Immunology_PRA Fact Sheet_JAN2015_Screen

IMMUNOLOGY
IMMUNOLOGY
PRA Health Sciences’ significant experience in the clinical development of autoimmune
drugs affords us a thorough understanding of the treatment communities and patient
populations of many key immunology disorders. We have experience across more
than 14 indications and have participated in the successful market approval of 4
immunology drugs.
EXPERIENCE
EXPERTISE
N o. OF A PP ROVE D DRU GS
4
100
2,500+
19,200+
More than one-third of our medical staff have have experience in supporting trials that involved
immunology indications. Additionally, more than half of our key clinical development directors are
experienced in the planning and conduct of clinical trials for immunology related diseases.
38
50
51
54
N o . OF CLINICAL STUDIES *
N o . O F CLI NI CA L SI TE S*
N o . O F CL INIC A L PATIE NTS *
* O VER TH E PA S T 5 YEA R S
OUR IMMUNOLOGY
EXPERTS MAKE
THE COMPLEX,
SIMPLE.
MEDICAL DIRECTORS
CRAs
=10%
CLINICAL TEAM MANAGERS
WITH IMMUNOLOGY EXPERIENCE
I N N O VAT I O N
Autoimmune disorders affect an estimated 23.5 million Americans. That’s
more than the number afflicted with cancer (9 million) or heart disease
(22 million). With the prevalence rising, patients, now more than ever, need
innovative solutions to safely advance better treatments to market. While
there are more than 80-100 autoimmune diseases, PRA has substantial
experience in many of the more common indications.
MORE THAN
21M
3.6 M
WORLDWIDE
RHEUMATOID
ARTHRITIS
WORLDWIDE
INFLAMMATORY
BOWEL DISEASE
125M
5M
WORLDWIDE
PSORIASIS
WORLDWIDE
Working on a
novel RA
compound, PRA
leveraged our
investigator
relationships
and attained FPI
by the sponsor’s
target date –
something the
sponsor had
never achieved
with this drug
before.
LUPUS
(including Crohn’s and
ulcerative colitis)
Lupus Central Review Services
In 2008, PRA established the Central Review Services unit to provide design
and operational expertise as well as physician–led review and grading of SLE
efficacy indices for our clients. SLE studies utilize a unique set of complex
efficacy endpoints that require a strong understanding of the operational
implications of the data on clinical trial results. PRA has developed an
innovative training program for our internal study staff, investigators, and
CRAs on the use and accurate application of SLE indices and tools being
used in each unique clinical trial.
“As incidence rates of autoimmune
disease continue to rise globally, PRA
is committed to partnering with our
clients to understand and cure these
debilitating illnesses.”
MICHAEL KIRCHENGAST, PHD
Sr. Vice President, Scientific Affairs
PROJECT DIRECTORS AND
MANAGERS
To date, PRA has
supported over
19 global SLE
clinical studies,
enrolled over
3,000 subjects,
and accurately
graded over
150,000+
assessments.
PRA's global investigator network provides
preferred access to established investigative
sites that accrue patients and deliver high-quality
clinical trial data.
We never forget that every global immunology
study is executed locally. With global offices
providing service in 80+ countries, our team
harnesses practical knowledge of local regulations,
standards of care, and cultural customs to maximize
safety and efficiency for your immunology trials.
The challenge of discovering safe, meaningful
treatments for autoimmune diseases seems daunting.
Their prevalence continues to rise, inflicting millions
of people each year. Moreover, many immunosuppressant
treatments often lead to devastating long-term side
effects. But while some may turn away from this
research challenge, we press forward, convinced that
innovation and tireless commitment will lead to
better outcomes and industry-changing discoveries.
To improve the drug development process for autoimmune
research, we employ highly dedicated and passionate people
and deliver unmatched scientific expertise. More than
that,we share the commitment to achieving life-changing
drug discoveries with patients and clients, because it
motivates and inspires them to bravely face the struggles
of tomorrow. By getting better medicines for autoimmune
diseases to market sooner, we can make a difference in the
quality of life for countless patients worldwide.
PRA
PRA Health
Health Sciences
Sciences conducts
conducts comprehensive
comprehensive Phase
phase I-IV
I-IV biopharmaceutical
biopharmaceutical drug
drug development.
development.
To
To learn
learn more
more about
about our
our solutions,
solutions, please
please visit
visit us
us at
at prahs.com
prahs.com or
or email
email us
us at
at prahealthsciences@prahs.com.
prahealthsciences@prahs.com.