Pharmaceutical Outsourcing Q3 2023 - 37

INDUSTRY NEWS
SECTION TITLE
Thermo Fisher Selected as Transplantation
Statistical and Clinical Coordinating
Center for National Institute of Allergy
and Infectious Diseases
The PPD clinical research business of Thermo Fisher Scientific was
granted a five-year award to provide a Transplantation Statistical and
Clinical Coordinating Center for the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health
in the United States. This center will offer a broad range of support
services critical to the design, development, execution and analysis of
NIAID transplantation clinical trials and research.
According to the United Network for Organ Sharing, the non-profit
serving as the nation's transplant system under contract with the
federal government, more than 40,000 organ transplants were
performed in 2022, setting an annual record, with total kidney
transplants exceeding 25,000 for the first time ever. Meanwhile,
the Health Resources & Services Administration within the U.S.
Department of Health and Human Services notes that more than
100,000 people are on the national transplant waiting list for all
organs combined.
Research advances continue to expand the understanding of the
biological mechanisms of solid organ transplant rejection and
acceptance, yielding significant improvement in one-year survival
rates and quality of life. While design of clinical trials in this field
can be challenging, the PPD clinical research business has the tools
and expertise necessary to help sponsors develop successful, costeffective
studies that minimize site and patient burden.
Thermo Fisher's PPD clinical research business has three decades
of experience successfully delivering clinical research services to
governmental agencies, contractors and nonprofits. The business
has conducted therapeutic, vaccine and medical device studies
on a global scale across all trial phases and a broad array of
therapeutic areas. During the past five years, it has conducted
nearly 150 studies in transplantation and related indications,
involving more than 7,000 patients at more than 2,200 research
sites around the world. More broadly, Thermo Fisher's transplant
diagnostics business offers advanced solutions to help improve
quality of life for transplant patients.
" The scope of clinical research supported by our transplantation center
enables us to help advance NIAID-sponsored transplantation studies,
the results of which are essential to minimizing or, more hopefully,
removing barriers to the success of transplantation procedures and
the complications of long-term immune suppression, " said David M.
Johnston, Ph.D., senior vice president and president, clinical research,
Thermo Fisher Scientific. " We welcome the opportunity to help
design and implement effective and efficient clinical trials to move
the science of transplantation forward. "
The center will provide services such as statistical design and
analysis; clinical protocol development, implementation and study
management;
biospecimen
tracking;
manuscript
publication
support; study management team organization and maintenance;
and collaboration with other stakeholders to plan, oversee, execute
and analyze NIAID-sponsored transplantation research.
The results of that research are essential to minimizing or removing
barriers to short- and long-term success of transplantation procedures
by
reducing
the morbidities
associated with
pharmacological
immunosuppression, inducing transplantation-immune tolerance
and improving understanding of the immunologic response to
allotransplantation.
In June, Thermo Fisher expanded its transplant diagnostics
capabilities by opening its One Lambda Laboratories. The CLIAlicensed
laboratory provides a suite of noninvasive, post-transplant
testing services dedicated to improving long-term outcomes
for transplant patients. The new lab will introduce a menu of
breakthrough assays that can detect rejection from at-home urine
samples, delivering results to clinicians with rapid turnaround, while
easing the burden on the patient by potentially eliminating the need
for an invasive biopsy. The lab also will offer customers research
services to advance the development of new immunotherapies and
immunosuppressive agents.
The NIAID project will be funded in whole with federal funds from
NIAID, the National Institutes of Health and the Department of Health
and Human Services under cooperative agreement U01AI178756. The
content of this announcement is solely the responsibility of Thermo
Fisher Scientific and does not necessarily represent the official views
of the National Institutes of Health.
Emergent BioSolutions to Lay Off 400
Emergent BioSolutions announced it is reducing investment in and
de-emphasizing focus on growth in its CDMO services business. As
a result, Emergent is reducing operations at its Bayview facility in
Baltimore, Maryland.
Additionally, Emergent
will
reduce operations at
its
facility in
Canton, Massachusetts, in response to changes in the volume of U.S.
government procurements of medical countermeasures. This action
will also result in a small reduction in operations at the company's
Rockville, Maryland, drug product facility.
Going forward, Emergent will focus on its core products business -
medical countermeasures and NARCAN® Nasal Spray -and on delivering
for its existing customers, including the U.S. and allied governments.
Emergent will maintain a level of operations at both Bayview and
Canton to ramp up production in response to new demand.
" The actions we are taking will further strengthen our core products
business and financial foundation, " said Emergent interim Chief
Executive Officer Haywood Miller. " This will better align Emergent's
businesses with a focus on our core products and delivering for
the needs of our customers.
It will provide us with flexibility to
respond to future customer demand while responsibly maintaining
manufacturing infrastructure deemed critical to respond to public
health threats. "
pharmoutsourcing.com | 37 | July/August/September 2023
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Pharmaceutical Outsourcing Q3 2023

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