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IRIS guide to the platform for parallel distribution industry users

Caterina Lucchini
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IRIS guide to the platform for parallel distribution industry users

The new IT platform launched by the European Medicines Agency is based on the Iris Regulatory & Scientific Information Management Platform, to directly and safely manage notifications of medicinal products intended for parallel distribution.

The new notification methods

The use of the new platform has become mandatory starting from February 11th; a single point becomes available for the management of all information and documentation relating to the parallel distribution of medicines. The Iris platform allows the control from multiple devices of the status of the notifications, and sends automatic updates to the distributors as soon as there are news about their practices.

Tools on EMA’s Webside

EMA share a manual explaining the use of the Iris platform for notification procedures  together with the guide for registration to the system.
The platform, initially created in June 2018 for the management of procedures related to orphan drugs, will be gradually extended to a greater number of regulatory procedures.

The manual touches this point:

  1. How to create an initial notification for parallel distribution
  2. How to create a safety update
  3. How to create an Update Parallel Distribution Notice Status
  4. How to add contributors to a draft PD notification
  5. How to delete a draft application
  6. How to display and sort submissions
  7. How to search for submissions
  8. How to respond to a notification email from EMA requesting VSI

Ema also announced that the filing of annual updates of the parallel distribution is suspended from 1 February to 30 April 2019, to allow an easier transfer of the Agency to the new Amsterdam office.

Food supplements chain discussion at Pharmintech on April 11th

Caterina Lucchini
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Food supplements chain discussion at Pharmintech on April 11th

How to guarantee a quality supply chain for food supplements? The event organized by Tecniche Nuove in partnership with Pharmintech, will be held on April 11th during the two days dedicated to the pharmaceutical, nutraceutical, cosmeceutical and biotechnology industries.

Market data on food supplements

The market for food supplements is constantly growing and, in Europe, Italy has a leadership position, with Euromonitor projections that will see it hold, in 2021, 20.6% of the entire European turnover of the sector.

In 2018, according to FederSalus data, Italy was once again the main market in Europe in terms of size and growth (23%) – with 3.3 billion euro and a positive trend of + 5% – followed by Germany (13% ), France (9%) and UK (8%).
The sector is growing in all geographical areas, in line with the change in people’s approach to their health, and the publications of the international scientific community on food supplements are multiplying.

The consumption of supplements therefore increases and with it the need for manufacturers to innovate the offer: just think that 91% of the value growth of the integrators (136 million euros) is linked to new launches and that the investments in new machines and plants, research and development, training, new technologies represent 11% of turnover (Federsalus data).
All this requires particular attention both to raw materials and to the development of production processes at the forefront of both regulatory and communication aspects.

How to register

SUBSCRIBE TO THE EVENT: FOOD SUPPLEMENTS, QUALITY CHAIN

Below is the detailed program of the event

10.00-10.15 – Integrator market trends – Paolo Bertozzi (TradeLab)
10.15-10.30 – Rules of communication of food supplements – Paola Minghetti (University of Milan – AFI)
10.30-10.45 – Safety and quality of the integrators – Gabriele Costantino (University of Parma)
10.45 am – 11.00 am – Guidelines for the development, production and communication of food supplements – by Massimiliano Carnassale (Federsalus)
11-00-11.15 – Experience from audits and inspections – Fernanda Ferrazzin (former GMP inspector Aifa / Ema – Ispe Italy)
11.15-11.30 – Novel food in the European Union – Vittorio Silano (Efsa)
11.30-11.45 – Use of multivitamin and multimineral supplements. An international study – Hellas Cena (University of Pavia and ICS Maugeri IRCCS)
11.45-12.15 – Debate

Challenges and opportunities of pharmaceutical production staged on April 10 at Pharmintech

Caterina Lucchini
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Challenges and opportunities of pharmaceutical production staged on April 10 at Pharmintech

The event organized by the partnership between Tecniche Nuove and Pharmintech on pharmaceutical production will take place on Wednesday 10 April in Bologna.

It will be the place where to discuss the new challenges and opportunities in this area with a major current focus on the SPC manufacturing waiver.

SPC manufacturing waiver

It has been discussed for long time. This is the SPC manufacturing waiver, for quicker access to medicines for patients. The event will be an opportunity to take stock of the steps that Europe has taken in recent months and to discuss, in real time about the direction to take and of future steps.

