05Nov/19
Veeva-Summit-19

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

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.

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28Oct/19
Cloud Comfortable

Life-Science Companies Are Becoming Cloud Comfortable

… And You Heard It Here First

By: Sandra K. Rodriguez, Market Analyst

Based on our interactions with companies large and small, cloud solutions for Quality, Operations and Maintenance Management are being increasingly adopted to lower costs (implementation, validation and maintenance from a technology standpoint) and for improved process and people efficiencies.

Not convinced? Earlier this year, we published our findings in a report titled “See Who’s Soaring to the Cloud in Support of Quality and Compliance.” Most of the companies we spoke to already had experience implementing a variety of business systems in the cloud including: Email, CRM, ERP, Document Management, Serialization and HR systems.

Most, if not all, software vendors that we either met or conducted briefings with this year have cloud offerings to support: AI/ML, APS, CTMS, EAM, MES, PLM, RIM, etc.

Executives we interviewed for our Cloud QMS report agreed that:

  • Modern cloud platforms have a secure infrastructure with very high availability and uptime
  • Value can be quickly achieved by unifying business functions on a cloud platform
  • System accessibility and availability is necessary for today’s global workforce
  • Moving to the modern cloud is not only a strategic move but one that supports a sustainable digital transformation strategy
  • Taking a cloud-first approached supports improved business outcomes by eliminating the need for an internal IT army

Over seven years ago, Axendia published a report based on a survey of 125 MedTech Executives.  We sought to understand “Balancing the Risks and Rewards of MedTech Globalization.”  At the time, Axendia’s position was simple:

To mitigate globalization growing pains and attain sustained benefits, the Med-Tech ecosystem will need to implement new strategies, processes, and technologies to proactively manage risk across the life-cycle of Med-Tech Products in a global and outsourced environment.

Today, we are seeing the adoption of modern cloud solutions that offer:

  • Holistic control over governance, risk management, and compliance practices
  • Enhanced visibility across the Med-Tech ecosystem
  • Improved collaboration with all constituents across the total product lifecycle

Being cloud comfortable doesn’t mean that every aspect of a company’s business is being managed in the cloud but Maintenance, Manufacturing and Quality clouds (to name a few) are quickly replacing on-premises applications.

Need help with your cloud strategy? Contact our Analyst Team today.

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

Register and watch this webinar On-Demand.

register

30Sep/19
MasterControl-250x250

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