Data analytics, AI and IoT is going to change the entire R&D scenario in next decade
— Kaushik Desai, Pharma Consultant
It is very much true that Pharmaceutical companies are changing their focus to adoption of new technologies, there are reasons for this strategy. The market drivers of new technology are intense global competition, uncertainties in energy and supply costs, decreasing product life cycles and exponential growth in IT sector. At the same time, there is surge of Pharma 4.0 concept globally. It is the latest wave of technological advances that will derive the next phase of pharmaceutical manufacturing. The pharma 4.0 broadly comprises of the convergence of people, physical systems, and data within a process to improve productivity, quality and profit by using the power of advanced data analytics. This evolution of advanced analytics is expected to improve insights in the science of making life saving drugs. The data analytics, artificial intelligence and IoT is going to change the entire research and development scenario in next decade and is expected to reduce the time and the cost of the development considerably. The automation and technology create the opportunity to leverage data and analytics to improve the processes.
It is a misconception that the technology driven innovations and solutions will reduce the manpower and its dependency. This will only change the requirements particularly with respect to skillset and there would be need for professionals with advanced skills and capabilities that match with the technological evolution. The automatic manufacturing and packaging lines will just reduce the human interventions and improve the efficiency of operations. Automation will drive the creation of new work for people. Humans will retain an advantage over digital workers in terms of creativity, critical thinking, complex information processing and interpersonal skills. The high-end machines are not going to talk to regulators during audit. They just aid the process. It is the responsibility of operators, supervisors and managers to explain the implementation and demonstrate the confidence in being able to consistently produce quality drugs. The integration of automated machines, input materials and operators are a must to get desired deliverables. Industry shall have robust training programs in place before putting any workman, supervisor or any other professional on the job. The training shall encompass to answer the questions how, why, what and who for better understanding before implementation of any new technology solutions. These initiatives are already taken by some of the pharma companies of repute. Many companies fail in implementing new technology to the expected level in spite of making heavy investments just because of not investing time and energy in human beings who are going to manage the show. The cost of investment in technology is much more than the human force and the failure rates are very high if not attended in a structured manner.
The new technology calls for skilled and educated professionals. The current curriculum of pharmacy does not equip budding pharmacist adequately with new technologies. The entry level pharmacists cannot visualize the technological advances in industry. The institutes are not expected to be equipped with automated machines and systems as they are very dynamic in nature. The industry and institutes need to work together to evolve a need-based curriculum for the benefit of industry. We all are very well aware that the changes in curriculum are highly complex and time-consuming process although much desirable on a long-term continuous basis. The academia can start certificate short term courses in partnership with pharma industry for pharmacists in the area of technological advances and compliance. The pharma machine manufacturers association can also play a supporting role in this initiative. Today, the younger generation is much more adaptive in using the advanced technology which is evident from their regular use of social media, internet, mobile apps etc. Now a days, we all communicate more in virtual world than the physical one. In such a scenario, it will be much easier to orient young budding pharmacists in pharma related technology solutions through short term specific courses. The reintroduction of apprentice training scheme of minimum one year by government will surely help the industry to develop professionals in managing the automated systems and machines. Also, to make technological innovations and digitization a success story, the government, industry, academia, pharma associations and regulators would have to come on a common platform and support each other in this exciting journey. There is initiation but the pace of work in this direction needs to be expedited.
Human error is one of the most cited observations in the regulatory audits. Technology driven data integrity issues are another area of concern. It has mainly arisen from improper understanding and implementation of new technologies by human work force apart from many other factors like organisation culture. It requires thorough introspection and the onus of investing in development of required skills of work force lies mainly with the company.
We are in the era of Industry 4.0 which talks about digitalization. Many large and medium scale pharma companies have initiated and implemented the automated digitalized systems to some extent. The next revolution or Industry 5.0 will be focused on the co-operation between man and machine, as human intelligence works in harmony with cognitive computing, by putting humans back into manufacturing with collaborative robots. The human force will be upskilled to provide value-added tasks in production, leading to mass customisation and personalisation for customers. The pharma organisations that identify potential job losses ahead of time can mitigate the negative effects of automation through retraining, improving their own operations in the processes.
In a nutshell, the adoption of new technology would not reduce the manpower but it will evolve a new set of professionals managing the changing phase. There has to be balance between dependence on technology and the required experience of the human force.
“With GAMP 5 and Pharma 4.0 initiative, we are headed to the automated era of the Pharma Industry”
— Kulshrestha Vikram V, Consultant – Belican Pharma Consultants
In this day and age where technology has become second nature, advancements in technology have proven to be a big advantage. We are living in an inconceivably competitive world, where technology is posing a challenge to its Man-power capabilities. A lot of new industries are rising and any established industries are gearing up to meet the market demand.
