BioSpectrum India Feb 2023

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4 BIO MAIL BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Vol 21; Issue 1; January 2023 How GENOMICS can REVOLUTIONISE HEALTHCARE PUNE Volume 21 Issue 1 January 2023 “India is well on its way to becoming a major global player in the medical sector” - Chander Shekhar Sibal, Executive Vice President & Head of Medical Division, Fujifilm India Too Much Of A Good Thing…28 Industry Expectations Riding Higher Than Ever – 31 BioSpectrum Asia Honours Industry Stalwarts – 38 How GENOMICS can REVOLUTIONISE HEALTHCARE Vol 21; Issue 2; February 2023 Publisher & Managing Editor: Ravindra Boratkar Editorial: Chief Editor: Dr Milind Kokje [email protected] Advisor - Content: Vijay Thombre Editor: Narayan Kulkarni [email protected] Executive Editor: Dr Manbeena Chawla [email protected] Assistant Editor: Nitesh Pillai [email protected] Assistant Editor (Digital): Sanjiv Das [email protected] Content Team: Singapore: Hithaishi C. Bhaskar [email protected] Social Media Communications: Poonam Bhosale [email protected] CFO & Special Correspondent: Manasee Kurlekar [email protected] Operations and HR: Asmita Thakar [email protected] Product & Marketing: Ankit Kankar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Circulation, Subscription and Media Enquiry: Sudam Walekar [email protected] South Region Apoorva Mahajan Key Account Executive “NITON”, Block B, First Floor, 11/3, Palace Road, Bangalore 560052 Mobile: +91-7724025888 [email protected] Mumbai Ankit Kankar Dy. General Manager Digital Intell & Growth 1st Floor, CIDCO Convention Center, Sector 30A, Vashi, Navi Mumbai, Maharashtra-400703. Mobile: +91-9579069369 [email protected] MM Activ Sci-Tech Communications Nagpur Manisha Boratkar 402, Govind Apartments, Shankar Nagar Square, Nagpur - 440 010. Tel. +91-712-2555 249 ‘BioSpectrum’ monthly publication is owned by MM Activ Sci-Tech Communications Pvt. Ltd., Published and Printed by Ravindra Boratkar, Printed at Spectrum Offset, D2/4, Satyam Industrial Estate, Behind CDSS, Erandawana, Pune - 411 038. and Published at ‘Ashirwad’, 36/A/s, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune - 411 045. Editor: Narayan Kulkarni. Website: www.biospectrumindia.com New Delhi Dr Manbeena Chawla Executive Editor 103-104, Rohit House 3, Tolstoy Marg, Connaught Place, New Delhi - 110 001 Mobile: +91-8861043732 [email protected] Pune Vipan Kumar Relationship Executive - Media Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Baner Road, Pune-411045 Mobile: +91-98347 45564 [email protected] INTERNATIONAL Singapore MM Activ Singapore Pte. Ltd. Saradha Mani General Manager #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Tel: +65-63369142 Fax:+65-63369145 [email protected] USA BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 E-mail: [email protected] Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 E-mail: [email protected] Scan QR code to access BioSpectrum India Digizine Acknowledgements/ Feedback The story on Genomic Revolution in the January 2023 edition clearly defines the market perception and real world opportunities. Post COVID-19, the Genome Diagnostics is a household name and Genome Sequencing has become commodity. Genomics is informatics, and scientists will have to shed long held beliefs, as claimed by Francis Collins, Human Genome Pioneer in USA. We need a very positive environment for Genomics led product diagnostics and Cell, Gene Therapy to compete with the western world and to bring out affordable medicines to the common man. Thank you BioSpectrum India for such a timely illustrative effort. - Ram Ramanujam, Bengaluru The January 2023 edition of BioSpectrum India is indeed an interesting read on multiple topics. - Ashok Bhattacharya, Mumbai With access to genome sequencing, an average consumer can reduce the odds of disease and enhance longevity most cost-effectively. - Anu Acharya, Hyderabad

Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, By the time this issue lands on your table, we all would have known our country’s financial position and the government’s plans and estimates for raising financial resources as well as expenditures. As the country’s budget for 2023-24 is presented on February 1, it is the most important news for the business community. Knowing this very well, we have made all efforts to incorporate the budget highlights pertaining to the pharma, life sciences and healthcare sectors in this issue, even at the cost of extending the printing deadline. However, also understanding the importance of bringing the budget to you on time, we have maintained a fine balance between incorporating the latest important development like budget and bringing forth the issue to you on time. Among the various diseases that are spreading fast in India, cancer occupies the top slot as the number of cancer cases and its mortality caused by it is very high. Mansukh Mandaviya, Union Health Minister of Health and Family Welfare, told Rajya Sabha last month that cancer cases and mortality have increased between 2020 and 2022. As per the National Cancer Registry Programme of the Indian Council of Medical Research (ICMR), the estimated cancer incidences were 13,92,179 in 2020 and rose to 14,61,427 in 2022. That amounts to 100.4 cases per lakh of the population. The estimated mortality caused by cancer increased from 7,70,230 in 2020 to 8,08,558 in 2022. The projected number of patients will grow in the coming years. Incidences of cancer are adding to the already overburdened Indian healthcare system. The only response to this growing problem can be early screening and detection. Knowing early signs of the disease and precancerous conditions through screening improves the treatment outcomes and survival. This is also one disease wherein new technologies are developed for early detection. Our content team has gathered information about them by talking to experts and presented the cover story developed to coincide with World Cancer Day on February 4. I am sure that our readers will find this article, which has thrown more light on new technologies, very useful. I am confident that this will be BioSpectrum’s most appropriate tribute to cancer victims, patients and survivors on World Cancer Day. After talking to experts our content team feels that the right policy measures will aid the medical fraternity to help patients suffering from a myriad of diseases in the days ahead. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com 5 [email protected] THE MOST SOUGHT-AFTER & MUCH TALKED ABOUT ANNUAL AWARDS NIGHT

Leveraging Early Cancer Detection Tech COVER STORY 23 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD. 6 BIO CONTENT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com 35 How CRISPRCAR-T therapy uses patient’s immune system to fight cancer 32 “Technology will play a significant role in reducing numbers of new cases and deaths” Raja Sekhar Kommu, Co-Founder and CTO, Karkinos Healthcare 29 How Early Diagnostic Tech Can Stop Cancer In Its Tracks Suraj Nair, Lead (TechSprouts), Ankur Capital Cancer is fast turning into an ‘epidemic’ and is the second leading cause of death globally. As per the Globocan Report of 2020, the annual global burden of cancer in 2020 in the country had hit the 1.93 crore mark with an annual death of 1 crore. The projected annual new cases globally will be 2.84 crore in 2040. According to the same report, the number of new cancer cases in India will be a whopping 17 lakh annually by 2035. In light of such alarming numbers, early detection still holds the key to cancer prevention. Though several technologies have been launched that can provide solace to the medical fraternity and patients alike in early detection, awareness on the disease and pre-testing remains a challenge in India. There are a few ‘Breakthrough Tech’ that hold a lot of promise. For instance, the Imperial College London has recently developed a surgical knife capable of identifying tumours that can detect endometrial cancer within seconds. The surgical knife could aid the treatment strategies for cancer by enhancing the diagnosis time and giving the go-ahead for treatment. Let’s explore some notable new technologies and also try to uncover the challenges in the fight against cancer.

Top Video Digital radiology is improving the quality of healthcare. Kalyan Sivasailam, CoFounder & Chief Executive Officer, 5C Network tells us how. Scan the QR Code » Santosh Marathe, Chief Executive Officer- Western Region, Apollo Hospitals shares his views on the evolution of genomics medicine in India. Scan the QR Code » Jesal Doshi, Deputy Chief Executive Officer, B Medical Systems talks about the trends shaping the Indian medical devices industry in 2023. Scan the QR Code » BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com BIO CONTENT 7 Vaccine 36 Sky’s the Limit for ChatGPT Application in Healthcare Union Budget 2023-24 19 Many Hits, Few Misses Regulars BioMail .......................................................................................04 Letter from Publisher...............................................................05 BioEdit ........................................................................................08 Policy and Regulatory News...................................................10 Finance News............................................................................14 Start-up News ...........................................................................16 Company News ........................................................................18 People News..............................................................................44 R&D News ..................................................................................45 Supplier News ...........................................................................48 Let’s Talk Health........................................................................50 Event Report 42 72nd Indian Pharmaceutical Congress “Centre is introducing researchlinked incentive programme to boost biotech product R&D” 38 108th Indian Science Congress (ISC) We need to invest in R&D to make more vaccines for tackling newer diseases: PM

8 BIO EDIT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com ‘Big-Budget’ Booster Shot Research, upgradation of technology and skill development appears to be the focus areas of Finance Minister Nirmala Sitharaman’s budget for 2023-24 as far as healthcare and life sciences sector is concerned. She has proposed a quantum leap in financial allocation for pharma development from Rs 100 crore in 2022-23 to Rs 1250 crore in the next financial year. The overall healthcare budget allocation has also seen a steep hike from 1.4 per cent of GDP in 2019-20 to 2.1 per cent in 2023-24, taking it to Rs 88,956 crore. The industry was expecting some incentives, particularly in taxes, for investment in research. However, the budget is not elaborative on that point with the FM just mentioning, “We shall also encourage industry to invest in research and development in specific priority areas.” The FM also mentioned “A new programme to promote research and innovation in pharmaceuticals will be taken up through Centres of Excellence (CoE).” But again without elaboration. Nevertheless, recognising the need for encouraging research is a step forward. Public and private medical college faculty and private sector research teams are being allowed to use facilities in select Indian Council of Medical Research (ICMR) laboratories, which is an encouraging move. Yet, some questions remain. Are these facilities at some labs not being used optimally currently by the ICMR? If so, why? Can’t ICMR expand its own research to utilise these facilities better? Nonetheless, this will surely help small and medium level companies to engage in research without setting up their own research infrastructure. These research initiatives will help the industry move ahead from generics in which Indian pharma is well established, to innovative drugs. The industry must take advantage of the concessions offered by the government and develop new drugs. This will, hopefully, help in affordable, locally produced medicines. The government will set up three CoEs for artificial intelligence (AI) in healthcare to foster partnership of industry players in conducting research and develop cutting edge applications. Also, dedicated multidisciplinary courses for medical devices are on the anvil, supported in existing institutions. This is expected to ensure availability of skilled human resources for futuristic medical technologies, high-end manufacturing and research. These steps will support health tech innovations. In healthcare, on the human resource front, 157 new nursing colleges will be established, in colocation with existing 157 medical colleges set up since 2014. This will address the current shortfall of nurses. By 2024, India will need 4.3 million more nurses to meet the WHO norm of 3 nurses per 1,000 population. We have, presently, just 1.7 nurses. The country already has 3 lakh nursing seats. The question is, will the shortfall be bridged by setting up 157 more colleges. Indian nurses are very much in demand abroad where a large number find employment. Hence, increasing the course capacity may not be enough. Perks, pay and other privileges, on par with the overseas institutions, might reduce this exodus. Eliminating sickle cell anaemia by 2047 is also another important initiative announced in this budget. Though the exact number of patients is not available, it is estimated that there are 18 million sickle cell trait (SCT) patients and 1.4 million sickle cell disease (SCD) patients among tribal population. Nearly 20 per cent tribal children die due to SCD before reaching the age of 2 and 30 per cent children die before reaching adulthood. Considering this, it is no doubt an important initiative. However, elimination appears to be difficult, as it is a genetic affliction. The Economic Survey of India, presented a day before the Union Budget, estimated India’s domestic pharmaceutical market to reach $65 billion by 2024 and $130 billion by 2030. All said and done, achieving the numerous estimated targets outlined in the budget will require tremendous effort and realistic implementation. Dr Milind Kokje Chief Editor [email protected]

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Union Minister Dr Jitendra Singh recently inaugurated “National Genome Editing & Training Centre (NGETC)” at National Agri-food Biotechnology Institute (NABI) Mohali, Punjab. NGETC is a oneroof state-of-the-art facility that will serve as a national platform to cater to the regional needs to adapt different genome editing methods, including CRISPR-Cas mediated genome modification. The minister said that due to a push from Prime Minister Narendra Modi, the startup movement has picked up momentum in India and led to creation of over 80,000 startups whose number was only about 350 before 2014. This quantum jump in the number of startups must equally and proportionally reflect in agri and biotech as well because this area is yet to be fully explored and taken advantage of by Indian entrepreneurs and youth. NGETC is the only facility that will serve as a national platform to cater to the regional needs to adapt different genome editing methods, including CRISPR-Cas mediated genome modification. National Genome Editing & Training Centre opens in Mohali India makes efforts to identify gaps in life sciences industry Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare, Government of India, recently addressed the roundtable discussion on “Opportunities in R&D and Innovation in Life Sciences” at the World Economic Forum, in Davos, Switzerland. The purpose of the meeting was to establish an affordable and accessible life sciences ecosystem, identify the gaps in the life sciences industry, extend opportunities for knowledge exchange and encouragement of innovation in R&D and identify investment opportunities to create a robust R&D and innovation ecosystem to increase the competitiveness of life sciences industry. Dr Mandaviya said that a large share of global value capture (nearly 40 per cent of a market of $6.65 trillion) in the life sciences sector lies in innovation-based products. Promoting drug discovery and innovation will unlock this value and will also enhance the industry’s contribution to Indian economy (additional $10-12 billion in exports every year) and create a large pool of jobs to enhance India’s differentiation vis-a-vis other developing economy. NHA introduces system to incentivise and encourage healthcare providers National Health Authority (NHA) is introducing a new system to measure and grade hospital performance under the flagship scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY). The new initiative will introduce the concept of ‘value-based care’, where payment will be outcome-based and providers will be rewarded according to the quality of the treatment delivered. Under the new model, the providers will be rewarded for helping the patients improve their health, which consequently will reduce the effects of the disease in the population in the long term. The step promises a significant increase in overall health gains and is expected to be a win-win for all concerned stakeholders from patients to healthcare providers, payers and suppliers. While the patients will get better health outcomes and higher satisfaction out of the services they receive, providers stand to get better care efficiencies. Similarly, payers will be able to maximise the health benefits generated out of the spending incurred. 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com

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Union Minister for Health & Family Welfare Dr Mansukh Mandaviya recently chaired the National Symposium on India’s Roadmap to Eliminate Lymphatic Filariasis (LF) at Vigyan Bhawan, New Delhi. According to him, LF is not a neglected disease as may be the case in some other countries, but a priority disease for elimination in a time bound manner. India is committed to eliminating Lymphatic Filariasis by 2027, three years ahead of the global target through mission mode, multi partner, multi sector, targeted drive for which we have drawn up the roadmap. The renewed five-pronged strategy for elimination of LF includes: • Multi-drug administration (MDA) campaign twice a year synchronised with National Deworming Day (February 10 and August 10) • Early diagnosis and treatment; engagement of medical colleges for strengthening morbidity management and disability (MMDP) services • Integrated Vector Control with multi sectoral coordinated efforts • Inter sectoral convergence with allied departments and ministries • Leveraging existing digital platforms for LF and exploring alternate diagnostics Govt emphasises on Lymphatic Filariasis as priority disease, not neglected Indian Oil Corporation has signed a Memorandum of Understanding (MoU), as part of its Corporate Social Responsibility (CSR) with the Central TB Division (CTD) under the Ministry of Health and Family Welfare, Government of India and the states of Uttar Pradesh and Chhattisgarh to undertake intensified tuberculosis (TB) elimination project. The MoU was signed in presence of Union Minister of Health and Family Welfare Dr Mansukh Mandaviya and Union Minister of Petroleum & Natural Gas and Housing & Urban Affairs, Hardeep Singh Puri. With a multi-pronged approach that addresses all aspects of TB at its different stages, this ambitious anti-TB campaign aims to ensure early identification of presumptive TB and prompt diagnosis using high-sensitivity diagnostic tests at the doorstep. The drive also aims to offer sustainable and equitable access to free high-quality TB treatment, care, and support services to the people of Uttar Pradesh and Chhatisgarh. Indian Oil Corporation signs MoU with Central TB Division 12 POLICY AND REGULATORY NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Madhya Pradesh launches Science, Technology and Innovation Policy 2022 Chief Minister Shivraj Singh Chouhan recently unveiled the Madhya Pradesh Science, Technology and Innovation Policy 2022. The main objective of this policy is to rank Madhya Pradesh as the top science, technology and innovation (STI) destination in the country, and to strengthen factors such as human resources, investment and knowledge-based labour force to position Madhya Pradesh in the top 5 states in the ‘India Innovation Index’ (from its current 13th rank) by the year 2030. The policy will also focus on developing an effective STI ecosystem and help Madhya Pradesh to increase knowledgebased production in the state by strengthening indicators such as research publications, innovations, startups, industrial design innovations and patents. There are plans to increase the enrollment ratio in STEM (science, technology, engineering and mathematics) courses at undergraduate, masters and PhD levels by promoting STEM education right from the elementary level, especially among girl students, by enriching the curriculum with STEM experiments and competitions.

