Axendia – Analytical Revolution in Medical Sciences

Daniel Matelis - Axendia

With the pandemic in the picture, all eyes have turned towards the Healthcare industry, especially Life Sciences. Life Sciences is directly involved in protecting and improving organism life, working day in and out to research and develop disease-fighting medicines and supplements. This industry has come into the limelight especially since the world has peeled its eyes towards the rollout of vaccines, etc.

This has also raised the importance of this industry, and its impact on the world, making it one of the foremost branches to measure the growth and development of medical evolution and progress.

Axendia is a class-leading enterprise dedicated exclusively to the Life Sciences industry, enabling companies and research institutes with analytical and strategic solutions that help them bring out exemplary products/services. They have been working in the industry for more than 15 years, delivering nothing less than excellence.

Their clientele comprises top companies in the Life Sciences industry, who are extremely satisfied and loyal to Axendia but also highly regard their best-in-class services and solutions. These factors make them one of the most trusted Pharma & Life Sciences solution providers in 2021.

In conversation with the Founder and President of Axendia, Daniel Matlis. Let’s understand more about Axendia, its services, and the Founder’s professional journey so far.

Brief us about Axendia, and what pushed you to establish it?

Axendia is a leading analyst and strategic advisory firm focused exclusively on the Life-Sciences industry including Bio-Pharmaceutical, Medical Device, and Diagnostic markets. Life-Science industry executives, technology and service providers, as well as regulators, rely on Axendia as their trusted source or actionable advice on the complex business, regulatory, and technology issues impacting our industry.

Axendia was founded in 2005 to support an unmet need: An Analyst firm with deep Life-Science industry knowledge that provides holistic, actionable insights that enhance visibility, control, collaboration, and resilience across the Life-Science value network to improve patient outcomes.  

Axendia serves the entire Life-Science ecosystem ranging from start-ups to Fortune 100 companies including Life-Science organizations, Technology & Service providers, and Regulatory Agencies.  

Tell us about the services offered by Axendia, and how they are a class apart?

Axendia provides trusted advice based on trusted sources. We operate at the intersection of three domains: business, regulatory, and technology issues that impact the Life-Sciences ecosystem. We provide strategic advice that enables our clients to prepare for, adapt to, and overcome disruption. To this end, we conduct primary quantitative and qualitative research that our clients leverage to support their strategies and enable them to make informed decisions based on their unique needs.

Our approach is tailored. We do not believe in force ranking vendors or crowning the best solution provider. Instead, we work with our industry clients to understand their intended use, culture, budget, and other requirements enabling us to provide advice based on each client’s unique needs, as well as support future growth.

When working with Life-Science organizations on transformational initiatives, we provide actionable insights based on the following guiding principles:

  • Demonstrate deep Life-Science industry understanding to offer a holistic recommendation that takes into consideration business, technology, and regulatory trends affecting the industry in general, their sector in particular, and their specific company needs.
  • Have the integrity to tell clients when NOT to start a project.
  • Provide recommendations based on each clients’ culture, values, requirements, and intended use of the system.
  • Help the client identify their real needs and wants vs. the perceived needs or wants.
  • Challenge the status quo when asked to recommend an initiative simply because “everyone else is doing it.”
  • Foster organizational culture change to enable genuine buy-in that will enable successful digital transformation.
  • Provide tailored insights needed to make the best decision possible! 

Tell us about the team of Axendia.

Our team has direct experience in the day-to-day operation of Life-Science organizations. As a result, Axendia professionals offer a unique combination of deep hands-on industry experience coupled with forward-thinking insights. We contribute to our client’s success by providing long-range visibility and helping them navigate the increasingly complex regulatory landscape.  

Our analysts provide insight and actionable advice based on first-hand experience working for industry organizations. Our team has an average of 25 years of industry experience. As a result, we have a deep understanding of the business, regulatory, and technology challenges and opportunities facing Life-Science organizations. 

In addition, we have established long-term trusted relationships with regulators including the US Food and Drug Administration. As a result, Axendia analysts have provided insights, advice, and research to FDA officials on a multitude of transformational initiatives including:

  • The ‘Case for Quality’ initiative.
  • The transition from Documented Evidence to Digital Evidence.
  • Computer Software Assurance for Manufacturing & Quality Systems.
  • Advanced Manufacturing, Modernization, and Digital Transformation.
  • Quality Metrics.
  • In-Silico Clinical Trials. 

Tell us about your professional journey.

I have worked in the Life-Sciences industry for over 30 years. I began my career at Johnson and Johnson as an automation and controls engineer where I led the implementation of shopfloor automation systems including robotics and vision systems as well as the development and implementation of computer integrated manufacturing solutions across the organization. I had the privilege of leading a team of engineers who pioneered the implementation of solutions connecting the shop floor to enterprise systems including ERP. I was also responsible for the implementation of computer system validation (CSV) policies and procedures as well as ensuring compliance with regulatory requirements on CSV. 

I then joined a start-up consulting firm as a partner, VP, and General Manager building a Life-Sciences consulting practice. Over my eight-year tenure, we grew the business from 15 to 150 consultants focused on systems development, auditing, implementation, process development, and validation as well as regulatory consulting focused exclusively on the Life-Sciences market. 

In 2005, I founded Axendia intending to provide Life-Science industry executives with holistic insights at the intersection of business, technology, and regulatory issues affecting our industry. To date, we remain the only Analyst Firm focused exclusively on Life-Sciences.

Please share some highlights of your business’s journey.

At Axendia we believe in educating clients and providing them the necessary tools to improve business outcomes across the entire Life-Science value network. One example is our ‘Straight from the Source’ webinar series. We have interviewed dozens of industry leaders from Life-Science organizations, regulatory agencies, and technology & service providers to enable the industry to learn from success.

For example, we have had the privilege to interview industry thought leaders from Amgen, FDA, Fresenius Medical Professionals Systems, Fujirebio Diagnostics, and Pfizer among others.

Every year, we publish a Life-Science industry radar identifying key developments and disruptors that will impact executives across the three domains we cover: business, technology, and regulatory. As a result, our clients gain advanced visibility on the trends, disruptors, and opportunities they should be prepared to address and plot a course for success.  

Share with us a client experience, and what they have to say about Axendia?

Some of our proudest moments stem from seeing our clients succeed. We foster the implementation of new approaches that enable them to streamline processes and improve patient outcomes by leveraging advanced technology while ensuring compliance with all applicable regulatory requirements.

Here is what our clients say about Axendia.

How has Axendia earned your trust?

  • Ability to engage ALL areas of the business and gain their confidence to provide desired feedback.
  • Consistent and constant display of expertise and valuable input.
  • Far more focused and concerned with adding value to our organization and providing quality deliverables than worrying about time and invoicing.  
  • Ability to lead out front when needed, and lead from behind when needed – and knowing the difference.
  • Understanding our organization as people first – processes second. A unique quality and ability that is difficult to find today.

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