‘The global drug development division is the engine that powers the Novartis pipeline’

The Global Drug Development (GDD) centre in Hyderabad, is one of the three major global development sites for Novartis.
Arno Tellmann, Head, Global Drug Development India, elaborates on the centre’s vision, its work towards  developing new and innovative drugs, the company’s transforming drug development with new age technology and more, in an exclusive interview with Lakshmipriya Nair

What is the vision of Novartis’ Global Drug Development (GDD) centre? What kind of new paradigms do you want to usher into the drug development life cycle?
Novartis Global Drug Development (GDD) centre in Hyderabad, India, is a fully integrated global centre, which plays a vital role in almost every aspect of drug development. The centre focusses on development programmes to determine and establish the safety and efficacy of a potential new medicine in humans. By bringing together digital revolution and advances in the pharma industry, it is opening up the possibility of treating targets, which were previously deemed ‘undruggable’.

How does the centre enable Novartis to lead from the front when it comes to the development of new and innovative drugs with far reaching impact?
The global drug development division is the engine that powers the Novartis pipeline. GDD India supports critical components of the drug development process across all therapy areas and Novartis’ pipeline, including innovative medicines (pharma and cancer treatments), and Sandoz (generics and biosimilars) and supports key global functions across clinical development, data management, biostatistics, and data analysis. The centre is playing a critical role in enabling Novartis’ strategy to bring life-saving medicines to market including breakthrough products like the heart failure treatment Entresto (sacubitril/valsartan) – known as Vymada in India, Cosentyx (secukinumab, AIN457) – Scapho in India, and Kisqali (ribociclib, LEE011) – Kryxana in India.

What will be the next frontiers in drug development and delivery? How is the GDD centre and Novartis as a company geared to master them?
Developing new medications is an expensive, slow and failure-ridden process. However, data and digital interventions could change that drastically. Novartis is committed to exploring opportunities to leverage new technologies such as artificial intelligence and machine learning that can help accelerate the drug development process. Our efforts are also directed towards fostering a vast ecosystem of partners across the healthcare and technology sectors, an area where the GDD centre in India will play a crucial role. Given the huge talent that we have in the technology sector here, we are looking for avenues to collaborate and innovate.

What are the areas of focus at this centre? Which are the innovative and breakthrough drugs/treatments that are being researched and developed here?
Globally, Novartis as an organisation works in six key therapeutic areas: cancer, cardio-metabolic, respiratory, immunology and dermatology, ophthalmology and neuroscience. India offers a critical mass of industry-leading talent. This enables GDD in India to support critical components of the drug development process across Novartis’ broad, integrated pipeline.
For instance, Novartis is developing a digital tool to enable independent early screening of leprosy using AI and deep learning. Novartis is also in the process of developing some of the most advanced malaria development programmes worldwide. The team in India is extending significant support to this programme. These compounds hold great promise and can go a long way in helping us support the central government’s commitment to eliminate malaria by 2030 in India.

How do you choose or shortlist the areas/segments for research and development? What are the parameters?
While our focus is on six therapeutic areas – cardio-metabolic, ophthalmology, respiratory, neuroscience, immunology and dermatology, and cancer, our priority is to identify the unmet needs of underserved populations and integrate these needs into our drug discovery and development strategy. We continue our long-standing commitment to reduce the burden of infectious and tropical diseases. Our innovation process also includes adapting existing products for different types of patients or diseases and for diverse environments. Most often, this work is done with a specific focus on poor and vulnerable patient groups, such as children or the elderly.

GDD centre’s webpage claims that it works at making the drug development process simpler, more flexible and efficient. So, what does it entail?
Applied to the drug development process, we are leveraging digital tools to transform the way we develop medicines, and the efficiency with which we do so. We are systematically improving all elements of clinical development by using machine learning to conduct predictive analyses on our operational data resources to facilitate data-driven decision-making in current and future trials.

How are new technologies such as biomolecular platforms, digital technologies and automation driving being deployed at the GDD centre to augment and accelerate R&D breakthroughs?
Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation. Integrating digital into the way we work has enormous benefit for Novartis by improving the way we work with data – one of the most valuable assets we have as a company. Utilising the latest emerging technologies helps us capture better data – making us smarter and more efficient in the ways we approach drug discovery and development.

How would the work being done at this centre enable progress to India’s healthcare scenario? What will be its impact?
As an integrated part of Novartis’ overall drug development process, GDD India plays a critical role in enabling Novartis’ strategy to bring life-saving medicines to patients across the world. It includes addressing India’s disease burden, especially when it comes to tropical diseases like malaria and leprosy and non-communicable diseases that have increased owing to changing lifestyles. Our breakthrough products like the heart failure treatment Entresto (sacubitril/valsartan), Cosentyx (secukinumab, AIN457), and Kisqali (ribociclib, LEE011), were supported by teams in GDD India, and all these drugs were also made available to patients in India soon after their global launch.

Does GDD centre have any collaborations with the government, academic institutions or research organisations? If yes, how do these partnerships work? If not, are you looking at any tie-ups in the recent future?
We look for collaborations where we can further existing and new interests in the area of drug development. For example, we collaborate with academic institutes like National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad to provide students an overview of a drug’s journey – from concept to clinic to commercialisation in order to help them develop industry-ready skills and capabilities. We have also set up a digital innovation lab in Hyderabad and have been engaging with the start-up ecosystem in Telangana to identify health tech companies passionate about disrupting healthcare to address real world problems. We continue to explore partnerships that will enable us to equip our associates with the skills and capabilities required to bring in efficiencies or explore new technologies such as AI and machine learning that can accelerate the drug development life-cycle.

Do you have similar centres in other countries? If not, why was India chosen to house this center? What makes it the ideal location?
The global drug development centre of Novartis in India is one of the three major global drug development centers for Novartis, the other two being in Switzerland and the US. It plays a key role in Novartis’ global vision of combining deep therapeutic area knowledge with advanced, integrated data analytics to drive an agile approach to drug development. This site has integrated development capabilities and the added advantage of housing key drug development functions under one roof resulting in enhanced collaboration internally as well as with Hyderabad’s thriving innovation ecosystem.