Express Pharma

‘India has no dearth of talent in biologics’

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Dr Surendra Chavan, Founder and CTO, Accutest Biologics, shares his views with Sachin Jagdale on India’s strength in the field of biologics

You have spent more than two decades working in the global biotech environment? What are the major differences observed by you between the global and Indian biotech industry?

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Dr Surendra Chavan

The global biotechnology industry is well established and rebounded strongly in the recent time. The Indian biotechnology sector has emerging market characteristics and is one of the fastest growing knowledge- based sectors, and is expected to play a key role in shaping India’s rapidly developing economy. The biotechnology industry in India is one of the most significant sectors building on technological advancements and leading to new discoveries to meet the rising demands from the pharma sector.

While the global biotechnology industry is focused on new drug discovery and novel technology platforms, the Indian biotech industry focuses mainly on biosimilars. In India, we have many assets and a strong pool of expertise where real collaboration between the industry and the academic institutes is key. In addition, the efforts and support from the government will further create opportunities for small and middle sized companies in the sector. With a huge base of talented, skilled and cost-competitive manpower and a well developed scientific infrastructure, India has great potential to become a leading global player in the biotechnology industry.

How is Accutest Biologics working towards removing/ minimising this gap/ differences?

Accutest Biologics, a leading CRO in the field of biosimilars, offers a complete package required for the characterisation of the product. We are very well poised to offer complete physico-chemical characterisation of the product as per the relevant guidelines to meet the applicable regulatory requirements. By offering end-to-end, customised and cost effective solutions, we also invest significant resources in educating our scientific staff while establishing a network with academic institutes.

India is still at nascent stage as far as biologics are concerned. What are the key changes that you would recommend to Indian biopharmaceutical companies?

India has no dearth of talent in this sector. Thus, I would recommend Indian pharma companies to develop expertise in all the sectors of biotechnology and especially in protein chemistry, molecular biology, and bioinformatics to participate in the growth potential. Also, they must exploit the scope provided by the Government of India for research and development (R&D) in the field of biotechnology.

Companies should cultivate novel technology platforms in biotherapeutics too (e.g. biologics, cell therapy, vaccines, regenerative, genomic, nanotechnology, and molecular devices), diagnostics, agriculture, food biotechnology and bio-energy which are affordable to India and other developing countries.

What type of cross talk you would expect between global and Indian biotech industry experts?

Both global and Indian biotech players can contribute in their respective way, leveraging on each other’s strengths, assets, know how and network. We at Accutest Biologics are actively engaging in this dialogue, which will all allow us to accelerate progress for the benefit of all.

Indian regulatory structure is often blamed for the slow growth of the Indian biotech industry. What is your take on this?

The regulatory structure needs enhancements to expedite the approval process. We already witnessed some favourable changes in the Indian regulatory agency, thanks to which the industry is on the way back to normal, contributing again to the growth of the Indian biotech industry.

How do you wish to see Accutest Biologics and the Indian biotech industry grow in the future?

Accutest Biologics will be a leading bioanalytical service provider for the global biotech industry, providing one-stop-solutions for innovations.

Our bio-analytical services include bio-assay (i.e. potency determination) and immunological properties. Together with our sponsors, we can perform customised studies therefore enabling pre-clinical in vitro comparability testing, pharmacokinetic (PK) and pharmacodynamic (PD) assess­ments in animal and human samples and immunogen­icity testing during clinical studies. We provide end to end solutions for the analytical characterisation of novel biologics and comparability solutions for biosimilars, covering from early stage product characterisation/ comparability to late stage preclinical and clinical characterisation/ comparability.

We also present ourselves as an ideal cost-effective partner for a biologics development organisation in its clinical phases. We offer both the clinical set-up (through the Accutest Clinical Development Group) for patient/volunteer/ data management and the analytical setup (Accutest Biologics) for developing and executing the analytical testing protocols that are required for determining the PK, PD, immunogenicity and other safety/efficacy parameters for an investigational biopharmaceutical drug.

The Indian biotech industry has a strong future, it will be a leader in many sectors such as biotherapeutics, diagnostics, food, agriculture and many more. Accutest is part of this.

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