Category Archives: Events

05Mar/19
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Disruption is on the Radar! You Must Plot a Course for Success.

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading

20Feb/19
Siemens CSA EBook Cover

FDA Shares a New Approach to CSV

A Straight from the Source Webinar

The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

Join us for a live webinar on March 7th at 1pm Eastern.  We will discuss FDA’s perspective on Computer Software Assurance (CSA) including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization.
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

Meet Your Trusted Sources

Dan and Cisco 2019 Webinar

 

 

 

 

 

 

Please Note:  This webinar is limited to the first 100 registrants.

Can’t make the live session? No problem!

Register for the live session and receive access to the on-demand recording!

register

12Feb/19
Radar Square for LSP-Zoom only-extra small

A Disruptive Storm Is On The Horizon

A Straight From the Source Webinar

A disruptive storm is on the Horizon and Life-Science Executives MUST plot a course to success.

Join us for a live webinar on February 20th at 11am Eastern as we discuss our insight and advise on Business, Regulatory and Technology Disruptors that are quickly approaching, including:

  • Artificial Intelligence/Machine Learning
  • Computer System Assurance
  • Digital Health
  • Digital Transformation
  • EU MDR
  • Globalization – Healthcare Markets
  • Industry 4.0/Manufacturing 4.0
  • Precision Medicine
  • The Internet of Medical Things (IoMT)

Meet Your Trusted Sources:

DRM-SKR-FEB-2019

Please Note:  This webinar is limited to the first 100 registrants.

register

 

 

04Dec/18
veeva logo

Veeva is Building the Life Sciences Cloud with High Speed and Velocity

Veeva 2018 Summit Event Brief

By: Daniel R. Matlis, President

Introduction

“We are building the industry cloud for life sciences,” said Peter Gassner, president and CEO of Veeva during his keynote at the company’s summit in Philadelphia. “We want the industry and your company to be more efficient and effective – supporting your journey to improve and extend human life,” Gassner added.

The event brought together more than 1,400 life science professionals and experts showcasing the latest advancements for speeding product development in the industry.

Right Speed, Right Velocity

“Speed is one of Veeva’s core values,” said Gassner. I have a slightly different perspective.  I took Gassner aside and explained that Axendia’s analysis of the company shows that Veeva is operating at the right velocity – not simply at high speed.

veeva imageUnfortunately, our industry is ripe with examples where companies have adopted systems at breakneck speed – often to mitigate a regulatory finding, only to realize the application brought them in the wrong direction.  Testament to the ‘right speed, wrong velocity approach’ are the multitude of QMS point solutions that were implemented as a reaction to 483’s and warning letters.

Veeva has been moving with speed in the right direction; working closely with their industry customers to provide mature, preconfigured out-of-the-box suites of unified applications on a single cloud platform that support key areas across the entire product lifecycle.

Veeva has become a strategic technology partner to more than 675 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is focused on customer success through its commitment to innovation and product excellence.

My interactions with industry executives at the Summit confirm that Veeva is enabling life science companies to realize the benefits of a modern, cloud-based architecture and mobile applications for critical business functions – without compromising on industry-specific functionality or regulatory compliance.

To learn how Bristol-Myers Squibb, Gilead and Sysmex America are using Veeva’s cloud for life sciences.

Register to receive the full event brief.

 

22Sep/18
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Whether Identical or Fraternal, Digital Twins Offer Deep Product, Process and Performance Insights

Siemens Industry Analyst Conference 2018 Event Brief

By: Sandra K. Rodriguez, Market Analyst

The mercury was climbing outside of the Boston Marriott Long Wharf as Siemens executives took the stage to kick off Siemens’ 11th Annual Industry Analyst conference August 27-30, 2018.  “The boundaries between systems are disappearing,” said Tony Hemmelgarn, President and CEO at Siemens PLM Software.   Over the past eleven years, the company has invested $11B in mergers and acquisitions.  As a result, Siemens has optimized its integrated solutions portfolio for next generation product development, manufacturing and service.

siemens imageIn contrast to prior conferences, where the focus was on pulling the “Digital Thread” throughout the enterprise, the theme for this year’s event was ‘Innovation Without Boundaries.’  In support of the theme, multiple customers took the stage to demonstrate how their organizations were innovating without boundaries.      

Less than 2 hours into the conference, I was struck by the possibilities of Medical Device companies accessing and sharing product, process or performance data and having the ability to feedback information to the master digital twin in one platform.  The real power of a master digital twin lead me to think about the concept of ‘digital fraternal twins’ for not only closed-loop product lifecycle management but also change and configuration management in Med-Tech.    

Register to learn why I think the power of digital fraternal twins holds significant value for Life-Sciences companies. 

I also review how companies like Hackrod, Tronrud, Visteon, KUKA and W.L.Gore and others are leveraging the Siemens portfolio.