The new realities in pharma R&D

India Pharma Inc is on the cusp of significant change. Its next phase of growth and continued progress is becoming increasingly dependent on the development of innovative and differentiated pharma products, speciality generic complex drugs or biologics and biosimilars across a range of indications. As a result, honing and amplifying its skills and capabilities in R&D has become an exigency for pharma companies to create intellectual property, improve product life-cycle management, and gain cost as well as market differentiation.

In fact, Indian Pharmaceutical Alliance (IPA) and McKinsey, jointly released a report, ‘The Indian pharmaceutical industry – the way forward’, which outlines that India needs to emerge as an innovation leader by 2030 to gain global leadership in the pharma industry. It states, “We believe the industry can aspire to build a strong innovation pipeline (with three to five new molecular entities launched or in late clinical trial phases and 10–12 incremental innovation launches per year by 2030) and enhance Indian pharma’s significance beyond generics, to biologics, new drug development and incremental innovations.” This, in turn, will be one of the crucial steps towards helping Indian pharma market enter the list of top 5 markets in the world from its current ranking of 11th market by value.

So, it is pivotal for India’s pharma R&D playbook to evolve and become more agile and responsive to new market realities and demands of healthcare across the globe. And, as it undergoes this transformation, the R&D sector will have to relook its strategies and redraw its approaches to standardise processes, ensure functional efficiency and expertise, track key performance indicators across different stages, balance both cost and quality of outcomes, as well as encourage scientific innovation.

In such a scenario, the role of digital and automation technologies is gaining a lot of prominence. As ‘The India Life Sciences Report 2019’, released by CII and Bain and Company highlights, “the life sciences industry will be disrupted and transformed by new digital players emerging across the value chain.” It emphasises that “life sciences companies must seriously evaluate how to play in this emerging digital landscape in a way that allows them to remain relevant and build the next engine of growth.”

However, it also notes that “life sciences incumbents have been slow to respond to this trend, and will need to evaluate how to effectively play in this new digital ecosystem.”

Therefore, in one of its recently organised events, Express Pharma, as a facilitator of the industry’s progress, brought together several experts and veterans to drive innovation in pharma R&D by harnessing the potential value of emerging technologies such as AI, Analytics and Automation. (Check report on page no 10). It also explored some other pivotal trends and approaches in pharma R&D that could have significant impact in improving productivity and efficacy.

Here, we present some of the key takeaways and crucial lessons from the esteemed speakers and panelists at this event.

Lesson 1: Digitise labs to accelerate quality and compliance

Dr Chaitanya Kumar Koduri Associate Director International Public Policy, Advocacy and Engagement United States Pharmacopeia spoke in detail about ‘Digital technologies and their challenges, impact on standards and medicine quality assurance’. One key takeaway from his session was that digitising pharma labs can bring in significant benefits to the whole product lifecycle from early drug development to manufacturing and patient care. Digital pharma labs can be crucial to upgrading quality standards and standing up to scrutiny from global regulators.

For instance, IOT implementation can connect analytics with equipment and devices, IT platforms and consumables to integrate the entire laboratory workflow. Similarly, some other technologies that can be adopted include digital data approval, archival and retrieval systems, electronic laboratory notebook and chromatographic data management systems, laboratory equipment analytics, wireless centralised sensors for temperature, humidity, oxygen, carbon dioxide, electronic based procurement process, digital equipment maintenance and calibration planning, digital quality records, digital metrics and electronic safety data sheets.

They can help streamline processes, further innovation, better quality controls and assurance, lead to more efficient and secured data exchange, optimise costs and supply real-time and accurate information to bring about a shift towards evidence-based experimentation and decision-making in R&D. Dr Koduri also informed that these technologies have been utilised in USP-operated labs as well and assured that through its standards and partnerships, USP can facilitate pharma companies to make the move towards setting up digital labs.

Lesson 2: GLP is key to R&D lifecycle management

The panel discussion on the above mentioned topics also had some very interesting takeaways. Expert panelists shared their insights on how Good Laboratory Practices (GLP) is crucial for developing and research activities and managing them as per internationally-recognised standards of quality. The panelists on this session were Viveka Roychowdhury, Editor, Express Pharma (Moderator); Dr Arani Chatterjee, Senior Vice President, Clinical Research, Aurobindo Pharma; Dr Ramakrishna Bangaru, Sr Vice-President, Mylan Laboratories; Dr Krishnakant Gandhi, MD, Solinova Life Sciences; Dr Lakshman Chunduru, Executive Director, Laurus Labs; and Dr Anil K Binnor, Associate Vice President, Head AR&D, Hetero Labs.

They emphasised on the pivotal role played by GLP-compliant labs in accelerating R&D productivity. Amongst the vital recommendations that the experts, one of them was about building a culture of quality and compliance across the organisation and how GLP can be a great way to build it in R&D labs. They expounded on the absolute necessity to ensure discipline and streamline systems and processes of pharma R&D for sustained progress. The panelists also spoke on how a tech transformation of labs and R&D centres is inevitable to improve productivity and efficiency.

