Dominika Kovacs, country manager of Takeda Romania, shares her insights on the growing pipeline of the organisation and the anticipated launch of a state-of-art stem cell therapy. She highlights the organisational changes in the last year, and how they have been inducive to double-digit growth for Takeda. Additionally, she reveals her strategy in consolidating and maintaining a leadership position in key areas such as rare haematology, oncology, and rare diseases.


Post Shire acquisition, how are you using your transformation and streamline expertise in your current role?

My purpose with the team is to implement Takeda’s mission, to bring better health and a brighter future for patients. In Romania, this translates in securing access to our cutting-edge innovative portfolio. Thus, our transformation entails creating strong partnerships with key stakeholders to create sustainable access by integrating their viewpoints and voices on how to deliver best in class solutions. One example is pay for performance models.

This has implications on the organisational competencies, capabilities and the modus operandi of engagement with partners (i.e. NGOs, physicians, patients’ associations, decision-makers, trade associations) where the aim is to align our collective efforts.

My mandate post Shire acquisition was to transform and build the organisation while ensuring business continuity and building the enabling resources to allow Takeda to meet patient’s unmet needs. In practice, this meant the team expansion so to include new Real-World Evidence (RWE) capabilities that serve Romania and the Eastern European region.

We also elevated capabilities for launch excellence, as we plan on introducing 11 new products within the next three years. We strive to go beyond the value of medicine and therefore patient services will be enhanced to holistically incorporate the patient’s journey.

This can take the form of vouchers to support diagnostics testing and cover a myriad of other support areas such as psychological or meal planning support.


What were your initial expectations, when moving from Portugal to Romania?

There were no initial expectations. I approached this opportunity with a curious mindset and sought to understand where we can have the greatest impact. I was impressed by the team’s high level of proficiency and dedication to tackle the strong unmet need in the country. Each country is unique and even elements that can be taken for granted, such as the distance from a specialist to a patient’s home, must be taken into consideration. This requires the organization to think differently. The first months were spent listening to our people, customers, stakeholders, and trying to prioritize and focus our approach.


What have been the key takeaways since your taking on the management of the affiliate?

The key takeaway is that, despite a potentially slow start, the only way to make a difference is through listening and partnerships. Takeda’s DNA is very much about perseverance. While the road might begin with challenges, when shared interests and mutual wins were found with various stakeholders, momentum was achieved. Through these means, we have secured access to three new medicines, launched new patients support programs, and make a difference even in areas afflicted by the medicine crisis, —all within less than a year.


What is the footprint of Takeda Romania today?

The employee base has grown about 10 per cent. This largely reflects the growth to accommodate the investment in building new capabilities. The business is growing double-digit and the momentum is used to bring innovative products for unmet needs.


What therapeutic areas are present in Romania and how do they meet the needs of the patients?

As the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people. Soon we will have a portfolio to serve the patients need comparable to Western Europe, which is something to be proud of considering the existing unmet needs.

Oncology is a strong base and was strengthened by adding a latest generation product in multiple myeloma. The gastroenterology franchise was ready but faced delays in access for reimbursement. The compelling need expressed by physicians and patient associations for inflammatory bowel disease (IBD) triggered Takeda to implement an early access program through donations. Consequently, physicians could treat patients that were most in need, while the access conditions were formed. A legislative framework that facilitates early access is a challenge, yet we found a way. As the old saying goes, “Where there is a will, there is a way.”  This solution bridged the entry into the Gastroenterology field with a treatment for ulcerative colitis and Crohn’s disease. Takeda has a strong GI portfolio which includes a stem cell therapy for complex perianal fistula disease and short bowel syndrome.

The legacy of Takeda and Shire revolutionized the treatment of haemophilia, which enabled the organization to be the leader in this area in Romania. It is impressive what the team has managed to do by elevating the standard of care, introducing personalized prophylaxes and supporting treatment guidelines to be closer to EU standards.

Furthermore, the Romanian subsidiary expanded by including immunoglobulins, thus contributing to one of the most sensitive unmet patient needs. This is one example of Takeda putting patients at the centre of our decision-making process. Several projects were launched simultaneously to support the call to action for immunoglobulins. Due to long manufacturing cycles and raw materials coming from human plasma, the allocation of products globally is made at least one year in advance.

Internally, we have secured significant allocation starting next year: 60 kilos in 2021, and 90 kilos in 2022. This is representing anything from a quarter to a third of the country’s need. Our efforts did not stop here though. Meanwhile, we have continued to actively evaluate opportunities to repurpose allocation from other parts of the world to Romania. This too has been successful and in the next few months we will bring in an additional 10 kg of Immunoglobulins. In addition to immunology, Takeda also has a strong presence in rare metabolic disease.


