The Most Sought-After & Much Talked About Annual Awards Night To Felicitate The Stalwarts Of Indian Biotechnology & Health Science Industry ---------- Supported by ---------- ---------- Powered by ---------- Hear from the Experts Search for a New Molecule: Shift from Generics to Novel Drugs To Know More Mail at: [email protected] or visit: www.biospectrumindia.com/bsiawards2023 30th June 2023 Hyatt Regency, New Delhi
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Vol 21; Issue 4; April 2023 4 BIO MAIL BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Vol 21; Issue 5; May 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 Mandar More Regional Business Manager 1st Floor, CIDCO Convention Center, Sector 30A, Vashi, Navi Mumbai, Maharashtra-400703. Mobile: +91-9870009281 [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 Reprinted for private circulation 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] Asia Pacific and South East AsiaAnkit Kankar DY. General Manager - Digital Strategy & Programmes #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Mobile: +65 90150305 [email protected] North America and Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 E-mail: [email protected] Acknowledgement/ Feedback I appreciate your support for the 90 million rare disease patients in India. It is their voice reflected in your BioSprectrum. Thank you so much for giving attention to this rare disease’s cause in India. Your article is well received in India and abroad. - Ramaiah Muthyala, US The story on medical devices sector’s growth has come out very well. - Jatin Mahajan, New Delhi ‘Who Put the Brakes on Med Devices Sector Growth’ is an excellent read. Brilliantly covered all the focus points including pain points, solutions and future. I really liked the balanced approach of writing. - Dr Sanjeev Relan, New Delhi Thank you BioSpectrum for featuring the article- Addressing ‘Orphaning’ of Rare Diseases in both India and Asia editions. - Ravi Shet, Hyderabad
Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, To move from generics, which is the core of Indian pharma, to new drug development, research is the key. Acknowledging this, among various other announcements in the Union Budget for 2023-24, for the pharmaceutical sector, the thrust of proposals was on encouraging research. The budget proposals were not restricted to only financial matters but had even novel ideas like allowing the private sector to use laboratory facilities of certain government labs. Some action on the basis of those proposals have already begun in the concerned departments. This will certainly encourage pharma companies to invest and engage more in research for new drug development. But before looking into the possibilities in future, it is necessary to find out what is the current status of R&D expenditures of pharma companies. A newspaper has claimed that the industry’s R&D budget is 4.4 per cent of net sales of Rs 2.4 trillion. In the US, it is 20 per cent of their net sales, revealing just how much more the Indian pharma has to spend on R&D. Another organisation estimated 7.2 per cent expenditure on R&D of the total revenue of $3.03 billion in 2021. Our content team has explored the R&D spendings of leading pharma companies in this edition. Next-generation sequencing (NGS) is another promising aspect of cutting edge healthcare that India seems to be getting serious about. A large number of labs are using it to discover the genetic causes of rare diseases and polygenic diseases. It is used by clinicians for patient diagnosis and clinical management and is used for personalised medicine in oncology. Experts in the field reveal that although India is lagging in NGS in the global arena, there is a huge scope for the country to excel in this sector. Hence, we have carried an informative piece about India’s tryst with NGS in healthcare. I am sure the exploration of the growth potential of Indian pharma and the key measures being undertaken will make this issue a good read. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com 5 Looking for a job? See open roles at www.biospectrumjobs.com n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... BIOSPECTRUM TALENT SOLUTIONS premier source of pharma healthcare & bio jobs
COVER 22 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD. 6 BIO CONTENT BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com 24 Venus Remedies 24 25 - Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre Torrent Pharmaceuticals - Sudhir Mehta, Chairman, Torrent Pharmaceuticals Indoco Remedies - Aditi Kare Panandikar, Managing Director, Indoco Remedies 25 Glenmark 26 26 Pharmaceuticals - Glenn Saldanha, Chairman and MD, Glenmark Pharmaceuticals Sun Pharmaceutical Industries - Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries Ajanta Pharma - Yogesh M Agrawal, Managing Director, Ajanta Pharma 27 Aurobindo Pharma 28 28 - K Nithyananda Reddy, Vice Chairman and MD, Aurobindo Pharma Alembic Pharma - Chirayu Amin, Chairman & CEO, Alembic Pharma Dr. Reddy’s Laboratories - K Satish Reddy, Chairman, Dr. Reddy’s Laboratories 29 Lupin 30 30 - Vinita Gupta, CEO, Lupin Biocon - Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Cipla - Umang Vohra, MD and GCEO, Cipla 31 Panacea Biotec 32 32 - Soshil Kumar Jain, Chairman, Panacea Biotec Alkem Laboratories - Sandeep Singh, Managing Director, Alkem Laboratories Strides Pharma Science - Arun Kumar, Executive Chairperson and Managing Director, Strides Pharma Science Could 7.5% R&D Spends Make India PHARMA INNOVATION HUB?
Top Video Sadguru Sri Madhusudan Sai shares more details about India’s first totally-free medical college recently inaugurated by Prime Minister Narendra Modi, to address the need for quality healthcare delivery in rural India. Scan the QR Code » Prof. Suman Chakraborty, Mechanical Engineering, Indian Institute of Technology (IIT), Kharagpur tells us how Infosys Science Foundation is promoting and encouraging crucial aspects of medtech research and why it is the need of the hour. Scan the QR Code » Rajinder Suri, Chief Executive Officer, Developing Countries Vaccine Manufacturers Network (DCVMN) highlights the need of funding for tuberculosis (TB) vaccine development. Scan the QR Code » BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com BIO CONTENT 7 Regulars BioMail .......................................................................................04 Letter from Publisher...............................................................05 BioEdit ........................................................................................08 Policy and Regulatory News...................................................10 Finance News............................................................................14 Start-Up News...........................................................................15 Company News ........................................................................17 WHO News.................................................................................19 World News ...............................................................................20 People News..............................................................................44 R&D News ..................................................................................46 Supplier News ...........................................................................48 Let’s Talk Health........................................................................50 Prenatal Testing 41 Non-invasive Prenatal Testing Runs Global Amartya Bose, Healthcare & Life Sciences Industry Analyst, Frost & Sullivan Speaking With 33 “Increase in DCT adoption has inevitably brought about regulatory considerations to ensure patient safety and secure data sharing” Jerome Armellini, Asia Head of Clinical Development & Operations Strategy, R&D Solutions Asia, IQVIA Asia Pacific NGS technology 35 Leveraging NGS-Tech in Healthcare Applications
8 BIO EDIT BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Reclaiming India’s Image I n view of linking the children’s death in Gambia and Uzbekistan to cough syrups produced by Indian pharma companies a few months back, the Indian government has launched a major confidence building exercise abroad. Diplomatic efforts are ongoing to prevent any adverse impact on Indian drug exports due to the purported syrup-linked-deaths. Trade officials in Indian missions abroad are interacting with regulatory authorities to maintain desired confidence levels on quality of Indian drugs. On the other hand, the Pharmaceutical Export Promotion Council (Pharmexcil) had sent delegations abroad. Pharmexcil sends delegation abroad regularly to crack new markets, to boost exports of drugs & to expand the scope of business. But, the purpose of this delegation was to increase the confidence in Indian medicines. The delegation was to have industry level interactions with pharma trade associations and also with regulators. Pharmexcil is also conducting workshops on international standards and compliances. The Indian Pharmaceutical Association (IPA) has been doing similar efforts locally for the last few years to introduce its member companies to international norms, standards and compliances so that these companies will ensure that their products comply with them. Even after five months since the cough syrup ‘incident’, the assessment has not yet been completed and various agencies are still looking into it. It is also imperative to unearth the underlying reasons why regulators in these countries have levelled baseless allegations against Indian manufacturing standards. The World Health Organisation (WHO) had, thus, rightly issued a warning to the regulators when government laboratories did not find toxins in the syrups, in subsequent testing. Pharmexcil’s efforts bring us to the issue of general upskilling for maintaining quality parameters, which is crucial for exports. Indian drug exports are key to our economy with exports soaring tremendously. From 2014 to 2022 pharma exports doubled to $24.6 billion. To maintain this pace and even improve upon it, along with the quality, innovating new products, that too non-generic, is also pivotal. With that vision, the pharma sector is now focusing more on R&D. The government has also revealed its detailed plan in the recent Union Budget to encourage research for developing original medicines. Just prior to the budget presentation, the US pharma industry, through Boston-based USA-India Chamber of Commerce (USAIC), suggested that India formulate a R&D policy for the pharma sector. Policies should aim to move up the value chain driven by R&D which would make India R&D hub, emphasised the USAIC. Indian pharma’s vision is to grow to $130 billion by 2030. For targeted growth and moving up the value chain, research and innovation is vital for a knowledge-driven sector like pharma as it lends a competitive edge. To be competitive in the world market, Indian pharma will have to focus on R&D, which it is doing now. That will require human resources with the right skills for research. The government has already been encouraging skill development required in different sectors, including pharmaceuticals. Even the World Bank’s collaboration has been sought and the programme ‘Skill Acquisition and Knowledge Awareness for Livelihood Promotion’ (SANKALP) has been launched to improve short term skill training through strengthening institutions. Skill development is particularly more important now in view of the new technologies of artificial intelligence, data analytics and machine learning that will play a key role in drug development. They are expected to significantly reduce the time and costs involved for new drug development. Another area where skilling is required is quality control. Although Indian labs ruled out the presence of any toxins in the cough syrups, a strict vigil on quality control will help maintain India’s image as the Pharmacy of the World with Impeccable Quality Standards. While promoting research and exports, the government will have to initiate various other steps and only then will it prove to be a real confidence building exercise. Dr Milind Kokje Chief Editor [email protected]
Following the National Pharmaceutical Pricing Authority (NPPA) price revision of 651 essential drugs out of the over 870 scheduled drugs under the National List of Essential Medicines (NLEM), the industry is in a tizzy and has voiced concern that the price revision in 15 to 20 per cent essential drugs has been done without prior intimation or consultation. Highlighting the fact that a draft Drug Prices Control Order (DPCO) calculation sheet is being circulated among the pharma companies for their suggestions before issuing the price revision list, the national drug pricing regulator could have been done it in a consultative manner, an industry official said citing that due to NPPA sudden price revision exercise, the price of 651 essential drugs has drastically come down by 6.73 per cent on average from April 1, 2023 onwards. The cost of these essential drugs had already come down by 16.62 per cent because of the capping of ceiling prices. The NPPA revised the list and prices of essential medicines in November 2022 and the work of revising the applicable ceiling price of such notified drugs had been initiated by the NPPA under DPCO, 2013. The Union Health Ministry, while justifying the same, stated that even if the prices were to go up by 12.12 per cent this year, the capping would help offset the hike. 651 essential drugs turn 6.73% cheaper from April 1 25,000 health facilities across India undergoing transformation to address climate issues Govt exempts customs duty for all drugs used in rare diseases treatment 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com The Central Government has given full exemption from basic customs duty on all drugs and food for special medical purposes imported for personal use for treatment of all rare diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification. In order to avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Services or District Medical Officer/Civil Surgeon of the district. Drugs/ Medicines generally attract basic customs duty of 10 per cent, while some categories of lifesaving drugs/vaccines attract concessional rate of 5 per cent or nil. While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the government has been receiving many representations seeking customs duty relief for drugs and medicines used in treatment of other rare diseases. Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from Rs 10 lakh to more than Rs 1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight. In a significant step towards transforming the public health infrastructure for improved sustainability, SELCO Foundation and IKEA Foundation, in partnership with India’s Ministry of Health and Family Welfare (MoHFW) and various State Health Missions, have launched a groundbreaking initiative ‘Energy for Health’. The programme recognises climate adaptation and mitigation at the centre to all efforts to upgrade the public health facilities across the world. The first-of-a-kind initiative will bring solar energy solutions with efficient medical and electrical equipment to 25,000 healthcare facilities in 12 states by 2026. Across the 12 states under this programme, there is a diversity in terms of topography, socio-economic vulnerabilities, disease burden and climate.
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The Ministry of Ayush and Department of Ex-servicemen Welfare, Ministry of Defence have signed Memorandum of Understanding to integrate Ayurveda in Ex-servicemen Contributory Health Scheme (ECHS) Polyclinics as an OPD service for a five years period. These will be established at 10 polyclinics based at Ambala, Mysore, Ranchi, Nagpur, Bhopal, Bhubaneshwar, Chennai, Meerut, Danapur, and Alleppey (Alappuzha). Ayurveda centres are already in place in 37 cantonment hospitals, 12 military hospitals of Armed Forces Medical College (AFMC) and Ayurveda OPD in AH R&R, AF Hospital Hindan and five ECHS polyclinics. The MoU was signed on behalf of the Ministry of Ayush by Dr Manoj Nesari, Adviser (Ayurveda), Ministry of Ayush and by Maj. Gen. N R Indurkar, MD, Ex-servicemen Contributory Health Scheme in the presence of Pramod Kumar Pathak, Special Secretary, Ministry of Ayush, Brig. Jitendra Singh, ECHS, Col AC Nishil, Director (Medical) and other officials of Ayush Ministry. 12 POLICY AND REGULATORY NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com The Indian Council of Medical Research (ICMR) has released “Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare, 2023” to ensure ethical conduct and address emerging ethical challenges in the field of AI in biomedical research and healthcare. These guidelines are also meant to provide a framework for ethical decisionmaking in medical AI during the development, deployment, and adoption of AI-based solutions. The guidelines are intended for all stakeholders involved in research on AI in biomedical research & healthcare, including creators, developers, researchers, clinicians, ethics committees, institutions, sponsors, & funding organisations. The guidelines include sections on ethical principles, guiding principles for stakeholders, an ethics review process, governance of AI use, & informed consent. ICMR releases ethical guidelines for application of AI in biomedical research and healthcare Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh has announced integrated strategy to achieve ‘TB Mukt Bharat’ and said that the Department of Biotechnology (DBT) is going to play an important part in this integrated holistic healthcare approach against elimination of Tuberculosis (TB), in keeping with Prime Minister Narendra Modi’s commitment of ‘TB Mukt Bharat’ by 2025. The Minister declared commencement of the pilot phase of Indian Tuberculosis Genomic Surveillance Consortium (InTGS) with successful completion of whole genome sequencing (WGS) of 182 strains of Mycobacterium tuberculosis (Mtb) isolated from TB patients and development of a novel blood bag technology at DBT-InStem, Bengaluru. Presentations on new initiatives on improving TB outcomes – a) AYUSH interventions to improve TB patient quality-of-life (QOL) b) Mapping drug resistance through genomics & artificial intelligence (AI) and novel blood bag technology to enhance quality and shelf life of stored blood, were made while Dr Jitendra Singh was interacting with the press on Bio-Next-Tech Innovations. DBT to play critical role in TB elimination by mapping drug resistance Ministry of Ayush and Ministry of Defence to establish Ayurveda OPD in 10 ECHS Polyclinic
14 FINANCE NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Rohini Nilekani Philanthropies announces Rs 100 Cr grant to NIMHANS, NCBS Rohini Nilekani Philanthropies has announced a grant of Rs 100 crore to the National Institute of Mental Health and Neurosciences (NIMHANS) and the National Centre for Biological Sciences (NCBS), in Bengaluru, to set up the ‘Centre for Brain and Mind’ (CBM). An inaugural programme for the Centre’s launch is being planned in the next few months. The Centre will further cuttingedge research to understand the causes, correlates, and course of five major illnesses - schizophrenia, bipolar disorder, obsessive-compulsive disorder, dementia, and addiction, and explore potential interventions and treatments for them. Under this MoU, Rohini Nilekani Philanthropies, founded by philanthropist Rohini Nilekani, will support the activities of the CBM for five years starting April 2023. Over five years, CBM will simultaneously pursue two tracks - long-term research and building capacity for both research and practice in the mental health field. Since 2016, NIMHANS, along with NCBS and inStem, have been collaborating on a project (then supported by the Department of Biotechnology and Pratiksha Trust), to build a research platform for facilitating discovery of better solutions for mental illness. Dr Moopen’s Family increases 4% stake in Aster DM Healthcare Huwel Lifesciences bags Rs 15 Cr Govt aid to develop room temperature stable PCR reagents Technology Development Board, a statutory body under the Department of Science & Technology, Government of India, has inked an agreement with Telangana-based startup Huwel Lifesciences for validation and commercialisation of Rapid Real time PCR reagents for storage and transport at room temperature. The board has approved a support of Rs 15 crore out of the total project cost of Rs 40 crore. Current RT-PCR reagents need to be transported and stored at sub-zero (-20) temperatures. Owing to the varied climatic and socioeconomic conditions of our country, it is a challenging task for shipping and storage in tier 2 & tier 3 towns. Cost of dry ice shipping and improper storage has been hampering the implementation of RT-PCR testing for disease diagnosis. The kits developed by the startup holds great market potential, as it may open up the large segment of markets in tier 2 and tier 3 towns and reduce shipment costs significantly. The promoters of Aster DM Healthcare have increased their shareholding by 4 per cent from 37.88 to 41.88 per cent, after acquiring an additional stake from one of the large private equity investors at an additional investment of Rs 460 crore. Aster DM Healthcare, with a turnover of Rs 10,253 crore in FY 2021-22, is performing well during this FY in turnover and profits with a stage of growth, due to restructuring of India and Gulf Cooperation Council (GCC) businesses being pursued actively. In India, the company is moving ahead with new projects like 350-bedded Aster Capital Hospital in Thiruvananthapuram, and 200 bedded Aster MIMS Hospital in Kasargod, Kerala, 150-bedded Aster Narayanadri Hospital in Tirupati, Andhra Pradesh, and 100-bedded Aster G Madegowda Hospital in Mandya, Karnataka, among others. It has also rolled out 239 Aster Pharmacies and 177 Aster Labs and patient experience centres already. With 4,095 beds in 15 hospitals in India going up to 4,670 in 18 hospitals next financial year, Aster shall be connecting all the above through the myAster App that is going to be launched this year to give omni channel care to the customers.
Clirnet launches India’s first AI-powered Doctor’s Assistant TR Life Sciences to re-invent healthcare projects in Delhi, Bihar, and North East Molbio Diagnostics, SigTuple to build next-gen AI-enabled portable devices Goa-based Molbio Diagnostics has collaborated with SigTuple, a Bengaluru-based medtech startup in the field of artificial intelligence (AI) for diagnostics, to build next-generation AI-enabled portable devices for many routines but critical diagnostic tests. These devices will enable testing to be performed at the point of care – a doctor’s chamber, a public health centre, or an emergency room of a hospital – without having to send samples to central laboratories. The aim is to reduce turnaround time for testing, reduce errors, and help in early diagnosis and initiation of correct treatment. Molbio and SigTuple are joining hands to collaborate on the development of AI-powered, battery-operated, portable devices for many diagnostic tests in the fields of haematology, biochemistry, electrochemistry and others. The testing process will be extremely simplified and will not require a trained laboratory technician to perform the tests. Accurate, laboratory-quality test results will be available to the patient within a few minutes. The collaboration builds on the strengths of the two organisations to drive cutting-edge technology which can make highquality diagnostics accessible to everyone. BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com STARUPS NEWS 15 Mumbai-based startup Clirnet has announced the launch of AiDA, the Artificial Intelligence (AI) powered Doctor’s Assistant. AiDA is designed to assist doctors and medical practitioners in their daily practice by providing quick, probable, and accurate diagnosis. Built on top of OpenAI platform, AiDA is a state-of-the-art tool that leverages advanced machine learning algorithms and natural language processing techniques to support doctors in making informed decisions, minimising potential of human error, and providing the best possible care to their patients. The benefits will be reaped by doctors across India, including those practicing in the remotest areas. AiDA in its first phase will help doctors with Differential Diagnosis (DDx) based on natural language queries, something the doctor community has sought for long. Excellent results have been obtained from the initial usage tests with doctors panIndia. DDx will assist the doctor to make an informed diagnosis by suggesting a list of medical conditions (with associated probabilities) that share the same symptoms. Requiring minimal tech skills, AiDA will help doctors achieve diagnostic excellence. With proven expertise and experience in transforming the healthcare delivery systems in India and Nepal, New Delhi-based healthcare consultancy startup TR Life Sciences has recently signed five Memorandums of Understanding (MoUs) with health projects in Delhi, Bihar, East and North Eastern part of India to create world-class facilities. The MoUs have been signed for restructuring and re-inventing healthcare projects which includes the expansion of Delhi-based Brahm Shakti Hospital, and the MoU was signed by its Managing Director BR Sharma. Another MoU was signed by Deepak Agarwal, Managing Director, DE Group for developing a chain of diagnostic centres in the Eastern region of India. An MoU was also signed with Asitav Sinha for developing a Medical, Nursing, and Pharmacy college in the North East region of India to transform the existing facilities and expand capacity.
Bengaluru-based startup Quantumzyme has recently been granted a patent for the transaminase enzyme by applying its revolutionary technology QZyme Workbench in India. The patent was granted for creating a green catalyst for one of the world’s most significant chemical reactions, which can be useful for pharmaceutical and agricultural industries. The groundbreaking “QZyme Workbench” technology can handle a wide range of important aspects of protein modeling and engineering, including structural refinement, ligand docking, conformational sampling, estimating substrate binding affinity, modeling catalytic reactions, identifying mutable hotspots, and further hotspot optimisation. In India over 74 million active patients and a big community remains undiagnosed. The introduction of more affordable drugs is expected to increase volumes due to improved accessibility. Sitagliptin (Januvia) had its last days in India in the year 2022 and while Sitagliptin is a newer molecule to the Indian market, the cost of therapy is anticipated to fall from Rs 45 per day charged by Merck to Rs 8-18 per day charged by generic competitors. Quantumzyme has discovered and optimised a new biocatalytic synthetic route for enantiopure chiral amine, a critical intermediate in the synthesis of Sitagliptin. Quantumzyme to develop green catalyst for pharma industry First-of-its-kind AI-based app to detect active TB cases within seconds Boehringer Ingelheim teams up with IIT-K to enhance TB screening process Startup Incubation and Innovation Centre (SIIC), the technology business incubator of the Indian Institute of Technology Kanpur (IIT-K), has signed a Memorandum of Understanding (MoU) with pharmaceutical company Boehringer Ingelheim India. The MoU was signed in the presence of dignitaries from SIIC, IIT-K, and Boehringer Ingelheim India. Prof. Ankush Sharma, Professor-in-charge, Innovation and Incubation, IIT-K, and Prabhat Sinha, Director, Government and Public Affairs, Boehringer Ingelheim India, were the signing authorities for this MoU exchange. The purpose of this collaboration is to extend support to nationally significant innovations developed at SIIC, with a specific emphasis on healthcare solutions that leverage technology to make a positive impact on patients’ lives. India Health Fund (IHF), a Tata Trusts initiative, is collaborating with ACT, a non-profit venture philanthropy platform, to support Hyderabad-based startup Salcit Technologies in piloting Swaasa - an artificial intelligence (AI)-led solution that can revolutionise the detection and early treatment of tuberculosis (TB) in India. IHF and ACT For Health will co-fund the development of Swaasa - an AI platform by Salcit Technologies that record cough sounds from suspected TB patients using a phone’s microphone and analyses them to decode unique cough signatures to detect the possible presence of pulmonary tuberculosis using a proprietary AI algorithm and give a report in just a few seconds. The grant by IHF and ACT For Health will aid Salcit Technologies in the technical validation of the Swaasa’s AI algorithm - the six-monthlong project will include the collection of cough sounds from about 5700 subjects (TB and Non-TB), the technical validation of the platform across six public health centres and the enhancement of the platform to reach an accuracy of 90 per cent for detecting the likely presence of TB. Unlike other cough screening algorithms coming to the market, Swaasa is a multi-focus platform that can be used for screening of various lung ailments including COVID-19, for which it is currently undergoing clinical trials. Swaasa is also registered with Central Drugs Standard Control Organisation (CDSCO), is HIPAA and ISO27001 certified and has two granted patents and three publications backing its technology and use. 16 STARUPS NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com
The University of Oxforddeveloped and Serum Institute of India (SII) manufactured and scaled up R21/Matrix-M malaria vaccine, leveraging Novavax’s adjuvant technology, has been licensed for use in Ghana by the country’s Food and Drugs Authority (FDA). This marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country. The successful registration was notified to SII by the FDA Ghana. SII is the manufacturing and commercialisation license holder for the vaccine. The vaccine has been approved for use in children aged 5 to 36 months, the age group at highest risk of death from malaria. It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria. The R21/Matrix-M vaccine has demonstrated high levels of efficacy and safety in Phase II trials, including amongst children who received a booster dose of R21/Matrix-M at one year following a primary threedose regime. According to Adar Poonawalla, CEO, Serum Institute of India the licensure of the R21/ Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. Serum Institute of India receives FDA clearance for its malaria vaccine in Ghana Global pharma major Lupin has announced the launch of its new state-of-the-art Regional Reference Laboratory in Bengaluru, Karnataka, as part of the expansion of its diagnostics network. The new laboratory marks a significant step forward in Lupin Diagnostics’ mission to provide accessible and affordable diagnostics and preventive healthcare services across India. The Regional Reference Laboratory complements the company’s existing network of 25 laboratories and 410+ collection centres across India. The new laboratory in Bengaluru is equipped with cutting-edge technologies and staffed by highly qualified clinical experts, enabling Lupin Diagnostics to deliver high-quality and reliable diagnostic services to patients and consumers across Bengaluru and neighboring cities. In addition to routine and specialised tests, the laboratory offers a comprehensive range of diagnostics services, including molecular diagnostics, cytogenetics, flow cytometry, cytology, microbiology, serology, haematology, histopathology, immunology, routine biochemistry, among others. Lupin Diagnostics unveils regional reference lab in Bengaluru Fujifilm India has launched an upgraded version of CAD EYE, an empowering tool based on Artificial Intelligence (AI) technology which assists gastroenterologists in early detection and characterisation of abnormal growth in gastrointestinal (GI) tract. The product was launched at a national event “GI Update 2023” at Mysuru, Karnataka. Fujifilm has introduced this technology for the first time outside Japan. This is the second chapter to the already existing AI diagnostic technology available for detection in colon. The newly launched AI technology will work on three different visualisation modes: White light, LCI (Linked Colour Imaging) and BLI (Blue Light Imaging). LCI mode is a combination of light settings which can visually enhance any abnormal lesion and inflammation. BLI mode magnifies the detected growth for better pattern analysis of cells. This technology is designed to solve two major screening problems- Lesion oversight (The lesions are in the view but cannot be detected) and Blind spots (Missing lesions when not in observation range). Fujifilm India launches new CAD EYE tool to detect abnormal growth in GI tract BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COMPANY NEWS 17
Coya to use Dr. Reddy’s Abatacept to develop COYA 302 Penumbra picks SMT as distributor for thrombectomy technologies in India India Medtronic, a wholly owned subsidiary of Irelandheadquartered Medtronic plc, has announced a partnership with Mumbai-based startup Qure.ai to integrate artificial intelligence (AI) for advanced stroke management in India. The partnership combines Medtronic’s leadership in neurosciences with Qure’s AI enabled innovations. The collaboration aims to provide AI solutions to comprehensive stroke centres as well as primary stroke centres and establish a hub-andspoke network which is connected via technology. This network will aid in faster identification, decision making and triaging of stroke patients, thus potentially facilitating better patient outcomes. Qure’s comprehensive set of solutions, qER and the Qure app, are specifically designed to assist clinicians in streamlining the stroke care pathway for patients. qER provides a speedy reading and interpretation of head CT scans along with other vital parameters. All the information is captured in the Qure app which is a platform for communication and brings together multidisciplinary teams from different hospitals. The turnaround time of reading and diagnosing head CT appears to have reduced from ~65 mins to~2 mins using qER as per public records. Medtronic to deploy Qure.ai innovations for advanced stroke management Mumbai-based Sahajanand Medical Technologies (SMT) has been selected as the exclusive distributor of US-based Penumbra’s peripheral and coronary vascular thrombectomy technologies in select domestic geographies in India. Under the terms of the agreement, SMT will bring healthcare providers Penumbra’s latest Indigo System portfolio, including CAT RX, which recently received India CDSCO (Central Drug Standard Control Organisation) approval, and Lightning technologies, upon regulatory approval, to address conditions such as coronary thrombosis, venous thrombosis, arterial thrombosis and pulmonary embolism. Penumbra’s Indigo System portfolio is designed for single session blood clot removal in peripheral arterial and venous systems, including the treatment of pulmonary embolism, and now with Lightning Aspiration Tubing, is the first and only computer-aided mechanical aspiration technology that can differentiate between clot and blood, which is designed to minimise blood loss. Additionally, Penumbra’s Indigo System CAT RX is designed for safe and efficient blood clot removal from the coronary and peripheral vasculature. US-based Coya Therapeutics, Inc. has announced a worldwide agreement with Hyderabad-based Dr. Reddy’s Laboratories. Under this agreement, Coya will in-license the proposed Abatacept biosimilar of Dr. Reddy’s for the development of Coya’s combination product for neurodegenerative diseases, COYA 302. It is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways, for the treatment of neurodegenerative conditions. COYA 302 comprises two components – COYA 301 and CTLA4-Ig. Coya will develop COYA 301. Under the terms of the agreement, Coya has been granted an exclusive, royaltybearing license to Dr. Reddy’s proposed biosimilar Abatacept for the development and commercialisation of Coya 302 for the treatment of certain neurological diseases for sale in multiple territories including North and South America, the EU, United Kingdom, and Japan. As consideration for the license, Coya will pay a one-time non-refundable upfront fee to Dr. Reddy’s. In addition, Coya will owe tiered payments to Dr. Reddy’s based upon Coya’s achievement of certain developmental milestones. 18 COMPANY NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com
Yale University and WHO to scale up behavioural sciences for better health initiative WHO lays focus on improving access to novel COVID-19 treatments The World Health Organisation (WHO) together with Unitaid and with the support of Medicines Law & Policy, have published a briefing document to support country access to affordable COVID-19 treatments. This briefing document is a factual explanation of some of the legal instruments that WHO Member States can use to promote public health and access to COVID 19 therapeutics in the framework of their multilateral trade obligations and rights, and according to their national legislation and level of development. It is intended to support countries dealing with challenges at the intersection of public health and intellectual property, to increase access to novel COVID-19 therapeutics and to facilitate alternative and more affordable sourcing of such treatments, where possible. WHO certifies Azerbaijan and Tajikistan as malaria-free The World Health Organisation (WHO) has certified Azerbaijan and Tajikistan for achieving elimination of malaria in their territories. The certification follows a sustained, century-long effort to stamp out the disease by the two countries. Certification of malaria elimination is the official recognition by WHO of a country’s malaria-free status. The certification is granted when a country has shown – with rigorous, credible evidence – that the chain of indigenous malaria transmission by Anopheles mosquitoes has been interrupted nationwide for at least the past three consecutive years. A country must also demonstrate the capacity to prevent the re-establishment of transmission. Azerbaijan detected its last case of locally transmitted Plasmodium vivax (P.vivax) malaria in 2012 and Tajikistan in 2014. With this announcement, a total of 41 countries and 1 territory have been certified as malaria-free by WHO, including 21 countries in the European Region. BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com WHO NEWS 19 The Yale Research Initiative on Innovation and Scale (Y-RISE) and the World Health Organisation’s (WHO) Behavioural Insights Unit (BI-Unit) have signed a Memorandum of Understanding (MoU) agreeing to work together over the next two years to contribute to the shared goals of promoting and enabling systematic use of the behavioural and social sciences in public health, designing, and scaling up evidence-based behavioural interventions. Behavioural insights can help improve understanding on how and why people behave in ways that affect their health, and help design policies and services that address behavioural factors for improved physical and mental well-being. WHO and Y-RISE will work together to respond to requests for technical support for the planning and design stage of pilot behavioural interventions as well as requests for examining complexities of scaling up behavioural interventions. They will also give strategic advice in the area of application of behavioural sciences to public health and capacity building.
