Blueprint for progress

The industry has focused on innovating business models in ways that are more patient-centric

The approval and launch of the COVID-19 vaccines is a beacon of hope as we enter 2021. Economic activity across markets has started normalising and we will continue to see stable trends and recovery and expect this momentum to be accelerated, particularly with the rollout of the vaccine.

The generic pharma industry has been focused on ensuring access of medicines to patients during these tough times and has ensured a stable supply chain through the pandemic. The industry has also focused on exploring ways of innovating business models in ways that are more patient-centric. The industry has leveraged technology to deliver information and medicines to patients and physicians in the backdrop of reduced in-person interactions.

We will seek to leverage these digital trends and we see digitalisation as a cornerstone of our business strategy, with a potential to impact across our value chain in research, manufacturing, quality operations, and commercial go-to-market strategies. Just as more patients seek engagement with physicians from the comfort of their homes through virtual platforms, we have been exploring ways of enabling our commercial teams to engage with Healthcare Practitioners (HCPs) via digital platforms. We look forward to accelerating this transformation across our value chain.

For us at Lupin, innovation is driven by what patients want and we are riveted to addressing their medical and access burden. We have accelerated the development of our novel products’ pipeline. We are excited and look forward to bringing these complex, limited-competition products to the market.

The thrust now should be on R&D to create new drug development opportunities

The disruption brought about by the pandemic made the pharma sector realise its strengths while exposing the chinks in the armour. Quick to realise its dependence on China for APIs, India soon reduced its dependence. Consequently, the government initiatives, which are already underway to make local drug manufacturers self-sufficient, will be crucial. Leveraging the ecosystem created during and before the pandemic, the thrust now should be on R&D to create new drug development opportunities. As an organisation, we would like to invest in R&D from our early success with the equine antibodies’ project. We are currently conducting phase III trials on Ulinastatin.

The pandemic tested the supply chain resilience too. It is imperative that the industry integrates digital innovation in a bid to strengthen the supply chain. Scaling up existing export markets while entering high-opportunity markets will create new avenues of growth. Also, the regulator and the industry have to display the same co-ordination and commitment as displayed during the pandemic to facilitate new growth areas for the sector.

A template for the future will be optimising the operations while developing enhanced trust in employees. A lean and efficient organisation improves efficiency while bringing down costs. Systems and initiatives that further enhance transparency, agility, accountability and collaboration will garner stakeholder confidence.

Innovative employee engagement practices built on greater trust in our people have empowered employees. A customer-centric and employee focused organisation is adept at wading through the challenges of the upcoming times.

Self-reliance and digitalisation will be a big part of our strategy

One of the biggest learnings, COVID-19 pandemic has brought us is that we, as individuals, as an industry and as a country, need to together work towards improving the healthcare system across the globe.

This year we needed to focus on the following:

• To look beyond regular by rising to the occasion
• The accelerated pace at which digitalisation needs to take place involving all stakeholders. We were able to transform and adapt ourselves quickly to the changing scenario.

We believe moving forward, self-reliance and digitalisation will be a big part of our strategy. We have aligned our supply chain and distribution strategies accordingly by making them more agile and resilient in face of disruptions. Digital tools and automation will play an essential role to expedite processes of approvals, remote monitoring, quality and risk – assessment amongst others.

We at Cadila Pharma continue to invest further in creating innovative healthcare solutions in the areas of vaccines, antibiotics and pain management, among other therapeutic areas. We are also looking at all government regulatory agencies for further alignment of their policies to support and ease the transition.

Create razor-sharp focus on prevention and wellness space

In reimagining its future success, India Pharma Inc must pay heed to all its learnings of the recent months – respecting nature, patient and employee centricity, agility and adaptability to embrace new technologies and work processes, de-risking, simplifying and strengthening its core business model, and finding traditional and unconventional avenues of growth.

Future success may depend on:

• Going beyond the development, manufacture and supply of products to weaving a web of services around them
• Embracing digi-tech across the value chain to find more efficiency, more predictability, friendlier and faster innovation and more precise customer touchpoints
• Reducing the carbon footprint of the total business including that of the supply chain and product end of life, to going carbon negative in 10-15 years by adopting renewable energy, green processes and creating carbon sinks
• Building a range of ‘biology’ and ‘clinical’ capabilities and go up the innovation value chain over the medium to long term
• Creating a razor-sharp focus on prevention and wellness space, with a keen eye on nutrition and proprietary Ayurveda
• Diversifying the geography and mix of supply to constantly integrate, indigenise and bring supplies closer to the markets

All stakeholders should work together to strengthen the clinical trial ecosystem in our country

That the COVID-19 pandemic has changed our world is clearly an understatement.

