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Pharma Bio: Interview with Dr Somesh Sharma

“The focus of interest lies in faster innovation, data management and AI learning tools to facilitate faster development.”

Somesh Sharma
SVP and Business Head for Discovery Chemistry at GVK Biosciences Pvt. Ltd

Somesh Sharma, SVP and Business head for Discovery Chemistry at GVK Biosciences Pvt. Ltd with more than 20years of experience in Drug Discovery field in his interaction with PBW talks about advances in Analytical instrumentation and about the impact of COVID-19 on bioprocessing businesses. He will be speaking at Purify’20, the annual conference dedicated to Chromatography Purification at Hyderabad.

The success of tomorrow’s laboratories will hinge on how well the various pieces of equipment perform in digitally transformed, connected scenarios. Your thoughts on the phenomenal advances in Analytical instrumentation over the last decade that have impacted the conventional techniques like chromatography and spectroscopy.

Pharmaceutical industry has realized the significance of laboratory and manufacturing digitization to accelerate the development of new medicines for unmet medical needs. The focus of interest lies in faster innovation, data management and artificial intelligence learning tools to facilitate faster chemical development. Historically, laboratory equipment’s were accustomed for manual interventions with limited application range and cumbersome data recording and retrieval process.

Advanced and innovative tools ascertain the ease and safe operational control from remote locations, assure experimental reproducibility, data interpretation and traceability. Drug development process generally demands robust and accurate analytical tools to cater three requirements – drug discovery (identification & elucidation), development (development & validation) and manufacturing (repeatability & robustness).

There is a tremendous improvement in technologies over the time – high performance liquid chromatography (HPLC) has changed to Ultra-high performance liquid chromatography (UPLC), CAD, Arc and 2D HPLC. Orbitrap GC-MS/MS, evolution of bench top mass spectrometry and nuclear magnetic resonance (NMR) instrument with high precision and accuracy, vibrational spectroscopies (infra-red and Raman), X-ray fluorescence spectrometry, elemental analysis & identifications (ICP-MS) and imaging techniques for identification for any substance.

New platforms in circular dichroism, super fluid chromatography (SFC) and simulated moving bed (SMB) helps in defining chirality and purification of racemic drug substance. There is also a steady progression observed in preparative HPLC, ion-exchange chromatography and dynamic axial compression (DAC) technology for parallel screening and purification of complex drug substances, where, there is shrinkage of column size noticed due to development of high-pressure system.

Besides these platforms, sampling is a critical factor in the analysis of any sample – poor sampling procedures lead to variable results and data integrity. However, smart work-stations with fully laboratory digitization helps to address this issue, wherein, real time instrument data recording with consistent & well defined structural formats, data storage, back-up, retrieval mechanism and integration with electronic laboratory notebooks (eLN), makes the process seamless and informative for knowledge sharing.The scientific instrument industry plays a vital role in the bioprocessing market, with companies offering analytical techniques and products that can help the market adapt to changing demands. One such change has been the COVID-19 pandemic, which has caused bioprocessing businesses to shift their priorities to be able to manufacture treatments and vaccines related to the virus once a vaccine is approved. Your observation.

Covid-19 pandemic has nearly impacted all global industries and institutions, including bioprocessing and biopharmaceutical industry. Undeniably challenging time has pushed industry to be more resilient, flexible and adaptive for new normal. Bioprocessing industry being part of ‘essential’ services kept their operations running with minimal disruptions, however, with remote site of any medication in short time, and to support business growth and expansion, industry requires calibration and realignment in following areas:

Staffing: Categorization of human resources – essential and nonessential staffs to implement enough social distancing norm at workplace. Flexible shift modules with cluster identification to avoid any disruptions and ensuring safe operations. Implementation of work from home policy will become a usual pattern in accordance to IT firms. More emphasis on talent build up will be initiated for forthcoming business opportunities.

Supply chain: More control and integration of supply chain will happen – backward or forward, to meet business demands. Long term contract, dependency on single suppliers and localization of sourcing will always be deliberated.

Inventory management: The need of hour is the implementation of smart inventory management system along with business strategy to circumvent delay in critical assignments.

Logistics: Movements of goods will be adversely affected due to delays in shipment and requires proactive planning, monitoring and execution.

Facilities: In order to address pandemic related bioprocessing, the modular facilities with single use systems will be preferred. Big companies might go for regionalization or decentralization of manufacturing sites as part of their disaster or contingency policies to avoid any disturbance in supply and demand.

Automation: In case of staffing challenge and desire to reduce onsite staff, industry will bring for more investment in automation for process improvement and cost control.

