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These are exciting times for the Life Sciences sector as it builds on its understanding of the disease at the cellular and genetic level to usher in new and differentiated therapies into the market. Furthermore, biomedical advances are likely to transform global health with early diagnosis and therapeutic intervention for chronic and killer diseases like autoimmune and cancer, with a promise to enhance the quality of patients’ lives.
The Top 5 scientific developments to be closely tracked in 2016 are:
Immuno-oncology is one of the most promising fields of science being explored by scientists to develop path breaking solutions for unmet medical needs. 2015 saw some spectacular advances in this area with a market opportunity of ~ US$40 billion by 2025*. PD-1 and PDL-1 targeting antibodies and Chimeric antigen receptor T-cells (CARTs), have demonstrated how technology can be leveraged for developing path breaking therapies in immuno-oncology. The USFDA recently approved a drug that relies on a genetically engineered version of the herpes virus to kill cancer cells and stimulate immune response against malignant tumours in skin cancer patients. Several other immune-stimulating viral therapies are also being evaluated e.g. a genetically modified polio virus to fight brain cancer and a reengineered common cold virus for treating a form of bladder cancer.
*Source: Leerink Partners
3D Bioprinting & Stem Cell Therapy
Stem cell therapy is also providing new hope in not only curing a number of debilitating diseases but also building organs under laboratory conditions for patients. Scientists believe that stem cell therapy is key to managing cancer, heart diseases, diabetes, Parkinson's disease, etc. in the near future.
Recently, TGA, Australia gave its first go-ahead to human studies for a revolutionary stem cell therapy aimed at halting/reversing the progression of Parkinson's disease, which affects up to 10 million people worldwide.
Scientists in Australia have also achieved a medical breakthrough of getting stem cells to form different cell types found in the kidney.
More significantly, a Bangalore-based tissue engineering start-up has made India’s first artificial human liver tissue with the help of 3D printing technology, using 10 million liver cells. This is a significant milestone that showcases the tremendous potential of 3D printing technology in organ development and has the potential to save many patient lives.
Biomarkers and Companion Diagnostics
Today biomarkers are providing a wealth of biological data, which are helping predict drug failures before expensive clinical trials as well as allowing scientists to identify patient pools that would respond favourably to a particular drug. We already have cancer drugs for patients with specific genetic mutations. It has also led to the emergence of ‘companion diagnostics’ that screen patients for biomarkers that gauge the safety and efficacy of a particular treatment. Recently, the US FDA approved the first companion diagnostic to detect a protein associated with non-small cell lung cancer while approving Merck’s Keytruda drug for the disease. The companion diagnostic will enable doctors to determine whether patients have high enough levels of the PD-L1 biomarker for Keytruda to be effective. Now, more sophisticated companion diagnostics are being developed, to assess a patient for multiple biomarkers related to multiple drugs.
Genomics has created a new breed of life scientists and researchers who look at disease in a very different way. A number of initiatives like U.S.-based medical geneticist Robert Green's MedSeq project, are currently looking at ways in which the profusion of genomics data and other clinical information can be integrated with day-to-day medical practice, in order to assist the medical fraternity in deciding on a specific line of treatment for their patients.
Already, genomic sequencing is being combined with molecular diagnostics, imaging and data analytics to decipher the cellular structure of malignant tumours and tailoring treatment regimens.
Last but not the least, the development of Biosimilars is going to provide affordable access to complex biologics in 2016. The first-ever US FDA approval for a biosimilar was granted to Filgrastim, in 2015. Encouraging developments in the highly regulated markets, point to the evolution of abbreviated clinical pathways that will allow speedier entry of biosimilars. With US$48 billion worth of patents on a number of blockbuster biologics slated to expire soon, global biosimilars market is poised for a rapid growth, going forward.
India is well poised to play a significant role in the biosimilars area where companies like Biocon, Dr Reddy’s, Intas, Zydus Cadila and others are engaged in developing high quality biosimilars to provide affordable access to these complex biologics.
Indian patients have had access to some of the biosimilars like Insulins, Analogs, Filgrastim etc. since early 2000s and more recently complex antibodies like Trastuzumab, Rituximab, Adalimumab etc. have also been introduced. This early experience with developing biosimilars will pave the way for Indian players to capitalize on this unfolding global opportunity.
We are living in extraordinary times, where technology is revolutionizing life sciences. Cancer is no longer a death sentence but a manageable chronic disease. We are witnessing the development of innovative therapies that are addressing the unmet patient needs for life-enhancing therapies. Clearly, it is time to look out for a new paradigm in global healthcare where the blind can see, the deaf can hear and the paralysed can walk.