BioSpectrum India July 2023

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Vol 21; Issue 6; June 2023 4 BIO MAIL BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Vol 21; Issue 7; July 2023 Publisher & Managing Editor: Ravindra Boratkar Editorial: Chief Editor: Dr Milind Kokje [email protected] Advisor - Content: Vijay Thombre Editor: Narayan Kulkarni [email protected] Executive Editor: Dr Manbeena Chawla [email protected] Assistant Editor: Nitesh Pillai [email protected] Assistant Editor (Digital): Sanjiv Das [email protected] Content Team: Singapore: Hithaishi C. Bhaskar [email protected] Social Media Communications: Poonam Bhosale [email protected] CFO & Special Correspondent: Manasee Kurlekar [email protected] Operations and HR: Asmita Thakar [email protected] Product & Marketing: Ankit Kankar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Circulation, Subscription and Media Enquiry: Sudam Walekar [email protected] South Region Apoorva Mahajan Key Account Executive “NITON”, Block B, First Floor, 11/3, Palace Road, Bangalore 560052 Mobile: +91-7724025888 [email protected] Mumbai Mandar More Regional Business Manager 1st Floor, CIDCO Convention Center, Sector 30A, Vashi, Navi Mumbai, Maharashtra-400703. Mobile: +91-9870009281 [email protected] MM Activ Sci-Tech Communications Nagpur Manisha Boratkar 402, Govind Apartments, Shankar Nagar Square, Nagpur - 440 010. Tel. +91-712-2555 249 ‘BioSpectrum’ monthly publication is owned by MM Activ Sci-Tech Communications Pvt. Ltd., Published and Printed by Ravindra Boratkar, Printed at Spectrum Offset, D2/4, Satyam Industrial Estate, Behind CDSS, Erandawana, Pune - 411 038. and Published at ‘Ashirwad’, 36/A/s, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune - 411 045. Editor: Narayan Kulkarni. Website: www.biospectrumindia.com New Delhi Dr Manbeena Chawla Executive Editor 103-104, Rohit House 3, Tolstoy Marg, Connaught Place, New Delhi - 110 001 Mobile: +91-8861043732 [email protected] Pune Vipan Kumar Relationship Executive - Media Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Baner Road, Pune-411045 Mobile: +91-98347 45564 [email protected] INTERNATIONAL Singapore MM Activ Singapore Pte. Ltd. Saradha Mani General Manager #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Tel: +65-63369142 Fax:+65-63369145 [email protected] Asia Pacific and South East AsiaAnkit Kankar DY. General Manager - Digital Strategy & Programmes #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Mobile: +65 90150305 [email protected] North America and Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 E-mail: [email protected] Acknowledgements/ Feedback Thank you BioSpectrum India for an engaging discussion about the healthcare landscape in India, about the numerous challenges within the field of medical technology, with a special focus on the imperative need for digital solutions to enhance healthcare services and bridge the healthcare gap in the country. Thank you for the interview feature on Siemens Healthineers. - Dileep Mangsuli, Bengaluru Thank you so much for the opportunity and coverage on Akums Drugs & Pharmaceuticals. - Pragati Jain, New Delhi Thank you BioSpectrum for supporting the bioincubator ecosystem with the ranking initiative. - Dr Manesh Thomas, Manipal The number of startups incubated, the number of jobs created, the amount of investment raised by the startups, and the success rate of the startups can all be used to gauge how well a bioincubator is performing. Great work BioSpectrum, for the elaborate feature on bioincubators. - Dr Vishal Gandhi, New Delhi

Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, The American author H Jackson Brown, Jr famously remarked, ‘Don’t work for recognition but do work worthy of recognition.’ BioSpectrum is honoured to present such personalities from the life sciences sector whose work in the last two years has, indeed, been worthy of recognition. As an esteemed media platform catering to the life sciences field BioSpectrum is honoured to, not only recognise but also appreciate their excellence in their respective work and areas by conferring upon them BioSpectrum Excellence Awards. I applaud all the recipients of the awards. I wish to particularly highlight the yeoman and selfless contribution of Dr K I Varaprasad Reddy to the biotech sector who was bestowed with the Lifetime Achievement Award. My heartfelt congratulations to Dr Krishna Ella and Mahima Datla, recipients of the Businessperson of the Year awards and the entrepreneurs for their remarkable financial performance in their respective fields. I admire the path-breaking contribution of Dr Varaprasad Reddy in initiating efficacious and cost-effective vaccines, within the reach of the common man in India. His contribution in the field of biotechnology has made India self-reliant in terms of vaccine production. He has been a true inspiration for people from all walks of life. As witnessed during the sudden onslaught of COVID-19, Dr Ella and his team swung into action and delivered a ‘success story of our times’ by creating a vaccine against the novel coronavirus. India’s vaccine self-reliance is also Dr Ella’s another major contribution that will be etched in our country’s history. You will read in detail about all of them, their work and their contribution in this edition which, I am confident, will be inspiring for our readers. This edition will also give you a glimpse of the glitter and glamour of the awards presentation ceremony. I and Team BioSpectrum are thankful to all our guests of honour, jurors, award recipients, their families and friends, industry leaders and other guests who were present to cheer on the awardees, our well-wishers, and all those who contributed in some way or the other to make this ceremony a grand success. Happy reading. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com 5 Looking for a job? See open roles at www.biospectrumjobs.com n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... BIOSPECTRUM TALENT SOLUTIONS premier source of pharma healthcare & bio jobs

A Living Biotech Legend DR K I VARAPRASAD REDDY Non-Executive Chairman, Shantha Biotechnics 11 22 JURY AWARDS 26 SPECIAL CATEGORY AWARDS 29 RANKING AWARDS 32 PANEL DISCUSSION AND EVENT COVERAGE BioSpectrum Excellence Awards 2023 6 BIO CONTENT BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com ACHIEVEMENT LIFETIME MAHIMA DATLA Managing Director, Biological E. Limited 16 BUSINESS PERSON OF THE YEAR 18 DR ANAND ANANDKUMAR Co-Founder & Chief Executive Officer, Bugworks Research ENTREPRENEUR GEETHANJALI RADHAKRISHNAN Founder & Managing Director, Adiuvo Diagnostics 19 WOMAN ENTREPRENEUR DR PRAGYA YADAV Scientist ‘F’ and Head of Maximum Containment Facility, Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune 21 YOUNG WOMAN SCIENTIST SSI MANTRA ROBOTIC SURGERY SYSTEM By SS Innovations (SSI) 20 PRODUCT OF THE YEAR 2021-22 BioSpectrum Excellence Awards Photo Gallary

BUSINESS PERSON OF THE YEAR Regulars BioMail ......................................................................04 Letter from Publisher..............................................05 BioEdit .......................................................................08 Policy and Regulatory News..................................10 Let’s Talk Health.......................................................50 Speaking With 48 “We will launch a Technology Development Centre to take fermentation technology to the next level” Mihir Mehta, Wholetime Director, Praj HiPurity Systems 43 “CDMOs in India are always looking for an edge to improve development and manufacturing processes while also lowering costs” Dr Udit Batra, President & CEO, Waters Corporation 45 “New bioincubators would be set up to cater to the growth of startup ecosystem including the tier 2, tier 3 regions” Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) BioSpectrum Excellence Awards 2020-21 BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIO CONTENT 7 ENTREPRENEUR WOMAN ENTREPRENEUR YOUNG WOMAN SCIENTIST PRODUCT OF THE YEAR 36 38 40 39 41 DR KRISHNA ELLA Executive Chairman, Bharat Biotech International Ltd.

8 BIO EDIT BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Dicey Price Wars The government and the pharma industry appear to be at loggerheads over the trade margin rationalisation (TMR) and drug pricing issue. There are two reasons for that. Firstly, a representation from the industry to the government and secondly, a new decision taken by the National Pharmaceutical Pricing Authority (NPPA). In its representation to the government, the pharmaceutical industry has taken up the issue of removing cap on low-price medicines and TMR. The industry wants the ceiling price of all low-priced drug formulations priced below Rs 5 per unit to be waived. In reality, this means waiving off price ceiling on every tablet, capsule, sachet with maximum retail price of Rs 5 and below and allowing the industry to decide its own price, which can go up anywhere from Rs 15 to 50, reducing government’s control over price fixing. The industry has also demanded that the medicines priced less than Rs 10 per unit should be exempted from proposed TMR. The government is planning to rationlise drug trade margins for widely used medicines. The move is initiated to bring down their prices. But, another reason for the move is to bring under government scanner, the drugs which are not part of the National List of Essential Medicines (NLEM) but commonly used for diseases like cancer and chronic kidney diseases and are expensive, increasing the healthcare expenditure of common people. Prices of the medicines in the NLEM list are capped. By controlling the trade margins of wholesalers, distributors and retailers the government wishes to control the prices of medicines which are outside this list. It is an old issue since the government had mooted the TMR in June 2022 itself. As the authorities and the industry are on two sides of the issue, both had a few rounds of meetings, the last one being in May, where the industry had sought a graded introduction of TMR. The industry has also been suggesting one molecule-one MRP for non-scheduled drugs as an alternative to ceiling trade margins. Some industry experts believe that the benefit of price reduction due to the TMR may not ultimately help the end consumer. Due to the ceiling on margins the sellers may opt to sell the drugs with higher prices to earn more from the capped margins. The NPPA’s plan to slash by half the ceiling price of off-patent drugs is also disconcerting for the industry. This move is expected to have a significant effect on the business as it is expected to reduce the prices of even patented drugs. NPPA will fix a new price after one year based on market data. This is being done to help streamline the pricing of innovative medicines. Drug manufacturers will have to reduce the price by half the moment the patent expires. Earlier, the companies could continue to charge the same price till generic versions were available in the market. On this issue, the industry’s contention is that the price fixation of fixed dose combinations (FDCs) reduces the 50 per cent price on the patent component. Prices of drugs which have become off patent two to three years back have already been reduced. The rising prices of Active Pharma Ingredients (APIs) is affecting the production cost and naturally affecting the end price. The second factor pertains to the investment and R&D costs. Any impractical control on prices may affect the industry’s wish and intention to promote R&D. Hence, the government will have to adopt a very cautious, balanced approach helping people on one hand and considering industry’s issues on the other. Dr Milind Kokje Chief Editor [email protected]

The Ministry of Ayush and the Ministry of Minority Affairs, Government of India, have jointly taken a significant step to promote and develop the Unani system of medicine in India. The Ministry of Minority Affairs has approved a grant of Rs 45.34 crore under Pradhan Mantri Jan Vikas Karyakram (PMJVK), a centrally sponsored scheme (CSS). With support of this scheme, Unani Medicine facilities will be upgraded at Hyderabad, Chennai, Lucknow, Silchar and Bengaluru locations. Central Council for Research in Unani Medicine (CCRUM) has been sanctioned a total amount of Rs 35.52 crore and National Institute of Unani Medicine (NIUM), Bengaluru has been sanctioned Rs 9.81 crore. A centre for fundamental research in Unani Medicine at National Research Institute of Unani Medicine for Skin Disorders, Hyderabad will be established at a cost of Rs 16.05 crore. Ministry has proposed cost of Rs 8.15 crore for a preclinical laboratory facility at Regional Research Institute of Unani Medicine, Chennai, Rs 8.55 crore for a centre of Ilaj bit Tadbeer (regimenal therapy) for musculoskeletal disorders at Central Research Institute of Unani Medicine, Lucknow, and Rs 2.75 crore for a centre of Ilaj bit Tadbeer (regimenal therapy) for skin and lifestyle disorders at Regional Research Institute of Unani Medicine, Silchar. Ministry of Minority Affairs grants Rs 45.34 Cr for promotion of Unani Medicine ICMR inks MoA with National Cancer Grid to revolutionise cancer care Centre launches the Export Promotion Council for Medical Devices The Union Minister of Health and Family Welfare Dr Mansukh Mandaviya has launched the Export Promotion Council for Medical Devices and a scheme titled ‘Assistance for Medical Devices clusters for Common Facilities (AMD-CF)’. This scheme aims to establish and strengthen common infrastructure facilities in the medical devices clusters and fortify testing facilities for medical devices. Dr Mandaviya also unveiled the National Medical Devices Policy, 2023. Dr Mandaviya launched the scheme on May 26 after inaugurating the 8th International Conference on Pharma and Medical Device Sector in New Delhi organised by the Department of Pharmaceuticals in association with Federation of Indian Chambers of Commerce and Industry (FICCI) to promote India as a manufacturing hub of quality medical products in the pharmaceutical and medical device Sector. The theme for the conference on the medical device sector was on “Sustainable MedTech 5.0: Scaling and Innovating Indian MedTech.” Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has signed a Memorandum of Agreement (MoA) with National Cancer Grid (NCG), an initiative of the Government of India through the Department of Atomic Energy and its grant-in-aid institution, the Tata Memorial Centre. The objective of the MoA is exclusively for clinical trials, focusing on the development of novel affordable therapies for India-specific cancers and cancers common in India. The agreement covers joint funding for multicentric, multidisciplinary, interventional trials for common/unique cancers. The NCG has been established to create a network of cancer centres, research institutes, patient groups and charitable institutions across India with the objective of developing uniform standards of patient care for prevention, diagnosis, and treatment of cancer; providing specialised training and education in oncology and facilitating collaborative basic, translational and clinical research in cancer. NCG today has over 270 hospitals in its network across India. 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com

