22 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com
AVAILABLE TOOLS
BioPharm: What tools are currently
available for companies to deal with
this potential increased volume of data?
Munnik (Iperion): Most compa-
nies are still struggling with the leg-
ac y of data capt ured and held in
documents. For large parts of the port-
folio, consistency between the regula-
tory information and the data stored
in documents needs to be checked,
e x t racted, and a l ig ned w it h ISO
IDMP/SPOR data.
Tools exist that can alleviate the
burden of the data extraction, and
which make use of artif icial intelli-
gence (AI). However, experts in the
interpretation of the regulatory data
have an important role to play too,
to assess the data extraction and data
transformation requirements.
Biotech companies (with a smaller
portfolio) have a potential advantage
in being able to leverage processes
and systems that work w ith str uc-
tured data in a shorter timeframe.
Kelleher (Generis): T here is
a move towa rds 'plat forms' which
l e v e r a g e t e c h n o l o g y s u c h a s
Elasticsearch for ver y rapid search-
ing in massive volumes of data. The
concept of data lakes is being married
to document /data repositories—for
example, our platform can contain all
enterprise data, documents, and busi-
ness processes in a single 'Information
Lake' to a l low the enter-one-and-
reuse that ensures data consistency
for pu r pose s suc h a s I DM P a nd
digital automations. There are t wo
key aspects to this: to have a plat-
form that does actually consist of a
single data source—rather than the
older-style platforms that are multiple
silos built with the same technology
and need connectors and even then,
still duplicate data; and to have a plat-
form that doesn't just act as a data
store but prov ides the place where
users can do their entire business
process, guided by wizards/automa-
tions, and where they have access to
all supporting data required, regard-
less of its provenance or data owners
within the company.
ACCELERATED UPTAKE
BioPharm: Do you feel industry's cau-
tious approach to technology advances
is changing?
Kelleher (Generis): Interestingly,
we have seen a major change in this
si nce t he pa ndem ic —t he r ate at
which companies are reaching out for
the kinds of automations, AI, single
'Information Lake' solutions has really
accelerated, and the fear of newer tech-
nologies, moving to the cloud, and
taking 'out of the box' pre-configured
solutions has dramatically decreased—
companies are looking for ready-made
solutions (with pre-packaged validation
thrown in) that can set them up for the
coming five-year explosion in industry
digital requirements and the faster pace
of drug development that we have seen
start during the pandemic.
Stulp (Iperion): Many bio/pharma
companies are looking into ways in
which AI might support and increase
efficiency internally. Within the regu-
latory field, the administrative burden
has only increased over the last few
years, with fewer people having to do
more work. We believe that the time is
right to do things smarter, quicker… to
optimize existing processes via a more
data-driven way of working.
REFERENCES
1. EMA, "Data on Medicines (ISO
IDMP Standards): Overview," ema.
europa.eu [Accessed Feb. 2, 2022].
2. EMA, "Substance and Product
Data Management Services,"
ema.europa.eu [Accessed Feb. 4,
2022].
BP
Quality and Regulatory Sourcebook Regulations: Data Integrity
"One emerging
trend is the
desire to increase
automations—having
a system that acts
as a 'dump' of data
or documents is no
longer sufficient."
—James Kelleher,
Generis
The European Medicines Agency
(EMA) has started to establish its
Data Analysis and Real World Inter-
rogation Network (DARWIN EU) Co-
ordination Centre (1).
According to a press release from
the regulatory agency, the center,
which is aimed at the development
and management of real-word
healthcare data sources across the
European Union (EU), will provide
EMA and other national competent
authorities within Europe with ac
-
cess to trustworthy and real-world
evidence. Additionally, scientific
studies that have been requested by
medicines regulators—and, later on,
by other stakeholders—can be con
-
ducted at the center.
The center is expected to provide
a useful resource to many stakehold-
ers, thanks to its use in supporting
decision making on the development,
authorization, and surveillance of
medicines. Furthermore, EMA antic
-
ipates the DARWIN EU Coordination
Centre will prove to be a beneficial
resource for the preparation and re-
sponse to future healthcare crises
and pandemics.
Reference
1. EMA, "Initiation of DARWIN EU Coor-
dination Centre Advances Integration
of Real-World Evidence into Assess-
ment of Medicines in the EU," ema.
europa.eu, Press Release, Feb. 9, 2022.
—The Editors of BioPharm International
EMA Establishes Real-World Evidence Center
