Shoji Kuroyama: Designing
Pathways for Treatments Without Trails
Despite extraordinary advances in medicine, certain
voices remain faint in the corridors of care. Among them are individuals living
with rare diseases, patients whose conditions are so uncommon they often fall
outside the reach of conventional treatment models. These are not just medical
outliers; they are children, parents, and communities waiting for answers that
rarely come. Their conditions may be few in number, but their need for
treatment is no less critical. Traditional healthcare systems, built to serve
the many, often struggle to accommodate the few. And in that silence, the need
for focused, purposeful intervention becomes not just important, but essential.
Shoji Kuroyama has
made it his mission to close that gap. From his early days as a sales
representative to his current role as President of Recordati Japan,
Shoji has redefined what it means to lead with precision and purpose. His
journey has spanned continents, therapeutic areas, and business functions, but
the throughline is clear, a commitment to bringing critical therapies to those
most often left behind.
Evolution from Rep to Regional Visionary
Shoji began his career in 1994 as a sales
representative in the Pharmaceutical Division of Kirin. He later moved into the
Marketing Department, where he served as a Product Manager. After earning his
MBA in New York, he joined Janssen Pharmaceuticals. There, he played a pivotal
role in developing and expanding the oncology business, especially in
hematologic malignancies. His responsibilities gradually grew to include new
therapeutic areas, hepatitis C, new product planning, and the integration of
Actelion into Janssen Japan.
At Janssen, Shoji also took on the role of
Asia-Pacific Regional Lead for Oncology and Hematology, based in Singapore.
Following that, he joined Incyte and spent four years building the foundation
for the commercial team to support the launch of a biliary tract cancer product
in Japan.
Throughout his career, Shoji gained a wide range of
experiences that shaped him as both a technical expert and a leader. As a
marketer, he learned to simplify complex messages for sales teams and to use
logic effectively. His career also taught him how to handle uncertainty and
build new business operations from scratch. These challenges strengthened his
flexibility, helped him avoid perfectionism, and inspired him to challenge the
status quo.
At Incyte Japan, Shoji worked in a lean structure that
required hands-on involvement across various functions. He personally led
initiatives such as press releases, media seminars, and pricing negotiations
with the Ministry of Health. This exposure deepened his understanding of
operational details and strengthened his appreciation for the efforts of his
team.
His time in Singapore also gave him valuable insight
into leading without formal authority. By collaborating with multiple country
organizations as a facilitator rather than a top-down leader, Shoji honed his
ability to influence and drive results through collaboration. Overall, his
career journey has given him a well-rounded leadership style built on personal
growth and leveraging diverse strengths.
Strategic Lens on Therapeutic Leadership
Shoji’s leadership across oncology, hematology, and
infectious diseases in both Japan and the Asia-Pacific region has shaped a
practical and principle-driven view of leadership. When it comes to business
models, he notes that the fundamental approach does not drastically change
across therapeutic areas. Whether the focus is hematology, infectious disease,
or rare diseases, success typically hinges on three core elements—targeting the
right audience, delivering the right message, and maintaining strong communication
with healthcare professionals.
He also observes that pricing strategies tend to
follow common methodologies, such as comparator-based or cost-based
calculations, particularly in Japan. While access frameworks and reimbursement
systems can vary between countries, the overarching business logic remains
consistent.
In drug development, rare diseases may involve
slightly different strategies. For example, in ultra-rare conditions, a smaller
data set—perhaps just a Phase I/II study in Japan along with global pivotal
data, may be sufficient for approval.
Drawing from his extensive experience across diverse
therapeutic areas, Shoji feels confident leading in the rare disease space. At
its core, he believes that a solid, fundamentals-based business model remains
effective regardless of the therapeutic category.
Bringing “Focused on the Few” to Life
Shoji is deeply committed to turning Recordati’s
philosophy of “Focused on the Few” into practical and meaningful actions.
First, the Japan team ensures appropriate product use by providing accurate,
timely information to healthcare professionals through webinars and in-person
interactions. This supports patients with rare diseases by equipping clinicians
with the knowledge they need.
Second, the team’s licensing-in strategy emphasizes
innovative products in the rare disease space. This helps mitigate the risk of
drug unavailability in Japan, ensuring patients have continued access to
essential treatments.
Third also refers to the team itself. Compared to
other mid-sized companies, Recordati Japan is a lean organization. This creates
a unique opportunity to foster inclusivity and responsiveness. Shoji and his
team actively listen to employee feedback and build a workplace where voices
are heard and valued.
In all these ways, Shoji is ensuring that the
philosophy of “Focused on the Few” is more than just a slogan, it’s a guiding
principle embedded in the team's daily operations.
Building a Strong Foundation for Rare Disease
Leadership
In his first year as President, Shoji's immediate
strategic priorities center on maximizing the value of Recordati’s current
pipeline in the Endocrinology/Metabolic and Hematology/Oncology business units.
At the same time, he is focused on acquiring rights to new compounds that can both offset potential
drug loss and meet high unmet medical needs in the rare disease space.
To achieve these goals, Shoji emphasizes the importance of enhancing Recordati’s presence and becoming the partner of choice for patients, caregivers, healthcare professionals, partner companies, and employees. A key enabler of this vision is talent, specifically, attracting and retaining top talent within the organization. Shoji believes the company is on the right trajectory, building a workplace culture that supports both innovation and collaboration.
