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01Sep/21

FDA Reports on The State of Pharmaceutical Quality

Remote Evaluations, Grading Industry on a Curve and Using AI to Predict Site Inspection Scores

By: Axendia Staff

The FDA issued its latest report on the State of Pharmaceutical Quality.  In the report, the Agency describes Pharmaceutical Quality as the ability of the pharmaceutical manufacturing industry to deliver quality drug products to U.S. patients and consumers. In addition, FDA defines quality drug products as those that are safe and effective and free of contamination and defects.  It is worth noting the absence of the word “compliant” in these definitions.

Hidden among Hand Sanitizer recall data were a number of significant developments on FDA’s regulatory approach.

This Brief represents Axendia’s analysis and insights on FDA’s Report on the State of Pharmaceutical Quality.

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16Aug/21

Innovating to Help Industries Transform

Event Brief – SAP Industry Analyst Base Camp 2021

By: Sandra K. Rodriguez, Senior Industry Analyst

Peter Maier, President, SAP Industries and Customer Advisory, opened the 2021 Industry Analyst Base Camp with words of caution, “there is still less consensus about the new normal and the future will be more dynamic and uncertain.” With a variety of industry cloud solutions ranging from Automotive, Banking, Consumer Products, Financial Services to Life Sciences and more, Maier said with confidence, “we are the market maker, once again.”

Recognizing that all companies have different starting points, SAP customers are optimizing existing systems and taking a multi-step approach to transition to a modular cloud architecture.  “Moving to the cloud is a journey, not a destination” added Julia White, Chief Marketing and Solutions Officer and Executive Board Member at SAP.  This architecture is comprised of SAP S/4HANA Cloud, Industry Cloud (3rd Party Apps and SAP), SAP Line-of-Business (LOB) Solutions and the SAP Business Technology Platform (BTP) which brings together enterprise applications into one platform for both cloud and hybrid environments. This includes hundreds of pre-built integrations for SAP and third-party applications. White accurately pointed out that many companies have relied on on-prem technologies for decades.  As a result, there are multiple paths customers can take to make the transition. It is not a one size fits all journey.

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05Aug/21

Digital Integration with PLM: A Fresenius Medical Care Success Story

By: Sandra K. Rodriguez, Senior Industry Analyst

Bill D’Innocenzo, SVP Digital Integration and Larry Dube, VP PLM Digital Strategy at Fresenius Medical Care share the secrets to their successful digital integration journey in this open and frank conversation.

We discuss:

  • How long does it take to build a strong foundation to implement a successful digital integration strategy?
  • Does culture change matter when shifting the mindset of your peers?
  • Who has the best in class, end-to-end solution to meet the needs and requirements of medical device companies who are embarking on their digital journey?

Take a sneak peak of our candid discussion in this video clip:

There’s much more! Watch this “Straight from the Source” webinar now.

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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