Tag Archives: Axendia

05Sep/19
sparta connection image

Partnering with Customers to Make Digital Quality a Reality

Sparta Connection 2019 Event Brief

By: Daniel R. Matlis, President

The theme at this year’s Sparta Connection was: “Making Digital Quality a Reality.” Under the leadership of Dana Jones, CEO of Sparta Systems, the company continues to focus on customer success by delivering on commitments, ensuring transparency, and building relationships to earn customer trust.

“We’re 100% committed to putting customers at the center of everything we do, and to partnering with them to accelerate their transformation to digital quality,” said Ms. Jones. “We’re also committed to giving our customers maximum freedom, flexibility and choice by providing a range of options with our cloud, on-premise and hybrid options.”

Sparta Blog Image

To support its commitment to provide flexibility, freedom and choice to deliver quality based on customer needs, Sparta is investing across 3 dimensions:

  • TrackWise® QMS – Sparta announced their continued commitment to the TrackWise on-premise product for existing customers. They also announced that the next version of the product, TrackWise 10, will be coming out in 2020.
  • TrackWise hybrid solution – TrackWise customers can expand the functionality of their existing on-premise instances by seamlessly adding TrackWise Digital cloud modules to TrackWise. This includes cloud modules such as Complaints, Intake and Supplier Quality Management.
  • TrackWise DigitalSM – over 120 customer have selected TrackWise Digital

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05Sep/19
Can Digital Evidence Replace Clinical Evidence-Small (1)

Can Digital Evidence Replace Clinical Evidence?

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital evidence  
  • How to create virtual patients with digital evidence to replace clinical evidence  
  • Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies 
  • Creating an in silico clinical trial playbook
  • Why data in PDF’s are not sufficient 

Meet Your Trusted Sources

Tina and Dan for CC

Register to view this webinar on-demand.

register

14Aug/19
ebook cover image

eBook: AI Drives Shift from Reactive to Predictive Quality

Regulatory Consideration for AI-Enabled QMS

Life Science companies must adopt Predictive Quality.  This eBook, sponsored by Sparta Systems, discusses how industry should leverage FDA’s Good Machine Learning Practices (GMLP) to implement AI in order to drive improved productivity and intelligent decision-making while meeting regulatory requirements.

AI EBOOK IMAGE 2“The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices,” said Dr. Scott Gottlieb, MD, 23rd Commissioner, US FDA.

The use of AI and ML can enable Life Science organizations to harness data and turn it into intelligent and actionable insights that enable predictive quality. AI systems can process data from point solutions to glean intelligence and  support decision-making.

In this eBook we also discuss:

  • Why you cannot validate AI with outdated CSV models
  • How AI is enabling the shift to predictive quality management
  • Implications for the Life Sciences industry

Register to receive your complimentary copy.

25Jul/19
Dassault France

Medidata: The Missing Link in Dassault Systèmes Powerful Portfolio to Support the Life-Science Industry

Dassault Systèmes Analyst Conference Brief 2019

By: Sandra K. Rodriguez, Market Analyst

The news out of this years’ Dassault Systèmes Analyst Conference was huge: a $5.8 Billion merger offer with clinical data giant, Medidata.  We received the news while traveling from our hotel to the Dassault Systèmes headquarters, nestled in Vélizy-Villacoublay, France.  Aside from the size of the deal – the largest in the history of Dassault Systèmes – Medidata was the missing link in its powerful portfolio to support the Life-Science industry.

Bernard Charlès, CEO and vice-chairman of the board of directors at Dassault Systèmes, opened the two-day meeting with, “To do ‘smart’ anything, you need to know the environment.  The platform phenomenon is not an IT topic… it’s a new way for companies to work.”  Dassault Systèmes now has 250,000 customers, with 25 million users in 140 countries.  The 3DEXPERIENCE platform currently consists of 11 brands/applications that support the ability for people and businesses to develop, collaborate and build products and services in both the virtual and real worlds.

Dassault Systèmes considers itself a Scientific company, first and foremost.   The Industry Renaissance theme of this years’ conference was explained in simple terms by Morgan Zimmermann, CEO for NETVIBES-EXALEAD (the Dassault Systèmes solution for turning large amounts of information into intelligence).  “Think of Renaissance as the new book. The book changed how we distributed knowledge; Industry Renaissance for Dassault Systèmes is the usage of experience as a new way to distribute knowledge and know-how” explained Zimmermann.

The 3DEXPERIENCE Platform offers both people and businesses, virtual universes to imagine, develop and collaborate using innovative solutions.

Life is the New Work Bench

Mentioned earlier in this brief, Medidata was the missing link in the Dassault Systèmes solution platform to support end-to-end product development in the Life-Sciences.  “Pharmaceutical and Biotech companies require roughly ten to twelve years in the R&D phase to bring a drug or therapy to market” explained Claire Biot, Ph.D., VP of Life Sciences Industry at Dassault Systèmes.  Therefore, shifting that timeline left early on in the clinical trial phase of a product adds significant value to Life-Sciences companies.

Image Courtesy of Dassault Systèmes

Image Courtesy of Dassault Systèmes – Claire Bisot.

Clinical trials are necessary to prove the safety and efficacy of a drug on not only a patient population, but the medical condition itself.

Download and read the entire Briefing Note.

01Jul/19
liveworx2019 image

The Augmented Workforce – Taking Human Capabilities to New Heights

PTC 2019 LiveWorx Event Brief

By: Eric M. Luyer, Industry Research Analyst

The theme at PTC LiveWorx this year was: “The Augmented Workforce – Taking Human Capabilities to New Heights.”  Approximately 13,000 people, attending in person as well as live streaming, took part in the annual industry conference held in Boston, MA, in early June.