Evolving Access in Japan’s Drug Landscape
Shoji acknowledges that the rare disease market in Japan continues to evolve, supported by incentives such as Orphan Drug designation from the Ministry of Health, Labour and Welfare. These designations typically offer protection from NHI price reductions and generic competition, making the market attractive for pharmaceutical companies.
However, he points out a growing concern: drugs targeting ultra-rare diseases, with very small peak sales potential, often fail to attract sufficient interest from industry players. This poses a risk of drug loss and access challenges for patients.
In response to these concerns, regulatory bodies such as the PMDA have introduced progressive frameworks designed to ease market entry. One notable example is the conditional approval system, which allows marketing authorization based on Phase I/II data, provided that confirmatory studies, such as Phase III trials, are conducted post-launch. This system significantly lowers the entry barrier for small- and mid-sized biotech firms that may lack the funding or resources for large-scale trials upfront.
Shoji sees this regulatory innovation as a critical enabler of growth in the rare disease sector. He hopes that such initiatives will continue to be developed, ensuring that innovative therapies can reach patients in Japan more quickly and effectively.
Education, Innovation, and Early Detection
Shoji believes that one of the most urgent challenges in rare disease care is the long and often arduous journey patients face before receiving a diagnosis and treatment. To address this, he emphasizes the importance of improving disease awareness, particularly around the burden of rare diseases and the critical role early diagnosis plays in patient outcomes. Recordati Japan remains committed to advancing medical education programs as a key tool in supporting this objective.
However, Shoji also underscores that the company’s highest priority is bringing new, innovative therapies to the Japanese market. He believes that the presence of effective treatments can, in itself, increase awareness and shift societal and clinical perceptions — helping to foster earlier diagnosis and stronger support systems around patients.
A Personal Commitment to Patient-Centricity
For Shoji, patient centricity is not a slogan, it is a deeply personal conviction shaped by
pivotal moments in his career. Early on, he admits he lacked a full
understanding of what it truly meant to be patient-centric. But while working
at Janssen as a product manager for a targeted therapy for multiple myeloma, he
witnessed firsthand how a breakthrough drug could dramatically improve not only
prognosis but also a patient’s quality of life.
That experience became a turning point. Since then,
Shoji has been unwavering in his mission to deliver innovative therapies to as
many patients as possible, aiming to transform lives through access to science.
At Recordati Japan, he actively embeds this principle into the company culture,
including hosting “patient voice” sessions during company kick-off meetings to
ensure that every employee, across both commercial and R&D teams, is
reminded of the people they ultimately serve.
A Story That Fuels Purpose
Among the many patient and caregiver stories Shoji has
encountered over the years, one in particular has left a lasting impact.
Through a patient advocacy group, he learned about a family affected by
hyperammonemia, a rare condition that can strike in early infancy. In this
heartbreaking case, delayed diagnosis led to irreversible intellectual
disabilities in a young child.
The story, Shoji says, was both shocking and deeply
moving. It highlighted the devastating cost of late intervention and reinforced
his resolve to drive awareness and access in Recordati’s key therapeutic areas.
For Shoji, preventing such tragedies is not just a professional goal — it is a
personal mission that continues to guide his leadership every day.
Blueprint for People-Centered Success
He places deep value on emotional intelligence in leadership, especially in an
industry driven by data, regulation, and science. For him, people are the true
driving force behind success. He believes that how passionately employees
connect with the organization’s mission—improving patients’ lives, is what
ultimately propels a company forward. Emotional engagement, he emphasizes, is a
critical success factor that data alone cannot replace.
Encouraging Voices in the Japanese Workforce
Having worked in both Japan and Singapore across various therapeutic areas, he
draws meaningful contrasts in leadership and communication styles. In his
experience, Asia-Pacific employees are often proactive in career development
and confident in sharing their strengths. In Japan, however, a culture of
humility can sometimes limit individuals from seizing growth opportunities.
Learning from his time abroad, he has made a conscious effort to adopt a more
assertive and strategic approach to career and business growth, advocating for
a mindset shift that encourages Japanese professionals to showcase their
capabilities more openly.
The Drive Behind Recordati’s Pipeline
He finds deep motivation in Recordati’s current pipeline, which is centered on
rare diseases. While patient numbers may differ by treatment in Japan, the
consistent factor that excites him is the strong sense of purpose and
contribution to patients’ lives. For him, working in the rare disease space
offers a unique opportunity to make a meaningful impact where it matters most.
KOLs and Regulators as Catalysts for Innovation
He envisions that key opinion leaders (KOLs) and Japan’s Pharmaceuticals and
Medical Devices Agency (PMDA) will play increasingly pivotal roles in
accelerating innovation. As Recordati brings new drugs from small biotech firms
in the US and EU to Japan, the perspectives of KOLs on epidemiology, treatment
algorithms, and unmet needs are invaluable for strategic planning and
negotiations. Equally important, he believes, is maintaining a deep
understanding of regulatory expectations and fostering timely, frequent
engagement with the PMDA. These relationships are critical not only for
streamlining drug filings but also for combating the growing issue of drug
attrition in the Japanese market.
Lessons in the Rearview
Reflecting on more than two decades in the pharmaceutical industry, he would
advise his younger self to never stop working hard. Consistency, perseverance,
and learning from failure, he believes, are the foundations for long-term
success. He encourages trusting the process and believing in one’s potential.
What continues to inspire him today is the people around him, his team, and
external stakeholders. He emphasizes that success is never a solo achievement;
it’s the result of shared commitment, collaboration, and a united drive to
improve patients’ lives.
