Category Archives: Technology

28Jun/19
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Artificial Intelligence Can Make Pharmaceutical Companies More Competitive

Quartic.AI Briefing Note

By: Eric M. Luyer, Industry Research Analyst

Axendia was recently briefed by the senior executive team of Quartic.ai, based in San Jose, CA, US.   Quartic.ai was founded in 2017 by veterans in process automation, manufacturing, and reliability in conjunction with data scientists to optimize the practical use of information through Artificial Intelligence (AI) deployment.  The company had been recognized last year as the fastest growing technology leader in industrial AI by CIO Review Magazine.

The mission of Quartic.ai is to enable subject matter experts (SME) to help solve manufacturing problems by using AI. “We look at this as becoming another tool in their tool-belt of problem-solving. What we’re building enables the SMEs to build their solutions with AI”, said Rajiv Anand the CEO of Quartic.ai.

According to Rajiv Anand, their vision and mandate is not to grow their business through providing services, but by providing the technology. Their technology is a complete “smart industry platform” to support process- and pharma manufacturing industries via digital transformation using the concepts of the Industrial Internet of Things (IIoT) and AI. Continue reading

26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence to accelerate product innovation supporting rapid introduction of life-saving technology for patients “Digital evidence” is already being used at FDA to predict clinical outcomes, inform clinical trial design, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on July 10 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital and real world evidence  
  • Modeling and Simulation to support improved quality and patient outcomes 
  • Examples of Digital Evidence currently in use at FDA 
  • The Review of the Futureharnessing the power digital and real world evidence through digital transformation 

Meet Your Trusted Sources

Tina and Dan for CC

Over 200 FDA employees are part of the Agency’s Modeling and Simulation working group. Find out what they are working on and more.  

Register to view this webinar on-demand.

register

13Jun/19
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7 Reasons Life-Science Companies are Implementing eQMS in the Modern Cloud

ComplianceQuest Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Prashanth Rajendran, CEO, and Nikki Willett, Chief Strategy Officer, at ComplianceQuest.  The company sees multiple drivers for an up-tick in the adoption of eQMS in the Life Sciences industry, especially on a modern cloud platform:

  • Electronic Quality Management System (eQMS) as a necessity for emerging growth companies
  • Digital transformation (Quality 4.0)
  • Collaborative global regulatory bodies requiring consistent control
  • The services society demanding more managed applications
  • The power of a single platform to meet multiple business needs
  • The role of quality in merger and acquisition activities
  • Operational efficiencies are driving the top line and profitability

Historically, QMS had been targeted at managing quality/compliance documents. The transition that Axendia has noticed in the marketplace is that while companies still require documentation to support quality processes, what is more important is the underlying data that is housed in those documents. Emerging growth companies typically will focus on the product and getting the product approved…and eQMS was not always at the top of the minds of executives.  However, we’re seeing quite a bit of a change in that emerging growth companies are seeing that going electronic as early as possible is a value and an efficiency gain for them, said Willett.

Register to receive the entire Briefing Note in your inbox.

15May/19
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Supply Chain Visibility: A Regulatory Necessity and Business Imperative

Brand owners are legally responsible for the safety, efficacy and quality of their products

By: Daniel R. Matlis, President

The globalization of life science products has created unique opportunities and demanding challenges for both industry and regulators.

The globalization and outsourcing of life science products began in the late 1990s. At the time, life science companies began to evaluate their core competencies and decided to outsource non-core competency functions. The primary reason for this trend was to lower costs.

Globalization has also opened new markets for life science products worldwide, with emerging economies representing fresh markets. Concurrently, issues with supply chain security became the responsibility of all parties involved in the procurement/sourcing, manufacturing, packaging and distribution of raw materials, intermediates, and final product to deliver safe and effective medicines to customers.

Recommendations for a New Supply Network Paradigm
Supply chain dynamics are prompting life science companies to seek innovative approaches that improve product safety while simultaneously enhancing clinical outcomes, reducing costs and risks, and ensuring regulatory compliance. To attain the sustained benefits of globalization, the life science products ecosystem must implement a new paradigm to manage global supply chains.

770_mainCompanies must implement new strategies while proactively reducing and controlling risks. This calls for changing the business, technology, and regulatory models traditionally used in the industry. The three key components to managing this shift are on-demand visibility, supply network control, and collaboration.

Continue Reading This Article in Medical Product Outsourcing

01May/19
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Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading