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Vol 21; Issue 10; October 2023 4 BIO MAIL BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Acknowledgement/ Feedback Recent advancements in extensive pre-training and diffusion modelling have propelled significant progress in generative AI across both Natural Language Processing (NLP) and computer vision sectors. This has led to ground-breaking real-world applications, including ChatGPT and MidJourney/Stable Diffusion. - Saurabh Singal, New Delhi Language models and artificial intelligence (AI) models have been known to have fairness issues or generate harmful predictions. In a crucial sector like healthcare, it is important to carry out research and determine responsible AI framework and guidelines needed to design, develop, deploy and monitor healthcare AI models. - Prof. B. Ravindran, Chennai Thank you so much for the interview feature on Novozymes in the October edition. We look forward to our continued engagement with BioSpectrum. - Priyangshu Dutta, New Delhi Vol 21; Issue 11; November 2023 Publisher & Managing Editor: Ravindra Boratkar CEO Manasee Kurlekar [email protected] 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] Content Team: Singapore: Hithaishi C. Bhaskar [email protected] General Manager (Strategy and Marketing) Ankit Kankar [email protected] Social Media Communications: Poonam Bhosale [email protected] Operations and HR: Asmita Thakar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Subscription: Vipan Kumar [email protected] Circulation and Media Enquiry: Sudam Walekar [email protected] South Region Vrushti Kothari Business Development Executive “NITON”, No. 11/3, Block “C”, Second Floor, Palace Road, Bangalore, Karnataka- 560052 Mobile: +91-7798935660 [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 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 Apoorva Mahajan Marketing and Communication Specialist Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Baner Road, Pune-411045 Mobile: +91-7724025888 [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 General Manager (Strategy & Marketing) #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: +65 90150305 E-mail: [email protected]
Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, November 14 is World Diabetes Day, a day that is significantly important for India considering the number of diabetic and pre-diabetic patients – over 10 crores and over 13 crores respectively -- in the country. It has already attained epidemic proportions worldwide. Its huge burden in India translates to a large population of individuals at risk of not only cardiovascular disease but also chronic complications of diabetes such as kidney, foot, and eye disease. The cost of treating them is crippling not just individuals, but also the society and the country as a whole. Diabetes is a chronic non-communicable and lifestyle disease. To a certain extent, it can be prevented and even controlled by lifestyle and diet. It’s noteworthy that our sister publication nuFFOODS Spectrum has dealt with countering diabetes with the right diet. In this issue’s cover story, our content team has looked into strategies like state-specific policies and technological interventions which are required on a war footing to arrest rising cases of the disease. State-specific policies are required because a recent groundbreaking published research paper has shown the state-wise prevalence of diabetes and pre-diabetes in India. Startups in several areas have raised hopes to improve the systems through innovations and employing new technologies. The Biopharma sector is no exception. Just a few months back, BioSpectrum published an article in which Dr Rajesh Gokhale, Secretary, Department of Biotechnology, was quoted saying that India has 95,000 registered startups of which 5,000 are in the biotech sector. Our content team has looked at the bio startups from a different angle. It has tried to find an answer to the question ‘can deep tech startups propel drug discovery? Aside from other articles and interviews, we have an important interview with the Director General of Pharmexcil, in which he has asked Indian pharma companies to remain updated and adapt to changing requirements. On the backdrop of the controversies surrounding exported Indian cough syrups the views of pharma export experts are important. I take this opportunity to extend my warm greetings on the occasion of Deepawali and New Year. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com 5 Looking for a job? See open roles at www.biospectrumjobs.com premier source of pharma healthcare & bio jobs n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... TALENT SOLUTIONS
24 GLP-1 medications could potentially emerge as significant market catalyst for diabetes Amit Mookim, Managing Director, IQVIA South Asia 27 “Through diligent management, people with diabetes can reduce risk of causing damage to other parts of the body” Omar Sherief Mohammad, Cluster Head India, Middle East & Africa, Roche Diabetes Care 28 New Pharma Research on Diabetes - Drugs & Vaccines Vandana Iyer, Industry PrincipalHealth & Wellness, TechVision, Frost & Sullivan Diabetes mellitus, a chronic metabolic non-communicable disease (NCD), has attained epidemic proportions worldwide. Several studies conducted over the last two decades have revealed a huge burden of diabetes in India, which translates to a large population of individuals at risk of not only cardiovascular disease but also chronic complications of diabetes such as kidney, foot, and eye disease. The cost of treating them is crippling not just individuals, but also the society and the country as a whole. For instance, diabetic foot ulcers and infections are responsible for more than 30 per cent of hospitalisations related to diabetes mellitus. On the other hand, there is a higher prevalence of diabetic retinopathy among the urban population than in the rural population. India must step up state-specific policies and technological interventions on a war footing to arrest the rapidly rising epidemic of diabetes. AI-Driven Therapeutics for DIABETES 6 BIO CONTENT BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 20 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD.
Biostartups - Webinar 31 Can Deep Tech Startups Propel Drug Discovery? BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com BIO CONTENT 7 Regulars BioMail ...........................................................................04 Letter from Publisher...................................................05 BioEdit ............................................................................08 Policy and Regulatory News.......................................10 Finance News................................................................12 Company News ............................................................13 Start-Up News...............................................................15 WHO News.....................................................................17 World News ...................................................................18 People News..................................................................43 R&D News ......................................................................46 Supplier News ............................................................. 4t8 Let’s Talk Health............................................................50 DeepTech Startups 37 Can India become a global hub for innovation in biotech and medtech? Kamal Bansal, Managing Director, GVFL (formerly known as Gujarat Venture Finance Limited) Refrigeration 39 Future of medical refrigeration looks promising Jesal Doshi, Director, Board of Medical Technology Association of India (MTaI) Molecular Diagnostics 41 Molecular diagnostics for early diagnosis of diseases- the way forward Suraj Nair, Lead- TechSprouts, Ankur Capital Top Video Prasad Rodagi, Founder Director, Altem Technologies talks about how 3D scanning and printing can enhance diagnostic capabilities in India. Scan the QR Code » Indian pharma exports continue to grow despite global challenges, says Lakshmi Prasanna, DirectorRegulatory Affairs at Pharmexcil (Pharmaceuticals Export Promotion Council of India). Scan the QR Code » Speaking With 35 “There is a pressing need for enhanced eye health research in India” Nikkhil K Masurkar, Chief Executive Officer, Entod Pharmaceuticals “Indian pharma firms must remain updated and adapt to changing requirements continually” Ravi Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) 33
8 BIO EDIT BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com R&D on Track? There have been two recent developments in the field of research and development and innovation in the pharmaceutical sector. Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare unveiled the national policy on R&D and innovation in the pharma and medtech sector in September 2023. Launching such a policy was crucial in view of Finance Minister Nirmala Sitharaman’s pharma research-related budget announcements like allowing private companies to use the government lab facilities for R&D and committing Rs 5,000 crore in the next five years under the Promotion of Research and Innovation in Pharma Med Tech sector (PRIP). Both these announcements would have been futile without a proper R&D policy. Hence, creating a proper practical framework to back up the budget announcements within seven months needs appreciation. By proposing streamlining the processes and incentivising the R&D efforts the policy intends to promote R&D and innovation to achieve high quality, accessibility, and affordability goals for medicines while bolstering India’s presence in the international pharmaceutical industry. Almost simultaneously, just before that, the Union Commerce Ministry released the draft patent amendment rules, to help speed up patent processing. Hence, the timeline for filing requests for examination has been reduced from 48 to 31 months. Also, the time for applicants to reply to notice on pre-grant opposition (PGO) has been reduced to two months. Although both amendments will help reduce the timeline, they would also pressure the involved parties to prepare their documents to respond. The introduction of a fee for PGO may compromise the position of interest groups to intervene in case of unmerited patents as such groups like those of patients’ interests, among others, may not be able to afford the fee. The amendments also propose extending the period of working statement submission from the current annual to three financial years. The condition to disclose where the patented product is manufactured and prices of those products has also been removed. Both these moves appear to be against transparency. Experts feel that these amendments may also affect the availability of essential medicines to the people at affordable prices. Another amendment that may affect the PGO is that the filing of PGO, which was previously open to anyone, will be at the discretion of the patent controller. The controller would have sole authority to decide who can file PGO. By such moves, the government’s intention to make drugs available at affordable prices remains unclear. On one hand, the medical council compelled doctors to write only generic names of drugs and not brand in prescriptions (the move was subsequently suspended due to stiff opposition from doctors) to make affordable drugs available to patients. On the other hand, the Commerce Ministry proposes amendments that may not make it possible to make drugs cheaper. The national R&D policy would create an enabling environment to promote R&D and innovation. Dr Mandaviya underlined the importance of the policy when he described this as a transformative stage in the Indian drugs and med-tech sector. Amendments suggested to the patent rules also expedite the process of getting patents and that too would help pharma companies. So, the whole environment and the ecosystem will be encouraging R&D and innovations in the pharma sector. However several experts and patient groups are opposing some of the amendments as they are not as favourable to patients as they claim. As a result, those amendments have become controversial. The government may have to reconsider some of the amendments taking into account the objections raised by public health advocacy groups. The sooner the government does that the better. Otherwise, it may have to take another long U-turn just as in the case of the new Drugs, Medical Devices and Cosmetics Bill 2023. Several powerful organisations had demanded recall of the bill which was to be moved in the Parliament in the monsoon session. The minister later assured the industry bodies that the bill would be adequately discussed with stakeholders. Let the patent amendment rules not face a similar situation and the government proactively consider the views of patients and public health groups. Dr Milind Kokje Chief Editor [email protected]
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To promote and enhance patient safety and improving the healthcare quality, NATHEALTH, Healthcare Federation of India has signed a Memorandum of Understanding (MoU) with the National Accreditation Board for Hospitals (NABH) and Healthcare Providers, a constituent Board of Quality Council of India (QCI), an autonomous body under Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India. The aim of this strategic partnership between the two prominent healthcare entities seeks to promote patient safety, enhance the quality of healthcare services, and drive positive changes in the healthcare ecosystem. By pooling their expertise and resources, these organisations aim to drive positive changes that have a lasting impact on the healthcare sector. Under this partnership, NABH and NATHEALTH will collaborate on various initiatives, including joint initiatives to enhance patient safety and quality healthcare practices; jointly develop a white paper/ awareness module on patient safety outlining the best practices around consumer safety measures and conduct a series of expert sessions to disseminate this across healthcare caregivers and broader health system. NABH, NATHEALTH collaborate to improve healthcare quality 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Karnataka unveils BengaluruDeclaration of FICCI Cancer Care Task Force Centre institutes Rashtriya Vigyan Puraskar spanning 13 domains The Government of India has come out with a new set of National Awards in the field of Science, Technology and Innovation known as “Rashtriya Vigyan Puraskar’’ (RVP). The objective of RVP is to recognise the notable and inspiring contribution made by the scientists, technologists, and innovators individually or in teams in various fields of science, technology and technology led innovation. The RVP shall be given in the 13 domains, namely Physics, Chemistry, Biological Sciences, Mathematics & Computer Science, Earth Science, Medicine, Engineering Sciences, Agricultural Science, Environmental Science, Technology & Innovation, Atomic Energy, Space Science and Technology, and Others. The representation from each domain/field, including gender parity will be ensured. All nominations received for the Rashtriya Vigyan Puraskar awards shall be placed before the Rashtriya Vigyan Puraskar Committee (RVPC) to be headed by the Principal Scientific Adviser (PSA) to Government of India and comprising Secretaries of Science Departments, members of Science and Engineering Academies and some distinguished scientists and technologists from different fields of science and technology. Dinesh Gundu Rao, Minister for Health and Family Welfare, Government of Karnataka, recently unveiled a comprehensive nine-target strategy as part of the Bengaluru-Declaration of FICCI Cancer Care Task Force. This initiative is dedicated to significantly reducing premature deaths caused by cancer, improving the quality of life as well as elevating cancer survival rates in the state. The FICCI Cancer Care Task Force requested the Government of Karnataka to provide emphasis on certain focus areas to improve the status of cancer care in the state, such as to drive screening coverage for cervical, breast and oral cancers in a significant manner; embed a robust gatekeeping and referral pathway for positive screened patients; and focus on increasing access to comprehensive cancer care facilities including medical, surgical and radiation oncology.
Tamil Nadu inks MoU with Maxivision to set up eye hospitals BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11 The Government of Tamil Nadu has signed a Memorandum of Understanding (MoU) with Maxivision Super Speciality Eye Hospitals to set up eye hospitals across the state under the project Velicham. Cataract is the leading cause of blindness in Tamil Nadu, accounting for about 82 per cent of all the cases among different causes. Glaucoma, Diabetic Retinopathy and other causes comprise six per cent each as the causes of blindness as per the Tamil Nadu Rapid Assessment of Avoidable Blindness and Diabetic Retinopathy survey. With an objective to cater primary eye care to large underserved people, in deep rural pockets of the state, the government has launched the project under the Public Private Partnership model with Maxivison Super Speciality Eye Hospitals. Maxivision plans to open 20 to 30 comprehensive eye hospitals and 100 plus vision centres to cater to the increasing needs for high quality, standardised eye care services across Tamil Nadu in the next two years. Through this MoU, the company will invest Rs 400 crore and employ over 2000 people in the state of Tamil Nadu within the next three to four years. Dr Mansukh Mandaviya, Union Minister of Chemicals and Fertilisers and Minister of Health & Family Welfare, Government of India recently launched the National Policy on Research and Development (R&D) and Innovation in Pharma-MedTech sector in India and Scheme for promotion of Research and Innovation in Pharma MedTech sector (PRIP). The Department of Pharmaceutical has proposed PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) scheme with a budget outlay of Rs 5000 crore. The objective of the scheme is to transform the Indian pharmaceuticals sector from cost based to innovation-based growth by strengthening the research infrastructure in the country. The scheme involves strengthening the research infrastructure by establishment of 7 Centres of Excellence (CoEs) at National Institutes of Pharmaceutical Education and Research (NIPERs). These CoEs would be set up in preidentified areas with a financial outlay of Rs 700 crore. Health Minister launches national policy on R&D and Innovation in Pharma-MedTech sector UAE, India ink MoU to drive investment and collaboration in advanced technologies The UAE and India will cooperate more closely in sustainable industrial development following a Memorandum of Understanding (MoU) signed recently at Emirates Palace. The MoU was signed by Dr Sultan Al Jaber, UAE Minister of Industry and Advanced Technology and Piyush Goyal, India’s Minister of Commerce and Industry. The MoU focuses on seven key areas, including supply chain resilience, renewable energy and energy efficiency, health and life sciences, space systems, artificial intelligence (AI), Industry 4.0 and advanced technologies, as well as standardisation and metroalogy. In health and life sciences, the countries will collaborate in the development of pharmaceuticals, the use of biotechnology, and R&D. Under the MoU, cooperation includes industrial and academic collaborations as well as collaborative research and development projects. The countries will also share best practices relating to science and technology policies.