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14 FINANCE NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Cipla has announced that its wholly owned UK subsidiary, Cipla (EU) has signed definitive agreements for equity investment of EUR 15 million in German firm Ethris GmbH, a global leader in delivering mRNAs directly to the respiratory system including administration by inhalation. The investment will facilitate a long-term strategic partnership between Cipla and Ethris for the development of messenger RNA (mRNA)-based therapies and fast-track Cipla’s participation in the mRNA space, enabling it to provide access to cutting-edge solutions developed by Ethris for the developing countries. A collaboration agreement is signed concurrently with the definitive agreement, which paves a path to market Ethris’ innovative portfolio in Cipla’s key emerging markets. The transaction is expected to get completed within 60 days from the date of signing of the agreement or such other time-period as may be mutually agreed between the parties in writing and shall be subject to completion of necessary regulatory formalities. Cipla invests €15 M in Ethris for developing mRNA-based therapies NIIF Fund of Funds has announced an anchor commitment of Rs 400 crore to Lighthouse India Fund IV AIF. With a target size of up to Rs 3,500 crore, Lighthouse Fund IV will invest in high-growth businesses in sectors such as healthcare, specialty manufacturing, digital transformation, and consumer products and services. NIIF’s participation as an anchor investor in Lighthouse Fund IV makes it the first domestic institutional investor and is expected to help the fund catalyse further capital from high-quality domestic and global institutions. Founded in 2006, Lighthouse has raised three private equity funds and has delivered a strong track record of marquee investments and exits. NIIF Fund of Funds invests in fund managers with a strong track record and sets a high standard of institutionalisation, including ESG practices. With this commitment, NIIF Fund of Funds is over 90 per cent committed across seven funds, investing in nationally significant sectors such as climate, affordable housing, healthcare and pharmaceuticals, innovation, deep technology, and manufacturing. NIIF announces Rs 400 Cr commitment to Lighthouse India Fund IV AIF Advent International, a global private equity investor, has entered into an agreement to acquire a significant stake in Hyderabadbased Suven Pharmaceuticals for Rs 6300 crore. As part of the transaction, Advent will be making an open offer to acquire additional 26 per cent of the outstanding equity shares of the company from the public shareholders. After the completion of this acquisition, Advent intends to explore the merger of its portfolio company, Cohance Lifesciences with Suven, to build a leading end-to-end contract development and manufacturing organisation (CDMO) for the pharma and specialty chemical markets. Cohance was launched by Advent in November 2022 as a new brand identity for its Active Pharmaceutical Ingredient (API) and CDMO platform, which comprises of three portfolio companies in RA Chem Pharma, ZCL Chemicals and Avra Laboratories. Advent buys majority stake in Suven Pharma for Rs 6300 Cr

E : [email protected] | P : 011-41081897 | W : www.abdoslifesciences.com SYSTEMS ELECTROPHORESIS

16 STARUPS NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Kiran Mazumdar Shaw leads investment in women’s health platform Gytree.com Gytree.com has announced its first round of fundraising, led by Biocon’s Kiran Mazumdar Shaw, Rainmatter Investments, Ajay Srinivasan, former CEO of Aditya Birla Capital, Anubhuti Sharma of San Francisco-based Millie Clinic amongst others. The startup uses technology to provide women with an intelligent dashboard, world class experts and personalised journeys for better health outcomes. Shaili Chopra is an award-winning entrepreneur who earlier set up Asia’s largest platform for women, SheThePeople (backed by Anand Mahindra). The demand for women’s health solutions and gytree. com emerged from within that 20 million strong community. According to Kiran Mazumdar Shaw, Gytree.com fills an important gap in using technology to solve for personalised health needs of women through products and services. Gytree.com would be the first platform of its kind to provide assistance at every step: symptom identification, timely diagnosis and longterm management. Even Healthcare sets up medical board to strengthen clinical protocols Bengaluru-based healthcare startup Even Healthcare, which recently raised additional funding of $15 million, has instituted a medical board consisting of globally celebrated healthcare professionals to oversee its clinical protocols in a bid to make primary care as good and efficient as in high-income countries. The board will take stock of the best clinical practices around the world and help Even doctors design care guidelines for members that result in marked positive patient outcomes. With this, Even hopes to design a blueprint for evidence-based care in India and show what good care looks like. The closest example of what the healthcare provider is trying to do is the National Institute for Health and Care Excellence (NICE) guidelines in England that help healthcare professionals prevent illnesses in patients using the best available evidence for specific conditions in specific people living a specific type of lifestyle. 6 startups under Health & Wellness sector receive recognition on National Startup Day Startup India Innovation week culminated with felicitation of winners of National Startup Awards 2022 on National Startup Day. The awards were presented by Union Minister of Commerce and Industry, Consumer Affairs, Food and Public Distribution and Textiles, Piyush Goyal in New Delhi. Multiple startups were recognised across various sectors such as agriculture, fintech, health & wellness, environment, construction, education & skill development, energy etc. Within the Health & Wellness sector, six startups received recognition- 1. YourDOST Health Solutions (Mental wellbeing)- The startup provides an online counselling and emotional support platform designed to foster mental wellness, 2. JC OrthoHeal (Medical Devices)- The startup focuses especially on the orthopaedics medical devices segment, 3. Algorithmic Biologics (Life sciences)- The startup provides cloud-delivered services to diagnostic labs that increases their efficiency by 20 times, 4. Prantae Solutions (Diagnostics)- The startup develops inventive and innovative products to enable decentralisation of early diagnostics, 5. Mallipathra Nutraceutical (AYUSH)- The startup is cultivating the world’s costliest, high medicinal value instilled Cordyceps mushrooms, 6. Medulance Healthcare (Access to Healthcare)- The startup is looking to solve the problem of ambulance availability by digitising the medical transportation segment.

DeepTek introduces AI powered lumbar spine quantification automation tool T-Hub and Atal Innovation Centre select 17 startups to boost healthcare innovation Hyderabad-based Technology Hub or T-Hub has launched the third cohort of the AIC (Atal Innovation Centre) T-Hub Healthcare programme to strengthen the technology innovations for the healthcare sector across India. The programme is designed to help entrepreneurs navigate the challenges around growth of the startup through expert-led workshops, specialised mentorship, market access, and investor and industry connect. From a total of 200+ applications, 17 startups have been handpicked after an extensive screening process by T-Hub, AIC and external industry experts. The startups were selected based on their cutting-edge deeptech innovations for healthcare and life sciences space, go-to market readiness, scalability, team composition, etc. The cohort focussed on areas such as - data digitisation, prevention and early detection, non-invasive medical devices, capacity building, diagnostic tools for cardiovascular diseases, cancer, and eye diseases and healthcare workers. Health tech startup Eka Care to foray into Nagpur Bengaluru-based connected health tech startup Eka Care is set to grow its presence in India by entering Nagpur. With a presence in more than 42 cities, Eka Care will now bring its comprehensive and personalised practice management platform to the doctors of Nagpur. The Eka Care platform can be customised by the doctor according to their speciality, which would make their clinical practice easier to manage and operate. With Eka Care, doctors can manage their appointments, digital prescription, billing, lab and pharmacy services, patients’ medical records, and their digital presence. Earlier this year, the health tech firm raised $15 million in a funding round led by Hummingbird Ventures, with participation from 3one4 Capital, Mirae Asset, Verlinvest, and Aditya Birla Ventures. Binny Bansal, Co-Founder of Flipkart, and Rohit MA, Co-Founder of the Cloudnine group of hospitals, have also invested in the firm. BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com STARUPS NEWS 17 Pune-based health tech startup DeepTek has announced the global launch of DeepSpine - an artificial intelligence (AI) powered lumbar spine quantification and metrics tool designed to analyse MRI lumbar spine images. The tool was launched at the Radiological Society of North America (RSNA)’s annual meeting in Chicago, USA. DeepTek’s new innovation DeepSpine provides AI powered quantification and analysis tool for lumbar spine MRI studies and can assist radiologists, technologists, orthopaedic surgeons and physio experts to get objective automated quantification and other document of lumbar spine, adding value to the radiology reports and decongesting the radiology workflow. DeepTek has been instrumental in transforming the radiology workflow by leveraging the power of AI. Its AI-powered radiology orchestration solution Augmento has already created waves across the Asia Pacific (APAC) and is also getting deployed in a progressive Singapore health system. Another flagship product by DeepTek is Genki - the AI-powered public health screening solution which is helping medical professionals across India, Philippines, Mongolia, and several other countries in the APAC region to eradicate tuberculosis (TB).

Mumbai-based pharma firm Cipla has announced the launch of Cippoint, a point-of-care (POC) testing device. This stateof-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved – indicating the device is approved by the European In-Vitro Diagnostic Device Directive, thus ensuring reliable testing solutions. With entry in these new segments, Cipla has expanded its product offerings for diagnostics laboratories and aims to bridge the current gap in the diagnostic ecosystem in India by providing reliable and accurate tests at affordable prices. Cippoint, an immunofluorescence based quantitative analyser, will allow healthcare professionals to get test results in 3 to 15 minutes, thus enabling a faster clinical decision-making process. Cippoint has an automated system and user-friendly interface which can be used even in rural areas, mobile vans, and remote areas with limited infrastructure. It aims to enable smaller healthcare establishments provide an accurate point-of-care testing experience, ultimately improving patient health outcomes. Cipla launches POC testing device for multiple health conditions Sai Life Sciences opens new HPAPI manufacturing facility at Bidar Theranica, Dr. Reddy’s bring Nerivio to millions of people with migraine in India Theranica, a prescribed digital therapeutics company based in Israel developing advanced neuromodulation devices for migraine and other pain conditions, has announced a strategic license and supply agreement with Hyderabad-based Dr. Reddy’s Laboratories, for the exclusive marketing and distribution of FDA-approved Nerivio in India, subject to completion of the regulatory approval process in India. Under the terms of the agreement, Dr. Reddy’s will be responsible for the regulatory approval of Nerivio in India, after which it will exclusively market Nerivio in India, manufactured and supplied by Theranica. The agreement includes licensing fees for exclusive rights to market Nerivio in India. While the agreement applies only to India, the companies will continue discussions about expanding to additional territories outside the United States and China. Nerivio is the first US FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals age 12 and older. Worn on the upper arm, Nerivio utilises remote electrical neuromodulation (REN) to trigger an endogenous descending pain inhibition mechanism known as conditioned pain modulation (CPM), which aborts or alleviates migraine headache and associated migraine symptoms. Sai Life Sciences, Hyderabad-based Contract Research, Development & Manufacturing Organisation (CROCDMO), has announced the opening of a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, Karnataka. The addition of this new facility expands the company’s expertise across HPAPI development and manufacturing, providing its customers with a streamlined pathway for new chemical entity (NCE) development. The new 16000 sq ft HPAPI block, located in the Bidar Manufacturing Campus of the company, is designed and validated to handle high potent molecules less than 1 μg/ m3 containment; it has inbuilt warehouse to store key starting materials (KSMs), intermediates and finished goods; it has dedicated sampling / dispensing area with isolators with three independent streams to handle commercial scale batches. 18 COMPANY NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com UNION BUDGET 2023-24 19 The Finance Minister Nirmala Sitharaman, has allocated a whopping Rs 88,956 crore to health expenditure, a Rs 2,350 crore hike of 2.71 per cent from Rs 86,606 crore in FY23. Though experts in the pharma and healthcare fraternity are gung ho about the budget, the medical devices industry was not so happy about it. The government’s last full-fledged Budget has evoked mixed responses. Prime Minister Narendra Modi, on the eve of the Budget, said that India’s budget will not only try to fulfil the hopes and dreams of the common man of India. Key highlights An allocation of Rs 89,155 crore to the Ministry of Health and Family Welfare is the right move for the life sciences sector. With this year’s budget announcement, Finance Minister (FM) Nirmala Sitharaman has shown her intention to increase public spending to improve the health delivery systems in the country. The FM during her speech in the Lok Sabha mentioned setting up 157 new nursing colleges to be established in co-location with the existing 157 med colleges established since 2015, scrapping old ambulances across states, and setting up a new programme for research in pharmaceuticals. She further mentioned the government’s mission to eliminate sickle cell anaemia by 2047. Research by public and private medical facilities and private medical facilities at selected ICMR labs was also mentioned by her in the Budget speech. For the medical devices sector, dedicated multidisciplinary courses for medical devices will be supported in existing institutions to ensure the availability of skilled manpower for future futuristic medical technologies, high-end manufacturing and research. The government will be creating three Centres of Excellence (CoEs) to boost Artificial The Union Budget 2023-24 has generated mixed reactions from the industry at large. Allocating a whopping Rs 88,956 crore to health expenditure, a Rs 2,350 crore hike of 2.71 per cent from Rs 86,606 crore in FY23, is a good move for the industry. However, the medical devices industry was left high and dry. Experts highlight the key takeaways of the budget and the ones not touched upon. Let’s feel the pulse of the industry after the Budget 2023-24 revelation. Many Hits, Few Misses Intelligence (AI) in India. These centres will be established in top Indian institutions to ensure that ‘we make AI in India’ and ‘make AI work for India. On a positive note The Organisation of Pharmaceutical Producers of India (OPPI) congratulated the government on the 2023-24 Union Budget tabled by the Finance Minister. Vivek Sehgal, Director General, OPPI mentioned, “The budget has brought much optimism to the healthcare and pharma sector by putting the focus on research and innovation. With the announcement of a new programme for research in the pharma industry being formulated, there is immense potential for the sector to remain competitive in providing quality healthcare to its people. Moreover, the impetus for publicprivate collaborations showcases the government’s emphasis on providing faster solutions to India’s health challenges. As OPPI, we are looking forward to putting in all our resources and aligning with the government to achieve the objective of healthcare for all.” Pharmaceutical R&D will help spur investment in innovations that can address areas of high disease burden and unmet health needs in India and as per Manoj Saxena, Managing Director, Bayer Zydus Pharma, “This is a long-awaited move, and we hope such a programme will provide sustained incentives for investment so that the Indian pharmaceutical industry becomes a global hub for both discovery and development work.” Welcoming the Budget announcements, Satish Reddy, Chairman, Dr. Reddy’s Laboratories, says “It is an inclusive budget with a boost to critical areas such as education, healthcare, environment and agriculture. Allocation of over 2 per cent of GDP to health, dedicated multidisciplinary courses for medical devices, the mission to eliminate sickle-cell anaemia and centres of excellence for AI for cutting-edge

