Interview with Lek Pharmaceuticals 2020

Interview with the Winner of the 6^th CEE Pharmaceutical Manufacturing Excellence Award!

- Manufacturing category -

To learn more about the award winning project, we interviewed Jernej Luzar, PhD Scientist in Pharmaceutical Development & Technology at Sandoz Development Center Slovenia.

Please introduce your company’s portfolio (or please provide a short company profile)

Jernej Luzar "Novartis is the leading provider of medicines in Slovenia, where Lek, Novartis Pharma Services and Sandoz, operate. Together we are building and maintaining the reputation of a dynamic, ethical, and trusted pharmaceutical company. Lek develops, manufactures, and markets effective, safe, and high-quality medicines and active pharmaceutical ingredients. With our knowledge, quality and experience we have gained an important role in Novartis' organizational structure, especially in the Novartis Technical Operations, Global Drug Development, Novartis Business Services and the generic division Sandoz.

We invest a great deal in the development, education and training of our employees. Over the last eight years, the company has taken on more than 2,700 new employees, making us one of the biggest employers in Slovenia. Novartis has invested more than EUR 2.5 billion in Slovenia since 2003. At the end of the year 2019, Novartis Slovenia had more than 4,400 full-time employees. Among them 530 hold an MA or PhD and last year they received numerous awards and recognitions for their work.

We are the leading Sandoz development center, and one of the key development sites for technologically demanding projects. In 2019, the Development Center Slovenia completed the development of and filed 21 drug product dossiers in the fields of anemia, oncology, rheumatology, anti-infectives, diabetes and potency disorders for medicines on the markets of Japan, Europe, the USA, China, Canada, Brazil and Russia. Sandoz has successfully launched several products that have been developed in Slovenia, from the fields of anti-infectives in Canada and Europe, nasal spray for allergy treatment in Russia, a cholesterol control drug in China and a medicine for the treatment of stomach diseases in the United States.

We are an integral part of the Slovenian research and development establishment, working closely with the research and development departments at our universities and other institutions. Our collaborations display the clear focus of Lek, Sandoz and Novartis to invest in research and development, innovation, and to create career opportunities for top students and researchers. As a best practice, we can point to our Regional BioCamp, a three-day forum that will celebrate its tenth anniversary this year, offering top students from Slovenia and other countries a unique opportunity to get to know firsthand, the work carried out in the pharmaceutical industry and to meet distinguished experts and top managers from Lek, Sandoz and Novartis."

What were the major achievements after the project had been implemented?

Jernej Luzar "We implemented smart design and planning of product trials, which resulted in shorter turn-around times for obtaining results. From the generic perspectives, application of data science assured successful bioequivalence studies and regulatory approvals enabling first-to-market products and gaining a competitive edge. Beyond the marketing benefits, the application of data science is reinforcing the learning and career growth of researchers."

What was the innovation within your project, which made you win the 6th CEE Pharmaceutical Manufacturing Excellence Award?

Jernej Luzar "We are using decision-making tools in practice to bring high-quality medicines to our patients worldwide. We are implementing the applicative science in our product development and all demonstrated examples resulted in successful process validation, bioequivalence and marketing approvals."

How do you think the recognition is helping you to gain further publicity?

Jernej Luzar "This recognition gives us an opportunity to present our modern approaches (adapting development processes to the growth of new technologies) to broader society. It allows us to show how we are striving to be curious in our everyday work. Such an award gives us the opportunity to influence other external collaboration partners (e.g. faculties and institutes) to increase their flexibility in encouraging young people to consider becoming data scientists."

In your opinion, how is the award supporting the developments of manufacturing excellence solutions in the CEE region?

Jernej Luzar "The Excellence Award gives us additional public recognition among external partners and broader society. External partners and society can get an overview about our way of thinking and working, which can contribute to start of a new collaboration with positive outcome for both sides. Knowledge sharing has a great potential to successfully overcome upcoming challenges and opportunities."

Which are the biggest challenges your department or company is currently facing? What type of new solutions or methods are you planning to introduce in your current and upcoming projects?

Jernej Luzar "We realized our biggest opportunity, rather than challenge, is to go big on data and digital as the global environment is transforming rapidly. Our company is keeping in step with modern approaches and even pioneering new innovative ways that can be used to help people access high-quality healthcare. Sandoz aims to be an agile global leader for branded generics, biosimilars and differentiated products."

Are you planning to apply for the award again in the future during PHARM Connect?

Jernej Luzar "Our research and development department is working on a lot of projects and initiatives and this award will encourage other departments to present their innovative approaches to generic and innovator communities in further."

Are you planning to attend PHARM Connect 2021?

Jernej Luzar "Yes, it would be our priority and honor to participate in new open-calls from PHARM Connect."

Is there anything you would like to add?

Jernej Luzar "I would like to thank the committee for presenting us with the award. Furthermore, I would like to thank my colleagues from pharmaceutical development for their contribution to data science application– Aleksandra Arandjelović, Anja Mejač, Biljana Janković, Boštjan Petek, Dane Božič, Katja Berginc, Katja Kristan, Klemen Kočevar, Leon Rižner, Lovro Selič, Matej Pavli, Matejka Burjak, Miha Jaklič, Nejc Klemenc, Ognen Jakasanovski, Polona Smrdel, Tijana Stanić Ljubin, and Žiga Urlep. This award is the result of outstanding teamwork. In addition, I would like to thank our leadership team with Luka Peternel as Head Pharmaceutical Development and Matjaž Tršek as Head Sandoz Development Center who support us in our everyday work and enable opportunities for us to grow and realize our potentials."

We are passionate about bringing together annually the best representatives and innovators of the pharmaceutical industry to create a valuable and engaged professional network in Central and Eastern Europe. If you think your solution is cutting-edge and should be recognized by the industry, apply for the next CEE Pharmaceutical Manufacturing Excellence Award and put your business in the spotlight by presenting your solution at the upcoming Congress!

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2020/03/10

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