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2023新药、新洞见:推进罕见病药物开发(英文版).pdf
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2023新药、新洞见:推进罕见病药物开发(英文版).pdf
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New Medicines,
Novel Insights:
Advancing Rare
Disease Development
FEBRUARY 2023
Novel therapies for rare diseases offer hope for
thousands of patients and their families. Bringing
rare disease treatments to market, faster: This
is the goal of every biopharmaceutical company
– and for Parexel. However, speed and efficiency
in the drug development process have value only
when driven by a thorough understanding of
the illness from the perspective of patients and
caregivers. In this report, we share best practices
to illustrate how companies can infuse a thorough
embrace of patient centricity throughout the many
interconnected processes along the journey.
Of course, that is easier said than done. While it
has been more than a decade since the concept of
patient-centricity emerged in our field, the industry
lags far behind other sectors in focusing product
development on the people it serves.
Why do many companies fail to engage effectively
with patients before designing their trials and
selecting endpoints? For one thing, multiple
stakeholders have divergent and even conflicting
priorities. And it takes time and money to
understand a rare disease and how it progresses.
Meanwhile, many companies find it daunting to
communicate with patients and fear that direct
collaboration could raise legal or ethical issues.
Individually, any one of these stakeholders can
recognize the signs of improved quality of life
for a given patient, even for a young child. But
collectively, they don’t know how to do that. And
while companies cannot make a drug commercially
viable if it is not compliant with technical standards,
that doesn’t much matter if a product does not
address what patients care about. That’s why
focusing on patients from the earliest stages of
development makes pragmatic sense.
3 | NEW MEDICINES, NOVEL INSIGHTS: ADVANCING RARE DISEASE DEVELOPMENT
Bringing rare disease treatments to market, faster
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