20 UNION BUDGET 2023-24 BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com solutions were some of the key highlights. We look forward to studying the detailed proposals.” Sharing her views, Kiran Mazumdar Shaw, Chairperson, Biocon & Biocon Biologics says, “The Budget focus on Pharma R&D and innovation is a step in the right direction because research- oriented incentives and policies can enable the Indian Pharma industry to become the R&D , bio-innovation and bio-manufacturing hub of the world. The over measures aimed at economically empowering women, committing to climate action, through a thrust on green economy, and energy transition and improving ease of doing business will all contribute towards building a $5 trillion Indian economy by 2025-26.” Echoing similar views, Amitabh Dube, Country President and MD, Novartis India says, “As an organisation, we have a long-standing commitment and have undertaken several initiatives to improve the lives of those affected by sickle cell anaemia and the announcement by FM to eliminate sickle cell anaemia by 2047 is very encouraging. We look forward to establishing more significant partnerships with relevant government stakeholders towards providing a comprehensive SCD management ecosystem to the patients.” ICRA believes that overall, the budget aims at increasing spending on the sector, improving universal health coverage, promoting R&D, and increasing skilled manpower, which is a positive. Shamsher Dewan, Senior Vice President & Group Head - Corporate Ratings, ICRA opines, “Continuing modest allocation towards the healthcare sector leaves India’s healthcare spend as a percentage of GDP well below the world average and other developing and developed nations.” While talking about the R&D in the pharma sector, Vijay Chawla, Partner and Head, Life Sciences, and Head, Risk Advisory, KPMG mentions, “Introduction of this scheme through various centres of excellence (CoE) will also help attract industry players to invest in R&D. Dedicated multidisciplinary courses for medical devices in existing institutions will ensure availability of skilled manpower for futuristic medical technologies, high-end manufacturing and research.” Research Society for the Study of Diabetes in India (RSSDI) thinks that setting up various nursing colleges across the country is a much-needed move. Says Dr BM Makkar, President, RSSDI, “This will help prepare the nation against an outbreak like Covid-19 so that we have adequately trained medical professionals.” As a Digital Therapeutics platform, Fitterfly sees this budget as an encouraging one where the government has focussed on AI and IoT integration in health management. According to Dr Arbinder Singal, Co-founder & CEO, Fitterfly, this move will help in increasing the adoption of smart wearables such as Continuous Glucose Monitors and other devices that record vitals. The CoE in Artificial Intelligence to be set up for sectors like health will ensure that the country starts creating tech-based solutions in-house. This will further encourage innovation in the country and ensure that the health tech sector in India picks up pace. Adding to it, Meena Ganesh, Co-Founder & Chairperson, Portea Medical, says “Overall, the budget has made a progressive stride towards the healthcare and startup sectors as well as in terms of giving a boost to women and their economic empowerment.” Girish Arora, Founder & MD, Alniche Life Sciences opines, “This year’s budget will improve healthcare infrastructure, strengthen the public healthcare system, promote research and development, expand coverage of healthcare services, and promote the use of technology to improve the overall healthcare system in India. With these initiatives, the healthcare sector will see a positive impact, leading to a healthier and more productive population.” Bharath Balasubramaniam, President Operations, Sankara Eye Foundation India mentions, “The focus on health infra in rural areas will certainly bring the entire network of digitisation under one umbrella. However, for not-for-profit hospitals, we were hoping for a better outcome from the budget in the form of tax benefits and operating incentives.” A not so good one Some experts however were critical of the budget. Starting with the medical devices sector, the industry was anticipating a positive response from the finance ministry. With imports of medical devices from China going up by nearly 50 per cent last year from Rs 9000 crore to Rs 15000, on account of low duties and convenience to import, a lot of domestic manufacturers had to shut shop. Rajiv Nath, Forum Coordinator, Association of

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com UNION BUDGET 2023-24 21 Indian Medical Device Industry (AiMeD) expressed his deep disappointment and anguish over the Union Budget 2023 given the cold shoulder shown towards the Indian Medical Device Industry. He mentioned, “It is highly disheartening that against Industry’s expectations and assurance by the various Govt. Departments, the government has not announced any measures to help end the 80-85 per cent import dependence forced upon India and an ever-increasing import bill of over Rs 63,200 crore.” However, Jatin Mahajan, Secretary, Association of Diagnostics Manufacturers of India (ADMI) and MD, J Mitra & Co gave a different view altogether. He opines, “The Central Government has taken due cognisance of the contributions made by the medical devices segment to the overall healthcare industry in general and the COVID period in particular. The government has made specific declarations on the industry, and many of these are in line with recommendations that we have been making to the Government. All these developments will promote the medical devices industry and create a favourable business environment.” Nikkhil K Masurkar, CEO, Entod Pharmaceuticals, is a bit disappointed by no announcement on any sort of GST changes and simplified regulations. He says, “We were expecting that the government would allocate separate funds for R&D, formulation and APIs. So, I hope these factors will be taken into consideration in the coming years.” On similar lines, Hitesh Sharma, Tax Partner and National Leader – Lifesciences, EY India opines, “The much-hoped income tax benefit in the form of higher R&D linked weighted deductions or simplification of the patent box regime was not considered. Also missed was extending customs exemption for goods used in the pharma sector for R&D beyond March 31, 2023.” According to Gautam Chopra, Co-Founder, and CEO, BeatO, “More support and allocation of resources for health-tech startups to become effective would have been appreciated, as well as integration of digital solutions by such startups within the public health system would help them take their products and services further and reduce the burden on the system.” Gautam Khanna, CEO, PD Hinduja Hospital and Chairman FICCI Health Services was looking forward to clear indications of the steps to be implemented for healthcare infrastructure development and move closer towards universal health coverage with increased expenditure as a percentage of GDP. Dr Azad Moopen, founder Chairman and MD, Aster DM Healthcare mentions, “The overall impetus for the healthcare delivery sector is missing. We were hoping for an increase in budget allocation for the industry which is essential to fulfilling the need gaps. The need to have more hospitals and healthcare facilities in rural and suburban areas to meet the rising demand remains untouched. Hope the government would put more focus on public-private partnerships (PPP) to address this. We were also hoping for concessions for NRIs residing abroad like a reduction on TDS for those who have a source of income in India and are required to pay taxes in the country they reside in, flight prices, and a health scheme for those who are returning to India to retire, among others. However, these remain untouched as well.” Sanjay Bhutani, Director, MTaI mentions, “More could have been done towards decreasing healthcare costs for patients, as the long-standing demand of the healthcare industry to zero rates the medical services under GST has not been implemented.” According to Dr Shravan Subramanyam, President, NATHEALTH, “The long-standing requirements of the sector to increase healthcare spending as GDP per cent to 2.5 per cent, custom duty reduction to balance demand with supply and the nascent healthcare manufacturing base in equipment scheme, streamlining embedded indirect taxes like GST in healthcare making a smooth flow of credit difficult across value chain and low-cost financing schemes to strengthen healthcare infrastructure, primary care and improved working capital has not been addressed.” Target 2024 Like each year, this year’s Budget seems to have had a positive impact on the healthcare and the pharma industry. Populist Budget is not always on the government’s radar, however, the FM seems to have touched upon the crucial requirements, which can be beneficial for the overall sector in the long run. With the election in 2024 and the government’s last full-fledged Budget before the Lok Sabha polls, it is anticipated that the next year’s budget will be a winwin for both the sector and the government. Sanjiv Das [email protected]

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BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER STORY 23 Leveraging Early Cancer Detection Tech Cancer is fast turning into an ‘epidemic’ and is the second leading cause of death globally. As per the Globocan Report of 2020, the annual global burden of cancer in 2020 in the country had hit the 1.93 crore mark with an annual death of 1 crore. The projected annual new cases globally will be 2.84 crore in 2040. According to the same report, the number of new cancer cases in India will be a whopping 17 lakh annually by 2035. In light of such alarming numbers, early detection still holds the key to cancer prevention. Though several technologies have been launched that can provide solace to the medical fraternity and patients alike in early detection, awareness on the disease and pre-testing remains a challenge in India. There are a few ‘Breakthrough Tech’ that hold a lot of promise. For instance, the Imperial College London has recently developed a surgical knife capable of identifying tumours that can detect endometrial cancer within seconds. The surgical knife could aid the treatment strategies for cancer by enhancing the diagnosis time and giving the go-ahead for treatment. Let’s explore some notable new technologies and also try to uncover the challenges in the fight against cancer. Cancer is associated with stigma, fear and anxiety. Apart from a cancer patient who has to undergo a host of tests and treatments like chemotherapy and radiation, the relatives accompanying the patients also suffer mental agony. India has a huge burden of cancer and according to Indian Council for Medical Research (ICMR) estimates on the ‘Burden of Cancers in India’, seven cancers accounted for more than 40 per cent of the total disease burden: lung (10.6 per cent), breast (10.5 per cent), oesophagus (5.8 per cent), mouth (5.7 per cent), stomach (5.2 per cent), liver (4.6 per cent) and cervix uteri (4.3 per cent). As per biomedcentral.com, the highest incidences of cancer are in the North (2,408 patients per 100,000) followed by the North East (2,177 per 100,000).

24 COVER STORY BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Incidences of cancer are going to show an upward trend with lung and breast cancer being common among males and females and it is a worrying sign. Cancers of the oral cavity and lungs in males and cervix and breast in females account for over 50 per cent of all cancer deaths in India. As a large proportion of cancers are diagnosed at the advanced stage, it leads to poorer survival, drainage of economic resources, along with loss of socioeconomic productivity. Cancer prevention and early detection remain critical goals worldwide. According to Keith T Flaherty, Director of Clinical Research, Massachusetts General Hospital Cancer Center, new methods that can be taken into primary care and remote care environments are not yet on the market, but are rapidly progressing in clinical validation studies. The biggest area of investment of development has been in blood-based methods for detecting DNA shed by cancer cells. He goes on to add, “The ability of these methods to detect smaller and smaller quantities of circulating tumour DNA, now make it feasible to detect a single copy of tumour DNA in a 10 ml tube of blood, which is the needed level to detect cancers at an early stage. Those tests also incorporate techniques for determining the ‘cell of origin’ in a way that suggests the cancer type that is developing. This is an important feature and it remains to be determined as to whether these tests will be equally useful across the spectrum of common cancers.” Early screening The key to preventing cancer is early screening. Screening helps to locate early signs of cancer or precancerous conditions. This leads to the treatment being more likely to be successful and the chances of survival are much better. New technology developments such as Artificial Intelligence (AI), liquid biopsies, genome editing, telehealth, robotics and gene therapies amongst others are powering better diagnosis and helping accelerate progress against cancer. While global cancer incidence is on the rise, rapidly increasing medical evidence coupled with numerous innovations in cancer diagnosis and treatment is improving how cancer is getting identified. Liquid biopsy is the analysis of tumours using biomarkers circulating in fluids such as blood for early detection of cancer. Multi-cancer early detection (MCED) test is now available that offers the detection of the presence of multiple different types of cancers using a simple blood sample. It is an Next Generation Sequencing (NGS)-based test that uses AI algorithms to analyse methylation patterns of cell-free DNA (cfDNA) in blood. AI-based algorithms are also available for screening cervical PAP smears to facilitate early detection of cervical cancer with higher accuracy. Theranostic markers are offered to the oncologists to guide targeted therapies and immunotherapy of their patients. A fully automated genomics laboratory for advanced molecular and genetic testing of cancers helps in detecting cancer. Realtime PCR, digital PCR, MLPA, Fragment Analysis, Sanger Sequencing, Pyrosequencing and Next Generation Sequencing are some of the methods being adopted in early cancer detection. For breast cancer, self-examination, yearly mammography above the age of 40 years and targeted biopsies can detect a large proportion of cancers in the early stage. For cervical cancers, yearly PAP smear and human papillomavirus (HPV) testing followed by cervical biopsies for high-risk cases are helpful. Monitoring serum PSA levels can help triage men in need of early biopsy to detect prostate cancer. For oral cavity cancers, early consultation for non-healing ulcers, white patches, growth etc. will detect oral cancers early. Other forms to screen cancer are advanced immunohistochemical markers on biopsy or excision specimens which serve as surrogates for molecular testing, as well as molecular testing by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next-generation sequencing (NGS) are modalities we offer. These tests help to treat physicians in making informed decisions for patients to avail precision and targeted medicine. However, Dr Jay Mehta, President & Head, Neuberg Oncopath mentions, “We are somewhere between developed and developing countries in the sense that we don’t have as many extensive screening programmes as needed for a population our size, however, we have progressed in terms of increased awareness among common people, offering affordable screening tests so the people can access healthcare earlier than they would have.” Projected cancer burden by gender from 2018 to 2040 Source: WHO Cancer Incidence in Thousands Estimated Cancer Burden by Year Male Female Both 2018 2025 2030 2035 2040 2000 1750 1500 1250 1000 750 500 250 0 570.05 664.39 770.83 860.59 870.51 882.96 955.39 784.02 689.35 1383.64 1555.20 1732.68 1912.20 587.35 1157.29