12 FINANCE NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Syngene International, a leading global contract research, development, and manufacturing services organisation, has announced the purchase of a 17-acre land parcel in Genome Valley, Hyderabad as an extension to its existing research campus. Construction of the new facilities will begin in 2024, following the necessary statutory approvals. The company anticipates an investment of up to Rs 788 crore to develop the expanded campus in Genome Valley to its full potential, including the creation of up to 1000 jobs in science, in the next 5 years. Syngene’s existing research facility in Genome Valley was inaugurated in 2020 and accommodates over 900 scientists. The research carried out on the site focuses on discovery chemistry and biology, primarily for the global pharmaceutical industry. Syngene injects Rs 788 Cr to expand Genome Valley campus Bharat Serums and Vaccines Limited (BSV) recently hosted the groundbreaking ceremony of its new manufacturing plant at Genome Valley in Hyderabad, Telangana, in the presence of K T Rama Rao, Minister for Industries and Commerce; and Information Technology, Electronics and Communications of Telangana. BSV currently has a manufacturing facility in Ambernath, Maharashtra that caters to domestic and more than 80 export markets and a manufacturing facility in Aachen, Germany, that serves the international markets. The new manufacturing facility in Genome Valley will cover an area of 10 acres and involve an investment of Rs 200 crore. It aims to provide long-term employment opportunities to the people of the Telangana state as well as upskilling of capabilities. With this manufacturing facility, BSV aims to significantly increase its capacity in producing injectables with the commissioning of the fill-finish formulation line in phase 1 and an additional multi-product line in phase 2 of the project. Mumbai-based Glenmark Pharmaceuticals has entered into a definitive agreement with Nirma Limited to divest 75 per cent stake in its subsidiary, Glenmark Life Sciences Limited (GLS), at a price of Rs 615 per share for an aggregate consideration of Rs 5651 crore, subject to closing adjustments. Glenmark Pharma owns 7.84 per cent in GLS after the divestment. The transaction is subject to customary closing conditions precedent, including receipt of regulatory and shareholder approvals. Pursuant to the transaction, Nirma Limited will make a mandatory open offer to all public shareholders of GLS. This deal aligns with Glenmark’s strategic intent of moving up the value chain to become an innovative/brand led organisation, with continuous focus on core therapeutic areas of dermatology, respiratory and oncology. Glenmark Pharma divests majority stake in Life Sciences biz for Rs 5651 Cr Bharat Serums and Vaccines invests Rs 200 Cr in new facility in Hyderabad
Cytiva opens new manufacturing facility and experience centre in India BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COMPANY NEWS 13 As India works to become a biologics manufacturing hub, global life sciences leader Cytiva is expanding with the opening of a 33,000 sq ft manufacturing facility in Pune. The new facility will manufacture Cytiva’s bioprocessing equipment including tangential flow, virus filtration, and inactivation systems. The facility will also be home to the Cytiva Experience Centre which will provide immersive training programmes for upstream and downstream technologies as well as digital and automation software. Additionally, customers will have greater access to thought leadership events and to demonstrations of Cytiva’s market-leading products, such as ÄKTA, Allegro, iCELLis and Sepax. Located at Hinjawadi Rajiv Gandhi Infotech Park, this new facility complements Cytiva’s existing facilities in Bengaluru which include a Fast Trak Centre, and a centre for research and development across bioprocess, discovery, medical, and genomic medicine businesses. AstraZeneca announces CDSCO approval of preventive therapy for Respiratory Syncytial Virus Biosergen and Alkem Labs to co-develop anti-infective for severe fungal infections Sweden-based Biosergen AB and Indian firm Alkem Laboratories have announced the signing of a co-development and licence agreement for BSG005, an innovative polyene macrolide, through phase II and phase III trials for sale in the Indian market. Biosergen is developing BSG005 for the treatment of severe and difficult-to-treat invasive fungal diseases. After the successful completion of two phase I studies, the first patient trial will be conducted in India on patients with severe fungus disease, who are intolerant or resistant to treatment with Amphotericin B. India is one of the countries with the highest incidence of difficultto-treat life-threatening fungal infections. Mumbai-based pharma company Alkem will manage the first clinical patient trial, which is expected to start immediately after the regulatory approval. The trial will enroll patients suffering from severe fungal infections such as mucormycosis (Black Fungus), aspergillosis, and candidiasis, who are intolerant or resistant to Amphotericin B. Alkem will invest in the clinical development of BSG005 and will be granted an exclusive licence to market it in India. AstraZeneca Pharma India has announced the marketing approval from Central Drugs Standard Control Organisation (CDSCO) to import and market ‘Palivizumab’ injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India. Respiratory Syncytial Virus (RSV) in children is a ‘major’ public health challenge faced across the globe today and is the second most common cause of death in children under 1 year of age (second only to malaria). This innovative therapy is indicated for prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for the disease. Currently, there is neither a vaccine nor a targeted treatment for RSV in India. Palivizumab however, is the only preventive therapy now approved in India that can help.
14 COMPANY NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Lupin acquires multiple legacy brands from Menarini to strengthen key therapy portfolio in India Mumbai-based pharma major Lupin has signed an agreement to acquire five legacy brands in strategic therapy areas - Gastroenterology, Urology and Anti-infectives from Menarini (A. Menarini India Private Limited and A. Menarini AsiaPacific Holdings Pte. Ltd.), along with the associated trademark rights. The brands are Piclin (Picosulphate Sodium), Menoctyl (Otilonium Bromide), Sucramal O (Sucralfate + Oxetacaine), Pyridium (Phenazopyridine) and Distaclor (Cefaclor). Lupin has been exclusively marketing these brands in the Indian market since July 2021 under a distribution and promotion agreement with A. Menarini India Private Limited. This strategic acquisition for the Indian market marks a significant step forward for Lupin as it continues to expand its presence in India. These legacy brands help Lupin in further enhancing its diverse portfolio and solidifying its position as a leading pharmaceutical organisation in India. Chennai-based Neuberg Diagnostics has announced the successful merger of Neuberg Supratech Reference Laboratory, Ahmedabad, and Neuberg Anand Reference Laboratory, Bengaluru, into Neuberg Diagnostics Private Limited. This merger has been facilitated through an NCLT court-based process, further solidifying Neuberg Diagnostics’ position as a frontrunner in the diagnostic industry. With a strategic vision to streamline operations and enhance efficiency, this merger brings together two prominent entities under the canopy of Neuberg Diagnostics Private Limited. The amalgamation has resulted in consolidating more than 80 per cent of the overall group revenues within a single entity, setting the stage for Neuberg Diagnostics to achieve remarkable milestones. The merger is projected to contribute to Neuberg Diagnostics’ ambitious target of achieving gross revenues exceeding Rs 1,000 crore as a group in the current fiscal year. With this united front, the company can leverage its enhanced capabilities to expand and offer an extensive range of cutting-edge diagnostic services to patients across India and beyond. Neuberg Diagnostics has set its sights on the future with plans to launch an Initial Public Offering (IPO) in the latter part of 2024 or the early months of 2025. Akums launches drug for ED and enlarged prostate treatment Neuberg Diagnostics merges Supratech and Anand Labs Akums Drugs and Pharmaceuticals, New Delhi-based contract manufacturing and development organisation (CDMO), has introduced an advancement in healthcare, the Tamsulosin + Tadalafil Capsule, to the Indian market. This innovative combined therapy, delivered in a fixed dose combination within a hard gelatin capsule, marks an important achievement for the company. Notably, Akums has become the first CDMO to obtain approval for the unique formulation of Tamsulosin 0.4/0.4mg + Tadalafil 2.5/5mg, as sanctioned by the Drugs Controller General of India (DCGI). Tamsulosin is a selective alpha 1A-adrenergic receptor antagonist. By impeding cGMP hydrolysis, Tadalafil promotes cGMP accumulation and the relaxation of vascular smooth muscle, facilitating the development of a physiologically-induced erection, contingent upon sexual stimulation.
SigTuple, a Bengaluru-based medtech startup that develops Artificial Intelligence (AI) powered digital microscopy solutions, has announced that its path-breaking device AI100 with Shonit (Peripheral blood smear application) has received US FDA 510(k) clearance. This is the first integrated hardware and AI medical device, and the first product in AI assisted digital microscopy from India to obtain the coveted clearance and one of the handful of companies in the world to obtain it. SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology, wherein a physical sample is digitally imaged through a microscopic lens and the AI models extract each cell and then classify it into over 30 different cell types. The pathologists can now review the samples remotely. Further, the AI helps make the pathologist be more efficient, by automating most of the review. Thus, the same pathologist can now handle a much larger number of samples than what she/he can currently, eliminating the need for an additional manual review. NeoDx Biotech Labs launches real time PCR kit for Acute Promyelocytic Leukaemia detection Medical Cobotics Centre opens in Delhi to foster innovation in healthcare SigTuple’s AI100 with Shonit receives US FDA 510(k) clearance BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com STARUPS NEWS 15 NeoDx Biotech Labs, a Bengalurubased startup at the forefront of innovative diagnostics, has introduced the PML-RARA Qualitative Real-Time PCR Kit and PML-RARA Quantitative Real-Time PCR Kit for the accurate and rapid detection of the PML-RARA fusion gene in Acute Promyelocytic Leukaemia (APL). A remarkable feature of NeoDx’s kits is their singletube assay, eliminating the need for additional cDNA steps during reverse transcription. Cancer is caused due to changes in the genes, which mainly affect cell growth and division. A reciprocal translocation between Chromosome 15 and Chromosome 17, expressed as t(15;17) causes Acute Polymyeloid leukaemia, a type of acute myeloid leukaemia (AML). NeoDx’s PML RARA Qualitative and Quantitative kits include TaqMan probes for specific detection of PML-RARA transcripts, alongside an internal control targeting the ABL1 gene, ensuring the robustness of the assay. These One-step RTPCR multiplex assays are specifically designed to detect PML-RARA transcripts in human EDTA whole blood or bone marrow aspirates, providing invaluable insights for diagnosing APL. iHub Anubhuti-IIITD Foundation (Technology Innovation Hub of IIIT-Delhi) and iHub Foundation for Cobotics (IHFC, Technology Innovation Hub of IIT Delhi) recently inaugurated their joint medical facility, ‘MCC-Medical Cobotics Centre’ on the Indraprastha Institute of Information Technology (IIIT) Delhi campus. The Medical Cobotics Centre is aimed at being India’s first state-of-the-art technology-enabled medical simulation and training facility for doctors, paramedics, technicians, engineers, biomedical researchers, and entrepreneurs. The centre is also equipped to offer hands-on simulation training to the medical fraternity across the country. The centre will also act as a test bed for many young startups in the medical field that are developing innovations in medical technology in digital medical healthcare and healthcare using AR/VR, AI, cobotics, robotics, cognitive sciences, and such. The MCC has launched its first ‘Call for Proposal’ for young startups, with funding up to Rs 1 crore available in digital healthcare and medical healthcare using the above application areas.
Pune-based startup Mylab Discovery Solutions has announced a groundbreaking advancement in new-born screening (NBS) with the introduction of its patentpending Point-of-Care device named MyNeoShield for newborn screening. This device is set to transform the landscape of new-born healthcare by making screening faster, more accessible, and more affordable, ultimately saving lives and preventing lifelong illnesses. The device supports all the seven tests done for newborn screening globallyG-6-Phosphate Dehydrogenase Deficiency (G-6-PDD); Galactosemia; Phenylketonuria; Biotinidase Deficiency; 17-Hydroxyprogesterone; Immunoreactive Trypsinogen; and thyroid stimulating hormone (TSH). Traditionally, new-born screening has been a complex process, involving the collection of samples from new-borns, their transportation to centralised testing centres, and a wait time of up to a day or more for results. This innovative device brings the power of new-born screening directly to healthcare providers, allowing for quick and efficient testing at the point of care. This Point-of-Care device for newborn screening is set to be available commercially from November. The company plans to take the device to global markets with its partners. Mylab unveils new-born screening device MyNeoShield 16 STARUPS NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Superceuticals unveils biochemical and biophysical analyser Gurugram-based startup Superceuticals has announced the launch of its revolutionary SC-AN 2.4 product. With an unwavering commitment to transforming healthcare in India, Superceuticals has introduced this state-of-the-art diagnostic and telemedicine marvel that is set to redefine the healthcare landscape. SC-AN 2.4 is a game-changing biochemical and biophysical analyser, employing advanced technologies such as electrical impedance, amperometry, voltammetry, cell counting, photometry, and immunological reactions with fluorescence assay. This kiosk-based system is capable of running over 85 parameters and delivering clinically validated reports within minutes, significantly reducing diagnosis time and human errors. It boasts an impressive array of key features designed to revolutionise healthcare. One of its standout capabilities is its ability to provide instant reports, delivering results in as little as 10 minutes, ensuring swift and efficient patient care. US FDA clears Qure.ai’s chest X-ray solution for identifying heart failure risk Mumbai-based startup Qure.ai has announced US Food and Drug Administration (FDA) clearance for measuring the cardiothoracic ratio (CTR) utilising its artificial intelligence (AI)-enabled chest X-ray solution, qXR-CTR. The qXR-CTR is a deep-learning-based computer vision algorithm designed for use by physicians in all inpatient and outpatient settings, to automate the CTR assessment on chest radiographs (CXR). Precisely, it measures the ratio of the maximum transverse diameter of the heart to the maximum inner transverse diameter of the thoracic cavity, providing the most accurate indicator of cardiomegaly on plain film. The clearance of qXR-CTR marks the company’s 12th FDA-cleared algorithm. Previous FDA-cleared findings by Qure.ai include Endotracheal Tube location, Tracheostomy tube location, Pneumothorax, and Pleural Effusion identification for CXR; qER for intracranial haemorrhage detection on head CT scans, and qER Quant for quantifying critical abnormalities on head CT scans.