The last update available concerns the current compromise which the Trilogue would seem to have arrived at the end of February. The decisions, however, are still in progress, and the compromise amendments on which the Trilogue was agreed should be able to be adopted by the end of the current term of the European Parliament.

Event details on “Pharmaceutical production: new challenges and opportunities”

To register for the event you must follow these instructions.

The detailed program is as follows:

15.00-15.30 – The market of active pharmaceutical ingredients: lights and shadows – Paolo Russolo (Aschimfarma)
15.30-16.00 – The production challenges. What innovations companies must implement to remain competitive – Alessandro Fava and Gianni Gottardo (FIS Fabbrica Italiana Sintetici)
16.00-16.30 – Traceability of pharmaceutical raw materials – Piero Iamartino (AFI)
4.30pm – 5.00pm – EU single market strategy: the SPC revolution in the EU in the world productive and competitive scenario – Sergio Napolitano (Medicines for Europe) or EU Commission representative (awaiting confirmation)
17-00-17.30 – Round table “SPC manufacturing waiver: opportunities and challenges“, with the participation of Afi, Aschimfarma, Assogenerici, EU Commission (pending confirmation), Ispe, Medicines for Europe

 

Synergy between anticancer drugs: how algorithm can help

Caterina Lucchini
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Synergy between anticancer drugs: how algorithm can help

How to optimize combination therapy for non-small cell lung cancer (Nsclc) and melanoma?

Researchers at Vanderbilt University have created the MuSyC algorithm (Multi-dimensional synergy of combinations) able to distinguish between the interactions between drugs that can give greater efficiency and speed in killing cancer cells from those that instead lead to fewer effects side. The work was published on Cell Systems; the algorithm was developed based on half a million tests on cancer cells with 12 thousand different drug combinations. The primary objective of the study was to calculate the synergy profile of 64 different anticancer drugs in combination with osimertinib, a standard of care for lung cancer Nsclc.

Potency and efficacy

MuSyC reveals that combining a mutant-EGFR inhibitor with inhibitors of other kinases may result only in synergistic potency, whereas synergistic efficacy can be achieved by co-targeting mutant-EGFR and epigenetic regulation or microtubule polymerization. In mutant-BRAF melanoma, MuSyC determines whether a molecular correlate of BRAFi insensitivity alters a BRAF inhibitor’s potency, efficacy, or both. These findings showcase MuSyC’s potential to transform the enterprise of drug-combination screens by precisely guiding translation of combinations toward dose reduction, improved efficacy, or both.

Action targets identification

The drugs tested by Vanderbilti University researchers were divided into four different categories, based on the action target:

  • mitotic checkpoints
  • epigenetic regulators
  • receptors and / or channels
  • kinases

The hope of the American research group is that now the MuSyC algorithm can help change the ways to discover and translate the most effective drug combinations into true clinical innovation. The next steps of the research see its expansion to the combination of three different medicines and the evaluation in more complex pre-clinical models, such as organoids that replicate different types of tumors.

 

Plan the 5G while already reasoning about the 6G

Caterina Lucchini
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Plan the 5G while already reasoning about the 6G

Cyberwar is the new cold war, with China and the US as the main actors of the ongoing geopolitical and economic clash, fought with weapons called artificial intelligence, Internet of things, blockchain, wearable device, smart city … all governed by a single central nervous system: the 5G network.

Towards 6G

But while the eyes of the world are focused on the commercial development of 5G (with USA in direct contrast to China-Russia axis), looking at today does not pay and in the war on technological leadership there are those who go beyond and aim for 6G. With China always on the top: Su Xin, head of a dedicated group from the Ministry of Industry and IT, fixes in 2030 the planned year for the launch of the technology that promises connections of 1Tbps per second. And always from the East comes the news that LG has inaugurated in Daejeon, 140 km south of Seoul, one of the first laboratories in the world dedicated to the development of 6G. A project that the South Korean giant will conduct in collaboration with the Korea Advanced Institute of Science & Technology.

Also in Europe something is moving, with the 6Genesis program of the University of Oulu in Finland: 250 million euros in eight years allocated by the university and other external partners to develop and provide the necessary skills for the society of the future.
What the real benefits of 6G will be is not entirely clear, but beyond the technological improvements in terms of speed and security of data exchange and coverage, those who will win the TeraHertz frequency control will enjoy an unprecedented competitive advantage.

Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations

Caterina Lucchini
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Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations

The European Medicines Agency (EMA) has recently pubblished the first guideline dedicated to in vitro medical devices, which begins to better outline the processes, roles and responsibilities that Ema and the competent authorities at national level will be called to assume in the light of the next, definitive entry into force of the new European regulation on medical devices (reg. EU 2017/745) and of that on in vitro diagnostics (reg. EU 2017/746) (in May 2020 and 2022, respectively).

“The big challenge we face is to ensure that we have the appropriate experience and resources to perform these new tasks adequately,” commented Ema’s general manager, Guido Rasi.

Focus on article 117

The first guideline, in the form of Questions and answers (Q&A), is particularly focused on article 117 on the new Regulation that introduces a new requirement for notified body involvement in a medicinal product with an integral medical device.

The guideline is organised as follow:

1. What is Article 117 and what does it mean for medicinal products?
2. How will the medical devices Regulation and in particular Article 117 impact new
marketing authorisation applications?
3. When is it required to provide the notified body opinion/ EU certificate / declaration of
conformity with my Marketing Authorisation Application (MAA)?
4. When the company has to submit the notified body opinion?
5. How does Article 117 of the medical devices regulation impact currently authorised
medicinal products with an integral medical device?
6. When the company has to provide a (new or updated) EU certificate / declaration of conformity /notified body opinion if there are changes to the device submitted through a variation /extension?

The Q&A is a living document that will be updated continuously, and will be marked by “NEW” or “Rev.” with the relevant date upon publication.

Italian pharma transfer of value: GIMBE Report

Caterina Lucchini
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Italian pharma transfer of value: GIMBE Report

Since last year, with the acknowledgment by Farmindustria of the indications of the deontological code of the European Federation of the pharmaceutical industry (Efpia), the associated pharmaceutical companies are called by 30 June to report and publish – using the appropriate form – the transfers of value made in the previous year for donations, training events, services and consultancy, as well as those for research and development.

GIMBE main Report data

In 2017 the average value of transfers per company was € 20.58 million (within a range of € 8.1-41.9 million), with an average impact on sales of 2.9% (0.8-4.3%). The Gimbe Foundation has also prospectively estimated the possible value of the total transfer of all companies associated with Farmindustria, equal to about € 550-580 million.
About a third of the transfers to healthcare professionals were published in aggregate form (€ 15.1 million), following the failure to consent to publication by interested parties. Of these, about half (€ 8 million) were allocated to events and the same number (€ 7.9 million) to services and consultancy.
There were just under fifteen hundred healthcare organizations that received transfers from the fourteen companies considered in the report, for an average amount of € 8.9 million (range € 2.0-24.2 million). More than half of the funds went to service companies (56.6%, € 70.6 million), followed by scientific societies (14%, € 17.5 million), by universities (6-8%, € 9 , 9 million), from hospitalization facilities (€ 8.7 million) and research organizations (€ 7, 4 million).
Forty-eight organizations each received more than half a million euros (3.2% of the total, 39.7% of the transfers), twenty-one those that received more than 1 million euros (1.4% of the total, 25 % of transfers).
As regards transfers dedicated to research and development (on average € 8.4 million per company, in the range 1.2-20.3 million), the Efpia code does not require companies to further detail the types of recipients (operators and / or organizations) and the specific intended use (fees, travel and accommodation and other expenses).

 

Digital transformation and robots

Caterina Lucchini
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Digital transformation and robots

One of the main obstacles to digital transformation is fear: the development of knowledge and awareness on robots allows us to define appropriate regulations and make innovation efficient and safe.

Reproducible intelligence

Probably, part of the suspicion surrounding the issue has to do with the term intelligence. However human intelligence is biochemical and, as such, not reproducible. That of machines does not work on the basis of complex chemical reactions, but is algorithmic and reproducible. Moreover the robot does not have its own ethics: it is the programmer (a human being) who attributes it to him. As Cingolani points out, it has a passive ethic.

iCUB

Those who fear robots have never seen the tender iCub, the spearhead of IIT. It has the size, shape and even the name of a child. iCub is a robot powered by as many as 53 engines and equipped with balance sensors so sophisticated that it guarantees an extraordinary balance. His hands have been designed to perform complex and precise handling tasks, such as those required in industrial production.

R1 and its medical application

R1 is less complex and higher (less child and therefore perhaps a little less likeable). The creature of Giorgio Metta, IIT’s deputy scientific director, is already working in the clinics. Thanks to his surprising ability to interact with human beings (he was presented as your personal humanoid) he is an assistive-rehabilitative robot. R1 is the result of the collaboration between the Genoa Italian Institute of Technology and IBM, which dealt with the implementation of artificial intelligence and cognitive computing. It draws on the cloud, where it can fish in a vast amount of useful data to perform the operations for which it is programmed. In the clinical reality of the Don Gnocchi Foundation it is used for robotic rehabilitation. But it can also be used for the rehabilitation of children with autism.

