“Within Orion, we serve as a messenger from research and development towards commercial operations. We also provide assistance in ensuring that the company’s external communication complies with official requirements and is scientifically accurate,” says Taru Blom, who has served as head of Medical Affairs since the beginning of 2022.
“In addition, our department helps various parties build cooperation that enables us to use external expertise in making our products available to patients and developing them further.”
The collection of data and views is also increasingly part of the department’s operations.
“This also covers research concerning products that have a marketing authorisation and that are already on the market. Our department is also responsible for late-stage drug development, which is why we participate in clinical research.”
Better results through knowledge and contacts
The role of medical affairs departments is changing globally from providing operational support to becoming a strategic player. This also applies to Orion. Various clearly defined tasks are increasingly supplemented by strategic work, for example, as well as the management of product launches from a medical viewpoint.
The shift towards a more active role is reflected in everything, from ways of working and internal and external contacts to financial investments and resources. Combined with the expansion of the product portfolio, this is increasing the amount of work.
In addition to producing, reviewing and publishing material, the department actively participates in publishing Orion’s research results in various forums.
“We are also increasingly collecting and publishing real-world evidence data, which is obtained when people use medicines that are on the market. This type of data should be used more in medicine.”
Significant partners include patient organisations, which help Orion understand what is important to patients. Even in this work, we must be careful to ensure that all the materials and communication methods are correct,” Blom points out.
“We are also responsible for how information about diseases that Orion deals with is shared in society. We provide information about diseases and their treatment on public websites, among other channels.”
Changing requirements are being monitored and discussed
Medical Affairs at Orion participates in drug development in its various phases. For example, the department participates in decision-making concerning research design and variables when the company is preparing to introduce new products to the market and reimbursement is being discussed.
“We participate in guiding research so that we can obtain data that can be used throughout the life cycle of a product. We must join these discussions as early as possible during product development.”
The authorities’ activities and official requirements have been under constant change for a long time. It’s important to be able to monitor these aspects and respond to them – in addition to seeking to affect future requirements.
“Active and systematic interaction with the authorities is extremely important for us, as is commenting on draft guidelines, for example. Meetings between pharmaceutical companies’ representatives, the authorities and universities are beneficial for all parties,” says Blom.
“Good and effective external contacts are needed, but internal monitoring systems are also important, because they enable us to be informed about future changes in good time.”
Orion’s Chief Medical Officer has many roles
As the head of her department, Blom feels she is primarily an enabler and developer who also participates in practical management and project implementation.
“As the Chief Medical Officer, I also need to solve many types of problems. My input is needed if defects or other problems are detected in products or operations that can affect safety, for example. In such situations, discussions with the authorities are also necessary.”
In addition to project work, Blom’s main focuses include a joint project in operational development.
“We have wanted to further clarify our ways of working and roles in these changing tasks so that we can invest in project content creatively and smartly, using tools that are already available,” Blom says.
“New technology is increasingly offering us opportunities to collect data and views. We will focus more on data and its effective use. This will benefit all research and development, and I’m happy to actively contribute to these efforts.”
Experts cooperating for the benefit of the patient
The team at Medical Affairs is quite small, considering that it takes care of Orion’s entire portfolio of products that are on the market, including both generic and proprietary products. Success calls for internal cooperation between various departments, as well as cooperation with external players. Cooperation between the head office and subsidiaries is also important.
The department has a total of 30 employees, including doctors and other specialists.
“Our common mission is clear: to work for the benefit of patients,” says Blom.
“Maintaining the public’s trust is particularly important for a pharmaceutical company. This requires that things are done correctly, down to the last detail – which is also an obligation
Text: Jussi-Pekka Aukia