ACHIEVEMENT LIFETIME A Living Biotech Legend DR K I VARAPRASAD REDDY Non-Executive Chairman, Shantha Biotechnics Shantha is the first company in the biopharma sector in India to ignite the growth of biotechnology based vaccines and therapeutic products. It is the only company that believed in- Make it available locally, and Make it affordable to the common man. It was also the first company in the country to have WHO pre-qualification for the recombinant DNA products. Aman with relentless determination, Dr K I Varaprasad Reddy brought about a biotechnology revolution in India when he established the first-of-its-kind biopharma vaccine company Shantha Biotechnics in 1992. He started his journey of vaccine development with one motto- Make it locally, make it affordable! Under his leadership, Shantha Biotechnics emerged as the first Indian company to develop, manufacture and market a recombinant DNA human healthcare product in India in the form of Hepatitis-B Vaccine called Shanvac- B. Shantha was also the first company to produce cholera vaccine, and the first to produce Interferon using an yeast system instead of E.coli, to give the benefit of less toxicity. Shantha was the first company to have World Health Orgnisation (WHO) pre-qualification for the recombinant DNA products. “Shantha is the first company in the biopharma sector to ignite the growth of biotechnology based vaccines and therapeutic products. It is the only company that believed in- Make it available locally, and Make it affordable to the common man”, says Dr Varaprasad Reddy. But adding these many ‘firsts’ was a part of a very tough journey. And it all started with anger and disappointment that eventually took shape of obsession. A righteous explorer Born in 1948 in Nellore district of Andhra Pradesh, Dr Varaprasad Reddy completed his education in the field of electronics engineering and computer sciences. The initial years of his career were spent at the Defence Electronics Research Lab, and later in Andhra Pradesh Industrial Development Corporation (APIDC). However, certain compromises in the values was the reason to quit the organisation eventually. Moving forward in 1985, he joined an ongoing company Hyderabad Batteries Limited and invested his time and money in building the organisation. With his hard work and entrepreneurial skills, Dr Varaprasad Reddy soon became the face of the company and BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 11

• Founder of India’s first biopharma vaccine company Shantha Biotechnics (1992) • Developed, manufactured and marketed the first recombinant DNA human healthcare productHepatitis-B Vaccine called Shanvac-B (1997) • Developed, manufactured and marketed Interferon and Erythropoietin in India (2002) • Received National Technology Award for Shanvac-B (in 1999) and Shanferon (in 2003) • Produced a combination vaccine- SHANTETRA (Hepatitis-B + DPT) (2005) • Recipient of Padma Bhushan by government of India in 2005 • Started supplying inactivated polio vaccine (IPV) to the government of India (2015) • Received Honorary Doctorates from SV University, Tirupati (2005); GITAM University (2011); and Vignan University (2018) • Launched first bivalent oral cholera vaccine Shanchol (2018) • Received WHO pre-qualification for the recombinant DNA products • Exported the recombinant DNA products from India • Initiated mass vaccination camps for immunisation, to reduce the cost of vaccination by eliminating the market chain • Worked with Ministry of Health to evolve Indian Pharmacopeia with recombinant DNA product specifications • Life Member of Federation of Asian Biotech Associations • Served as Chairman, Technical Advisory Group, National Biopharma Mission initiated by Biotechnology Industry Research Assistance Council (BIRAC) • Serving as Director on the Board of Sparsha Pharma International (India); Sparsha Pharma Inc. (US); Advanced Bioscience Laboratories Inc. (US); Diabetomics Medical (India) MILESTONES 12 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com started receiving many awards. But his success started pinching others, and again on certain ethical issues he deferred with his partner which made Dr Varaprasad Reddy to quit the organisation. For this righteous man, unethical and bad experiences were adding up one after the other during his career of 12-15 years. There came a point when he thought of going back to his village to lead a simple life. He had almost made up his mind but destiny had something else planned out for him. Right before his final decision to move to his village, a call came from his cousin to visit him in the US. In need of some peace and quiet time, he went to the US and soon after, accompanied his cousin to Geneva for a health conference. Instead of having a good time, this experience too turned out to be an unpleasant one in Dr Varaprasad Reddy’s life. “At the summit, many derogatory comments were being made about India and neighbouring countries, particularly due to high cases of hepatitis B in our country. India needed vaccines but could not afford them. So, the western countries were belittling the Indians by calling them beggars, as India was looking for some subsidised vaccines or donated vaccines from the western society.”, recalls Dr Varaprasad Reddy. During this summit, he realised the actual situation of hepatitis B in India. An engineer by profession, he had absolutely no idea about how this infectious disease kills people and how it can be prevented. He gradually reached out to a few doctors in the US and India in order to understand this disease and its transmission better, and why so many people are suffering from this condition in India. He further says, “I learnt that more people die in a day because of Hepatitis B than with human immunodeficiency virus (HIV) in a year. Hepatitis B is much more infectious than AIDS.” He found that millions were dying due to hepatitis, especially the poor people since they could not afford the vaccine which costed around Rs 2520 for 3 doses, i.e. Rs 840 per dose, supplied by either British firm SmithKline Beecham (SKB) or LG (South Korea). This realisation led to the birth of a determination in Dr Varaprasad Reddy’s heart and mind that hepatitis B must be eliminated from India, by developing a recombinant DNA vaccine in the country, and that too at an affordable price of Rs 50. But his passion and belief did not receive much support from the government or industry in India. A legend in the making His resolve to develop the Hepatitis B vaccine indigenously, began in 1991. He started collecting information about the process of developing a vaccine. Although he received support from a few

With wife Vasanta and daughter Sravanthi (She worked for Shantha Biotechnics for 9 years as Commercial Director) BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 13 The first biotechnology-based product was developed without a single rupee in support from the Indian banks. Instead, Yusuf Bin Alawi Abdullah, Foreign Minister of the Sultanate of Oman, was quite impressed with my determination and commitment that led to an investment of Rs 1.82 crore, to get the ball rolling. Also he arranged a long term loan of Rs 15 crore from Oman International Bank with his personal guarantee and agreed to invest in my commitment towards creating a vaccine for social causes. Sultanate of Oman, was quite impressed by Dr Varaprasad Reddy’s determination and commitment which led to an investment of Rs 1.82 crore, to get the ball rolling. Also he arranged long term loan of Rs 15 crore from Oman International Bank with his personal guarantee. He deputed one of his executive, Khalil Ahmed to Shantha Biotechnics to assist me in running the company. After the launch of Shanvac-B, Dr Varaprasad Reddy was now in need of more funds to scale up the production and send it to the market. Thankfully, around that time, the government had established the Technology Development Board (TDB) to fund home-grown technologies and indigenous product development. He approached TDB and received a loan of Rs 8 crore. While it seemed that Dr Varaprasad Reddy’s efforts were finally being recognised, the situation was actually getting tougher for him. Competition within the market made it worse. The main competitor GlaxoSmithKline (GSK) (back then it was SmithKline Beecham) reduced its vaccine price from Rs 840 per scientists at Osmania University in Hyderabad for starting the basic laboratory work, there were multiple challenges on the way. The scientists, particularly Dr Gita Sharma, were enthusiastic about this project and helped him to prepare the project report for submission to government licensing authorities and also started experimenting on development of the vaccine. As she has no previous experience of developing a vaccine she could not continue on this developmental project. But her help was very useful to approach the government with the report. “There was no role model to follow, to develop a recombinant DNA technology for vaccine. I visited Dr Anji Reddy and few other industry leaders, but all of them told me that this task was an impossible one and I was wasting my time”, mentions Dr Varaprasad Reddy. Another major issue was that there was no policy to encourage biotechnology within the government and its departments. On top of that, no Indian bank had heard of biotechnology back then and thus refused any monetary support in this noble cause that Dr Varaprasad Reddy had set his heart on. Shantha Biotechnics, named after Dr Varaprasad Reddy’s mother, came into existence in 1992. With no support from the government and banks in India, things were not at all looking bright for this entrepreneur. In early 1993, a detailed discussion with Dr Guntaka Rami Reddy, a renowned microbiologist from Columbia University in the US, opened new doors. The research work for developing the hepatitis B vaccine caught some speed, only to get stuck again when the administrative in-charge asked Dr Varaprasad Reddy to vacate the lab his scientists were using at Osmania University. Dr Guntaka’s helped to prepare the clone, the first step for vaccine development. After that Dr Guntaka moved on to a different project. Shantha’s scientists did the rest of the product development and completed in all the aspects until the final product is ready for licensing. The work re-started at another laboratory in the Centre for Cellular and Molecular Biology (CCMB), in Hyderabad. In 1995, Shantha Biotechnics moved into its own space and established an R&D centre and manufacturing facility. The first batch of the vaccines was ready in March 1996. Post clinical trials, the product was finally unveiled on 18 August 1997. “The first biotechnology-based product was developed without a single rupee in support from the Indian banks. Instead, Omani Foreign Minister agreed to invest in my commitment towards creating a vaccine for social cause”, Dr Varaprasad Reddy highlights. Yusuf Bin Alawi Abdullah, Foreign Minister of