The insertion of humanoids in rehabilitation departments, in the industry and in our homes is already in place and destined to become increasingly widespread. Robots are destined for a rapid technology transfer, because there is a powerful driving force able to drag them towards the market: the need.

 

Falsified medicines: new rules to enhance patients’ safety

Caterina Lucchini
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Falsified medicines: new rules to enhance patients’ safety

Commission Delegated Regulation (EU) 2016/161 details the characteristics of the safety features, how medicine authenticity should be verified and by whom. There are currently no plans to exempt additional prescription medicines or product categories from the requirements to bear safety features (“whitelisting”).

From now on, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies – including on-line pharmacies – and hospitals will have to check the authenticity of medicines before dispensing to patients. This is the final step in the implementation of the Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU.

The Italian and Greek markets are for the time being exempt from the introduction of the new measures, as they have already adopted similar control systems.

Is it possible to read dows a Q&A dedicated to manufacturers here.

“On 9 February 2019, we will reach yet another milestone for patients’ safety across the EU. Almost 7 years after its adoption, the implementation of the Falsified Medicines Directive will be complete thanks to the introduction of end-to-end verification and safety features on prescription medicines. In other words, every pharmacy or hospital in the EU will be required to have a system that will make the detection of falsified medicines easier and more efficient.  While some more work will need to be done after the launch of the system to make sure that the new system functions properly across the EU, I am positive that we are providing another safety net for citizens to protect them from the dangers of unauthorised, ineffective or dangerous medicines”, said Commissioner for Health and Food Safety Vytenis Andriukaitis. “Since the beginning of my mandate, I have been encouraging national ministers to monitor the implementation of this new system and help all stakeholders prepare for the new rules that prevent falsified medicines ending up in the hands of patients. In the coming weeks and months, the new system will be monitored to make sure that it functions properly. Still, I am eagerly anticipating tomorrow’s launch given that, on the eve of the European elections, it is yet another example of the added value of EU cooperation” he added.

Big data for pharmacovigilance studies

Caterina Lucchini
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Big data for pharmacovigilance studies

Currently, most of the global work for signal research in the post marketing phase is based on data from the Individual case safety reports (Icsr). However, the tendency is to use big data for pharmacovigilance studies more and more massively.

Post marketing drug safety analysis are used now a huge numbers of data related to reporting of adverse reactions from disparate sources. What are the potentials and the critical points?

Health Database network

The growing use of health database networks led to development of new analytical methodologies through the elaboration of large volumes of heterogeneous data, as done by the Observational health data sciences and informatics (Ohdsi), which developed
methods and tools for building network infrastructures database. Similarly, the Protect initiative showed how it is possible to conduct analysis on multiple databases, through
the adoption of common protocols rather than through analysis centralized data. Moreover, EMA has coordinated a network of centers of Pharmacoepidemiology and pharmacovigilance (Encepp) consisting of about 200 public institutions and Contract research organization (Cro) involved in activities related to pharmacoepidemiology and pharmacovigilance. In the context of database networks used for pharmacovigilance, two are the initiatives of reference implemented internationally:

  • Sentinel (FDA)
  • EU-Adr (EU)

Other international networks have been established in recent years, with the aim of increasing the power of the post marketing studies on drugs and vaccines, including Aritmo, Safeguard, Advance, Sos, Euromedicat in Europe, Cnodes in Canada and Asian pharmacoepidemiology network (Aspen) in Asia and Australia.

Social media

Social media are heterogeneous data source. The use of these data for pharmacovigilance is full of challenges, not least the fact that the main purpose of most publications is different from reporting a suspected link between one specific health intervention and an adverse event. Clearly, when clinical or patient concerns come expressed on social media about the perceived damage associated to a health intervention, these should be treated
as such. Furthermore, the way in which patients and health professionals consider the effectiveness of treatments or define needs dissatisfied is important for those who develop drugs. However the potential adverse event posted on Social Media often do not meet the basic regulatory definitions of an Individual case safety report (ICSR). In fact, an Icsr is considered valid if it contains at least:
a. an identifiable patient;
b. an identifiable marker;
c. a suspicious drug;
d. an event / negative result.

 

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