Advice Pharma Staff

AIFA: a research-driven Coronavirus Task Force

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A strategy for the fight against Coronavirus in which the promotion of clinical trials, with the parallel collection of data necessary for the purpose, is one of the building blocks that make up the action plan of the Agenzia Italiana del Farmaco (AIFA – Italian Medicines Agency) .

As highlighted by AIFA itself in a press release published on its website, a crisis unit has been set up on four fronts: drugs in off-label use; research and development/access to experimental drugs; national management guidelines; and the fight against shortages of medicines at hospital level.

The Ministry of Health also recognised the need for this plan last week. “The vaccine will be the ultimate weapon – said the Minister, Roberto Speranza -. In this world match Italy is with all our scientific community, in a relationship of full collaboration with pharmaceutical companies”. But Speranza also stressed that the measures to manage the COVID-19 emergency are moving to date on the four levels identified by the Agency.

Promotion of clinical trials and off-label use. The evolution of trials

It is mainly on the research front that the most obvious needs have emerged. AIFA has in fact underlined its role in “evaluating all clinical trials on medicines for patients with COVID-19”. In this regard, with the help of the Scientific Technical Commission (CTS), it has activated a “simplified procedure that aims to promote, regulate and supervise access to therapies potentially useful to combat this pandemic”.

In this simplified management of clinical trials, the Agency has prepared an updated list of ongoing trials, but also a list of drugs used outside clinical trials. The National Health Service (by way of derogation from Law 648/96) has therefore included the off-label use of medicines registered and approved for the use of different pathologies. Among these are chloroquine, hydroxychloroquine (two antimalarial drugs with preliminary data on potential antiviral activity); as well as lopinavir/ritonavir and, subordinately to the latter, darunavir in combination with cobicistat or ritonavir (drugs used to treat HIV infection). To these are added the antiviral Remdesvir and the monoclonal antibody Tocilizumab. “Other experimental protocols, both independent and proposed by pharmaceutical companies, are being evaluated, with further therapeutic alternatives that could represent new options”, reads the AIFA website.

The “management” factor and the creation of a Task Force

The other two lines of the AIFA strategy concern the management of the phases necessary to ensure the start of the research. Already at the beginning of last month, the Agency stated that it has started a series of actions to “combat shortages of medicines”, facilitating the import of critical products through contact with marketing authorisation holders (MAHs) and importers to ensure the regularity of supplies of medicines used at hospital level during the emergency. But all this takes place under the lens of the control booth which sees the participation, alongside AIFA, of the Civil Protection and the National Institute for Infectious Diseases Lazzaro Spallanzani (INMI), national reference centre for research and treatment of infectious diseases and WHO Collaborating Centre for highly contagious diseases. This task force has the task not only to develop national management guidelines for COVID-19 cases, but also to follow the progress of clinical trials and to provide all available information on ongoing trials.

Milano for Covid, superare la pandemia con un approccio multidisciplinare

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a project multidisciplinare, intellettualmente laico e collaborativo. È quanto portato avanti da “Milano for Covid – Uniti per informare”, l’iniziativa promossa dal dottor Eric Manasse e che coinvolge un team composto da 40 esperti in differenti ambiti: sanità, economia e ricerca, industria e ambiente, area legale e sicurezza informatica; nato con l’obiettivo di generare analisi, creare report e informare cittadini e istituzioni.

La squadra di Milano for Covid intende offrire un approccio polisettoriale al superamento dell’emergenza innescata dalla pandemia Covid-19. Tra gli obiettivi, in particolare, il contributo della comunità scientifica per l’avvio e la costruzione di nuovi modelli e dinamiche comunicative volte a veicolare contenuti certi, ideologicamente “laici” e tempestivi. E perché ciò avvenga è necessaria una visione “omnicomprensiva e multidimensionale in grado di elaborare analisi, informazioni e proposte chiare, a beneficio di chi decide e dell’intera collettività”.

