BPIT to tackle cyber-security and plant resilience

The Information Technology Phorum (BPIT) will be tackling cyber-security and plant resilience in 2018. This is a vast subject for the phorum to approach. Initially they are conducting a survey on plant resilience to understand which of the many issues are important for the members. They will then work together to start on priority initiatives which can address some of the questions posed by the subject. While the prevention side may be more about improving what is already in place, the recovery aspect of plant resiliency is expected to be leading the in-depth discussions.

The issue of plant resiliency impacts all members and not only from cyber threats. Those members whose plants have suffered from natural disasters, like that of Hurricane Maria impacting Puerto Rico earlier this year, found that they have very similar challenges with plant recovery. It is also clear that newer cyber attacks, impacting data integrity, are possible.

 

The goal for BPIT is to take the findings from the survey and use this to bring together initiatives and work programs that focus on key aspects of plant resiliency. It is anticipated that ensuring data integrity will be increasingly important too. The collaboration of member companies will help create best practices to enable independent plant operations, speedier recovery, and improved protection standards with the goal of minimizing the impact on biopharmaceutical manufacturing from cyber attacks and natural disasters.

The survey results will be collated and reviewed in January 2018, and priority work agreed at a BPIT leaders call at the end of the month.

A cyber attack suffered by Merck MSD in June 2017 prompted a new discussion about cyber-security and plant resilience at the recent BPIT meeting in October 2017, San Francisco, USA.

Terry Rice, Merck MSD CISO, explained to the Phorum how it had been exposed to a malware attack through its use of document management software. Merck MSD kindly shared some of its learnings from the event with the group, and continues to speak about the incident to the US government amongst others.

The serious impact of such an event is clear to the BPIT Phorum and it raised some in-depth discussions about the issues surrounding an attack. Hackers regularly target organisations, but this amount of damage is unusual as protection methods often work. It is increasingly the case that it is when, not if, a large-scale cyber security incident occurs.

As a starting point, recent practice-sharing sessions have looked at recovery, segmentation and protection. Future collaborations, supported by workstream charters, will look at both tactical and strategic deliverables in the cyber security space.

Merck MSD kindly shared some of its learning points on the recovery side, including the level of customer service it received from its suppliers. As it was the only bio-pharmaceutical company impacted by this malware attack, it was able to quickly get operations back online. Had this not been the case and several companies been attacked the pressure, and ultimately recovery timescale, would have increased for everyone involved.

The case study of this event raised questions around how prepared members were in their plant resiliency. It raised issues around how digital plants are set up and the vulnerabilities that are faced by all members. While it is essential that all parts of the business are able to communicate and that plants continue their digital transformation alongside an Internet of Things, architectures may need to change and this is a place where the team will focus. Other areas of focus also include how to manage outsourced suppliers. Do the other business interests held by a third party increase the risk for the member?

These questions along with any others raised in the survey will form part of initiatives and work programs within BPIT in the new year.

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544

Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

Read More
The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

Read More
Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and[...]

Read More
Formulation team drive for more value

Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product robustness studies, was[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Why leaders should go to where work is performed to learn about success, failure and risk
Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

Read More
Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

Read More
How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

Read More
The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

Read More
Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

Read More
BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

Read More

IaaS Cloud webinar recording play back
Read More
New BPIT guidance to align cloud services to regulatory requirements
Read More
Data Integrity and Agile Webinars to support industry response to regulators
Read More
How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

Read More
Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

Read More
A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
Digital plant maturity model webinar replay
Read More
Digital Plant Maturity Model workstream to host webinar
Read More
New guidance available on Forecasting and Demand Planning to streamline supply chain performance
Read More
Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

Read More
Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

Read More
BEBPA risk assessment workshop
Read More
New toolkit to accelerate single-use design and specification

The single-use user requirements toolkit is now live and available for free download on the BioPhorum website  The toolkit streamlines the design and specification process[...]

Read More