APR January/February 2022 - 62
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FORMULATION AND DEVELOPMENT
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Enabling Technologies Consortium:
Implementations of Wearable Enhanced Knowledge
and Analytics Platforms for Pharmaceutical Laboratories
Len Blackwell,1 Brian Good,2 Geoffrey Kinnel3
Peter Tattersall3
1
3Bristol Myers Squibb
Introduction
Core tools used for research and development in pharmaceutical
laboratories, such as media capture, integration, and electronic
notebooks, have not kept pace with the electronic multimedia tools
and capabilities that are common in other personal and home-use
technology. Within the Enabling Technologies Consortium, a collection
of like-minded development scientists worked together on nextgeneration
lab wearable and documentation solutions to align across
pharmaceutical companies and influence vendors to meet future
business needs. The use of wearable technology in laboratories and
interface of devices with Electronic Laboratory Notebook (ELN) and
other applications using a software agnostic approach was identified
as a key opportunity. The subsequent assumptions, goals, results, and
suggested next steps follow.
Background
Since the dawn of the scientific process, curious and enterprising
scientists have needed the ability to record thoughts, observations
and results in an easy and continuous way. Perhaps the most famous
historical example of this is Leonardo da Vinci's notebook. Fortunately,
technology improvements have made that process easier. Notably,
about 20 years ago, professional scientists were able to take a big step
forward with the maturation of the ELN.
In the last ten years computer and mobile technologies have advanced
exponentially with processing power, connectivity, affordability and
ease of use. However, pharmaceutical companies have been slow
to adopt use of these new technologies. As a result, pharmaceutical
professionals often do not have access to the same technology in their
laboratories as they do in their homes.
The topic of transforming the way scientists document and capture
data within the laboratory was raised within the Analytical working
group of the IQ Consortium (International Consortium for Innovation
& Quality in Pharmaceutical Development). Identifying and removing
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barriers to these technologies, and reaping the resulting productivity
and quality gains is a priority for the IQ member companies.1
Biogen
2Eli Lilly
&
As an
outcome of a meeting on the subject at the IQ Summit in 2018, a
working group was formed (Next Generation Capture Working Group).
The working group included 15 individuals from 12 mid to large
pharmaceutical companies. The group focused on surveying and
understanding the technology landscape within the industry by
inviting each member company to share their respective informatics
technology platform and visions. It was clear from these early
discussions that while some details at each company differed, the
members experienced highly similar struggles to take advantage of
new information technology.
The next phase of the discussion was an open period for " blue
sky thinking " . To help the group consider the way in which these
technologies could evolve, the conversation shifted to technical and
organizational maturity.2
The team examined the many dependencies
and barriers to implementation for transformative ideas. This helped
the team further organize the needs and potential technology
solutions. The group then agreed to and published the transformation
map that serves as a general guide to improving capabilities (Figure 1).
In late 2019 the working group leader met with IQ leadership to discuss
the next steps. The outcome of this discussion was a decision to move
this project into the Enabling Technologies Consortium (ETC) to focus
on certain key areas in the transformation map. The ETC is a derivative
of the IQ consortium that provides member ETC companies with a
framework and funding mechanism to develop new technology.
The guidance and best practices give a working team the framework
needed to develop request for information, receive vendor responses
and set a contract with partners for technology development.
The team published their request for information and within 60 days
had multiple industry responses. After careful consideration by the
project team and the ETC Board of Directors, the decision was made to
move forward with two vendors that appeared to have complimentary
areas of strength. Apprentice was selected for their experience
with wearable implementations and strength in the execution of
processes and procedures. Varya Technologies was selected for their
lightweight and flexible information platform which matched design
APR January/February 2022
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