The initial days of the pandemic-induced lockdown led to difficulties in managing clinical trials. The patients could not visit hospitals and the logistics supply chain was also impacted. During this time, maintaining patient safety was of paramount importance and so was maintaining the quality and integrity of clinical trial data.

Many innovative risk mitigation strategies were deployed, for example:

• Direct to patient shipment of investigational medicinal products (IMP) so that the patient receives IMP at their home,
• Home nursing care visits for the administration of IMP or for collecting biological samples which were required for evaluating patients’ safety and IMP efficacy,
• Video/teleconsulting of trial participants by doctors, etc.

The clinical trial protocols were amended to accommodate the flexibility that was required to mitigate the pandemic induced risks. The Regulators and the Ethics Committees accorded priority review for such amendments.

While the pandemic accelerated the adoption of these changes that have made a positive impact, it is imperative that these should be continued in 2021 and beyond. Moreover, there will be a wide-scale adoption of digital technologies in clinical trials, e.g., digital biomarkers, digital informed consent, e-health record directly feeding data to the e-CRF, etc.

We will see more decentralised trials being conducted wherein the patient will be able to participate in the clinical trials from the comfort of his/her home and will need to visit the hospital site only for specific purposes.

The COVID-19 pandemic has caused wide-scale awareness amongst the general public about the importance of clinical trials to prove the safety and efficacy of drugs and vaccines. This should continue since it will aid greatly in the development of innovative treatment options for the patients.

It will be important for all the stakeholders to work together in the future for strengthening the clinical trial ecosystem in our country. This will help in our endeavour of finding safe and efficacious treatment options for the unmet medical needs of our patients.

All stakeholders should work together to strengthen the clinical trial ecosystem in our country

The current COVID-19 pandemic is unprecedented, and the global pharma response has revealed many important lessons, laying significant blueprints for progress in two areas: collaboration and use of technology.

The extraordinary circumstances of the pandemic have re-stated the importance of global partnerships across the private, public and civil sectors. Cooperation across the pharma industry has accelerated its ability to share intellectual property, enhance its manufacturing capacity, secure supply, and ensure affordability of its products.

Specifically, the expertise and manufacturing capacity of India Pharma Inc., essential for the world’s recovery, challenged the traditional misconception that Western pharma companies can do it all. The success of pandemic preparedness and response depends on a strong network of agile partners that can come together effectively.

The use of emerging technologies has also played an important role in accelerating the crisis response. For example, artificial intelligence (AI) has helped scientists pinpoint precise information by analysing thousands of scientific papers on the topic, it supported the prediction of old and new drugs and treatments that might alleviate the disease, it enabled the rapid diagnosis of patients with COVID-19. More importantly, AI could support supply chains of millions of doses to and within low- and middle-income countries. Indian manufacturers and distributors investing in and leveraging the power of these technologies for procurement, track-and-trace or product recall activities can be at the forefront of what may set a new standard for the industry.

The next Access to Medicine Index, coming in January 2021, will offer an in-depth analysis of best practices that will help shape the future of the pharma industry.

 In Indian pharma, phygital is taking roots in all the organisational functions

The biggest blessing in disguise of an otherwise catastrophic COVID-19 pandemic has been forcing organisations to have a fresh look at their traditional, considered-almost sacrosanct, operating business model.

During the pandemic, physical was just not possible, so came digital forcefully. As the pandemic wanes, which hopefully it will sooner than later, a new business model is taking shape, using the best of both – physical plus digital, giving birth to a new-kid-on the- block called ‘Phygital’.

In Indian pharma, like other industries, phygital is taking roots in all the organisational functions – front-end, back-end and support functions alike. The pace of digitalisation has accelerated manifold, though the scale of adoption is varying, depending upon the outlook of the management.

In the front-end functions sales/marketing, phygital is visible in patient engagement (digital therapeutics, chatbots etc.), customer engagement (teleconsultation, e-patient education, e-CMEs, webinars etc.) and salesforce management (sales force automation, chatbots, digital cycle meetings, digital award functions etc.).