dose to Rs 520. In addition, the company started writing letters to doctors about how unsafe is the vaccine developed by Shantha Biotechnics. Following this episode, Dr Varaprasad Reddy approached the Drug Control General of India (DCGI) to refute the claims being made by GSK. A series of comparative tests across centres were conducted between the global product and Shanvac-B, only to reveal that Shantha’s vaccine had higher antibody titres. The international journal “Vaccine” published these results thereafter. Dr Varaprasad Reddy points out, “After the results were published, more than 200 doctors came together to support Shantha and its product, thereby silencing the sceptics.” While he had thought of selling the vaccine at an affordable price of Rs 50, the marketing department of a major pharma company in India said that since the GSK price stands at Rs 520, Shanvac-B should be priced at Rs 519. Dr Varaprasad would hear none of this. So, he began recruiting people to start his own marketing department for marking efforts to sell the vaccine at Rs 50. However, when the vaccine was finally hitting the market shelves, its cost stood at Rs 180 after adding all the costs at different levels in the marketing chain. In order to bypass these extra costs in the marketing chain, Dr Varaprasad Reddy joined hands with the Indian Medical Association and started organising mass vaccination camps to sell the vaccine directly. This is a very innovative step undertaken by Dr Varaprasad Reddy. Shantha Biotechnics eventually ended up selling the vaccine at Rs 50, and earned a revenue of Rs 8 crore in the first six months, and Rs 23 crore in the first year. In 2001, Shantha became the first Indian company to obtain pre-qualification certificate from the World Health Organisation (WHO). Another turning point In November 2006, the Omani shareholder hoped to harvest his investments in Shantha, while Dr Varaprasad Reddy was not very keen to go public. The investor then offered his price to buy the stakes at $80-85 million (since he had a 50 per cent stake), as the valuation of Shantha stood at $175 million. Since Dr Varaprasad Reddy did not have enough money, he brought in French firm Merieux Alliance Group to buy those 50 per cent shares from the Omani Minister, and finalised the deal. Later, Merieux invited another vaccine manufacturing company Sanofi which wanted to make use of Shantha’s capabilities of developing affordable and high quality vaccines. Merieux sold out all their share to Sanofi at a very high valuation of the company, 850 million Euros. Shantha majority shares were finally acquired by Sanofi in 2009. At that time, all employees sold their shares to Sanofi but Dr Varaprasad Reddy did not sell all his shares, and still he his holding some part of his shares. Today, he continues working as the non-executive Chairman of Sanofi Healthcare India previously known as Shantha Biotechnics. “I decided the prices for vaccines in India for 11 years, after Sanofi took over Shantha. Affordable cost is my mantra. I resigned after 11 years as per the contract, but the Board insisted that I stay. I was drawing a salary of Rs 1.5 lakh per month when I was heading Shantha Biotechnics, but when Sanofi came, they increased my salary exorbitantly on par with their international norms and standards. After paying my taxes, I started donating most of my salary for social causes”, says Dr Varaprasad Reddy. Dr Varaprasad Reddy is a proud man today with his simplicity and honesty being his prized possessions. He has many awards to his credit with the most prestigious one being Padma Bhushan by the government of India in 2005 and the most current one being the YSR Life Time Achievement award in 2022 from the Government of Andhra Pradesh. He is also currently involved in numerous social activities such as developing comfortable living spaces for old and ill people. “We have great doctors, great engineers in our country but not great leaders. The vaccine scenario has changed considerably in India. Currently, we are strong in production but we should collaborate with other countries for joint development and own the patent rights, to become global leaders”, Dr Varaprasad Reddy concludes. 14 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com

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BUSINESS PERSON OF THE YEAR 2021-22 MAHIMA DATLA Managing Director, Biological E. Limited Enhancing Effective Vaccine Availability Worldwide With a Bachelor’s Degree in Business Administration from Webster University, London, Mahima Datla has been with Biological E. Limited (BE) since 2001 and is currently its Managing Director. She directly oversees strategic operations within the organisation and leads the work related to public policy. She has served in various capacities across a diverse range of functions, including Biotechnology & Projects; Operations and Strategic Business Development. Under Mahima’s leadership, BE has demonstrated consistent growth given the successful WHO pre-qualification and launch of several vaccines. Under her leadership the company has generated revenue of Rs 2588 crore in 2021-22 as against Rs 1418 crore in 2020-21 up by 82 per cent. Mahima Datla, daughter of late Dr Vijay Kumar Datla, was appointed as the Managing Director of Hyderabad-based Biological E. Limited in 2013. After the demise of Dr Vijay Kumar Datla, Chairman and Managing Director of BE in 2013, the firm’s top post was left vacant, soon after which 35-year old Mahima took charge as the new head of the 70 year old vaccine and pharmaceutical manufacturing company. Over the years, BE has achieved a unique distinction in the manufacturing space of vaccines and pharmaceutical products. Originally incorporated as Biological Products in 1953 by Mahima’s grandfathers GAN Raju and Dr DVK Raju, the company was the first vaccine maker in south India. It became 16 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Biological Evans (BE) when UK-based Evans Medical acquired a 40 per cent share in 1960s, which it sold to GlaxoSmithKline in 1978, which was subsequently bought back by the promoters in 1995. With Mahima spearheading the company for the past 10 years, BE has embarked on new initiatives for organisational expansion such as developing specialty injectable products for global markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market. The key highlight of FY 2021-22 for BE and Mahima was when the company’s efforts were recognised for the development of Corbevax, India’s first indigenously developed protein subunit vaccine against COVID-19. Corbevax is a recombinant vaccine, developed from the Receptor Binding Domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build the immune response against the virus. While COVID Suraksha Programme’s endeavour to accelerate vaccine development played a crucial role in the initial development of Corbevax, the mechanism that was setup with the support of Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) allowed Mahima to scale up to a capacity of about 1.2 billion doses per year making the dream of accessibility, affordability and supply, a reality. FY 21-22 also saw BE’s partnership with the US International Development The key highlight of FY 2021-22 for BE and Mahima was when the company’s efforts were recognised for the development of Corbevax, India’s first indigenously developed protein subunit vaccine against COVID-19. FY 21-22 also saw BE’s partnership with the US International Development Finance Corporation (DFC) for the expansion of the company’s vaccine manufacturing facility in Hyderabad and finalising a US government financing arrangement of $50 million.

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 17 What were the key highlights of FY 2022-23, especially with the COVID-19 situation waning? The COVID-19 vaccine development was indeed very challenging when we had to develop, manufacture and scale-up our vaccine product within a time frame of 18 months. But, it was also very rewarding for the company since everyone was working together as a team with a strong sense of purpose. Also, we were delighted that despite our focus on COVID-19 vaccine development, our routine vaccines supplies to UNICEF and the government were not disrupted. There were some initial roadblocks, but we could overcome those challenges. We were able to generate a revenue of Rs 3800 crore during FY 22-23, out of which the COVID sales were around Rs 2200 crore. Which new products are in the pipeline this year? Please share details. Our 14-valent paediatric Pneumococcal Conjugate Vaccine, (PCV14) against S. pneumoniae infection has recently received approval from the Drugs Controller General of India (DCGI) for manufacture and commercialisation in India. The government typically buys about 80 million doses of this vaccine from various manufacturers and it is a Rs 1500 crore market. In the future, we are also going to develop a 24-valent Pneumococcal Conjugate Vaccine. We are also planning to launch our hexa-valent product. We already have a significant share in the pentavalent vaccine space, but now we hope to see a shift of preference in the market from penta- to hexa-valent vaccine with the addition of Inactivated Polio Vaccine (IPV) to the pentavalent combination of Diphtheria, Pertussis, Tetanus, Hepatitis-B and Finance Corporation (DFC) for the expansion of the company’s vaccine manufacturing facility in Hyderabad and finalising a US government financing arrangement of $50 million to expand the company’s capacity to produce COVID-19 vaccines. Around April 2022, the company received a nod from the Drugs Controller General of India (DCGI) for emergency use authorisation of Corbevax for the 5-12-year age group, addressing the vaccination needs of children affected due to COVID-19. Apart from Biological E, Mahima has served on the executive committee of DCVMN (Developing Countries Vaccine Manufacturers Network) and as Haemophilus influenzae - Type b (Hib). We are planning to develop 100 million doses of the hexavalent product. Biological E. Limited has also completed the technology transfer of the next generation novel-Oral Polio Vaccine against Type-2 strain and has qualified manufacturing facility that can produce >500 million doses of this vaccine, which will be distributed in countries facing outbreaks as well as contributing to product stockpile maintained by UNICEF. In the coming 18-24 months, we are opening our new R&D centre at Genome Valley, as a world class pilot facility for developing clinical materials for four different products. Are you exploring newer technologies to develop vaccines, as mRNA and CRISPR are gaining much importance? Biological E. Limited has been selected as a recipient of mRNA technology from the World Health Organisation (WHO) technology transfer hub. After examining a number of proposals from India, the World Health Organisation’s Advisory Committee on Vaccine Product Development (PDVAC) selected Biological E. Limited as a recipient of mRNA technology from the WHO technology transfer hub. This partnership with WHO will enhance our ability to develop next generation mRNA vaccines that could be more suitable globally and expand the reach of vaccine availability worldwide. Also, the mRNA technology has a big role to play in the therapeutics space. On the other hand, while CRISPR is a very promising tool, we would take one-step at a time and re-visit exploring the CRISPR technology for vaccine development or for other purposes at a later stage. “We are going to develop a 24-valent Pneumococcal Conjugate Vaccine” the President of the alliance. She is also a board member of GAVI (Global Alliance for Vaccines and Immunisation) and DRILS (Dr. Reddy’s Institute of Life Sciences), India. Currently, she is also engaged in the capacity of board member with GHIT (Global Health Innovative Technology) fund, a Japanese government innovation healthcare fund for improving global access to healthcare. Besides being the chairperson for FICCI, Telangana, she is also the Vice-Chairperson of the Life Sciences Advisory Committee formed by the Government of Telangana and is on the Governing Council of Public Health Foundation of India (PHFI), Hyderabad.

● With a team of 35, developed BWC0977, a highly potent, intravenous broad-spectrum antibiotic for the treatment of multidrug-resistant Gramnegative infections ● BWC0977 is currently undergoing Phase I clinical trials in Australia ● More than 8 patents filed in India, UK, USA, and Rest of the World regions, of which more than half have been granted ● Raised Rs 61 crore in 2020 and Rs 146 crore in February 2022 MILESTONES ENTREPRENEUR 2021-22 Catalysing AMR innovations DR ANAND ANANDKUMAR Co-Founder & Chief Executive Officer, Bugworks Research 18 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com The growth of novel drug development in India is likely to be slow as it requires a large, sustainable pool of funds. In addition, it requires an investment mindset willing to take risks due to the long gestation period in transforming ideas into life-saving products. Hopefully, the success of a company like Bugworks and others in India, and an evolving mature funding ecosystem should catalyse widespread innovation in India. Dr Anand Anandkumar is the Co-Founder and Chief Executive Officer (CEO) of Bugworks, an Indo-USA-Australia biotech startup, supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), working on tackling the massive problem posed by untreatable bacterial Superbugs, which are implicated in hospital/community infections and bioterrorism situations. More recently the company has also forayed into the design of differentiated Immuno-Oncology assets, targeting several solid tumours. Bugworks hopes to make a massive impact on humanity by addressing large unmet medical needs while making its products affordable and accessible to all. The company is supported by blue chip investors from across the globe and is also actively supported by several governments for its work on AMR and Bio-Defense preparedness. The US government, Department of Health and Human Services and Department of Defense, work closely with Bugworks as it advances its novel antibacterial assets through clinical trials. The year 2021 saw Bugworks Research announcing that the first human dose was administered in Phase 1 clinical trial evaluating BWC0977: a next-generation broad-spectrum, novel bacterial topoisomerase inhibitor (NBTI), supported by CARB-X. Dr Anand was previously the Co-Founder and Managing Director at Cellworks, a Bay Area and Bengaluru based company which is a pioneer in using modeling and simulation to support personalised cancer therapy. Prior to the biotechnology experience, Dr Anand was a professional in the semiconductor industry with about 15 years of global experience in designing high end Integrated Circuits, Chip Design and operations management experience in US/China/Japan/UK and India. He is a globalisation specialist in both semiconductor and biotechnology spaces, having co-founded the Indian Semiconductor association and being an Executive council member of the Indian Biotech Association. Dr Anand received his Bachelor’s degree in Electronics and Communication from College of Engineering Guindy, Anna University, India (1986) and a MS & PhD in Electrical and Biomedical engineering from George Washington University in Washington D.C (1992). He won the distinguished alumnus award from Anna University in 2016. Dr Anand is a globally recognised key opinion leader in the Antimicrobial resistance (AMR) Industry and speaker in global platforms including the G20, WHO, UN, APIF-Japan etc. Dr Anand is also cofounder and mentor to more than 4 biotech startups in the Bengaluru life-science cluster including Biomoneta, Impres Health and Ignite Life sciences foundation.