The World Bank Board has approved a EUR92.30 million ($100 million equivalent) Health Sectors Programmatic Development Policy Loan for Bosnia and Herzegovina (BiH). The programme will provide budget support to underpin policy efforts by BiH authorities to improve the financial sustainability of the healthcare systems and quality of health services its citizens receive. This programme aims to improve the financial sustainability of health institutions, by helping clear arrears in the health sector and introduce measures that would prevent the generation of new arrears. It also aims to introduce incentives for improved service delivery and stronger primary healthcare, as well as reforms to improve environmental management and strengthen tobacco control. The design of this programme was informed and supported by a complementary World Bank programme, the Health Systems Improvement Project, and technical assistance, including a functional review of the sector’s performance and ongoing activities to strengthen the transparency and accountability of health systems in BiH. The World Bank portfolio of active projects in BiH comprises 12 operations totaling around $720 million. World Bank provides $100 M to improve healthcare systems in Bosnia & Herzegovina Pilot project to democratise manufacturing and availability of medicines in Sub-Saharan Africa Gavi launches new learning initiative to address final barriers to immunisation equity Gavi, the Vaccine Alliance has launched the Zero-Dose Learning Hub (ZDLH), a new mechanism to improve how data and evidence are leveraged to successfully identify and reach the millions of children who have not yet received a single routine vaccine shot – “zerodose” children – and the missed communities in which they live. The goal of the ZDLH collaboration is to supplement existing and ongoing monitoring efforts by building deeper understanding and sharing learning on the complex array of factors that impact efforts to reach zero-dose children, particularly in lower-income Gavi implementing countries. Funded and coordinated by Gavi, ZDLH is composed of Country Learning Hubs in Bangladesh, Mali, Nigeria and Uganda, as well as a global hub led by JSI Research and Training Institute, Inc. (JSI), with support from the Indian Institute of Health Management Research (IIHMR) and The Geneva Learning Foundation (TGLF). The global hub will provide technical and operational support to countries; and disseminate learning across immunisation stakeholders at the community, national, regional and global levels. 20 WORLD NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com In cooperation with Oak Crest Institute of Science based in California, the H3D Foundation has announced the award of $721,209 in funding from the United States Agency for International Development (USAID) through MATRIX, a USAID project to advance the research and development of innovative HIV prevention products for women. The awarded Integrated Special Project (ISP) will support a pilot project aimed at evaluating an innovative continuous flow technology for cost-effective manufacturing of active pharmaceutical ingredients (APIs) in South Africa. MATRIX initiated the ISP programme to support projects that will add value to and strengthen the capacity of research and development to be conducted in the Global South. The pilot project consists of technology transfer and capacity building, facilitated by Oak Crest, to University of Cape Town (UCT) scientists who will deploy a Synthetron system at UCT for the rapid and efficient synthesis of antiretroviral agents used to prevent and treat HIV.
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com WORLD NEWS 21 Therapy for rare bone disorder shows promise in US-based clinical trial Africa CDC launches pathogen genomics and bioinformatics fellowship programme The Africa Centres for Disease Control and Prevention (CDC), a public health agency of the African Union has launched the Africa PGI – Pathogen Genomics and Bioinformatics Fellowship Programme, a continental workforce development programme targeting public health laboratories in the African Union Member States to improve the use of pathogen genomic data for outbreak detection and disease surveillance. Building on existing efforts and to further expand genomics capacity beyond COVID-19, the Africa CDC in partnership with the African Society for Laboratory Medicine (ASLM), and regional centers of excellence has developed and launched the Africa PGI Pathogen Genomics & Bioinformatics Fellowship Programme. The Africa PGI – Pathogen Genomics and Bioinformatics Fellowship Programme has 3 tracks; a wet-lab track (Next-Generation Sequencing of pathogens), a dry-lab track (Public health bioinformatics data analytics, interpretation, and reporting), and a track on genomic epidemiology to be included at a later stage. Major boost to progress in tuberculosis testing as diagnostics partners come together Foundation for Innovative New Diagnostics (FIND) and partners have announced a set of agreements between FIND, Johns Hopkins University, University of California San Francisco (UCSF), Rutgers University and Heidelberg University Hospital that bring together the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB), DriveDx4TB (a Unitaid-funded project led by FIND), Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) and Rapid Research in Diagnostics Development for TB Network (R2D2) projects to form the largestever coordinated effort to accelerate tuberculosis (TB) diagnostic development. A Joint Steering Committee with representatives from each project has been established, to coordinate technology scouting activities, and refer products with potential to the appropriate project, depending on their needs and development stage. A clinical trial at the National Institutes of Health (NIH), in the US, found that a medication, denosumab, significantly reduced abnormal bone turnover in adults with fibrous dysplasia, a rare disease marked by weak and misshapen bones. Bone turnover, a process in which old bone is continuously replaced with new bone, is unusually accelerated in fibrous dysplasia and contributes to bone abnormalities. The study of eight participants was carried out by researchers from the National Institute of Dental and Craniofacial Research (NIDCR) and the NIH Clinical Center. The results showed that denosumab may improve patients’ quality of life by enabling healthy bone formation. Fibrous dysplasia stems from gene mutations that cause scar-like (fibrous) tissue to replace healthy bone starting in early childhood. These fibrous lesions, which are marked by accelerated bone turnover, weaken bones, leading to bone deformities, fractures, physical disabilities, and pain. In some cases, the lesions can press up against organs and nerves, impairing functions like vision and breathing. Denosumab is a medication licensed by the US Food and Drug Administration to treat bone problems from osteoporosis and cancer.
22 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Areport by India Brand Equity Foundation (IBEF) stated that India’s domestic pharmaceutical market was estimated at $42 billion in 2021, which is likely to reach $ 65 billion by 2024 and may further expand to reach nearly $120-130 billion by 2030. The country’s vast pool of scientific talent, strong system of higher education, low operating costs, conducive regulatory environment and supportive government policies have made it an attractive destination for drug development, clinical trials, and commercial manufacturing. A growing population, significant R&D investments, a modernised manufacturing base and the prevalence of chronic diseases have fuelled the growth of the pharma sector. And the backbone of the success can be largely attributed to robust R&D measures in recent years. Post COVID-19, pharma players have increased their R&D investment. Several pharmaceutical companies have already established R&D centres in India, which serve as innovation hubs. Pfizer’s R&D centre in Chennai focuses on drug discovery and development, while Novartis’ Hyderabad centre is also working on developing novel drugs, with plans to invest $100 million in the centre. Meanwhile, Merck has announced the inauguration of its healthcare R&D Excellence Centre in Bengaluru, which shall utilise innovations to improve healthcare solutions. On the other hand, Bayer’s Data Science and Analytics Centre in Hyderabad contributes to the global R&D for pharmaceutical drug development to launch new innovative therapies to address the unmet healthcare needs of patients. To encourage the pharma industry, the Government of India launched the Product Linked Incentive (PLI) scheme for pharmaceuticals in 2021 with a financial outlay of Rs 15,000 crore over a period of six years. In the recent budget, the government allocated Rs 3,201 crore ($419.2 million) for research. It may be noted that four pharma companies have received the first tranche of incentives of up to Rs 165.74 crore under the PLI scheme of the Department of Pharmaceuticals. The firms include Dr. Reddy’s Laboratories, Biocon, Strides Pharma Science and Premier Medical Corporation. The scheme was floated to boost indigenous production of active pharmaceutical ingredients which are the key raw materials in manufacturing drugs. To add to this the Union Budget 2023 saw Finance Minister Nirmala Sitharaman announcing a programme to promote research and innovation in the pharmaceutical sector to be taken up through Centres of Excellence (CoE). “Establishment facilities in select Indian Council of Medical Research (ICMR) labs will be made available for research by public and private medical college faculty, private sector research teams to encourage collaborative research and innovation”, Sitharaman said, urging the industry to invest in R&D in priority areas. Could 7.5% R&D Spends Make India PHARMA INNOVATION HUB?
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COVER 23 Company Location Total sales revenue (In Rs Cr) Percentage of revenue spent on R&D Amount of R&D spend in 2021-2022 (In Rs Cr) Venus Remedies Panchkula, Haryana 575.18 3.53 20.31 Indoco Remedies Mumbai 1503 4.97 74.64 Sun Pharmaceutical Industries Mumbai 38426.4 5.8 2219 Ajanta Pharma Mumbai 3341 6 216.53 Alembic Pharma Vadodara 5306 17 869.82 Aurobindo Pharma Hyderabad 23456 6.7 1600 Torrent Pharmaceuticals Ahmedabad 8508 6 516 Alkem Laboratories Mumbai 10634 5.3 567 Lupin Mumbai 16192 8.7 1402 Dr. Reddy’s Laboratories Hyderabad 21439 8.2 1748 Cipla Mumbai 21763 5.16 1122 Glenmark Mumbai 12340.9 10.4 1278 Panacea Biotec New Delhi 235.5 5.27 12.4 Strides Pharma Science Bengaluru 3094 3.14 97 Biocon Bengaluru 8396 8.45 710.5 TOTAL 175209.98 12453.2 Total R&D expenditure of Top 15 pharma companies for 2021-22 Sharing his views on the pharma innovations in the country, Sujay Shetty, Global Health Industries Advisory Leader, Partner, PwC India says, “The key driver to move up the value chain will be building a strong, innovation-based pipeline with potential breakthroughs in next-generation products (nongenerics). India has opportunities in complex generics, speciality pharma, biosimilars and novel biological drugs, vaccines and preventives and other areas of unmet needs. There is also a huge potential to establish the country as the global innovation hub of the future. Innovation in both products and processes has the potential to be India’s big-ticket to development.” Talking about pharma R&D, Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI) opines, “Over the past few years, India has emerged as an attractive destination for pharma companies’ investments in innovation. Despite a few challenges, pharma companies are investing heavily in R&D activities in India, with a focus on drug discovery and development. The country’s strengths in drug discovery and development, along with favourable government policies, and a large pool of skilled professionals, are bound to make India a global leader in pharmaceutical innovation in the coming years.” India is the powerhouse of generic pharmaceuticals and its achievements are lauded globally. Companies need to think much more deeply about investing in R&D to develop new molecules, biosimilars and high-end medical devices to become the global pharma innovation hub. The cost of doing R&D in India is one-fifth the cost compared to developed nations, which is a big advantage. Along with scientific talent, a large patient pool which has not been exposed to modern medicines and patent protection makes India favourable for R&D. Though many companies have undertaken R&D measures, a lot more needs to be done to climb the innovation curve. In FY 2021-22, the average R&D spend by pharma companies was 7.5 per cent of the total revenues, where in Alembic Pharma, Lupin, Dr. Reddy’s Laboratories and Glenmark invested more in R&D. Let’s take a look at the R&D investment details of the top 15 pharma companies namely Biocon, Venus Remedies, Indoco, Sun Pharmaceutical Industries, Ajanta Pharma, Alembic Pharma, Aurobindo Pharma, Torrent Pharma, Alkem Laboratories, Lupin, Dr. Reddy’s Laboratories, Panacea Biotec, Strides Pharma Science, Cipla and Glenmark during FY 21-22. The cumulative R&D expenditure of these 15 companies was Rs 12,453.2 crore for the year 2021-22. Sanjiv Das [email protected]
24 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Venus Remedies Haryana-based Venus Remedies Limited (VRL) spent Rs 20.31 crore on R&D and invested 3.53 per cent of its total sales of Rs 575.18 crore on R&D. Each year, an approximate budget of Rs 2-3 crore is allocated for the procurement of R&D equipment. VRL acquires various pharmaceutical laboratory testing equipment such as HPLC’s, kidney chip systems, UV spectrophotometers, incubators, biosafety cabinets, bio analysers, hematology analysers, particle counters, LC-MS, among others. Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies is a fully equipped interdisciplinary drug discovery and development centre located in Baddi, Himachal Pradesh. Dedicated to maintaining the effectiveness of existing antibiotics, the company is working on toxicity reduction by developing innovative Renal Guard technology. This initiative aims to minimise the side effects of nephrotoxic antibiotic compounds, such as polymyxin B (VRP-034), colistin (VRP-044) and amikacin (VRP-035). Key highlights: ● 100+ new registrations in FY 22 ● 300+dossiers filed in 60+ countries ● 760+ global market authorisations ● The company installed the kidney-in-achip model that promises to radically change the methodology for screening drug toxicity ● Launched R3SET dealing with pain management ● VRP-034 is in the clinical study phase, VRP-035 & VRP-044 are in the pre-clinical development phase ● The WHO’s Antibacterial Pipeline Review 2022 featured 10 preclinical candidates from India, with five of them being developed by VMRC. ‘‘The Venus Remedies R&D portfolio demonstrates a progressive approach to drug development, featuring 15 patented products brought to market, with several others in the pipeline. As a pioneer in R&D-driven pharmaceuticals from India, we place particular emphasis on addressing antimicrobial resistance and have created a range of patented superbug-fighting solutions, including Elores. Our comprehensive approach includes advanced drug delivery systems, targeted drug deliveries and molecular biology research.’’ - Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre Torrent Pharmaceuticals In FY 2021-22, Ahmedabad-based Torrent Pharmaceuticals, posted total revenues of Rs 8508 crore and the R&D expenditure was registered at Rs 516 crore i.e 6 per cent of the revenue. The company has a state-of-the-art R&D Centre at Bhat near Ahmedabad which is spread out over 125,000 sq metres with a built-up area of 41,000 sq metres and around 999 are employed at the R&D centre. The company is currently developing several in-house New Chemical Entities (NCE) in the areas of metabolic, cardiovascular, gastrointestinal, and dermatological disorders. The company has cumulatively filed 827 patent applications for NCEs from these and earlier projects in all major markets of which, 504 patents have been granted/accepted so far. The most advanced discovery programme of the company is a metabolic modulator NCE, “Omzotirome”, for the treatment of diabetes. Key highlights: ● 13 patents filed ● 120+ projects under development ● 5 ANDA filed in FY 2021-22 ● Launched the once a week Nasal Spray of Methylcobalamine for the management of vitamin B12 deficiency ● Unveiled new products to mitigate the risk of COVID-19 with the introduction of Molnupiravir and Baricitinib in the Indian market ‘‘Torrent Pharma’s emphasis on efficient and effective R&D has accelerated the expansion of its product portfolio. Product development efforts are focused on meeting unmet market needs across therapeutic categories, utilising the available market opportunities to propel the development of novel products and formulations. The extensive portfolio of BGx and Gx exemplifies the organisation’s exceptional research capabilities and operational excellence.’’ - Sudhir Mehta, Chairman, Torrent Pharmaceuticals