In the support functions, phygital has found a place in Finance/HR processes (robotic process automation, AI/ML-driven predictive analytics, chatbots, digital employee connect programs/ recognitions, digital internal/ statutory audits, digital AGMs etc.)

Backend functions like manufacturing/quality/supply chain/regulatory have also embraced digital tools/ technologies like eBMR, MES, eQMS, eDMS, eLIMS, eLN, virtual audits, track-and-trace etc., on shop floors/laboratories)

A hybrid employees-working model deploying judiciously both, work from home as well as office is widely seen and publicly announced by many companies.

New stakeholders/vendors have stepped in the eco-system like digital agencies/evangelists/ consultants/service providers for all organisational functions, cyber-security companies, e-pharmacies, National Digital Health Mission etc.

The new operating business model, phygital has turned out to be an organisational re-engineering exercise resulting in increasing efficiencies, driving away from the avoidable costs from the system, bringing about speed and transparency and very importantly improved decision making being data-based. The proof of the pudding is in eating – quarterly results announced by the majority of pharma companies indicate a significant surge in operating, profits across the board despite a marginal drop in sales. That also is the reason why the new operating model is here to stay.

The pandemic has also brought out a stronger sense of purpose, not only within the industry but also in the minds of external stakeholders, that pharma is a noble, essential and integral part of the critical healthcare eco-system serving the patients by ensuring discovery, manufacturing, promoting, supplying and reaching the medicines. After all doctor diagnoses the disease, but it’s the medicine that treats the disease.

Learning from the supply crunch, many nations are localising their supply chains

Global lockdowns due to COVID-19 resulted in a strapped distribution of essential drugs when the world needed it the most. Learning from the supply crunch, many nations are localising their supply chains to avoid such future fiascos. Under this global supply chain flux, exporters need to strengthen their value proposition of cost-effective manufacturing at high quality. Many Indian companies too found themselves in a precarious situation as the supply chain of critical pharma APIs (antibiotics etc.) from China was disturbed. While it is not easy to quickly substitute scale capacities, this pandemic has surely elevated the important lesson in self-reliance for API production for India which had been propping up time and again since India’s dependence on imports grew.

Lockdowns also resulted in heavy disruption to the backbone of pharma information dissemination – the regular visits to the medical fraternity by medical representatives (MR). Many companies have switched to digital interactions which are appearing to be as effective and highly preferred by key opinion leaders (KOL) and other medical representatives. The pandemic has also resulted in new opportunities in preventive drugs, wellness formulations, and nutrition supplements that enhance immunity.

As large chunks of the populace contract COVID-19, new drugs like favipiravir have become the choice of treatment. Many companies have benefitted due to the timely set up of facilities for the manufacture of these drugs indicating that agility and strong CMO partnerships can lead to the realisation of higher top lines.

The development of COVID-19 vaccines at a record-breaking pace by companies like Bharat Biotech and Zydus Cadila also indicates the competitive pace of innovation in biopharma. If approved for popular use at acceptable safety and efficacy, the in-process developed capability for vaccine approval can come in handy for companies looking to develop similar viral vaccines in the future.

We are witnessing adoption of degree-linked apprenticeships, the nayi talim of the 21^st century

COVID-19 amplified the skill gap in the economy which has set new rules for talent creation. Over the last couple of years, the pharma sector has been warming up to the idea of apprenticeships. In the last three years, the sector witnessed a growth of an average of 40 per cent in the apprenticeship hiring in the factories. Though major hiring of apprentices happens in the production facilities, organisations experimented by engaging apprentices in R&D and also in other functions like quality checks and supply chain management. As the industry was grappling with reverse migration, pharma sector relied on apprenticeships to cater to talent shortage to address the increase in the consumer demand.

The current apprenticeship engagement outlook shows that amongst all the sectors, pharma has the highest forecast for apprenticeship engagement which stands at 42 per cent in the H2 of 2020 and we expect the trend to continue for at least a couple of years till the impact of current pandemic settles down.

Employers have realised that apprenticeships are a better way to prepare the workforce, ensuring an optimum level of productivity. We are also witnessing a trend of adoption of degree-linked apprenticeships, which is the nayi talim of the 21^st century. Though it is still in the nascent stage we expect in a year the trend will catch up in the industry as more organisations will witness the merit.