ENTREPRENEUR 2021-22 WOMAN Setting new protocols for wound management ● Launched first flagship product Illuminate in 2020 ● 4 granted Indian Patents and 1 European and 1 US patent and multiple pending patents in other countries ● Raised Rs 6.5 crore since inception, including Rs 4 lakh grant in 2020 ● Developed TOPSE smartphone application that uses AI for Lateral Flow Assay readout analysis for FnCas9 based detection of SARS-CoV2 in patient samples MILESTONES GEETHANJALI RADHAKRISHNAN Founder & Managing Director, Adiuvo Diagnostics Early assessment and management of infections caused by bacteria and fungus is crucial to accelerate wound healing. Failure to do so can lead to prolonged diagnosis, increase in treatment cost and hospital stay, delay in wound closure, amputation, and mortality. There is a huge unmet need to detect wound infections early on and to continuously monitor wounds to accelerate healing. BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 19 Geethanjali Radhakrishnan, a Bioengineer from Sastra University in Thanjavur, obtained her MBA in Quality Management from BITS Pilani. She began her career by working in research and then as a software developer at Tata Consultancy Services for a period of four years. Hailing from the hills where access to healthcare is at least 100 kms away, she felt that her bioengineering background would be better utilised to develop healthcare solutions for low resource settings. In 2015, she founded Adiuvo Diagnostics with the goal of creating advanced diagnostic and screening solutions in healthcare specifically tailored towards low resource settings. Geethanjali is an IGNITE 2017 fellow at Judge Business School, Cambridge, and holds five granted patents and four pending patents. Under her leadership, Adiuvo has developed a first-of-its-kind imaging device named “Illuminate” that can non-invasively detect and classify pathogens on wounds, along with automated measurements, in under 2 minutes, compared to the gold standard culture method which takes 3-7 days for a definitive result. The same device can be customised for blood, sputum (Mycobacterium tuberculosis), and urinary infection detections, antibiotic susceptibility testing, cancer diagnostics, and more. The device is 100 times faster compared to standard tests, 92 per cent cheaper and can improve wound healing through early assessment by 3X times. Adiuvo has 4 granted Indian Patents and 1 European and 1 US patent and multiple pending patents in other countries. The company has deployed 25+ Illuminate devices across India and has screened more than 20,000 patients. During the COVID-19 pandemic in 2020 and 2021, with the knowledge and expertise from Illuminate, Geethanjali developed TOPSE smartphone application. This application uses artificial intelligence (AI) for Lateral Flow Assay readout analysis specifically for FnCas9 based detection of SARS-CoV2 in patient samples, with high specificity/ sensitivity. Additionally, her startup developed and assembled a low-cost portable reader device for TATA MD for the same application. Based on the existing customer feedback, her team has integrated NIR Reflectance imaging in Illuminate to aid in rapid tissue oxygen saturation and blood flow assessment, along with 3D wound analytics. Geethanjali is currently in the process of obtaining regulatory approvals for Illuminate in several developing countries. There are also plans of obtaining US FDA and CE approvals for this device. Geethanjali is also working towards preventive wound care developing an AI-enabled wound teleconsultation platform along with a team based out of US.

Decentralising excellence for robotic surgeries SSI MANTRA ROBOTIC SURGERY SYSTEM By SS Innovations (SSI) The wonders that a robotic surgery system can do is beyond imagination. With technological advancements pervading this space at a rapid pace, it is only a matter of time before surgical robots will become the mainstay in surgeries and make hi-tech and qualitative healthcare accessible to every citizen. - Dr Sudhir Prem Srivastava, Chairman and Chief Executive Officer, Sudhir Srivastava Innovations (SSI) PRODUCT OF THE YEAR 2021-22 20 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Although robotic surgeries have been around in the country for more than a quarter of a century, the penetration of robotic surgeries has not been as deep and wide when compared to the Western world. It was the vision of Dr Sudhir Prem Srivastava, Chairman and Chief Executive Officer at Sudhir Srivastava Innovations (SSI) to return to India from the US to launch robotic programmes. Dr Srivastava’s tryst with robotic surgery in India dates back to 2002 when he did his first robotic surgery in the country at Escorts Heart Institute. Meeting a 22-year-old woman brought by her brother, who was diagnosed with a hole between the two heart chambers, was a turning point in his life. It served as the catalyst for him to develop an affordable robotic surgical system, which will bring down the cost of surgeries. A team of 150 professionals have put in their effort to bring to light the first and only Made-in-India surgical robot system. The modular multi-arm SSI Mantra Surgical Robotic System has various cutting-edge technological characteristics. It has a 32-inch large 3D 4K monitor, a 23- inch 2D Touch panel monitor for all patient-related information display, a virtual real-time image of the robotic Patient Side Arm Carts, the ability to superimpose holographically reconstructed DICOM images, and it supports the use of 3-5 robotic arms. With a live demonstration, the product was officially launched in 2021 in New Delhi. Later, the state-of-the-art SSI MANTRA robotic surgery system was first commercially installed at Rajiv Gandhi Cancer Institute, New Delhi in July 2022. Since then, the system has been installed in Sanjeevani CBCC USA Cancer Hospital, Raipur; Continental Hospital, Hyderabad; Hindusthan Hospital, Coimbatore and Cytocure Hospital, Mumbai. The system has performed more than 140 flawless surgeries across these hospitals. In its latest achievement, SSI MANTRA was used for the first time for cardiac bypass surgery at Continental Hospital, Hyderabad. SSI MANTRA can be used for various surgical specialities including head and neck (ENT), Thoracic, General Surgery, Urology, Gynecology and Cardiac Surgery. The made-in-India SSI Mantra will bring a paradigm shift in India’s robotic surgical systems market as this will make robotic surgery affordable to the general public while reducing dependency on imported systems. It costs Rs 4-5 crore in comparison to global products available for Rs 15 crore. To revolutionise the future of robotic surgeries across the world, SS Innovations has signed an acquisition with Avra Medical Robotics. Now, the company is available on NASDAQ. Another key factor about SSI Mantra is its average life span of 10 years. SS Innovations has plans to develop a host of other patient-centric disruptive innovations and technologies that would “Decentralise Excellence”. My goal has always been to introduce the multiarm surgical robotic system to developing economies and smaller cities in developed nations. That is not to say that this would be the final point for SS Innovations. There are plans to develop a host of other patient-centric disruptive innovations and technologies that would “Decentralise Excellence”.

YOUNG WOMAN SCIENTIST 2021-22 Making India self-reliant in Science ● Number of publications268 ● H Index- 45 ● Impact of the inventionShe was instrumental in isolating the SARS-CoV-2 virus and conducting animal studies to develop indigenous COVID-19 vaccines Covaxin and ZyCoV-D. ● Among the few scientists who detected the first three COVID-19 cases in India. ACHIEVEMENTS DR PRAGYA YADAV Scientist ‘F’ and Head of Maximum Containment Facility, Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune This is one of the best times for the younger women generation as the new generation now has full support from the society, as compared to earlier days. But of course, without hard work and dedication, nothing can be achieved. As women, we must appreciate each other’s work and be motivated to work harder. BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 21 Dr Pragya Yadav is an Indian virologist known for her research contributions in the field of communicable diseases and highly pathogenic viral infections, such as Crimean–Congo hemorrhagic fever (CCHF), Nipah, Ebola. She completed her doctoral degree in biotechnology at the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune in affiliation with the University of Pune in 2004. During the same year, she joined as a Scientist in ICMR-NIV, in India’s first Biosafety Level-3 (BSL-3) laboratory. She learned to work in a containment laboratory, prepare standard operating procedures (SOPs) and validation of containment facilities. During the year 2005-06, she received International Emerging Infectious Disease (IEID) fellowship from Association of Public Health Laboratory, US to get trained in Biosafety Level-4 laboratory and got acquainted to work with high-risk pathogens and containment facility at special pathogen branch of the Centers for Disease Control and Prevention (CDC), US. After returning from the US, she was involved in setting up the Biosafety Level 4 (BSL-4) laboratory at NIV, which got operationalised in 2013. Currently, she is in-charge of BSL-4 laboratory. Dr Pragya has been working in the field of public health, since the last two decades. And this experience brought her in the limelight during the pandemic when extensive research took place across laboratories to develop effective vaccines and diagnostic test kits against COVID-19. She is among the few scientists who detected the first three COVID-19 cases in India. She was successful in quick isolation of SARS-CoV-2 virus from clinical specimens which were utilised by Bharat Biotech to generate the first indigenous vaccine- Covaxin in India. Subsequently, Dr Pragya successfully carried out several preclinical studies using Covaxin which paved the way for clinical trials. This first indigenous vaccine was approved and rolled out by the Government of India under the National COVID-19 vaccination programme in 2021. The early isolation of the virus and subsequent work in developing the indigenous COVID KAVACH IgG ELISA against SARS-CoV-2 was a major contribution in the national surveillance of SARS-CoV-2 which helped in the fight against COVID-19 in India. She has also studied the efficacy of the Covaxin and Covishield vaccines against the newly emerged SARS-CoV-2 variants of Concern like Alpha, Beta, Delta and Omicron and sub lineages. As a result, she won the Outstanding COVID-19 Frontline Warrior Award by NASI, during the year 2021-22; and COVID Worrier Award by the Governor of Maharashtra in 2020. Her contributions in virology and public health have helped in saving human lives and the saving economy in different outbreaks in India and set a true example for the country making self-reliance in science.

22 BIOSPECTRUM JURY AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Dr K I Varaprasad Reddy, Founder, Shantha Biotechnics Lifetime Achievement Award Seen in the pictures: (L-R) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Renu Swarup, Former Secretary, Department of Biotechnology (Jury Chair); Dr Taslimarif Saiyed, CEO & Director, C-CAMP (Jury Member); Dr Milind Kokje, Chief Editor, BioSpectrum India Product of the Year SSI Mantra Surgical Robotic System, received by Ishan Shinde, Vice President of Strategic Programmes, SS Innovations Businessperson of the Year Mahima Datla, MD, Biological E Entrepreneur of the Year Dr Anand Anandkumar, Co-founder, Bugworks Research Young Woman Scientist of the Year Dr Pragya D Yadav, Scientist-F, National Institute of Virology Woman Entrepreneur of the Year Geethanjali Radhakrishnan, Founder, Adiuvo Diagnostics 2021-22

To know more about TCI Chemical Please Scan above QR Code Transport Corporation of India Limited TCI House, 69 Institutional Area, Sector 32, Gurugram - 122001 | Tel.: +91 - 124 - 2381603-07 E-mail Id: [email protected] | Website: www.tcil.com | CIN: L70109TG1995PLC019116 Ensuring Safety Containers are equipped with GPS/VTS Containers with HSE standards & PPE Customer care unit & 24x7 emergency response Safe & Secure Chemical Logistics Solutions Cosmetics, adhesives, etc. End-to-end solutions, from storage to transportation On-time delivery Single Point of Contact (Key Account Management) Temperature controlled storage services

Celebrating Success- BioSpectrum Award Winners Seen in the pictures: (L-R) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Renu Swarup, Former Secretary, Department of Biotechnology, Government of India (Jury Chair); Dr Taslimarif Saiyed, CEO & Director, C-CAMP (Jury Member); Dr Milind Kokje, Chief Editor, BioSpectrum India Businessperson of the Year Sai Prasad, Executive Director, Bharat Biotech received on behalf of Dr Krishna Ella, Executive Chairman, Bharat Biotech Product of the Year Covaxin, received by Sai Prasad, Executive Director, Bharat Biotech Woman Entrepreneur of the Year Dr Rachana Tripathi, Co-founder, Huwel Lifesciences Young Woman Scientist of the Year Dr Ritu Trivedi, Principal Scientist, Central Drug Research Institute Entrepreneur of the Year Hasmukh Rawal, MD, Mylab Discovery Solutions 24 BIOSPECTRUM JURY AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com 2020-21

26 SPECIAL RECOGNITION AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Bioinnovation Leader of the Year Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Balvinder S. Sawhney, Assistant Secretary General, FICCI (fifth from left) and Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Bioinnovation Leader of the Year Award to Bangalore Bioinnovation Centre Bangalore Bioinnovation Centre Emerging BioStartup of the Year Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India and Dr Shirshendu Mukherjee, Mission Director, BIRAC, Dr Milind Kokje, Chief Editor, BioSpectrum India, presenting the Emerging BioStartup of the Year award to Qure.ai Qure.ai Special Recognition in Cell and Gene Therapy Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India and Dr Shirshendu Mukherjee, Mission Director, BIRAC, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Special Recognition in Cell and Gene Therapy Award to ReGrow Biosciences ReGrow Biosciences Best Innovator for COVID-19 solutions Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Karan Mehrotra, Marketing HeadIndia and Regional Marketing Manager- South Asia, Middle East & African countries, Elekta, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Best Innovator for COVID-19 solutions Award to Dr Vishal G Warke, Director- R&D, Cell Culture & Immunology, HiMedia Laboratories Dr Vishal G Warke, Director- R&D, Cell Culture & Immunology, HiMedia Laboratories Industry Leader of the Year Dr Gangadhar M Warke, Founder, Chairman & Managing Director, HiMedia Laboratories Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Karan Mehrotra, Marketing Head- India and Regional Marketing Manager- South Asia, Middle East & African countries, Elekta, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Industry Leader of the Year Award to Dr Gangadhar M Warke, Founder, Chairman & Managing Director, HiMedia Laboratories

For More Information and Collaboration, Email: [email protected] Join the forefront of medical advancements today. MedTech Spectrum Naviga�ng the World of Medical Technology Discover the limitless potential of medical technology at MedTech Spectrum. Explore MedTech Spectrum to gain valuable knowledge, explore emerging trends, and stay informed about the transformative impact of technology on healthcare. The Business of Medtech and Healthcare www.medtechspectrum.com Stay ahead in the world of medical technology with MedTech Spectrum. Explore our comprehensive media portal for exclusive articles, expert insights, and breakthrough innovations in healthcare technology.

