we.CONECT: The Pop in your Job – In your position as Associate Director, ITS Compliance at Sanofi, you say your Pop in hte Job is to find better ways to get the right results for compliance in your company. Which tasks or responsibilities would you name as particularly interesting? What is most exciting, and why does this make you passionate about your job?
Daniel Matlis: In 2005, follwing extensive discussions with Life-Science executives, we discovered an unmet need for a firm that provides a holistic view of the industry by offering trusted advice on business, technology and regulatory issues. Driven to successfully address this need, Axendia was born. Today Axendia is a leading analyst and strategic advisory firm. We maintain trusted relationships with regulators, industry executives and technology and service providers.
A significant factor for Axendia’s success is our unique approach of providing tailored strategic advice. We believe that there is no one standard solution that fits all clients, therefore our approach is to offer tailored solutions that take in to consideration each client’s present, as well as their future needs.
we.CONECT: At Pharma MES USA, you will be presenting on MES releated news and latest regulatory updates for pharma and biotech manufacturing. Why do you think do companies need to be briefed and udpated regularly on these kinds of changes?
Daniel Matlis: As a result of our long term relationship with regulatory agencies, We have provided input to FDA on quality and regulatory strategies, and have presented findings from ouwn primary research to Agency leadership and staff. Axendia is also actively involved in a number of transformational initiatives including the Case for Quality, Quality Metrics, the transition to Digital Evidence and the of Modeling and simulation accross the Product Lifecycle. Axendia’s relationship with regulators has resulted in a deep understanding of the shifting regulatory landscape.
we.CONECT: From your experience, what are usually the most important drivers for regulatory related projects in pharma and biotech – functionality, speed, process optimization, security, user/customer satisfaction, cost, or maybe something completely different?
Daniel Matlis: The use of technology in support of Manufacturing, Operations, and Quality delivers significant advantages for Life-Science companies. Automation systems and digital technologies deliver enhanced product quality and safety that result in reduced patient risk. In addition, they can reduce or eliminate opportunities for error, increase business value, and support resource utilization.
Computer System Validation (CSV) has been a significant barrier to improving digital capability, product quality, and patient safety in our industry. As a result, FDA is encouraging industry to implement automation systems and digital technology solutions throughout the product lifecycle.
we.CONECT: Looking at the starting phase and the first pocs of projects you have done with clients in the more recent past– Where do/did you see major accomplishments and success stories for achieving the overall project objective? Does this vary based on specific indicators like company size, project topic, etc.?
Daniel Matlis: To support changing regulatory frameworks and business models, forward thinking Life-Science companies are not just considering digital transformation 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. To this end, companies must recognize that transforming organizational culture and behaviors is imperative to ensuring the success of digital tranformation initiatives.
we.CONECT: What were the major challenges and what is your advice to overcome them?
Daniel Matlis: Today, technology is no longer the limiting factor. Success must be build on cultural change, improved colaboration and strong master data governance.
we.CONECT: Looking at the future, which topics and trends with regards to pharmaceutical regulatory and technology compliance do you see in the upcoming 12 months? Into which direction will the topic evolve?
Daniel Matlis: Disruption is on the radar! Life-Science executives must plot a course for success. Due to Axendia’s track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.
To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream
While we have plotted some disruptors closer than others, Life-Science Industry innovators are already harnessing the tail winds of this positive disruption to leapfrog their competition. It is only a matter of time before these trends become mainstream.
Many disruptors are closely connected and Life-Science organizations must take a holistic view when it comes to business, regulatory and technology trends in order to plot a course to success.
In this session we covered topics including:
- Closing the Loop/Total Product Lifecycle Management and Shifting from Compliance to Quality
- Global Regulatory Harmonization
- The Impact of the Internet of Medical Things (IoMT)
- Manufacturing 4.0/Industry 4.0
For more details, view our Webinar On-Demand: 2019 Life-Science Radar. (Please link to: https://zoom.us/recording/share/gdm-eXtUzHA_AVfdbF_yUOEgwIj91jiICEF80A_nvDmwIumekTziMw )
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