The Ministry of Education is actively encouraging the institutes of higher education to kick start degree apprenticeships where the programmes will be tailor-made to create talent based on the job roles. Over the coming years, we expect the sector to also focus on high-level skill development to cater to R&D and faster adoption of automation.

Incorporate more digital technologies, decentralised trial approaches and real-world evidence models into clinical trials

It will be imperative for organisations to incorporate more digital technologies, decentralised trial approaches, and real-world evidence models into clinical trials to maintain continuity and ensure that patients continue to receive much-needed study medications. Technology will play a crucial role in ensuring better outcomes in terms of efficacy, scalability, and timeliness of vaccine and drug development. A good example of this is cloud computing, artificial intelligence (AI), and advanced analytics that are accelerating clinical trial timelines, increasing efficiency and thereby speeding market access.

Using data-driven monitoring techniques will provide near real-time insights into how sites are conducting studies, such as how they are accumulating data and treating patients. It is a proactive review, designed to detect risks in site performance and enable early intervention to mitigate any emerging risks. Similarly, central monitoring will allow organisations to review the accumulated scientific and medical data for the emergence of risk, trends, outliers, variance, propagation, and other atypical data.

An extension of technology will be to utilise RWD/RWE to accelerate innovation and improve efficiency in the new global regulatory environment.

Companies will develop omnichannels and tools to interact, communicate, train, support and sell to their customers

It is not circumstances that build character, but they reveal it instead’. This is the thought that immediately comes to my mind as we take stock of the lessons learnt from the ongoing pandemic and plan the way ahead.

Organisations that held steady on their core values, planned well, and have exhibited the ability and willingness to adapt quickly are the ones that will continue to thrive post the pandemic. Having long term, strategic as well as annual plans, is part of the playbook of almost all companies. However, the assumptions underlying these plans might change and scenarios might have to be re-evaluated because of the pandemic. For the coming year, companies will create and develop omnichannels and various tools as they seek to interact, communicate, train, support and sell to their customers.

The fundamental ways that teams across the company work will change. For example, I have personally witnessed that in online meetings, more opinions and views are heard, thanks to the chat functions as opposed to in-person meetings where only one person’s opinions can be heard at a time, making these interactions richer and more democratic. Finally, another imperative would be to re-design the organisation to keep employees safe as well as delight our customers as the modes of working and channels of interaction change and evolve!

Advanced automation and IIoT is leading pharma companies to rethink their business models

The pandemic made us realise the importance of using technology in improving operations, efficiency and enhancing customer service. With this forceful digital transformation, Indian pharma companies managed to run their business without lowering quality and safety standards. This includes meeting market requirements by using various available IoT technologies for machines, lines, plants and factories.

Despite all the mutilation, the pandemic made Indian pharma sector rethink their potential to adopt digital technologies. It has given the industry an opportunity to change by opening new horizons for their businesses and has made them aware of untapped potential to rise above their current position. By systematically analysing and networking large volumes of data, pharma companies can improve production efficiency, target customers more effectively, explore new products, business models and distribution channels. The advanced automation and Industrial Internet of Things (IIoT) is changing value chain forever and leading pharma companies to rethink their business models from the ground up.

But, digital transformation is a journey and it should not be mistaken for a plug and play kind of implementation. A clear vision and an understanding of goals are essential before starting the project. At the same time, it is essential to get buy-in from various stakeholders – management, individual execution teams and its members as well as automation and digitisation partners. All team members need to contribute and provide critical analysis of various gaps in existing processes and possible technologies, which could be leveraged to bridge these gaps. The best way to implement digital transformation necessary to remain competitive in this new environment is with your competent automation partner. We, at B&R, offer complete hardware and software solutions, comprehensive service and hard-earned expertise in the automation and digitalisation of machinery and equipment.

For 2021, we have set a goal to meet science-based targets for antibiotic discharges in effluents

Several business disruptions followed the COVID-19 pandemic but the scale of loss of human lives and the increase in global inequity has been much larger and significant.

Centrient aims to ensure that sustainable and accessible antibiotics reach all patients, globally. For 2021, we have set an internal goal to meet the science-based targets for antibiotic discharges in effluents – the Predicted No Effect Concentrations (PNEC) – in all our wastewater streams and in those at our supplier sites.

We are also looking to continue collaborations with key stakeholders in the ecosystem, including governments at both the Centre and states, to support initiatives aimed at containing AMR, and ensuring that antibiotics continue to save lives, during and beyond the current pandemic.