2. Setting a new pace of change
The lessons of the last
year can help power the
discovery, development
and delivery of new
treatments for all health
conditions.
• Phase II and III protocol procedures have
increased 44% since 2009,
• Patient stratification and novel
biomarkers/endpoints driving a rise in trial
complexity.
More treatments
in development
+ market
stratification
• AI-based methodologies reduce time spent for
discovery from 4.5 years to a year.
• Virtual clinical trials grew by over 50%
in 2020.
• Average treatment duration of decentralized
trials was 36% (140 days) faster
Treatments are
coming to market
faster than ever
• Driving 81% of biopharma revenue growth and
61% of all revenues (2021-2026).
• The average NPV of New Science treatments to
be launched from 2022-2026 will exceed
traditional counterparts by 69%.
New Science
is more important
than ever
3. COVID-19 highlighted many orthodoxies
within life sciences that have now been
dispelled
Orthodoxy 1
We can’t change the
way we discover
medicine
Orthodoxy 2
We can’t deviate from
in-person clinical
trials, at premier sites
Orthodoxy 3
We can’t rapidly scale
manufacturing for new
modalities
4. What if we could…
Accelerate
early process
development
Accelerate filing
and approval of the
CMC dossier
Execute flawless
tech transfer of
manufacturing process
between teams
Optimize and speed
the manufacturing
process
6. Putting the digital thread in life sciences
(DTLS) to use
A biopharma client with one of the
most exciting pipelines in the
industry.
Looking to create a digital bridge
between R&D through
manufacturing to enhance new
product launch capability.
New product introduction and
technology transfer is historically
paper driven, time and effort
intensive and error prone.
This creates risk of delays in
product launch and ripple effects
in wider portfolio.
Leveraged and enhanced existing
IT platforms to create a digital
product profile and digitization of
the manufacturing control
strategy.
Initial pilot on a biologic tech
transfer resulted in more than 20%
reduction in effort.
The
opportunity
The typical
challenges
The DTLS
outcome
7. Migrate and
free-up
resources
Accelerating the digital thread with cloud
Adopt modern
application
development
practices
Gain faster,
deeper insights
with analytics
Ensure security,
compliance
and resiliency
Organize for
speed and agility
Bridge skills
and experience
gaps rapidly
8. Technical
Outcomes
Creating end-to-end integration with DTLS
Rapid drug discovery and
accelerated clinical
development
Smart factories for small
and large molecule drugs
Holistic view
of data
Interconnected
global network
Lifesaving treatments
reach more patients
Rapidly scale up manufacturing to support new clinical
and commercial launches
Quickly evaluate manufacturing feasibility with rapid feedback to
development cycle
Create end-to-end visibility by integrating operational manufacturing
information from disparate systems
Seamlessly bring data together across data lakes and source
systems to enable additional processing or transfer of information