider, which in turn will take charge of the upload to the EU Hub. In any case, the direct flow of serialization data from the CMO to the European Hub is never allowed.

Connection option for CMOs

The legal responsibility is exclusively of the owner of AIC. The data can be sent to the European Hub in two different ways:
1. The CMO sends the data to the OBP which in turn posts it on the European Hub
2. The CMO uses an intermediate gateway to send data to the European Hub. The gateway provider must be certified and authenticated by EMVO.
Any gateway provider can be sponsored, registered and certified after an assessement
positive by EMVO.

Some dettails on the gateway provider

■ The Gateway Provider is a third party paid and contracted by an OBP.
■ The Gateway Provider supports, partly or totally, the development, implementation, provision, use and / or operation of the OBP interface to the EU Hub.
■ It is important that EMVO is informed as soon as possible about the type of provider chosen by the OBP.
■ Through the Gateway, the OBP data will be sent to the European Hub.
■ The Gateway Provider must be certified and authenticated by the customer.

EMA highlights of 2018

Caterina Lucchini
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EMA highlights of 2018

2018 was very fruitful for the European Medicines Agency (EMA), which issued 84 positive opinions for human medicines, compared to only five negative ones. The new active substances passed through the caudine forks of the regulatory assessment were 42; ten applications for authorization withdrawn. Orphan drugs have been the masters even in the last year, with 21 approvals, in addition to 3 new advanced therapy products, four approvals with accelerated assessment process (150 days instead of 210) as they still respond to needs disregarded, three products approved with procedure for exceptional circumstances and one with conditional MA.

All the information are collected in the EMA overview on the authorisation and safety monitoring of medicines for human use.

The new products approved in 2018

Most of the new products are anti-cancer medicines (23 products), followed by products to fight infections (11) and neurological ones (10). Among the latter we report a product for pediatric use for the treatment of infantile spasms (West syndrome) and partial resistant epilepsy (Kigabeq, vigabatrin). Other products approved for younger patients approved in 2018 are Amglidia (glibenclamide), for the treatment of diabetes mellitus of the newborn, infants and children, and Slenyto (melatonin), aimed at children and adolescents suffering from insomnia and they are suffering from diseases of the autism spectrum.
The anti-cancer medicine Rubraca (rucaparib camsylate) has been approved with conditional authorization, with the obligation to conduct a new clinical safety and efficacy study with respect to chemotherapy to better evaluate its potential in the treatment of relapsing ovarian tumors.
All three products approved for exceptional circumstances are intended for endocrinology and are indicated, respectively, for enzyme replacement therapy of mild and moderate alpha-mannosidosis (Lamzede, velmanase alfa), for the treatment of non-neurologic manifestations of mucopolysaccharidosis VII ( Mepsevii, vestronidase alfa) and for lipodystrophy (Myalepta, metreleptina). For these products, Ema has established post-authorization obligations, which may include the creation of patient registries for long-term safety and efficacy assessment and / or the conduct of new clinical trials that deepen some aspects of treatment. An integrated immunogenicity report was also requested for Myalepta.
Another product approved as an orphan drug and recalled by Ema in its annual summary is Namuscia (mexiletine hydrochloride), dedicated to adult patients with non-dystrophic miotic disorders; it is the first product of this type approved in Europe.
Among the ATMP therapies stand out the approval of Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), the two CAR-T therapies for the treatment of some blood cancers, and Luxturna (voretigene neparvovec-rzyl), which aims to correct the defects of RPE65 gene responsible for hereditary retinal dystrophy, a severe and rare ocular disease that can lead to blindness.
The accelerated approvals concerned the first-in-class Hemlibra product (emicizumab-kxwh), which prevents bleeding episodes in patients with haemophilia A and coagulation factor VIII inhibitors; Takhzyro (lanadelumab-flyo), based on monoclonal antibodies for the prevention of recurrences of hereditary angioedema, and two neurological products for the treatment of hereditary amyloidosis mediated by transthyretin (Onpattro, patisaran and Tegsedi, inotersen).

Lastly, the 65 new indication extensions recommended by Ema for products on the market, among which the approval of Kineret (anakinra) for the treatment of Still’s disease (a variant of rheumatoid arthritis) in adult patients and children.
The five negative opinions follow the impossibility for the CHMP committee to reach an agreement on the benefit-risk balance of the products, and have concerned EnCyzix (enclomifene, against male hypogonadism), Dexxience (betrixaban, for the prevention of venous thromboembolism ), Eladynos (abaloparatide, against osteoporosis), Alsitek (masitinib, against amyotrophic lateral sclerosis) and Exondys (eteplirsen, for Duchenne muscular dystrophy).

Finally, within the “Medicines for All” program, Ema also approved Fexinidazole Winthrop (fexinidazole) for the oral treatment of African populations suffering from sleep sickness, a tropical infectious disease with a potential risk of life caused by Trypanosoma brucei gambiense .

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