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COVER 25 Mumbai-based Indoco Remedies has been consistently spending up to 5 per cent of its sales on R&D. The total revenue for FY 2021-22 was Rs 1503 crore. Recurring R&D expenses to net sales are 4.97 per cent at Rs 74.64 crore for FY 2021-22, as compared to 4.9 per cent at Rs 59.7 crore in the previous year. This includes R&D employee costs of Rs 30.26 crore and other R&D expenses at Rs 44.38 crore. The R&D equipment has a shelf life of 10 years. Indoco’s R&D Centre located at Rabale, Navi Mumbai has a team of 400+ employees. Regulatory submissions are done in highly regulated as well semi-regulated countries like the US, Europe, Canada, Australia, South Africa, New Zealand and WHO-Geneva. Indoco has secured ANDA Approval for Lacosamide Tablets on the Day of patent expiry enabling a day-one launch in the US market. Key highlights: ● Filed around 113 Process Patents, 41 for Finished Dosage Forms and 72 for APIs. ● 12 new launches in the US and Canada. ● 69 marketing authorisations ● Expedited Approval by US FDA for Acetylcysteine Injection for Covid Care ● Filed MUPS (multi-unit particulate system) based solid product, a generic equivalent of the antihypertensive product having huge potential. ● Complex generic ophthalmic suspension developed and subjected for Bio Equivalence waiver through in vitro comparison and received approval from US FDA (developed for a US Generic Customer), with no queries received for the data submitted. ● 3 patents were granted by the Indian Patent Office. ● 3 of filed patents were awarded as the Best Patents by IDMA ● Received best Composition Patent Awards in 2021-22 for 4 Indian formulation Patents and 1 International Patent ● A total of 5 ANDAs in the US have been approved and 8 Marketing Authorisations have been granted in the EU and UK. ‘‘Research and development at Indoco is an expression of our commitment to excellence through innovation. Indoco’s R&D function has evolved as the business has expanded and has developed expertise in process research and custom synthesis, impurities synthesis as a turnkey project, extractable and leachable identification/isolation and analysis, development of complex generics, first-to-file complex injectables and ophthalmic suspensions, especially nanoemulsions and suspensions. We are constantly evolving and innovating ourselves to develop products and processes that will help us stay ahead of industry trends by identifying and addressing quality issues early on, thus leading to better products and services for customers.’’ - Aditi Kare Panandikar, Managing Director, Indoco Remedies Indoco Remedies Glenmark Pharmaceuticals I n FY 2021-22, Mumbai-based Glenmark Pharmaceuticals’ total R&D expenditure for the year stood at Rs 1,278 crore, which comprises 10.4 per cent of total revenue from operations that stood at Rs 12340.9 crore. The company has four R&D centres in Sinnar, Mahape, Taloja and Lausanne. The company employs around 1400 personnel at its R&D centres. During FY 22, it invested Rs 662.7 crore in Ichnos, its integrated biotechnology company to develop novel treatment solutions for existing and emerging disease challenges. Key highlights: ● Submitted a total of 19 ANDA applications to the U.S. FDA, while 12–15 ANDA applications are expected to be submitted in FY 23 ● In Jan 2022, Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray, received FDA approval in the US “As Glenmark continues to grow from a generics company to an integrated, researchled global pharmaceutical company, we embed innovation and R&D at the heart of what we do to develop breakthrough therapies for patients. With more than four decades of strong innovation and R&D, we leverage purposeful business practices to deliver value generated outcomes for all our stakeholders.’’ - Glenn Saldanha, Chairman and MD, Glenmark Pharmaceuticals
26 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Sun Pharmaceutical Industries T he R&D spend for Mumbai-based Sun Pharma was at Rs 2219.4 crore in FY 2021- 22 which is 5.8 per cent of sales in FY 21- 22. The total revenue was registered at Rs 38426.4 crore. The R&D team comprises over 2,700 people. The company invests up to 7-8 per cent of its global revenues into R&D every year. Key highlights: ● Launched 77 new products in the domestic market ● Developed and filed ~200 formulation dossiers globally ● Ilumya (Tildrakizumab) was undergoing Phase 3 clinical trials for psoriatic arthritis indication ● Launched two speciality products – Ilumya and Cequa – in Canada ● Sun Pharma’s partner, China Medical System Holdings (CMS), received regulatory approval for Ilumetri (tildrakizumab) in Hong Kong ● Ilumetri (tildrakizumab) was commercialised ‘‘Our R&D investments were approximately Rs 2200 crore, at 5.8 per cent of overall sales. During the year, we filed approximately 200 formulation dossiers globally. We continued our R&D efforts to develop differentiated generics and innovative speciality products. Some of the clinical trials for our speciality products got delayed during FY22 due to the pandemic but are expected to gradually normalise in FY23. We have multiple R&D centres and a strong R&D team which enables the development of new products for various markets globally. We remain disciplined in identifying future R&D projects for the US generics market and the focus is on developing complex products. Investments for developing the long-term speciality pipeline are expected to continue and R&D investments are expected to increase as clinical trials for speciality products gain traction.’’ - Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries Ajanta Pharma During FY 2022, total R&D expenses of the Mumbai-based Ajanta Pharma, were Rs 216.53 crore which is 6.89 per cent of total turnover. The company has incurred Rs 12.19 crore as capital expenditure and Rs 204.34 crore ( Rs 139 crore - FY 2021) as recurring expenditure on R&D (standalone basis) for the FY2022. The company has developed and launched robust and cost-effective formulations for curing hypertension, BP, diabetes, heart ailments, post-operative inflammation. The company plans to file 10 to 12 ANDAs in FY 2023. The R&D facility is spread across 100,000 square feet and has 800+ scientists. Based in Romania in February 2022. ● Entered into an exclusive patent licensing agreement with H Lundbeck A/S to market and distribute its version of Vortioxetine in India under the brand name, VORTIDIF ● Launched a novel formulation in cough management – Chericof 12 in India ● Received Emergency Use Authorisation (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of MSD and Ridgeback’s molnupiravir under the brand name Molxvir in India. ● The Speciality R&D pipeline has 4 molecules undergoing clinical trials viz. Ilumya, SCD-044, MM-II, GL0034 ● For FY 22, 42 formulations were developed and filed from its R&D locations for the Indian and regulated markets and 153 dossiers were submitted for filing in various emerging markets. ● Filed 100+ drug master files across various markets during the year in Mumbai, the facility has a range of state-ofthe-art equipment for formulation development, working on different dosage forms such as tablets, capsules, powders, oral liquid, topical creams/ointments/lotions, sterile eye drops/ suspension, nasal sprays, dry powder inhalers, and injectable. The research centre primarily focuses on development of new formulations with an objective to introduce 1st to market products providing convenience and better patient compliance. It has been taking continuous initiatives towards technology absorption, adaptation and innovation at its R&D Centre, encompassing latest technological developments in the field of research. It has an equally well-equipped Active
‘‘Our long history in the pharma industry has its roots in our R&D strength. The nine R&D centres that we run today are supported by a pool of world-class talent and highly trained regulatory and intellectual property teams. We are building a diversified portfolio of finished dosage forms in orals, liquids, topicals, biosimilars, nasal, and parenteral products targeted at the global markets, and in FY22 our primary R&D focus was complex parenteral products. Our long-term goal envisions a shift to a higher mix of branded products within the categories where we have a dominant presence. An array of distinctive brands will enable us to make our own space and to shift from the crowded generics market, with better command over profitability and user segments. Our new product development capability along with our manufacturing flexibility and very large geographic presence would act as force multipliers.’’ - K Nithyananda Reddy, Vice Chairman and MD, Aurobindo Pharma BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COVER 27 ‘‘Revenue from operations grew by 16 per cent to Rs 3,341 crore displaying robust performance. Our EBITDA margin normalised to 28 per cent in FY 2022, as marketing and R&D activities returned to normalcy post COVID-19 disruptions.’’ - Yogesh M Agrawal, Managing Director, Ajanta Pharma Aurobindo Pharma I n FY22, Hyderabad-based Aurobindo Pharma spent Rs 1600 crore in R&D, i.e 6.7 per cent of the total revenue. The total revenue is Rs 23456 crore. Out of the total R&D expenditure, 20 per cent of R&D spending went towards advancing the biosimilars pipeline. The company’s R&D team of over 1500+ scientists working in nine research facilities spread across the globe (five in India and four in the US). The focus on building its capabilities have been instrumental in supporting its filings for Drug Master Files (DMFs), Abbreviated New Drug Applications (ANDAs), and formulation dossiers promptly. It is one of the more frequent DMF and ANDA filers in the USA. During FY 2022, the company built a specialised characterisation centre with state-of-the-art equipment especially for peptides and complex generic products at its Hyderabad research centre. The centre is established to meet the characterisation requirements following FDA guidelines for peptide drug products and is equipped to fulfil end-to-end characterisation requirements of peptides, proteins and complex molecules. Key highlights ● 22 products were launched in FY 2022 ● 36+ billion diverse dosage forms manufactured in FY22 ● 19 ANDA Filings approved in FY22 ● The company has filed for 44 APIs, of which 17 are US DMFs, 9 in Canada, and the others in Europe ● Successfully filed 60 ANDAs for the US market, which includes FTFs and complex generic products ● Filed 56 ANDAs in the US and received approvals for 25 products, including tentative approvals for 5 ANDAs ● 24 dossiers have been filed in the EU and approvals received for 16 products ● 23 dossiers have been filed in emerging markets and approvals received for nine products ● Filed two oncology biosimilars with the European Medicines Agency during FY22 and are having 3 more biosimilars in Phase 3 clinical trials Pharmaceutical Ingredient (API) lab to synthesize thigh value APIs for some of its key products. Many of the formulations developed at the R&D lab are first of its kind and now hold leading positions in its sub-therapeutic segments across different geographies. It has its facilities located at Dahej in Gujarat, Guwahati in Assam, Paithan, Chitegaon and Chikalthana, Waluj in Aurangabad, Pithampur in Madhya Pradesh. Key highlights: ● Launched 16 new products in FY 2022, including 4 first-to-market products in the country. ● First generic company to obtain WHO Pre-Qualification for difficult antimalarial product ARteMetheR + LUMefAntRIne tabs
28 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Dr. Reddy’s Laboratories Hyderabad-based Dr. Reddy’s Laboratories in FY 2021-22 spent Rs 1748 crore or 8.2 per cent of revenue, versus 8.7 per cent in FY2021 on R&D. The R&D spend in FY2022 increased by 6 per cent over the previous year due to an increase in the development activities relating to our biosimilars and drug discovery businesses. Total revenue grew by 13 per cent to Rs 21439 crore in FY2022. Growth was primarily aided by increase in volume and new product launches across our businesses including sale of COVID-19 products. During the year 2020-21 and 2021-22, the total investment in R&D and capital expenditure were to the tune of Rs 1,310 crore and Rs 1,426 crore, respectively. These include R&D and capex investments in specific technologies to improve the environmental and social impacts of products and processes. Key highlights: ● Launched 20 brands in India, including Sputnik-V (COVID-19 vaccine), 2-deoxyD-glucose (2DG) and Vicra ● As on March 31, 2022, the company had 90 US generic filings pending approval ● Forayed into digital healthcare with the launch of Svaas Wellness ● Completed Phase 1 study of DRL_TC, a proposed biosimilar of tocilizumab ● World Economic Forum recognised Dr Reddy’s Hyderabad factory as part of its Global Lighthouse Network ● Launched in-house palbociclib (PRIMCYV) to widen access to high-quality breast cancer drug ● Launches Difluprednate Ophthalmic Emulsion 0.05 per cent in the US Market ● Launched Lenalidomide Capsules in the US with two of six strengths eligible for first-to-market, 180-day exclusivity ● Entered into a licensing agreement with Slayback Pharma to obtain exclusive rights in the first-to-file ANDA for the private-label version of Lumify in the US. ● Launched of Bortezomib for Injection, 3.5 mg Single-Dose Vial in the US market ● Launched over-the-counter, store-brand equivalent of Allegra-D 24 HR in the US market ● Launches Fesoterodine Fumarate Extended-Release Tablets in the US market ● Launched generic version of Nexavar (sorafenib) Tablets, USP, 200 mg in the U.S. market ● Enters into an exclusive partnership with HK inno.N Corporation to commercialise novel molecule Tegoprazan in India and select emerging markets ● Launches of Posaconazole Delayed-Release Tablets in the US market ● Launches Methylprednisolone Sodium Succinate for Injection, USP in the US market ● With MediCane Health launched medical cannabis products in Germany ‘‘In the near term, we will continue to drive productivity improvement and focus on our core therapeutic areas and big brands. In the medium to long term, our strategy is to build a healthy pipeline of differentiated products in relevant therapies including biosimilars and expand our presence in areas such as nutraceuticals.’’ - K Satish Reddy, Chairman, Dr. Reddy’s Laboratories Alembic Pharma V adodara-based Alembic Pharma incurred Rs 869.82 crore as R&D expenditure against Rs 719.27 in FY 2020-21. The total R&D expenditure as a percentage of total turnover was 17 per cent. The company posted revenue worth Rs 5306 crore in FY 2021-22. The R&D spend in Q3FY23 was Rs 157 crore as compared to Rs 154 crore showing a growth of 2 per cent. The percentage of growth was 10 per cent in Q3FY 2023 as compared to 12 per cent in Q3FY 2022. The company has three R&D centres in Vadodara, Hyderabad and the US. The company has three R&D segments – formulations, API and peptides – that cumulatively employ 1,200+ R&D experts. Key highlights: ● Launched 7 brands worth Rs 50 crore ● Till March 2022, 230 ANDAs filed ● Filed 15 ANDAs for injectable products ● Acquired a 40% stake in Aleor Dermaceuticals held by Orbicular Pharmaceutical Technologies ● In FY 22 launched 13 new products in the US
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COVER 29 ‘‘We believe that our investment in R&D will lead to sustained value creation both in terms of topline growth and improving access and affordability of our medicines to patients around the world. We aim to enrich our portfolio by identifying and developing new and improved products as well as partnering across the value chain to achieve scale and impact.’’ - Vinita Gupta, CEO, Lupin Lupin I n FY 2021-22, the total revenue from operations for Mumbai-based Lupin stood at Rs 16192 crore. The company invested Rs 1402 crore in R&D. In FY 22, the company invested 8.7 per cent of the total turnover in R&D. With R&D centres in seven locations across the globe, employing over 1,400 personnel, Lupin innovates by leveraging advanced technologies, superior competencies and strategic alliances. The stateof-the-art R&D Lupin Research Park (LRP) is located in Pune and functions as the hub of global research activities. The campus houses a generic research unit, encompassing API and finished product research, Novel Drug Discovery and Development (NDDD) unit and from recently, the biosimilar research unit. Lupin’s Inhalation Research Centre in Coral Springs, Florida, is a specialised facility focused on the research and development of inhalation products for the treatment of asthma and COPD as well as other respiratory conditions. Lupin’s Novel Drug Discovery and Development efforts continue to yield new and highly differentiated therapeutics in the areas of oncology, immunology, and metabolic diseases, with two promising agents currently undergoing human clinical trials. Key highlights: ● 61 patents secured ● 19 ANDA filings ● 26 regulatory approvals received ● 1008 active patents ● Lupin had 9 product launches in FY22 with the launch of authorised generic Brovana (arformoterol) ● Forayed into Antiretroviral (ARV) therapy for providing high-quality, affordable generics to emerging countries for the management of HIV infection. ● Received market authorisation and successfully commercialised biosimilar Etanercept (Nepexto) in key EU markets with its marketing partner, Viatris. ● Received approval from US FDA for Tenofovir Alafenamide tablets ● Unveiled Regional Reference Laboratory in Hyderabad, Indore ● Launched Lurasidone Hydrochloride Tablets in the US ● Launched LYFE, the digital therapeutic solution for holistic heart care ● Launched Sacubitril and Valsartan Combination Drug for heart failure ● Launched novel fixed-dose triple drug combination DIFIZMA DPI to Treat Inadequately Controlled Asthma ● Launches authorised generic version of PENNSAID 2% w/w in the US ● Launched Rufinamide Tablets USP in the US ● Signs MoU with Govt of Rajasthan to strengthen healthcare ● Launched Formoterol Fumarate Inhalation Solution in the US ● Luforbec 200/6 (beclometasone 200 mcg / formoterol 6mcg) a certified carbon-neutral inhaler is launched in the UK for the treatment of adult asthma ‘‘At Alembic, we are firmly focussed on making our operations digital. For this, we have drawn the contours of a digital blueprint which will be implemented in a phased manner. We have reworked some bits of our R&D strategy to ensure that every rupee is judiciously invested in the right areas. This will allow us to maximise the bang for every buck. Moreover, with most of our capacity build-up in place, we hope to maximise returns from our investment in the years to come. This liquidity will then be deployed to fuel our strategic initiatives which are aligned to sectoral demands.’’ - Chirayu Amin, Chairman & CEO, Alembic Pharma ● In FY 2022 filed 2023 ANDAs in the US ● Introduced five new products in the domestic market ● Introduced 3 new technologies such as spray drying, hot melt extrusion and wet milling using Dyno-mill were introduced in R&D for making the drug products
