Orion
Orion
Blue-ribbon
Celebrating its centenary, the globally operating Finnish pharma company Orion is continuously investing in research and development of new drugs and treatment methods, using 10-15% of its net sales in pharmaceutical R&D.
Orion develops human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company focuses on more effective and safer drugs in three core therapy areas: central nervous system (CNS) disorders, oncology and respiratory. In addition, Orion is developing veterinary pharmaceuticals and generic drugs. In Finland Orion is the clear market leader, and its products are marketed in over a hundred countries.
The company´s net sales were nearly EUR 1,1 billion and the investments in R&D were EUR 118 million in 2016. Orion has altogether 3,500 professionals in over 20 countries in Europe, India and China, and 500 of them are working among drug innovations in the Research and Development Unit. Most of the R&D operations, all manufacturing plants, and 2,700 experts are in Finland.
Molecule on the way
Developing a new medicine from an idea into a finished drug, including also the required authorization from the authorities, takes 10-15 years.
For a start, a target in the human body – most commonly a protein or gene – with a role in development of illness or causing symptoms must be identified, and then, suitable drug molecules selected for further research. To confirm that the molecules are sufficiently safe for testing in humans, in vitro and in vivo studies are performed.
The possible drug is first tested on healthy humans, and at a later phase, on actual patients. The total costs of developing a new drug may be up to EUR 700-800 million.
”The computerized systems of a pharma company must be validated so that they qualify for the authorities´ requirements”, underline Business Lead Satu Alanko and Project Manager Jenny Ristimäki who led the information management system renewal related to Orion´s R&D sample management.
When Orion initiated to build up its information management system for the sample collection over ten years ago, the discussion about biological sample collections was still young in Finland.
”As sample collections have various dimensions, we contemplated all ethic viewpoints thoroughly. From the very beginning, we designed the system with due care so that the system-to-be would also meet the future needs.”
Orion has in use altogether four LabVantage laboratory information management systems (LIMS) delivered by Software Point. Three of them are LabVantage Biobanking type systems used in inventory management of compounds and biological samples, in sample logistics, and as a sample collection. The fourth system is used in the laboratory quality control in Orion´s plastic manufacturing plant producing cuvettes, tablet jars and dipslides.
All novel molecules pass through the compound and inventory management system administering the whole life cycle of the molecules. Every single jar and tube is identified with a code given by the system, the code is printed on a label, and the label is stuck on a container. Also balances are integrated into the system and the weighing results transfer to the system automatically.
”Some of the molecules needed in developing new drugs are tremendously expensive. Every precious milligram is carefully utilized.”
The biological sample management system is used for administering the logistics of the research samples, and already 500,000 biological samples have gone through the system.
”There is a vast number of samples, and research is done also outside our premises. With the LIMS system we see in real time where the samples are.”
With the sample collection Orion manages biological samples, informed consents and documents.
”In clinical examination the sample donor is asked for giving consent and for using the sample in research. The samples are double-coded so that no sample can be traced to the donor. On the other hand, the donor may any time ask to delete his samples – and in this case, the research centre requests these samples to be deleted. The double-coding ensures the process so that the identity of the donor shall never be revealed.”
From standard to optimizing
Before Orion decided on LabVantage product portfolio provided by Software Point, Ristimäki and Alanko carried out a thorough evaluation process.
”To find a partner capable to deliver what we need, we must first know what we want. So we visited various conferences, seminar presentations and events abroad. We also visited LabVantage Group in the United States and Software Point offices in the Nordic countries, meeting many people. A good customer collaboration shows through.”
The sample collection was Orion´s first joint venture with Software Point. In addition to Jenny Ristimäki and Satu Alanko leading the project, the project team consisted of experts from all units using the information management system around Orion.
”We tried to keep the core team as compact as possible to keep the project progressing smoothly.”
Specification is the most important phase of the project, and this was our big success.
"It pays the effort to take a rain check on which elements will bring along the biggest benefits to the system and where standard is enough and how much customizing is needed.”
”In this magnitude and together with a partner, it was new also for us, to put up a system having such an impact on the core R&D operation. It required the project manager to consider the whole with all details, and at the same time, to control the sprawling along the way. We learnt a lot ourselves, but we also taught softwarepointers our industry-related matters so that they were able to support us.”
Building up the sample collection, there were four Software Point specialists configuring at Orion in the beginning. The final part was accomplished with remote connection and meetings at need.
”We initiated the sample collection with an iteration plan, but the working method was later changed into a conventional cascade model which stiffened doing a little bit. We endeavoured to make it perfect straight away but learnt that there´s no point. Therefore, when building the sample management system as well as the compound and inventory management system we iterated all the time – it shortened the lead-time and engaged people more.”
Software Point receives recognition from Alanko and Ristimäki for searching solutions and getting briskly down to business.
”The collaboration is very good. The Service Manager is a true professional, he sorts things out and goes the extra mile for the project to succeed. The attitude! He weighs up and also suggests easier alternatives. He is very an important partner for us.”
The implementation of the first system took more time; the second was ready done in eight months, and the third in a half year.
”Software Point is a resilient provider – the speed is tough and Software Point stays in our tempo.”
Shared communication increases interaction
According to Satu Alanko and Jenny Ristimäki, the biggest advantage gained along with LabVantage LIMS is work efficiency.
”Now everyone can check from the system if we have a certain sample; it is no longer behind anyone or any business unit. Spare milligrams are no longer left unused. Clear, high-quality labels speed up our work.”
”Though the business environment, corporations and internal processes are changing, nothing bigger has had to be changed in these systems. In addition to the measurable benefits, they received good verbal feedback in our user inquiry: the systems clarified our employees´ own processes and improved information flow – now different business units are much more in contact with each other.”
More info: Orion
Text: Software Point
Photos: Orion
27.11.2017
