Experts from Kapaji and the Jagiellonian Center of Innovation would like to invite you to take part in unique workshops that will cover the comprehensive development of generic drugs, from the selection of molecules to clinical trials, both from an industrial and technical perspective.
How well do you know all phases of generic drug development?
Considering the huge interest in the last year’s workshops, which we jointly organized, on advanced analytical techniques for the characterization of API and medicinal products, we decided to go one step further and organize another workshops for specialists in the pharmaceutical industry. Last year, academic and industry experts showed the participants, with real-life examples, how sophisticated and custom analytical techniques can help understand and control the behaviour of active substances and drugs in development and routine production. This time, we want you to take a look at the entire drug development process.
The molecule selection based on technical, clinical and business potential as well as the patent landscape is critical know-how of each generic company. To deliver complex generic projects successfully, on time and on budget, project management is an essential element. The technical feasibility for selected molecules must translate into the first preformulation trials. These include a full understanding of the original drug product (reverse engineering), advanced API characterization, and identification of the critical quality attributes for the API and the drug product. The formulation experts convert all the knowledge and experience gained during the preformulation phase into robust formulation processes at an industrial scale. At the same time, the analytical expert develops and validates all the analytical methods to give the formulation scientist an insight into the process.
The clinical expert is responsible to understand the in vivo behaviour and variability, and combines all the knowledge collected in previous phases into the specific clinical design. Passing the clinical trial successfully is then the cherry of the cake.
Like a chain, generic development is only as strong as its weakest link. Missing or underestimating a link may easily lead to failure. Missing competence at a certain phase, leaves the outcome to chance.
This is the beauty and the pitfall of generic drug product development.
The workshops we have prepared are aimed at showing the strengths and weaknesses of the entire process. We want to discuss together, on the basis of specific examples and many years of experience, how the best industry experts would solve all these challenges. The special guest of the workshops will be a representative of the Celon Pharma, who will show the meanders and intricacies of analytical techniques, based on the latest solutions in the field of chromatography and mass spectrometry. What is more, during the workshops we will offer a unique opportunity to take advantage of individual consultations and listen to opinions on your specific projects or problems from the experts leading the entire event. As part of the workshops, we will also take you to our laboratories to present a wide range of research cooperation opportunities with the Jagiellonian Center of Innovation. During the workshops, there will also be an opportunity to meet Diag-Med, which is the sole representative of Bruker laboratory equipment in Poland. Such a seminar, combined with workshops, is a unique opportunity to broaden your knowledge and exchange experiences.
Where and when?
The workshops that we offer will last two days (October 12th-13th, 2023) and will be conducted entirely in English. Upon completion, each participant will receive a certificate. The full agenda, together with the registration form, can be found on the website:
The workshops will take place at the headquarters of the Jagiellonian Center of Innovation, i.e. in the Life Science Park in Kraków. Since the number of places is limited, it is advisable to register as soon as possible.