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER STORY 25 Breakthrough technologies Experts at the Imperial College London have recently developed a surgical knife capable of identifying tumours that can detect endometrial cancer within seconds. The surgical knife could aid the treatment strategies for cancer by enhancing the diagnosis time and giving the go-ahead for treatment. Dubbed Rapid Evaporative Ionisation Mass Spectrometry (REIMS), the surgical intelligent knife (iKnife) can rapidly identify human tissues in real time and is a form of ambient mass spectrometry. The intelligent surgical knife can locate the presence of endometrial cancer using standard electrosurgical methods. It is known to identify different tissue types, including lung, colon and liver. Innovation-driven company PredOmix with its cost-effective cancer detection blood test called OncoVeryx-F is capable of detecting early-stage cancers in women with 98 per cent accuracy. Backed by metabolomics-based technology, the new age innovation enables the screening for earlystage cancers. Designed for women, the screening tool accurately diagnoses cancer before tumour development begins with high specificity. Says Dr Kanury VS Rao, Co-Founder & CSO, PredOmix, “While global cancer incidence is on the rise, rapidly increasing medical evidence coupled with numerous innovations in cancer diagnosis and treatment is improving how we identify, perceive, comprehend, and treat cancer. What once seemed impossible in the field of cancer research is now a reality. Accelerating progress against this disease may be possible if these technologies are further investigated and used.” The current cancer screening solutions at Datar Cancer Genetics are CE accredited, with the US Food and Drug Administration (FDA) having granted ‘Breakthrough Device Designation’ for the earlystage breast and prostate cancer detection tests. Says Dr Vineet Datta, Executive Director, Datar Cancer Genetics, “Genetic research over the past few years has rapidly increased the incorporation of such solutions in clinical practice. With the benefits of genetic testing getting increasingly established, efforts must be made to increase access to genomic services for all who can benefit. India is at the cusp of a revolution in biotech innovation, and genetic tests offer diverse purposes, including screening and diagnosis of genetic disorders, prediction of drug responses and identifying therapies that provide personalised cancer care.” Apart from this, Virtual Tumor Board’s (VTB) National Cancer Grid (NCG) initiative aims to provide standardised care to individuals across the country. Different centres from across India join this virtual tumour board to discuss the management of oncology cases. Mention can be made of Karkinos Healthcare which aims to significantly enhance access to cancer care services by creating a technologyenabled data-driven platform and distributed cancer care model (DCCM), wherein the knowledge architecture is centralised and the delivery systems are democratised and distributed. The DCCM encompasses a ‘hub-and-spoke and further spoke’ hospital infrastructure on the back of robust technology and clinical decision support systems. Dr Moni Abraham K, Co-Founder, Medical Director and CEO, Karkinos Kerala mentions, “We have a technology platform where a patient can assess whether there is an elevated risk of particular cancer or not. When somebody is diagnosed or suspected as a highly elevated risk, we need to send them to what we call a community cancer centre. We aim to significantly enhance access to cancer care services by creating a technology-enabled datadriven platform and DCCM, wherein the knowledge architecture is centralised, and the delivery systems are democratised and distributed. The DCCM encompasses a ‘hub-and-spoke and further spoke’ hospital infrastructure on the back of robust technology and clinical decision support systems.” Bengaluru-based Mestastop has created three proprietary platforms, both in vitro and in vivo, along with patient tumour translational validation, to unravel the complexity of metastasis drug discovery and early predictive diagnostics. These platforms are ready to be used for novel drug discovery, drug repurposing and profiling current anti-cancer leads or candidates for their antimetastatic effect. About 9.6 million people died of cancer globally in the year 2016 and 90 per cent of those deaths were due to metastasis, i.e. spreading “While India has recently established the National Cancer Grid to promote use of digital technologies and tools to improve cancer care across the country, the increased fund allocation would facilitate in tracking the clinical care and outcomes of a large sample space of the defined patient population” - Dr Sundeep Jain, Founder GI & HPB Surgeon Abdominal Cancer Foundation, Jaipur

26 COVER STORY BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com “New methods that can be taken into primary care and remote care environments are not yet on the market, but are rapidly progressing in clinical validation studies. The biggest area of investment of development has been in bloodbased methods for detecting DNA shed by cancer cells.” - Keith T Flaherty, Director, Clinical Research, Massachusetts General Hospital Cancer Center “We are somewhere between developed and developing countries, given that we don’t have as many extensive screening programmes as needed for a population our size. However, we have progressed in terms of increased awareness among people, offering them affordable screening tests, enabling them to access healthcare earlier than they would have.” - Dr Jay Mehta, President & Head, Neuberg Oncopath “The primary goal of the screening programme is to detect cancer at an early stage, especially when an individual is asymptomatic and may have a family history. If detected early, the cure rates are better and the treatment is also not expensive.” - Dr Nitin Malekar, Director, Harae Dx Corp “What once seemed impossible in the field of cancer research is now a reality. Accelerating progress against this disease may be possible if these technologies are further investigated and used.” - Dr Kanury V S Rao, Co-Founder & CSO, PredOmix of the primary tumor to other parts of the body. Mestastop is not into the early detection of cancer but in the early detection of the metastatic probability of cancer, i.e., of solid tumours. According to Mestastop, a minimum of 10^9 (^ refers to the power of) cancer cells are needed to be recognised by a PET scan, and 10^5 cells are required to be detected by liquid biopsy. PET scan is the gold standard, as a liquid biopsy can still have false negatives. This means that even if one has 90,000 cancer cells in the body, the person will be clinically undetected. This highlights the importance of increasing the sensitivity of detection, or in other words, early detection, even when the cancer is small. Arnab Roy Chowdhury, Founder, Mestastop Solutions opines, “90 per cent of cancer deaths are due to metastasis, and once the tumour metastasises, i.e., spreads, there is almost no curative treatment. Clinicians use the node status of primary tumour patients to understand their metastatic probability, but it has a lot of variations and could be better. METSCAN can take a primary patient tumour and then predict its metastatic probability, thereby empowering clinicians in their decision-making ability.” Medical diagnostics company Harae Dx Corp has developed a next-generation automated multicancer early detection system to revolutionise current methods of cancer screening with liquid biopsies. The non-invasive portable rapid cancer diagnostic system can offer reliable test results in as little as 30 minutes. The system is based on a multiapplication platform using a proprietary lab-on-adisc centrifugal microfluidic technology. Says Dr Nitin Malekar, Director, Harae Dx Corp, “The primary goal of the screening programme is to detect cancer at an early stage, especially when an individual is asymptomatic and may have a family history. If detected early, the cure rates are better and the treatment is also not expensive, thus helping doctors and patients to accomplish the best results. Additionally, it reduces the morbidity, mortality and disease burden in the society at large.” Apollo Hospitals Navi Mumbai recently launched Apollo Genomics Institutes to provide comprehensive care to patients and families with genetic disorders. Genomic medicine is a new medical discipline that deals with genetic disorders and helps in the diagnosis and treatment of rare and inherited diseases. This move is likely to help in the early detection of cancer. Genetic research over the past few years has rapidly increased the incorporation of such solutions in clinical practice. With the benefits of genetic

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER STORY 27 “We aim to significantly enhance access to cancer care services by creating a technology-enabled data driven platform and distributed cancer care model (DCCM), wherein the knowledge architecture is centralised, and the delivery systems are democratised and distributed.” - Dr Moni Abraham K, Co-Founder, Medical Director and CEO, Karkinos Kerala “India is at the cusp of a revolution in biotech innovation and genetic tests offer diverse purposes, including screening and diagnosis of genetic disorders, prediction of drug responses and identifying therapies that provide personalised cancer care.” - Dr Vineet Datta, Executive Director, Datar Cancer Genetics “Major challenges that we face in our war against cancer include – a low level of awareness amongst the general public about cancer, late detection of cancer, poor access to specialised cancer care especially in rural and remote parts of the country and high cost of treatment.” - Dr Rajiv Tangri, Technical Director, Histopathology and Cytopathology, Dr Lal PathLabs “Cancer survival increases with early detection. Unfortunately, when cancer is diagnosed, about 50 per cent of cases are already at advanced stages. Early intervention is made possible by early diagnosis of cancer or precancerous changes.” - Manikandan Bala, MD India & SA, Senior Vice President, Direct Sales Strategies & TIMEA & Asia Pacific, Elekta testing getting increasingly established, efforts must be made to increase access to genomic services for all who can benefit. India is at the cusp of a revolution in biotech innovation, and genetic tests offer diverse purposes, including screening and diagnosis of genetic disorders, prediction of drug responses and identifying therapies that provide personalised cancer care. Referring to enhancing survival rates, Manikandan Bala, Managing Director, India & SA, Senior Vice President, Direct Sales Strategies &, TIMEA & Asia Pacific, Elekta says, “Cancer survival increases with early detection. Unfortunately, when cancer is diagnosed, about 50 per cent of cases are already at advanced stages. Early intervention is made possible by early diagnosis of cancer or precancerous changes.” Elekta has launched innovative cancer treatment in the form of radiation therapy and launched two radiotherapy offerings called Elekta Harmony and Elekta Unity. All the above technologies, among others, are likely to become game changers in early cancer detection and will indeed bring hope to the medical fraternity and patients. However, there remains a host of challenges while going in for early detection of cancer. Underutilised facilities General awareness about cancer including its risk factors and early symptoms is relatively low in India. Fewer people seem to be concerned about developing cancer in their lifetime in India compared to the global average. The natural outcome is that fewer people go in for screening tests like pap smears, and mammography as a routine practice. Dr Rajiv Tangri, Technical Director of Histopathology and Cytopathology, Dr Lal PathLabs opines, “Despite the availability of cancer screening programmes and excellent clinical diagnostic facilities in India, the services are mostly underutilised. Major challenges that we face in our war against cancer include – a low level of awareness amongst the general public about cancer, late detection of cancer, poor access to specialised cancer care especially in rural and remote parts of the country and high cost of treatment.” Almost 75-80 per cent of patients have advanced disease (Stage 3-4) at the time of diagnosis. This is mostly due to the late diagnosis which in turn is due to a low level of awareness in the population and among community physicians, lack of screening programmes, lack of diagnostic facilities locally and the requirement to travel long distances to reach a

28 COVER STORY BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com The way forward Government bodies should evaluate the performance of the innovations to traditional techniques in mass screening programmes, following which certain tests/technologies can be incorporated into routine screening guidelines. Dissecting the economics of cancer screening is key to ensuring the equitable distribution of resources and appropriate interventions to improve cancer outcomes via early detection. Early diagnosis can reduce the cost of treatment, with estimated costsavings in the disease course to be two to four times less than those diagnosed at later stages, including the adverse financial impact on the patient and their family. Early diagnosis of key individual risk factors is crucial for improved prevention of serious illness. The cancer burden will continue to increase over the next 15-20 years, with much of this increase seen in parts of the world where the health systems are already struggling. The proportion of patients receiving genetic tests will only increase as more data points enumerate the benefits of such solutions. However, additional factors like regular cancer screening, healthy eating, vaccination, and avoiding tobacco and alcohol consumption remain critical strategies for not just preventing cancer, but also reducing the detrimental effects of cancer. The Government of India has taken proactive steps over the past decade in the prevention and early detection of cancer and has launched various schemes to strengthen cancer control activities. Expanding the ambit of the National Cancer Registry could halt morbidity and mortality rate. As Dr Sundeep Jain, Founder GI & HPB Surgeon Abdominal Cancer Foundation, Jaipur, rightly points out, “While India has recently established the National Cancer Grid to promote the use of digital technologies and tools to improve cancer care across the country, the increased fund allocation would facilitate in tracking the clinical care and outcomes of a large sample space of the defined patient population. The data from the registry can also help device public health interventions to create awareness about prevention and early detection of these cancers.” Cancer cannot be treated by building cancer centres alone. Currently, one in eight of us will develop cancer in our lifetime and the numbers are only going to increase. As with most health related dictums, everyone must adopt a ‘Forewarned is forearmed’ outlook to put a stop to cancer. Sanjiv Das [email protected] Organisation Used for Imperial College London Surgical knife capable of identifying tumours can detect endometrial cancer within seconds PredOmix Cancer detection blood test called OncoVeryx-F is capable of detecting early-stage cancers in women with 98 per cent accuracy Datar Cancer Genetics Cancer screening solution for earlystage breast and prostate cancer detection tests Karkinos Healthcare Technology-enabled data driven platform and distributed cancer care model (DCCM) Mestastop Early detection of cancer and early detection of the metastatic probability of cancer Harae Dx Corp Next-gen automated multicancer early detection system to revolutionise current methods of cancer screening with liquid biopsies Elekta Medical Systems India Elekta Harmony and Elekta Unity Radiation therapy GenWorks A new device, Braster Pro for early detection of the disease Mylab Discovery Solutions PathoDetect HPV Detection Test is a real-time PCR-based screening solution to detect high-risk types of HPV in individuals. Niramai Artificial Intelligence-based Thermalytix solution for early detection of breast cancer Technologies in the offing major tertiary cancer centre, financial constraints and stigma associated with the diagnosis. The situation is even worse in rural areas which constitute almost 70 per cent of the total population. This is further compounded by factors like limited finances, language and cultural differences etc. A large proportion of cancers are diagnosed at an advanced stage which leads to poorer survival, drainage of economic resources, along with loss of socio-economic productivity. Cancer prevention and early detection remain critical goals worldwide. India is still lagging in terms of the sensitivity and efficiency of liquid biopsy. However, on the brighter side, image-based detection, e.g., lung cancer has improved due to artificial intelligence.

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER 29 How Early Diagnostic Tech Can Stop Cancer In Its Tracks « Suraj Nair, Lead (TechSprouts), Ankur Capital Surviving any form of cancer is challenging. It is more challenging if detected in the later stages. Data suggests that average 5-year survival of patients who were detected with cancer at an early stage was 91 per cent which dropped to 26 per cent at late stages. Nearly 10 million deaths were reported in 2020 due to cancer, almost half of which were from breast and lung cancer put together. Detection of cancers at early stages is therefore very important for effective therapy. Traditionally, there were two broad techniques available for early screening and diagnosis of cancers: tissue biopsy and the use of radiographic imaging. Tissue biopsy involves observing under the microscope, a small tissue extracted from the area of the body which may be cancerous. This is performed by a pathologist. In most cases, this is done only after symptoms are seen and is therefore used for diagnosis rather than screening. Tissue biopsy, however has several drawbacks- it is invasive in nature and therefore painful, its costly and time consuming and struggles to capture the heterogeneity of the tumors effectively. Therefore, it is not an effective strategy for early detection of cancers. Digital pathology emerged as a tool to reduce the burden on pathologists and avoid manual errors in analysing the images. Digital images of tissue biopsies can be stored on secure servers and subsequently analysed using Artificial Intelligence (AI) tools. Ibex Medical Analytics is one of the pioneers in the field of using AI in biopsies and has raised more than $50 million in venture capital funding. Paige and PathAI are just some of the other companies in this space. Despite its immense potential, penetration of digital pathology tools in the clinical settings has remained low due to challenges in digitising 100 per cent of tissue biopsy images and an inherent inertia in the system to adopt digitisation. The growth of the digital pathology market will depend heavily on the ability of the early adopters to scale up the technology into larger clinical settings and set examples for the late movers in the market. Another technique which has emerged since the early 2000s is the liquid biopsy test. This test involves analysis of cancer tumor cells (CTC) or other cancer biomarkers such as circulating tumor DNA (ctDNA), exosomes and miRNAs in blood, plasma, serum, saliva or urine samples. This provides information on the genomic and proteomic profile of the cancer cells and can help in effective precision medicine to be used in therapy. One of the major advantages of a liquid biopsy test is that it is non-invasive, which means it reduces pain, injury or infections which are often associated with tissue biopsies. Moreover, serial liquid biopsy can help in detecting the heterogeneities in tumors and their genetic profile. Liquid biopsy can be used for screening and diagnosis of cancers. The first clinically approved liquid biopsy test was commercialised in 2004 by Menarini Silicon Biosystems to detect advanced breast cancer, colorectal cancer, and prostate cancer. However, liquid biopsy based on ctDNA analysis was only accepted as a diagnostic tool