The World Anti-Doping Agency (WADA) and World Health Organisation (WHO) have signed a four-year Memorandum of Understanding (MoU) to allow experts from both international organisations to collaborate and share information on issues where anti-doping and public health intersect. The agreement will run until October 1, 2027 and provides a framework of cooperation between WHO and WADA to further their goals, specifically with regards to health promotion, the prevention of substance abuse and emerging drugs, and the promotion of clean sport. The themes of the MoU include prevention and assessment of health risks associated with psychoactive substance use and related disorders, with a focus on doping compounds and substance use among athletes; awareness raising and advocacy for clean sport and substance misuse prevention worldwide; collaboration on substandard and falsified medical products, including identification of new emerging psychoactive drugs through sharing of information, mutual support, and engagement with sport federations; and reporting on abuse and misuse of falsified and substandard medical products in sport. WHO, WADA sign MoU to collaborate on clean, drug-free sport Germany has deepened its longstanding engagement with the World Health Organisation (WHO) with two new agreements: one to contribute a further €40 million to WHO’s work in health emergencies, and a second to host the Berlin-based WHO Hub for Pandemic and Epidemic Intelligence. The Hub was established with Germany’s support in Berlin in September 2021 to provide the world with better data, analytics and decisions to detect and respond to health emergencies. With the new contribution, Germany has provided €53.5 million so far this year to support WHO’s response to more than 50 active health emergencies. Germany is an all-time top donor to WHO’s Contingency Fund for Emergencies (CFE), having contributed €115 million since the CFE’s inception in 2015. The contributions have made a significant impact on the health of people caught up in humanitarian crises. Germany commits additional €40M to WHO’s health emergency initiatives The World Health Organisation (WHO) has recommended a new vaccine, R21/Matrix-M (developed by the University of Oxford and the Serum Institute of India), for the prevention of malaria in children. The recommendation follows advice from the WHO: Strategic Advisory Group of Experts on Immunisation (SAGE) and the Malaria Policy Advisory Group (MPAG). The R21 vaccine is the second malaria vaccine recommended by WHO, following the RTS,S/ AS01 vaccine, which received a WHO recommendation in 2021. Both vaccines are shown to be safe and effective in preventing malaria in children and, when implemented broadly, are expected to have high public health impact. Malaria, a mosquito-borne disease, places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year. Demand for malaria vaccines is unprecedented; however, available supply of RTS,S is limited. The addition of R21 to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk. WHO recommends R21 vaccine for malaria prevention in updated advice on immunisation BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com WHO NEWS 17
The Pan American Health Organization (PAHO) and FIND have signed an agreement to expand access to essential medical diagnostic tests in Latin America and the Caribbean. The partnership will focus on improving equitable and timely access to quality-assured, cost-effective diagnostic technologies and services to improve health outcomes, advance towards health for all, enhance pandemic preparedness, and contribute to the Sustainable Development Goals (SDGs) in the Region. The PAHO and the global non-profit FIND agreement seeks to promote testing and diagnostics at the first level of health care, which can improve the timely diagnosis and contribute to the implementation of national disease elimination strategies. The partnership will also strengthen regional capacity for the development and manufacturing of diagnostic technologies, facilitate key dialogues to promote innovation in diagnostics and provide technical support to strengthen regulatory capacity for diagnostics in Latin America and the Caribbean. CEPI, Global Affairs Canada deepen collaboration to strengthen international biosecurity Africa gets $1B shot in the arm to boost health systems PAHO and FIND improve access to diagnostics in Latin America and the Caribbean The Coalition for Epidemic Preparedness Innovations (CEPI) has announced a renewed collaboration with Global Affairs Canada of CAD 1 million in funding to accelerate the development of vaccines against emerging infectious diseases. This funding will support CEPI’s continued work to manage the inherent biological security risks of the 21st century, bolstering the coalition’s ability to engage with the security community, and catalyse new and stronger health security partnerships. Through this collaboration, CEPI will continue efforts to advance the 100 Days Mission, a goal to reduce the time taken to develop safe and effective vaccines against pathogens with pandemic potential to 100 days. In addition, as stewards of global public funds, CEPI has a critical responsibility to ensure that CEPIfunded R&D is conducted safely and securely. This funding builds on Global Affairs Canada’s investment of CAD 100 million announced earlier this year to support CEPI’s five-year strategic plan. Global Affairs Canada’s Weapons Threat Reduction Programme (WTRP) will support the development and implementation of CEPI’s biosecurity strategy. The World Bank has approved the Health Emergency Preparedness, Response, and Resilience Programme (HEPRR) which, over the course of two to three phases, is expected to drastically improve multi-sectoral preparedness and response to health emergencies in Eastern, Central, and Southern Africa. In the first phase alone, the programme is expected to reach more than 182 million people, with the number of beneficiaries increasing substantially over the next seven years as additional countries and implementing partners join. The programme provides $1 billion in credit and grant financing, with $359 million provided under phase 1 which covers the following countries or institutions: Ethiopia, Kenya, Sao Tome and Principe, the East, Central and Southern Africa Health Community (ECSA-HC) and the Intergovernmental Authority on Development (IGAD). 18 WORLD NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com
The US Food and Drug Administration (FDA) has announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The committee should be fully operational in 2024. To support the development of safe and effective digital health technologies while also encouraging innovation, the FDA will solicit views from the committee, which will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds. This will help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations. France releases new global health strategy EC, EIB, Gates Foundation join hands to address global health opportunities US establishes new advisory committee on digital health technologies France has released its Global Health Strategy for 2023-2027, in Lyon recently. As a lead player for shaping global health policies, France has called on national and international stakeholders to support building a new global health architecture towards achieving the Sustainable Development Goals (SDGs) and in particular SDG3, focused on ensuring healthy lives and promoting wellbeing for all, at all ages. The new Health Strategy aims to help reduce health inequalities and strengthen the One Health approach to better prevent and prepare for future global health emergencies. It urges the global community to address the health consequences of climate change and the environmental impact on health systems. The 2023- 2027 French Strategy for Global Health is the fruit of collaboration involving a wide range of French actors: public agencies, civil society organisations, higher education and research organisations, scientific institutions, foundations, organisations of human, animal and environmental health specialists, local government bodies and the private sector. They will all be represented within a monitoring committee to track the Strategy’s implementation and progress. The European Commission (EC), the European Investment Bank (EIB) and the Bill & Melinda Gates Foundation have announced a new financing partnership to address critical global health opportunities: eradicating polio and ensuring that innovations in health are more accessible to the people who need them most. The expected €1.1 billion financing package aims to provide new funding to eradicate a human disease for only the second time in history and help solve the health and development challenges faced by the world’s most vulnerable people, who otherwise do not get fair access to healthcare services and innovations. The partnership marks a significant increase in funding for global health and human development under the European Commission’s European Fund for Sustainable Development plus (EFSD+) and is expected to include a match of new complementary funding for global health by the Bill & Melinda Gates Foundation, maximising the impact of every Euro committed by the EU and the European Investment Bank. BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com WORLD NEWS 19
Diabetes mellitus, a chronic metabolic non-communicable disease (NCD), has attained epidemic proportions worldwide. Several studies conducted over the last two decades have revealed a huge burden of diabetes in India, which translates to a large population of individuals at risk of not only cardiovascular disease but also chronic complications of diabetes such as kidney, foot, and eye disease. The cost of treating them is crippling not just individuals, but also the society and the country as a whole. For instance, diabetic foot ulcers and infections are responsible for more than 30 per cent of hospitalisations related to diabetes mellitus. On the other hand, there is a higher prevalence of diabetic retinopathy among the urban population than in the rural population. India must step up state-specific policies and technological interventions on a war footing to arrest the rapidly rising epidemic of diabetes. AI-Driven Therapeutics for DIABETES 20 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 21 According to the Indian Council of Medical Research (ICMR) study conducted in 2021, India has over 101 million people living with diabetes compared to 70 million people in 2019, with at least 136 million people (15.3 per cent of the population) having prediabetes. A ground-breaking research paper of a comprehensive epidemiological study funded by ICMR was recently published in the globally acclaimed medical journal, The Lancet Diabetes and Endocrinology, revealing that Goa has the highest prevalence of diabetes while Uttar Pradesh is at the lowest. Likewise, Sikkim has the highest number of cases with prediabetes while Mizoram has the lowest. Funded by the ICMR and Ministry of Health and Family Welfare, Government of India, the Indian Council of Medical Research–India Diabetes (ICMRINDIAB) study is the largest survey on diabetes and other metabolic NCDs undertaken in India. On one hand, this study identifies regional and state-level variations in the prevalence of diabetes across the country. At the same time, on the other hand, it highlights the growing complications due to the rising number of diabetes cases. “There is a sizeable population in India at risk of long-term organ complications due to metabolic diseases such as diabetes, which are likely to pose a major public health challenge in the near future. There is also evidence that the epidemic is spreading to rural areas, which lack the health infrastructure needed to effectively diagnose and manage these conditions”, says Dr V Mohan, Chairman, Dr. Mohan’s Diabetes Specialities Centre (DMDSC) and Madras Diabetes Research Foundation (MDRF). The Diabetes Domino Effect Complications from diabetes can be classified as microvascular which include nervous system damage (neuropathy), renal system damage (nephropathy) and eye damage (retinopathy), diabetic foot ulcers or macrovascular disease that include cardiovascular disease, stroke, and peripheral vascular disease. Based on a figure of about 40 million people with diabetes in India, there would be at least 7 million with diabetic retinopathy, 0.8 million with diabetic nephropathy, 10.4 million with diabetic neuropathy, 8.5 million with coronary artery disease, and 2.5 million with peripheral vascular disease. The burden due to diabetic complications is very high in India simply because of the large number of people with diabetes. Data reveals that approximately, 12-15 per cent of people with diabetes suffer from diabetic foot ulcers at least once in a lifetime, and 5-24 per cent of them finally lead to limb amputation within 6-18 months “There is a pressing need for more innovative programmes and institutions for noncommunicable diseases, particularly diabetes.” - Dr Jitendra Singh, Union Minister of Science and Technology, Government of India “There is a sizeable population in India at risk of long-term organ complications due to metabolic diseases such as diabetes.” - Dr V. Mohan, Chairman, Dr. Mohan’s Diabetes Specialities Centre (DMDSC) and Madras Diabetes Research Foundation (MDRF) “For people living with type 2 diabetes, insulin is essential in reducing the risk of kidney failure, blindness and limb amputation.” - Dr Kiran Mazumdar Shaw, Executive Chairperson, Biocon “Cell therapy-based approaches have several advantages compared to others, as it allows therapeutic targeting of different phases of wound healing in diabetic foot ulcers.” - Dr Pawan Gupta, Senior Vice President, Medical and Regulatory Affairs, Stempeutics
22 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com after the first evaluation. On the whole, diabetic retinopathy and diabetic foot ulcer are the most frequent, and the most disabling complications of diabetes mellitus, with a sinister impact on patients’ quality of life. As a result, diabetic retinopathy, one of the first manifestations of microvascular disease, remains today, despite improvements in monitoring and treatment, one of the leading causes of blindness worldwide. Leveraging AI Technology In India, the threat of diabetic retinopathy is looming with a recent study showing a 16.9 per cent prevalence. This has led to the call for more innovative approaches to prevent and treat diabetic retinopathy. One promising solution is the use of artificial intelligence (AI) for improved eye care in patients with diabetic retinopathy. Although, currently there are a few private players in India, both at the industry and academic level, that are utilising AI and related technologies to develop new tools for quick detection of diabetic retinopathy, its complete implementation is still a long way to go. To name a few, Bengaluru-based companies such as Remidio, and Forus Health are some of the prominent players that are strengthening the use of AI in the timely and effective detection of diabetic retinopathy in India and other parts of the world. Remidio has developed the world’s only smartphone-based automated algorithm that works offline. The algorithm harnesses deep learning technology deployed on a smartphone-based fundus camera, Remidio NM-FOP, to detect referable diabetic retinopathy within 10 seconds. The company has recently received CE mark approval for its technology, closely following the nod received from Singapore’s Health Sciences Authority (HSA). “People with diabetes require regular and repetitive annual retinal screening for timely detection of diabetic retinopathy in addition to diabetes assessment. The current utility of AI in diabetic retinopathy is limited to preventive care, that is, in screening, with a rising interest in predictive features toward disease advancement and treatment burden. The integration of AI into healthcare can help in larger coverage for screening for diabetic retinopathy but there are several challenges that stand in the way of wider adoption of AI such as workflow integration, enhanced explainability and interpretability, workforce education, data quality, access, and sharing and compliance with privacy”, says Dr Rajiv Raman, Senior Vitreo-Retinal Consultant, Sankara Nethralaya. In a similar vein, Dr Doris Macharia, Senior Vice President, Global Programmes, Orbis says, “In India and elsewhere around the world, investment in AI is needed to bridge the gap in eye care management, especially in ways that can make managing diabetic retinopathy cost-effective, easier, and more convenient, eventually reducing vision loss and blindness in the country.” Besides diabetic retinopathy, there’s promising technology to detect diabetic foot ulcer. Punebased biotech startup Mylab Discovery Solutions has recently partnered with a UK-based firm to develop a kit to detect diabetic foot ulcers. It is one of the world’s first point-of-decision molecular technology solutions, delivering early identification of the spectrum of microbial flora in the ulcer and supporting clinicians to plan appropriate Major complications arising due to diabetes ● Diabetic Retinopathy ● Diabetic Foot Ulcers ● Neuropathy ● Nephropathy ● Cardiovascular Disease ● Stroke
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 23 “People with diabetes require regular and repetitive annual retinal screening for timely detection of diabetic retinopathy in addition to diabetes assessment.” - Dr Rajiv Raman, Senior Vitreo-Retinal Consultant, Sankara Nethralaya “The public health centres should engage more with the industry players that are developing multiple diabetes management apps in order to educate, raise awareness and increase communication.” - Dr Uma Nambiar, International Healthcare Consultant “In India and elsewhere around the world, investment in AI is needed to bridge the gap in eye care management, especially in ways that can make managing diabetic retinopathy cost effective.” - Dr Doris Macharia, Senior Vice President, Global Programmes, Orbis “UK NHS’s Diabetic Eye Screening Programme in GP offices, was able to eliminate Diabetic Eye Disease as a cause of blindness in working age adults, through early detection.” - Dr Anand Sivaraman, Founding Director & Chief Executive Officer, Remidio antimicrobial therapy regimes. Another complication that arises from diabetes is nerve damage. One in ten people and one in two diabetics suffer from Peripheral Neuropathy, a chronic clinical condition, wherein the peripheral nervous system is damaged. Various epidemiological studies from India have shown the wide prevalence of nerve damage varying from 5 to 2400 per 10,000 population. The prevalence of nerve damage in India is estimated to vary between 13.1 and 45 per cent in different populations which could be attributed to different types of diabetes. Highlighting the technological advancements in this space, researchers at the Department of Mechanical Engineering, Indian Institute of Science (IISc), Bengaluru in collaboration with the Karnataka Institute of Endocrinology and Research (KIER), have developed a set of unique self-regulating footwear utilising 3D printing technology. The footwear can be especially beneficial for people who have diabetic peripheral neuropathy. The researchers have currently collaborated with Bengaluru-based startups Foot Secure and Yostra Labs to commercialise this product. Another example is of Mumbai-based startup
GLP-1 medications could potentially emerge as significant market catalyst for diabetes With millions of people diagnosed with diabetes in India and an even larger undiagnosed population, we are confronted with a significant impending burden caused by non-communicable diseases. Diabetes not only impacts the human body with its own set of symptoms, but also significantly elevates the risk of comorbidities such as cardiac, renal, and other inflammatory conditions, owing to fluctuations in glucose levels. The irony is that while income levels are rising in India, one must make an even more critical assessment of how our consumption patterns are creating more problems for us. As the prevalence of the disease continues to rise, one key concern is our capacity to effectively address the condition. Currently, the available resources are relatively limited in terms of specialists, which emphasises the need for Amit Mookim, Managing Director, IQVIA South Asia 24 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Ayati Devices, in collaboration with the Indian Institute of Technology (IIT) Bombay, which has developed a quick screening tool to quantify the severity of foot neuropathy. The product has been approved by the Central Drugs Standard Control Organisation (CDSCO). Addressing Complications Effectively With insulin and oral anti-diabetic drugs holding the major interest of the Indian pharma sector, there are very few companies that are investing in developing specific solutions for diabetes-related complications. The market for oral antidiabetic drugs is fragmented whereas the market for insulin is concentrated in nature with top players dominating the majority of the industry. The volume of new entrants in the patented oral antidiabetics and insulin market is low, while in the generic oral antidiabetics market it is comparatively higher. “Insulin is the bedrock of diabetes treatment. It turns a deadly disease into a manageable one for 9 million people with type 1 diabetes. For people living with type 2 diabetes, insulin is essential in reducing the risk of kidney failure, blindness and limb amputation. However, one out of every two people needing insulin does not get it because of a number of factors including high prices”, points out Dr Kiran Mazumdar Shaw, Executive Chairperson, Biocon. Addressing diabetes-related complications, Asprius Lifesciences, a Gujarat-based pharmaceutical company, has developed a new treatment for diabetic neuropathy. The company has already filed a patent for its innovative fixed-dose combination drug. Focusing on another diabetes-related complication, diabetic nephropathy or complication related to the kidneys, Bayer recently launched its drug Finerenone to treat chronic kidney disease associated with type-2 diabetes in India. The drug will be sold under the brand name Kerendia in India. Mumbai-based pharmaceutical firm Alkem Laboratories is exploring the use of 4D bioprinting technology in collaboration with a South Korean company to treat the deep, non-healing, chronic wounds associated with diabetic foot ulcers. Likewise, Bengaluru-based Stempeutics Research, a group company of Manipal Education and Medical Group, is currently undergoing phase 3 clinical trials for its innovative product to treat non-healing diabetic foot ulcers. The company has out-licensed the product to pharmaceutical firm Cipla for exclusive marketing rights for five years in India. According to Dr Pawan Gupta, Senior Vice President, Medical and Regulatory Affairs, Stempeutics, “Current standard of care for treating non-healing diabetic ulcer includes local wound