30 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Biocon B engaluru-based Biocon in FY 2021-22 registered gross R&D spend of Rs 710.5 crore as against Rs 627 crore in FY21. Biocon’s consolidated revenues grew 14 per cent to Rs 8397 crore for the full year, led by biosimilars & research services revenues increasing 24 per cent & 19 per cent. The net R&D spending in FY22 was Rs 310 crore, representing 9 per cent of revenues. The R&D expenditure in Profit and Loss for FY22 increased by 8 per cent to Rs 595 crore (Rs 553 crore in FY21). Biocon has its R&D sites located in Bengaluru and Chennai. Syngene operates dedicated facilities for three global companies: Amgen, Baxter and Bristol Myers Squibb (BMS) at its Bengaluru campus. These facilities offer science at scale delivered by teams of scientists working exclusively with in-house client R&D teams to design sustainable solutions to the challenges associated with discovering and developing new medicines. Key highlights: ● Received approval from the US FDA for ANDA for Mycophenolic Acid, which is indicated for the prophylaxis of organ rejection in adult patients receiving kidney transplants ● Strengthened US formulations portfolio with the launch of Labetalol Hydrochloride tablets and Esomeprazole Magnesium Delayed-Release capsule ‘‘We continue to make R&D investments to be able to bring more products into the market in both generics & biosimilars, in line with our commitment to making affordable healthcare accessible to all. For 9MFY23, Biocon’s Gross R&D investments increased by Rs 360 crore, or 75 per cent year-on-year, to Rs 839 crore. At 15 per cent of Biocon’s 9M revenues (excluding the Research Services business), the higher level of R&D investments is largely on account of the biosimilars business as several assets are currently in clinical development. Gross R&D expenditure is expected to normalise at ~13 per cent of Biocon’s revenues (ex-Syngene) as we accrue full revenues from Viatris’ biosimilar businesses.’’ - Kiran Mazumdar-Shaw, Executive Chairperson, Biocon ● Launched Posaconazole, an antifungal drug and Dorzolamide, an ophthalmic product ● US FDA approved bGlargine 100U as interchangeable bGlargine in the second half of the year, improved market share of bTrastuzumab in the US and improved performance in other developed and emerging markets. ● Syngene’s dedicated R&D centres witnessed renewal of its strategic collaboration with Amgen ● Plans to establish a vaccine R&D division to support the development of both vaccines and biologics for communicable diseases, providing longterm growth drivers for this business ● Development of synthetic and fermentationbased generic small molecules for anti-infective, oncology, cardio-vascular, nephrology and transplantation segments. ● Formulation development for Abbreviated New Drug Applications (ANDAs). ● Generation of Intellectual Property Development – Process Patents for manufacture of key Generic Small Molecules and Biotherapeutics ● Focus on innovative technologies in API process development. ● Clinical development pertaining to Novel programmes. Cipla R &D has been a major focus area for Mumbai-based Cipla to strengthen its complex portfolio. In FY 2021-22, R&D spending increased by 21 per cent vis-à-vis the previous financial year as clinical trials were initiated for a respiratory asset in FY 2021-22. The total R&D expenditure in FY 2020-21 was Rs 1,122 crore or 5 per cent of overall revenues. In FY 2021-22, the revenue grew by 14 per cent to Rs 21,763 crore (FY 2020-21: Rs 19,160 crore) and the five-year CAGR stood at a healthy 8 per cent. The company has five R&D units and employs more than 1500 in the segment. The company’s five state-of-the-art R&D facilities are located in New York in the US and in Maharashtra and Karnataka. During the year, the company optimised its R&D capabilities by closing one of the R&D facilities, located in Kurkumbh, Maharashtra. As on March 31, 2022, Cipla has 169 approved ANDAs and NDAs, 19 tentatively approved ANDAs; and 69 under-approval ANDAs and NDAs for the US markets. There are plans to enhance its API R&D and manufacturing capacities in therapeutic areas such as respiratory, gastrointestinal and oncology and pursue backward integration for manufacturing KSMs and critical API intermediates to have more control over the supply chain. Key highlights: ● 93 products launched
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com COVER 31 Panacea Biotec T he total R&D expenditure by New Delhibased Panacea Biotec in FY 2021-22 was Rs 12.49 crore which is 5.27 per cent of the net standalone revenues of Rs 235.5 crore. The consolidated revenue from operations increased by 5.83 per cent to Rs 661 crore for fiscal year 2022 from Rs 624 crore for fiscal year 2021, primarily due to increase in revenue from domestic pharma formulations business. The company has state of art R&D Centres at Lalru and New Delhi manned with experienced scientists having deep roots within the academic community in important clusters in India, US, and Germany among other countries, working on several key projects in vaccines and biopharmaceuticals. The company’s Vaccine R&D Centre has an excellent portfolio of innovative paediatric vaccines which protect children against dreadful diseases such as polio, hepatitis, diphtheria, tetanus, pertusis and haemophilus influenza. Further to broaden the existence of Panacea Biotec in the market, it is developing the new generation vaccines like SARS-CoV-2 Vaccine and antibody, Pneumococcal Vaccine, Dengue Tetravalent vaccine, Typhoid Conjugate vaccine and universal flu vaccine. The company has successfully completed the Phase I/II study of its Dengue and Pneumococcal Conjugate vaccine and is currently preparing for Phase III clinical trial related activities. There are around 102 R&D professionals including around 70 scientists engaged in R&D centres, around 971 employees are engaged in production, quality control and quality assurance, around 252 employees are engaged in sales and marketing and logistics and around 897 in other functions. ‘‘In FY 2021-22, our R&D spending increased by 21 per cent visà-vis the previous financial year. We invested 5.16 per cent of the consolidated revenue in strengthening our R&D prowess. The company’s R&D expenditure in various technologies is focussed on improving the environmental and social impacts of our products/processes. We ensure our R&D colleagues are abreast of the regulatory developments through ‘Cipla Regulatory Intelligence Shared Platform’.’’ - Umang Vohra, MD and GCEO, Cipla ● New modules on guidelines for drug-device combinations and regulatory guidelines for Brazil and China were released for the benefit of R&D colleagues ● The company has launched multiple respiratory products in Spain, including Fluticasone MDI, Fluticasone + Salmeterol MDI and Ipratropium MDI, through our recently established frontend presence. ● Received US FDA approval for a generic therapeutic equivalent version of Sunovion Pharmaceuticals’ Brovana ‘‘Panacea Biotech’s R&D efforts have been its greatest strength. The areas of research are New Chemical Entities (NCE), New Biological Entities (NBE), Novel Drug Delivery System (NDDS), Novel peptides, human monoclonal antibodies and Vaccines. Our ambitions are backed by sustained delivery through our distinguished, ultra-modern, state-of-art R&D centres with ~70 scientists and deep roots within the academic community.’’ - Soshil Kumar Jain, Chairman, Panacea Biotec Key highlights: ● Targets to launch of the world’s first fully-liquid wP-IPV based pentavalent vaccine Easyfour-Pol ● Scaling up vaccine sales in the private market in India including through launch of new vaccines. ● Increasing participation in institutional vaccine business with UNICEF, PAHO, etc. ● Expediting development of tetravalent Dengue vaccine DengiAll, Pneumococcal Polysaccharide Conjugate Vaccine NucoVac11 and other vaccines and launch thereof in India and institutional markets. ● Launch of Paclitaxel protein bound particles for injectable suspension, Cyclosporine and other products, which are currently under approval, in the US
32 COVER BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Strides Pharma Science B engaluru-based Strides in FY 2021-22 registered Rs 97 crore as R&D investment. The total revenue was Rs 3094 crore. The company has 274 ANDAs, including 249 approved ANDAs, which provides substantial growth visibility in the near term for the US business and an opportunity to launch new products for the other global markets. With over 200 plus scientists, the R&D team offers solutions across the entire product development value chain. Global Formulation R&D centre at Bangalore drives high value product delivery via latest technology platforms. Strides R&D is imbibed with continuous learning and innovation and is actively engaged in the development of a wide range of dosage forms with special emphasis on novel drug delivery systems for solid orals (modified release tablets and capsules) and soft gelatin capsules for both Regulated and Emerging markets. Key highlights: ● Retained volume market share for key base molecules. ● Relentless focus on supply chain and customer advocacy ● Successful completion of Chestnut Ridge acquisition in the US with ~150 ANDAs in ‘‘We persistently work towards the production of apex quality generic products, branded generics, APIs, & nutraceuticals, which are marketed in India as well as globally.To achieve this commitment, we strongly focus on the enhancement of its R&D capabilities. We are committed to making novel therapies more accessible. In line with this objective, during FY 2021-22, the company entered into an exclusive licence agreement with Johns Hopkins University (JHU) for the development & commercialisation of JHU’s novel target & technology that will help patients with colorectal cancer. We licensed technology from Harvard University’s Office of Technology Development (OTD) to bring novel therapies for the treatment of ischaemic injury and vascular diseases to market. The licence grants the Company commercialisation rights in the US & India.’’ - Sandeep Singh, Managing Director, Alkem Laboratories Alkem Laboratories Mumbai-based Alkem Laboratories invested Rs 567 crore or 5.3 per cent of its revenues in R&D during FY 2021-22 as compared to Rs 532 crore or 6 per cent of its revenues in R&D during FY 2020-21. The total operating revenue has been registered at Rs 10634 crore. The company has its R&D facility in Taloja (Navi Mumbai), Mandva and Ankleshwar (Gujarat), Pune, Indore and the US. The six R&D centres employ more than 500 scientists. Key highlights: ● The company forayed into the respiratory segment through the launch of the pulmocare division, which saw an encouraging response with a higher than the market growth rate ● Filed 14 abbreviated new drug applications (ANDAs) with the US FDA and received 21 approvals (including 3 tentative approvals). ● Launched 18 products in Fy 2021-22 ● Unveils Connect2Clinic, an online platform for participating medical professionals and healthcare staff to connect with their patients ● Enzene, the subsidiary company, received marketing authorisation to commercialise 3 biosimilar products in India, namely Teriparatide, Romiplostim, and Denosumab diversified dosage formats including controlled substances, hormones, nasal sprays to further accelerate portfolio differentiation ● Diversification of product portfolio that now comprises of acute and chronic products ‘‘Other regulated markets or ORM is an important part of our growth strategy, fuelled by our frontend in key markets and IPled B2B partnerships in Europe, Australia, and other parts of the world. In these markets, our R&D investments will fast-track growth opportunities for the Rx and OTC portfolios, as several new products will be launched in FY 2022-23. With 249 approved ANDAs and to launch ~20 products each year and have 100+ commercial products in the US in the medium term. Further, we are focusing on cost improvement programmes (CIPs) through alternative API vendors and manufacturing network optimisation to achieve improved COGS and operating margins.’’ - Arun Kumar, Executive Chairperson and Managing Director, Strides Pharma Science
“Increase in DCT adoption has inevitably brought about regulatory considerations to ensure patient safety and secure data sharing” « Jerome Armellini, Asia Head of Clinical Development & Operations Strategy, R&D Solutions Asia, IQVIA Asia Pacific BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com SPEAKING WITH 33 Streamlining laboratory processes accelerates the development of therapies. Digitalisation is transforming the execution practices of biopharmacology and clinical research. In an age of digital innovation, researchers can simplify clinical trials and research and development by integrating lab data, resources, and processes into unified environments. Adopting Decentralised Clinical Trials (DCT) models can improve research outcomes, productivity, with better compliance. Stakeholders (drug, vaccine, and medical device developers) and CROs must redefine end-to-end approaches to increase efficiency, security, and accessibility of clinical trials. Digitalised clinical trial and R&D practices in pharmacovigilance can address operational constraints and development challenges. In an interaction with BioSpectrum, Jerome Armellini, Asia Head of Clinical Development & Operations Strategy and R&D Solutions (Asia) at IQVIA, Asia Pacific delves deeper into the decentralised drug discovery landscape. Edited excerpts; How do you define the essentials of a decentralised approach in the current drug discovery landscape? It is essential that such an approach is being considered as early as at the study design stage. Indeed, successfully executing DCTs is about more than selecting a technology platform or digital components. Every study will require a different combination of technologies, support services, and training to optimise results. This process is based on a thorough review of the targeted patient population, the trials’ inclusion/exclusion criteria, duration, patient expectations, protocols, endpoints, and other study requirements. Decentralised trials leverage technology, including connected devices, and specialised services to engage participants in the community and facilitate patient centric care through remote pre-screening, tele-visits, at-home treatment and the increasing role of mobile research nurses and staff. While catering to a fast-moving drug discovery landscape, a decentralised approach aims to bring the patient voice to the trial, reduce the burden on sites and patients, and increase trial awareness, diversity inclusion as well as reach to patients living further away from sites by expanding traditional site boundaries to deliver a more personalised trial experience. Finally, to ensure a successful decentralised trial, it is also essential for trial sponsors to address the unique concerns and motivations among different populations and demographics to effectively translate patients’ interest to trial participation, through the help of an end-to-end digital patient journey solution. How well are emerging biotechs and biopharmas leveraging digitalisation? Emerging biotechs and biopharmas (EBPs) have been increasingly leveraging digitalisation throughout the drug discovery process, from drug development strategies to decentralised trials. In designing more efficient and effective clinical trials, EBPs are increasingly using Artificial Intelligence (AI) and Machine Learning (ML) to leverage multi omic data and algorithms that are based on historical clinical trials, real-world data and molecular data, to observe the responses of digital patients and improve trial outcomes. AI/ML can also be used to hone the clinical development plan by tailoring the trial to a specific population as algorithms can predict and gauge the trial’s effectiveness in the subpopulation and proposed indication. Overall, EBPs are leveraging digitalisation to drive innovation and improve patient outcomes, both globally and in APAC. However, the extent of digitalisation varies across regions and countries, depending on factors such as a regulatory environment, infrastructure and many others. In their journey towards digitalisation, EBPs sometimes
