Category Archives: Latest

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.

01Oct/19
digital transformation

Culture Change Management in Support of Digital Integration at Fresenius Medical Care

A Straight from the Source Webinar

To support changing regulatory frameworks and business models, forward thinking Life-Science companies like Fresenius Medical Care are not just considering digital integration but are implementing strategies that unify Product Lifecycle Management (PLM), Quality Management Systems (QMS), Manufacturing Execution Systems, (MES), Enterprise Resource Planning (ERP) and a variety of other software solutions.

To assure improved outcomes, all these systems must ultimately coexist which is why a digital integration strategy is critical.

In this Straight from the Source Webinar featuring Bill D’Innocenzo, SVP of Digital Integration at Fresenius Medical Care, we discuss why Digital Transformation is a Journey… Not a Project! We will also review why transforming organizational culture and behaviors is imperative to ensuring the success of new business models in support of improved outcomes.

Join Fresenius Medical Care’s Bill D’Innocenzo and Axendia’s Sandra Rodriguez for a live webinar on October 30th at 11:00 AM ET.

Meet Your Trusted SourcesSlide1

Key Takeaways:

• 5 Steps to a Successful Digital Integration Strategy
• Why you must build a cross-functional team during the digital transformation journey
• Why transforming organization culture first is imperative to supporting new business models
• The road to a successful digital integration strategy is first paved by the people leading the change

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

register

30Sep/19
MC Logo

Quality Can Only Improve… IF We Allow the Information to Focus on Providing Quality Products

MasterControl Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Team at MasterControl.   The company’s mission is to make life changing products available to more people sooner.   One way MasterControl is setting out to achieve its mission, is by enabling its Life-Science customers to obtain what it calls Product Lifecycle Excellence (PLx).  With over 650,000 users spanning more than fifty countries, MasterControl is well positioned to bring a much needed correlation between Product Lifecycle Management (PLM) and Quality Management to the Life-Science industry.

The Need to Connect Decision Loops

Companies typically have quality data spread all over the organization.   Paper-driven production processes on the shop floor are also still a reality in many companies.  These pockets of quality data, when consolidated, have the potential to offer valuable insights to product quality data across the entire lifecycle.  With PLx, MasterControl is seeking to close the gap in the digitalization of the manufacturing environment.   “We looked at how to build an application that is easy for operators to adopt and use, easy for manufacturing environments to deploy and connect to their other systems.  And, in the process, completely eliminate paper off of the shop floor,” said Matt Lowe, Executive Vice President at MasterControl.

Another reality is that although advances in PLM and Manufacturing Execution Systems (MES) have been rolled out over decades, QMS data is often siloed and paper still exists on the shop floor.  The result is a disconnect in information that may range from clinical study quality issues to poor shop floor data integrity.  Additionally, complaint data is often times not looped back into the organizations’ overall quality system.   “Being able to launch quality incidents from the shop floor, enforce training and fill the gap between ERP, MES and LIMS allows companies to achieve next level digital manufacturing excellence and that’s what we’re pursuing,” said Terrance Holbrook, Director of Product Management. Continue reading

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
sparta connection image

Partnering with Customers to Make Digital Quality a Reality

Sparta Connection 2019 Event Brief

By: Daniel R. Matlis, President

The theme at this year’s Sparta Connection was: “Making Digital Quality a Reality.” Under the leadership of Dana Jones, CEO of Sparta Systems, the company continues to focus on customer success by delivering on commitments, ensuring transparency, and building relationships to earn customer trust.

“We’re 100% committed to putting customers at the center of everything we do, and to partnering with them to accelerate their transformation to digital quality,” said Ms. Jones. “We’re also committed to giving our customers maximum freedom, flexibility and choice by providing a range of options with our cloud, on-premise and hybrid options.”

Sparta Blog Image

To support its commitment to provide flexibility, freedom and choice to deliver quality based on customer needs, Sparta is investing across 3 dimensions:

  • TrackWise® QMS – Sparta announced their continued commitment to the TrackWise on-premise product for existing customers. They also announced that the next version of the product, TrackWise 10, will be coming out in 2020.
  • TrackWise hybrid solution – TrackWise customers can expand the functionality of their existing on-premise instances by seamlessly adding TrackWise Digital cloud modules to TrackWise. This includes cloud modules such as Complaints, Intake and Supplier Quality Management.
  • TrackWise DigitalSM – over 120 customer have selected TrackWise Digital

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