A few years ago, the hot topic that was discussed at most of the forums was how to deal with the challenges posed by the VUCA world, not knowing that we will face one such real global disruption in the form of COVID-19 pandemic soon.
“There are decades when nothing happens but there are weeks when decades happen.” COVID pandemic was one such brutal disruption the world went through, and has come out much wiser with a lot of learnings that are known as ‘New Normal.’
The world has learnt that with the help of innovative technology, it is possible to witness a never-seen-before feat of producing a potential vaccine candidate in mere months for a novel virus.
We realise like never before that we have entered into an era of disruptive innovation and recognise that those who keep pace with innovation will be the future leaders.
Challenges of the VUCA world
Talking about the challenges in the pre-COVID era, there are questions and realisations that:
◆India is no longer the low-cost centre for the manufacturing of pharmaceuticals?
◆ The price of medicines (patented and generic) will fall in the next five years?
◆Cost of manufacturing will increase?
◆ Our compliance with regulatory expectations, particularly the US FDA, continued to be a lingering issue and remain an ongoing concern.
◆ Amazon, Google and Apple will have a profound impact in healthcare in the next decade
Balancing three Cs – Customer, Cost and Compliance
The pharma industry is faced with the challenge of balancing overlapping three circles—Customer expectations; Profit and efficiency – Cost control; Legacy and reputation – License to operate; within the constraints of shrinking resources and time.
The pharma industry has been focussing, amongst others, at the latest technologies like complete digitisation of operations, automation at manufacturing units and Big Data and Machine Learning to enhance accuracy, reduce time and efforts, and remain in the state of compliance.
The focus has already shifted to smart innovation that will give a disproportionate return in terms of improved efficiency. We need to work on the principle of ‘Less is More’ which is the new mantra.
Industry 4.0
The tremendous ongoing digital transformation – better known as Industry 4.0 – is profoundly changing manufacturing, processing and production industries. The term Industry 4.0 encapsulates all the rapidly evolving technologies, processes and practices that are currently changing the world of manufacturing.
Advanced technology is undoubtedly becoming the backbone of futuristic quality assurance in the pharma and biotech industry.
Digitisation – A strategic priority in post-COVID era
Post-COVID-19, adoption of digitisation has become a strategic priority for business in the pharma industry. Such benefits will be highlighted in the areas of:
◆R&D
◆Manufacturing and Quality
◆Role of regulators in supporting innovation
Pharma R&D
The advent of new emerging technologies like AI, IoT, digitisation and automation have the potential to revolutionise every element of the pharma industry from drug discovery to production to efficient and secure supply chain to monitoring of ADRs.
Some of the benefits in the area of drug discovery and R&D include use of digital tools in
◆ predicting the behaviour of new chemical compounds in potential drugs
◆ selection of target molecules using high-throughput screening
◆ predicting patient outcomes from Electronic Health Records (EHRs)
◆Virtual and decentralised clinical trials, etc.
These tools will help in developing new innovative products for patient benefit that include the patient-related quality attributes in the design of the product and make the novel drugs available to the patients on fast track.
Pharma manufacturing
Some of the potential applications of Industry 4.0 are seen in the form of continuous manufacturing technology.
◆ Use of the Internet of Things (IoT) for data collection in real time from the networked equipment can help in predictive maintenance of equipment, thus reducing the downtime.
◆ Use of track-and-trace technology for ensuring supply chain integrity, etc.
◆Predictive quality analytics is a tool used by manufacturers to forecast the quality of the products, components and materials that are already in the production process. It can address the root causes of problems in advance—before any quality issues occur.
Pharma labs
Quality 4.0 is a less-hyped, but quickly emerging concept within Industry 4.0.
Creating a fully integrated lab of the future that adopts modern technologies and practices, and is data-driven, enables manufacturers to develop, manage and maintain quality standards throughout their supply chains.
As a subset of Industry 4.0, the development of analytical methods alongside the product developments assumes a significant importance, and it is expected that the tools of digitisation are used in developing robust, simplified and validated test methods. These methods have to be transferrable and have to be integrated in the smart lab of the future.
The big pharma companies have adopted these technologies in building digitised and automated labs and have improved operational efficiency in terms of savings up to 40 per cent of the cost. The concept of distributed labs is being used in supporting the continuous manufacturing technologies for providing real-time on-line feedback on key
quality parameters.
Role of regulators
The role of the regulators and the government is equally important in providing an ecosystem that encourages and facilitates innovation. During the development of COVID vaccine and related drugs, we have seen the regulators world over adopting flexibilities in the process of:
◆ approval of new products for emergency use,
◆ providing GMP flexibilities in terms of accepting remote /virtual inspections,
◆extension of validity periods of GMP certificates, etc.
The learnings from this period can be leveraged to introduce simplified regulatory processes by adopting a risk-based approach. The industry and the regulators have to work together to bring such approaches in practice for alleviating the concerns about compromise to patient safety.
Adaptive challenges
The adoption of new innovative technologies of this scale is a transformational change that requires a huge capital investment and a compelling business case. Besides, we need to have a qualified team with the required capabilities for such adoption.
This is an adaptive challenge more than a technical challenge since we have to break the barrier of inherent immunity to change that exists in us and in our systems.
Therefore, it is important that digitalisation initiatives are built within the company’s quality system. This requires a leadership team with systems’ thinking abilities to appreciate that a modern pharma quality system integrates all five manufacturing systems to operate within and interact with each other.
Improving a part taken separately will not improve the whole system, but, at times, can damage it. Any improvement implemented outside of a QMS will not be scalable and sustainable.
Therefore, we need to focus not only on a small q (QC) but a BIG Q (Quality System).
We cannot do today’s work with yesterday’s methods and still be hopeful to succeed tomorrow. What brought us here will not take us any further if we do not focus on innovation. Innovation is the key to success for the pharma industry.
Automation and digitalisation will not replace humans, but instead augment the human capability. It is this integration of human capabilities with technology that will lead to beneficial results that neither humans nor technology can alone deliver.