30 COVER BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com in the US in 2016. Since then, a few other tests have become commercially availableName of test Description Date of FDA Approval cobas EGFR Mutation Test v2 Detects specific mutations in the ctDNA circulating in the blood of people with non-small cell lung cancer (NSCLC) 2016 Guardant 360 CDx Detects specific mutations in the ctDNA circulating in the blood of people with non-small cell lung cancer (NSCLC) 2021 FoundationOne Liquid CDx Detects specific mutations in the ctDNA circulating in the blood of people with nonsmall cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and breast cancer 2021 The use of liquid biopsy as a tool for cancer screening and diagnosis is still in its nascency and more trials and validations need to be conducted for the products to be widely accepted in the market. However, a plethora of genetic and proteomic information on humans has been generated over the last decade which has encouraged a multi-omics approach to the discovery of cancer biomarkers. This is expected to open up opportunities to detect tumors which currently have no early diagnosis, track the progress of cancers during therapy and identify very specific mutations regularly. Moreover, use of advanced AI tools trained on the multi-omics information can reduce the timelines for identifying unique biomarkers. Finally, screening of multiple cancers from a single test is an avenue which has seen major developments. The field has seen significant venture capital investments in the last few years. 2021 saw close to $800 million invested into companies building cancer screening tools. Delfi Diagnostics, a company developing AI based liquid biopsy tests raised a series B round of $225 million in 2021 for a total funding of $330 million. The company is developing single and multi-cancer liquid biopsy blood tests. The company is currently validating the technology for early detection of lung and other cancers in the CASCADELUNG clinical trial. Grail, which is developing a multi-cancer blood based detection test, raised around $390 million in 2020, for a total funding of more than $1.9 billion. The company is currently collecting clinical data on over 73,000 participants through two clinical trials. Similarly, Thrive Early Detection raised a $257 million series B to commercialise its multi-cancer blood test. Many other companies in this space such as Freenome, Epic Sciences, Guardant Health, Nucleix, Inivata, NAVERIS, Genecast, AccuraGen, Cirina, Jiyinga Technology, Resolution Bioscience, Haystack Oncology have raised significant private funding over the last few years. One of the most interesting companies in the AI personal medicine market is Imagene AI, which is using deep learning algorithms to reduce the time for identification of biomarkers from many weeks to just under 2 minutes. The company has raised more than $21 million. In India, Strand Life Sciences launched its liquid biopsy tests for detecting lung cancer, colorectal cancer, breast cancer and bladder cancer in 2018. Actorius Innovations and Research has also developed a liquid biopsy test for lung, breast, colorectal, head and neck cancers. Their technology has already been approved by the Central Drugs Standard Control Organisation (CDSCO). Oncophenomics is another company which is commercialising a liquid biopsy test in India. Radiographic imaging, on the other hand, has been recommended only for three types of cancers as of today- breast cancer, colorectal cancer and lung cancer. Imaging is however also done for screening of other cancers such as colon, kidneys, cervix among others. Imaging techniques are used primarily for

screening of these cancers and are usually followed by a biopsy test for diagnosis. However, newer technologies are also helping in accurate diagnosis. Scientists and pathologists continue to debate on the risk to reward benefits of the various imaging modalities- radiology imaging may even harm the healthy cells and tissues due to prolonged exposure times, thereby leaving them at risk of developing cancer later. To overcome these challenges, new technologies are emerging along with the use of AI/machine learning (ML) tools to enable faster and accurate screening of cancers. While traditional methods including PET, X-ray, CT-Scans, MRI, Mammography and ultrasound have seen gradual improvements over the years, newer tools with the ability to identify patterns in images using algorithms have been able to disrupt the industry and lower the TAT for the screening of cancers. Apart from the larger companies in this market such as Siemens Healthineers, startups such as Niramai, Kheiron Medical, Deepwise, SkinVision and Lunit are also making their mark. Niramai has built an alternative to mammography by using thermal imaging along with an AI/ML software for early detection of breast cancers. Mammography, which is recommended to be done every two years for women between the age group of 50 and 74, is painful and highly uncomfortable for women. Niramai’s technology on the other hand, is highly non-invasive, radiation free and can be performed without any pain and discomfort. It is also recommended for women of all ages. Its patented machine learning algorithm analyses the The use of liquid biopsy as a tool for cancer screening and diagnosis is still in its nascency and more trials and validations need to be conducted for the products to be widely accepted in the market. However, a plethora of genetic and proteomic information on humans has been generated over the last decade which has encouraged a multi-omics approach to the discovery of cancer biomarkers. This is expected to open up opportunities to detect tumours. images obtained and is able to accurately detect the occurrence of breast cancer at a very early stage. Their medical device recently received US FDA clearance. The company has raised more than $6 million in private funding. Kheiron Medical has also built a deep learning AI platform to assist radiologists in accurate and faster diagnosis of breast cancer. The company has raised more than $22 million in private funding. Many of the tasks in the radiology labs such as screening of images, tumour measurements and segmentation are repetitive and tedious. They are also affected by human errors and incorrect diagnosis. The use of these AI/ML tools can significantly reduce the errors and improve the diagnostic performance. All said and done, early diagnosis of cancers has seen technological disruption over the last decade, both in biopsies as well as radiography imaging. Large datasets from genomics, proteomics, biopsy images have incentivised the use of artificial intelligence and machine learning tools to process this data and provide accurate and faster diagnosis. Genetic testing for screening these cancers is also picking up. The next decade will be challenging- these technologies need to scale up and have widespread adoption which will require validation through large heterogeneous datasets. This is especially challenging for liquid biopsies, since identification of patient cohorts comes with biases and the tests currently lack accuracy. Secondly, the inherent inertia in the system will have to be overcome, either by incentivising the use of these new technologies through insurance payer models or by enabling policies mandating their use as part of the patient journey. Last, but not the least, patients will have to be educated on the advantages of using these tools for cancer screening and diagnosis. BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER 31

“Technology will play a significant role in reducing numbers of new cases and deaths” « Raja Sekhar Kommu, Co-Founder and CTO, Karkinos Healthcare ‘Close the care gaps’ – a bold theme set for 2022-2024 World Cancer Day campaigns that fall on February 4 each year – intends to make a huge difference in delivering cancer care to the people. For 2023, an extended theme ‘Uniting our voices and taking action’ exhorts that meaningful steps must be taken to reduce cancer incidence and make early diagnosis more accessible. Bearing the theme in mind, BioSpectrum India connected with Raja Sekhar Kommu, Co-Founder and CTO, Karkinos Healthcare, whose company is leveraging new-age technologies to take evidence-based action in democratising cancer care. Edited excerpts; The 2020 International Agency for Research on Cancer (IARC) GLOBOCAN’s cancer statistics reports that there were an estimated 19.3 million new cases of cancer and almost 10 million deaths from cancer. How can intervention by new age technologies make a difference to these numbers? We have to pay attention to both the numbers here - number of new cases and number of deaths. The reason for such alarming numbers is because of the lack of awareness about cancer, lack of accessibility of cancer care and poor affordability of treatment. In most cases, cancer gets detected in the late stage making it very difficult for oncologists to save lives. Technology, therefore, has a significant role to play to improve both the numbers. With the help of technology, one can leverage existing distribution networks to increase the awareness about cancer, thereby nudging the population to go for periodic checks for assessing their individual risk for common cancers. In addition, with advances in technologies the diagnosis for cancer is moving from invasive to non-invasive techniques such as liquid biopsy. It is possible to screen and diagnose large populations at a fraction of cost. Both these result in improving the overall new cases and helps move the needle from illness construct to wellness construct. In addition, with advances in immunotherapy and reducing sequencing costs - it is just a matter of time for molecular testing to become a first line of companion diagnosis, ensuring the right treatment is given the first time to an individual who needs to be treated. The large amounts of data that gets generated as part of molecular testing, coupled with existing 32 COVER BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com

imaging and electronic health records of an individual, can be easily analysed now with machine learning algorithms. This creates the perfect feedback loop back to improve the accuracy of diagnosis and to identify early warning signs of cancer. We are anyway aware of how machine learning helps in the development of new cancer vaccines, cancer immunotherapies and cancer cell therapies. Karkinos Platform is meant to change the way cancer care is delivered, i.e., made more accessible and affordable. Can you elaborate about its Platform’s purpose and the technology involved? Karkinos platform was developed with the primary purpose as an oncology platform that binds the widely prevalent fragmented cancer care infrastructure in India into an efficient and highly functional network. To accomplish this, Karkinos’ 4D model of Detection, Diagnosis, Delivery, and Discovery has been designed. Karkinos Platform acts like the glue that integrates varied and fragmented treatment touchpoints – creating a Distributed Cancer Care Network (DCCN). The platform can connect an NGO personnel doing a cancer risk assessment at doorstep of a citizen; a trained technician doing a mammogram in a mobile camp unit; a molecular biologist doing genome sequencing in a lab; a physician administering chemotherapy at a day care centre; a medical physicist doing radiation therapy planning; an oncologist prescribing the next step of treatment; an expert participating in a molecular tumour board remotely and most importantly the patient themselves, thus, giving everyone a one single, and relevant view of the information that enables them to effectively do their respective tasks. Karkinos Platform is conceived to enable interoperability by design, evolve an integration ecosystem, to execute at population scale, to separate data from application and further separate application from user experience, which caters to both clinical and research – ultimately helping to achieve better outcomes for patients and making the journey accessible and affordable. The platform integrates and analyses data from multiple sources, combines data from different modalities and makes it easily accessible and actionable for Karkinos’ Care Professionals and Partners. The platform is designed as a cloud native construct hosted on Google Cloud, leveraging multitude of cloud technologies. The platform primarily uses openEHR, an open data standard to store clinical data in the Clinical Data Repository and uses FHIR for exchanging information with systems outside Karkinos. We strongly believe in Open Source and leverage many open-source tools & products from Cloud Native Computing Foundation. We also intend to make contributions to Open Source in due course. Additionally, the platform is built with security and privacy considerations in mind, as it will be handling sensitive patient data. Technologies like AI, ML, NLP are all being explored for their applications in oncology - ranging from early diagnosis to advanced cancer research. How, according to you, are these technologies supporting the oncology vertical? AI, ML, and NLP are all being used in oncology to support various aspects of cancer care, including early diagnosis, treatment planning and advanced cancer research. For instance, Karakinos’ Cancer Risk Assessment App is an ML-driven questionnaire chatbot that presents procedurally generated questions as per the respondent’s inputs to generate a risk score immediately. In terms of early diagnosis, AI and ML are being extensively used to analyse imaging data, such as CT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER 33

and MRI scans, to identify signs of cancer in the early stages. This includes using deep learning algorithms to analyse images and identify patterns that indicate the presence of cancer. Additionally, AI and NLP can be used to analyse patient data from electronic health records, such as lab results and medical history, to identify patients at high risk for cancer and to help triage patients for further evaluation. Karkinos’ Oncology specific NLP model OncoKEEN derives structured intelligent longitudinal insights from vast troves of historical treatment data to drive better, faster analysis of the patient care continuum - supporting research and identifying gaps in care. In terms of treatment planning and cancer research, AI and ML are being used to analyse large amounts of data, such as genomic data and patient outcomes, to: Identify the most effective treatments for individual patients. This includes using ML algorithms to predict which patients will respond best to a particular treatment and to identify new drug targets. Understand the underlying biology of cancer and to identify new targets for drug development. Additionally, AI and ML can be used to identify patterns in patient data that may indicate new cancer subtypes or to discover new biomarkers for cancer diagnosis. On these lines, Karkinos has partnered with prestigious academic institutes in the country such as IIT Madras for the National Centre for Precision Medicine in Cancer and IIT Guwahati for the Centre of Advanced Research on Diagnostics in Cancer (C-CARD) to drive data driven cancer research. It is the age of preventive and precision medicine. Unless technology is implemented, preventive or precision medicine in cancer care cannot be achieved. How do you support this statement? Modern cancer care is characterised by three important facets: 1. State-of-the-art clinical medicine, which may include evidence-based and sophisticated therapies targeted to patients’ tumour and biological characteristics. 2. An approach to care that is attentive to the spectrum of patients’ needs (i.e., physical, psychosocial, functional, spiritual). 3. Use of systems solutions, both human and machine, that support organisations in achieving their clinical medicine and patient-centred care delivery goals. Optimising these delivery features for a disease as complicated and heterogeneous as cancer often entails complex decision making, multiple handoffs between primary and specialty care providers, and coordination among cancer care team members. Preventive and precision medicine are both centred around the idea of using individualised information, such as genetic and molecular data, to tailor treatment and prevention strategies to each patient. In order to achieve this, large amounts of data need to be analysed and interpreted. Technologies like AI, ML, and NLP are particularly well-suited for this task, as they can process and analyse large amounts of data quickly and accurately. How do you see onco-tech evolving in the future? In the future, technology will play a significant role in the fight against cancer. Some of the areas where technology is likely to evolve and make an impact include: Early detection: Advances in imaging technology, such as AI-powered imaging and liquid biopsies, can improve the accuracy of early cancer detection. With 5G networks also getting commissioned, the early detection can happen in a point of care device in a screening camp or at the individual’s home. This will help to identify cancer at an earlier stage when treatment is more likely to be effective. Precision medicine: As more data is collected on the genomic and molecular characteristics of cancer, technology will continue to evolve to help make sense of this data and to personalise treatment for each patient. Cancer research: Technology such as AI and ML will be used to analyse large amounts of data from cancer research to help identify new targets for drug development and to better understand the underlying biology of cancer. Cancer Immunotherapy: Advancements in fields such as genomics, bioinformatics, and AI, will continue to help in the discovery of new cancer immunotherapies and cancer vaccines. Cancer Cell Therapies: Advancements in fields such as stem cell biology, genetic engineering, and AI, will continue to help in the discovery of new cancer cell therapies. Data exchange: Maturity in exchanging multimodal clinico-genomic patient data that is longitudinal and generational will be available for cancer research. This will play a crucial role in AIML cancer projects globally. All these advancements will certainly help in reducing the cancer incidence and aid cancer research to a large extent. Anusha Ashwin 34 COVER BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com

Gene-editing pioneer Jennifer Doudna’s discovery on Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR Associated Nuclease 9 (CRISPR/Cas9) technology has brought about several new avenues in cancer treatment. This tool uses only a single nuclease protein complex with 2 short RNA as a site-specific endonuclease, which makes it a simple, powerful, and flexible genome editing tool to target nearly any genomic locus. Also, recent developments in therapeutic engineered T cells and effective responses of CD19-directed chimeric antigen receptor T cells (CAR-T) therapy has been rapidly growing in cancer therapy. The combination of CRISPR/Cas9 technology as a genome engineering tool and CAR-T cell therapy (engineered T cells that express chimeric antigen receptors) is leading to further explorations in cancer treatment. For years now, cancer patients have been treated with various types of therapies, including conventional strategies like chemo-, radio- and targeted therapy, as well as immunotherapy like checkpoint inhibitors, vaccine, and cell therapy, etc. Among the therapeutic alternatives, T-cell therapy like CAR-T (Chimeric Antigen Receptor Engineered T cell) and TCR-T (T Cell Receptor Engineered T cell), have emerged as the most promising therapeutics due to its precision clinical efficacy. According to Research&Markets, in 2012, there were only 12 clinical trials investing in CAR-T cell therapy products. Today, that number has risen to over 500. Between 2017 and 2021, four CAR-T products have hit the market and this number is projected to reach double digits within five years. The earliest approvals, Kymriah and Yescarta, have been commercially available since 2017 and 2018, respectively, & have been infused into nearly a half million patients worldwide. In July 2020, the US Food and Drug Administration approved a third CAR-T cell therapy, Kite Pharma’s brexucabtagene autoleucel (sold as Tecartus). In February 2021, Breyanzi became the fourth CAR-T approved cancer therapy. More recently, the antitumour activities of CAR-T cells have shown great improvement with the utilisation of CRISPR/Cas9 gene editing technology. It has been found that the genome editing system could be a powerful genetic tool to use for manipulating T cells and enhancing the efficacy of cell immunotherapy. Before CRISPR was invented, CAR-T cells were generated using other genome engineering technologies. As CRISPR/Cas9 gene editing enables manufacturing of CAR-T cells with improved anticancer effects, considering the heterogeneity of cancer cells, this therapeutic approach is believed to have improved treatment outcome where the immunotherapy not only treats the cancer condition but also enhances the normal capacity of the patient’s immune system. Dr Shailendra Vyas, a scientist turned-entrepreneur and Founder of Bioheaven360 Genotec Pvt Ltd, opines that CRISPR has been identified as the next generation technology for cancer cell editing and treatment. He says, “The biggest advantage can accrue from the fact that there are so many genes which can cause cancer and the mutations differ between patients. Thus, what we see is as many CRISPR clinics upcoming wherein gene editing can be done and directed therapies can be given to patients. The biggest advantage is that the therapies can be of low cost and effective.” Also, conventional cancer treatments, like radiation therapy or chemotherapy, cannot discriminate between healthy cells and cancerous cells. This means that the treatment destroys both types of cells, resulting in severe side effects. In contrast, CAR-T therapy uses a patient’s own immune system to fight cancer. Explaining from his company’s research standpoint, Dr Vyas says, “Bioheaven360 is trying to understand the downstream and off-target effects of CRISPR edited cells. We focus mainly on the regulators that are a part of natural defence mechanisms in cells and may act as a hurdle to CRISPR applications. Gene editing will take its own time till it reaches the market as cancer therapy. In India, where a large part of the population requires low-cost treatments ‘asap!’ We must not ignore other established immediately possible solutions like recombinant therapeutic antibodies or CAR T-Cell therapies or look towards other costeffective solutions. CRISPR based CAR T-cell therapies are gaining popularity and will be of significance in the near future.” Scientists, therefore, are confident that exploring both gene-edited cell treatments will empower the treatment of numerous sorts of cancer. The surface is being scratched and this combination tool will open up several new avenues to cost-effective cancer treatments and become the go-to treatment mode in the personalised cancer medicine arsenal. Anusha Ashwin How CRISPR-CAR-T therapy uses patient’s immune system to fight cancer BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com COVER 35

