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pi | contact@3-14.com | www.3-14.com
The life sciences industry in 2018
What are some of the major evolutions shaping the future life sciences landscape?
pi | contact@3-14.com | www.3-14.com
Handling data correctly will be crucial
3 | pi © 2017 pi | contact@3-14.com | www.3-14.com
For several years now, the different regulatory
agencies have emphasised the importance of
accurate and reliable data as one of the backbones
of cGMP compliance.
High quality data throughout the product's lifecycle is
essential to steer innovation, efficiency and strategy.
Data integrity remains a critical component of every
company’s Quality System.
Data Integrity
4 | pi © 2017 pi | contact@3-14.com | www.3-14.com
As of May 2018, the General Data Protection
Regulation (GDPR) will replace the 1997 Data
Protection Directive.
Compliance to the GDPR will be one of the main
challenges for many industries in 2018, with the life
sciences industry being no exception.
With the growing importance of data, how will the
landscape adapt to these new regulations and
successfully solve the conflict between the rights of the
individual and the current regulatory framework?
Data Privacy
5 | pi © 2017 pi | contact@3-14.com | www.3-14.com
From the use of big data in clinical trials to medical
devices gathering personal data, the business values
of data is only increasing.
Following its increase in value, both small and bigger
players have fallen victim to an increasing number of
cyber attacks.
Upgrading and maintaining data security will be a
crucial aspect of any business in the years to come.
With the solutions readily available, the real challenge
will be the successful transfer to these new
technologies.
Data Security
pi | contact@3-14.com | www.3-14.com
We are moving closer and closer to
our patients.
7 | pi © 2017 pi | contact@3-14.com | www.3-14.com
The Internet of Things (IoT) is making its entrance in the
life sciences industry. New technological innovations are
paving the way for a better follow-up of patients and a
decrease in overall healthcare cost.
The past year, tech giants have displayed increased
determination to enter the market of approved medical
devices.
Following this evolution, the major regulatory bodies
have taken steps to both stimulate and regulate this
upcoming shift in use of technology.
Medical Devices
8 | pi © 2017 pi | contact@3-14.com | www.3-14.com
Looking at the opportunities medical devices offer and the
new and innovating ways pharmaceutical drugs can be
delivered and even administered, we are most definitely
moving towards an industry where patient centred
healthcare is very much real.
The industry is interacting more and more directly with its
end users, offering new and cost-effective ways to treat
patients. Future healthcare will be designed to meet the
needs and preferences of individual patients.
This greater patient responsibility and usage will improve
the overall quality of life and take pressure of the existing
healthcare system.
Patient Centred Healthcare
pi | contact@3-14.com | www.3-14.com
A (r)evolution in manufacturing
10 | pi © 2017 pi | contact@3-14.com | www.3-14.com
As the industry tries to limit downtime and reduce
waste as much as possible, we see a shift towards
investments in continuous manufacturing with
increased automation being a part of this evolution.
In an increasingly competitive landscape, this focus
on efficiency and operational excellence will help to
increase profitability whilst respecting the necessary
levels of quality.
Continuity is key
11 | pi © 2017 pi | contact@3-14.com | www.3-14.com
Our value proposition
pi is the strategic partner of choice to some of the world’s leading life science companies.
We offer our clients unique expertise and strategic consultancy of the highest quality.
We dedicate ourselves to bringing excellence to the life sciences industry.
We’ve grown by learning how to be better.
Better resourced to focus our faculty of consultants’ singular experience and knowledge.
Better managed to share their depth of understanding.
Better prepared to challenge orthodox thinking.
And better able to redefine accepted best practice.
To accept no other standard than excellence.
Connect with us on LinkedInVisit our website Follow us on Twitter

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The life sciences industry in 2018

  • 1. pi | contact@3-14.com | www.3-14.com The life sciences industry in 2018 What are some of the major evolutions shaping the future life sciences landscape?
  • 2. pi | contact@3-14.com | www.3-14.com Handling data correctly will be crucial
  • 3. 3 | pi © 2017 pi | contact@3-14.com | www.3-14.com For several years now, the different regulatory agencies have emphasised the importance of accurate and reliable data as one of the backbones of cGMP compliance. High quality data throughout the product's lifecycle is essential to steer innovation, efficiency and strategy. Data integrity remains a critical component of every company’s Quality System. Data Integrity
  • 4. 4 | pi © 2017 pi | contact@3-14.com | www.3-14.com As of May 2018, the General Data Protection Regulation (GDPR) will replace the 1997 Data Protection Directive. Compliance to the GDPR will be one of the main challenges for many industries in 2018, with the life sciences industry being no exception. With the growing importance of data, how will the landscape adapt to these new regulations and successfully solve the conflict between the rights of the individual and the current regulatory framework? Data Privacy
  • 5. 5 | pi © 2017 pi | contact@3-14.com | www.3-14.com From the use of big data in clinical trials to medical devices gathering personal data, the business values of data is only increasing. Following its increase in value, both small and bigger players have fallen victim to an increasing number of cyber attacks. Upgrading and maintaining data security will be a crucial aspect of any business in the years to come. With the solutions readily available, the real challenge will be the successful transfer to these new technologies. Data Security
  • 6. pi | contact@3-14.com | www.3-14.com We are moving closer and closer to our patients.
  • 7. 7 | pi © 2017 pi | contact@3-14.com | www.3-14.com The Internet of Things (IoT) is making its entrance in the life sciences industry. New technological innovations are paving the way for a better follow-up of patients and a decrease in overall healthcare cost. The past year, tech giants have displayed increased determination to enter the market of approved medical devices. Following this evolution, the major regulatory bodies have taken steps to both stimulate and regulate this upcoming shift in use of technology. Medical Devices
  • 8. 8 | pi © 2017 pi | contact@3-14.com | www.3-14.com Looking at the opportunities medical devices offer and the new and innovating ways pharmaceutical drugs can be delivered and even administered, we are most definitely moving towards an industry where patient centred healthcare is very much real. The industry is interacting more and more directly with its end users, offering new and cost-effective ways to treat patients. Future healthcare will be designed to meet the needs and preferences of individual patients. This greater patient responsibility and usage will improve the overall quality of life and take pressure of the existing healthcare system. Patient Centred Healthcare
  • 9. pi | contact@3-14.com | www.3-14.com A (r)evolution in manufacturing
  • 10. 10 | pi © 2017 pi | contact@3-14.com | www.3-14.com As the industry tries to limit downtime and reduce waste as much as possible, we see a shift towards investments in continuous manufacturing with increased automation being a part of this evolution. In an increasingly competitive landscape, this focus on efficiency and operational excellence will help to increase profitability whilst respecting the necessary levels of quality. Continuity is key
  • 11. 11 | pi © 2017 pi | contact@3-14.com | www.3-14.com Our value proposition pi is the strategic partner of choice to some of the world’s leading life science companies. We offer our clients unique expertise and strategic consultancy of the highest quality. We dedicate ourselves to bringing excellence to the life sciences industry. We’ve grown by learning how to be better. Better resourced to focus our faculty of consultants’ singular experience and knowledge. Better managed to share their depth of understanding. Better prepared to challenge orthodox thinking. And better able to redefine accepted best practice. To accept no other standard than excellence. Connect with us on LinkedInVisit our website Follow us on Twitter