PLUMESTARS ATTENDED THE 59TH AFI SYMPOSIUM

Also for this year, Plumestars participated at the 59th AFI Symposium, the Italian Conference of the Industrial Pharmacists, held on 5, 6 and 7 June at the new Pala Congressi in Rimini.

The AFI Symposium is the important conference that for almost 60 years involves the interlocutors of the pharmaceutical sector at an international level, and this is why it is confirmed year by year an important moment of encounter and exchange between the protagonists of scientific research and the Companies. As for the update exam of great importance and considerable authority.

It consists of several scientific sessions, culminates with the Lectio magistralis and the Plenary Session and also includes spaces dedicated to:

  • The startup square, for young companies in the pharma-biotechnology world and medical and diagnostic devices, divided into short conferences focused on technology transfer in the presence of leading experts in the sector, with the aim of creating a network with companies in the world pharmaceutical;
  • Workshops with companies in the sector;
  • 10 technological innovations, where the latest proposals of the companies selected by the AFI Board that exhibit at the Symposium are presented;

PlumeStars presented, in a speech of Prof. Paolo Colombo (PlumeStars CEO), “Hyalcis: Hyaluronic-Cisplatin Film for Implant for Malignant Mesothelioma Recurrences”.

Hyalcis exploits nanotechnology and advanced material research results to bring to market an innovative medical treatment of mesothelioma. The studies until now conducted revealed an interaction between the polymer hyaluronic acid and cisplatin that gave rise to a drug-polymer complex, lymphatically absorbed and blood distributed.

The uptake by pharmaceutical industry of the hyaluronic- cisplatin film technology studied by PlumeStars will assign a more effective cure against recurrences of this rare and very aggressive form of cancer that is difficult to diagnose and highly resistant to anticancer drugs.

The film requires an advanced manufacturing process in order to guarantee its quality, in particular sterility.

Hyalcis combines a known active principle, cisplatin, with a polymeric material, hyaluronic acid, providing an innovative solution to post-surgery prevention of mesothelioma recurrences. The novel product has a demonstrable added value compared to the presently applied chemotherapy (IV or pleura surface washing) and radiotherapy treatments, since it allows a strict dose control and implantation easiness.

Hyalcis transfers the PlumeStars research results to the cancer therapy. PlumeStars technology could be transferred to treat other forms of cancer, thus multiplying the beneficial impact for society (e.g. ovarian cancer) and market.

The innovation provides clear societal benefits by more efficiently addressing a relevant illness form which full recovery is extremely rare.

PlumeStars gets the SME-Instruments Phase 1 grant within Horizon 2020 program

PlumeStars srl, the start up at University of Parma, received a new financial funding within the Horizon 2020 program. In the last round of the EIC SME-Instrument Phase 1 – cut off of 13 February 2019 – 277 small and medium-sized enterprises from 25 EU countries have been selected for funding. PlumeStars is one of them.

PlumeStars got a contribution of 50,000 euros for preparing the Business Plan of its Orphan Medicine Hyalcis. The productis a Polymeric biodegradable film, loaded with cisplatin drug, the active substance for cancer treatment. The film, developed and tested in collaboration with the Department of Medicine & Surgery (Prof Paolo Carbognani) and Department Food & Drug (Prof. Fabio Sonvico) of the University of Parma, is proposed to be implanted in the thoracic surface after the removal of primary tumor in the pleural mesothelioma cancer. The product, already tested in animals, obtained the Orphan medicine designation and is on way for studies in human trials, with the goal of market authorization application.

Most of the selected SME-Instrument candidates are active in the ICT, health and engineering sectors: the beneficiary companies come from Spain (46), Switzerland (23) and France (22). 21 Italian companies are beneficiaries, including PlumeStars srl.

The SME- Instrument program is part of the European Innovation Council (EIC) pilot project, which supports high-level innovators, entrepreneurs, small businesses and scientists with funding opportunities and acceleration services.

Workshop PlumeStars-PTM: “The importance of statistics in QbD” – Parma, 23-24 maggio 2019

PlumeStars, in collaboration with PTM Consulting, organizes on 23-24 May 2019 a workshop sponsored by the Department of Food and Drug Sciences of the University of Parma entitled:

“THE IMPORTANCE OF STATISTICS IN DESIGN QUALITY –

How to use statistical tools in a risk-based approach to optimize formulation and development in QbD “

This workshop is organized by a research scientist in the field of R&D with the aim of providing theoretical information on the importance of using statistics to optimize processes.