28 SPECIAL RECOGNITION AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Best Workplace in Bio & Health Science business Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India and Dr Shirshendu Mukherjee, Mission Director, BIRAC, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Best Workplace in Bio & Health Science business Award to Siemens Healthineers India Siemens Healthineers India Businessperson of the Year in Life Sciences Industry Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Dr Ravi Rathod, Advisor Health, PHD Chamber of Commerce and Industry, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Businessperson of the Year in Life Sciences Industry Award to Amit Sehgal, Managing Director & Country Head, Avantor India Amit Sehgal, Managing Director & Country Head, Avantor India Excellence in Medtech Innovation Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Dr Ravi Rathod, Advisor Health, PHD Chamber of Commerce and Industry, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting the Excellence in Medtech Innovation Award to Dräger India Dräger India Most Promising Company: Engineering Solution & Services for Pharma, Biopharma & Nutraceutical Industry Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Dr Ravi Rathod, Advisor Health, PHD Chamber of Commerce and Industry, Dr Milind Kokje, Chief Editor, BioSpectrum India presenting Most Promising Company: Engineering Solution & Services for Pharma, Biopharma & Nutraceutical Industry Award to Praj HiPurity Systems Praj HiPurity Systems

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com INDUSTRY RANKING AWARDS 29 Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Vinod Kotwal, Member Secretary, National Pharmaceuticals Pricing Authority (R) presenting the Award. Top Indian Biopharma Company of the Year Serum Institute of India (2020-21 & 2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Vinod Kotwal, Member Secretary, National Pharmaceuticals Pricing Authority presenting the Award. Top Indian Industrial Enzyme Company of the Year Rossari Biotech (2020-21 & 2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Rajiv Chhibber, Joint Coordinator, Association of Indian Manufacturers of Medical Devices (AiMED) (third from left) presenting the Award. Top Indian Medical Devices & Diagnostics Company of the Year Transasia Bio-Medicals (2020-21 & 2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Vinod Kotwal, Member Secretary, National Pharmaceuticals Pricing Authority presenting the Award. Top MNC Biopharma Company of the Year Novo Nordisk (2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Vinod Kotwal, Member Secretary, National Pharmaceuticals Pricing Authority presenting the Award. Top MNC Industrial Enzyme Company of the Year Novozymes South Asia (2020-21 & 2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Subhra Ranjan Chakrabarti, Director of Operations, Biotechnology Industry Research Assistance Council (BIRAC) (R) presenting the Award. Top BioSupplier Principal Company of the Year Waters India (2020-21)

Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Subhra Ranjan Chakrabarti, Director of Operations, Biotechnology Industry Research Assistance Council presenting the Award. Top BioSupplier Principal Company of the Year HiMedia Laboratories (2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Subhra Ranjan Chakrabarti, Director of Operations, Biotechnology Industry Research Assistance Council presenting the Award. Top BioSupplier Distributor Company of the Year Premas Life Sciences (2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Satya Dash, Founding Head Strategy-BIRAC, Founding CEO-BITS BioCyTiH Foundation presenting the Award. Top BioIncubator of the Year (in public sector) Centre for Cellular and Molecular Platforms (2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Satya Dash, Founding Head Strategy-BIRAC, Founding CEO-BITS BioCyTiH Foundation presenting the Award. Top BioIncubator of the Year (in private sector) KIIT Technology Business Incubator (2021-22) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Subhra Ranjan Chakrabarti, Director of Operations, Biotechnology Industry Research Assistance Council presenting the Award. Top BioSupplier Distributor Company of the Year Genetix Biotech Asia (2020-21) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Satya Dash, Founding Head Strategy-BIRAC, Founding CEO-BITS BioCyTiH Foundation presenting the Award. Top BioIncubator of the Year (in private sector) Venture Center, Pune (2020-21) Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India; Dr Satya Dash, Founding Head Strategy-BIRAC, Founding CEO-BITS BioCyTiH Foundation presenting the Award. Top BioIncubator of the Year (in public sector) Bangalore Bioinnovation Centre (2020-21) 30 INDUSTRY RANKING AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM AWARDS CEREMONY 31 R avindra Boratkar, Managing Editor and Publisher, BioSpectrum India announced the launch of MMA Spectrum Foundation to become a partner in the progress of the Bio & Health Sciences startups ecosystem. There are several other objectives of the foundation to promote startup culture and take them to the next level. Welcoming the gathering of over 200 industry leaders for the BioSpectrum Excellence Awards 2023 held at the Hyatt Regency in New Delhi on June 30, Boratkar said “Very soon the foundation will commence its activities. It will work for the overall development of Bio & Health Sciences, Life Sciences and Food and Agriculture sectors and all sub-sectors under them. For this purpose, we will be setting up groups of experts to empower youngsters for launching and developing startups, and to guide and mentor young entrepreneurs.” “India’s bioeconomy is poised to touch $300 billion by 2030 and with its rising innovation and scientific temper, it is poised to join the global wave of a New Industrial Revolution. India is emerging as the world’s major bioeconomy with fast growing biotech startups. The number of biotech startups has increased from 50 to 5,000 in the last 8 years. India has the potential to move from 5,000 to 50,000 within the biotech startup sector”, Ravindra Boratkar, Managing Director, MM Activ Sci-Tech Communications stated. “There are many experts from the field. Soon, we will surely be seeking cooperation and guidance from industry experts to mentor entrepreneurs. I am confident that industry captains are glad and enthusiastic to guide the startups,” he added. Talking about the awards ceremony he said “BioSpectrum honours personalities from the life sciences sector whose work has, indeed, been worthy of recognition. As an esteemed media platform of the life sciences field, BioSpectrum not only recognises but also appreciates their excellence in their respective work areas by conferring upon them BioSpectrum Excellence Awards. Last year we could not organise it due to COVID, hence this year we are giving awards for two years.” MM Activ Sci-Tech Communications launches MMA Spectrum Foundation Dr K I Varaprasad Reddy, Non-Executive Chairman, Shantha Biotechnics, Lifetime Achievement Award winner lighting the lamp to inaugurate the BioSpectrum Excellence Awards 2023 ceremony in presence of (L-R) Dr Milind Kokje, Chief Editor, BioSpectrum India, Ravindra Boratkar, Managing Editor and Publisher, BioSpectrum India, Dr Renu Swarup, Former Secretary, Department of Biotechnology (Jury Chair) and Dr Taslimarif Saiyed, CEO & Director, C-CAMP (Jury Member)

National Institute of Virology. Dr Renu Swarup also presented the Businessperson of the Year 2020-21 Award to Sai Prasad, Executive Director, Bharat Biotech who received on behalf of Dr Krishna Ella, Executive Chairman, Bharat Biotech; Product of the Year 2020-21 Award to Covaxin COVID-19 vaccine, received by Sai Prasad, Executive Director, Bharat Biotech; Entrepreneur of the Year 2020-21 Award to Hasmukh Rawal, MD, Mylab Discovery Solutions; Woman Entrepreneur of the Year 2020-21 Award to Dr Rachana Tripathi, Co-Founder, Huwel Lifesciences and Young Woman Scientist of the Year 2020-21 Award to Dr Ritu Trivedi, Principal Scientist, Central Drug Research Institute. In his address Dr K I Varaprasad Reddy, Non-Executive Chairman, Shantha Biotechnics recalled his tough and solo journey of developing recombinant DNA vaccines with a motto of offering them at an affordable price three decades ago. He said, “Shantha is the first company in the biopharma sector to ignite the growth of biotechnology based vaccines and therapeutic products. It is the only company that believed inMake it Available locally, and Make it Affordable to the common man. But adding these many ‘firsts’ was a part of a very tough journey. And it all started with anger and disappointment that eventually took the shape of obsession.” Sharing the hard days of venturing into complex biotechnology industry space, Dr Varaprasad Reddy said, “With no role model to follow, to develop a recombinant DNA technology for vaccine, I visited Dr Anji Reddy and few other industry leaders, but all of them told me that this task was an impossible one and I was wasting my time.” Dr Varaprasad Reddy, who overcame the unethical and bad experiences, had set the prices for vaccines in India for 11 years since the launch of Shantha Biotechnics. He said “We have great doctors, great engineers in our country but not great leaders. The vaccine scenario has changed considerably in India. Currently, we are strong in production but we should collaborate with other countries for joint development and own the patent rights, to become global leaders.” Besides Jury awards, Industry Ranking Awards and Special Recognition Awards were also presented to the winners after a panel discussion. Dr Milind Kokje thanked the gathering for making the celebrations memorable, while Dr Manbeena Chawla, Executive Editor, BioSpectrum India conducted the entire ceremony of BioSpectrum Excellence Awards 2023 with poise and perfection. 32 BIOSPECTRUM AWARDS CEREMONY BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com In her address, Dr Renu Swarup, Former Secretary, Department of Biotechnology (Jury Chair) congratulated all the award winners for their performance and achievements, and complemented BioSpectrum for its efforts in bringing the hidden jewels into the limelight. “These efforts of BioSpectrum are going to help the young students of biotechnology to see these winners as role models. As the country is offering huge opportunities in the biosciences space, the young minds can grab these through their skill sets and talent to make a difference to society”, she said. Congratulating BioSpectrum for launching MMA Spectrum Foundation she wished all success in its endeavour of providing the very best to the upcoming and young entrepreneurs in different fields of life sciences. In his address as jury member, Dr Taslimarif Saiyed, CEO & Director, C-CAMP said, “It was my pleasure to be on the Jury panel for the prestigious BioSpectrum Jury Awards. BioSpectrum Jury Awards go back a long way to 2003 when the biotech ecosystem in India was a fledgling. Thanks to the vision and tireless dedication of some eminent colleagues from this ecosystem, a few of whom I am sharing the Jury panel with, that fledgling of 2003 has become one of the top three startup capitals in the world, in a journey of 20 years of striving, focus and quiet ambition. India as a global biotech powerhouse has arrived as we saw during the pandemic years. The pandemic years were not only of tremendous churn but also of phenomenal capacity- building which have strengthened India’s position as a global biotech hub and inspired the global market and investor confidence that we are now seeing for indigenous technologies from India.” Along with Ravindra Boratkar, Dr Taslimarif Saiyed and Dr Milind Kokje, Chief Editor, BioSpectrum India, Dr Renu Swarup presented Lifetime Achievement Award to Dr K I Varaprasad Reddy, Founder, Shantha Biotechnics; Businessperson of the Year 2021-22 Award to Mahima Datla, MD, Biological E; Product of the Year 2021-22 Award to SSI Mantra Surgical Robotic System, received by Ishan Shinde, Vice President of Strategic Programmes, SS Innovations; Entrepreneur of the Year 2021-22 Award to Dr Anand Anandkumar, Co-Founder, Bugworks Research; Woman Entrepreneur of the Year 2021-22 Award to Geethanjali Radhakrishnan, Founder, Adiuvo Diagnostics and Young Woman Scientist of the Year 2021-22 Award to Dr Pragya D Yadav, Scientist-F,

