Category Archives: Business

04Oct/21

Digital Transformation: The Business Imperative for Life-Sciences

By Daniel R. Matlis, President

“Necessity is the mother of invention,” says the ancient proverb.  In my opinion, the corollary is: “disruption is the matriarch of transformation,” especially for the Life-Sciences industries.

The COVID-19 epidemic has been the biggest global disruption in our generation. It represents a watershed moment for transformation throughout our industry.

Disruption is the new normal. This new paradigm is forcing Life-Science companies to re-imagine the way they operate; transforming and accelerating product development, regulatory review, manufacturing, and distribution cycles aimed at improving patient outcomes.

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27Sep/21

“Orchestrating” the Sales-to-Manufacturing Process

KBMax Briefing Note

By:  Eric M. Luyer, Industry Research Analyst

Axendia was recently briefed by the executive team at KBMax about their offering to the Bio-Pharma Industry.

KBMax offers innovative and engaging technology in the visual “Configure, Price, Quote” (CPQ) and Visualization market, “orchestrating” the sales-to-manufacturing process in an engineer-to-order environment.  KBMax was acquired by Epicor in May 2021. This acquisition will continue to drive growth for Epicor as they now have the ability to offer KBMax software as a stand-alone system or integrate it into the Epicor ERP suite to generate new, cross and up-sell revenues.

Steve Murphy, CEO of Epicor commented on the acquisition:It’s a perfect time for businesses to reach our customers in new and compelling ways. The integration of KBMax’s technology into our platform will solve that challenge for our customers, enabling them to create an information-rich and immersive online buying experience. The integration of next-gen CPQ tools with our ERP system will enable vital connectivity points to our customers across inventory, costs, pricing, and customer data”.

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01Sep/21

FDA Reports on The State of Pharmaceutical Quality

Remote Evaluations, Grading Industry on a Curve and Using AI to Predict Site Inspection Scores

By: Axendia Staff

The FDA issued its latest report on the State of Pharmaceutical Quality.  In the report, the Agency describes Pharmaceutical Quality as the ability of the pharmaceutical manufacturing industry to deliver quality drug products to U.S. patients and consumers. In addition, FDA defines quality drug products as those that are safe and effective and free of contamination and defects.  It is worth noting the absence of the word “compliant” in these definitions.

Hidden among Hand Sanitizer recall data were a number of significant developments on FDA’s regulatory approach.

This Brief represents Axendia’s analysis and insights on FDA’s Report on the State of Pharmaceutical Quality.

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16Aug/21

Innovating to Help Industries Transform

Event Brief – SAP Industry Analyst Base Camp 2021

By: Sandra K. Rodriguez, Senior Industry Analyst

Peter Maier, President, SAP Industries and Customer Advisory, opened the 2021 Industry Analyst Base Camp with words of caution, “there is still less consensus about the new normal and the future will be more dynamic and uncertain.” With a variety of industry cloud solutions ranging from Automotive, Banking, Consumer Products, Financial Services to Life Sciences and more, Maier said with confidence, “we are the market maker, once again.”

Recognizing that all companies have different starting points, SAP customers are optimizing existing systems and taking a multi-step approach to transition to a modular cloud architecture.  “Moving to the cloud is a journey, not a destination” added Julia White, Chief Marketing and Solutions Officer and Executive Board Member at SAP.  This architecture is comprised of SAP S/4HANA Cloud, Industry Cloud (3rd Party Apps and SAP), SAP Line-of-Business (LOB) Solutions and the SAP Business Technology Platform (BTP) which brings together enterprise applications into one platform for both cloud and hybrid environments. This includes hundreds of pre-built integrations for SAP and third-party applications. White accurately pointed out that many companies have relied on on-prem technologies for decades.  As a result, there are multiple paths customers can take to make the transition. It is not a one size fits all journey.

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30Jul/21

Medical Device Cybersecurity Throughout the Product Life Cycle

By: Thomas Maeder, Industry Analyst, Axendia

“The United States faces persistent and increasingly sophisticated malicious cyber campaigns that threaten the public sector, the private sector, and ultimately the American people’s security and privacy,” begins the May 2021 presidential executive order on improving the nation’s cybersecurity.  Recent crippling cyberattacks on the Colonial pipeline and JBS Foods, and the SolarWinds and Microsoft Exchange hacks, among others, have painfully highlighted the fragility of the information and operational technologies on which the modern world so heavily relies. 

Cybersecurity in Healthcare

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