Tag Archives: FDA

10Oct/19
Brain - small - low res

Reimagining Medicine – The Novartis and Microsoft Collaboration

Developing New Drugs Has Become as Much an AI and Data Science Problem as it is a Biology and Chemistry Problem

By: Ellyn McMullin, Research Associate

Bringing a new medicine to market is a costly and time-consuming process.  Nine out of 10 drug possibilities fail somewhere along the way.  As a result, on average, it costs life sciences companies $2.6 billion to introduce a single new prescription drug.  Streamlining drug development is an urgent issue from uncovering new ways to treat age-old sicknesses, to developing new vaccines to prevent highly-contagious diseases from turning into global pandemics, the impact in terms of lives saved worldwide would be enormous if new medicines could be invented faster.

Novartis and Microsoft recently announced their collaboration to explore how to take advantage of advanced Microsoft AI technology combined with Novartis’ life sciences expertise to find new ways to address the challenges underlying every phase of drug development.  There have been amazing scientific advances in recent years based on the ability to analyze huge amounts of data in new ways.  Developing new drugs has become as much an AI and data science problem as it is a biology and chemistry problem.

The exponential increase in digital health information in recent years offers new opportunities to improve human health; however, making sense of all the data is a huge challenge.  The issue isn’t just an issue of overwhelming volume. Much of the information exists in the form of unstructured data, such as research lab notes and clinical trial results, which is typically stored in disconnected systems. This approach makes bringing all that data together extremely difficult.

The goal of the new collaboration is to utilize Microsoft AI solutions to analyze large amounts of information and discover new correlations and patterns critical to finding new medicines.  The Microsoft data scientists and Novartis research teams are targeting three specific areas:

  • personalized treatment for macular degeneration
  • manufacturing new gene and cell therapies more efficiently with an initial focus on acute lymphoblastic leukemia
  • a focus on using AI to shorten the time required to design new medicines

Vas Narasimhan, CEO of Novartis, said, “As Novartis continues evolving into a focused medicines company powered by advanced therapy platforms and data science, alliances like this will help us deliver on our purpose to reimagine medicine to improve and extend patients’ lives. Pairing our deep knowledge of human biology and medicine with Microsoft’s leading expertise in AI could transform the way we discover and develop medicines for the world.”

Microsoft CEO, Satya Nadella, added, “Our strategic alliance will combine Novartis’ life sciences expertise with the power of Azure and Microsoft AI. Together, we aim to address some of the biggest challenges facing the life sciences industry today and bring AI capabilities to every Novartis employee so they can unlock new insights as they work to discover new medicines and reduce patient costs.”

This strategic alliance is an important collaborative effort that promises to have a profound impact on how breakthrough medicines and treatments are developed and delivered.

Read the Microsoft Blog Post and The Novartis Press Release.

We also welcome you to read our eBook to discover How AI is Driving Predictive Quality.

24Sep/19
Validation - original (1)

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

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.

05Sep/19
Can Digital Evidence Replace Clinical Evidence-Small (1)

Can Digital Evidence Replace Clinical Evidence?

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital evidence  
  • How to create virtual patients with digital evidence to replace clinical evidence  
  • Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies 
  • Creating an in silico clinical trial playbook
  • Why data in PDF’s are not sufficient 

Meet Your Trusted Sources

Tina and Dan for CC

Register to view this webinar on-demand.

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26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar Available On-Demand

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.  

Register to view this webinar on-demand.

register

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.