Changing Regulations Compelling Pharma Companies to Digitize
Stephen Smith, Commercial Manager, Novatek Europe
Stephen Smith, Commercial Manager, Novatek Europe
Stephen Smith began his journey of integrating technology and robotics in the healthcare industry 20 years ago. He sought to specifically persuade the pharmaceutical sector to leverage automation and software to streamline their operation to minimize errors and reduce patient health risks. Smith then moved to South America to transform the 15 years behind Europe and America sectors, followed by his return to London as the commercial manager for Novatek Europe after the pandemic struck.
In an exclusive interview with Pharma Tech Outlook Europe magazine, Stephen Smith shares his valuable insights regarding the importance of technology in the newly evolving pharmaceutical industry. He also discusses the factors that compel the sector to adapt and digitize its processes to ensure compliance, safety, efficiency, and cost-effectiveness.
Throughout your career, what challenges have you encountered that you believe can be resolved through technology and automation?
One example of a project undertaken during the beginning of my career was pharmacy automation, where we created a robot that handed over medicines in hospitals.
The robot addressed three critical challenges – speed, efficient stock management, and enabling pharmacists to engage with patients more.
Big hospitals having 1500 to 2000 patients daily often find themselves pressured when keeping up with the demand for medicines. The robot automates the process and increases the speed and accuracy of disbursing
medicines as per patient medication. Automating this process also reduces the risk of human error in supplying expired medicines that can negatively affect patient health and lead to financial losses for hospitals, especially in the US.
The robot also automates the stock-keeping processes as it lets the hospital know of shortages of certain medications and provides relevant information to pharmaceutical companies that supply those medicines.
Thirdly, the pharmacists would have more time to engage with patients and answer their questions while the automated system searches for the medicine.
Automating pharmacies in hospitals brought immense benefits to end users and patients. On the other hand, my current work in Novatek is software-based and particularly focused on helping pharmaceutical companies in environment monitoring, utility monitoring, and end-to-end sample management. I also help companies shift their operations from paper-based to digitized processes. There are a few reasons that necessitate this transformation.
Pharmaceutical companies collect vast amounts of data from various critical areas while manufacturing, forming data lakes. Ineffective utilization of the available information leads to mistakes, problems, and non-compliance issues. The fear of stepping into the unknown compels the sector to reject the latest data technology and algorithms that perform predictive analytics compared to the media industry. My mission is to convince companies to look at digitization as a solution to these challenges.
What are some of the latest trends shaping the future of pharmaceutical compliance and patient safety?
When focusing on assisting pharmaceutical companies, compliance with regulations is essential. For instance, EU Good Manufacturing Practice (GMP) Annex 1, recently revised due to the technological advancement in the industry, compels these firms to automate their manufacturing processes. Although it
will positively influence the European industry, many companies strive to solely improve their contamination control and risk management strategy instead of digitizing their operations. However, the most efficient method to execute control contamination is by using automation and digitization.
“I believe the industry’s future will pivot around artificial intelligence. It will enhance quality, minimize chances of error, and ensure compliance to regulatory standards.”
Artificial intelligence is a necessary tool for pharmaceutical companies aiming to delve into predictive analysis. The potential of artificial intelligence in the industry is immense. I have witnessed the development of machine learning algorithms to analyze vast amounts of data. It can also identify patterns and generate insights, enabling the industry to predict patterns before they happen.
For instance, if a contamination control problem occurs amidst a pharmaceutical manufacturing process, artificial intelligence can predict the issue before it happens and stop the deviation incident.
How do you envision the future of healthcare in terms of enhanced care delivery, patient safety, and protocols?
I believe the future of the industry will pivot around artificial intelligence. It will enhance quality, minimize chances of error, and ensure compliance with regulatory standards. This excites me as I hear numerous pharmaceutical companies discussing removing humans from the manufacturing equation to eliminate contamination by using robots and automation in laboratories. This enables humans to focus on their responsibilities instead of performing mundane tasks that AI can undertake.
Pharmaceutical companies require courage to overcome the fear of the unknown and the expertise to begin their journey along the path of digitization and adoption of AI. This fact is proven by the number of giant firms that rely on paper to record data generated by the manufacturing process. We must guide them to a better path.
The seismic shift in manufacturing processes is what I will see in the next 10 to 15 years. EU GMP Annex 1 was the beginning of transformation, and the future revision of this regulation will make it inevitable for pharmaceutical firms to go down this route.
What advice would you give to aspiring individuals and fellow peers who want to pursue a successful career in the pharmaceutical sector?
My advice is to keep learning as the industry is rapidly evolving. Knowledge is power. Numerous highly qualified and experienced individuals in the pharmaceutical space are willing to impart information on changing industry regulations and how to be better consultants, microbiologists, and analysts. Online materials like magazines and interviews are also available with the latest industry news. Those willing to participate in this industry must give their 100 per cent and continuously consume knowledge to succeed.
