The ability to have telemedicine makes healthcare more accessible to people
Published on : Monday 04-12-2023
Janice Abel, Principal Consultant, ARC Advisory Group.
One of the challenges during Covid was in the supply chain and this drove the need for implementation and improvements in the supply chain. Supply chain planning and scheduling is key digital technology that is integrated to warehouse and transportation management technologies. Advanced analytics and AI are being built into and even embedded in these technologies so that the technology recognises changes and makes predictions for the workers so that they can quickly adjust to the changes. Track and trace is either a separate part of this solution or included with the solution because companies must be able to trace the product to the pharmacy or even the consumer to prevent any type of abuse.
Data analytics including AI are being embedded into almost all digital technologies including drug discovery and development to help eliminate toxic raw materials or chemicals (including additives) from new drugs, eliminate duplicate drugs, assays to improve consistency and quality. Most companies have a toxicity database that they have developed. There is a move for a universal toxicity database to leverage previous research & development and accelerate drug development. Some companies do not want to share their toxicity information because they believe it is their IP and have spent a lot of R&D funds developing their toxicity database and believe that by sharing their database it would make them less competitive. Another use of analytics in R&D is to eliminate duplicate drugs so that new drugs are more effective or less toxic.
What challenges do pharmaceutical companies face when implementing digital transformation initiatives, and how can these be overcome?
Some of the challenges include:
1. Worker shortages, workers with the right skill sets and acceptance of change – new technology, however, with the right change management and training this obstacle can be overcome.
2. Integration to pharmaceutical company’s infrastructure.
3. Cybersecurity, IT, bandwidth, and other legal issues.
How is the adoption of telemedicine and digital health platforms influencing healthcare delivery in the pharmaceutical industry?
Covid also led to an advancement and acceptance of telemedicine using digital health platforms. The ability to have telemedicine makes healthcare more accessible to people in remote locations, or in situations where they could not obtain healthcare previously. Having a digital health platform is an enabler for the provider whether for telemedicine or in the office.
How is digital transformation impacting the pharmaceutical industry's research and development processes?
Digital transformation is involved in automating research and development particularly in clinical trials. However, the biologics processes have not caught up with automation as yet. For example, at ARMI – which is Advanced Regenerative Manufacturing Institute in the US – their R&D and clinical trials areas have automated many processes include producing raw materials for the biologists, but the problem is that they have not determined the biologics yet to produce, although they are almost there – a new pancreas or liver. They have automated the process of producing personalised skeletal and ACL tissue using Rockwell Automation, so it is just a matter of time before all R&D are almost as automated as production. Other companies like AspenTech and Siemens are also advancing their automation technologies into R&D.
What regulatory considerations and compliance challenges do pharmaceutical companies encounter during their digital transformation journey?
There are still many regulatory challenges. Some of those are the same challenges that kept the industry more paper or document driven over the years. However, because of Covid this is changing. Most major countries in the world have their own version of pharmaceutical regulations starting with the US FDA (Food and Drug Administration, the EU’s EMA (European Medicines Agency), China’s NMPA (National Medical Products Administration, formerly, China Food and Drug Administration), India’s CDSCO (Central Standard Control Organisation), UK’s MHRA (Medicines and Healthcare Products Regulatory Agency, and Canada’s Health Canada. However, there is a strong movement to try to harmonise and streamline regulations. This will expedite manufacturing and processing of pharmaceutical products. The world we live in is global and as we witnessed during Covid the world has a need to obtain pharmaceutical products to save lives. Major manufacturing technologies are increasingly integrating to and automating the research and development processes so that they can be scaled up quickly with automation. Automation technologies are increasingly more important than ever because they can help improve quality, consistency, and time to market.
(The views expressed in interviews are personal, not necessarily of the organisations represented.)
Janice Abel is a consultant and lead analyst in the areas of enterprise manufacturing intelligence (MES)/manufacturing execution systems (MOM), operational historians/industrial data operational platforms and more. She is also helping companies with digital transformation and digital changes. She has done extensive research and consulting on automation technologies spanning the entire spectrum of process and manufacturing industries. Her experience includes over 30 years of helping both suppliers and end user clients develop strategic plans to market, adopt, and use technologies. She has been doing research and consulting for the chemical, oil & gas, pharmaceutical and biopharmaceutical, consumer products, medical devices, and other industries throughout most of her professional career. At ARC her technology focus is on operational data, data platforms, manufacturing execution systems, AR/VR, digital twins, advanced operational analytics, and other technologies.