All posts by Administrator

30Jul/21

Medical Device Cybersecurity Throughout the Product Life Cycle

By: Thomas Maeder, Industry Analyst, Axendia

“The United States faces persistent and increasingly sophisticated malicious cyber campaigns that threaten the public sector, the private sector, and ultimately the American people’s security and privacy,” begins the May 2021 presidential executive order on improving the nation’s cybersecurity.  Recent crippling cyberattacks on the Colonial pipeline and JBS Foods, and the SolarWinds and Microsoft Exchange hacks, among others, have painfully highlighted the fragility of the information and operational technologies on which the modern world so heavily relies. 

Cybersecurity in Healthcare

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13Jul/21

Dassault Systèmes Articulates Interconnected Life-Science Vision

Dassault Systèmes 2021 Analyst Conference Event Brief

By: Sandra K. Rodriguez, Senior Industry Analyst and Daniel R. Matlis, President

Dassault Systèmes continued to articulate its interconnected Life-Science vision at the 2021 Analyst conference.

“In the experience economy, business science and innovation are all about relationships,” said Bernard Charlès, Vice Chairman, Chief Executive Officer at Dassault Systèmes. “The real phenomenon of the platform is about building an interconnected continuous interactive loop with your value chain from design to user experience,” he added.

“We are not talking about upstream and downstream applications anymore, it’s a continuous flow of imagine, create, produce, advocate, value and use,” said Charlès.

While Axendia does not believe in force ranking vendors because there is no BEST (see: Who is the Best Technology Vendor?), Dassault Systèmes executives were the first to articulate their avant-garde vision to support the Life-Science value network from end to end.  This vision is backed by an impressive offering portfolio aimed at providing an interconnected and continuous interactive platform that supports the Life-Science value network from end to end. 

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23Jun/21

Quantum Computing Opens New Opportunities for Life-Sciences in Europe

IBM and Fraunhofer Unveil Fastest Quantum Computer in Europe – Event Brief

By: Eric M. Luyer, Industry Research Analyst Axendia Inc.

Axendia Inc. was present on 15-JUN-2021 at the official inauguration of the first IBM Quantum Computer in Europe by IBM and the Fraunhofer-Gesellschaft. The setting was a compact virtual live event with highly distinguished guest speakers: Dr. Angela Merkel – German Chancellor, Dr. Arvind Krishna – CEO and Chairman IBM, Prof. Dr. Reimund Neugebauer – President of the Fraunhofer – Gesellschaft e.V. as well as various representatives of large industries such as Trumpf, Bosch, BASF, BMW and others.

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02Jun/21

Leading Companies Modernize Quality Management in the Cloud

Veeva Briefing Note

By: Sandra K. Rodriguez, Sr. Industry Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality and Kent Malmros, senior director of Vault Training at Veeva Systems.  Veeva Systems (www.veeva.com) is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers continue to increase in numbers and now include 14 of the top 20 largest pharmaceutical companies. Leading companies around the world are adopting a cloud culture to lower the cost of implementation and ownership, enable collaboration with external partners, and simplify business processes.  To date, more than 175 biopharma, contract manufacturers, generics, and medtech companies, have adopted Vault QMS to streamline and automate quality processes. “As a trusted partner, Veeva has been collaborating closely with life sciences companies globally on their digital quality initiatives,” said Mike Jovanis, vice president, Veeva Vault Quality. “We are committed to customer success and will continue to deliver customer-focused innovation across product development and manufacturing.”

Vault QMS is part of the Veeva Vault Quality Suite, including Vault Product Surveillance, Vault QualityDocs, Vault Station Manager, and Vault Training to automate and harmonize quality processes globally.

Veeva’s continuous innovation is helping customers proactively manage quality and increase agility. Over the last year, new features for Vault QMS include:

  • Seamless connection between Vault QMS and Veeva Vault Registrations to reduce cycle time and increase transparency within post-market change control
  • Quality Risk Management (QRM) advancements, including FMEA methodology to support proactive identification and mitigation of risks
  • Fully automated process for external auditees such as CMOs and suppliers to respond to audit findings directly within the system
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28May/21

AI-Assisted Automated Visual Inspection: An Amgen Success Story

By: Sandra K. Rodriguez, Senior Industry Analyst

The team at Amgen’s Juncos, Puerto Rico facility successfully implemented and validated the first AI-enabled visual inspection system in a production line. Hear directly from Amgen’s Jorge Delgado, Process Development Scientific Director and Manuel Soto, Senior Process Development Scientist.

We discuss the differences between AI, Machine Learning and Deep Learning, as well as demonstrating proof of concept and implementing the technology in a GMP environment.

Hear the incredible benefits achieved and much more in this “Straight from the Source” webinar.