Category Archives: Business

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

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

12Feb/19
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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

 

 

14Jan/19
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White Paper: Stop Managing Paper in a Data-Driven World

How Electronic Batch Records (EBR) Can Support Quality Metrics

By: Sandra K. Rodriguez, Market Analyst

Many life science companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs. For many emerging and mid-market companies, however, paper batch records and a hyper-focus on compliance remain a reality. The result is a reliance on paper-based processes in a data-driven world.

Companies that have made the shift from paper to data-driven intelligence are aspiring to gain visibility by unlocking valuable manufacturing data to support quality metrics, as well as initiatives such as lean manufacturing, quality by design and continuous improvement. Companies that do not have access to this level of visibility should consider investing in the appropriate quality systems now. Regardless of their size, companies seeking to implement innovative electronic batch record (EBR) and quality management systems (QMS) now have a choice: either on premise or in the cloud.

Today the FDA intends to drive life science companies to harness data from manufacturing and quality systems and turn that data into intelligence. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) provides the FDA with the authority to conduct electronic inspections (e-Inspections) and target onsite inspections based on quality metrics.

Register to receive your complimentary copy of this White Paper.  We discuss:

  • Why Shift from Paper
  • FDA’s Request for Quality Metrics
  • Why Compliance and Quality Are Not the Same
  • The Role of Executive Leadership

This white paper was written by Axendia, Inc. and sponsored by MasterControl Inc.

 

04Dec/18
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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.