34 SPEAKING WITH BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com face challenges such as regulatory limitations and getting the right stakeholder support. However, with the help of an experienced CRO, they can successfully leverage digitisation by ensuring that stakeholders understand the benefits of digital adoption through education, training and support, and monitor regulatory developments closely. How do you describe the development and operational aspect of DCTs in the Japan and Asia Pacific region? The adoption of DCTs has rapidly soared in the last three years due to the rush to conduct clinical trials during and after the pandemic, and the increased competition among biotech companies. Additionally, the highest quarterly utilisation of decentralised methods shown in Q4 2022 suggests that the industry continues to push into new territory with this set of innovations. In Asia Pacific, the increase in DCT adoption has inevitably brought about regulatory considerations to ensure patient safety and secure data sharing between patients and investigators. China has imposed strict data privacy laws for the use of AI/ ML when targeting and engaging patients, such as the Personal Information Protection Law (PIPL) and Personal Data Security Specification (PDSS). EBPs and biotech companies in Asia Pacific need to examine regulations in the areas of data privacy, data residency, and data stewardship before embarking on a digital adoption. Several regulators in Asia Pacific and in the rest of the world, are also developing recommendations for sponsors on DCT deployment (such as, but not limited to, the EMA Recommendation Paper On Decentralised Elements published in December 2022). In Japan, the Pharmaceuticals and Medical Devices Agency is planning to provide DCT guidelines. With this, DCT adoption in Japan will increase. It is therefore helpful to engage a CRO that knows the best practices across different countries and has the global regulatory landscape understanding, operations support and technology to support digital activities of sites, patients, and sponsors, to accelerate digital adoption in the region. What should clinical and biopharma operations consider when adopting DCTs? How do companies weigh elements at risk? Clinical and biopharma operations can consider these aspects when adopting DCTs. First, the trial endpoints must be measurable through a DCT approach and appropriate trial support tools can be adopted based on the clinical trial phase. Second, the regulatory environment in chosen countries must support the required DCT elements such as tele- or home visits, direct-topatient investigational medicinal product (IMP) shipment, etc. Third, operations must ensure a convenient end-to-end patient experience throughout the DCT process. Decentralised trials are more than just a technology, there is still the need to include a strong human touch to support patients and sites. Companies can weigh all those critical elements by finding a partner with the expertise to run such trials globally and understand the local compliance and restrictions. Sponsors that partner with mature providers, for a managed service or full-service, will benefit from a successful DCT experience. An experienced partner that is very familiar with the General Data Protection Regulation (GDPR) and data privacy laws, will have the resources to support the needed compliance. How do you summarise the benefits of adopting DCTs? What is the current status of DCTs in the APAC region? A key benefit of DCTs is the patient-centricity of the trial design. DCTs provide a convenient endto-end patient experience that reduces the patient burden, e.g., cutting down travel times and costs, and improving patient engagement and satisfaction. This leads to new patient access, compliance and retention, faster enrolment and trial completion with measurable benefits for sponsors. Many EBPs who develop medicines for rare diseases are also able to enrol patients that would not have participated in a study under the traditional model. DCTs can also decrease site burden by using a technology platform that acts as a better engagement channel and allows EBPs to gain access to real-time patient progress on demand. A whitepaper that compared DCTs to traditional study models showed that DCTs delivered time and cost efficiencies at virtually every point in the clinical research journey. However, there will always be a role for in-person trials as some patients feel more comfortable being examined by a clinician. Hybrid models, a mix of face-to-face interactions and technology access, are now a permanent fixture of the clinical trial landscape. The adoption of DCTs is gaining momentum in APAC, such as, but not limited to Australia, China, South Korea, Taiwan, Japan and Malaysia, with many countries starting to implement or develop regulations and/or guidelines for these trials. Hithaishi C Bhaskar [email protected]
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com NGS TECHNOLOGY 35 I ndia is making huge strides in the nextgeneration sequencing (NGS) market. It has to be remembered that the sequencing of the SARS-CoV-2 has helped to develop vaccines in record time, track the emergence of viral variants and invest in timely strategic plans to control the spread. Having a genome database in place for the Indian population will ease the process of developing companion diagnostics and personalised medicine. Realising the potential of genome Leveraging NGS-Tech in Healthcare Applications India is seeing an increasing application of next-generation sequencing (NGS) both in research and clinical settings. A large number of labs are using it to discover the genetic causes of rare diseases and polygenic diseases. It is used by clinicians for patient diagnosis and clinical management and is used for personalised medicine in oncology. India holds a huge potential to be one of the biggest genomics markets based on NGS technology due to its rich genetic diversity. Healthcare diagnostics is currently the focus of various industry players. Other fields are still under-explored and carry huge potential. Promoting public-private partnerships, regulated by policies given the human resources with the right skill set and training, can push India to the front on the global stage. Let’s explore how India, with the help of NGS, can bring in a potential change in the healthcare scenario in the country. sequencing, governments, startups and healthcare companies are foraying into the market. Human genome sequencing has the potential to determine the role of individual genes and their ability to cause diseases. Data generated through these sequencing technologies offer opportunities to assess genetic predisposition to a disease, diagnose heritable cancers and develop tests to prevent adverse drug reactions. The availability of the genome database for the Indian population is likely to ease
36 NGS TECHNOLOGY BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com the process of developing companion diagnostics and personalised medicine and offers access to stratified samples for the research. The India market Way back in 2009, India announced the sequencing of the first human genome. The IndiGen programme, funded by the Council for Scientific and Industrial Research (CSIR), aimed to undertake whole genome sequencing of a thousand Indian individuals representing diverse ethnic groups from India. The programme aims to create a pilot dataset to enable genetic epidemiology of carrier genetic diseases towards enabling affordable carrier screening approaches in India. The human genome datasets would also be utilised for prioritising Pharmacogenomics variants specific to the Indian population for optimising therapy and minimising adverse events. In the public sector, NGS is being used mostly for R&D activities and genome sequencing for building databases and for public health surveillance. In the private sector mostly working towards delivery. India is slowly adopting NGS as it has become an enabling technology for any life science domain. From basic research applications and is moving well towards discovery, development, quality assurance and quality control (QA & QC) and diagnostic applications. According to the Indian Council of Medical Research (ICMR), as on March 23, 2022 India has NGS facilities available in 84 institutes spread across 24 States and 3 UTs, with 63 operational sites. These NGS platforms are mainly from Illumina, Ion Torrent, and Nanopore. However, a lot of NGS facilities in academic and government labs and private companies are already being phased out. With advances in technologies and applications, these facilities are unable to match world standards. Back in 2015, there were majorly 2 to 3 players, while in 2021 there are about 13 to 14 primary players in the Indian market and about 3 to 4 companies Source: ICMR NGS Capacity in India India oncology NGS market The India oncology NGS market is expected to reach $70.60 million by 2028, registering a CAGR of 19.6% from $19.71 million in 2021. The development of companion diagnostic assays for personalised medicine, growing adoption of sequencing platforms for cancer diagnosis, and increasing investment for the development of genomic databases are the key driving factors for market growth. The increasing need for user-friendly sequencing workflows along with cost-effective solutions contribute to the rising adoption rate of this technology in India. The availability of the genome database for the Indian population eases the process of developing companion diagnostics & personalized medicine and offers access to stratified samples for the research. In addition, a rise in cancer incidence in India is expected to be a high impact rendering driver of the market. For instance, the WHO states that 851,678 deaths and over 1,324,413 cancer cases were registered in 2020 in India. Source: Research and Markets What is Next-generation Sequencing (NGS)? NGS is a technology in which millions of DNA strands can be sequenced through massive parallelisation. This technique is also known as high- throughput sequencing. The low cost, high accuracy and speed, and precise results, even from low sample inputs, are the main advantages NGS offers over Sanger’s sequencing method.
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com NGS TECHNOLOGY 37 have an optimal level of capacity and infrastructure to perform NGS workflows. The key advantage is the diversity in the populations, which assists in collecting a large pool of samples. As Dr Deepak Modi, Scientist, ICMR-National Institute for Research in Reproductive and Child Health points out, “India has a bright future and will be the largest consumer market for NGS. With the 10000 Indian genomes sequenced and the availability of a reference database, we will be in a position to rapidly deploy in the diagnostic and personalised medicine segment in India.” The growth story Bengaluru-based Bionivid Technology has collaborated with numerous research institutions and universities in India and abroad, that offer contract research services in bioinformatics, genomics and NGS data analytics. The company plans to expand in two strategically important cities in the next six months. Says Roli Budhwar, COO, Bionivid Technology, “India holds a huge potential to be one of the biggest genomics markets based on NGS technology due to its rich genetic diversity. Healthcare diagnostics is currently the focus of various industry players. Other fields are still under-explored and carry huge potential. Promoting public-private partnerships, regulated by policies given the human resources with the right skill set and training, can push India to the front on the global stage. Overall the genomics industry in India is expected to grow in the coming years, driven by advancements in tech, increase in demand for precision medicine, expanding applications in agriculture and funding support.” Bengaluru-based Eurofins Genomics India delivers projects using advanced Illumina NextSeq500 platform, HiSeq2500, MiSeq, PacBio sequel with high-performance computational infrastructure. The company provides high-quality DNA/RNA oligonucleotides, NGS, Gene synthesis and sequencing services. According to Dr Vedam Ramprasad, CEO, MedGenome Labs, India, NGS will remain one of the key technologies for the genomics industry across applications and will find additional use cases in combination with technologies for other omics. The increasing popularity and adoption of genetic testing in India will likely result in terms like NGS becoming common parlance (similar to RT-PCR in this postCOVID world). Primary growth drivers are improved awareness among clinicians and consumers, more accurate and precise diagnostics, new targeted therapeutics and a projected increase in disposable income of the Indian middle-class population. MedGenome Labs has its primary lab in Bengaluru India has a bright future and will be the largest consumer market for NGS. With the 10000 Indian genomes sequenced and the availability of a reference database, we will be in a position to rapidly deploy in the diagnostic and personalised medicine segment in India. - Dr Deepak Modi, Scientist, ICMR-National Institute for Research in Reproductive and Child Health India holds a huge potential to be one of the biggest genomics markets based on NGS technology due to its rich genetic diversity. Overall the genomics industry in India is expected to grow in the coming years, driven by advancements in tech, and increase in demand for precision medicine. - Roli Budhwar, COO, Bionivid Technology NGS will remain one of the key technologies for the genomics industry across applications and will find additional use cases in combination with technologies for other omics. The increasing popularity and adoption of genetic testing in India will likely result in terms like NGS becoming common parlance. - Dr Vedam Ramprasad, CEO, MedGenome Labs (India) A huge price war is killing the market for service providers. It may be noted that government research institutes are not going for quality and heading for the lowest quote which is pulling the research level down. - Arpita Ghosh, Asst Director Bioinformatics, Eurofins Genomics India
38 NGS TECHNOLOGY BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Sr. No. State No of sites Institute 1 Andaman & Nico. Island 1 1. ICMR-RMRC, Port Blair 2 Andhra Pradesh 2 2. GMC, Guntur 3. SMC Vijayawada 3 Assam 3 4. ICMR-RMRC, NE Region, Dibrugarh 5. NEIST, Jorhat 6. GMC Guwahati 4 Bihar 2 7. IGIMS, Patna 8. ICMR-RMRIMS, Patna 5 Chandigarh 2 9. IMTECH, Chandigarh 10. GMCH, Chandigarh 6 Chhattisgarh 1 11. AIIMS, Raipur 7 Dadra, Nagar and Haveli 1 12. SVBCS, Silvasa 8 Delhi 7 13. NII, Delhi 14. AIIMS, Delhi 15. NCDC, Delhi 16. IGIB, Delhi 17. ILBS, Delhi 18. LNJP, Delhi 19. MAMC, Delhi 9 Goa 1 20. GMC, Goa 10 Gujarat 2 21. GBRC Gandhinagar 22. BJMCH, Ahmedabad 11 Haryana 2 23. MDU Rohtak 24. THSTI, Faridabad 12 Himachal Pradesh 1 25. Dr. RPGMC, Tanda 13 Jammu and Kashmir 1 26. SKIMS, Srinagar 14 Jharkhand 2 27. RIMS, Ranchi 28. MGM Jamshedpur 15 Karnataka 7 29. BMCRI, Bangalore 30. MMCRI, Mysuru 31. IISC, Bangalore 32. JNCASR, Bangalore 33. KIMS, Bangalore 34. InSTEM-NCBS, Bangalore 35. NIMHANS, Bangalore 16 Kerala 2 36. RGCB, Trivandrum 37. ICMR-NIV Field Unit, Alappuzha 17 Madhya Pradesh 4 38. DRDE Gwalior 39. AIIMS Bhopal 40. SAIMS Indore 41. NIRTH, Jabalpur Next Generation Sequencing Capacity of India (as of March 2022) 18 Maharashtra 9 42. GMC Aurangabad 43. AIIMS Nagpur 44. ICMR-NIV Pune 45. KIID, Mumbai 46. IISER, Pune 47. BJMC, Pune 48. NEERI Nagpur 49. NCCS, Pune 50. NCL, Pune 19 Manipur 1 51. IBSD, Imphal 20 Meghalaya 2 52. Pasteur Institute, Shillong 53. NEIGRIHMS Shillong 21 Mizoram 1 54. ZMCH, Falkawn 22 Odisha 2 55. RMRC Bhubaneshwar 56. ILS Bhubaneshwar 23 Puducherry 1 57. JIPMER Puducherry 24 Punjab 2 58. GMC Patiala 59. GMC Amritsar 25 Rajasthan 5 60. SNMCH, Jodhpur 61. AIIMS, Jodhpur 62. MGMC Jaipur 63. SMS, Jaipur 64. GMC Kota 26 Sikkim 1 65. STNM Gangtok 27 Tamil Nadu 4 66. NIRT, Chennai 67. GMC, Theni 68. SPHL, Chennai 69. KIPMR, Chennai 28 Telangana 3 70. GMC Secunderabad 71. CDFD, Hyderabad 72. CCMB, Hyderabad 29 Tripura 1 73. AGMC, Tripura 30 Uttar Pradesh 6 74. KGMU Lucknow 75. NBRI, Lucknow 76. IMS-BHU Banaras 77. CDRI Lucknow 78. RMRC, Gorakhpur 79. NICPR Noida 31 Uttrakhand 2 80. DMC, Dehradun 81. AIIMS Rishikesh 32 West Bengal 3 82. NIBMG, Kalyani 83. IICB Kolkata 84. NICED Kolkata Source: ICMR and according to the company, it is the South Asia’s largest CAP-accredited NGS lab and houses the latest NGS equipment (at par with global industry leaders). The company additionally has five other labs across the country focusing on various molecular and genetic diagnostic technologies. These facilities apart from processing thousands of samples for genomic testing every month also support patients with genetic counselling and walk-in sample collections. Mumbai-based Godrej Memorial Hospital recently introduced comprehensive genome testing that identifies an individual’s predisposition to over 150 conditions and genetic traits. The hospital has partnered with HaystackAnalytics, based out of IIT
