Establishes Working Group with the FDA on Nonclinical Initiatives
PHILADELPHIA–(BUSINESS WIRE)–BioCelerate,
a subsidiary of TransCelerate
BioPharma Inc., today announced a collaboration with the Food and
Drug Administration (FDA) to launch a joint working group which will
explore methods to enable more effective analysis of nonclinical studies
across the research community. Discussions are aimed at supporting more
efficient and data-driven decision-making during early-stage research
and development.
The working group of BioCelerate and the FDA’s Office of Computational
Science (OCS) will evaluate and publish findings related to the use of
study datasets leveraging Clinical Data Interchange Standards
Consortium’s Standard for Exchange of Nonclinical Data (CDISC SEND). The
group will also evaluate methods, tools and/or common templates which
may contribute to more effective analyses or use of nonclinical research
data.
“This collaboration is another step forward as part of the FDA’s
longstanding commitment to advancing a more efficient and data-driven
decision-making processes,” stated Janet Woodcock, Director of the FDA’s
Center for Drug Evaluation and Research.
The collaboration between the BioCelerate and FDA stems from
conversations around BioCelerate’s past work in data sharing and
recently launched initiatives that focus on nonclinical study
optimization:
-
The SEND Implementation for Cross-Study Analysis initiative is
evaluating barriers and opportunities for using SEND data sets for
cross study comparisons and analysis. Results of the evaluation may
serve as future recommendations for CDISC, the standard setting
organization governing the SEND data standard. -
The Common Templates for Nonclinical Studies initiative has
produced a draft protocol template for repeat-dose toxicology studies
that is designed to help CROs and sponsors by reducing errors,
improving operational efficiencies, and reducing costs during the
interpretation and execution of studies. This team is currently
evaluating public feedback on the draft and planning additional
discussions with stakeholder groups later this year to further improve
upon the template.
“Both BioCelerate and the FDA see SEND as a critical enabler for both
single-study and cross-study analysis, and this collaboration helps the
R&D ecosystem further validate decisions and diminish attrition
earlier,” said Dalvir Gill, PhD, CEO of TransCelerate BioPharma, Inc.
“Given that SEND is one of the FDA’s required standards for data
submission, it is critical to maximize the value of datasets using this
standard.”
Toxicology Data Sharing Initiative Grows Volume of Data
Since launching DataCelerate®, a technology platform to enable R&D data
sharing, in May 2018, BioCelerate’s Toxicology Data Sharing (TDS)
initiative has established effective data sharing agreements across
participating Member Companies to support sharing of studies. Nearly 80
percent of studies within the Toxicology and Nonclinical Background
Control modules of DataCelerate are provided in SEND (structured)
format. These First in Human-enabling studies have the capacity to be
correlated more directly with early clinical safety data. To date, the
initiative has identified eight targets in the database (two for which
multiple compounds are available).
TDS will enable companies to perform better translation of nonclinical
findings and attempt to close critical gaps that exist in understanding
the relationship between patient response and preclinical toxicology
findings. Later this year, the platform will release enhanced
functionality including the ability to voluntarily share and search for
compound structures.
Raja Mangipudy, Executive Director of Toxicology, Bristol-Myers Squibb
and BioCelerate’s Toxicology Data Sharing Initiative Lead, noted,
“Having access to this data, participating Members are able to
confidently make smarter decisions on compound progression, ultimately
helping ensure that viable therapies are brought to patients faster. We
are excited about the future for DataCelerate®, which has the potential
to connect to numerous other data sources and potentially provide
linkages to clinical data to derive analytics in the future.”
BioCelerate Membership Expands
Pfizer and Janssen Research & Development, LLC, one of the
Pharmaceutical Companies of Johnson & Johnson, are founding members of
TransCelerate, and the most recent members of BioCelerate.
John Burkhardt, DVM, PhD, Senior Vice President, Drug Safety R&D at
Pfizer commented, “Given the success of the Toxicology Data Sharing and
Nonclinical Study Optimization Initiatives and the great engagement with
global regulatory authorities thus far, we saw an opportunity to further
improve upon our nonclinical capabilities by joining this collaboration.
BioCelerate’s collaborative approach allows us to move toward a higher
competency in predicting outcomes that helps us judge feasibility of R&D
programs.”
Cindy Afshari, Ph.D., DABT, Global Head of Nonclinical Safety, Janssen
Research & Development said, “We believe BioCelerate provides an
intuitive database platform and data visualization approach that will
enable Janssen toxicologists to begin to glean new insights to data as
it is contextualized across the broader data content.”
About BioCelerate
BioCelerate focuses on the identification and development of pragmatic
and tangible solutions to improve efficiencies in nonclinical research,
with the end goal of improving overall drug development efficiency to
bring new medicines to patients faster. Initiatives are approved by a
Governing Council made up of participating BioCelerate Companies.
BioCelerate is a separate legal subsidiary of TransCelerate BioPharma
Inc. with separate funding and support. To participate in BioCelerate,
you must be a Member Company of TransCelerate. TransCelerate membership
is available to biopharmaceutical research and development organizations
who engage innovative discovery, development and manufacturing of new
drugs.
For more information, please visit http://www.transceleratebiopharmainc.com/biocelerate,
https://twitter.com/transcelerate,
or www.linkedin.com/company/transcelerate-biopharma-inc-.
Contacts
Company
Leigh Anne Minnier
Communications Manager
201-841-5768
leighanne.minnier@transceleratebiopharmainc.com
Media
Bliss Integrated Communication for TransCelerate
Vicky
Aguiar, 212-584-5470
vicky@blissintegrated.com