Stringent regulatory and compliance requirements the top challenge when implementing digital for Indian Pharma companies: EY report

As Indian pharma companies prepare to shift from supplying commodities to supplying innovations, technology is altering the way health care is imagined and delivered, according to an EY report, “Today for tomorrow: realizing the potential of Life Sciences 4.0”, released at BioAsia 2020 – Asia’s largest Life-sciences & Health-tech convention.

The accelerated technology and scientific advancement in the Fourth Industrial Revolution, or Life Sciences 4.0, is changing the traditional model of health. The combination of smart devices and sophisticated AI-based algorithms has made it possible to remotely diagnose, monitor and treat disease, leading to a shift in health care delivery from hospitals and clinics to patients’ homes.

People are now comfortable using wearables and sensors to track their health and fitness. Data generated from these devices empowers individuals to make their own health choices and fuels a shift from disease treatment to better management, and ultimately disease prevention.

With the increasing focus on personalization, there is a shift from a one-size-fits-all model of care, where treatments are developed for the entire population, to tailored interventions. This is becoming the reality in the oncology and rare disease space, where individualized cell and gene therapies (ICGT) are manufactured from a patient’s own tissue. Because the delivery of ICGT treatments requires new manufacturing, delivery and information management processes, companies need to plan and ensure the entire product value chain is aligned to deliver such innovative individualized therapies at scale in the future.

Sriram Shrinivasan, Global Generics and National Health and Lifesciences Leader, EY, says: “Life Sciences 4.0 is all about the ability of the life sciences companies to strategically move from one stage of business maturity to another at the right time and with the right capabilities. Indian companies may be behind their global peers, but they have the advantage of learning from global failures and successes.

Executives in most of the companies understand the urgent need to embrace digital. Those that differentially invest in data-centric technologies and change management to accelerate the business impact will be best positioned to reap reward. As organizations plan their digital agendas, it is important to bridge the gap between a technology’s potential and its successful delivery. Companies need to develop an exponential mindset that leverages technology for business model reinvention and empowering the workforce.”

Pamela Spence, EY Global Health Sciences and Wellness Industry Leader, “We are in the midst of moving from population care to personalised care. Future value in Health Care lies in how organisations can unlock the power of data to fuel innovation to deliver better personalised health outcomes. It is also access to skills rather than total ownership of skills that will become important as we see the emergence of fluid ecosystems operating across industries to deliver health benefit”

Potential of digital and data to reinvent the entire business value chain
The evolving health care ecosystem is creating new opportunities for life sciences companies to capture future value through the development of personalized products and services and end-to-end solutions.

As life sciences companies prepare to launch new business models, the core expectations of each business function continue to shift. Each business function should operate at optimal efficiency and quality today and should be competent to enable the future growth of the organization. Additionally, all business functions should be integrated with each other to allow real-time sharing of data and insights. Digital technologies, such as artificial intelligence, augmented reality/virtual reality (AR/VR), wearables and sensors, blockchain, etc., have the potential to transform all business functions.

Notably, as global pharma’s senior management continue to realise the significance of successful digital investments, they are reorganizing to fill a perceived talent gap. Since 2016, about 70% of the top 10 biopharma companies have appointed chief digital officers (CDOs) to their organizations, demonstrating the overall organization’s commitment to the effort.

Digital strategy implementation and way forward

According to an EY analysis based on responses from the survey with 20 industry experts of top Indian domestic and multi-national pharma companies, most Indian companies are already beyond the digital inertia stage. They understand the necessity to adopt digital technologies to remain relevant and competent in the future.

The survey also revealed that stringent regulatory environment, change management and unavailability of usable data are the top challenges in implementing digital.

• 70% of respondents consider stringent regulatory and compliance requirements as the top challenge when implementing digital
• 57% of the leaders believe that change management can be very challenging in implementing a digital change
• 43% of the respondents cited inaccurate data as a hindrance to implementing digital program

Regulatory action associated with using new technologies and the complexity of getting fresh approvals can discourage companies from implementing technologies, especially those which are disruptive and lack a long track record. The second most cited challenge was ‘change management’. While an organization’s top management may want to implement a digital change, disbursing information about the benefits to the lowest possible level, particularly in large organizations, is difficult. Further, data inaccuracy is another concern. While life sciences companies have access to abundant data, it is a challenge to find an authentic source that provides accurate data. Unavailability of skilled workforce and lack of consensus between business, strategy and technology teams were also flagged as key hurdles.

Despite the challenges, companies in India have started taking small, experimental steps towards their 4.0 journey. Currently, these activities are mostly fragmented. Those that define a practical strategy for implementing digital across the organization to meet current challenges and future growth are likely to get a competitive edge.

EY prepared the  “Today for tomorrow: realizing the potential of life sciences 4.0” report through extensive primary and secondary research and analysis. During the primary research, EY interacted with 20 leaders of top Indian domestic and multi-national pharma companies