Category Archives: Regulatory

15Jul/19
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More Than Skin Deep: Dassault Systèmes is Transforming the Patient Experience

Dassault Systèmes 3DExperience North America 2019 Forum Event Brief

By: Daniel R. Matlis, President

At this year’s 3DEXPERIENCE North America Forum, Dassault Systèmes continued to demonstrate its commitment to transforming the patient experience.

Under the leadership of Bernard Charlès, Vice Chairman, Chief Executive Officer, the company continues to substantially deliver on the promise: “to enable innovative patient experiences through a Holistic Patient-Centric strategy.”  (Read:  Dassault Targets Life-Sciences with Mind, Body and Soul)

According to Charlès there are several concurrent themes that are impacting the Life Science industry with Bioscience playing a major role.

  • Healthcare is expensive
  • Healthcare needs to be more inclusive
  • Life-Science product development needs to take advantage of technological changes

“Dassault Systèmes is investing massively in Life Sciences to transform the patient experience with a culture of sustainable innovation and the use of cutting edge technology,” added Charles.

At the 3DExperience Forum, the company once again delivered on their vision with the introduction of IASO, an oncology treatment concept that contains a removable patch that attaches to the patient’s skin to deliver a biologic solution, dosed through a connected, wearable and reusable device.  IASO aims to showcase how Dassault Systèmes 3DEXPERIENCE platform enables its customers to transform the patient experience with innovative solutions that combine many technologies to safely shift the point of care from the clinic…to the patient’s home.

Download a PDF of the complete Event Brief

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

06Jun/19
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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.

 

 

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