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM PANEL DISCUSSION 33 “The government is working on a new R&D policy where it will be addressing most of the pain points of the life sciences industry. The government notification will be issued soon,” said Dr Vinod Kotwal, Member Secretary, National Pharmaceutical Pricing Authority (NPPA), while speaking at a panel discussion on the topic “Search for a New Molecule: Shift from Generics to Novel Drugs” organised at the BioSpectrum Excellence Awards 2023 ceremony in New Delhi on June 30. She further said “We request all the industry members to participate in the discussion and share their concerns and suggest ways to overcome gaps and improve the current situations. The new R&D policy is expected to reduce the burden of the industry as it will shorten the time for getting approvals.” Dr Vinod Kotwal also stated that the government has been doing its bit in supporting R&D activities. “We need a collaborative approach involving government, venture funds, entrepreneurs to move from developing generics to novel drugs.” Talking about the issues before the regulators, Dr Vinod Kotwal said “In fact there are still many issues before the regulators. The government on the other side is making its sincere efforts by reaching out to industry leaders indirectly to take their views and opinions, before introducing any regulations. The industry has to come forward with suggestions, feedbacks to improve and overcome the issues that are hindering the growth of the industry.” Speaking about the ecosystem Dr Anandkumar, Co-Founder & CEO, Bugworks Research, said “The ecosystem for innovation has been much better as compared to a few years back. Now we have 5,000 startups in the biosciences space “Centre is working on a new R&D policy to address the pain points of the industry” Dr Satya Dash, Founding Head Strategy, BIRAC and Founding CEO, BITS BioCyTiH Foundation was the moderator of the panel discussion (left), along with the panelists (L-R) Dr Anand Anandkumar, Co-Founder & CEO, Bugworks Research, Dr Parul Ganju, Co-founder and CEO, Ahammune Biosciences, Dr Vinod Kotwal, Member Secretary, National Pharmaceutical Pricing Authority (NPPA), Saurabh Singal, Founder, KnowDis/ Molecule AI and Sai Prasad, Executive Director, Bharat Biotech

34 BIOSPECTRUM PANEL DISCUSSION BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com as compared to 50 eight years ago. But still, we lack the ecosystem which we find in places like Boston, Basel, Silicon Valley, Israel that have appropriate infrastructure for working on novel ideas.” Making his views on the pain points of the industry Dr Anandkumar said “The key pain point is the unavailability of a skilled talent pool to work on novel drug discovery areas. We have huge talent in the country in areas such as generics, chemistry, biology, developing novel vaccines like mRNA, mDNA among others, but not in novel drug discovery. Meanwhile we are now witnessing a reverse brain drain with India emerging as the pharma and vaccine hub of the world. Experts from the bioclusters of the world are looking at India. Hopefully in the coming few years we can compete with global giants in the drug discovery space.” Talking about the industry expectations he said, “The government should double the public health spending to 3 per cent of the gross domestic product (GDP) to support the healthcare transformation from the current spending of 1.5 per cent of the GDP. India has been spending nearly 0.6 per cent on research and development (R&D). It should be increased to 2 per cent as countries such as the United States of America spend 2.8 per cent, while Korea spends 4.2 per cent of their GDP on R&D.” Sharing his thoughts further on innovation, Dr Anandkumar said “Innovation is happening in the country where risk appetite is low. More research is needed for which the industry has to look at global models. Innovation comes at a cost. India has to look for a differential pricing model so as to invest in innovation and R&D.” Echoing similar views, Sai Prasad, Executive Director, Bharat Biotech said – “Innovation comes at different costs. It is difficult to follow the single pricing model. We should have a differential pricing model so that companies can reinvest returns on R&D.” Referring to the hurdles before the industry, Sai Prasad said “We are still facing too many regulations. 100 per cent presentations with involvement of so many departments and ministries. Getting approvals is becoming delayed.” “In the vaccine and small molecules space we have launched innovative products by developing novel platforms and technology which have benefited the whole nation. However, we are still far behind in the novel and new drug molecules as innovation is not an easy thing,” said Sai Prasad while making his points on the gaps in the industry. Sharing his views on issues that need the attention, Saurabh Singal, Founder, KnowDis/ Molecule AI said “Deeptech is yet to take a shape in the country. VC funding for novel drug discovery is still a long way to go.” On expectations from the government, Singal said “We expect some non-fiscal support to be provided in addition to already available support-measures, to make best of the growth opportunity. The industry is keen on getting more support for R&D spends through fiscal (for example, Higher tax deduction on R&D spend) and non-fiscal support.” Elaborating her views on the pain points, Dr Parul Ganju, Co-founder and CEO, Ahammune Biosciences, said “The risk appetite is a key issue in Indian life sciences industry. The companies are comfortable with the routine works/jobs and unable to take challenges in doing new things. Venture funding is another issue for innovation.” She further said “We feel it will take another 5-6 years for venture capitalists (VC) to understand the industry. Besides, we need a few success stories like Pfizer and Novo Nordisk in India. That will bring and garner more confidence among VC to invest in the area of innovation in life sciences.” Referring to the expectations Dr Parul said “The government has increased the outlay for healthcare. We want more tax rebates /reduction for innovation as well.” Dr Satya Dash, Founding Head Strategy, BIRAC and Founding CEO, BITS BioCyTiH Foundation who moderated the panel discussion said that Dr Varaprasad Reddy of Shantha Biotechnics, BioSpectrum Lifetime Achievement Award Winner 2023 is a role model for many entrepreneurs who are in the business of life sciences area. Dr Varaprasad Reddy brought a complex novel biotechnology platform & launched vaccines at an affordable price. With no industry background, he overcame all the hurdles like finance, risk involved, skilled workforce & regulatory issues as his aim to offer or launch affordable products was very much loud & clear that brought him laurels later. The Indian pharmaceutical industry has long been recognised as a global leader in the production of generic drugs, which has helped to bring affordable healthcare to millions of people around the world. However, with the increasing demand for more effective and personalised therapies, Dr Satya Dash concluded that there is a need for the industry to shift its focus from generics to novel drugs. The panel discussion was sponsored by Lonza and CPC.

ENTREPRENEUR WOMAN ENTREPRENEUR YOUNG WOMAN SCIENTIST PRODUCT OF THE YEAR BioSpectrum Excellence Awards 2020-21 BUSINESS PERSON OF THE YEAR DR KRISHNA ELLA Executive Chairman, Bharat Biotech International Ltd.

BUSINESS PERSON OF THE YEAR 2020-21 During FY 2020-21, when COVID-19 was raging across the globe, Dr Krishna Ella and his team at Bharat Biotech International took up a huge challenge in developing an efficacious vaccine. Under Dr Ella’s leadership, Bharat Biotech invested more than Rs 50 crore towards product development and manufacture of the COVID-19 vaccine Covaxin, along with other vaccine candidates. This was a very significant at-risk investment, as most of it was made prior to data readouts and any procurement contracts. In hindsight, this was a defining moment for Dr Ella and his company, in his ability to trust internal R&D and product development capabilities to make at-risk strategic investments. Bharat Biotech brought forth 4 different vaccine platform technologies. Two of which, namely Covaxin and Incovacc, have been successfully established. Under the leadership of Dr Ella, the company witnessed a growth of 35 per cent in sales revenue to Rs 1439 crore during 2020-21 as against Rs 1066 crore in 2019-20. It recorded 480% growth in sales as its revenue touched Rs 8352 crore for 2021-22. The company so far distributed over 5 billion vaccine doses globally, to the Government of India, state governments, UNICEF, GAVI, International Foundations, and many developing world countries at the most competitive and affordable prices. Many products have been audited and approved globally. “Initially, we repurposed existing and new facilities to manufacture, Covaxin, eventually manufacturing around 650 million doses. We have now destroyed around 50 million doses of the final drug product. Based on our internal demand projections we ramped down manufacturing operations for Covaxin starting January 2022. Most of these facilities have now been repurposed and have commenced manufacture of our other products”, said Dr Ella. The development of India’s first COVID-19 vaccine, a monumental feat, during 2020-21, adds to the many feathers in Dr Ella’s cap including Padma Bhushan, received in January 2022. It has not only given a huge boost to the Indian vaccine industry, which has been known for its manufacturing capability, but now it has brought R&D into focus. According to Dr Ella, “The Indian vaccine industry is in a good position globally, but there are global headwinds in the realm of new technologies and downward pricing pressure for existing products. Every company has to address these issues for A Visionary Serial Entrepreneur 36 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com As an industry and country, we should streamline our regulatory processes, enhance public healthcare funding, encourage startups to help innovation and accelerate newer, higher quality vaccine development. DR KRISHNA ELLA Executive Chairman, Bharat Biotech International Ltd.

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 37 ● Serial entrepreneur: Ventured into veterinary vaccines, food processing and developing biotechnology infrastructure ● Associated with several committees: Scientific Advisory Committee to the Union Cabinet; CSIR Governing Council; CCMB Governing Council; Research Council for CSIR National Laboratories; Board of Visitors – Global Health Institute, University of Wisconsin-Madison. ● Recipient of several awards: Padma Bhushan, ET Now Special Recognition for Healthcare Industry Award, J R D Tata—Best Entrepreneur of the Year Award, Marico Innovation Award and University of Southern California—AsiaPacific Leadership Award, BioSpectrum Person of the Year Award, IPA Industry Excellence Award, FICCI Best Technology and Innovation Award, Prime Minister of India, Business Leader of the Year, Pharma Bio World etc. ACHIEVEMENTS themselves. As an industry and country, we should streamline our regulatory processes, enhance public healthcare funding, encourage startups to help innovation and accelerate newer, higher quality vaccine development.” Bharat Biotech is exploring novel technologies such as mRNA, CRISPR, among others and also carefully studying their safety aspects which are yet to be fully established. For Dr Ella, the primary focus is always on the safety of vaccines. He believes that as efficacy may wane over time, safety remains paramount. Popularly known as a Serial Entrepreneur, Dr Ella has founded multiple group companies to indigenously develop and manufacture technologybased solutions for veterinary, agricultural and horticultural sciences. He was instrumental in the successful acquisitions of Chiron Behring from GSK and Intervet from Merck in 2018. Dr Krishna Ella has served several national and international boards / advisory positions in his 35 years of multi-faceted journey in the life sciences sector. He is serving as a Member of the Governing Body of the Council of Scientific & Industrial Research (CSIR); Central Food Technological Research Institute (CFTRI); Research Council of Centre for Cellular and Molecular Biology (CCMB); Technology Information, Forecasting and Assessment Council (TIFAC); Governing Body Council, ILS, Bhubaneshwar, to name a few. Dr Ella was born in a Telugu-speaking Hindu family in Tiruttani village, in the Tiruvallur district of Tamil Nadu In 1969. He earned a bachelor’s degree from the Tamil Nadu Agricultural University and joined for a Master’s degree at the University of Agricultural Sciences, Bengaluru. On a Rotary fellowship, he completed his master’s degree from the University of Hawaii. He completed his PhD from the University of Wisconsin–Madison in the department of plant pathology. In 1996-98, Dr Ella relocated to India, from the US, with a vision and passion to start a biotech/life sciences company to manufacture next-generation vaccines and biologicals. He, thus, founded Bharat Biotech International Ltd, along with his wife Suchitra Ella. Dr Ella’s vision fructified over the last two decades to establish one of the largest biological facilities in Genome Valley, Hyderabad. The project started with an investment of Rs 12.5 crore, and is today the most innovative and fastest-growing company with 16 vaccines and 5 therapeutic molecules. The company is manufacturing and distributing a plethora of new vaccines for infectious diseases such as Hepatitis B, Rabies, Polio, Rotavirus, Typhoid, Japanese Encephalitis, COVID-19, etc. Under Dr Ella’s strong leadership and vision, the company is carrying out several R&D projects for Zika, Chikungunya, Malaria and other infectious diseases. Bharat Biotech’s technical teams are currently working on vaccines against Malaria, Cholera, Chikungunya and Non-Typhoidal Salmonella, etc. Some of these vaccines will reach licensure during 2024 and beyond. “Bharat Biotech was a startup 25 years ago when we were the first company to establish in Turkapally, a small village on the outskirts of Hyderabad. I gave a proposal to the erstwhile Andhra Pradesh Government to establish ‘Genome Valley’ as a biotechnology hub, which is now a reality with more than 100 companies functioning here”, said Dr Ella. The growth of Bharat Biotech, with Dr Ella as its leader, has been synonymous with the growth of Genome Valley in Telangana. It is indeed a commendable achievement for Dr Ella to be a founding member of both entities, as they will continue to make the country proud for decades to come.

