26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar

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.  

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

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.

06Jun/19
ispe cover

The Surge of CAR-T Products Drives Medicare to Evaluate Coverage

An Excerpt from ISPE’s iSpeak Blog

By: Sandra K. Rodriguez, Market Analyst

“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years, reflecting significant scientific advancement and the clinical promise of these new innovations.” stated Scott Gottlieb M.D., 23rd Commissioner of Food and Drug Administration in a January 2019 press release.

One such new therapy is Chimeric Antigen Receptor T-Cell (CAR-T) Therapy. “The new immunotherapy treatment CAR-T represents a paradigm change in cancer therapy. For the first time, cancer treatment can be directed specifically to the cancer cells, sparing most of the normal cells, and resulting in very high remission rates in patients who have otherwise failed all other available treatment. Many patients who would have otherwise succumbed to their disease, are alive and well today, as a result of the CAR-T treatment” commented Mounzer Agha, MD, UPMC, Hillman Cancer Center.

The Centers for Medicare & Medicaid Services (CMS) recently proposed to cover this new form of cancer therapy as there is no national Medicare policy. This lapse allows Medicare Administrative Contractors (MAC) to determine whether and how much to pay. The proposed determination would require Medicare to cover the therapy nationwide which would improve access and promote better patient outcomes.

Continue Reading the Full Article

In related news, Novartis announced the world’s most expensive drug – with a price tag of over $2 Million for a one-time treatment.  See the press release.

28May/19
Dan and Cisco 2019 Webinar

FDA Answers Your Questions on the New Approach to CSV

Q&A from an Axendia Straight from the Source (SftS) Webinar

By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President

In our recent webinar, we discussed FDA’s perspective on Computer Software Assurance (CSA).  FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

In this “Straight from the Source” webinar, we discussed FDA’s perspective on CSA including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

There were many more questions submitted than could be answered in the time allotted.

Register and receive your internal-use copy of the full Q&A.

 

 

21May/19
IoPP Logo

Puerto Rico Packaging Summit 2019

Event Brief

By: Sandra K. Rodriguez, Market Analyst

The Puerto Rico Packaging Summit 2019 took place in Condado, Puerto Rico.  The summit focused on the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter’s core organizational value: Packaging Contribution.  The Summit drew 129 attendees, representing 48 companies.

The message was simple and clear: We Speak Packaging. Speak Packaging With Us.

IoPP PresentersToday, advanced technologies including deep learning, artificial intelligence and robotics are playing a key role in an important piece of the supply chain and manufacturing processes.  Presentations by Amgen, Adents, Rockwell Automation, Pfizer and Hi-Tech Products demonstrated not if or when, but how automation and technology is already impacting manufacturing and operations in the Life-Sciences.

Jorge Delgado, Sr. Manager of Process Development at Amgen explained that deep learning can help overcome some challenges in Automatic Visual Inspection (AVI).  “Even with multiple techniques, it is still a challenge to effectively detect particles using current AVI technologies for particle detection,” said Delgado. Continue reading