a broader involvement of consulting physicians and various medical specialties in managing the disease pathways. There is also a growing need for increased awareness among patients and their caregivers. Globally, diabetes is a condition where we have seen that through a combination of medication and a shift in lifestyle, encompassing dietary habits and exercise routines, we can not only effectively manage the condition but also potentially reverse it, particularly in its early stages. Digital tools (such as wearables) have been particularly helpful in this regard. We are seeing an increase both in their adoption as well as their effectiveness to nudge people towards the right behaviour. These tools also offer an ongoing dialogue between care providers and patients, helping in better management of this lifestyle disease. As the healthcare infrastructure develops in India, it is heartening to see an increased supply of chronic medicines through Jan Aushadhi centres, including drugs for diabetes management. The recent patent expiries, resulting in loss of exclusivity of drugs such as sitagliptin, vildagliptin, dapagliflozin, and more recently, linagliptin, have driven generics volume expansion in the market. The doctors are also increasingly prescribing a combination of molecules, with the expectation of driving better outcomes. A noteworthy international development has been the introduction of new GLP-1 medications, by two global pharmaceutical companies, for treating type 2 diabetes and addressing obesity, a significant contributing factor to the onset of diabetes. This could potentially emerge as a significant market catalyst, as its adoption grows across countries. That being said, in India, there is still a need to raise awareness, encourage healthier eating habits, promote a healthier lifestyle, and expand access to both medications and healthcare providers. BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 25 care with sterile dressings, repeated debridement of necrotic tissues, and pressure off-loading. However, most results are far from satisfactory, and about 20 per cent of patients with diabetic foot ulcers undergo limb amputation. Since DFU is a complex clinical condition, current approaches endeavour to address one single approach, which leads to the failure of complete healing. Cell therapy-based approaches have several advantages compared to others, as they allow therapeutic targeting of different phases of wound healing.” Also, Mumbai-based Centaur Pharma has already launched a new chemical entity (NCE)- based product for the treatment of diabetic foot ulcers in the Indian market, in collaboration with German company Cyto Tools. Entod Pharma is another player from Mumbai that has recently developed a saffron-based eye care supplement to treat and manage diabetic retinopathy, along with other eye-related diseases. Diagnose, Identify, Treat Although the Union Health Ministry has launched an ambitious initiative of screening and putting 75 million people with hypertension and diabetes on standard care by 2025, equal attention is needed to diagnose, identify and treat the organ complications that arise due to diabetes in an economical way. Currently, there is a dearth of economic evidence about screening programmes, affected age groups, and frequency of screening for diabetes and related diseases in Indian settings. “Right intervention to delay the onset of diabetes and the related complications is key. The public health centres should engage more with the industry players that are developing multiple diabetes management apps in order to educate, raise awareness and increase communication about prediabetes, diabetes and the related complications. Health education and the engagement of people with diabetes about the related complications such as diabetic retinopathy, the risk it poses to their vision and the need for annual retinal examination, are essential and should be made mandatory”, says Dr Uma Nambiar, international healthcare consultant. Sharing his perspective, Dr Anand Sivaraman, Founding Director and Chief Executive Officer, Remidio says, “There is an urgent need to make the diagnosis of diabetes and complications such as diabetic retinopathy accessible and affordable, particularly at primary care centres, using technology like AI and portable imaging systems that can be used by nurses and health workers. For instance, UK NHS’s Diabetic Eye Screening Programme in GP offices was able to eliminate Diabetic Eye Disease as
26 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Source: https://drropindia.org/diabetic-retinopathy/ Map of India showing the location of districts where The Trust’s Diabetic Retinopathy project was implemented In fact, the government of Kerala is trying to replicate the same model with Remidio’s device with deployment in more than 150 primary health centres. Dr Jitendra Singh, Union Minister of Science and Technology who is also a renowned diabetologist and Professor, is optimistic that India is ready to lead technology-driven diabetes care. But he insists that results would be better following public-private partnerships. “There is a pressing need for more innovative programmes and institutions for non-communicable diseases, particularly diabetes. The necessity of dedicated diabetes institutions for research and training will lead to ultimately contributing to better healthcare and well-being for all. It is therefore the right time to generate as much Indian data as possible because the goal should be to develop Indian treatment regimens for Indian patients, and Indian solutions for Indian problems. And this would be possible with effective collaboration between the public and private sector”, the minister emphasised. We hope to see more investments and engagements from both the public and private sectors in India in newer technologies and areas to detect diabetes and related complications more accurately and economically in the years to come. Dr Manbeena Chawla [email protected] a cause of blindness in working-age adults, through early detection. The programme commenced in 2003 and reached population coverage across the whole of England by 2008. The benefit of the programme is that, in the UK, diabetic retinopathy is no longer the leading cause of certifiable blindness in the working age group.” A Diabetic Retinopathy pilot project was implemented in 10 districts in 10 selected states from 2014-2019 as part of the UK-based Queen Elizabeth Diamond Jubilee Trust (The Trust) wider programme to prevent avoidable blindness across the Commonwealth. The objective of this initiative was to pilot integrated models of comprehensive, sustainable and replicable DR care embedded in the public health system. During the course of the programme implementation, several operational research projects were conducted. Different interventions to promote DR screening were tested, including health education, screening at the point of care, financial incentives for health workers and health education delivered by community peer support groups. The accuracy of smartphonebased technology to detect DR was also evaluated. The programme also resulted in the publication of national diabetic retinopathy guidelines for India. Diabetic Retinopathy Project in India
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 27 “Through diligent management, people with diabetes can reduce risk of causing damage to other parts of the body” « Omar Sherief Mohammad, Cluster Head India, Middle East & Africa, Roche Diabetes Care While India is significantly burdened by diabetes-related complications, constituting a considerable portion of the global statistics, public-private partnership appears to be a key mantra to combat the disease. Omar Sherief Mohammad, Cluster Head India, Middle East & Africa at Roche Diabetes Care (RDC) talks to BioSpectrum about how the company is collaborating with the government in fighting the chronic problem of diabetes in the country. Edited excerpts; How is RDC addressing the diagnosis/ treatment of diabetes-related complications such as retinopathy, neuropathy, foot ulcers etc. in India? What are the key challenges in identifying the co-morbidities? Regular screening and self-monitoring of blood glucose (SMBG) are two critical tools in managing diabetes and its related complications. While screening can help detect diabetes at an early stage, regular monitoring can help ensure that people with diabetes spend more time within the range. Together these two enable detection of complications early and also timely intervention which helps to reduce the risk of disease progression and long-term burden. Roche offers smart blood glucose monitoring (BGM) devices, Accu-Chek, that facilitate effective blood glucose monitoring, contributing to improved management of co-morbidities associated with diabetes. Accu-Chek smart BGM devices connect seamlessly via Bluetooth with the innovative mySugr app and play a crucial role in supporting individuals in their diabetes management journey. With the help of connected meters one can easily transfer their blood glucose data to the app. The app then uses this data in tracking blood glucose levels and patterns of peaks and lows, medication, and other relevant health data like diet, HbA1C analytics etc. Through this diligent management, people with diabetes can ensure that they spend more time within the specified range, thereby reducing their risk of causing damage to other parts of the body leading to comorbidities. How is RDC strengthening its association with the government to improve screening of diabetes nationally, along with the related complications? In 2023 Roche partnered with Tamil Nadu state government for their Makkalai Thedi Maruthuvam (MTM) programme aimed towards early detection, timely management and reduction of noncommunicable disease (NCD) burden by door-to-door screening of population above the age of 18 years. To execute this programme, Roche collaborated with VinCense – a public health based digital solution partner to conduct population based NCD screening & management in Madurai Corporation Urban Primary Health Centres (UPHCs). Through this joint initiative, Roche leveraged technology in order to improve accessibility, availability and affordability of diagnostics and to design data-driven models to improve the public health care system. In the pilot phase of the project (December 2022 to September 2023), Roche supported screening of 67,370 persons in Tamil Nadu. We have also successfully collaborated with the Government of Uttar Pradesh, supporting both the Gestational Diabetes and Non-Communicable Disease Programmes. This collaborative effort bridges learning and execution gaps by training team members and reaching out to Auxiliary Nurse Midwife (ANM) and An Accredited Social Health Activist (ASHA) workers across blocks in the state, covering over 18 districts, 110 blocks, and training more than 3125 Anganwadi and Asha workers. Further Roche conducted a diabetes screening and awareness camp at the Accountant General Office in Bhopal, Madhya Pradesh, testing over 200 people from the Indian Audit & Accounts Department. Furthermore, RDC extended its partnership with the state Government of West Bengal for the 6th term, reinforcing our commitment to improving diabetes care. We also collaborate with non-for-profit organisations such as Sweetlings and Changing Diabetes in Children (CDiC) which is a part of the Novo Nordisk Education Fund (NNEF) to provide access to diabetes care to underprivileged children with type 1 diabetes across the country.
28 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com The Indian Council of Medical Research –India Diabetes (ICMR-INDIAB) study published in 2023 reiterates the significant non-communicable diseases (NCDs) burden in the country. While the diabetes epidemic seems to have peaked in some of the more developed states, most of the less developed states are still in the initial take-off phase. The prevalence of other cardiometabolic risk factors such as obesity, hypertension, and dyslipidaemia is uniformly high across the country, particularly in the urban areas. The focus should be on implementing interventions to minimise the progression of prediabetes to diabetes in states where the diabetes epidemic has yet to peak, and providing optimal care to ensure comprehensive risk factor reduction in individuals with diabetes so as to prevent complications in those states where the epidemic has already stabilised. Thus, there are serious implications for the nation, warranting urgent state-specific policies and interventions to arrest the rapidly rising epidemic of metabolic NCDs in India. I ndia is the second largest contributor to the worldwide diabetes population after China. According to the International Diabetes Federation (IDF) the number of Indians with diabetes increased to 101 million in 2021 from 77 million diabetics in 2019 accounting for a 31 per cent increase. The Indian Council of Medical Research– India Diabetes (ICMR-INDIAB) study published in 2023 reported that the overall weighted prevalence of diabetes in India was 11.4 per cent and with significantly higher prevalence in urban areas at 16.4 per cent when compared to rural areas at 8.9 per cent (figure 1). Rising disposable income for the growing middle class and sedentary lifestyle practices are New Pharma Research on Diabetes - Drugs & Vaccines « Vandana Iyer, Industry PrincipalHealth & Wellness, TechVision, Frost & Sullivan likely to be the major causes for the higher prevalence of diabetes in urban India. A lack of proactive public measures will also increase diabetes prevalence in rural areas in the next five years. The National Noncommunicable Disease Monitoring Survey (NNMS) conducted between 2017 and 2018 reported that only 45.8 per cent of the population with Diabetes Mellitus (DM) were aware of it, only 36.1 per cent of DM patients were being treated and only about 15.7 per cent of them had their DM under control. Thus, there is a rising need in India to improve diabetes awareness, implement preventive measures, increase treatment outreach, and develop effective treatment protocols. Source: Frost & Sullivan New Drug & Vaccines Most classes of diabetes drugs, such as Sodiumglucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas, thiazolidinediones, meglitinides, metformin, α-glucosidase inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and dipeptidylpeptidase IV (DPP-4) inhibitors, are available in India. Cardiovascular and renal risks are some of the key concerns impacting mortality and quality of life in diabetic patients. Hence, the current treatment regime has largely shifted to a focus on improving diet and lifestyle, managing weight loss, and reducing health risks as opposed to just achieving glycemic control. Research has revealed that SGLT-2 inhibitors and GLP-1 receptor agonists are some of the most effective classes of drugs for managing diabetes, as they provide substantial cardiovascular and renal benefits. However, these drug classes are associated with risks such as several gastrointestinal events, ketoacidosis, and genital infections among others. Thus, there is a need to develop novel drug classes,
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com COVER 29 provided they can offer significant health and cost benefits compared to existing drug classes. For instance, Eli Lilly’s recently approved dual glucosedependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, tirzepatide, was shown to provide improved benefits for weight loss when compared to SGLT-2 inhibitors and GLP-1 receptor agonists. Tirzepatide was also shown to have fewer side effects and gastrointestinal adverse events. However, the cost of the drug, which can be up to Rs 70,000 for a single shot, will be a prohibiting factor for adoption in the Indian market. Cost-effective indigenous type 2 diabetes (T2D) treatments are likely to have a larger adoption potential in India. For instance, in 2022, Glenmark Pharmaceuticals launched Zita D for type 2 diabetes management. The drug is a fixed dose combination (FDC) of DPP-4 and SGLT2 inhibitors, teneligliptin and dapagliflozin. It is known to be effective against adults with uncontrolled T2D with or without comorbidities. This FDC is priced at Rs 14-15/tablet, which is about 50 per cent less than AstraZeneca’s dapagliflozin that is approximately priced at Rs 30/ tablet in India. 2022 also witnessed the launch of Alkem Laboratories’s Dapanorm Trio which is a FDC of dapagliflozin, sitagliptin and metformin for treating T2D. Priced at about Rs 20/tablet, it is much less than the total cost of all the individual drugs. Similarly, generic version of sitagliptin in India cost about Rs 8 to 18/day which is significantly lower than the Rs 45/day cost of Merck’s JANUVIA (sitagliptin). Finerenone is also a promising non-steroidal mineralocorticoid receptor antagonist (nsMRA) which is approved for T2D patients with chronic kidney disease (CKD). It is the first nsMRA that has shown to reduce all-cause mortality and hospitalization for heart failure. The drug has also demonstrated improved renal outcomes. Emerging research has also revealed that finerenone may also be effective in T2D patients without CKD, which may expand its usage in the future. India also witnessed the launch of Cadila Pharmaceuticals’ Jankey M in 2022, which is a FDC of sitagliptin and metformin. In the same year, Glenmark launched SITAZIT M which is also a FDC of sitagliptin and metformin. This FDC is useful for glycemic control in T2D patients and is also known to provide cardiorenal advantages and beta cell protection. Novel formulations of existing drugs are also being explored in the Indian market. For instance, semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), was largely available in injectable formulations. However, in 2022 Novo Nordisk launched an oral semaglutide formulation that used Sodium N-[8-(2-hydroxybenzoyl)amino] caprylate (SNAC) to enhance its bioavailability and prevent stomach degradation. This oral semaglutide formulation is known to improve glycemic control, while also demonstrating weight loss and cardiac safety benefits. Although it is cheaper than the US pricing, Novo Nordisk’s drug still costs Rs 10,000/ month in India, which restricts its accessibility, especially in the rural regions. However, oral drug formulations are likely to get a wider adoption when compared to subcutaneous delivery formats. However, the use of novel drug delivery formulations for insulin is not sufficiently explored in the Indian landscape. Insulin treatment for both T2D and type 1 diabetes (T1D) is still largely given through injectable formulations. In 2018, Cipla partnered with MannKind Corporation, US to market Afrezza, an inhalable insulin formulation, in India. While there are developments that help transdermal insulin delivery via microneedle patches or use of chemical enhancers in topical The IDF has predicted that the number of diabetics will grow to 134 million in 2045. A major factor for rising diabetes risk in urban India is obesity and this is largely attributed to Indian people moving away from traditional diets to sugar-rich, nutrient-poor diets which is coupled with a sedentary lifestyle. As urbanisation increases in India, there is likely to be a rise in T2D among the Indian population. Indians also have higher propensity towards insulin resistance, possibly due to the tendency towards increased incidence of central obesity in the Asian Indian phenotype. There is also an increased genetic risk in younger Indians for T2D.