«Milano for Covid è la dimostrazione che la muldisciplinarietà è la base della crescita collettiva», sostiene Alessandro Ferri, Managing Director di AdvicePharma tra gli esperti coinvolti nell’ambito Economia e Ricerca. «Il contributo fornito da ciascun professionista, sotto la guida del dottor Manasse, è una spinta a superare l’individualità delle proprie competenze e dei propri ambiti di attività, per raggiungere un obiettivo comune, quello di una società non soltanto “sana” ma anche “consapevole” e “informata”».

Come riportato sul sito, il gruppo di lavoro “Uniti per informare” abbraccia nove macro discipline e altrettante nazionalità fra i propri membri, e intende avanzare proposte concrete applicabili in diverse aree: la definizione di un nuovo piano di emergenza pandemico, fondato su un sistema decisorio centralizzato e in grado di abbracciare tanto gli ambiti medici e sanitari, quanto quelli legali e comunicativi; la creazione di una nuova relazione fra pubblico e privato, in cui l’Unione Europea si configuri come soggetto autorevole in grado di agire nell’interesse di tutti gli Stati membri, armonizzandone le differenze e valorizzandone le peculiarità; lo sviluppo di nuovi modelli di business che guardino alla società nel suo insieme, alle sue componenti più deboli e alle generazioni future; una spinta definitiva verso la digitalizzazione, estesa all’intera società attraverso una formazione capillare e infrastrutture all’altezza dei nuovi flussi di dati. Il tutto dando nuova centralità al settore medico che, anche nell’emergenza Covid-19, si è dimostrato vera guida socio-scientifica nei Paesi colpiti. E questo anche attraverso la creazione di cluster che lo rendano sempre più autonomo e indipendente.

Digital for Clinical Day 2019

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Accelerate Clinical Development with Digital Strategies

November 7, 2019 – 9AM/6PM

Sala Carassa Dadda – Politecnico di Milano, Milan (Italy)

The success of digital transformation in medical research and patient care requires a solid understanding of the two basic interacting components, namely “patient care” and “digital”, at all levels. This event is intended to be a moment of confrontation on the digital transformation in the field of patient care research and management.

The technologies and the digital environment offer many opportunities to identify the health needs of the population and meet them by providing better health care, from prevention and enhancement of behaviors in favor of health, to the study of therapeutic interventions, from clinical research to the administration of care, management of chronicity. As such, digital technologies have the potential to transform health services and care research so as to contribute to the objectives of the health system.

The results and outcomes of the digital transformation in this area will depend significantly on the quality of the process of integrating IT innovation. It will benefit the end users of digital health services, such as professionals, health users or citizens, as well as developers and distributors of digital health services, and governments through their regulatory bodies.

The whole process of development, production, financing, implementation and evaluation requires careful evaluation in this context; the event wants to address these issues with a panel of experts in the field.

Modulo di iscrizione

Nordic ePharma Day

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Advice Pharma is among the sponsors of Nordic ePharma Day – Copenhagen, May 31 2017.

The LS Academy event for the Nordic countries. Dedicated to European clinical research legislation and its impact, with the title of this year’s ePharmaDay event being Implementation of Clinical Trial Regulation EU 536/2014 and National adoption. What lies ahead: Impact on Clinical Trials and Stakeholders.

ePharma Day 2017

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Advice Pharma with ICE Online at Italian ePharma Day 2017, May 18, 2017, Milan.

ePharma Day 2017 is dedicated to the upcoming entry into force of the new European Regulation 536/2014 on clinical trials of medicines, scheduled for October 2018, which is focusing the attention of all professionals involved in the clinical research process.

The new regulation makes substantial and important changes in the way clinical trials are conducted and in the relations between Sponsors, Ethics Committees, Regulatory Agencies and Researchers.

Thinkheart with GISE

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Advice Pharma at Thinkheart with GISE, April 20-21 2017, Florence.

With the appointment in Florence, GISE, for years engaged in collecting data on the activities of hemodynamic centers in Italy, calls to collect representatives of health professionals, policy makers, administrators and patients for the definition of a model of interventional cardiology in our country that can be in constant positive evolution and truly sustainable.