Regulatory

Regulatory Matters: Collaboration is key for Life (Sciences) in 2017 – Part Two

The Life Sciences sector is very innovative. The Boston Consulting Group found that almost 20% of the world’s most innovative companies came from the sector. In fact, PwC suggests that Healthcare will surpass Computing as the largest industry by R&D spend by 2018.

Shining a light on the innovation paradox

Yet, for all the effort, there is still a lack of new products. Last year marked a six-year low for new drug approvals by the FDA. The rise of treatment-resistant superbugs has shone a light on the fact that there hasn’t been a completely new antibiotic for over 30 years. The poor return on R&D investment explains the paradox between innovation increase and new product decrease. Deloitte found that returns on research and development investment at the top 12 pharmaceutical companies fell to just 3.7 percent in 2016 from a high of 10.1 percent in 2010.

While many Life Sciences executive remain upbeat about the development of new medicines, it’s clear that two factors will drive success: achieving improved operating efficiencies internally and creating more strategic alliances externally.

The Internet of Things will increase the focus on cybersecurity

In 2014, the Financial Times found that cyber security for the healthcare and pharmaceutical industries worsened at a faster rate than any other sector. As the sector becomes more and more IT driven in terms of innovation, R&D and manufacturing, cyber crime has been increasing in areas such as intellectual property (IP) theft, international espionage and denial of service attacks. As the sector looks to embrace digital transformation and the Internet of Things (IoT), cyber security is likely to be top of every CIOs priority list.

The trend towards preventative and outcome-centric models relies on the ability to monitor and measure the health of individual patients. Whether wearables or other intelligent medical devices, the requirement for some form of online connectivity creates a vulnerability. At a recent cyber security conference, experts showed how items such as an insulin pump can be hacked. This represents a real threat to the individual but also raises the possibility of devices such as pace makers being used to launch denial of service on other targets. Addressing cybersecurity concerns, the FDA has issued guidance to medical device manufacturers to mitigate and manage cybersecurity threats.

The excitement around IoT has to be tempered with the need to deliver water-tight security. This stretches way beyond the ability to gain access to user devices. It has to encompass data in transit and the management and storage of data within the life sciences company itself. Security-by-Design – built into all OpenText solutions – will become a foundational element of every part of the IT infrastructure for healthcare and pharmaceutical companies.

Achieve operational efficiencies to improve margin and time to market

With the focus firmly on value-based medicine, personalized care and population health, the Life Sciences sector is experiencing new levels of convergence and collaboration. Companies have begun to transform their business operations through collaborative product development and new service development.

The ‘not invented here’ model is no longer appropriate for increasingly complex and expensive product lifecycles. As Deloitte points out: “Collaborating throughout the product development lifecycle is becoming an increasingly common and effective way for biopharma and medtech companies to offset mounting R&D costs, funding shortfalls, increasing disease complexity and technology advances”.

In 2017, life sciences companies are transforming their traditional, linear supply chain into a supply chain of dynamic, interconnected systems that integrate their ecosystem of partners. This new supply chain modality allows organizations to extend their value chain beyond product development into the enablement of care in an increasingly outcome-based healthcare environment.

By creating a secure, open and integrated supply chain, organizations are able to reduce cost, increase quality and manage risk across the partner ecosystem. It provides the foundation to quickly and easily extend the partner network for Life Sciences.

As you evaluate your business strategies and priorities over the next 12-18 months, collaboration with trusted partners like OpenText can prepare your organization for the challenges ahead. Contact me at jshujath (@opentext.com) to discuss how we can help.

If you missed the first blog in this two part series, you can view it here.

About Jaleel Shujath

Jaleel Shujath
Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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