36 CHATGPT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com The buzz around ChatGPT, the latest generative AI tool is just too overwhelming. The buzz got millions excited in just around a week of its launch, because it seemed like it would gobble up Google — the search engine that this universe practically runs on. This mind-blowing new chatbot technology, ChatGPT, is a large language model trained by San Francisco-based tech company OpenAI. Why did it grab the world’s attention in a short time since its launch? There are several reasons, but the compelling one is that ChatGPT is an uber cool conversational AI tool that offers intelligent, computer-generated conversations. The software application is designed to mimic human-like conversation in response to user queries, which is enabled by superior computing power to perform written tasks. The best feature about chatbots is that they allow interaction in a seemingly ‘intelligent’ human-like conversational manner, where the GPT or the Generative Pre-training Transformer produces the output in a neatly drafted content format. In short, ChatGPT generates responses based on the natural language process inputs. What can ChatGPT do? Practically anything under the sun. Well, that might be an exaggeration. However, ChatGPT can spin any kind of written content or design ideas based on a topic or a keyword. It has the ability to translate languages in just seconds, as notably the tool can speak more than 50 languages. What I have understood from social media handles is that ChatGPT is empowered to generate wireframes and build complex python codes. It can turn text-heavy content into simple meaningful passages. Many, in fact, dub ChatGPT as an invaluable teacher, who can simplify explanations to even the toughest math problems that one finds impossible to crack. So, let me show you an example. I asked ChatGPT, how it is useful in biotechnology and the responses were just mind blowing! Like I said, ChatGPT can summarise complex topics and where market predictors see the future is its ability to make intelligent conversations apart from its ability to contribute in data-backed drug discovery activities. And, as for the fact that it can generate scientific papers, a recent news on ChatGPT being one of 12 authors on a preprint of a medical journal paper has got the regulatory authorities’ heads to turn. ChatGPT in healthcare Healthcare service is one of the most customer facing businesses and it has several mundane tasks that consume time as well as other resources. To make healthcare services more sustainable and error-free, ChatGPT is expected to offer assistance in several ways. Conversational AI, as you know, has the potential to revolutionise healthcare administration by streamlining communication, automating tedious Sky’s the Limit for ChatGPT Application in Healthcare 2023 has started with a bang, bringing forth lots of exciting news on the healthcare AI front. The future days are going to be marked by technology interventions that only revolutionise the healthcare and life sciences domain bearing in mind that equity to healthcare services is yet to be addressed and the needle needs to point towards last mile healthcare delivery.

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com CHATGPT 37 tasks, and providing more accurate and efficient processes for both patients and providers. Here is what ChatGPT says it can do to make healthcare services better: ChatGPT itself states that one of the main benefits of using ChatGPT in healthcare is its ability to improve communication where the natural language processing tool can understand and respond to patient inquiries and concerns, reducing the workload of healthcare providers (who generally spend a significant amount of time answering repetitive patient concerns). Ranging from patient communication to automating back-office operations in healthcare, ChatGPT is going to be a shoulder to lean on as healthcare organisations scale up digitalisation. On January 10, 2023, Microsoft considered investing $10 billion in OpenAI. This investment by Microsoft is a bid to take on Google’s dominance in the search engine market. Google’s ubiquity has contributed tremendously in providing resources and information related to any industry-agnostic query asked and Microsoft Bing is eyeing a major share of this service. Google’s counter to ChatGPT Google Health has been a major contributor to several AI-related developments in healthcare. So, there is no way that Google will not tap Conversational AI and Generative AI tools to offer services and products in the healthcare domain. Countering ChatGPT, Google responded to Open AI’s ChatGPT by announcing its MultiMedQA specifically for answering medical queries. Google Research and DeepMind recently introduced MedPaLM, an open-sourced large language model for medical purposes. MedPaLM provides datasets for multiple-choice questions and for longer responses to questions posed by medical professionals and non-professionals. These comprise the clinical topics datasets for MedQA, MedMCQA, PubMedQA, LiveQA, MedicationQA, and MMLU. In addition, a new dataset of curated, frequently searched medical inquiries called HealthSearchQA was added to improve MultiMedQA. AI-powered Chatbots to see an upward trend Accenture estimates that AI applications will cut annual U.S. healthcare costs by $150 billion in 2026. These savings are expected to result from a wider range of AI applications. With chatbots gaining popularity, they are expected to do much more than just chat alongside the potential to combine language skills with image and video recognition. This can be justified by noting Microsoft’s collaboration with Novo Nordisk to develop an AI-based Chinesespeaking chatbot for diabetic patients. Industry experts predict that the next generation of large language models, like GPT-4, could even be trained in multiple modalities, becoming generalist AI capable of performing a variety of tasks. 2023 has started with a bang, bringing forth lots of exciting news on the healthcare AI front. The future days are going to be marked by technology interventions that only revolutionise the healthcare and life sciences domain bearing in mind that equity to healthcare services is yet to be addressed and the needle needs to point towards last mile healthcare delivery. Anusha Ashwin ChatGPT itself states that one of the main benefits of using ChatGPT in healthcare is its ability to improve communication where the natural language processing tool can understand and respond to patient inquiries and concerns, reducing the workload of healthcare providers. Ranging from patient communication to automating back-office operations in healthcare, ChatGPT is going to be a shoulder to lean on as healthcare organisations scale up digitalisation.

the media, said, “By 2050, it is estimated that our global population will likely reach 9 billion people. And we have to ensure that every single one of these people will be able to enjoy a substantial quality of life without being detrimental to our natural resources and environment.” The 5-day event, which commenced from January 3, 2023, consisted of 28 plenary sessions witnessing the participation of 32 foreign speakers. These sessions also featured 26 women speakers in the form of eminent scientists, researchers and top technocrats. Expressing her delight about the focus on women empowerment at ISC 2023, Dr N Nallathamby Kalaiselvi, Director General, Council of Scientific and Industrial Research (CSIR) said, “It is exciting to see how India is putting focus on women in different ways and it is getting reflected in the focal theme of the Indian Science Congress itself. They have chosen very carefully that science and technology for sustainable development is through women empowerment. That is because wherever the word sustainable development comes, it becomes inseparable from women empowerment.” Another key highlight of ISC 2023 was that the mega science and technology event was hosted by Rashtrasant Tukadoji Maharaj Nagpur University in its centenary year. It was after 49 years that the university hosted the ISC which is the biggest science and technology event in the country, organised by 108th Indian Science Congress (ISC) We need to invest in R&D to make more vaccines for tackling newer diseases: PM 38 EVENT REPORT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Prime Minister Narendra Modi addressed the 108th Indian Science Congress (ISC) via video conferencing on January 3, 2023. The focal theme of this year’s ISC was ‘Science and Technology for Sustainable Development with Women Empowerment’ which witnessed discussions on issues of sustainable development, women empowerment and the role of science and technology in achieving this. Speaking about the result of India’s tryst with the scientific approach, the Prime Minister said that India is being counted among the top countries of the world as India moved to 40th place in the Global Innovation Index in 2022 from 81st place in 2015. “India is among the top three nations in the world in terms of the number of PhDs and startup ecosystems”, he said. “Efforts of science can turn into great achievements only when they come out of the lab and reach the land, and their impact reaches from global to grassroots, when its ambit is from ‘journal to zameen’ and when change is visible from research to real life”, he added. The PM further said, “We need to invest in R&D to make more vaccines for tackling newer diseases. Integrated disease surveillance is being conducted at inter-ministerial level to keep a tab on emerging diseases. We have to make India the most advanced laboratory of modern science.” After the inaugural event, Dr Jitendra Singh, Union Minister of State (Independent Charge) for Science & Technology and Earth Sciences, addressing Dr Jitendra Singh, Union Minister of State (Independent Charge) for Science & Technology inaugurating the mega science exhibition ‘Pride of India’, at the 108th ISC by cutting the ribbon at Rashtrasant Tukadoji Maharaj Nagpur University on January 3, along with dignitaries (from L-R) Jagdish Patankar, Executive Chairman, MM Activ Sci-Tech Communications, Devendra Fadnavis, Deputy Chief Minister of Maharashtra, Dr Vijay Laxmi Saxena, President General of the Indian Science Congress Association (ISCA), Calcutta and Ravindra Boratkar, Managing Director, MM Activ Sci-Tech Communications; Publisher & Managing Editor, BioSpectrum.

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com PARTNER CONTENT 39 How Agappe’s Mispa i-Series Delivers Faster Diagnosis for Better Treatment « Thomas John, Managing Director, Agappe Diagnostics Agappe, with its 28 years of experience in the IVD industry, has always been at the forefront of the introduction of new age goods and technologies with the purpose of providing a quicker and more accurate diagnosis, thereby assisting the rural and urban population, not only in India, but also 75 plus countries. Prior to this decade, the latex-based technology was accounting for almost 35 per cent of all specific protein estimations. The latex approaches come with their own set of restrictions and require a more time-consuming process to generate the results. The conventional latex method has been replaced with the introduction of the Mispa I Series, which uses a combination of nephelometry and immunoturbidimetry technology to determine protein concentration. This new method offers a wider measuring range, greater sensitivity and improved linearity at a more reasonable price. In 2011, Agappe planted the first seed of our intelligent breed, the Mispa iSeries, with the goal of providing protein estimation of a high grade at affordable costs to customers. Within a decade, Mispa iSeries established itself as the industry leader in specific protein testing across the world. Agappe presently has 15000+ happy customers in India and 75 plus nations abroad, using Mispa i-series instruments. First intelligent breed equipment was launched with 6 parameters onboard during 2011. Second generation Mispa i2, a patented Nephelometry equipment, was launched in 2012, which is a purely Indian made product with a unique patented technology to provide more accurate and reliable results. It serves 25 parameters with better sensitivity and linearity which ensures flexibility in laboratory testing with marginal investment. The convenient pack size of reagents in 15T and 30 with 35 days open vial stability for Mispa i2 reagents packs make this equipment very much suitable for medium and small labs with lower turnover. Mispa i3 being prefilled individual cartridges has no open vial stability issues, they come in 10s and 30s test packs. The Mispa iSeries instrument utilises smart card calibration technology, which eliminates risk of reagent waste as well as time-consuming and error-prone manual calibration. It also saves money on the cost of the calibration, as well as the cost of reagents. This capability is therefore highly useful for parameters such as HbA1c, CRP, and RF, as well as other parameters that require multipoint calibration otherwise. The factory calibrated smart card for the Mispa i-series allows users to enjoy trouble-free operation. Agappe introduced the third-generation specific protein analyser Mispa i3 in 2017 which features a prefilled cartridge and enables testing of 23 different parameters with improved sensitivity and linearity. The assay panel covers a variety of profiles, such as those for cardiovascular risk, allergy, COVID, diabetes, rheumatic, and osteoporosis screening, among others. Wide test panels that include multiple patient profiles assist medical professionals in making a rapid diagnosis of disease as well as monitoring patients’ progress toward recovery. The calibration of smart cards enables hassle free test processes without any additional calibration in the laboratory, on an affordable proposition. The Mispa i3 also uses prefilled reagent cartridges which can deliver the report within five minutes. This allows for a quicker diagnosis and monitoring of the patient. The Mispa i3 is distinguished from other instruments by its automation, affordability and its easy and convenient pack sizes for all special parameters. In addition to the three Design Registrations, the Indian Patent Office granted a patent in 2022 for the technology employed in the equipment. Mispa iSeries has established itself as a benchmark in terms of specific protein testing and is the first option of clients when it comes to protein estimation. During the challenging periods of COVID-19, Mispa iSeries served humanity with the improved nephelometry method by providing more than 10 million accurate results of COVID prognostic parameter tests such as CRP, D DIMER, and FERRITIN.

