Kurt Stoeckli

Kurt Stoeckli, President and Chief Scientific Officer, Glenmark Pharmaceuticals, talks to P.B. Jayakumar about the latest trends in drug research globally.

President and Chief Scientific Officer, Glenmark Pharmaceuticals

Biologics drug research is gaining emphasis, while for novel chemical entities (NCEs), the number of newly marketed drugs is declining... Pharma companies have shifted their innovation models towards new biological entities ( NBES), based mainly on scientific breakthroughs, and marked progress in translational medicine. This is a natural evolution in life science industry. NBES are generally less cost-effective and more challenging to scale up and manufacture. In fact, even minor changes in the manufacturing process can cause significant, potentially clinically-relevant changes in efficacy or immunogenicity – the ‘success’ rate of addressing an unmet medical need and developing a novel medicine appears to be favourable for NBES. That’s because most biologics act via highly specific targeted mechanisms, allowing for the selection of specific patient sub-populations, and hence, sizable clinical trials to rapidly demonstrate clinical proof of concept. Only then do you have a potential drug in hand. Biologics also have the ability to work on multiple diseases where the same target is of critical importance. Challenges and limitations remain for both therapeutic modalities. NCES are not going away; they will undergo a kind of ‘renaissance’ if applied more specifically.

Many leading Indian drug companies have discarded original drug research and are looking at in-licensing opportunities. Your comments… New drug research is not gaining a big ecosystem in India due to apprehensions about patent protection system and quality concerns. The regulatory requirements are different in the generic space than in innovative drug development. A company with a generics business working towards innovative medicines must make significant investments in protected industry assets that fulfil the highest standards. Licensing has been an integral part of our business strategy. But new drug research requires robust business development in a highly collaborative environment. We should have ‘partners in development’ who shoulder the responsibility of taking a drug from the clinic to the market. ~