Skill building: Rx for R&D

Over the past years, India has re-emerged as a hub for clinical research due to its cost-effective nature and evolving regulatory landscape. Simultaneously, the Indian pharma industry is exploring its options to move beyond manufacturing generics. The pharma industry has the potential for immense growth in India, however, ever-evolving regulations, rapidly transforming technology, and increasing healthcare demands necessitate the pharmaceutical sector to keep up with these emerging trends. To align the industry with its ambitious goals, fostering and continuously skilling the right talent is crucial, especially in R&D.

Skill gaps in pharma R&D 

However, there are many gaps that need to be plugged in this area. Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI) and Member, Indian Pharmaceutical Association (IPA) cites high failure rates in clinical trials, long development timelines, limited innovation, high cost, data integration challenges, patent engagement and complex regulatory requirements as major gaps and challenges in pharma R&D. He suggests mitigation methods that must be encouraged and says, “Recent publications highlight the use of AI and machine learning to predict clinical trial outcomes and optimise trial designs. In addition, studies show increased use of biomarkers to identify patient subgroups more likely to respond to treatment.” To combat the long timelines, the FDA and EMA have expanded expedited pathways for promising therapies, as witnessed during COVID-19. 

His recommendations include research-based partnerships with biotech firms to drive innovation, novel mechanisms of action and PPPs to share costs and risks, particularly in early stage research. However, implementing these remedial methods will foremost require the R&D personnel to be competent and adept, and keep pace with the latest advancements, therefore intensifying the need for skilling and continuous upskilling. 

A workforce that can operate and comprehend emerging AI/ML technology, be abreast of the developments in the regulatory landscape and generally be open to upskilling themselves to keep up with the demands of the industry has become an imperative for success in pharma R&D.

Fortuitously, pharma companies have recognised this need and have implemented several initiatives to upskill their R&D talent.

Companies must prioritise skilling and training 

Suneela Thatte, VP and Head – Healthcare R&D for India, Merck KGaA Darmstadt offers insights and states that emerging technologies like AI/ML are enabling more efficient data processing, predictive modelling, and automation of routine tasks, thus enabling researchers to focus on strategic thinking and innovation. “As a result, R&D professionals must now be adept in not only scientific skills but also in data-driven decision-making and technology integration. Continuous learning and upskilling in these areas are essential for staying relevant and competitive in the evolving pharmaceutical landscape,” adds Thatte. 

Giving an overview of Merck’s endeavours in this direction, Thatte informs that the company implements constructive skilling methods, promotes cross-functional collaboration, and fosters knowledge-sharing, and mentorship programmes. She explains that cross-functional training sessions within R&D India helps Merck’s employees understand the roles and responsibilities of their counterparts in different functions to develop clear insights into the skill sets that the industry demands. Thatte explains, “We are also enabling our employees with the opportunity to explore Generative AI, equipping them with valuable insights and skills that can help them stay ahead of the curve. Moreover, regular feedback mechanisms help us identify skill gaps and adapt our training to align with evolving industry needs.”

Training to lead 

Pharma associations can aid in addressing major gaps in R&D skills by incentivising initiatives across its member companies and many have taken the lead in this direction. Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. These programmes cover areas such as regulatory changes, advanced research methodologies, and digital tools in drug development. It collaborates with universities and research institutions to create specialised courses tailored to the needs of the pharma industry.

Arora says, “IPA advocates for government policies that promote skill development in the pharma sector, including pushing for funding and support for training initiatives.” Thus, acting as a mediator between the government and the industry. IPA also emphasises the importance of digital skills by providing resources and training related to data analytics, artificial intelligence, and other emerging technologies that are reshaping R&D. Furthermore, initiatives aimed to enhance knowledge sharing through publishing white papers, guidelines and research reports as well as providing network opportunities to foster dialogue between the industry and regulators assure that the industry remains informed. 

Role of the government 

In August 2023, the government introduced the Scheme for Promotion of Research and Innovation in the Pharmaceutical and Medical Technology Sector (PRIP), 2023, under the National Policy on Research and Development and Innovation in the pharma and medtech sector (1).

An article titled “Zoomed Out | Why PRIP is a groundbreaking enabler for the pharma and med-tech sector” written by Neha Aggarwal and Nitish Palagummi from Deloitte Touche Tohmatsu India, affirms that the PRIP scheme can prove to be revolutionary provided that its complementary factors can facilitate its scalable impact. However, the importance of specialised and experienced pharma researchers cannot be overstated, if India is looking to scale its pharma R&D sector.

Therefore, the government has also incentivised schemes and programmes to skill its youth population to foster economic growth for the nation. The Union Budget 2024-2025 aims to prioritise employment and skilling, recognising its crucial role towards attaining its goal of Viksit Bharat. Likewise, Arora explains how the National Skill Development Corporation (NSDC) drives industry collaboration through innovative finance mechanisms like the Skill Impact Bond, which has trained and placed thousands of youths, including a significant proportion of women. The Directorate General of Training (DGT) also partners with major corporations to provide industry-relevant skills training, preparing trainees for Industry 4.0 and beyond. 

Arora maintains that while India faces significant challenges with its skill gap, the government’s proactive initiatives have shown progress in bridging this divide. “These efforts address talent shortages and prepare India’s youth for a global economy, emphasising the need for sustained investment and collaboration. Training institutes are promoting the objectives of the skill development policy, and improved allocation of funds towards private and public institutions will further accelerate the goal,” he says.

Academia’s contribution is key 

While continuous upskilling is essential, creating industry-ready talent at academic institutes is also very important. As the industry continues to grow faster than ever, students must be exposed to all the latest developments and evolving skill sets required to enter the field well-equipped. Therefore, academia needs to match up with the ever-increasing expectations of the industry and revamp their outdated curriculums.

As per the responses received from the surveyed companies in the Assessment of Skills Requirements of the Indian Pharma Industry (2), clinical research, pharmaceutics, pharmaceutical analysis, medicinal chemistry, and pharmacology and toxicology are currently in major demand in the country. Yet about 0. 71 per cent of the surveyed students were looking for jobs and wanted to join the industry rather than going for higher studies and only about 52 per cent of the surveyed students were looking for hard-core R&D jobs. And, this is a point of concern. 

A KPMG report titled “Human Resource and Skill Requirements in the Pharmaceutical Sector” recognises the lack of focus on research to be the reason behind fewer PhDs and Post-Doctoral fellows entering the industry. Since the industry lacks innovative ideas and primarily focuses on reverse engineering, it makes the job role less attractive (3). The report determines that students are reluctant to join the pharma sector as they aren’t preferred for placements and lucrative streams are more palatable compared to the pharma sector. Additionally, the employees lack productivity due to poorly designed training processes, and industry professionals aren’t concerned with academic curriculum. The All India Survey on Higher Education (AISHE) report 2021-22, also highlights the talent pool in India with advanced skills is limited to only 429 PhD Pharmacy pass-outs. This number is significantly low compared to the pharma industry’s unquantified need for highly skilled talent that can contribute to innovation in the manufacturing sector and bolster the industry’s vision (4).

Bridging the industry-academia gap

In an earlier interview with Express Pharma, Kanishk Duggal, COO, ICRI, highlighted the need to build