30 COVER BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com formulations, they are not available in India. Such innovations may enhance the insulin-based treatment uptake, especially in people that are averse to injections. Additionally, there are smart insulin pens, such as Medtronic’s InPen, that connect a person’s insulin dosing data with a mobile app via Bluetooth, enabling real-time tracking of insulin dosage, glucose, and carbohydrate levels. This helps in the intelligent management of diabetes. However, such technologies are not yet available in India. There are several guidelines that are available for dietary and lifestyle changes for diabetes prevention, but vaccination for diabetes is largely underexplored. Early research has revealed that use of adjuvants such as alum in combination with immunotherapies for T1D and autoimmune diabetes can help enhance immune response in patients. Self-antigen-based vaccinations, such as insulin-autoantigen vaccine have shown to enhance insulin production. BCG vaccine administration has shown to restore β-cell function in T1D rodent models. Protein-based vaccines, such as DPP-4 inhibitor-based vaccines have shown early promise in T2D management. IL-1β-targeted epitope peptide (1βEPP) has been shown to provide hyperglycemic control in T2D management. Enteroviruses (EV)-based vaccine are also being studied for preventing the onset of T1D. However, vaccine research is still nascent and needs to be explored further in clinical settings before they are commercialised. Outlook The IDF has predicted that the number of diabetics will grow to 134 million in 2045. A major factor for rising diabetes risk in urban India is obesity and this is largely attributed to Indian people moving away from traditional diets to sugar-rich, nutrientpoor diets which is coupled with a sedentary lifestyle. As urbanisation increases in India, there is likely to be a rise in T2D among the Indian population. Indians also have higher propensity towards insulin resistance, possibly due to the tendency towards increased incidence of central obesity in the Asian Indian phenotype. There is also an increased genetic risk in younger Indians for T2D. However, diabetes can still be prevented and well managed by proactively ensuring healthy diet and lifestyle practices. This is partly achieved through Indian health insurance companies that offer plans for diabetes. The insurers not only provide coverage immediately but also offer discounts during policy renewal on meeting wellness goals set by the health coach assigned by the insurer. There is a need to increase diabetes awareness and education through public and private programs among the rural population and prevent its rise in these regions. Research institutions should focus on the development of newer forms of cost-effective drugs and vaccines. There is promising research coming out of Indian universities like Indian Institute of Technology Bhilai and Shiv Nadar University that have developed “Smart Insulin”. This product addresses the challenges that diabetic patients must face with injecting insulin at frequent intervals and suffering with side effects like hypoglycemia. “Smart Insulin” is an extended-release formulation that is effective for up to two days. Such university findings could make their way to the clinic in future but there is a need for more innovations to reduce the burden of diabetes on the health system. Additionally, public and private establishments should proactively promote diabetes care among Indian nationals by adopting newer medications and integrating them with mobile and at-home technology advances that aid remote diabetes care and monitoring. There should be equitable access to public and private healthcare infrastructure across all national regions for the effective prevention and management of diabetes. Following traditional nutrient-rich diets, having an active lifestyle, and periodically monitoring overall wellness can provide holistic health benefits in a fast-evolving nation. This can have long term positive implications on the prevention of diabetes in India. (with inputs from Lonita Lawrence, Senior Research Analyst, Growth Opportunity Analytics – TechVision, Frost & Sullivan) Diabetes can still be prevented and well managed by proactively ensuring healthy diet and lifestyle practices. This is partly achieved through Indian health insurance companies that offer plans for diabetes. The insurers not only provide coverage immediately but also offer discounts during policy renewal on meeting wellness goals set by the health coach assigned by the insurer. There is a need to increase diabetes awareness and education through public and private programs among the rural population and prevent its rise in these regions. Research institutions should focus on the development of newer forms of cost-effective drugs and vaccines.
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com BIOSTARTUPS - WEBINAR 31 I n recent years, the field of drug discovery has witnessed a remarkable transformation, thanks to the advent of Artificial Intelligence (AI). This revolution is not confined to any particular region; it’s a global phenomenon reshaping the pharmaceutical landscape. Experts believe that AI is proving to be a game-changer in the quest for new medicines across the world. “Developing a medicine means putting thousands of pieces in a puzzle together. AI has been used in some form or the other for the last 30 years, even in designing drugs and developing formulation, but in the last 10 years, it has come to be used in almost all the processes of drug discovery,” says Dr Sudip Roy, Founder, Prescience Insilico. One of the initial steps in drug discovery is the identification of potential drug targets, which conventionally takes years. But now, AI algorithms, particularly machine learning and deep learning, analyses vast datasets to identify proteins and genes associated with diseases, which not only expedites the process but also reduces the chances of failure. Besides, AI is now being used to identify existing drugs that can be repurposed to treat other diseases. Using AI, a large amount of data on pharmaceutical compounds can be analysed to study any connection between the existing medicinal compounds and various diseases. The findings can lead to many cost-effective treatments. By analysing genetic and clinical data, AI can also identify the most suitable treatments for individual patients, what is popularly called personalised medicine. This, researchers believe, has potential to minimise the treatment’s side effects and improve its effectiveness. Secondly, it has reduced the cost of drug discovery. Billions are spent on various stages of drug discovery such as early stage drug discovery, early stage target discovery, pre-clinical trials, biological trials, and clinical trials. ‘‘Currently, the average cost to bring a drug to the market is $2 billion. But AI is reducing the cost significantly,” says Dr Roy. Besides, AI-driven predictive modelling is another breakthrough in drug discovery. AI algorithms help researchers analyse chemical structures and biological data to predict the potential efficacy and safety of a drug candidate. “By doing so, AI reduces the time and resources required for experimental testing, ensuring that only the most promising compounds move forward in the development pipeline,” says Dr Roy. “In fact, this precision in drug design not only expedites the development process but also reduces the chances of failure in later stages of clinical trials,” he adds. Adding on, entrepreneurs believe that AI has proved to be a boon for startups as it allows them to excel despite smaller teams and smaller fundings. Today, there are many startups worldwide, which focus on one aspect of drug discovery. Some of them are believed to be much faster and more efficient than even the large-scale pharmaceutical companies, where multiple layers of approvals are needed for a molecule to move from one stage to another. “We deal with biological molecules, a class of molecules which has been there for 30-40 years. So, there is knowledge and literature available but data is sparse, about these large molecules. We have a generative AI model that generates new antibody drugs from the learnings of the existing data. Also, we have a cross-domain team from both biological and computational domains because it requires experts from both sides to solve the problem”, says Dr Aridni Shah, Co-founder and Chief Executive Officer, immunitoAI. But how easy is it for these pharma startups to get the required funding? Startups, says Dr Aridni, have been funded heavily in developed nations. But the investments biotech startups are getting in India are not enough. “There are two major reasons for that—first, the investors in India lack expertise needed for evaluating the potential of a biotech startup, and second their risk appetite is low. One who invests in drug discovery needs to be patient as the outcomes and return on investment take much more time compared to other fields,” she says. Another challenge that the startups in industry face is the access to data, ethical considerations and regulatory framework around the use of AI in drug development. “For AI to work efficiently it Can Deep Tech Startups Propel Drug Discovery?
32 BIOSTARTUPS - WEBINAR BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com requires algorithms, and building reliable algorithms requires a lot of preclinical and patient data. This data typically resides in silos within established organisations. It is difficult for startups to invest in generating the data. Different countries have different regulatory frameworks, which limits the adoption of this revolutionary technology across countries” says Dr Achintya Das, Head, Data and Computational Science, Syngene International. “In India, for example, as per Digital Personal Data Protection Act, only the Union Government has access to individuals’ data.” Though under section 17 (3) of Digital Personal Data Protection Act, the Central government can allow this data to be used by some startups, they need to anonymise the data so that privacy of people is not compromised. “The technology that converts this personal data into anonymous data is expensive, and it will be a while before it becomes affordable,” says Dr Das. Agrees Dr Reji Joseph, an Associate Professor at the Institute for Studies in Industrial Development (ISID) saying, “I recently came across a report in which CPHI, a global community for pharmaceutical professionals, predicts that 50 per cent of the drug approval in the US in the next 10 years will involve AI. This is the potential that AI is offering. It has a lot of potential for developing therapies for rare and difficult-to-treat diseases. Statistically, of 10,000 molecules identified, only one reaches the market. But AI helps researchers in narrowing it down.” According to Morgan Stanley, an American financial service company, even the modest improvements in early-stage drug development success rates enabled by the use of artificial intelligence and machine learning could result in an additional 50 novel therapies over a 10-year period, representing a more than $50 billion opportunity. Morgan Stanley Research biotechnology analysts estimate that a 20 to 40 per cent reduction in costs for preclinical development across a subset of US biotech companies could generate the cost savings needed to fund the successful development of four to eight novel molecules. Data analysts believe that soon most of the drugs will be designed by machines using AI, and not humans. Both researchers and pharma companies believe that AI has huge potential, especially for a country like India which has the 3rd largest startup ecosystem globally in terms of number of startups. All the country needs to do is fill the gaps. “We need to invest in deep-tech startups which will strengthen our hold on AI. They will help pharma startups to do better. We need to foster collaborations and partnerships among researchers, AI experts, and pharmaceutical companies to accelerate the development of new treatments. Positively, in due time the industry can gain investor’s confidence too,” says Dr Joseph. (The spokespersons were a part of the webinar titled: ‘How AI is revolutionising the drug discovery and development process’, hosted by BioStartUps, a BioSpectrum platform.) Gunjan Sharma [email protected]
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 33 “Indian pharma firms must remain updated and adapt to changing requirements continually” « Ravi Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) The Indian Pharmaceutical Industry is celebrating an unprecedented milestone, with exports reaching a staggering $25.3 billion by the end of the first quarter of the 2023 fiscal year. This remarkable achievement, reflecting over 100 per cent growth in the past decade since 2013-14, has been made possible through the collaborative efforts of the industry, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), and the government. Together, they have not only fortified India’s pharmaceutical foundation but also paved the way for expanding into new global markets. We had the privilege of sitting down with Ravi Uday Bhaskar, Director General of Pharmexcil, to gain insights into this extraordinary journey. Edited excerpts: How do you perceive India’s pharmaceutical and biotechnology growth over the past decade, and what role has Pharmexcil played in propelling India’s exports? The growth we witness today is the culmination of over three decades of dedicated efforts by all stakeholders. India’s adoption of an open economy policy in the 1990s unleashed the potential for private enterprises with innovative ideas and attracted substantial global investments into the pharmaceutical and biotechnology sectors. Transitioning from a country dependent on healthcare imports, India has not only achieved self-sufficiency but also emerged as a key player supplying high-quality medicines to over 200 countries globally. This extraordinary journey saw India’s pharmaceutical exports increase from a meager $3.9 billion in 2004-05 to over $25.3 billion in 2023, reflecting consistent growth of more than 100 per cent each decade. Pharmexcil, established in 2004 with its headquarters in Hyderabad, has played a pivotal role in promoting and catalysing India’s pharmaceutical exports. The council identifies industry challenges related to generic exports, collaborates with stakeholders, and advocates for solutions with the Indian government and international agencies. Through seminars, interactive meetings, conferences, and buyer-seller gatherings, Pharmexcil enhances networking among export partners. Furthermore, the council advises the central government on policy matters concerning pharmaceutical exports and assists member companies in claiming Market Access incentives (MAI) refunds. Pharmexcil has also facilitated Indian pharmaceutical and biotechnology trade delegations abroad and hosted international delegates to acquaint them with the domestic industry. Despite remarkable export growth, India’s pharmaceutical sector faces challenges. What are the major challenges, and how can they be overcome? Undoubtedly, India is a global leader in producing high-quality generic medicines at affordable prices, earning the moniker “Pharmacy of the World.” Nevertheless, the industry grapples with challenges such as evolving international safety and standard regulations and fierce competition from other generic manufacturers. To address these challenges, Indian
34 SPEAKING WITH BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com pharmaceutical firms must remain updated and adapt to changing requirements continually. Both state and central governments should encourage the industry to embrace new and advanced technologies by offering incentives and support. Continuous innovation and adherence to global quality and safety standards will be key to maintaining India’s growth in pharmaceutical exports. How did the COVID-19 pandemic impact the Indian pharmaceutical sector? While the COVID-19 pandemic disrupted global businesses, India’s pharmaceutical industry, especially the vaccine sector, experienced a resurgence. Despite supply chain disruptions, pharmaceutical exports grew significantly from $15.4 billion in FY15 to $24.6 billion in FY22. During April to December 2022, exports reached $18.8 billion, showcasing a positive growth of 3.6 per cent over the same period. The pandemic saw the development of indigenous vaccines in India, such as Bharat Biotech’s Covaxin and Zydus Cadila’s Zycov-D. India is also developing its first indigenous mRNA vaccine, HGC019, in collaboration with HDT Biotech Corporation, US. Global manufacturers, including Serum Institute of India, Moderna, Gamaleya, and Janssen, received COVID-19 vaccine approvals in India. India is a major global exporter of vaccines, with approximately 60 per cent of the market share, making it a significant player in the global COVID-19 vaccine distribution. Could you elaborate on the recent issue of substandard cough syrup in Africa and its impact on India’s exports? The unfortunate incident of substandard cough syrup causing the deaths of children in Gambia, Africa, has indeed tarnished the image of the Indian pharmaceutical industry. The World Health Organization also raised concerns after identifying discrepancies in the cough syrup product, leading many countries to express apprehensions about the quality control standards of certain pharmaceutical companies. The Indian government has taken this issue seriously and promptly shut down the identified units, with stringent legal actions to be taken based on the investigation report. It’s important to note that this incident does not negate India’s capacity to produce high-quality, affordable generics. Over 50 per cent of India’s exports are directed toward the highly regulated markets of the USA and the EU, with more than 703 registered manufacturing sites holding USFDA approval, constituting nearly 20 per cent of the total such sites worldwide. What are the key strengths of the Indian pharmaceutical industry, and how does India contribute to global healthcare? India’s major strength lies in its ability to produce high-quality generic medicines at affordable prices. The presence of highly skilled human resources has propelled India to become the largest exclusive generic exporter globally. The success story of providing affordable HIV treatment from India is an exemplary achievement, reinforcing India’s reputation as the “Pharmacy of the World.” From a global perspective, India is a pivotal player in the pharmaceutical and healthcare sectors. While the global market grew by just 1 per cent in 2022, India’s pharmaceutical exports increased by 3.25 per cent to reach $25.3 billion. This highlights India’s status as the fastest-growing pharmaceutical hub worldwide. In conclusion, India’s pharmaceutical industry has achieved remarkable export growth, bolstered by the collective efforts of industry stakeholders, government support, and the contributions of Pharmexcil. Despite challenges, India continues to excel in the global pharmaceutical arena, setting new standards in quality, affordability, and innovation. As the “Pharmacy of the World,” India plays a crucial role in global healthcare and pharmaceutical trade. Amguth Raju Undoubtedly, India is a global leader in producing high-quality generic medicines at affordable prices, earning the moniker “Pharmacy of the World.” Nevertheless, the industry grapples with challenges such as evolving international safety and standard regulations and fierce competition from other generic manufacturers. To address these challenges, Indian pharmaceutical firms must remain updated and adapt to changing requirements continually. Both state and central governments should encourage the industry to embrace new and advanced technologies by offering incentives and support. Continuous innovation and adherence to global quality and safety standards will be key to maintaining India’s growth in pharmaceutical exports.