In today’s digital enterprise, the objective of PTC is not only unlocking new levels of productivity, insight and efficiency with automated processes and emerging technologies, but also to use these tools to “augment” the workforce.   PTC is predominantly positioning emerging technologies such as Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR) and 3D Printing.  When added to the existing capabilities of Computer Aided Design (CAD), Product Lifecycle Management (PLM) and the Internet of Things (IoT), AR will become more complementary to workers’ creativity and labor satisfaction.  It is PTC’s premise that things that make us all uniquely human – intuition, creativity, decision making – will be more powerful and useful than ever, if we optimize the use of these emerging technologies.

Digital Transformation

The emphasis of LiveWorx was helping industries with their Digital Transformation strategy and approach.  PTC sees AR as an ideal tool for training.  Workers benefit by getting a 3D- understanding of production processes and the challenges in a production environment (where the shortage of skills is often a challenge – yet shorter lead-times are expected.)

PTC AR PhotoImplementing an “Augmented Workforce” as part of the digital transformation process requires new strategies, a strategic roadmap and bold experimentation – as well as a culture ready to embrace change.

The use of AR makes a workforce more complete, rather than being replaced by it – where workers and machines unite to make and manage what’s next.  In her keynote address, Maria Wilson DDA, of Howden Group noted, “Augmented reality extends the value of our IoT data, and it changes our customers’ experience of owning and operating equipment.”

The Digital Thread

Jim Heppelmann, CEO of PTC, emphasized the importance of having the technology and the tools available to have full insight of what’s happening in the product lifecycle:  from design – engineering – manufacturing & supply chain – customer operations – customer services to Corporate/CXO.  In his keynote, Heppelmann explained the capabilities of the current PTC offerings for manufacturers:  from complex configuration management to high performance computing, including how CAD + PLM + IoT + AI follow and support the concept of the Digital Thread.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

According to Heppelmann, “A digital thread means the information that was originally created for one purpose – say an engineering prototype – gets reused for many different processes.  The digital thread weaves its way across the value chain. ” The digital thread is in fact a framework which connects the data flows to provide a holistic view of all data of (all) assets and the processes linked to these during the lifecycle of the product. All information including protocols, security and standards are visible and transparent.

The concept of the digital thread describes the traceability of the data that supports the digital twin(s) back to requirements (i.e., design phase), parts and controls that can make up the physical asset(s) or the entire production process.

Life-Sciences and The Future of Medical Innovation

The Life Science industry is in a state of transition at many levels, with new market entrants (e.g. Google and Amazon) and a wave of mergers and acquisitions shaking up the competitive landscape.  Now more than ever, medical innovators face an increasing need for technology solutions to support the transition to connected healthcare, personalized and precision medicine, and improved patient outcomes as a service — all while ensuring compliance with regulatory requirements.

PTC’s portfolio and expertise aims to help medical device manufacturers gain a competitive advantage in a complex, fast paced and highly regulated marketplace. With targeted focus on quality in the design phase, combining Additive Manufacturing (3D printing) capabilities (specifically AR and VR in support of quality for design, services and training) PTC is offering its Life Science clients well-thought-out, and high-performing technology solutions that can grow with the increasing complexity of quality and regulatory requirements.

Life Science innovators face transformative opportunities and challenges. The health-care value chain is becoming more collaborative, outcome-based and metrics-driven. Precision medicine, additive manufacturing, and connected medical products are rapidly expanding the art of the possible. For medical innovators and the healthcare communities they serve, the future is bright in the eyes of PTC’s solutions development group.

Cybersecurity

In this new digital world, cyber safety and security must become everyone’s responsibility, and work must be done to address the challenges and threats around safety and security. “Sophisticated software and hyper-connectivity are fuelling innovation at an unprecedented pace,” said Joshua Corman, SVP and Chief Security Officer, of PTC. “Those conditions can potentially introduce new classes of accidents and adversaries,” added Corman.   PTC has subsequently initiated a Coordinated Vulnerability Disclosure (CVD) Program that supports the reporting and remediation of security vulnerabilities that could potentially affect the environments in which PTC products operate, including industrial and safety-critical industries.

Announcements: Featured Partnerships

At LiveWorx 2019, strategic partnerships were on display.  First, Rockwell Automation.  This partnership is expected to accelerate growth for both companies and enable them to be the partner of choice for customers who want to transform their physical operations with digital technology. “Leveraging Rockwell Automation’s industry-leading industrial control and software technology, strong brand, and domain expertise with PTC’s award-winning technology, enables industrial enterprises to capitalize on the promise of the Industrial IoT. I am incredibly excited about this partnership and the opportunity it provides to fuel our future success,” said Jim Heppelmann, CEO of PTC.

Secondly, PTC’s partnership with Microsoft.  On June 10th, PTC announced that it has expanded its strategic alliance with Microsoft by delivering its industry-leading PLM solution Windchill on Microsoft Azure. Optimizing Windchill with Azure is yet another milestone in the growing alliance between the two companies since the initial announcement in 2018. PTC and Microsoft have closely collaborated on integrating Azure IoT with PTC’s IIoT solution platform, which has allowed customers to create innovative products and improve operations with IoT connectivity, rich contextualization, business systems orchestration, and breakthrough user engagement via mixed reality.

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In conclusion, LiveWorx 2019 was an interesting and forward-thinking conference this year…especially for organizations that are either starting or are already on their journey of digitally transforming their key business processes.

Download a PDF of this Event Brief.