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Given the long history of infectious diseases in India, the scientific community in the country has started to explore the potential of new biotechnologies – i.e., gene editing, synthetic biology, genomics—to prevent and treat them. Despite new energy in biotechnology start-ups, development of novel technologies for certain public health applications lags because funding is not available to take products/businesses to scale, in part due to insufficient confidence that they will get access to the Indian market. This is due to India’s poorly coordinated multi-layered regulatory system and uncertainty about state regulations/policies. (Other vital elements of countries’ public health capacity, including disease surveillance and diagnostics, are inherently less commercial and so depend almost entirely on public funding, unlike vaccines and treatments which can be commercially driven).
The session convened representatives from the scientific and the venture capitalist community to discuss the scope of new biotechnologies in potentially improving public health capacity and to explore ideas for giving fresh impetus to research into infectious diseases. The discussion highlighted the role of funding—both through government and private sources—in establishing a robust and sustainable research ecosystem. It also noted the potential for leapfrog progress in India if biotechnology could be harnessed better. The meeting was moderated by Gagandeep Kang, professor of microbiology at the Christian Medical College.
Discussion Highlights
• Scope of biotechnology in tackling infectious diseases: The coronavirus pandemic enhanced awareness that biotechnology can be vital for public health. This awareness needs to be built upon noted participants. They discussed how advancements in biotechnology—including DNA sequencing, genomics, gene editing, and synthetic biology—have the potential to diagnose, prevent, and treat infectious diseases. Scientists are using these advancements to develop diagnostics for rapid and sensitive detection of pathogens, vaccines for effective prevention, and drugs for improving treatment of infectious diseases. Further, advances in genome sequencing can aid in developing a surveillance model to track the evolution of the pathogen and pathogenesis of the disease.
• Building a cohort of skilled scientists and entrepreneurs: Participants highlighted that relatively few countries have ecosystems that combine science, public health, policy, and financing in ways that are sufficient to serve national needs and perhaps to export. They noted that researchers working at well-funded research institutions might be generating knowledge that will not become usable for public health (and/or commercial applications) unless complementary actors and incentives are generated. Discussants therefore emphasized that focused research programs are needed to develop vaccines, therapeutics, and diagnostics, which will both depend on and encourage young scientists who care about the public health applications of biotechnology. Graduate and post-graduate courses should introduce translational courses to minimize the skill gap in this sector, added experts.
• Limited financial support for biotechnology research: Participants highlighted that the private capital market (VC) for biotech research and development is relatively small and is mostly constrained beyond proof-of-concept work. But to take promising ideas to the next levels, which ultimately must be done to provide vaccines and treatments to people, larger pools of capital are needed. Here India faces governmental and private sector challenges that are probably related. Developing, testing, and bringing to market biotech products take a long time and are fraught with uncertainty. While the government has promoted many programs, the diffused and scattered nature of such programs inhibit successful development and commercial outcomes for the industry. In the private sector, VC and other sources of innovation capital tend to operate on shorter timeframes and smaller scales than those necessary to bring such biotech products or treatments to market, therefore creating the need for larger and longer-term sources of capital to build successful programs in this sector. But those sources need encouragement and confidence through enabling eco-system of (1) efficient and predictive regulation, (2) structured and consolidated public resource deployment, (3) enabling market access support and (4) favourable private equity and capital market regulations to capital churn.
• Strengthening support to building a sustainable research ecosystem: India would benefit from mobilizing its infrastructure, money, and talent resources to address these challenges, stated participants. While big pharma companies in India have the talent, exposure to the global environment, and understanding of the landscape, they need incentives to encourage translational research, added experts. A more effective ecosystem would help to bridge the gap between the generators and consumers of relevant information and diminish the chicken and egg problem that constrains investment in relevant science and technology. It might also help to overcome the problem of siloed data.
• Facilitating market access: To enable market access, it is important to link innovators and payers and to introduce regulations that support entrepreneurs (or at least do not deter them). New ways to certify products are needed. Participants recommended that India find ways to support translational activity that builds on R&D to encourage entrepreneurs in the field. Exciting ideas need to be supported early, while addressing how they can be applied in commercialized. In some situations, particularly for early-stage development, an early hand-off to more experienced manufacturing or development partner might work better, discussed participants. They further noted that the development pathway should be broken down into different stages wherein different kinds of funders are invited to fund different stages to ensure commercialization of products—an approach that implies a need for some coordination to assure that all stages are covered. Further, a larger R&D budget alone cannot secure a quantum leap for innovation in India unless efforts are also coordinated between government and industry to bolster confidence that products that meet established criteria will be allowed market access with predictable timetables and returns. Much can be accomplished, however, if start-ups, other industry segments, VC, and government can work together.