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 35 “There is a pressing need for enhanced eye health research in India” « Nikkhil K Masurkar, Chief Executive Officer, Entod Pharmaceuticals World Sight Day 2023 on October 12 recently reminded us to realign our focus on eye healthcare and research. The increasing prevalence of vision-related issues in India presents a significant concern and a formidable challenge for pharmaceutical companies in the region. Recent estimates indicate that there are approximately 62 million visually impaired individuals in India, with a staggering 8 million among them suffering from total blindness. Among a few key players in the eye healthcare space, Mumbai-based Entod Pharmaceuticals is pioneering advancements in ophthalmic super-specialty solutions by introducing new divisions to focus on glaucoma management and ophthalmic surgical products. BioSpectrum interacted with Nikkhil K Masurkar, Chief Executive Officer, Entod Pharmaceuticals to know more about the contribution of the company and the pharma industry in the eye healthcare sector. Edited excerpts: What are the key highlights at Entod Pharma for FY 23-24? What are the revenue & growth projections as compared to the previous fiscal? Are there any new launches, investments, partnerships in the pipeline in the coming months? The company’s brand new state-of-the-art The Department of Scientific and Industrial Research (DSIR) approved ophthalmic R&D centre will engage in new molecular discovery, formulation development, personalised ophthalmic medicine and focus on areas such as biologicals, stem cell based therapies and gene therapies. The company is expecting a growth of over 35 per cent year-on-year (YoY) with a growth rate more than twice that of its covered market. We intend to launch several new speciality medicines in the ophthalmic, ENT and derma segments. These are innovative solutions to be born out of our completed R&D projects. The company is also actively investing in generative AI-led drug discovery, quality analysis and clinical trials, and intends to be a pioneer in robotic process automation in sterile manufacturing. Entod Pharmaceuticals’ ongoing phase 3 clinical trials for Atropine 0.05 per cent and Pilocarpine 1.25 per cent eye drops are expected to complete by the end of this calendar year, which should allow them to hopefully commercialise these by April 2024. At the same time the company is rapidly expanding its sales field force for stronger sales promotion on the ground and penetration right from metros to rural areas. Furthermore, the company will soon launch a new ophthalmic veterinary division focusing on quality eye care for pets. What are the major challenges facing the pharma companies in the eye care market in India? How is Entod addressing those challenges? According to the National Blindness and Visual Impairment Survey, cataracts are responsible for 66.2 per cent of cases of blindness in individuals over the age of 50. Following cataracts, diabetic retinopathy emerges as a major source of ocular morbidity and potential blindness if not promptly addressed. India holds the unenviable title of the world’s diabetes capital, and diabetic retinopathy is evolving into a condition of significant public health concern. Recent research reveals that 16.9 per cent of individuals with diabetes are afflicted by diabetic retinopathy. Moreover, the World Health Organisation (WHO) forecasts that in 2010, nearly two billion people were affected by myopia — a quarter of the global population. By 2030, they anticipate myopia to afflict a staggering 3.3 billion individuals. To combat these pressing issues, we are steadfast in our commitment to introducing
36 SPEAKING WITH BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com innovative vision care products in India. A recent milestone is the launch of Cyclo Tears eye drop, the world’s first dry eye therapy incorporating self-emulsifying drug delivery systems (SEDDS) technology. This heralds a novel therapeutic approach for addressing inflammatory dry eye disease in India. Furthermore, we are in the final stages of introducing an eye drop that promises relief for individuals, predominantly those over 40, grappling with presbyopia. This product has garnered approval from the US Food and Drug Administration (FDA) and is already available in the market. What are your views on the R&D, innovation taking place in India to combat various eye diseases? Where are the gaps, and what more needs to be done? While the industry is making commendable strides in developing solutions for eye health concerns, there is a pressing need for enhanced eye health research in India. Allocating greater resources and fostering a genuine research culture within our medical colleges is essential for a more promising future. Investment in Research and Development (R&D) holds the potential to refine design and manufacturing processes, ultimately elevating the quality and effectiveness of products. Moreover, it can facilitate the creation of advanced testing and regulatory frameworks, ensuring the safety and efficacy of medicines. Furthermore, there is a critical demand for a well-trained cadre of ophthalmologists to address these issues comprehensively. A substantial endeavour is warranted to elevate the quality of residency training nationwide and augment funding for robust research. Only through these measures can we cultivate a pool of professionals equipped to provide comprehensive ophthalmic care and adeptly incorporate emerging ideas and technologies. Until then, challenges like myopia, cataracts, glaucoma, age-related macular degeneration, and others will persist as ongoing hurdles into the future. How do you foresee the implementation of stem cell therapy in curing certain eye diseases in India? Disorders or ailments affecting the eye arise from damage or dysfunction in one or more of its integral components. The specific disorder that develops is contingent upon which component(s) are affected. The challenge in addressing these issues lies in the fact that, unlike the replaceable electronic components of a camera, obtaining new biological components for the eye is a complex endeavor. This is where stem cell technology holds promise. Stem cells serve as a wellspring of fresh, specialised cells and offer a potential avenue for replacing impaired cells within the eye. Various types of stem cells can be utilised in diverse ways, tailored to the specific disorder being addressed. Recent advancements in preclinical research have bolstered the belief that stem cells possess the potential to regenerate degenerated cells or take the place of cells in numerous significant diseases, including ocular disorders. In experimental trials, the introduction of healthy stem cells in lieu of deteriorated retinal cells has spurred cell regeneration, facilitated the establishment of new intercellular connections, and contributed to the enhancement of visual function. Stem cells exhibit the capacity to differentiate into various cell types within their environment, including retinal neural cells and photoreceptors. Prior experimental studies have demonstrated the remarkable compatibility of stem cells with retinas, enabling seamless integration with Müller, amacrine, bipolar, horizontal, and glial cells, as well as photoreceptors. What are your major expectations from the government to improve eye care in India, in terms of new policy announcements or collaborations with the industry? Increased Funding for Research and Development (R&D): I believe that the government should allocate more resources towards R&D in the field of ophthalmology. This would facilitate the development of innovative treatments, drugs, and technologies that can address a wide spectrum of eye-related disorders. Support for Stem Cell Research: Given the promising potential of stem cell technology in eye care, I would encourage the government to provide incentives and funding for research in this area. Streamlined Regulatory Processes: It is crucial for the government to work in tandem with the industry to establish efficient and transparent regulatory processes. This would accelerate the approval and market entry of new and advanced eye care products, ensuring that they reach patients in need in a timely manner. Encouraging Public-Private Partnerships: Collaboration between the government, private sector, and non-profit organisations can greatly amplify the impact of eye care initiatives. By fostering partnerships, we can collectively work towards improving access to quality eye care services across the country. Dr Manbeena Chawla [email protected]
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com DEEPTECH STARTUPS 37 India has an immense potential for biotech and medtech startups to transform healthcare and make substantial contributions to the nation’s progress. There are many challenges as well before these startups. They can overcome the challenges and thrive with the support of regulatory authorities, investors and the government. By recognising and addressing the unique challenges inherent to these sectors, the country can firmly establish itself as a global hub for innovation in biotech and medtech. I n the thriving world of technology startups in India, startups from the biotech and medtech sectors stand out as unique. Known as DeepTech startups, they dive deep into the fields of science and technology and create innovations that hold the potential to revolutionise healthcare, offering ground-breaking solutions that can enhance lives and contribute to the nation’s growth. Their influence, especially biotech, extends well beyond healthcare. They also have applications in other sectors, including the food industry. Challenges However, these sectors also have to deal with unique challenges due to their complex and heavily regulated nature. Let’s look at some of the hurdles these startups face and propose simple yet effective solutions to promote growth and innovation in this critical sector. One of the most significant challenges faced by biotech and medtech startups in India is dealing with the complex regulatory aspects. Because of safety concerns and ethical considerations, these sectors are understandably subject to rigorous regulations. Even in developed countries, the regulatory landscape is still evolving. To address this challenge, encouraging collaboration between startups and regulatory bodies is essential. There is a need to establish platforms where startups can work closely with regulators to help streamline the compliance processes. Through open communication and cooperation, regulatory requirements can evolve in sync with technological advancements, reducing the regulatory burden on startups and enabling them to focus on their core strengths. Another important step is providing dedicated Can India become a global hub for innovation in biotech and medtech? « Kamal Bansal, Managing Director, GVFL (formerly known as Gujarat Venture Finance Limited) support and guidance to startups in understanding and adhering to these regulations. Innovative ideas can be tested in a controlled environment ensuring compliance. Such an approach can enable startups to refine their products and services while remaining in compliance with the regulations. Biotech and medtech startups also often face unique financial challenges due to the nature of their products and services. The products they are working on typically require extensive research and development and rigorous trials before they can be taken to the market. Few startups are capable of sustaining themselves during such prolonged gestation periods. This challenge can be mitigated by establishing grant programmes and venture funds tailored specifically to support biotech and medtech startups. These initiatives can provide the much-needed financial support during the lengthy development phases, reducing the financial burden on startups. There is also a challenge of public perception and awareness, particularly in the food industry, which can lead to scepticism and even opposition to the technology. It is essential to educate the public about their benefits to address any concerns that they may have. This is all the more necessary since investors often perceive biotech and medtech startups as highrisk investments. Uncertainties related to product development, regulatory approvals, and market acceptance contribute to this perception. To attract more investment, startups can focus on building strong evidence of efficacy and safety through welldesigned pilot studies and clinical trials. Creating a nurturing ecosystem for DeepTech startups in biotech and medtech is also crucial for their growth and success. Establishing specialised
38 DEEPTECH STARTUPS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com One of the biggest factors for the growth of biotech and medtech startups is the availability of a highly skilled workforce. Systems need to be put in place to ensure a steady supply of highly skilled and industry-ready professionals. Collaborative efforts between the government and industry can result in the establishment of skill development programmes tailored to the specific needs of these sectors. These programmes can include training programmes, scholarships, and incentives to encourage individuals to pursue careers in biotechnology and medical technology. incubators and accelerators focused on biotech and medtech sectors can provide such startups with the mentorship, resources, and networking opportunities they need. These initiatives can help startups refine their ideas, develop robust business plans, and pave the way for connecting with potential investors. Promoting collaboration between startups and academic institutions can also go a long way in driving innovation. It can also ensure a platform for young innovators to flourish. Offering grants and incentives for joint research projects can enable startups to access cutting-edge technologies and expertise, further giving a boost to their existing resources. Market access, workforce and industry-academia cooperation Another formidable challenge for all startups, particularly those in niche areas like biotech and medtech, is accessing the markets. To a great deal, this is because of the dominance of players who have already established themselves. The government can step in and create procurement policies that favour innovative startups. This approach can provide startups with an initial market to showcase their products. Adopting such policies in procurement by the government, government agencies, and Public Sector Undertakings (PSUs) through the procurement portal have already proven successful in supporting women-led businesses and MSMEs and can be extended to include startups. One of the biggest factors for the growth of biotech and medtech startups is the availability of a highly skilled workforce. Systems need to be put in place to ensure a steady supply of highly skilled and industry-ready professionals. Collaborative efforts between the government and industry can result in the establishment of skill development programmes tailored to the specific needs of these sectors. These programmes can include training programmes, scholarships, and incentives to encourage individuals to pursue careers in biotechnology and medical technology. Additionally, building strong partnerships between universities and industry can also facilitate the transfer of knowledge and skills. This can be achieved through joint research projects, internships, and industry-sponsored educational programmes. Tapping the inherent potential By addressing these and other challenges through strategic policy measures, targeted funding, and the creation of a supportive and collaborative ecosystem, the country has the potential to emerge as a global leader in the biotech and medtech sectors. These startups have the capacity to drive innovation, enhance healthcare outcomes, and contribute significantly to economic growth. India, with its vast demographic dividend and technological capabilities, is uniquely positioned to excel in these critical sectors. In the end, I would like to reiterate the immense potential of biotech and medtech startups to transform healthcare and make substantial contributions to the nation’s progress. These startups can overcome the challenges they face and thrive with the support of regulatory authorities, investors, and the government. By recognising and addressing the unique challenges inherent to these sectors, the country can firmly establish itself as a global hub for innovation in biotech and medtech. It is also important that the country is successful in this endeavour since these startups are not just businesses or potential unicorns in the making; they have the potential to transform the healthcare and food sector and create a healthier and better future for all of us.
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com REFRIGERATION 39 The confluence of the COVID-19 pandemic and the Russia-Ukraine war has generated an unprecedented and intricate impact on the medical refrigerator market, reshaping its dynamics in profound ways. This nexus of global events has triggered a series of cascading effects, engendering shifts in search behaviours, online trends, and market demands. As the pandemic swiftly engulfed the globe, people’s online activity escalated dramatically. With lockdowns confining individuals to their homes, the virtual realm emerged as an essential avenue for connection, information, and commerce. Consequently, the medical refrigerator market experienced an immediate surge in relevance, as search queries veered towards health updates, remote work solutions, and entertainment options. The exceptional growth in the healthcare industry today is driven by several factors such as a surge in chronic illnesses, the government’s initiatives to improve healthcare infrastructure, and increased investments in the sector. Consequently, the medical refrigeration device market in India has also seen commensurate growth in recent years. With the ever-growing demand for healthcare services and the need for proper storage and transport of medicines, vaccines, and blood products, the market for medical refrigerators has also expanded rapidly. Growth The market for medical refrigeration devices in India is growing for several reasons. There is a rise in the number of clinics and hospitals, along with a growing population, resulting in a boost in the demand for these devices to store blood, medications, vaccines, and other essential medical supplies. It has increased the need for refrigeration devices with cutting-edge temperature-control capabilities. Technical advancements in the medical industry have made these devices more refined, efficient, and more appealing to buyers. As a result, India is presently experiencing rapid growth in the medical refrigeration market. In addition, the number of medical and pharmaceutical products that require precise Future of medical refrigeration looks promising « Jesal Doshi, Director, Board of Medical Technology Association of India (MTaI) temperature conditions is increasing significantly especially in fields such as oncology. Research published by Benzinga has shown that India’s medical refrigeration device market has been growing at an average rate of 8.5 per cent. In 2017, the revenue for medical refrigeration devices in India was nearly $10.4 million. Medical refrigerators play a critical role in preserving the integrity of temperature-sensitive medical resources. However, they come with their own set of challenges. Challenges The Medical cold chain industry in India suffered from high capital costs, outdated technology, opaque networks, lack of skilled resources, poor reverse logistics, and extensive complexity. Some of the major challenges that we face in the medical refrigeration industry are: ● Lack of Awareness:There is a general lack of awareness regarding the importance of maintaining the intended temperature of medicines, drugs, vaccines, and other biologics. Especially during transportation resulting in the spoilage of critical and expensive medical resources. There is also a general attitude where people mistakenly think that a domestic household refrigerator can do the work of a medical refrigerator. ● Temperature Precision: Maintaining precise temperatures required for various medical products, such as vaccines, blood samples, and medications, can be challenging due to fluctuations. ● Energy-efficient and Sustainable systems: Medical refrigeration devices can be energy-intensive, leading to high operational costs and environmental concerns especially ones that use non-green refrigerants.
