Category Archives: Events

06Dec/19

2020 Life Science Radar – Webinar Registration is Open!

Business, Events, Latest, Regulatory, Technology, ,

An Axendia Straight from the Source Webinar

Disruption is on the radar! Life-Science executives must plot a course for success. That was the theme of our “Straight from the Source” 2019 Life-Science Radar webinar featuring Axendia’s Analysts.

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 2019 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.

Join us on January 29th at 11am Eastern. Axendia’s Analysts will discuss the updated 2020 Life-Science radar.

Many disruptors are closely connected and Life-Science organizations must take a holistic view when it comes to business, regulatory and technology trends in order to plot a course to success.

Can’t make this time? Register and you will be able to watch the On-Demand recording after the event.

register

02Dec/19

FDA Discusses Challenges and Opportunities for 3D Printing in Life Sciences

Events, Latest, Technology, , ,

A Straight from the Source Webinar 

The interest in 3D Printing (a/k/a Additive Manufacturing) has risen spectacularly the last decade.  The use of 3D Printing technology has wide-ranging applications across the Health Technology Ecosystem, including surgical, healthcare, pharmaceutical and medical devices.  In fact, over 100 medical devices using 3D printed components have been cleared by FDA. 

With the rise in utilization of 3D Printing in Medical Devices, FDA’s interest in additive manufacturing has significantly increased.  To address how the technology can affect the quality, safety and effectiveness of these products, FDA published guidance for industry titled: “Technical Considerations for Additive Manufacturing Devices” by Dr. Matthew Di Prima.

Join FDA’s Matthew Di Prima and Axendia’s Eric M. Luyer in for a live webinar on November 20th at 11am ET.  This webinar is now available on-demand.

Meet Your Trusted Sources 

Di-Prima-Luyer-Webinar-Twitter

In this webinar, we discuss FDA’s perspective on: 

  • Current capabilities of 3D Printing in Life Sciences 
  • Challenges and opportunities for 3D Printing in Life Sciences 
  • Case studies on FDA reviewed and approved devices on the market 
  • Collaborations Industry, Universities and Standard Development Organizations 
  • Regulations, guidance and Standards for 3D Printing  
  • Vision for future uses of 3D Printing in Healthcare  
  • Point of Care  
  • Personalized Medical Devices  

Register and watch this webinar on-demand.

register

13Nov/19

Inventing New Horizons with Science as a Catalyst

Events, Latest, Technology, ,

Event Brief: Science in the Age of Experience 

By: Sandra K. Rodriguez, Market Analyst

I had the opportunity to cover “Science in the Age of Experience” in Boston in October.  The annual Dassault Systèmes conference brought together 500 attendees, representing 250 companies.  This year customer presentations focused on new ways of experiencing and shaping science in Life (better living), in Engineering (product innovation) and in Nature (sustainable planet).

Bernard Charlès, Vice Chairman and CEO of Dassault Systèmes opened the event by stating, “You can’t have knowledge if you don’t have knowhow.” Charlès continued with, “The biggest challenge in innovation is over-communicating and under-understanding.”  The agenda was filled with presentations by members of MIT and Harvard, plus Dassault Systèmes’ clients who are seeking to not just understand the correlations between product, nature and life… but are inventing new horizons with science as the catalyst.

Standing on Solid Ground with SOLIDWORKS

Hugh HerrHugh Herr, Professor of MIT Media Lab and co-director of the MIT Center for Extreme Bionics; Founder of BionX, Inc., had both legs amputated from just under the knee after suffering from frostbite during a mountain climbing accident in the early 1980s. He pointed out the surgical procedure that doctors performed following his accident had not changed since the late 1800s.  As a result, although he could walk again with the help of his first set of prosthetics, he was unable to associate the feeling of pressure or movement in his ankles or feet.  With both pant legs rolled up to expose his bionic limbs he stated, “From the knee down, my legs are a bunch of nuts and bolts.”   He then informed us that in addition to the nuts and bolts are sensors, and an entire bionic ecosystem that gives him the ability to move, walk, jump and pivot naturally.  Continue reading →

05Nov/19

Transforming Quality, a Top Priority for Customers at Veeva Summit 2019

Business, Events, Latest, Quality, Regulatory, Technology

Veeva Summit 2019 Event Brief

By: Daniel R. Matlis, President

Veeva has become a strategic technology partner to more than 775 customers across the globe, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva-Summit-Check-In

I had the opportunity to cover the 2019 Veeva R&D Summit in Philadelphia, PA in September.  The event brought together more than 1,700 life science professionals and experts to share the latest market trends in the industry, experience innovative technology, and share best practices. The annual event has experienced 25% attendance growth compared to 2018.

This brief focuses on my first-hand interactions with leading industry executives leveraging Veeva’s quality offerings to modernize quality management in the cloud.

The following executives shared how they are leveraging modern cloud-based solutions to transform quality management:

  • James Choi, VP and CIO at Samsung BioLogics, shares his vision for modernizing manufacturing quality.
  • Chris Lamont, Director, Global QMS Programs at Bristol-Myers Squibb presents the company’s journey to achieve enterprise quality with Vault QMS.
  • Jennifer Trundle, Associate Director, Quality Management Systems at Gilead discusses the successful expansion of Vault QualityDocs across the global enterprise.

Continue reading →

24Sep/19

What to Expect in FDA’s Draft Guidance on Computer Software Assurance

Events, Latest, Regulatory, , , ,

Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting

On August 22, 2019, I was invited by the IoPP – Puerto Rico Chapter to present key takeaways from FDA’s anticipated Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software.  Thirty-two attendees from fifteen companies attended the quarterly meeting at the C3Tec campus in Caguas, Puerto Rico.

Sandra IoPP PR 2Background:  Unfortunately, when the Medical Devices Current Good Manufacturing Practice (CGMP) Final Rule, Quality System Regulation, became effective on June 1, 1997, they had an “unintended consequence”:  Validating Computer Systems to death!

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the Life-Science industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risks to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally, this single-mindedness has led to low rates of investment in automation and digital technologies.

To streamline and improve non-product computer system validation, industry launched a shared effort with FDA to identify causes of misperceptions, to clarify, and to promote the best practices.

Their analysis of the issue shows that:

  • The industry lags in implementation of automated systems and new technologies due to lack of clarity, outdated compliance approaches, and perceived regulatory burden.
  • Some companies struggle to understand the root cause of issues in order to improve product quality.

Their vision to achieve a new mind-set:

  • Drive a paradigm shift in applying value-driven and patient-focused approaches to streamline non-product software CSV.
  • Use critical thinking and risk-based, agile approaches to streamline assurance activities and evidence capture.

Their plan to meet their objectives:

  • Develop streamlined practice recommendations and pilots.
  • Modifications to the 820.70(i) and 820.50 regulatory language.
  • Guidance development centered on this software category.

Roque Redondo, VP Business Development at Mirus offered his perspective during the Q&A session by commenting, “It’s very important to understand if companies that provide software to our industry can demonstrate that they really have strong QA Systems in such a way that we can all rely on their software development programs.  I strongly recommend doing a survey of these companies to find out if they will be completely open to QA Audits from their clients to fully demonstrate that their QA Systems are in place and trustful.  In addition, it will be good to investigate if the excessive amount of CSV efforts done in the industry are due to the current guidelines or to the interpretation of the guidelines.”

It was a pleasure to share this information locally to my industry peers.

To hear the FDA’s perspective on the New Approach to Computer Software Assurance in our Straight from the Source webinar series, access it on-demand.