40 EVENT REPORT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com India must focus on impactful science, not just derivative science: Prof. Ajay Sood “India is among the top three nations in the world in terms of the number of PhDs. While the number of PhDs are increasing in India, the country’s share in the top 1 per cent of published research is less. India needs to focus on impactful science, and not just derivative science,” said Prof. Ajay Sood, Principal Scientific Advisor to Government of India. Speaking at a plenary session Prof. Sood, said that PhDs need not continue in the academic space throughout their career. “Our mindset has been that if you have done a PhD, you can only become a professor. This is not a sustainable way. Further growth of the startup sector, particularly deep-tech, can provide numerous job opportunities to PhDs in the industry. India has emerged as the third largest ecosystem for startups globally and the deep tech startup landscape in India has seen rapid growth”, he concluded. ISC 2023 also witnessed a plenary session where Dr N Nallathamby Kalaiselvi, Director General, Council of Scientific and Industrial Research (CSIR); Dr M Ravichandran, Secretary, Ministry of Earth Sciences; and Dr Alka Sharma, Adviser, Department of Biotechnology (DBT) deliberated upon the challenges and opportunities in Science & Technology for 2030. MM Activ Sci-Tech Communications. “This is not my first Indian Science Congress, but it is one of the better ones,” said Nobel Laureate Dr Ada Yonath, at the valedictory session of the 108th Indian Science Congress. Dr Ada, a 2008 laureate of the L’Oreal-UNESCO For Women in Science Awards, won the Nobel Prize in Chemistry in 2009 for her pioneering discoveries on the structure and function of ribosomes, the protein synthesisers in cells. Her research has also been key to understanding how antibiotics work. Pride of India – Mega Science Expo A mega science exhibition ‘Pride of India’, a key attraction in the 108th Indian Science Congress was inaugurated by Dr Jitendra Singh, on January 3, 2023. “The ISC venue has been built over 30,000 square metres. The Pride of India exhibition alone is spread over 9,000 square metres. Leading R&D Institutions like the Indian Council of Medical Research (ICMR), the Indian Council of Agricultural Research (ICAR) and the Council of Scientific & Industrial Research (CSIR) functioning in diverse streams of science, have showcased their latest work and initiatives”, said Ravindra Boratkar, Managing Director, MM Activ SciTech Communications; Publisher & Managing Editor, BioSpectrum. Hall of Pride, a dedicated pavilion, displayed the work and life of the Indian women scientists who have created an indelible mark globally in various scientific streams and given the country a place of pride in the world. Complementing the theme of the Indian Science Congress, this unique pavilion, designed by India’s leading artists, was conceptualised to salute the contributions and progress made by women in the field of science and technology. Vigyan Jyot (the Flame of Knowledge) remained lit at the venue of the Indian Science Congress Pride of India Expo for the duration of the Congress. Lakhs of students, dignitaries and members of the public visited Vigyan Jyot and took an oath to spread the awareness of science. Dr Manbeena Chawla [email protected] PM Modi addresses 108th Indian Science Congress via video conferencing Lighting of Vigyan Jyot (Flame of Knowledge) at the Indian Science Congress Pride of India Expo

Stable Box design for holding tip rack without toppling L-Shaped Footprint Overlapping Lid Closure 16 Slotted Pillar design 12 Rib design to enhance Strength • The new robust box design enhances stability and prevents uneven aspirations. • Overlapping lid closure prevents exposure of tips to contamination. • Boxes for all universal tip racks for holding different tip sizes. • L-shaped footprint at the bottom corners ensures easy stackability. • Slotted Pillars along the sides of the box minimise the warpage and this ensures less force to pick up the tips using any universally designed pipette. • A Sturdy Box design that allows desired pipette pressure for picking tips without toppling. • Ribs all around tip box Bottom & Lid respectively to enhance strength and prevent warpage. • A flange along the sides of the lid and new lid hinge design allows proper lid opening for tip access. This feature also allows the lid to be opened without distortion in shape TIP OF AN ICEBERG - Like the tip of an iceberg can be seen above water level, a number of other problems with Pipette Tips rather stay unknown. One example is hindered access from the Tip Box when picking up the tips which results in incorrect pipetting volumes. “This may result in nonreproducible data” Some problems with Pipette Tips boxes are obvious like: Tips have to push powerfully onto the tip rack in order to achieve an efficient tip fit. Loose gripping of the Pipette Tips due to non-sturdy Tip Box Uneven aspiration during liquid handling due to nonsturdy Tip Box Toppling of the racks while picking up the tips The New Generation Tip Box from ABDOS Life Science helps the scientists handle the pipetting steps with utmost precision and thereby eliminates costly errors caused by the tip box design. The new Gen 2 Tip Box is designed for Robust handling, anti-Warpage, and anti-Shrinkage. A Flange & new Hinge design on the lid offers strength – allows complete opening of the lid and an Overlapping Lid Closure & Positive Snap Lock allows the lid to be closed tightly. The new Tip Box has been patented for Design & Usage by ABDOS Life Science for better handling of liquid samples and laboratory reagents. ABDOS’ Indigenously developed Design improves the strength and helps to reduce the environmental burden. Tip box durability enhances the usage duration & curbs the wastage. Design of Tips box ensures compatibility with major pipette brands. A New improved, Patented, Gen2 Tip Box design by ABDOS Life Science. Design & Utility Patent: The new design of Generation 2 Pipette tip box of ABDOS Life Science addresses a few major concerns associated with warping and shrinkage of the box that may lead to contamination. The base of the tip box has also been designed to be sturdy with 4 L-shaped footprint at the corners for stack ability. The flange & the hinge design on the lid provides the strength to allow the lid to open fully to facilitate unhindered pipette access while picking up the tips from the rack, most importantly while handling a multi-channel pipette. The new tip box can accommodate all types of pipettes & tips. The new Gen-2 Tip Box from ABDOS Life Sciences: Improves your Pipetting Precision BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com PARTNER CONTENT 41 • A cross-sectional view of positive snap-lock mechanism between tip box bottom & lid to lock the box perfectly and open with an easy but firm lift with the thumb. Conclusion: ABDOS Life Science has patented the new design for Design & Usage for better handling of liquid samples and laboratory reagents. designfor superior handling experience. Built on Durability, Antiwarpage & Anti-shrinkage technology ABDOS Life Science’s New Generation Tip Box enables scientists to handle pipetting steps with extreme precision, eliminating costly errors. New Snap Lock New Snap Lock Clear Lid for better Visibility Flange & New Lid design for Unhindered Pipette Access • A B D O S I n d i g e n o u s l y d e v e l o p e d design provides the strength and Stability. • Tip box durability enhances the usage time & prevents wastage to reduce the environmental burden. • Design of Tips box ensures compatibility with major pipette brands and allows easy access to all 96 tips. Scan this QR code to view our Product Catalogue Discover more at: https:// www.abdoslifesciences.com/ Gaurav Sharda Product ManagerInternational Business

42 EVENT REPORT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com 72nd Indian Pharmaceutical Congress “Centre is introducing researchlinked incentive programme to boost biotech product R&D” The 72nd Indian Pharmaceutical Congress (IPC) was held at the Rashtrasant Tukadoji Maharaj Nagpur University in Maharashtra in January this year. At the Congress, organised by the Indian Pharmaceutical Congress Association (IPCA) and the Department of Pharmaceutical Science of Rashtrasant Tukdoji Maharaj Nagpur University, Union Minister Nitin Gadkari appealed to the pharma industry to exploit its ‘immense export potential’. Gadkari, while inaugurating the three-day congress, said that more exports will create more employment. “But, for more exports we need to do more research, for good quality products and at an affordable cost. Reputation of the Indian pharma industry and its products is very high in the world. That needs to be exploited further”, he added. Later, speaking at the CEO forum, Gadkari explained the importance of centrally located Nagpur, equidistant from different important places. He also described the city’s several distinctive advantages and the infrastructural facilities available for the industry and appealed to the pharma industry to look at Nagpur to ‘set up shop’. V G Somani, Drug Controller General of India (DCGI) and IPC President, in his presidential address said that Indians must focus on the next set of avenues to feed the growth engine of the industry to be the real well-managed and quality pharmacy of the world. It was imperative that India re-evaluates its current role within the global pharmaceutical industry, exploring possibilities to consolidate and strengthen its positioning. The Union Minister Nitin Gadkari who inaugurated the 72nd Indian Pharmaceutical Congress (IPC) at the Rashtrasant Tukadoji Maharaj Nagpur University in Maharashtra along with other dignitaries on January 20 was presented a memento by the organisers.

BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com EVENT REPORT 43 “The Centre is all set to introduce a researchlinked incentive programme shaped on the lines of the production-linked incentive (PLI) scheme to boost research and development of biotech products in the country”, remarked Somani. The PLI scheme will give companies incentives on incremental sales from products manufactured in domestic units. Dr T V Narayana, General Secretary, Indian Pharmaceutical Congress Association, presented an annual report and commended the work done by 12 lakh pharma professionals during the pandemic. Dr Dominique Jordan, President of the International Pharmaceutical Federation (FIP) pointed out that 2 billion people worldwide don’t have easy access to medicines. Hence, he pointed out that the theme of the conference ‘Access to Affordable and Quality Medical Products’ is important. Access to quality medicines should be developed. Later, speaking at the CEO Forum, S Sridhar, Pfizer Country Head, suggested that the government should allow innovative and differential prices. Dr Rambhau Devraj, Technical Director, Pulse Pharmaceutics, said that innovation needs protection and hence innovators should be protected. Ajit Singh, Chairperson, ACG group, suggested that the government should provide benefits for research. He cited an example of Germany where his new research is being done and how the German government provides a lot of benefits. Jitendra Sharma, MD and Founder CEO, Andhra Pradesh Medtech Zone, said medical grade vacuum seals required for certain types of needles are not produced in India. Medtech and surgical equipment industry aims to do import substitution, he said. He said that just as Sialkot, in Pakistan, is a surgical industry hub, a similar hub can be created in India. In response, Somani said “For those who want to expand their capacities, the regulator is working towards making the industry do business with ease”. Later, participating in different sessions, the industry, academic and regulatory experts presented views on different topics related to pharmaceuticals. Aditi Kare Panandikar, MD, Indoco Remedies, presented her views on women in pharma in 2030. She said that among the 49.5 million pharma workforce, only 11 per cent were women. Of them, the highest 21 per cent were in the corporate sector, 17 per cent in R&D and 12 per cent in manufacturing and only 5 per cent in sales and marketing. We need more women in leadership positions by 2030 and women holding high positions now, to change the picture. Emphasising the need for more women in the industry she said that if 50 per cent of the pharma customers are women, the companies cannot come out with right products for them unless 50 per cent women are there in the strategy teams. Sameer Gokhale, Lead, Health Economics and Market Access, Novartis, explained the health technology assessment concept. Rubina Bose, Deputy Drug Controller described the regulatory perspective about biosimilars and vaccines. Manjiri Gharat, Vice President, FIP, elaborated on how antimicrobial resistance (AMR) is a global public health challenge and a silent pandemic. 1.27 million deaths in the world are directly connected to AMR and 5 million indirectly. She pointed out that although India has the highest number of AMR, proper figures and data from India aren’t available. Improper disposal methods of antibiotics and overuse of antibiotics in animals are also causing AMR. Dr Shridhar Reddy, Global Head, Hetero, spoke, at length, about Artificial Intelligence (AI) in pharmacovigilance. Dr Krishna Ella, Executive Chairman, Bharat Biotech, in his presentation explained how the configuration of medicines is going to reverse from 70 per cent chemicals and 30 per cent biology today to 30 per cent chemicals and 70 per cent biology in 2030. Later, talking to media personnel, Dr Ella expressed the need for inspiring entrepreneurs for innovations by giving them concessions like tax holiday for new products developed. He also suggested that the government should give import subsidies for life-saving drugs. Along with the scientific sessions, a separate Pharma HR conclave was held. Around 10,000 delegates and students participated in the Congress. Dr Milind Kokje [email protected] “Indians must focus on the next set of avenues to feed the growth engine of the industry to be the real well-managed and quality pharmacy of the world. It was imperative that India re-evaluates its current role within the global pharmaceutical industry, exploring possibilities to consolidate and strengthen its positioning. The Centre is all set to introduce a research linked incentive programme shaped on the lines of the PLI scheme to boost R&D of biotech products in the country.” - V G Somani, Drug Controller General of India (DCGI) and President, IPC

Akums Drugs appoints Arvind Srivastava as President of HR Akums Drugs & Pharmaceuticals has appointed Arvind Srivastava as President of HR. He comes with more than 26 years of comprehensive experience in people management operations and restructuring organisations. Srivastava spearheaded HR process reengineering and proposing innovative HR solutions in manufacturing plants as well as in corporate offices. Before joining Akums Drugs & Pharmaceuticals Ltd, he worked with Bansal Group of Companies as Chief Human Resources Officer (CHRO) & Group Head HR from April 2021 to December 2022. Previously, he was associated with Usha International as Senior General Manager of HR and Rockman Industries Ltd. as CHRO. An alumnus of the University of Allahabad, he completed his Bachelor of Laws – LLB, from University of Lucknow, and started his career as Head-HR & Admin at DCM Chemicals. Wipro GE HealthCare has appointed Chaitanya Sarawate as the Managing Director, Wipro GE HealthCare and President and CEO, GE HealthCare South Asia. Sarawate will work closely with Dr Shravan Subramanyam for a smooth transition as he integrates into his new role, effective February 13, 2023, and will be reporting to Elie Chaillot, President and CEO, GE HealthCare Intercontinental. Sarawate brings with him over two decades of corporate and healthcare experience and has been with GE HealthCare for over 12 years. In his new role, he will be responsible for strengthening company’s market leadership position in South Asia by driving localisation strategy and delivering clinical excellence, access and precision care. Prior to this, Sarawate was the Chief Marketing & Strategy Officer for AKA (ASEAN, Korea, Australia & New Zealand), where he spearheaded organisational transformation that drove enhanced visibility, increased empowerment, and gains through segment specialisation. New Delhi-based startup BeatO has announced the appointment of Dr Navneet Agrawal as its Chief Clinical Officer. Dr Agrawal will head BeatO’s proprietary Diabetes Care Programmes. He is an MBBS, MD, Ph.D., FCCP, FIACM, Dip. Diabetology with over 22 years of clinical experience and more than 16 years of teaching experience. He has published more than 100 research papers in several prestigious national and international journals. Dr Agrawal has treated over a lakh patient hailing from metros, tier 2 and tier 3 towns across India and helped them to control and manage their diabetes. He has trained over 300 diabetes educators and imparted his rich and diverse experience to train and certify qualified and dedicated diabetes educators and doctors from across the country. He has designed the clinically verified BeatO Diabetes Care Programmes which provide personalised digital care solutions with proactive and supervised diabetes counseling by doctors and health experts on diet planning, exercise advice, and medication. The programme has over 25,000 enrolled users and is tailormade for people with pre-diabetes, type 2 diabetes, gestational diabetes, and type 1 diabetes. BeatO appoints Dr Navneet Agrawal as Chief Clinical Officer Chaitanya Sarawate joins Wipro GE HealthCare as MD 44 ACADEMICS NEWS PEOPLE NEWS BIOSPECTRUM BIOSPECTRUM | | FEBRUARY 2023 AUGUST 2021 | www.biospectrumindia.com | www.biospectrumindia.com

Researchers from the Advanced Centre for Treatment, Research & Education in Cancer (ACTREC), Tata Memorial Centre (TMC), India, have recently demonstrated therapeutic benefits of a prooxidant mixture of resveratrol and copper (R-Cu), in patients undergoing chemotherapy for advanced gastric cancer. Combining R with Cu (R-Cu) leads to the generation of free oxygen radicals which can inactivate the offending cfChPs. This study was supported by Department of Atomic Energy, Government of India, through its grant CTCTMC to Tata Memorial Centre. According to Prof. Indraneel Mittra, Dr. Ernest Borges Chair in Translational Research and Professor Emeritus, Department of Surgical Oncology at TMC/ ACTREC, evidence suggests that R-Cu can be a novel, cost-effective, and non-toxic agent which can be used for multiple disease conditions including cancer and metastasis prevention. Chromatin comprises a complex mixture of DNA and proteins and forms the structural basis of chromosomes in the cellular nuclei. When cells die, they release cell-free chromatin particles or cfChPs into the circulatory system. Researchers at ACTREC discover novel therapeutic agent for host of diseases Union Minister Dr Jitendra Singh has launched “One Week One Lab” campaign highlighting India’s global excellence in technology, innovation and startups. Each of the 37 CSIR (Council of Scientific & Industrial Research) Labs spread across the country is dedicated to a different exclusive area of work and the “on week, one lab” campaign will offer an opportunity to each one of them to showcase the work being done by it so that others can avail of it and stakeholders learn about it. According to the Director General, CSIR, Dr N Kalaiselvi, all the 37 labs have to come out with lots of success stories in the next seven years for a mid-term appraisal in 2030, to fulfill the vision of Prime Minister to make India innovation hub of the world in 2047. The campaign will also focus on academia and skill development, where interested students from varying domain get to know about the research activities and facilities of the CSIR laboratories and get a connect for future prospects. All 37 CSIR labs in India to turn into global centres of research and innovation In two recent studies, researchers at the Indian Institute of Science (IISc), Bengaluru and Unilever have collaborated to develop computational models of bacterial cell walls that can speed up the screening of antimicrobials, molecules which can kill disease-causing bacteria. Antimicrobials kill bacteria either by disrupting the cell wall’s lipid membrane and destabilising the peptidoglycan layer, or by translocating through the cell wall layers and disrupting the cell membrane inside. However, the actual mechanisms of interaction between antimicrobial molecules and these cellular barriers are poorly understood. The research team at IISc is the first to propose a comprehensive molecular model of the cell wall for Staphylococcus aureus. In one study, the team created an ‘atomistic model’, a computer simulation that recreates the structure of the cell wall down to the level of individual atoms. In the other study, the team used their model to compare the movement of different surfactant molecules through the peptidoglycan layer in E. coli. IISc develops computational models to speed up screening of antimicrobials BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com R&D NEWS 45