What growth trends have you witnessed associated with the therapeutic areas that you offer?

The oncology franchise has had strong consistent growth and we are now entering the field of gastroenterology with access to two new products. Takeda continues to be the leader in rare diseases and is strengthening the established business with new products. The trend we see is the increasing need for data, such as patient registries. This information is a key element to sustainable health ecosystems and patient care.


How does Takeda ensure that patients have access to the latest innovations?

A value proposition dossier for each brand is put together to understand and balance the burden of disease and quality of life impact with the cost of the treatment. This creates a transparent business case and supports sustainability.

The organization aims to be flexible and find innovative ways to propose mutually beneficial solutions for patients while taking into consideration the legislative and budgetary restrictions of authorities. Alofisel®—a cutting-edge stem cell therapy—crystalizes this very well. It is the first drug of its kind to be approved in Europe with Western EU countries seeking access currently. Early on, the organization engaged with stakeholders to make it available in Romania. A pay-by-performance outcome-based model was the intended way forward, but the current legislative framework is not a full fit. Instead, we committed to assess case-by-case patient outcomes together with the National Health Insurance. This is a positive sign of innovation, not only in terms of molecules but in the approach the healthcare ecosystem is taking.


Are there any new launches planned for 2020?

Alofisel® will launch in May of this year and the organization is currently training hospitals and physicians to handle this unique stem-cell therapy that has a 72-hour shelf life.

In the last three months, Entyvio® and Ninlaro® were launched with the former being an inflammatory bowel disease (IBD) biologic and the latter in multiple myeloma The first patient treated with Entyvio® was a 19-year-old student who otherwise would have had to abandon her studies and resort to invasive surgery. Luckily, through the early access program, she was able to go into remission.

We hope to launch additional products which are currently in various stages of the reimbursement process.


What makes a successful launch in Romania?

Launch excellence is one of the capabilities that are being enhanced, and cross-functional readiness is a crucial factor. This entails lining up all requirements that enable a physician to prescribe and the patient to receive the medicine. Each launch is unique and must factor in the patient journey such that the right patient at the right time has access. As soon as the reimbursement status is given, physicians and pharmacists should be able to order your products.

To support this, the plans are pressure tested with everyone who is part of this process, communities of physicians, pharmacists, national and local health insurance houses, to critically assess preparations and readiness; including the assumptions upon which they are compiled on. It is important to have defined and well understood in the healthcare ecosystem the patient profile, treatment guidelines and supply plan. Takeda in Romania has its own warehouse which lets us supply products with a very quick turnaround.


Takeda ranked third as a pharmaceutical company in the Global Top 100 Most Sustainable Corporation for the fifth consecutive time and Global Top Employer for the third year. How does it feel, as a leader and representative of Takeda, when receiving these international accolades?

I feel proud and want to recognize the hard work of the people in this organization and around the world who have contributed to these accomplishments. Takeda with our Japanese heritage has a strong commitment to corporate social responsibility.  As employees, we get to vote on social programs to support globally and recently Takeda announced our commitment to carbon neutrality.


With the start of 2020, what message did you share with your team?

The focus will be on operational excellence as we optimize and fine-tune the new structure and roles post-integration. The aim is to build on last year’s momentum and increase our effectiveness as an organization. At Takeda, one of the main objectives of the Senior management team is to provide the context to empower their team’s work and increase their agility. It is critical that we incorporate the voice of our customers.


What are your objectives and priorities moving forward?

People are my priority; they are the only sustainable competitive advantage and drive the impact and reputation of an organization. I want to ensure that we can find the best people, develop and retain them while providing each employee with a clear line of sight as to how their role impacts the organization.

Another objective is to elevate the company and its external perception in Romania. Not many individuals understood who this Japanese company was in the country, and I want Takeda to become an essential player and partner in the market.


What leadership style, or Takeda-ism value, do you want to bring into the country?

I hope to role model our Takeda leadership behaviours that are grounded in being authentic and fair, perseverant and having honesty and integrity. This is the approach that we take in all our collaborations and I want to demonstrate that you can embody these principles and still be successful in the business. Furthermore, I want to accelerate the capabilities of our people, by exposing them to different ways of thinking.


What advice would give to any new fresh GM coming into this market?

Be curious, listen, and spend time exploring this beautiful country. There is no one flavour or one-size-fits-all as each county is unique.