With the advent of GAMP 5 and the Pharma 4.0 initiative, we are inevitably headed to the automated era of the Pharmaceutical Industry. It is easy to get lost in the plethora of opinions and approaches to their implementation, but one must always begin with the most basic question, is it really necessary?
As we work on making Pharma 4.0 a reality, the common fears involve the reduction in Man Power. However, if we dive deeper, there is more to the picture than what meets the eye. Though there is a high probability of people at the shop floor level losing their jobs, the market for skilled labour that can operate the advanced sophisticated systems and interpret the data generated by it will increase tremendously.
Man Power with definite skill sets will become even more desirable than before since there will be engineers required to maintain the data banks, IT experts which monitor the systems and their integrities, Pharmacists which work in close association with these experts to design and implement systems which will be at par with the ever-evolving industry standards.
Furthermore, as the Global demand of healthcare products increases, prerequisites for the industry are not just limited to ensuring Product Quality, but also extended to ensuring Patient Safety and efficient Patient Central Medication. Earlier concepts of assuring the quality of product were limited to manufacturing and testing aspects, but now the scope has extended to Supply Chain Management and Patient Experiences, and automation is bound to deliver efficiently on that.
As far as the Research Wing of the industry is concerned, the software is already an essential part of modelling and virtual testing of the hypothesised or newly synthesised molecules yet to undergo trials. With automation introduced to this sector, the processes involved can be accelerated and their efficiencies can also be drastically improved. It will not hamper the human aspect of the process, only accelerate the rate. We discover and introduce new products to the markets, which can further increase the number of people employed in these sectors.
With all the spick and span image of an automated industry, we must still consider some of the less desirable ramifications of this revolution. Unemployment, which has become rampant in today’s economy, may continue to rise among the unskilled labours who will not be able to comprehend the complex and sophisticated systems hence introduced.
The upfront cost of automation might twit many big companies but inevitably when automation becomes the norm, small or medium scale enterprises will find the expense unbearable and this would certainly reflect in their probable non-compliance.
Today the question is not about the steps pharma companies should take to enhance manpower capabilities, but, how should the inevitable change be managed. As the employment of technology is only in two main domains today, i.e performing mechanical work and managing data, man still retains the key roles. Technology can provide us accurate data and its analysis, but how to act on it is still on the man.
In conclusion, even though we are still a long way from achieving complete automation reality, we must take steps to update and equip over work-force with the traits and skills which the future will demand. Once that is taken care of, the industry and its personnel might initially tremble but the step towards automation will be vindicated in favour of not just the industry but the mankind it serves as well.
“Technology is not a replacer but an enabler to do better things in a faster way”
— Himanshu Saxena, Founder Director – Sisha Pharma
Pharmaceutical Industry is as old as history of mankind. Humans were experimenting with cures even when they were cave dwellers. The modern pharmaceutical science is based on research and evidence. Technology has always been the companion in human evolutionary cycle. Technology and Quality go hand in hand. In fact, one of the important things we forget is the fact that we humans are the birth givers of new technology either by way of invention or by way of discovery. Technology is not a replacer but an enabler to do better things in a faster way. There is a change in the disease profile over the last many decades. We are witnessing old diseases but now caused with more and more resistant varieties of microorganisms. New diseases are beginning to show up on account of various mutant varieties of microorganisms. We require new technology to deal with these new diseases.
All this has created the need in the pharmaceutical manufacturing space to be more and more technology enhanced so that the drug is manufactured in a faster and controlled manner and reduce the side effects. In fact, the advent of Bio Pharmaceuticals is speeding up with the usage of high-end technology in the process of manufacturing protein-based compounds from microorganisms. Even in the synthetic chemistry processes, machines are being made more and more intelligent, capable of self-operations based on a pre-determined manufacturing recipe developed by humans. Hence there is a great need for pharmaceutical technology knowledge to be imparted to all the professionals in the industry.
The western pharma industry has already taken a giant leap in furthering the cause of high-end technology being part of the curriculum in their universities. The world of pharmaceutical research, manufacturing, quality control, drug testing, clinical trials etc are now extremely engaged with high tech instruments and equipment. Even the regulatory agencies are now mandating proper controls on the technology so that it can ensure continuous and proper manufacturing with evidenced audit trails. Medicine is moving towards targeted cure with astonishing recovery results for the patients.
It is important how to continuously make our manpower exposed to high end technology and how can we better our learning and training both on the job and off the job, in such a fashion that technology is continuously upgraded. Remember technology needs humans to upgrade. One starting point could be the overhauling and upgradation of our education curriculum in our pharmaceutical and engineering institutions. What we are teaching and what we are witnessing at the pharmaceutical manufacturing place are two different things. Another important aspect is how much are the manufacturing companies investing in upgrading the technology and keeping their workforce updated with modern concepts and implementation.