40 REFRIGERATION BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com ● Regulatory Compliance: The healthcare industry is subject to stringent regulations related to medical refrigeration to ensure patient safety. Compliance can be complex and demanding. Despite that in India there are many gaps in the policies and guidelines that allow substandard local players to operate in the market. Overcoming challenges This growth is predominantly attributed to the growing adoption of energy-efficient and precise cooling strategies within the biomedical refrigerators and freezers industry. However, addressing the various challenges in this field requires a multifaceted approach. ● Awareness and training programmes are the need of the hour to ensure the best practices are followed during storage and transportation of valuable medical samples and resources. ● Advanced control tech minimises fluctuations to maintain precise temperatures, ensuring safe medical storage. ● Energy efficiency is crucial, encouraging eco-friendly refrigerants in cost-effective devices, reducing costs, and aiding conservation. ● Meeting regulatory compliance is vital. Streamlined processes, simplified requirements, and strict adherence are essential for product safety. Raising awareness about low-temperature importance is key. Government’s initiatives The government’s initiatives and policies profoundly influence the accessibility and affordability of healthcare services for individuals and communities. By implementing initiatives that prioritise healthcare innovation and research, the government can foster a conducive environment for advancements in medical technology and treatments. ● Temperature Control Protocols: In India, regulations ensure that these temperaturesensitive products are stored and transported at the optimum temperatures to maintain their efficacy and safety. However, these regulations have room for improvement to make them more robust and effective. These include setting clear standards for temperature control, monitoring, and compliance to prevent product spoilage or degradation. ● Investments to Strengthen Medical ColdChain Infrastructure: Investments are needed to strengthen the Cold-Chain infrastructure to ensure medical products remain safe and effective. These include upgrading storage and transportation facilities, adopting advanced temperature monitoring and control technologies, and providing training for healthcare personnel involved in handling these products. These investments are crucial to guarantee the integrity of medical supplies and contribute to better healthcare services in India. These regulations and investments can help drive positive change in the healthcare market and improve the overall quality of healthcare services. Environmental considerations Do you know these medical refrigeration machines can greatly impact the environment? They consume a lot of energy and sometimes refrigerants that are not so friendly to the planet. Medical refrigeration has a substantial environmental footprint, primarily due to energy consumption and the use of harmful refrigerants. However, the healthcare industry is actively pursuing eco-friendly alternatives like hydrofluoroolefins (HFOs) and natural refrigerants such as CO2 and hydrocarbons. These choices emit fewer greenhouse gasses, promoting environmental sustainability. Technological advancements, including efficient compressors and insulation materials, contribute to energy savings in refrigeration. Moreover, solarpowered refrigeration solutions, like those offered by B-Medical Systems, are emerging as eco-friendly alternatives, especially in hot climates and remote areas with inconsistent power supply. These systems benefit the environment and reduce operational costs for healthcare facilities. Outlook Recent advancements in medical refrigeration technology are transforming healthcare. IoT sensors have become increasingly common in cold-chain equipment. These are small devices embedded in cold-chain equipment such as refrigerators, freezers, and shipping containers. These sensors can measure temperature, humidity, and other environmental conditions and transmit that data to a central system. Our investments and collaborative efforts aim to raise the bar for temperature control standards, ensuring the safety and efficacy of medical supplies and vaccines nationwide. Moreover, artificial intelligence algorithms analyse data from refrigeration units, detecting potential issues in real-time for proactive maintenance and preventing spoilage. These advancements also enable predictive analytics, optimise inventory management, and ensure timely restocking of essential supplies. Due to these developments, the future of medical refrigeration looks extremely promising.
BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com MOLECULAR DIAGNOSTICS 41 Molecular diagnostics are a set of tools and techniques to analyse biological markers in the genome or sometimes even in the proteome, which would indicate the presence of diseases including various types of cancers, infections such as TB, Pneumonia, UTIs, prenatal testing for diseases such as Thalassemia or Down Syndrome. Molecular diagnostics at the point of care presents a significant opportunity, not just in the clinical diagnostics industry, but also in allied industries such as livestock- poultry, fish and seafoods as well as in food testing. We are living in the age of genomics- where DNA is the new currency. The cost of sequencing the entire human DNA has dropped from $10,000 dollars in 2011 to less than $1000 today, thanks to advanced ‘Next Generation Sequencing’ (NGS) technologies. As costs have reduced, access to sequencing has improved. COVID-19 was a shot in the arm as many new laboratories installed NGS machines. Lower costs, higher throughput and easier access has meant faster genomic data generation and in large quantities. Novel biomarkers have been identified for various types of cancers, infectious diseases and this has driven the growth of the molecular diagnostics industry. Molecular diagnostics are a set of tools and techniques to analyse biological markers in the genome or sometimes even in the proteome, which would indicate the presence of diseases including various types of cancers, infections such as tuberculosis (TB), Pneumonia, urinary tract infections (UTI)s, prenatal testing for diseases such as Thalassemia or Down Syndrome. Apart from human diseases, molecular diagnostics also has applications in plant and livestock disease diagnosis. One of the major advantages of molecular diagnostics solutions is the ability to detect the biomarkers at very low concentrations, thereby enabling early diagnosis. These tests are cost effective and can be performed at the point of care. The detection for Molecular diagnostics for early diagnosis of diseases- the way forward « Suraj Nair, Lead- TechSprouts, Ankur Capital the tests is done using DNA sequencing, fluorescent probes, microarrays or Fluorescence In Situ Hybridization (FISH). Rising investments Although molecular diagnostics tools have been around for more than 30 years, investments into startups in this space have seen a rise since 2013, driven by the advancements in sequencing technologies and gene editing tools such as CRISPR, as well as new isothermal molecular diagnostic technologies. Investments in molecular diagnostics increased from around $1 billion in 2013 to more than $4 billion in 2019. However, COVID-19 gave a major push towards investments into this sector, driven by a major requirement for early detection of the infection. RT-PCR and other isothermal tests such as Loop Mediated Isothermal Amplification (LAMP) became a standard for diagnosis during 2020-21. Investments rose to more than $6 billion in 2020-21, a rise of 1.5 times from the previous year. Molecular diagnostics market saw a growth of more than 200 per cent YoY in 2019-20 and was expected to be worth more than $15 billion in 2023. Some of the largest companies in India in this sector include Medgenome which has raised a total of $185 million, MolBio Diagnostics ($117.5 million), Strand Life Sciences ($13 million) which was acquired by Reliance Industries Limited’s subsidiary Reliance Strategic Business Ventures Ltd for Rs 393 crore or close to $50 million, Mylab Discovery Solutions and Tata MD who developed kits for
42 ACADEMICS NEWS MOLECULAR DIAGNOSTICS BIOSPECTRUM BIOSPECTRUM | | NOVEMBER 2023 AUGUST 2021 | www.biospectrumindia.com | www.biospectrumindia.com COVID-19 detection along with molecular diagnostics solutions for TB detection. New generation companies such as D-Nome are using advances in synthetic biology and protein engineering to develop room temperature PCR solutions for point of care diagnostics. From RT-PCR to isothermal solutions - the path towards point of care (POC) molecular diagnostics The PCR technique was invented in 1985 by Kary B. Mullis. It enables scientists and technicians to make many copies of a scarce sample of DNA. Using “primers”, which map to a desired gene or DNA fragment of interest, the PCR technique can be used to amplify and hence detect the presence of the target DNA. Further, PCR technique is quantitative: it can be used to determine the amount of target DNA that is present in a sample. Diagnostic tests commonly utilise PCR or RTPCR techniques. Here, “RT” stands for reverse transcription, which means that the technique can also be used to detect RNA. Once the target DNA or RNA of a pathogen is isolated, a PCR test for it can be formulated. PCR-based tests also have high sensitivity and specificity, which translates to low false negative and low false positive rates. These characteristics have made it the gold standard for various diagnostic tests. Most famously in recent years, the PCR technique was used to construct the gold-standard RT-PCR tests for COVID-19. Further, the quantitative nature of the PCR technique means that they can be used for applications beyond yes/no diagnostic tests. However, diagnostic tests that use PCR also have a few drawbacks. Firstly, they require expensive equipment, skilled technicians and multiple reagents for the different steps involved. They also require many cycles alternating between high and low temperatures to amplify the target DNA. These drawbacks have resulted in PCR tests having long turn-around times and being performed only in wellequipped central labs. Thus, alternatives to PCR tests are needed which can be performed at the point of care (POC) itself. Several alternatives to PCR-based diagnostics have been developed in research laboratories around the world with the aim of overcoming some of the drawbacks that PCR tests face. The core at each of these techniques is the ability to amplify nucleic acids: DNA and RNA. Some of the techniques developed are loop-mediated isothermal amplification (LAMP), nucleic acid sequencebased amplification (NASBA), strand-displacement amplification (SDA), rolling circle amplification (RCA) and recombinase polymerase amplification (RPA). Their major advantage over PCR is that they take place at constant temperature, i.e., they are isothermal processes. This means that they are good candidates for accessible tests that can be done costeffectively and at the POC. However, they face their own challenges in reaching the simultaneously high sensitivity and specificity of PCR tests, which requires clever research and engineering to achieve. Further, separate primer design is required to develop these isothermal tests for different diseases and designing primers for these alternatives is generally a more difficult task than doing it for a PCR test. However, molecular diagnostics at the point of care presents a significant opportunity, not just in the clinical diagnostics industry, but also in allied industries such as livestock- poultry, fish and seafoods as well as in food testing. Isothermal molecular diagnostics solutions which can be done at room temperatures could create opportunities in the POC diagnostics market. Several alternatives to PCR-based diagnostics have been developed in research laboratories around the world with the aim of overcoming some of the drawbacks that PCR tests face. The core at each of these techniques is the ability to amplify nucleic acids: DNA and RNA. Some of the techniques developed are loopmediated isothermal amplification (LAMP), nucleic acid sequence-based amplification (NASBA), stranddisplacement amplification (SDA), rolling circle amplification (RCA) and recombinase polymerase amplification (RPA). Their major advantage over PCR is that they take place at constant temperature, i.e., they are isothermal processes.
The Nobel Assembly at Karolinska Institutet has decided to award the 2023 Nobel Prize in Physiology or Medicine jointly to Dr Katalin Karikó and Dr Drew Weissman for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19. Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times. Dr Katalin Karikó is a HungarianAmerican biochemist specialising in ribonucleic acid-mediated mechanisms, particularly in vitro-transcribed messenger RNA for protein replacement therapy. On the other hand, Dr Drew Weissman is an American physician-scientist best known for his contributions to RNA biology. His work was used for the development of mRNA vaccines, the best known of which are those for COVID-19 produced by BioNTech/Pfizer and Moderna. Dr Weissman’s laboratory in the US focuses on studying RNA and innate immune system biology and applying these findings to vaccine research and gene therapy. 2023 Nobel Prize in Medicine for Katalin Karikó and Drew Weissman for breakthroughs made in mRNA vaccine tech BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com PEOPLE NEWS 43 Biocon Board appoints Peter Bains as Group CEO Hyderabad-based Aragen Life Sciences has announced the appointment of Dr Vikas Shirsath as Senior Vice President and Head – Chemical Development Solutions. Dr Shirsath has over 24 years of experience scaling businesses and driving contract research, development, and manufacturing organisation (CRDMO) growth strategy. He has built a reputation for his scientific innovations, leadership skills, team-building ability and strong operational performance. During his career journey, he has held board-level positions and served on several scientific advisory committees. He has to his credit over 25 international publications and more than 110 granted national phase patents. Prior to joining Aragen, Dr Shirsath worked with Syngene International, Jubilant Biosys, Piramal and Suven. At Aragen, he will be responsible for the operations and growth of the Chemical Development Solutions vertical. Dr Vikas Shirsath to lead Chemical Development Solutions at Aragen Biocon has announced that its Board has approved the appointment of Peter Bains as the Group Chief Executive Officer (CEO), with effect from September 18, 2023. He will be reporting directly to Kiran Mazumdar-Shaw, Chairperson, Biocon Group. Bains has accordingly stepped down from his role on the Biocon Board as an Independent Director with immediate effect, to assume this strategic executive responsibility. He has a unique fit and profile for the role having both extensive global leadership experience and success across the biopharmaceutical field and a comprehensive understanding of the Biocon Group, having led Syngene for 5 years, taking it through its very successful IPO in 2015. Siddharth Mittal, CEO & MD, Biocon; Shreehas Tambe, CEO & MD, Biocon Biologics; and Jonathan Hunt, CEO & MD, Syngene International will continue to have independent charge of their businesses and will work with Bains to strengthen synergistic strategic leadership at a Group level to maximise the combined value of all three businesses.
