11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

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07Nov/17
CIO Logo square - smaller

Axendia Recognized by CIOReview in Pharma and Life Sciences Issue

Company Named to 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017

From CIOReview’s special issue: A distinguished panel composed of CEOs, CIOs, VCs, analyst and the editorial CIOReview board, has selected the top pharma and life sciences tech solution providers. In our selection process, we looked at the vendors capability to fulfill the need for cost-effective and flexible solutions that add value to the pharma and life science landscape.

“We believe that there is no one standard solution that fits all clients, therefore our approach is to offer tailored solutions that take into consideration each client’s present, as well as their future needs,” said Daniel R. Matlis, President and Founder at Axendia.

To be recognized by CIOReview as a Most Promising Pharma and Life Sciences Solution Provider is powerful evidence of the effectiveness of our approach.

Axendia’s imposing reputation in the Life Sciences and Healthcare space can be attributed to our dynamic work culture built on the values of respect, integrity and  passion.  As a result, we offer a unique combination of hands-on experience, coupled with strategic vision. We are committed to building and nurturing long-term relationships with our clients and fostering a spirit of cooperation, collaboration and trust with every single engagement.

Pharma & Life Sciences CIOReview

It is an honor to be named to the 20 Most Promising Pharma and Life Sciences Tech Solution Providers – 2017.

Full Page Article Here.

03Nov/17
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ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions

By: Daniel R. Matlis

Axendia was recently briefed by ComplianceQuest’s executive team.  The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.Network_Navy_F

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

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25Oct/17
blackswan

Two Black Swans, One Devastated Region

A Hurricane Named Maria 

By:  Sandra K. Rodriguez, Market Analyst

Disclaimer:  Being based in Puerto Rico, I lived through Irma and Maria; however best practices recommendations apply to anywhere in the world that may suffer a catastrophic event.

A black swan event is one that is extremely rare and unlikely.  Hurricane Irma stormed through the Caribbean on September 6, 2017.  Two weeks later, on September 20, 2017, Hurricane Maria made landfall in Puerto Rico and collided with the supply chains of leading life science companies who have a manufacturing presence on the island.

Scott Gottlieb, M.D., Commissioner of the FDA, took notice immediately and issued a press release within five days to address how the agency would help the island recover and what steps should be taken to avoid critical drug supply shortages for US citizens residing on the island and the US mainland.  Gottlieb wrote, “News coverage has touched on an issue about which we at FDA are very concerned and we are working around the clock to address – the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island.” Continue reading

16Oct/17
Image Courtesy of Forbes

When it Comes to 3D Printing, the Future is Already Here

Webinar Availalbe On-Demand – Experts Share Real World Insights 

By:  Eric Luyer, Market Research Analyst

According to the FDA, when it comes to 3D printing, you might say that the future is already here. Due to its versatility, the agency is evaluating the applications of 3D printing in devices, drugs and biologics and to medical applications across the entire ecosystem.

To gain first hand insight on the use of 3D printing in Life Sciences and Healthcare, Axendia assembled an expert panel for a roundtable discussion:3d printing panelists

  • Thomas Marchand, Co-Founder & CEO of BIOMODEX provided the industry perspective
  • Jenny Chen, a trained neuro-radiologist and founder/CEO of 3DHEALS, shared the physician’s perspective
  • Stavros Stefanis, leader in Deloitte’s Product Development practice, shared insights on the use of 3D printing across the product development lifecycle

The webinar was held on September 28th and sponsored by Dassault Systèmes (3DS).

3D printing in Life-Sciences is NOT Science Fiction, it is Science FACT

To date, FDA has cleared over 85 applications for 3D-printed medical devices which span across many product lines such as prosthetics and implants and last year, FDA approved the first 3D printed Drug – Aprecia’s Spritam. Continue reading