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