The first day will be dedicated to the introduction of the principles of Quality by Design and Quality Risk Management which have become an integral part of the drug development process with ICH from Q8 to Q12.

The second day will be dedicated to statistics and the main theme, one of tradition and one of innovation: the factorial DoE and the Analytical Quality by Design.

Factorial Factor: it’s the most effective tool in the pharmaceutical field and throughout the drug development process, thanks to its versatility and the possibility of applying it to different contexts and scenarios

Analytical quality by definition: how to use the method for the development and validation of an analytical method (with reference to ICH Q14 – Guideline for the development of the analytical procedure and ICH Q2 (R1) – Analytical validation).

Through the presentation of practical cases, thanks to the work experience, we deepen the use of statistical tools, in particular the factorial DoE, in different implementation scenarios, on different types of pharmaceutical processes and forms.

In particular we will explore in a synergistic way to obtain the best result in terms of quality, costs and results.

Download the program

PlumeStars -PTM- _2019_Download poster

For more information and to register contacts:

Laura Monica – Administrative and scientific secretariat – info@plumestars.com

To Dr Eride Quarta the “Best Poster Award” at the European Federation for Pharmaceutical Sciences Annual meeting

Eride Quarta, PhD student in Drugs, Biomolecules and Health Products of the University of Parma, coordinator Prof. Marco Mor, received the “Best Poster Award” Award, at the EUFEPS Annual Meeting 2019, held in Frankfurt, Germany, 6-8 March 2019.

The award was given for the presentation of the research “Pulmonary administration of a novel insulin powder in comparison to Afrezza”, carried out in collaboration with Prof. Francesca Buttini and Prof. Paolo Colombo and Prof. Elisabetta Barocelli, of the Department of Pharmaceutical and Food Sciences of the University of Parma.

Read more “To Dr Eride Quarta the “Best Poster Award” at the European Federation for Pharmaceutical Sciences Annual meeting”

The business of the future: rare diseases

Among the number of diseases affecting people, there are some that affect few individuals. Consequently, there is no interest from pharmaceutical companies to study and develop drugs and medicines, since it prevails the equation: few patients, few earnings.

But this was a temporally referable reality at the beginning of the millennium: rare diseases were called “orphans” because they were orphans of research, treatment and investment. But now everything has changed and we are witnessing, for some years now, a real revolution.

As reported in the Italian newspaper La Repubblica of February 26, 2019 “the supports of EU and USA for these forgotten diseases have turned the problem into an opportunity. The rare disease market, with therapies that cost an average of $ 140,000 a year per patient, have become the new goldmine of the drug giants “.

In this regard, always La Repubblica, reports the brilliant experience of the Swiss firm Roche that has bought for 4.8 billion Spark Therapeutics: The American company “has only 250 employees and 68 million of revenues in 2018 (more or less like a SME). However, it has one of the most promising products in the world of orphan drugs: Luxturna, a product able to avoid blindness in some serious eye conditions. The patients affected by this disease are not many, but the cost of therapy – about $ 450 thousand – added to the public subsidies, have made possible to discover, develop and get approved a medicine at cost of about 700 million. Thus, the small Spark turned into a jewel of multibillion dollar value”.

The rare diseases become a new business for pharmaceutical giants.

Read the article of La Repubblica 26-02-2019

 

 

 

 

 

PLUMESTARS ATTENDED AT “OPEN AND SCIENCE INNOVATION” CONFERENCE

PlumeStars participated at the conference “Open & Science Innovation” held on 25th February at Milan.

The conference, promoted by Airi – Italian Association for Industrial Research aims to highlight some cooperation practices between industrial and public research, characterized by quality and novelty, as well as possibilities for technological transfer methodologies and tools.

Read more “PLUMESTARS ATTENDED AT “OPEN AND SCIENCE INNOVATION” CONFERENCE”

Prof. Ruggero Bettini was elected member of Aimbe – American Institute for Medical and Biological Engineering

PlumeStars is pleased to inform you that Professor Ruggero Bettini, member of the company, has been elected to the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows.

AIMBE is a non-profit, honorific society of the most accomplished individuals in the fileds of medical and biological engineering. AIMBE’s missions is to advocate for biomedical engineering innovation through public policy initiatives.

No other organization brings together academia, industry, government, and scientific societies into a highly influential community in medical and biological engineering.

Being part of the AIMBE College of Fellows enables intimate networking and public policy engagement among trailblazers at the pinnacle of their careers.

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