Time is Money: The Hidden Cost of Inefficient Laboratory Practices Manual inventory management practices make it rather cumbersome for scientists to carry out daily responsibilities. Firstly, scientists need to perform the laborious and time-consuming process of manually entering inventory records, sometimes mid-experiment. Scientists face reagent-related obstacles without streamlined or digital inventory management. As lab staff uses them, common reagents may get lost. Without an inventory system, it’s hard to find reagents or get a stock overview. Multiple bottles are opened at once, causing waste and mismanagement. 60% of the scientists we surveyed said they have an inventory management tool, but 90% struggle to find consumables. Laboratory managers and R&D leaders who aren’t familiar with scientists’ daily challenges notice that workflows take longer than expected but rarely suspect inventory mismanagement. Despite having an inventory system, their monthly checks reveal expired reagents or a sudden reagent shortage. They are unaware that the system is unreliable and inconvenient to use. To perform root-cause analyses, they spend more time and resources combing through error-prone manual data interventions but instead discover data silos or graves with irretrievable information. Motion waste: When information is all over the place Motion waste may seem rather innocuous, but in closer analysis, it often results in a two-pronged attack on the laboratory’s overall research output: • The unreasonable costs of having highly trained scientists performing low-value tasks every day. • The lost value to the research project as capable laboratory personnel are obligated to prioritize mundane inventory management over high-value contributions. Longer time-to-market could cost the pharmaceutical industry competitive advantage. In contract research organizations (CROs), motion waste can slow project turnarounds. A report by the EU Commission estimates that improper data management in research costs the European economy €10.2 billion annually. The report recommends research data be FAIR: findable, accessible, interoperable, and reusable. Without a reliable system, annual stock reviews or audits are difficult. During data intervention by a regulatory authority or laboratory manager, recapturing old data records into preferred formats takes time. Frequent data cleaning causes motion waste as scientists pause research to organize inventory records. Inconsistent data entry and poor data governance in a lab can increase motion waste as team members decipher each other’s records. In a recent case study, pharmaceutical company researchers spent up to 50 minutes finding a sample. Unproductive time across thousands of employees can hurt a company’s performance. To reduce motion waste, R&D leaders must investigate why their scientists spend time on mundane inventory tracking. Also, Ineffective lab practices can lead to lower professional satisfaction, underperformance, or employee turnover. Spoilage waste: When expired reagents need to be tossed Most lab managers have discarded expired reagents, sometimes before using them. 52% of researchers discard unused or expired stock. Disorganized inventory records make predicting lab reagent usage difficult. So lab managers overstock. As a result, they miss opportunities to plan experiments to use reagents before they expire. Lack of a reliable system to monitor real-time inventory stock leads to spoilage waste that drains laboratory budgets. The true cost of spoilage includes shipping, maintenance, storage, and safe disposal. When ignored, these hidden numbers can burden the lab financially. Improper storage can cause spoilage. When reagents 46 PARTNER CONTENT BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com

aren’t discarded promptly, they can be mistakenly used in research projects. Out-of-date reagents invalidate research findings because they don’t work properly. Using expired cell culture media or antibodies yields unreliable data. Even with early intervention, repeated experiments will exhaust time and resources. Failing to notice or act on expired reagent usage can compromise data integrity for current and downstream experiments, rendering results unusable. Behind every expired reagent wrongfully used due to inventory tracking issues is a large stockpile of time, money, and resources already spent on the research project that could be wasted due to noncompliance or irreproducibility. Both factors are integral to early drug discovery labs and CROs, exposing financiallyvulnerable projects to more costs and putting company’s reputation and future at risk. Disorganized Inventory Management Increases the Risk of Non-Compliance Highly regulated lab environments have a particular concern to maintain reagents and stocks reliably. In controlled protocols within regulated labs, using expired, improperly stored, or vaguely documented materials can result in the rejection of all associated results to stay in compliance. The loss of time and resources, connected to isolating, tracking, and eliminating reagents and data that could be associated with procedural non-compliance may be substantial. Regular audits are commonplace in pharmaceutical and drug discovery laboratories. Regulatory bodies such as the U.S. Food and Drug Administration and European Medicines Agency expect time-stamped, user-identified information on each consumable in the laboratory. In preparation for an audit, team members can spend significant time tracking down and manually double-checking documents. Without organized inventory records or reliable consumable tracking, laboratories must cross their fingers during audits, in case any violations are uncovered. Better Inventory Practices Can Save Time, Reduce Costs and Improve Research & Production Outcomes The direct and indirect costs of manual, errorprone inventory management can take a huge toll on the company’s output and industry standing. As the scientific and pharmaceutical community embraces a digital revolution, laying the foundation of best practices with efficient, user-friendly digital inventory systems not only boosts productivity but also generates tangible financial gains. Forward-thinking laboratories that replace repetitive admin tasks with suitable digital platforms can maintain compliance, retain scientific talent, expedite research timelines, and, ultimately, attract bigger funders. LANEXO® Inventory Manager is an offering from Merck’s growing portfolio of digital laboratory productivity initiatives – it lets you automatically track the chemicals you have in stock, see where they’re stored, and tell at a glance if they’ve been opened or if they’ve expired. Comprised of a mobile app and RFID labels, the LANEXO® mobile app captures data from lab consumables with just a few taps on your device and stores the information in a secure cloud. You can access detailed, real-time inventory data – including SDS, owner, opening and expiry dates, location, usage and disposal information – anytime, anywhere. This way, LANEXO® application not only simplifies your stock management across multiple sites, but it also ensures full regulatory compliance, such as with FDA regulation 21 CFR Part 11. It’s time to say goodbye to Excel, pen and paper. Discover the fast track to an audit-ready lab. C&EN BrandLab report sponsored by Millipore Sigma. Chemical Waste: The true cost of inefficient inventory management, June 2021: https://connect. acspubs.org/ lanexo-chemical-waste-report?partnerr ef=CENmilliporesig malanexo. BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com PARTNER CONTENT 47

Germany-headquartered Sartorius has extended a strategic collaboration partnership agreement with US-based RoosterBio to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) - based exosome production platform that delivers industry-leading yield, purity, and potency. Additionally, this collaboration will focus on the development of comprehensive analytical techniques for the characterisation of exosomes and the entire spectrum of extracellular vesicles (EVs) to establish quantitative strategies for quality control of exosome purification intermediates and final drug product. Sartorius and RoosterBio will develop scalable platform purification processes using Sartorius’ comprehensive toolbox of solutions to maximise exosome productivity while maintaining therapeutic attributes. Sartorius & RoosterBio to advance downstream purification for exosomes manufacturing Agilent invests $725M to expand production of nucleic acid-based therapeutics Mumbai-based HiMedia Laboratories has announced that their RT-PCR kits are capable of detecting the recently discovered BF.7 SARS-CoV-2 variant. The portfolio includes: MBPCR243 – A 4 Gene COVID-19 Multiplex Detection Kit and MBPCR255 – Hi-PCR® Triplex COVID-19 Detection Kit. The company tested the impact of the variant on their Triplex PCR Kit. Mutations, especially in RNA viruses are expected and SARS-CoV-2 is no exception. According to Dr Rajas V Warke, Director of HiGenoMB and Virology, HiMedia Labs, multiplexing has the advantage of higher sensitivity as it detects more than one region of the target, while also being capable of detecting mutations. As the new variant is wreaking a havoc worldwide, it becomes imperative to test the accuracy of the existing kits. To determine whether their RT-PCR kits can detect the BF.7 variant of the virus, the R&D team at HiGenoMB analysed the sequenced data in depth. This CE-IVD and CDSCO approved kit that also detected the earlier variants such as the Delta and Omicron has shown 100 per cent binding, indicating that the new found variant will not hamper the sensitivity of the kit (MBPCR255). HiMedia Lab’s RT-PCR kits detect new BF.7 variant of SARS-CoV-2 48 SUPPLIERS NEWS BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Agilent Technologies has announced that it is investing approximately $725 million to double manufacturing capacity of therapeutic nucleic acids in response to rapid growth of the $1 billion market and strong demand for the company’s high-quality active pharmaceutical ingredients (API). Therapeutic nucleic acids, also called therapeutic oligonucleotides or oligos, are short DNA and RNA molecules that serve as the API for drugs targeting a growing number of diseases, including cancer, cardiovascular disease, and rare and infectious diseases. The market for therapeutic oligos is currently estimated at $1 billion and is projected to grow in the double digits annually over the next five years, reaching $2.4 billion in 2027. The addition of two new manufacturing lines (known as Trains C and D) will enable Agilent to meet growing demand for siRNA, antisense and CRISPR guide RNA molecules. Agilent expects customer shipments from the expansion to begin in 2026.

Avantor and Catalent enter into multi-year supply and services agreement Qiagen has announced the launch of EZ2 Connect MDx for use in diagnostic laboratories, making the in vitro diagnostic (IVD) platform for automated sample processing available for widescale use 18 months after being made available for research. With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes. The device now carries the EU’s CE-IVD compliance marking for IVD for the European Union and other countries that accept this designation. It is also available in the United States, Canada and other countries. EZ2 Connect MDx can extract nucleic acids from blood plasma, serum, stool and other sample types using magnetic-bead technology. High process safety is ensured with prefilled and sealed reagent cartridges, as well as load checking through integrated cameras. Other features include UV decontamination, onboard pipetting and heating as well as automated piercing of the sealed cartridge. The resulting analyte is compatible with a variety of downstream technologies such as real-time PCR, digital PCR and nextgeneration sequencing. Qiagen launches EZ2 Connect MDx platform for automated sample processing in diagnostic labs SCHOTT opens new facility in US BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com SUPPLIERS NEWS 49 SCHOTT has opened a new facility in Phoenix, Arizona, US to expand the development and manufacturing of diagnostics and life science consumables. Launching the first fully integrated microfluidic foundry in the United States validates SCHOTT’s global growth plan and increases production capabilities to help get these products to market faster and more efficiently. The new, almost 40,000-square-foot facility, comprising of clean room, high volume manufacturing of microarrays and microfluidic devices, allows the company to onshore critical manufacturing supporting the US government’s renewed interest in reshoring and revitalising American manufacturing to secure critical domestic supply chains. The Arizona facility will mark SCHOTT’s third diagnostics location, with other centres of excellence located in Jena, Germany, and Melbourne, Australia. However, this will be the first location to place a special emphasis on bioscience capabilities using high-density microarrays for diagnostic and life science research. Over the next few years, it will create 150 jobs in the greater Phoenix area, growing SCHOTT MINIFAB’s employee base in Phoenix by 300 per cent. Avantor, a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, has entered into a multi-year supply and services agreement with Catalent, the leader in enabling the development and supply of better treatments for patients worldwide. Under the terms of the agreement, Avantor will be the primary supplier of a broad range of laboratory supplies, clinical and production materials, and services to Catalent, expanding the companies’ existing relationship. According to Alessandro Maselli, President and Chief Executive Officer, Catalent, Avantor is a terrific partner that brings diverse capabilities and expertise across modalities and geographies, which is essential to meeting global health needs. Catalent has built tremendous global capabilities and a reputation as a trusted collaborator to pharma, biotech and consumer health partners throughout the development and production lifecycle, according to Michael Stubblefield, President and Chief Executive Officer, Avantor.

50 LET’S TALK HEALTH BIOSPECTRUM | FEBRUARY 2023 | www.biospectrumindia.com Betting on Personalised Neoantigen Cancer Vax According to a recent report, trials of cuttingedge cancer vaccines could kick off in the UK this year by German vaccine maker BioNTech, as part of a new government partnership to fast track development of the same mRNA technology behind the most successful COVID-19 vaccines. As many as 10,000 cancer patients in the UK are to be treated with personalised mRNA cancer treatments by 2030. The tremendous experience with mRNA vaccines in the COVID-19 era is gradually moving the area of cancer vaccines forward. A time may come when cancer vaccines will be a part of the immunisation history and oncologists will be overjoyed knowing that immunised patients are protected not only against infectious pathogens but against specific types of cancers. But unlike other vaccines which protect us from a disease, cancer vaccines are currently being explored as a promising therapeutic strategy in the immunotherapy of solid tumours, specifically, for the treatment of people who already have cancer. Personalised cancer vaccination strategy, indeed, can be a potent approach to trigger a broad-based anti-tumour response that is both beneficial and relevant to individual cancer patients. Back in 2015, for the first time, a personalised vaccine to treat patients with melanoma was reported in the US. In this study, neoantigens were identified using an immunohistochemistry approach and then the patient’s dendritic cells loaded with the neoantigens were transfused into the patient, which resulted in enhanced antitumor T cell responses. Similarly, German scientists reported the use of RNA-based personalised vaccines using neoantigens in 2017, that included 13 melanoma patients. Eight of these patients had no further tumour development in the following 23 months. Neoantigens are tumour-specific antigens generated by mutations in tumour cells, which are only expressed in tumour cells. Tumour neoantigens are broadly categorised into two types: (i) shared neoantigens, and (ii) personalised neoantigens. Shared neoantigens are similar in different cancer patients thus can be used in a wide-spectrum therapeutic approach for patients with the same mutated gene. On the other hand, personalised neoantigens are unique and differ from patient to patient, therefore, the application of neoantigens in this case should be targeted to each individual i.e. personalised therapy. With the wide application of high-throughput omics and the development of neoantigen prediction technology, immunotherapy based on neoantigen has become a new research hotspot. As more scientific and clinical data reveal the remarkable effects of neoantigen-based vaccine therapies in a variety of cancer types, there is ample reason to believe that neoantigen-based therapies will be a promising area of cancer immunotherapy. Currently, no study has shown the optimal number of neoantigens for a tumour vaccine. A neoantigen vaccine usually contains several to dozens of neoantigens. For example, a personalised neoantigen DNA vaccine encodes up to 40 neoantigens. Additionally, several obstacles remain in the development and widespread use of neoantigen-based personalised cancer vaccines. The long cycle of cancer genome sequencing, neoantigen identification, and verification of immunogenicity add to the high cost of personalised vaccines, making them economically unfeasible for widespread use in cancer patients. Development of improved bioinformatics tools for characterisation of neoantigens, a more in depth understanding of tumour immunology, and advances in vaccine development and delivery methods will prove critical for the development and use of novel neoantigen-based cancer vaccines in the future. At present, the scientific community in India is basking in the glory of the successful development of India’s first indigenous tumour antigen SPAG9, trademarked as ASPAGNII, which is being used in dendritic cell (DC) based immunotherapy in cervical, ovarian cancer and will also be used in breast cancer treatment. With personalised neoantigen cancer vaccines based on DC showing promising antitumour effects in clinical studies world over, India surely has much to look forward to in this space. Dr Manbeena Chawla Executive Editor [email protected]