There are huge technology leaps in the manpower training and development methodologies. Today in this era of global e-connectivity, the technology content and its disbursement to targeted audience is easy. Our workforce needs to be tech enabled. The younger generation of pharma engineers are very apt in running many of the PLC based machines at our plants.
If India needs to continue to keep itself relevant as the Pharmacy of the World, we need to ensure that money is allocated for the manpower training and development and our industries should keep on investing in new technology. Manpower should be continuously exposed to new technology by always aligning what is happening globally. Companies should invest in knowledge sharing and give chance to our young engineers to go outside the country and see for themselves what all are the advancement in technology. Attending technological seminars, meaningful interactions with equipment suppliers and a thought process of replacing old machines with always better technology. Our institutions, our manufacturing companies all have a role to play. The government should increase the funding for new technology at our IIT’s, IICT’s, NIPER’s, DBT’s and Science Colleges. We should incentivise the industry for using newer technology. Today the integration of AI and manufacturing is heralding new frontiers of technology. Factories 4.0 are the ‘in’ thing. We need our manpower to be technically qualified to run factories of the future.
Technology overdependence is to be looked in the context of continuation of usage of old technology verses new technology. In a knowledge driven domain like pharma, technological overdependence can lead to less out of the box thinking. Of course, one of the other main challenges will be, what will be the cost of getting this technology and how can we pay for all this advancement. The pay scales will also raise as we make the manpower more technologically upgraded. The cost of drugs and the price point are sensitive, but the treatment given to patients is also equally important. I am sure that new technology will secure India’s position globally as a leading provider of medicines and pay for all the funds needed for advancement and technological percolation to all levels of pharma
Lastly, we depend on technology which is continuously upgrading. Remember the old dial phone of yesterday and the mobile smart phone of today. We need to harness continual development of technology for more and better-quality products and balance the need with continual knowledge sharing and upgradation. People and technology need to embrace dynamism for mutual
“Tech acts as a force multiplier for human capabilities”
— Harish K Jain, Director – Embiotic Laboratories & Secretary, KDPMA
It is true that Pharma Companies are investing increasingly on technology to drive innovations whether it is Data Analytics, Artificial Intelligence, Machine learning, Robotics, Algorithms or any other. However it is not true that technology alone can drive innovations. Technology is employed to support the efforts of manpower and acts as a force multiplier for human capabilities. Manufacturing and Analytical advances have the potential to speed up innovations and research as well decrease overall costs in view of rising cost of human resources.
Some of the foremost reasons why advanced technology is employed is for Manufacturing, Innovation and research is:
- For lead Generation from huge number of entities in hand
- Complex Processes for Complex Molecules/Complex Dosage forms which otherwise would not have been possible
- Need for Validated methods for Manufacturing & Analysis
- Ever increasing Regulatory requirements to maintain reliable data and ensure compliance
- Competitive research where focus has shifted heavily to safety margins sometimes even at the cost of efficacy.
- Large Scale Manufacturing for conventional products
In current scenario manpower alone or technology alone is not sufficient. What we require is correct synergies between the two. This calls for higher level of skilled manpower to use the advanced technologies as well as Multi-disciplinary approach. Foe example for manufacture of Oral dosage forms, a Pharmacist alone cannot work in isolation. He needs to be appropriately skilled in engineering as well, whether it is Nano technology, Information Science, AI capabilities, Data Analytics etc.
It is prudent for Pharma Companies to employ skilled personnel from Multiple disciplines as well as understand basics of newer disciplines to explore synergies. Ex: Some of the Biological products which were earlier manufactured from Animal sources are increasingly being produced using Fermentation and Bio reactions technology. Similarly many Plant origin products are now manufactured using Synthetic route, classic example being caffeine. This has been possible using Multi-Disciplinary approach. Companies need to employ manpower with experience and training necessary to effectively deploy and operate technological solutions.
Technology driven processes to an extent ensure reliability and consistent quality in large scale. However there are limitations of technology as well as on over dependency on this approach. Technology is expensive, technology driven processes have long implementation time, integration challenges, usability/interoperability , unlike humans cannot improve with experience, No Original creativity (cannot think of itself) which is gift of nature to humans. Moreover technology works on availability of data (which many of the times is incomplete or unreliable), one size fits all approach which is not always possible and does require supervision which can be provided by human manpower. The challenge is availability of experienced and skilled manpower. This comes at huge cost.
In addition there are Ethical challenges:
- the potential of technology to give rise to job losses
- the need to redeploy or retrain employees to keep them in jobs
- fair distribution of wealth created by machines
- the effect of machine interaction on human behaviour and attention
- the need to address algorithmic bias originating from human bias in the data
- the security of systems (eg autonomous weapons) that can potentially cause damage
- the need to mitigate against unintended consequences, as smart machines are thought to learn and develop independently.