ENTREPRENEUR 2020-21 Hasmukh Rawal is the Managing Director and Co-founder of Pune-based startup Mylab Discovery Solutions. Rawal has played a pivotal role in many strategic initiatives that shaped the company’s future. In 2011, he conceived the idea of starting Mylab along with the co-founder, Shailendra Kawade with a vision of bringing high-end diagnostics at affordable prices to masses and making a social impact. With an aim to develop diagnostics solutions which are built in India and for India, he set up a state-of-the art R&D facility in 2015 and make it an epicentre of innovations. He was instrumental in starting a 20000 Sq. Ft.+ manufacturing unit in Lonavala Industrial Area between 2016 and 2017 to increase production and move from R&D to full-fledged manufacturing. In 2019, the manufacturing facility got approval from Food and Drug Administration (FDA) and The Central Drugs Standard Control Organisation (CDSCO), Class C and Class D diagnostic kit manufacturing approvals for critical Molecular Diagnostic products: HIV, HBV, HCV, NAT, COVID-19 and received Test License for about 100 more products. In 2022, his vision led to the development of India’s most advanced Innovation Centre for diagnostics, ‘Mylab Global Innovation Centre’. Rawal has many firsts to his credit. He played a vital role in making Mylab the first company in Asia and second company in the world to develop and manufacture FDA approved ID-NAT kits for accurate detection of HIV, HBV, HCV and other infections. He also spearheaded the development of India’s first fully automated extraction and PCR-ready system, Compact XL. In 2020, at the onset of the pandemic, he led the development and successful launch of first Made in India RT-PCR test for COVID-19 and thereafter, the COVID-19 Rapid Antigen Test. During the second surge of the pandemic, he was instrumental in rolling out ICMR-approved and The National Accreditation Board for Testing and Calibration Laboratories (NABL) certified mobile testing labs for molecular testing to increase RTPCR testing. He is leading the discovery and development of diagnostic solutions for the infectious and non-communicable diseases such as HIV, TB, oncology, HPV, Ankylosing Spondylitis, oncology, etc. that threaten the health of India’s population. Under his leadership and guidance, the company is now distinctly positioned to serve the needs of the TB programme of India with the most comprehensive portfolio of solutions for screening, detection and prevention. Rawal is a biotechnologist-turned-entrepreneur and holds a postgraduate degree in medical biotechnology. Helming cutting-edge diagnostic solutions HASMUKH RAWAL Managing Director & Co-founder, Mylab Discovery Solutions ● Developed the first made-in-India’s test kits for COVID-19 in a record time of 6 weeks in 2020 ● Launched ‘Compact XL’ in 2020- India’s first fully-automated Sampleto-PCR-ready system for molecular diagnostics ● Developed India’s first at-home COVID-19 test in 2021 ● With a team of 108, increased its revenue to Rs 840 crore during FY 20-21 from Rs 9.5 crore in FY 19-20 MILESTONES For the last 2-3 years, we have been investing a lot in building new products. For instance, we are currently investing around Rs 300 crore in a new manufacturing facility in Pune. Right now there are so many areas in healthcare, particularly diagnostics, that are unexplored which require a lot of investment. One of the most important areas is that of non-communicable diseases such as cardiovascular, obesity, diabetes. The therapeutics for these areas require the right diagnosis and right prognosis. 38 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com

ENTREPRENEUR 2020-21 Integrating science with entrepreneurship WOMAN DR RACHANA TRIPATHI Chief Executive Officer, Huwel Lifesciences ● Catered one of the highest numbers of COVID-19 kits in India through Govt tenders in 2020, 2021 ● Services during COVID-19 time were recognised by NITI Aayog and declared Huwel as one of the best startups ● With over 30 staff members, generated revenue of Rs 23 crore (EBITDA) during FY 20-21 ● Manufactured 32 RT-PCR diagnostic kits across infectious diseases, genetic diseases and cancer markers ● Raised funds from Department of Science & Technology, Department of Biotechnology MILESTONES Life is not easy as an entrepreneur in science. Handling constant pressure of survival in every aspect is an art to learn. There is determination to conquer and the dream is on. BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 39 Hailing from the city of Allahabad in Uttar Pradesh, Dr Rachana Tripathi belongs to a family of freedom fighters, poets, and scientists. She did her graduation from Allahabad university, and post-graduation in biotechnology from DAV Indore. For PhD, she moved to the southern part of India, where she spent an entire year at the Indian Institute of Science (IISc) in Bengaluru and then moved to the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad to complete her PhD. During this time, she also got the opportunity to work at the National Institutes of Health in the US. Dr Rachana’s entrepreneurial journey began after she completed her PhD. The first lap was in the form of a pathology lab called Anoop Labs in Allahabad where the focus was on developing several polymerase chain reaction (PCR) and real time PCR assays for different diseases like tuberculosis (TB), Japanese encephalitis (JE), transplant panel etc. based on the requirement of the region. After 2007, she moved back to Hyderabad along with her husband, and established RAS Lifesciences. At RAS, Dr Rachana developed several recombinant proteins as a part of contract research to earn quick money. Later on, she was able to establish a molecular diagnostics testing laboratory and developed several lab assays since not many molecular kits were available back then. Slowly, she moved towards molecular diagnostic manufacturing, thereby developing and manufacturing molecular assays. Her startup venture was then developing several RT PCR and Loop mediated isothermal amplification (LAMP) based assays. Later in 2012, BioMerieux, a french firm, acquired a 60 per cent stake in RAS for $1.6 million. Dr Rachana continued working with BioMerieux, and this experience gave her an opportunity to understand the basics of design control and quality systems. After exiting RAS, she started Huwel Lifesciences in 2017, along with her husband. The startup has now emerged as a high-end molecular diagnostics kit manufacturer which enables reference labs and hospitals to provide reliable and high-quality diagnostics services to clinicians. When COVID-19 started back in 2020 in India, Huwel Lifesciences was one of the first few companies to develop a COVID-19 test kit that received approval for commercial use from the Union Health Ministry and the Indian Council of Medical Research (ICMR). Quantiplus CoV was the detection kit developed by the firm based on the published protocol of Centers for Disease Control and Prevention (CDC) — the national public health agency of the US. But of course, many challenges came along with this achievement as there were multiple import restrictions. Hence, Dr Rachana’s focus shifted towards making all the kit components including plasticware in-house. ‘Make in India’ helped her team to control the cost, consistency, quality and maintain supply timelines. Very recently, the startup has received a financial support of Rs 15 crore from the government for validation and commercialisation of Rapid Real Time PCR reagents for storage and transport at room temperature.

Covaxin, India’s first indigenous COVID-19 vaccine by Hyderabad-based Bharat Biotech International Limited (BBIL), developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8 degrees. Despite being under the scanner due to political pressure when its launch was announced in 2020 by ICMR, the product has emerged as a huge saviour when the scramble for an effective COVID-19 vaccine was making people worried across the country. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Biosafety Level 3) high containment facility, using Whole-Virion Inactivated Vero Cell derived platform technology. The Drug Controller General of India (DCGI) granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response, in 2020. A total of 375 subjects were enrolled in the Phase 1 study and generated excellent safety data without any reactogenicity. In Phase 2 study, 380 participants of 12-65 years were enrolled. Covaxin led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses. Later, the Phase 3 clinical trial in India involved around 26,000 volunteers. In addition, the vaccine was proven to neutralise the COVID-19 variants - B.1.1.7 (Alpha) first isolated in UK, P.1- B.1.1.28 (Gamma) & P.2 - B.1.1.28 (Zeta) first isolated in Brazil, B.1.617 (Kappa) first isolated in India, B.1.351 & B.1.617.2 (Beta & Delta) first isolated in RSA & India. Efficacy data demonstrate 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant. The government granted permission for the emergency use of Covaxin on January 3, 2021, which turned out to be a giant leap for innovation and novel product development in India. It was a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addressed an unmet medical need during this pandemic, the bigger goal was to provide global access to populations that need it the most. The World Health Organisation (WHO) validated the vaccine for emergency use and Covaxin has been granted emergency use approval in 13 countries. FY 20-21 also saw the US market generating its interest towards making this product available to its people. As a result, US-based firm Ocugen Inc inked a deal with Bharat Biotech, for clinical development, registration, and commercialisation of Covaxin for the US market. Early during the COVID-19 pandemic, the company decided to repurpose existing and new facilities to manufacture Covaxin with eventually manufacturing around 650 million doses. Bharat Biotech had invested more than Rs 50 crore towards product development and manufacture of Covaxin, along with other vaccine candidates that were evaluated. This was a very significant at-risk investment, as most of it was made prior to data readouts and any procurement contracts. In hindsight, this was a defining moment for Bharat Biotech in its ability to trust its internal R&D and product development capabilities to make at risk strategic investments. Stepping up to the Challenge COVAXIN COVID-19 VACCINE by Bharat Biotech Bharat Biotech’s response to the pandemic was through 4 different vaccine platform technologies. Two of which namely COVAXIN and INCOVACC have been successfully established. We are now future ready and will be able to successfully address future pandemics with these and other platform technologies that are available. - Dr Krishna Ella, Executive Chairman, Bharat Biotech International Limited PRODUCT OF THE YEAR 2020-21 40 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com

YOUNG WOMAN SCIENTIST 2020-21 Driving force in addressing metabolic bone disorders DR RITU TRIVEDI Senior Principal Scientist, Central Drug Research Institute (CDRI), Lucknow ● Number of publications148 ● H Index- 34 ● Number of Patents- 3 ● Impact of the inventionDiscovered potential new drug target for osteoporosis ● Industry collaborations, Licensing dealsTechnology transfer of osteoporosis drug candidate to Aveta Biomics, USA, for further clinical development and commercialisation in February 2022 ACHIEVEMENTS It’s been a tough and long scientific journey. I have just been working my way out alongside facing all the deterrents that any one faces during a scientific journey. The academic career phase for most women is very tough as there are other responsibilities to take care of. But one must not give up and just hang on to one’s career. BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 41 APhD in Endocrinology from Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow and a postdoctoral in Developmental Biology from National Institutes of Health (NIH), Bethesda, US, Dr Ritu Trivedi has come a long way in her scientific career. This experience and expertise allowed her to combine her basic and translational experience to set-up her own lab at Central Drug Research Institute (CDRI), Lucknow. She has also worked on the standardised fraction of Dalbergia sissoo that acts as an osteogenic agent that has led to translational benefits as a rapid fracture healing agent as well as is valuable in primary osteoporosis. Further, her work on the nanoformulation of Spinacia oleracea has led to a product for osteoarthritis treatment. These technologies have been licensed to Gujarat-based Pharmanza Herbals for postmenopausal osteoporosis and osteoarthritis and both are in the market by the name Reunion and Joint Fresh respectively. The product Reunion commercialised in February 2015 and Joint Fresh in 2018. Reunion has been marketed all over India since May 2017 by Eris Lifesciences (also in Gujarat), a manufacturer of lifestyle-related drugs and is among the fastest growing generic and formulation-based drug companies in India and Joint Fresh is being marketed by Aeran Lab India, based in Mumbai. The products have a huge market in India where the burden of fracture is staggering not only from fractures caused due to postmenopausal osteoporosis or from road accidents that occur almost every minute but also with a large population being affected by osteoarthritis. Significant additional revenue is being accrued by Pharmanza Herbal (the manufacturer) and Eris Lifesciences and Arean Lab (the marketing companies) by selling the innovative product developed by Dr Ritu and her team. Recently, a Memorandum of Understanding (MoU) has been signed with Aveta Biosciences, a US based company, for exporting Reunion to the US market. In 2020, Dr Ritu received the NASI-Reliance Industries Platinum Jubilee Award in the Biological Sciences category, highlighting her hard work in developing new products and being able to successfully commercialise those. She has also served as a Member of the Thematic Group-Health, initiated by the office of Principal Scientific Adviser, Government of India for formulation of India’s new Science, Technology, and Innovation Policy (STIP) in 2020. Her other recent achievements include being listed in India’s top 20 promising innovators: Torchbearers of Indian Bioscience R&D; and 75 under 50: Scientists Shaping Today’s India, published by Vigyan Prasar.