BIOSPECTRUM BIOSPECTRUM | | APRIL 2023 MAY 2023 | www.biospectrumindia.com | www.biospectrumindia.com NGS TECHNOLOGY TUBERCULOSIS 39 Human genome is a blueprint for life and DNA sequencing is the key to unearthing these insights. Genomics is changing the face of healthcare in therapy areas such as oncology, tuberculosis and infectious diseases. - Dr Anirvan Chatterjee, CEO, HaystackAnalytics Rapid changes in technology, particularly the need to buy new equipment every three years is a big challenge. Pricing of the reagents, particularly without local suppliers and everything being imported, is a big problem. - Dr Raja Mugasimangalam, Founder and CEO, Genotypic Technology The biggest challenge for the Indian NGS market is the lack of genotype-phenotype correlations for Indians at a population-wide and an individual-level, and most of the available databases are based on Caucasian populations. Large-scale genetic studies are required to identify actionable mutations and to create a database specific to the Indian population. - Samir Vyas Country General Manager, India, Agilent Bombay, to launch the Health Genometer Smart Plan. Dr Anirvan Chatterjee, CEO, HaystackAnalytics says that the human genome is a blueprint for life and DNA sequencing is the key to unearthing these insights. Genomics is changing the face of healthcare in therapy areas such as oncology, tuberculosis and infectious diseases as the technology of NGS has given breakthrough solutions in identifying the right pathogens and helping in the timely diagnosis of the disease. Reliance Industries has announced its foray into genome testing through the acquisition of Bengalurubased Strand Life Sciences in 2021 for a sum of Rs 393 crore for 80 per cent stake. The test kits developed by Strand Life Sciences will be rolled out at Rs 12000 i.e. 86 per cent cheaper than other available options in the market. In October 2022 Illumina partnered with GenoScreen, an innovative genomics company, to launch a package combining Illumina products and the GenoScreen Deeplex Myc-TB assay. The targeted NGS based test for the rapid and extensive detection of anti-TB drug resistance. Agilent, having its Diagnostics and Genomics (DGG) Center of Excellence (CoE) based at Mansear, Haryana, offers an extensive portfolio of NGS research products for quality control of nucleic acids, for library preparation and automation. It also offers tools for NGS data analysis and reporting. Agilent SureSelect library preparation and target enrichment reagents include custom and catalog panels, such as the SureSelect Human All Exon v8 panel and the SureSelect Cancer Comprehensive Genomic Profiling assay. Challenges Amidst the slow but steady growth, India has a long road ahead to become a master in the NGS market. A host of challenges are currently being faced, the major ones being awareness, affordability and education and skilled resources. Very few healthcare workers are aware of the power of NGS technology. Another challenge is the required skill for NGS data processing and analysis. Says Dr Raja Mugasimangalam, Founder and CEO, Genotypic Technology, “Rapid changes in technology, particularly the need to buy new equipment every three years is a big challenge. Pricing of the reagents, particularly with no local supplier and everything imported is a big problem. Lower-cost services from Korea and China are a big challenge for Indian service providers. Diagnostic companies that have received funds for molecular diagnostics based on NGS are cutting costs just to show some toplines and entering the genomics services market.” Even one requires good hands-on wet lab protocol-based molecular biology techniques specifically for NGS data generation. Another important thing missing is the skill needed for analysing the big data generated through the NGS platform. Integration of computational technologies like Bioinformatics, Artificial Intelligence (AI), Machine Learning (ML) and biological sciences is the need of the hour. Very few academic institutions have courses on
40 NGS TECHNOLOGY BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Leading Global Players In NGS Market ● Illumina, Inc. ● Oxford Nanopore Technologies ● PierianDx ● 454 Life Sciences Corporation (Roche Holding AG) ● Thermo Fisher Scientific, Inc. ● Pacific Biosciences of California, Inc. ● Beijing Genomics Institute ● Lucigen ● Perkinelmer, Inc ● Qiagen N.V. ● Hamilton Company ● QIAGEN ● Macrogen ● Agilent Technologies, Inc ● Genomatix GmbH Source: MarketWatch Some of the key players operating in the India oncology NGS market ● Illumina, Inc. ● Genotypic Technology Pvt. Ltd. ● Tecan Trading AG ● SciGenom Labs Pvt. Ltd. ● Xcelris Labs Ltd. ● Eurofins Scientific ● 4baseCare ● MedGenome ● Sayre Therapeutics ● Redcliffe Lifesciences ● Partek Inc. ● Bio-Rad Laboratories ● Myriad Genetics ● Hologic, Inc. (Gen-Probe Inc.) ● Perkin Elmer, IncVela Diagnostics ● Premas Life Sciences Pvt Ltd (PLS) Source:Grand View Research NGS data analytics or bioinformatics in general. There is a lot of data being generated but the workforce with the right skill set to analyse and interpret this data is missing. As experts point out, there are needs for some computational skills such as using Linux interface, R or python and also some coding abilities. The younger generation of biology graduates should acquire skills to make themselves market ready. According to Arpita Ghosh, Assistant Director Bioinformatics, Eurofins Genomics India, there are too many small and new players after COVID-19 who have received some surplus funds. A huge price war is killing the market for service providers. It may be noted that government research institutes are not going for quality and heading for the lowest quote which is pulling the research level down. Dr Modi goes on to add that quality control is another challenging area for the NGS market in India. There are a few India-specific guidelines for minimal essential standards for NGS data. As a consequence, there is often poor-quality data floating around and even used for clinical decision making which is quite dangerous. Also there is no Indian equivalence of the American College of Medical Genetics and Genomics (ACMG) guidelines to interpret and use the NGS data for clinical decision making. This makes it difficult for the counsellors and clinicians for effective decision making. Talking about the challenges, Samir Vyas, Country General Manager, India, Agilent says, “The biggest challenge for the Indian NGS market is the lack of genotype-phenotype correlations for Indians at a population-wide and an individual-level, and most of the available databases are based on Caucasian populations. Large-scale genetic studies are required to identify actionable mutations and to create a database specific to the Indian population. A few initiatives have been taken in this direction. An example includes the Department of Biotechnology Genome India (a pan-India project which aims to catalogue genetic variation in India) and is focussed on Whole Genome Sequencing of representative populations across the country.” Relatively high cost of sequencers and consumables, unavailability of local suppliers and vendors, low awareness and affordability for clinical applications and lower spending on genomics research in India, when compared to developed countries such as the US, are a few of the notable challenges in this sector. Apart from this, there are no national consensus guidelines on the use of clinical genomics to improve patient care. Future of NGS in India NGS has been critical in decreasing the cost of sequencing, from $1 million per whole genome in 2007 to $200 in 2023, resulting in the relatively wide adoption of genomics (NGS based) across a variety of applications. Though India is lagging in NGS in the global arena, there is a huge scope for the country to excel in this sector. Government should promote NGS and need to go hand in hand with the private players and ensure the right skill with the requisite funding. Sanjiv Das [email protected]
BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com PRENATAL TESTING 41 Non-invasive Prenatal Testing Runs Global « Amartya Bose, Healthcare & Life Sciences Industry Analyst, Frost & Sullivan 2023 is the year of the growing preference for early disease detection and prevention, minimally invasive testing methods, and consumerization in diagnostic testing. Non-invasive prenatal testing (NIPT) is a powerful tool empowering clinicians and prospective parents with valuable clinical insights to make informed decisions regarding pregnancy management. With guidelines for NIPT expanding and payers reimbursing for screening procedures, clinically validated virtual care platforms will open the aperture to a larger addressable NIPT market. Non-invasive prenatal testing (NIPT) requires the evaluation of fetal cells or cell-free DNA obtained from a maternal blood sample during pregnancy. Since its debut in the United States and China/Hong Kong in 2011, the molecular screening test used to detect fetal congenital anomalies is the fastest-spreading prenatal genetic technology globally, accounting for 38 per cent of the prenatal genetic testing market. Technological innovations shaped by commercial interests Although Next Generation Sequencing (NGS)- based methods have been majorly used, technology evolutions encompassing qPCR, dPCR, and amplification technologies aim to further drive the quality of tests and reduce costs. The commercial sector is broadening its scope to include sex chromosome aneuploidies, rare autosomal trisomies, and sub-microscopic copy-number variants. Automated in-lab workflows and remote patient monitoring in pregnancy are enabling providers to better manage pregnancies and risks. A new generation of screening tests is promising to enhance pregnancy management by providing information about placental development acquired in real-time with trophoblast cells, implying a focus on targeted management of at-risk pregnancies. As the technology evolves, debates surrounding the expansion of NIPT beyond chromosomal abnormalities will increase. Hence for test developers, the role of private clinics and biomedical professionals is key to spearheading access, especially in underpenetrated regions. Another strategy central to attracting customers includes validation studies. While clear guidelines and services to address potential medical and ethical issues are critical for the responsible future use of NIPT, leveraging complementary informatics technologies that enhance data analysis and reporting capabilities will be vital in accelerating new product development, in addition to expanding core intellectual property portfolio and sample preparation technology. Commercial potential across geographies With 140 million babies born globally, NIPT represents an exciting opportunity, with many geographies still in the nascent stages of adoption. A large US market offers significant potential. There are about 4 million babies born in the United States each year, and 97 per cent of high-risk pregnancies and 56 per cent of average-risk pregnancies are covered. NIPT is widely adopted throughout Europe, though only a few countries have a national policy that regulates its use. NIPT for all pregnancies is covered in the Netherlands and Belgium as a first-tier screening test. Within Asia-Pacific, the rising number of women postponing pregnancy until later in life across China, Australia, India, and Japan is favouring adoption. Thailand and Vietnam are other markets with sizable populations offering significant opportunities. Expanded clinical applications, such as autosomes and microdeletions, spur innovation in the sector, making it a viable industry in the long term. Growing competitiveness with substantial new entry The market is in the growth phase. The dominance of large-scale companies in the industry, including Natera, Illumina, LabCorp, Roche Molecular Systems/ BioReference Laboratories, and BGI Genomics, is
42 PRENATAL TESTING BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com challenged by new entrants in the field embracing non-PCR, non-NGS-based methods to enable broader adoption, like the Vanadis NIPT system from PerkinElmer. To further reduce implementation costs, companies like Atila Biosystems are harnessing the power of digital PCR to detect targets that indicate possible chromosomal anomalies—trisomy 21 associated with Down Syndrome, trisomy 18 associated with Edwards Syndrome, and trisomy 13 associated with Patau Syndrome and foetal fractions. As NIPT marches toward becoming the standard screening tool for pregnancies worldwide, companies like Bionano Genomics emerge as game changers, with optical genome mapping (OGM) analysis providing high-throughput, comprehensive follow-up genome analysis in case of a positive NIPT screen or for highrisk pregnancies following an abnormal ultrasound. OGM can be developed as the basis of a new standard of care in prenatal genetic analysis because of its ability to identify all types of structural variants. Other notable new participants encompass Dutch biotech VyCAP, Danish ARCEDI Biotech, and US-based RareCyte, which developed methods for separating circulating trophoblast cells from maternal blood samples. Rapid advancements in novel techniques imply an enriching product matrix for decentralised NIPT. Growth strategy to address the surge in test volume 2023 is the year of the growing preference for early disease detection and prevention, minimally invasive testing methods, and consumerization in diagnostic testing. The three macro trends imply volume growth and improved test economics for NIPT, driven by growing awareness of preventing chromosomal anomalies such as Downs Syndrome. With guidelines for NIPT expanding and payers reimbursing for screening procedures, clinically validated virtual care platforms that enable obstetrician-gynaecologists to deliver prenatal care offer risk-specific experiences, detect risk more quickly, and automate critical elements of care, driving the adoption of guidelinerecommended NIPT. As adoptions surge, workflow improvements via artificial intelligence-based technologies (deep neural networks and probabilistic modelling) learning from millions of processed samples are poised to improve positive predictive value, lower the cost of goods sold, and reduce the nocall rate. Cell-based NIPTs represent another promising field in research, addressing the challenges associated with whole-fetal-cell isolation from the maternal blood draw. However, evidence will decide the success of this next-generation approach in bringing tests from screening to diagnostics. The path of fetal cells might be long, but the rewards are promising. New technologies must undergo validation for responsible clinical implementation. Increasing public awareness of testing is critical to prepare prospective parents for crucial decision-making. Remote pregnancy monitoring platforms delivering medical-grade fetal wellness checks will empower providers and patients to expand care delivery. Due to the advanced nature of technology, achieving economies of scale is key to incremental growth. Hence, techniques should enable providers to support expectant parents with more accurate, timely, and personalised pregnancy management options. NIPT is a powerful tool empowering clinicians and prospective parents with valuable clinical insights to make informed decisions regarding pregnancy management. Technological advances and responsible innovation make it a promising screening avenue for the detection of additional genetic conditions. Industry participants carving distribution and marketing agreements to expand access and coverage, in addition to product development and commercialization agreements, will effectively navigate the coming age of distributable kits, offering new solutions to expand testing to all autosomes and microdeletions. Empowering laboratories with computational frameworks for sequencing-based NIPT analysis to enable the characterisation of disease transitions and their reflection in the blood will open the aperture to a larger addressable NIPT market. NIPT is a powerful tool empowering clinicians and prospective parents with valuable clinical insights to make informed decisions regarding pregnancy management. Technological advances and responsible innovation make it a promising screening avenue for the detection of additional genetic conditions. Industry participants carving distribution and marketing agreements to expand access and coverage, in addition to product development and commercialization agreements, will effectively navigate the coming age of distributable kits, offering new solutions to expand testing to all autosomes and microdeletions.
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Dr Soumya Swaminathan steps in as Board Member of CEPI Dr Sanjay Chaturvedi has been appointed as the Chief Executive Officer (CEO) of Apitoria Pharma, a wholly owned subsidiary of Hyderabad-based Aurobindo Pharma. Dr Chaturvedi is an accomplished leader with close to three decades of rich experience in various prestigious organisations. His proven success of creating and growing organisations demonstrates his commitment to strategy and transformative excellence. Prior to this role, he was associated with IOL Chemicals and Pharma as Executive Director & CEO. He has also worked as the President at Praj Industries. He has earlier worked with Aurobindo Pharma from 2013 to 2015 as the Senior Vice President. Dr Chaturvedi has also gained experience working as the Vice President and Global Head - Sales and Marketing at Dr. Reddy’s Laboratories. Aurobindo Pharma names Dr Sanjay Chaturvedi as CEO of subsidiary IOL Chemicals and Pharmaceuticals appoints Vikas Vij as CEO 44 ACADEMICS NEWS PEOPLE NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 MAY 2023 | www.biospectrumindia.com | www.biospectrumindia.com Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) has announced a new board memberDr Soumya Swaminathan (Independent). Dr Soumya previously served as Chief Scientist at the World Health Organisation (WHO) and was instrumental in the establishment and implementation of COVAX, which has enabled access to over 1.9 billion COVID-19 vaccines globally. Prior to that she was Secretary to the Government of India for Health Research and Director General of the Indian Council of Medical Research from 2015 to 2017. She is a globally recognised researcher on tuberculosis and HIV and brings over 30 years’ experience in clinical care and research. She has also worked throughout her career to translate research into impactful programmes. From 2009 to 2011, she also served as Coordinator of the UNICEF/UNDP/World Bank/ WHO Special Programme for Research and Training in Tropical Diseases in Geneva. She is an elected Foreign Fellow of the US National Academy of Medicine and a Fellow of all three science academies in India. IOL Chemicals and Pharmaceuticals, a leading manufacturer of pharmaceutical (APIs) and specialty chemicals based in Ludhiana, has appointed Vikas Vij as the new Chief Executive Officer (CEO), with effect from April 3, 2023. Vij’s role is expected to aid the company to bolster growth across domestic and international markets by leading IOL’s portfolio enhancement and efficiencies. He takes over from Dr Sanjay Chaturvedi. Vij has a techno-commercial background with a nuanced understanding of Active Pharmaceutical Ingredients (API), Finished Dosage Forms (FDF), Custom Pharmaceutical Services (CRAMS), specialty chemicals, and operations from his previous leadership roles across the pharma value chain. He was previously associated with Cipla as the Senior Vice President of API and Access Business Units. In his career spanning over 30 years, he has donned various roles in Ranbaxy, GVK Biosciences, Alembic Pharmaceuticals, Sun Pharma, and Apollo Hospitals.