“Manpower in pharma inc can complemented by constant advancement in technology”
— Sripal Bachawat, Director -C-Square Info Solutions
Technological Unemployment is the loss of jobs caused by technological change. It’s a key type of structural unemployment. Technological change can lead to short term job losses is widely accepted. But its lasting effect on long term unemployment is a controversial issue that has been discussed since ages.
We have all read multiple articles on this topic with different views from different stakeholders.
Let’s look at it from a tech companies perspective that is striving towards digitization of the pharma supply chain thus enabling better visibility and transparency in the whole process.
Pharma industry is different from most of the other industries as it requires specialized manpower for almost all their process. Even the sales executive has to be a B Pharm graduate to have a meaningful conversation with the doctor. The Retailer needs a license to run a pharmacy. In short, its an industry that has always felt the need for specialized manpower. The same has been complemented by
constant advancement in technology.
There are two aspects of the Pharma industry that is man-power dependent and thus could be impacted by technological development. Lets look at them separately
1. Research and Development: There have been some amazing developments in the recent past in the field of medical research and new product development. With new technological advances the requirement of skilled man power has also
increased. The challenge here for the companies is to ensure that they upgrade their existing workforce to adapt to the new technological advances.
2. Marketing: Unlike other industries, Pharma marketeers cannot directly market their products to the end user (patients). Here the entire process is man-power dependent. In spite of the technological advances in the field of brand communication, brand detailing via medical reps is still the backbone of Pharma marketing. There have been many pilots in the pharma industry to replace the human component of brand detailing – remote detailing. But none have been able to replace the MRs.
3. Sales: The distributors have to spend a lot on their salesman for order taking alone. Major chunk of the order placed by the retailer to the distributor is either via a salesman or on call. In both the cases the distributors have to spend an amount close to 1.5 per cent of the order value on processing the order. With tech companies seeing an opportunity in this have launched multiple products to enable B2B transactions. This could lead to loss of jobs for the salesman. An optimist would try and employ these people in more productive ways for growing their business.
Technological advances have its Pros and cons. It all depends on the approach of the individual or the company. It can be an enabler helping the work force to work more efficiently or it could be something leading to unemployment.
“Companies need to be pro-active about training new comers on new tech”
Rajashri Survase Ojha, Lead Auditor – Raaj Pharmalearning
The human capital has become the most important factor in any companies’ success. Whereas, technology is a set of tools that we use in different ways to increase efficiency. The Industrial Revolution destroyed some jobs but created many more with specific skills. The new jobs required a completely different skills set – you can’t turn an assembly plant worker into a data scientist overnight, if at all. The Industrial Revolution played out of several decades and yet still caused massive social upheaval, unrest and widespread deprivation for many.
Indeed, while technology lowers the number of repetitive and physically intense jobs, it creates others that didn’t exist before. This is particularly true in the area of nanotechnology, an emerging technology that is already transforming our world.
To address the skills shortage in a deeper-rooted, more meaningful way, companies must increase their investment and focus on training in a more consistent way in order to create a sustainable pipeline of domestic talent. Increasing usage will require a dramatic change in attitude. It will require a stronger commitment by senior leadership and more direct involvement in training and development activities.
It will require companies to be more proactive in working with freshers, new joiners to help younger workers develop the technical and softer skills they need. The stunningly high levels of youth unemployment may be the biggest long-term threat to economic prosperity. If these younger workers don’t develop the right skills soon, companies won’t be able to seize opportunities and build for the future. Businesses can provide feedback that will enable educators to link classwork to business.
Technology is constantly evolving, requiring workers to regularly update skills and develop new ones. This applies not only to IT specialists but to employees in most disciplines. At the same time, demographic and economic factors are changing rapidly and profoundly impacting companies’ workforce needs.
The world is a very different place in the Human Age. Companies need to be able to respond quickly to changing conditions, adding highly skilled talent when and where necessary. Repurposing employees demands innovative training. Some of the best training offered today was collaboratively designed by workers and employers.
In a fast pacing digital communication world, companies’ target is to win the race before their competitor. Earlier, the knowledge source was derived from the calculated experience but in the era of Big Data, from macro to micro level, each step is dependent on technology enabled solution. The shift is a result of increased pressure on R&D departments to develop not only new products faster than the past, but the increasing demand of customised therapies. Big Data, AI or industry 4.0 have changed the competitive landscape of the industry and driving the demand significantly. Moving further, the industry needs to gear up for next phase of evaluation which is Industry 5.0. It is the revolution, which man and machine will reconcile and find ways to work together to improve the means and efficiency of production. As some of our experts pointed out, there will be shift but still need of knowledgemnet enhancement will keep growing.