44 ACADEMICS NEWS PEOPLE NEWS BIOSPECTRUM BIOSPECTRUM | | NOVEMBER 2023 AUGUST 2021 | www.biospectrumindia.com | www.biospectrumindia.com The Organisation of Pharmaceutical Producers of India (OPPI), which represents global researchbased pharmaceutical companies, has appointed Anil Matai as its Director General (DG). Matai, a seasoned general management professional, has extensive experience in the life sciences space having worked across MNCs including spearheading operations across Novartis India, GSK India, and Global Pharma, Dubai. After superannuating as Managing Director of Zydus Healthcare, Matai was engaged as Senior Advisor - Life Sciences at IQVIA Consulting and Information Services India, and most recently as Operating Partner at Jashvik Capital - a midmarket Private Equity Fund focused on Healthcare & Consumer sector. He has functioned on the boards of Zydus Healthcare, Bayer Zydus Pharma, Novartis Healthcare and Biochem Pharmaceutical Industries. OPPI appoints Anil Matai as Director-General GNRC Hospitals, the largest healthcare chain in North East, has appointed Dr Vinoth Kumar as Group Chief Supply Chain Officer. Prior to that, Dr Kumar held leadership positions at Apollo Hospitals Group, Global Health City and Jehangir Hospitals. Dr Kumar is a seasoned healthcare supply chain management professional, an innovator, author, researcher, and a sustainability advocate. His career is marked by a unique blend of academic, research, and industry experience, spanning more than two decades. He has held various leadership roles in internationally renowned healthcare institutions, including Apollo Hospitals Group, Global Health City, and KIMS Health. He has received numerous awards and accolades from organisations both within the country and abroad. A remarkable achievement is his recognition in the India Book of Records (IBR), Asia Book of Records (ABR), World Book of Records (UK) and Guinness World Records. Notably, he is the first healthcare supply chain management professional in India to achieve this feat. GNRC Hospitals appoints Dr Vinoth Kumar as Group Chief Supply Chain Officer Ahmedabad-based Zydus Lifesciences has announced the appointment of Punit Patel as President and Chief Executive Officer (CEO), Americas. He will be responsible for the business operations of all Zydus entities in North America which include generics, injectables and specialty business, rare and orphan disease portfolio and also future forays into novel therapeutics. He will be based out of the group’s office in Pennington, New Jersey, US. His deep understanding of the complex generic pharmaceutical market (specialty, 505b2, injectables & biosimilars), coupled with his people leadership and resultsdriven style, unlocks value by enabling long-term strategy to be translated into actionable plans. Prior to his joining Zydus, Patel was the President of Red Oak Sourcing, helming a multi-billion-dollar generic portfolio. He was overseeing all aspects of Red Oak’s business including setting and implementing the strategic roadmap, overseeing supplier relationships, managing financial obligations, transforming company culture and collaborating with the company’s stakeholders – CVS Health, Cardinal Health and OptumRx. Zydus appoints Punit Patel as President and CEO to lead business operations in North America
IIT Mandi proposes protein-based vaccine against pork tapeworm Indian Institute of Technology (IIT) Mandi researchers have made significant strides in the development of vaccines against the pork tapeworm (T. solium). This tapeworm is responsible for both intestinal infections and the more severe brain infection that leads to seizures. The research, conducted in collaboration with scientists from Dayanand Medical College and Hospital in Punjab and the CSIRInstitute for Himalayan Bioresource Technology in Himachal Pradesh, presents a novel, faster, and more effective approach to producing vaccines for challenging infectious diseases. The identification of the right protein fragment with strong vaccination potential is a painstaking and time-consuming process. A more innovative and efficient approach is needed to expedite progress in tapeworm vaccine development and the IIT Mandi researchers used a combination of protein studies and bioinformatics to develop a method of selection. The amalgamation of protein studies with bioinformatics is a groundbreaking approach for identifying potential proteinbased vaccines in a costeffective and timely manner. The Indian Institute of Technology Kanpur (IIT-K) has developed a novel technology titled, “A Continuous Lung Health Monitoring System”. The technology has been innovated by a group of inventors from IIT Kanpur, IIT Kharagpur, and the International Institute of Information Technology (IIIT) Naya Raipur. The Ministry of Electronics and Information Technology (MeitY), Government of India has provided financial support for the innovation. The technology has been protected by Indian Patent application no. 202311027111. The technology is a low-cost, ubiquitous, unobstructive, and compact system that can help healthcare teams to track patients’ lung health status. The system includes an acoustic mask with highly sensitive sound sensors and an intelligent corded device to sense the inaudible breathing sounds from the user’s mouth and nose. The corded device of the mask consists of a WiFi module for sharing the lung health status with the health-care provider. The device is equipped with a highly-durable battery that provides seamless continuous monitoring and a local storage unit that stores the processed audio data for longterm inferences and a processing unit that has inbuilt memory and microprocessor. IIT-K develops novel technology to monitor lung health Researchers from the Indian Institute of Science Education and Research Bhopal (IISER Bhopal) have identified a specific circular RNA (circRNA) called ‘ciTRAN’, which plays a crucial role in multiplication of the AIDS-causing HIV-1 virus within the human body. The researchers developed a novel approach called ‘circDR-Seq’, to successfully capture circRNAs from T-cells (white blood cells) infected with the HIV-1 virus and identified a specific circRNA named ciTRAN, which plays an important role in the multiplication of the virus. The results indicate that HIV-1 virus hijacks this host-encoded ciTRAN in such a way that it can use it to multiply efficiently. This discovery uncovers a previously unknown aspect of how viruses like HIV-1 overcome transmission barriers. Another important result from this research was that the researchers developed a small protein molecule that can inhibit viral transcription, in the context of virally-induced ciTRAN. By showing how ciTRAN promotes the virus’s ability to multiply efficiently, this study offers promising avenues for the development of novel therapeutic interventions. IISER Bhopal identifies circular RNA that plays crucial role in HIV-1 virus replication 46 R&D NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com
Scientists at the Indian Institute of Science (IISc), Bengaluru have developed a new approach to potentially detect and kill cancer cells, especially those which form a solid tumour mass. The scientists have created hybrid nanoparticles made of gold and copper sulphide, which can kill cancer cells using heat, and enable their detection using sound waves. Early detection and treatment are key in the battle against cancer. Copper sulphide nanoparticles have previously received attention for their application in cancer diagnosis, while gold nanoparticles, which can be chemically modified to target cancer cells, have shown anticancer effects. In the current study, the IISc team decided to combine these two into hybrid nanoparticles. The researchers say that the nanoparticles can also help diagnose certain cancers. Existing methods such as standalone CT and MRI scans require trained radiology professionals to decipher the images. The photoacoustic property of the nanoparticles allows them to absorb light and generate ultrasound waves, which can be used to detect cancer cells with high contrast once the particles reach them. IISc discovers hybrid nanoparticles that shine new light on targeting cancer cells BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com R&D NEWS 47 IIT Jodhpur designs antimicrobial peptide from snake venom India’s fight against tobacco takes a significant step forward with a groundbreaking clinical trial conducted at Bengaluru’s Krishnadevaraya College of Dental Sciences, which has firmly established the efficacy of Nicotine Replacement Therapies (NRT) in aiding smoking cessation. The study concluded that the combined use of two successful smoking cessation methods, i.e., behavioural counselling and NRT in the form of nicotine gums, significantly enhances success rates in smoking cessation. This is the second such clinical trial to present compelling evidence on the effectiveness of NRT in helping smokers successfully quit the habit. In another landmark study by S.C.B. Dental College & Hospital, Cuttack, Odisha, nearly 70 per cent of trial participants were consumers of smokeless tobacco. This is the first trial in the world to demonstrate the efficacy of NRT in smokeless tobacco consumers. Trial finds behavioural counselling and NRT efficacious in smoking cessation Researchers at the Indian Institute of Technology (IIT) Jodhpur have conceptualised, designed, and synthesised an antimicrobial peptide molecule, SP1V3_1, from snake venom, that can kill gram-positive and gram-negative bacteria like E. coli, P. aeruginosa, K. pneumoniae, and MRSA (methicillin-resistant Staphylococcus aureus) by adopting a helical conformation while interacting with bacterial membranes. The peptide molecule has been found to be non-toxic based on various studies. The peptide was also found to promote wound healing in the murine model and prevent on-site postsurgical infections by MRSA. In this design strategy, the primary aim has been to reduce toxicity of the snake venom without losing its antimicrobial property. Thus, the researchers truncated the snake venom peptide and eliminated the toxic part. Further, they stitched helical short peptides at N-terminus for the smooth entry of the newly designed therapeutic inside the bacterial cell.
Revvity expands access to base editing technology Belgium-headquartered company Eurofins has opened its state-ofthe-art Biopharma services campus in Genome Valley, Hyderabad. This is the second campus in India after Bengaluru. As a part of its ambitious growth plans, the company will be investing around Rs 1,000 crore and will create employment opportunities for around 2,000 people over the next 6-7 years. The Hyderabad campus has about one lakh sq ft of laboratory and office space, located on 15 acres of land. The campus in Genome Valley will provide services in discovery chemistry and discovery biology, safety toxicology, bioanalytical services and formulation development to global pharmaceutical companies. Hyderabad campus shall be expanded to become the showcase site for Eurofins in India, encompassing services across the complete pharma R&D value chain from discovery to development. Eurofins’ Genome Valley Biopharma services campus to encompass complete pharma R&D value chain Waters Corporation has introduced DynaPro ZetaStar instrument from its Wyatt Technology portfolio for nanoparticle analysis. The new instrument simultaneously enables dynamic and static light scattering and dynamic and electrophoretic light scattering (DLS/SLS/ELS) measurements, all in one device. By combining multiple light scattering techniques and automatically assessing data quality and performing adaptive data capture, the ZetaStar instrument delivers both increased sensitivity and faster measurements to aid the precise development of complex biologics, using extremely low sample volumes. Designed to support the expanding needs of biopharma formulation and development laboratories, the ZetaStar instrument helps scientists working in gene therapy, vaccines, mRNA, and proteins develop more stable therapies. Waters launches ZetaStar instrument for nanoparticle analysis 48 SUPPLIERS NEWS BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com American firm Revvity, Inc. has unveiled its groundbreaking Pin-point base editing platform reagents, providing researchers with unparalleled access to implement the advanced gene editing technique in their preclinical laboratories. Base editing represents a pivotal advancement in CRISPR gene editing, providing the capability for complex and safe multi-gene editing, which can result in enhanced functional genomics insights for optimising drug development, as well as streamlining cell line and cell therapy development and manufacturing. The Pin-point platform is one of the few established base editing technologies currently being employed in clinical settings, positioning it as both a discovery and therapeutic tool. The initial reagents launch includes mRNAs for nCas9 and rat APOBEC, as well as three guide RNAs designed to knockout the TRAC, CD52 and PDCD1 loci. These reagents have undergone extensive validation and have demonstrated their performance in T-cells and induced pluripotent stem cells (iPSCs). Furthermore, Revvity offers the flexibility of ordering custom guides for other targets through its Dharmacon custom gRNA ordering tool for the Pin-point base editing platform, supporting diverse research applications.
Sartorius, SPARTA Biodiscovery partner on novel nanoparticle analysis platform BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com SUPPLIERS NEWS 49 Germany headquartered life science group Sartorius and UK-based startup SPARTA Biodiscovery have agreed to partner on SPARTA’s analysis platform, which helps speed up the development, manufacture, and quality control of nanoparticles for biopharmaceutical drugs. Nanoparticles are small polymer or lipid capsules that act as carriers to deliver active agents to the target cells. As part of the cooperation, Sartorius will invest up to £3.5 million in a minority shareholding in SPARTA Biodiscovery through its corporate investment unit Sartorius Ventures. The SPARTA Biodiscovery team spun off from Imperial College London, where it developed the core technology and prototype for the platform in the group of cofounder Professor Molly Stevens FRS, FREng. The SPARTA technology, Single Particle Automated Raman Trapping Analysis, uses spectroscopy to analyse populations of individual nanoparticles quickly and automatically at high throughput, helping to accelerate nanoparticle development and optimise quality control during production. US-headquartered Promega Corporation has announced plans to develop and commercialise a microsatellite instability (MSI) companion diagnostic (CDx) in vitro diagnostic (IVD) kit with UK-based pharmaceutical company GlaxoSmithKline (GSK) to identify adult cancer patients with MSI-H solid tumours who may be eligible for potential treatment with GSK’s Jemperli (dostarlimab-gxly). The collaboration agreement leverages the companies’ complementary strengths to expand personalised healthcare options to more patients using high quality diagnostic tools and treatments. The future CDx indication under development will utilise the Promega PCR-based five-marker MSI panel with Jemperli, an anti-PD-1 monoclonal antibody (mAb). Promega, GSK to develop microsatellite instability companion diagnostic IVD kit Agilent Technologies sells NGS player Resolution Bioscience to Exact Sciences Agilent Technologies, Inc. and Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, have entered into a definitive agreement for the sale of Resolution Bioscience to Exact Sciences. Agilent Technologies had acquired Resolution Bioscience Inc, a leader in the development and commercialisation of nextgeneration sequencing (NGS)- based precision oncology solutions, for $695 million. The acquisition complemented and expanded Agilent’s capabilities in NGS-based cancer diagnostics and provided the company with innovative technology to further serve the needs of the fastgrowing precision medicine market.
50 LET’S TALK HEALTH BIOSPECTRUM | NOVEMBER 2023 | www.biospectrumindia.com Fighting Next-Gen Dengue I n 2023, and as of October 2, over 4.2 million cases and over 3,000 dengue-related deaths have been reported from 79 countries/territories globally. Within Asia, dengue outbreaks have been reported in India, Bangladesh, Afghanistan, Cambodia, China, Laos, Malaysia, Nepal, Philippines, Singapore, Sri Lanka, Thailand and Vietnam. Caused by any of four distinct serotypes (DENV 1-4) of single-stranded RNA viruses of the genus Flavivirus, dengue has emerged as the fastest spreading mosquito-borne viral disease globally. In India, dengue is endemic in almost all states. All four antigenically distinct serotypes of the virus that display significant immunological cross-reactivity due to 65–70 per cent homology have been reported from various parts of the country over the years. Combined with a complex transmission cycle and high seroprevalence, dengue evolution in the country has been shaped in complex and unexpected ways. According to recent reports in India, the more common Dengue 1 strain manifests in symptoms such as fever and body aches, but the new strain Dengue 2, found to be emerging in Uttar Pradesh, can lead to high fever, vomiting, skin rashes and dengue shock syndrome. The new variant is more lethal and it could lead to multiple organ failure in some patients and even death. A multi-institutional study on dengue led by researchers at the Indian Institute of Science (IISc), Bengaluru shows how the virus causing the disease has evolved dramatically over the last few decades in the Indian subcontinent. As per the researchers, until 2012, the dominant strains in India were Dengue 1 and 3. But in recent years, Dengue 2 has become more dominant across the country, while Dengue 4, once considered the least infectious, is now making a niche for itself in South India. As a result, many private players in India are trying to understand the dynamics of dengue diagnosis, control and management by developing new products and strategies. For instance, Pune-based startup Mylab Discovery Solutions has introduced two state-of-theart tests for the detection of dengue infections, in the form of the dengue rapid gold test and the dengue high accuracy dry luminescence assay test. Likewise, Bengaluru-based startup GenWorks has launched an immunochromatographic one-step rapid card solution for qualitative early acute dengue detection. Further, the Karnataka government has announced the development of a mobile app, which, along with an artificial intelligence (AI)-based model, can provide dengue predictive analysis. At present, the National Center for Vector Borne Diseases Control (NCVBDC), Ministry of Health and Family Welfare (MoHFW) is working with identified ministries, states, government institutions and development partners under a common platform to develop a strategic framework for dengue control. Amidst these developments, India is also getting closer towards producing an effective dengue vaccine. On August 30, Cyrus S Poonawalla, Chairman and Managing Director of Serum Institute of India, revealed that the company plans to develop a dengue vaccine in approximately one year. Few other players such as Hyderabad-based Indian Immunologicals, New Delhi-based Panacea Biotech are also in the process of developing vaccines for dengue in the coming years. In another recent development this year, the Indian Council for Medical Research (ICMR) has approved a research grant to a group of researchers at the Indian Institute of Technology Delhi (IIT-D) for the development of a nano-vaccine against dengue. Globally, there are two live attenuated tetravalent vaccines available- Dengvaxia and Qdenga, and this list is awaiting the presence of indigenous vaccines from India. Due to the immense public health burden from dengue infections in India, it is important to understand the genetic diversity, spatial incidence, effectiveness of vaccines and the potential emergence of new variants of the dengue virus in the region. The public and private sectors should increase their focus and R&D investments in studying this condition, and finding solutions in the best possible way. Dr Manbeena Chawla Executive Editor [email protected]