Ahmedabad-based Intas Pharmaceuticals has announced the appointment of Dr Narahari Chittoor Rao as Associate Vice President- Cell & Gene Therapy. Dr Rao has over two decades of experience in the biotech industry having worked for both large multinational companies and startups. In addition to traditional biologicals such as recombinant proteins and antibody based projects, he has also worked with newly emerging modalities such as mRNA and viral vectors. His experience spans process and product development from pre-clinical stage to commercially manufactured products. He was previously serving as the Head of Global Process Development at Pune-based Enzene Biosciences. He has also worked with companies like Ultragenyx Pharmaceutical, Moderna Therapeutics, Bristol-Myers Squibb, GlaxoSmithKline, Amgen, to name a few. Intas Pharma appoints Dr Narahari Chittoor Rao as Associate VP- Cell & Gene Therapy Dr Ashutosh Raghuvanshi, Managing Director and CEO, Fortis Healthcare has been announced as the new President of NATHEALTH – an apex body representing the entire ecosystem of the Indian healthcare industry. He takes charge from Dr Shravan Subramanyam, erstwhile President of NATHEALTH during FY 2022-23. A cardiac surgeon turned management leader, Dr Raghuvanshi has over 35 years of healthcare experience and numerous national and international healthcare awards under his belt. Before joining Fortis, Dr Raghuvanshi spent over 18 years with Narayana Health, a leading healthcare chain operating over 28 hospitals, in various leadership roles including as its Vice Chairman, Managing Director and Group Chief Executive Officer (MD & CEO), where he played an instrumental role in getting the company successfully listed on the Bombay Stock Exchange (BSE). His past tenure includes stints with the Bombay Hospital, Apollo Hospitals, Vijaya Heart Foundation and Manipal Heart Foundation. Dr Ashutosh Raghuvanshi steps in as new President US-headquartered CitiusTech Healthcare Technology, with presence in Mumbai and of NATHEALTH Bengaluru, has announced that its Board of Directors has appointed Rajan Kohli, an experienced technology executive as Chief Executive Officer (CEO). Kohli joins CitiusTech from Wipro, a global leader in technology services and solutions, where he spent nearly three decades and was responsible for $6 billion in annual revenues. He most recently served as the President of the iDEAS (Integrated Digital, Engineering and Application Services) business, supporting clients globally across industry segments. He has held a variety of leadership positions at Wipro, including Head of Banking & Financial Services and Chief Marketing Officer, Kohli also founded and scaled Wipro Digital in the decade before taking over leadership of the iDEAS global business line. Established in 2005, CitiusTech develops software and technology solutions for over 140 leading healthcare and life sciences organisations, including large healthcare providers, payers, pharmaceutical organisations and medical technology companies. CitiusTech names Rajan Kohli as CEO BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com PEOPLE NEWS 45
New visual detection test of SARS-CoV-2 to identify infection at early stage Vadodara-based Cryogenic Liquid Storage, Distribution and Re-Gas solutions provider, INOXCVA, has achieved a significant milestone by completing the fabrication of India’s first indigenously designed zero-boil-off 4K helium cryostat for a whole-body 1.5T Superconducting Magnetic Resonance Imaging (MRI) magnet system. The fabrication of the MRI cryostat was carried out at their state-of-the-art facilities in Vadodara, Gujarat. The introduction of this technology would lead to lowering of MRI expenses, and therefore making healthcare more affordable in India. With the significant milestone coinciding with the celebration of Amritkaal, commemorating 75 years of independence, the MRI magnet system has been named I-Amrit 1.5, i.e. Indian Advanced MRI Technology 1.5. With this achievement India became the sixth nation in the world to indigenously manufacture MRI Magnet System. India becomes the sixth nation in the world to indigenously manufacture MRI Magnet System IIT-M commercialises software for photoelastic analysis and simulation for biomedical application 46 ACADEMICS NEWS R&D NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 MAY 2023 | www.biospectrumindia.com | www.biospectrumindia.com A team of researchers from National Institute of Animal Biotechnology (NIAB) and Gandhi Medical College, in Hyderabad, has developed a rapid and robust platform for early and on-field detection of SARS-CoV-2 virus. The developed lateral flow immunoassay (LFIA) strips can be useful as a portable, point of care device (PoC) for on-site detection of SARS-CoV-2 particularly at home or even in rural areas. Moreover, the cost of LFIA strips is much less as compared to standard RT-PCR test making it a more economical option for people who cannot afford the RT-PCR test. The LFIA for the detection of Receptor Binding Domain (RBD) of SARSCoV-2 could provide an efficient substitute for RT-PCR tests. It can detect the RBD antigen of the SARS-CoV-2 at an early stage of infection with a visual line of detection (LOD). A smartphone app (Color grab) has been used for the qualitative analysis of the test strip. The developed LFIA working on the principle of antigen-antibody interaction holds the potential to be used for detection of SARS-CoV-2 without any requirement of skilled personnel and subsequently reduce the spread of the virus. Indian Institute of Technology Madras (IIT-M) has commercialised four state-of-the-art software packages in the field of photoelastic analysis and simulation through an industry partner. The softwares have applications in diverse fields ranging from agricultural applications to locomotion of organisms to mitigating stresses or identifying defects in 3D electronics. Novel applications for photoelasticity include areas like biomedical and conventional stress analysis involving complex loading and boundary conditions in aerospace, civil, mechanical, and manufacturing engineering fields as well. Photoelastic stress analysis has seen a sea change with the advent of digital computers and imaging technologies. Hitherto, there has been no comprehensive software platform to implement such developments in research laboratories and industries using this technique. This is the first comprehensive software for experimentally-based photoelastic stress analysis tool. Doctors, agriculturists and biologists are now increasingly turning to use photoelasticity for solving their domain problems. They can authentically process recorded images using the software for deriving important conclusions from their studies. IIT-Madras has entered a licensing and monetisation agreement with Online Solutions (Imaging), Chennai.
A team of researchers from National Institute of Animal Biotechnology (NIAB) and Gandhi Medical College, in Hyderabad, has developed a rapid and robust platform for early and on-field detection of SARS-CoV-2 virus. The developed lateral flow immunoassay (LFIA) strips can be useful as a portable, point of care device (PoC) for on-site detection of SARSCoV-2 particularly at home or even in rural areas. Moreover, the cost of LFIA strips is much less as compared to standard RT-PCR test making it a more economical option for people who cannot afford the RT-PCR test. The LFIA for the detection of Receptor Binding Domain (RBD) of SARS-CoV-2 could provide an efficient substitute for RT-PCR tests. It can detect the RBD antigen of the SARSCoV-2 at an early stage of infection with a visual line of detection (LOD). A smartphone app (Colour grab) has been used for the qualitative analysis of the test strip. NIAB develops LFIA strips for early stage detection of SARS-CoV-2 IIT-M develops coronaviruses’ antibodies database ‘Ab-CoV’ Researchers at the Indian Institute of Technology (IIT) Mandi have conducted a study to identify the most significant risk factors for cardiovascular diseases (CVDs) among adults aged 45 and above in India. The research team utilised data from the Longitudinal Ageing Study in India (LASI), a nationally representative longitudinal survey of 73,396 individuals aged 18 and above covering all Indian states and Union Territories. The data were collected from wave 1 of the study launched under the aegis of the Ministry of Health and Family Welfare, Government of India, with International Institute for Population Sciences (IIPS), Mumbai, being the nodal agency. The researchers included 59,073 older adults aged 45 and above, after cleaning the data. The study found that environmental exposure is a significant risk factor for the occurrence and progression of CVDs in older adults in India. A majority of the population of India resides in rural areas and uses unclean fuels for cooking and other purposes, exposing them to harmful smoke emitted from burning them. Second-hand smoke exposure, commonly referred to as passive smoking, is believed to have similar cardiovascular effects and risks comparable to active smoking. The study also identified behavioural risk factors such as physical inactivity leading to CVDs. IIT Mandi pegs environmental exposure as significant risk factor for CVDs in older adults BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com R&D NEWS 47 A team of researchers at the Indian Institute of Technology Madras (IIT-M) has developed an online open-source database of coronaviruses’ neutralising antibodies encompassing crucial features such as binding affinity and neutralisation profiles (IC50 and EC50) of antibodies. The database called ‘Ab-CoV’ contains detailed information about all COVID-related antibodies identified so far, including the source of each antibody, and the viral protein(s) and virus strains they recognise. ‘AbCoV’ can also aid in the development of drugs against new variants of SARSCoV-2. Ab-CoV database includes 1,780 coronavirus-related antibodies including 211 nanobodies and contains more than 3,200 data points on half maximal inhibitory concentration (IC50), half maximal effective concentration (EC50) and binding affinity (KD). Ab-CoV also has a wide range of search and display options through which users can directly search and download the processed data, based on the antibody’s name, viral protein epitope, neutralised viral strain, antibody, and nanobody.
American firms Thermo Fisher Scientific and Arsenal Biosciences, Inc. (ArsenalBio) have announced an update to their strategic collaboration to further the development of manufacturing processes for new cancer treatments. This research and process developmentfocused collaboration has enabled ArsenalBio to develop a robust manufacturing process for their next-generation, programmable autologous T cells for the treatment of cancer. ArsenalBio recently advanced its lead product candidate into clinical manufacturing of its autologous integrated circuit T cell (ICT) therapy for platinum-resistant ovarian cancer. ArsenalBio’s work to develop multi-functional CAR-T cell therapies is enabled by Thermo Fisher’s Cell Therapy Systems (CTS) portfolio of products, including the Gibco CTS Xenon Electroporation System and the Gibco CTS Rotea Counterflow Centrifugation System. Thermo Fisher began its collaboration with ArsenalBio in 2020 to help ArsenalBio overcome challenges associated with cell therapy manufacturing by working together to support development of a clinical-scale gene editing process. Thermo Fisher and ArsenalBio to support clinical manufacturing of autologous T-cell therapies BD introduces advanced ultrasound technology for optimal IV placement Germany-headquartered Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has signed an agreement to acquire Polyplus for approximately 2.4 billion euros from private investors, including ARCHIMED and WP GG Holdings IV B.V., an affiliate of Warburg Pincus. Polyplus, with around 270 employees, develops and produces transfection as well as other DNA/RNA delivery reagents and plasmid DNA in high quality and GMP grade. These are key components in the production of viral vectors used in cell and gene therapies and other advanced medicinal therapeutic products. Recording significant growth rates, Polyplus is expected to generate sales revenue in the upper double-digit millioneuro range and a very substantial EBITDA margin in 2023. The proposed transaction is subject to customary conditions, including completion of the information and consultation of the works’ council and approval by regulatory authorities and is expected to close during the third quarter of 2023. Founded in 2001, Polyplus is based in Strasbourg, France, and has locations in France, Belgium, the US, and China. Sartorius Stedim Biotech acquires Polyplus for €2.4 B 48 SUPPLIERS NEWS BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com BD (Becton, Dickinson and Company), a leading global medical technology company based in the US, has launched a new, easy-to-use advanced ultrasound device with a specialised probe designed to provide clinicians with optimal IV placement. The BD Prevue II System addresses an unmet need in IV access through real-time needle depth markers. The system features the BD Cue Needle Tracking System, offering a highquality ultrasound image of the needle trajectory, and is compatible with BD Cue Needle Tracking-enabled catheters. Simulated studies show that pairing a needletracking system with ultrasound guidance may help reduce the number of attempts and time to successful vessel access which, according to the American Institute of Ultrasound in Medicine, may make vascular access procedures safer and easier for clinicians and patients. More than 90 per cent of hospitalised patients receive IV therapy through a peripheral IV catheter, representing hundreds of millions of patients a year.
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50 LET’S TALK HEALTH BIOSPECTRUM | MAY 2023 | www.biospectrumindia.com Which Therapy Could Trump Thalassemia? Every year, May 8 is observed as International Thalassemia Day to increase awareness about this genetic blood disorder that affects millions of people across the globe. Although people with thalassemia usually have mild to severe anaemia and associated symptoms such as fatigue, pale or yellowish skin, dark urine, and an enlarged spleen, afflicted children might experience stunted growth. Thalassemia affects approximately 4.4 out of every 10,000 live births throughout the world, caused by mutations in the DNA of cells that make haemoglobin molecules that are made of alpha and beta chains. While, alpha-thalassemia is particularly common among certain populations of Southeast Asian descent, beta-thalassemia is the most common form of thalassemia among populations of Mediterranean, African, and South Asian ancestry. As per the laws of genetics, for a child to inherit thalassemia, both parents must be carriers. The severity of thalassemia one has, depends on the number of gene mutations the child inherits from the parents. Studies have revealed that India has the largest number of children suffering from thalassemia, with more than 10,000 children born with the disease every year. Four million Indians are thalassemia carriers, while more than 100,000 are actual patients. The beta-thalassemias are prevalent in India, with an estimated 7,500-12,000 new births each year. The prevalence of beta trait in Central India ranges between 1.4 and 3.4 per cent, while in South India it ranges between 8.5 and 37.9 per cent. But the real challenge is the lack of awareness of this disease in India, because both or either parent of a child could be a thalassemia gene carrier without showing any symptoms or with just mild anaemia, that can go undetected throughout their lives. Adding on, the treatment involves blood transfusion, bone marrow transplant and gene therapy, making it highly cost intensive for parents of children born with thalassemia. Over the past few years, there has been a great deal of global progress in the development of novel treatments for thalassemia, including gene therapy and gene editing. For instance, last year the US Food and Drug Administration (FDA) approved the first cell-based gene therapy to treat adult and paediatric patients with beta-thalassemia who require regular blood transfusions. bluebird bio, Inc.’s Zynteglo is a one-time gene therapy product administered as a single dose. Although a potential risk of blood cancer has been associated with this treatment, no cases have been seen in studies of Zynteglo. Another US-based firm Vertex Therapeutics is nearing a historic US FDA submission of the first CRISPR-based gene editing therapy for treating beta-thalassemia. If approved, exa-cel will be the first gene editing therapy based on CRISPR technology, likely to compete with bluebird bio’s Zynteglo. While bluebird is pricing Zynteglo at $2.8 million, Vertex aims to ensure that broad patient access and reimbursement deals are in place when exa-cel is approved. On the other hand, US-based Bristol Myers Squibb (BMS) has announced the commercialisation of its first-in-class therapy, particularly in Egypt, indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta thalassemia. In the Middle East region, Burjeel Medical City will be assessing the effectiveness and safety of Mitapivat, a drug that has shown promise as a treatment for thalassaemia. Abu Dhabi will take part in the phase 3 trials, called Energise and Energise-T, which will test Mitapivat’s effectiveness on adults with thalassemia, in 2023. While novel drug/therapy development is still miles away for Indian pharmaceutical companies, multiple initiatives are being taken in the country to create networks of healthcare professionals who can work together to provide the best possible care for patients with beta-thalassemia. In the end, a comprehensive multidisciplinary approach of medical, psychological and social support is the need of the hour. Dr Manbeena Chawla Executive Editor [email protected]