Information and technology: Organization might encourage employees to work from home during pandemic like situations, which in turn, requires improvement in IT infrastructure and cybersecurity controls. New platforms such as cloud based services, industrial internet of things (IIoT), artificial intelligence and machine based learning will become accessible as innovation driver.

Bioprocessing industry will strive for opportunity in faster and customized R&D activities, and push for streamlining approval considerations from regulatory bodies to speed-up product development. More, collaborative and interactive communication will be witnessed between academia and industry. Outsourcing business will keep on flourishing as a risk mitigation for large supplies and faster R&D activities.Your comments on the Make in India initiative of Government of India and its impact on Pharma sector?

India is one of the fastest growing economic in the world and Government’s push to “Make in India’ campaign a reality has resulted in fundamental structural changes in pharmaceutical sector. The Government of India has planned to incentivize bulk drug manufacturers and reduce dependency on China for active pharmaceutical ingredients. The department of pharmaceutical has set up a venture capital fund to facilitate start-ups ecosystem in the research and development in the pharmaceutical industry. For smooth functioning, an inter-ministerial co-ordination committee is formed for periodic review and address any issues. Moreover, Government of India unveiled “Pharma Vision 2020”, with prime objective of making India a drug discovery and innovation centre in ‘end to end’ manufacturing.

The success of all these initiatives will rely on contemporary technologies and talent availability. With such a huge young population available in country, it becomes imperative to provide relevant training and development, and make them ready for job opportunities. Life Sciences Sector Skill Development Council (LSSSDC) is one the best initiative undertaken under National Skill Development program, where focus is majorly on talent development for Pharmaceutical, Bio-pharma and Contract research organizations.

In this pursuit, industry-relevant skill training programs (based on job roles) have mapped with training centers and assessment bodies. Beyond this, training of trainers (ToT) program help selected trainers to understand new training requirement and make modifications in existing modules. LSSSDS also works in close association with industry to provide ‘training on demand’ program to meet immediate business requirement. To address training for high capex sensitive job roles, Virtual Reality Simulation (VRS) modules have been implemented. The other important activity is on assessment and certification of already employed workforce under ‘Recognition of Prior Learning’ (RPL) program, to make sure talent is always compliant as per business requirement. During Covid time, on-line training modules have become quite important in upskilling the work force – LSSSDC is working closely with Department of Biotechnology (DBT) to provide gamut of trainings for biotech industry.

However, in order to keep the supply engine robust and sustainable, it is critical to nurture quality and excellence in pharmaceutical education and research, develop a cross-functional mutli-disciplinary culture and ecosystem for academic and industry interactions. Finishing school concept for students is a stepping stone to meet shortage of skilled human resources requirement for industry.
New opportunities you see for boosting Healthcare Sector to emerge through this tough time?

Covid-19 pandemic has put global economy in doldrums, amongst all sectors, healthcare sector has been challenged mostly, and ramifications of this will change the dynamics of healthcare industry. It has put biopharmaceutical industry under tremendous stress in bringing and in developing vaccines as soon as possible and created new growth opportunities in healthcare, including:

Behavioral healthcare: The pandemic has resulted in unprecedented levels of social isolation and financial pain, there is an increased demand of behavioral healthcare.

Modular facilities: Great attention is drawn towards infection control facilities and segregation of intensive or critical care units in hospital layout to address pandemic like situation. More thoughts on scalability of operations and integration of multifaceted resources.

Virtual care services: Online, phone-based consultancy or home based care will be attractive opportunity as patients will show reluctance in visiting hospitals. Remote patient engagements like virtual rehabilitation and assistants will be a common precedence in future. Artificial intelligence and data management tools will play a crucial role in patient management for nonacute cares.

Ambulatory care: As patients will choose to avoid hospitals, an increase in ambulatory care or day care services will be noticed.

Diagnostic: The demand of in-vitro testing platforms will see a surge in their services to manage disease spread in new normal post pandemic.

Digital healthcare: More funding in data analytics will be required to support Onclick assessment of patient outcome data. This will lead to a conducive ecosystem for startups in digitization of easily scalable, readily deployable and tractable solutions.

Regulatory environment: Digitization of regulatory operations can be disruptive in bringing life saving medicines fast to market, and lead to end of paper-based document management. As healthcare industry will begin new journey post-Covid, resurgence of value based care services, digitization and integration of medical services, with tailored made delivery systems will transform the future of this industry.

Source: Pharma Bio World (PBW)
View Dr. Somesh Sharma’s profile

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