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including a guest commentary from an industry leader, our two-part series on
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Revolutionizing and
personalizing global health
By E. Kevin Hrusovsky, PerkinElmer Inc. As the complexity and volume of data continue to rise, bioinformatics is emerging as one of the cornerstones of personalized medicine, from enabling discovery and development of novel treatments and diagnostics to facilitating collection, analysis and interpretation of data that ultimately helps an individual patient. SPECIAL REPORT PART 1: ‘Good enough’ is no longer good enough By Randall Willis, ddn Features Editor Aiming beyond the standard of care in oncology SPECIAL REPORT PART 2:
An aside on side effects
By Randall Willis, ddn Features Editor Are we really making things better for cancer patients? High-profile oncology partnership By Jim Cirigliano, ddn Contributing Editor Araxes Pharma and Janssen Biotech ink oncology drug development deal Natural neighbors By Kelsey Kaustinen, ddn Features Editor OSU, Biosortia link up to identify natural products for potential cancer treatments |
New companions for new tests
March 2012
SHARING OPTIONS:
TARRYTOWN, N.Y.—As it continues to strengthen its foothold
in the diagnostics field, Siemens Healthcare Diagnostics has established two
new companion diagnostics partnerships, one with ViiV Healthcare and one with
Tocagen. The two partnerships will target the development of diagnostic tests
for HIV and brain cancer respectively, and provide Siemens with a strong boost
in the companion diagnostics market.
“Siemens’ presence in the emerging companion diagnostics
market enables us to leverage our innovation capabilities and deep clinical
knowledge to help improve pharmaceutical drug safety and effectiveness,”
Michael Reitermann, CEO of Siemens Healthcare Diagnostics, said in a press
release. “More so, it helps align Siemens with new classes of therapies
tailored to the individual that hold the promise of improving patient care and
delivering on the goal of personalized medicine.”
The partnership with ViiV Healthcare will be centered on
clinical trials related to Celsentri/Selzentry (maraviroc), ViiV’s novel CCR5
co-receptor antagonist for the treatment of CCR5-tropic HIV. ViiV’s Phase III
MODERN study will compare Celsentri/Selzentry with Truvada, both in combination
with darunavir/ritonavir. The trial will compare the performance of a genotypic
test with that of a phenotypic test in identifying patients that would benefit
from use of Celsentri/Selzentry, and subject to U.S. Food and Drug
Administration (FDA) approval, Siemens might commercialize their genotypic
tropism diagnostic test.
“Our partnership with Siemens Healthcare Diagnostics is a
valuable part of our commitment to addressing patient needs through developing
innovative treatment approaches,” Dr. John Pottage, chief scientific and
medical officer at ViiV, said in a press release. “Celsentri/Selzentry is an
important treatment option for people living with CCR5-tropic HIV and we
continue to support the evolution of tropism testing to provide physicians with
accurate, accessible and affordable companion diagnostics.”
Siemens’ partnership with Tocagen will focus on diagnostic
tests to support clinical trials related to Tocagen’s viral gene therapy, Toca
511 and Toca FC, which are under investigation for the treatment of primary
brain cancer. The studies consist of patients with high-grade glioma, such as
glioblastoma multiforme. The companies will work together on the assays used in
the studies, and pending FDA approval, Siemens may commercialize diagnostic
tests that can monitor patient levels of Toca 511 and Toca FC.
“We believe that developing the necessary diagnostic tests
with the right diagnostic partner is an important component for the successful
commercialization of Toca 511 and Toca FC,” Harry E. Gruber, CEO of Tocagen,
said in a statement. “Siemens’ capabilities in developing commercial viral
assays in addition to their market presence in the diagnostics space make them
an excellent complement to Tocagen’s focus on the development and
commercialization of viral gene transfer products to treat advanced cancer.”
Trevor Hawkins, CEO of Next Generation Diagnostics at
Siemens Healthcare, says the new partnerships fall in line with the company’s
new initiative, Siemens Agenda 2013, a two-year global initiative. He notes
that ViiV and Tocagen are very different in size, which is a bonus for Siemens
as it highlights their ability to work with “a broad spectrum of partners.”
“Siemens is in a rather unique position here,” he adds. “We
do not have a pharma division, and so we are able to have the luxury of working
both with the established players and the up-and-coming future leaders in this
marketplace, such as the Tocagen relationship that we’ve now established.”
Hawkins says he expects companion diagnostics to only become
more prevalent as the pharmaceutical industry moves forward, citing “a growing
linkage between therapies and required companion diagnostic assays.” While
companion diagnostics have been particularly common in oncology, as a way to
determine patients’ responsiveness to therapies, they are gaining popularity
for that purpose in other therapeutic fields as well, for patient
stratification and to help determine dosing levels. The industry, he says, “is
moving towards a model where therapies will need to be tailored more and more
to the individual.”
“When we think about companion diagnostics, people often
think that these are molecular tests, and in many respects they are, but
there’s also immunoassay tests, there’s also imaging that is used as part of
companion diagnostics,” says Hawkins. “What is exciting from Siemens’
perspective is that we have leadership positions in imaging, in diagnostics, in
molecular—and we have enabled ourselves to bring together these pieces of the
jigsaw puzzle to solve what is quite a complex problem, in terms of being able
to give physicians the most up-to-date information on how to make decisions
about how they treat their patients.
“We do foresee this area growing, and growing rapidly, and
we wholly anticipate future partnership with large and merging pharma partners
going forward,” he adds. Code: E031215 Back |
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