Technology woud help in generating high-quality and reliable data, quality assurance, enhanced performance, significant cost reductions, reduced risks and more. The panelists also accentuated how pharma companies need to develop products which are reproducible, credible and acceptable to global regulators and GLP-compliant labs will have a huge role to play in ensuring this outcome.

Lesson 3: Adopt new R&D models to boost innovation

Pushpa Vijay Raghavan, Director, Sathguru Management Consultants, spoke on how computational and in-silico possibilities can be used to power pharma R&D. Highlighting how R&D in pharma in a very expensive endeavor, she pointed out that the cost of development of a new drug is around $2 billion, and the average time for development is about 10 to 12 years. Yet, only 8 per cent of discovered drugs get regulatory approval.

Thus, the most important insight from this session was that to correct the misbalance caused by low R&D input/output-ratio and increase their productivity, it is time for the pharma sector to embrace newer R&D models. And, adoption of technologies such as in-silico, computational modelling, proteomics can usher new paradigms in pharma R&D with more efficient processes, faster drug discoveries, newer applications for pre-approved drugs as well as reduced costs and time-to-market.

Vijay Raghavan pointed out that these technologies have been around for quite some time but are coming of age now. Thus, they can be pivotal in building a more comprehensive ecosystem, a captive use and service mode for R&D, which can offer significant benefits to both, innovator companies as well as generic manufacturers. In the Indian context, they can help leverage the opportunity in specialty pharma, repurpose known drugs, help in drug design and reformulation and help CROs in drug discovery services.

She advised that it is time to strengthen India Pharma Inc by using real-world evidence gathered with the help of these technologies and enable its resurgence as a global leader.

Lesson 4: Innovation through co-opetition: A strategy worth exploring

Dr Tathagata Dutta, VP & CSO, Jamp Pharma explored how co-opetition, an act of cooperation between competing companies, business entities, institutions or individuals for mutual benefits, can be the cure-all to problems faced by pharma R&D.

Pointing out that this is not really a new practice and the world has seen several examples of it across sectors and areas, he built a very strong case for co-opeition and threw light some of its major advantages. Enabling resource sharing, learning from partners and knowledge sharing, protection of valuable core competencies, reduction in costs, risks, and uncertainties associated with innovation, minimising the time of innovation of new products, protecting market position, creating entry barriers for other competitors, creating a win-win situation for all stakeholders were some of them.

But, he also informed that it has some drawbacks like high risk in leakage of vital information, asymmetric sharing of resources, skewed decision-making power, higher degree of conflict, loss of organisational independence in decision making, etc.

Yet, the most important takeaway for this session was that the pros outweigh the cons and if companies learn to strategically balance competition and cooperation it can help in gaining global competitive advantage through intangible assets like better values, more knowledge and improved capabilities.

Lesson 5: R&D outsourcing can drive growth

Dr Rajendar Bandari, Associate Director, Slayback Pharma highlighted that the urgent need for cost containment to reduce massive R&D spends and counter declining return on investments has been a key driver behind the rising trend of R&D outsourcing in the pharma sector. But, pressure from regulating bodies and governments on drug pricing, and the need to improve productivity and efficiency across the value chain, has also contributed to a surge in R&D outsourcing.

His presentation underlined how outsourcing can also complement and strengthen capabilities of companies and enable a more innovative ecosystem in pharma R&D. And, as the industry increasingly becomes aware of its potential, its market is growing at a very rapid pace. This is clearly evidenced by the fact that the global healthcare contract research organisation (CRO) market size is expected to reach $54.7 billion by 2025.

In the course of his presentation, he also explained how use of microscale, parallel experimentation technology in R&D outsourcing can provide substantial paybacks and listed down three of them.

• Automated parallel experimentation speeds preclinical research and enable scientists to deliver experimental results much faster.
• Advanced informatics predicts outcomes earlier and gives directional analysis to accelerate preclinical development.
• Microscale experimentation uses less expensive, early development material, allowing more experiments earlier and at less cost.

One major learning from this session was how outsourcing can be much more than a strategy to just cut costs. It can be an effective tool to capture value, i.e., for developing and preserving intellectual property as a key competitive differentiation and increasing productivity. It also accentuated that pharma companies can reduce risk in drug discovery by collaborating with biotech companies to discover early stage compounds, as well as by sponsoring basic research at universities or licensing compounds.

The way forward

Life sciences companies have to inculcate best practices and change their R&D models to improve their outcomes, become more efficient and yet retain their cost-competitiveness. Boost profits of their existing drugs and create new revenue streams for new-age and innovative products will also be dependent on this transformation. It is time for the players in the sector to wake up to new realities and adapt to them to remain relevant in future.

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