42 BIOSPECTRUM EXCELLENCE AWARDS BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com Year Lifetime Achievement Business Person of the year Entreprenuer of the year Product of the year Special Category 2002-03 Prof. MS Swaminathan, Founder, M S Swaminathan Research Foundation (MSSRF), Chennai Dr Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Limited, Bangalore Dr Krishna M Ella, Chairman and Managing Director, Bharat Biotech India Ltd (BBIL), Hyderabad AVADIS Strand Genomics, Bangalore Andhra Pradesh - State of the year 2003-04 Dr Manju Sharma, Former Secretary, Department of Biotechnology, New Delhi Dr Cyrus Poonawalla, Chairperson, Serum Institute of India Pvt Ltd, Pune Dr KK Narayanan, Managing Director, Metahelix Life Sciences Ltd, Bangalore JEV Chex XCyton Diagnostics Ltd, Bangalore 2004-05 Prof. N K Ganguly, Former Director General, The Indian Council of Medical Research (ICMR), New Delhi Dr M K Bhan, Secretary, Department of Biotechnology Sudhir Pai J, Chief Executive Officer and Managing Director, Lotus Labs Pvt Ltd, Bangalore Q-Vac Serum Institute of India Pvt Ltd and Shantetra - Shantha Biotechnics Ltd 2005-06 Dr RA Mashelkar, Former Director General, Council of Scientific and Industrial Research (CSIR), New Delhi M Ramasami, Managing Director, Rasi Seeds (P) Ltd, Coimbatore Dr Villoo Morawala-Patell, Founder and Chairperson & Managing Director, Avesthagen Limited, Bangalore Plasma proteins Reliance Life Sciences Private Limited, Navi Mumbai Kapil Sibal, Minister of Science and Technology, Government of IndiaLeadership Award in BT - Special 2006-07 Dr Pushpa Mittra Bhargava, Former Director, Centre for Cellular and Molecular Biology (CCMB), Hyderabad Dr K I Varaprasad Reddy, Managing Director, Shantha Biotechnics Ltd, Hyderabad Dr Vijay Chandru, Co-Founder and Chairman, Strand Life Sciences Ltd, Bangalore BIOMAb EGFR Biocon Ltd, Bangalore Gujarat - State of the year 2007-08 Prof. G Padmanaban, NASI-Platinum Jubilee Chair and Honorary Professor, Department of Biochemistry, Indian Institute of Science (IISc), Bangalore Prof. Samir K Brahmachari, Director General, Council of Scientific and Industrial Research (CSIR), New Delhi Anuradha Acharya, Chief Executive Officer, Ocimum Biosolutions Ltd, Hyderabad XCyto Screen XCyton Diagnostics Ltd, Bangalore and Reditux - Dr. Reddy’s Laboratories Ltd, Hyderabad 2008-09 Prof. D Balasubramanian, Director, LV Prasad Eye Institute, Hyderabad Hari S Bhartia, Co-chairman and Managing Director, Jubilant Organosys, New Delhi Apurva Shah and Binoy Gardi, Co-Group Managing Director and Co-Founder and Apurva Shah, Co-Group Managing Director and Founder Veeda Clinical Research Pvt Ltd, Ahmedabad Dry Tri-T STAT ReaMetrix, Bangalore 2009-10 Prof. Obaid Siddiqi, Founder-Director of the Tata Institute of Fundamental Research (TIFR) National Center for Biological Sciences, Bangalore Glenn Saldahna, Chief Exective Officer, Glenmark Pharmaceuitcals Ltd, Mumbai Dr Rashmi Barbhaiya, Chief Executive Officer, Advinus Therapeutics Pvt Ltd, Bangalore cry1C bt gene Metahelix Life Sciences Ltd, Bangalore 2010-11 Dr Lalji Singh, Vice-Chancellor, Banaras Hindu University Prof. Virander S Chauhan, Director, International Centre for Genetic Engineering and Biotechnology (ICGEB) and Dr Chetan Chitnis, Principal Investigator, Malaria Group, ICGEB, New Delhi Supreet Deshpande, Founder and Director, V Life Sciences Technologies Pvt Ltd, Pune PacliALL Panacea Biotec Ltd, New Delhi 2011-12 Dr S Natesh, Former adviser, Department of Biotechnology, New Delhi Dr Renu Swarup, Managing Director, Biotechnology Industry Research and Development Assistance Council, New Delhi Shrikumar Suryanarayan, Chairman, Sea6 Energy, Chennai JEEV Biological E Ltd, Hyderabad 2012-13* Dr MK Bhan, Former secretary, Department of Biotechnology, New Delhi Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech India Ltd (BBIL), Hyderabad Ajay Bhardwaj, Chief Executive Officer, Anthem Biosciences, Bangalore ALZUMAb Biocon Ltd, Bangalore 2019-20 Dr Cyrus Poonawalla, Chairperson, Serum Institute of India Pvt Ltd, Pune Binish Chudgar, Vice Chairman & Managing Director, Intas Biopharmaceuticals Ltd, Ahmedabad Kavita Iyer Rodrigues, Chief Executive Officer, Zumutor Biologics, Bangalore ROTAVAC 5D Bharat Biotech, Hyderabad and TrueNat - MolBio Diagnostics, Goa Dr Geetha Manjunath, Chief Executive Officer, Niramai, Bangalore - Woman Entreprenuer of the year * No awards announced from 2013-14 to 2018-19 BioSpectrum Excellence Award Winners from 2002-03

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com SPEAKING WITH 43 “CDMOs in India are always looking for an edge to improve development and manufacturing processes while also lowering costs” « Dr Udit Batra, President & CEO, Waters Corporation I n February, Waters Corporation, a global leader in analytical instruments and software, entered into an agreement to acquire Wyatt Technology, a pioneer in innovative light scattering and fieldflow fractionation instruments, software, accessories and services, for $1.36 billion in cash. BioSpectrum spoke with Dr Udit Batra, President and CEO, Waters Corporation about the acquisition and how the company will expand the product portfolio of Wyatt Technology in the Indian market. Edited excerpts: What prompted Waters to go in for this acquisition? There are many reasons, but three stand out. Chief among them is a common mission that we share to help lower the costs and increase access to biotherapies. Biologics, including cell and gene therapies, can dramatically change the quality of life for a significant percentage of the population and there is considerable demand for developing these drugs. But the astronomical costs of delivering these therapies are a major barrier to adoption. Wyatt’s innovative products are used to determine the properties of novel therapeutics such as cell and gene therapies, vaccines and proteins, as well as synthetic polymers and nanoparticles. This is complementary to the work we already do in the large molecule separation and characterisation space. We believe that combining our capabilities with Wyatt’s, a company with robust exposure to bioanalytical characterisation, can help our customers to lower the costs of biologic drug development and manufacturing. That, in turn, can help increase patient access and affordability of these life-changing therapies. Second, bioanalytical characterisation for new modalities is a significant market opportunity, with a $1.8 billion total addressable market and 10-12 per cent projected annual growth. With our joint efforts, we are well-positioned to build a high-growth bioanalytical characterisation business. Finally, this acquisition adds significant value for our shareholders. Wyatt is immediately accretive to Waters’ revenue growth and margin profile. But it is more than the profit for us - the long-term potential to help our biopharma customers develop and bring to market life-saving therapies at a lower cost is solving a problem that truly matters. How would you describe the benefits of Wyatt’s light scattering technologies? Wyatt’s scientists were the first to commercialise online multi-angle laser light scattering instruments over 40 years ago and have been consistently defining and redefining state-of-the-art macromolecular characterisation instrumentation, software, and services. Bioanalytical characterisation encompasses both the chemical and physical makeup of molecules. At Waters, we have the technology and capabilities to understand chemistry, but we are missing the ability to fully characterise the physical characteristics of large molecules. This is the true value of Wyatt’s light scattering technologies – they allow us to examine the size, aggregation level and interactions amongst larger species. This will enable us to solve critical challenges associated with manufacturing high-quality biological, and cell and gene therapies, ultimately helping biopharma customers to drive consistency in manufacturing and reducing costs. Also, over the years, Wyatt has introduced several complementary technologies, including well-plate-based dynamic light scattering and fieldflow fractionation for separating nanoparticles. These innovative product offerings are used across the value chain in discovery, product development, manufacturing, and QA/QC settings. Scientists use these instruments to determine the critical quality attributes of cell and gene therapies, vaccines, and proteins. These products are also useful to our materials customers for characterising synthetic polymers and nanoparticles. What is the added benefit for scientists in using light scattering for applications in which LC-MS or LC-UV is also used? Wyatt detectors will provide orthogonal

44 SPEAKING WITH BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com measurements for our portfolio to support stronger identification and aggregation—which are two critical quality attributes for all biopharmaceuticals. Measuring orthogonally offers a unique, and meaningful edge to the data and helps address the bias that could exist from only using one instrument in testing. By expanding our analytical capabilities beyond what LC-MS can provide alone, Wyatt brings new expertise and stronger data to novel modality applications which will help improve our ability to solve customer problems more quickly and efficiently. What are the technical challenges for characterising cell and gene therapies that light scattering and field-flow fractionation technologies are well-suited for? A major challenge in characterisation is size, and it is also an underappreciated measurement in gene therapy. Take mRNA therapies, for example, one of the biggest breakthroughs was its delivery by lipid nanoparticles (LNP) and there is only one specific size and charge of the LNP that is effective. Light scattering and electrophoretic light scattering are the ideal technologies to uncover these findings and lead to such breakthroughs. Light scattering provides scientists with critical quality attributes like identification and efficacy for viral vector-based gene therapy. It can quantify the molecular weight and size for identification and whether a gene has its genetic payload (empty or full) for efficacy. Field flow fractionation, an alternative separation technique for purity and impurity measurement, is ideal for large complex molecules like some selected viral vectors and LNPs that are prone to shearing (or changing shape) under traditional separation. As the size of biologic therapies grows to sizes of up to one micron, this is becoming a high-growth area of science, and Wyatt’s field flow fractionation can help. How does Waters intend to bring Wyatt’s products into the local market? We know that premier institutions in India are using Wyatt light scattering technology in their laboratories. For example, hepatitis A virus studies from IIT-Delhi and structural protein work from The National Centre for Cell Science in Pune and IIT-Delhi. We see strong opportunities with the combination of the Waters-Wyatt portfolio, and we have a strong direct and distributor presence in India. Given the concentration of Contract Development and Manufacturing Organisations (CDMOs) in India, these organisations are always looking for an edge to improve development and manufacturing processes while also lowering costs. This need will be especially acute as the drug pipeline opens up for novel modalities such as AAVs and mRNA. If a CDMO can establish itself as highly efficient, highly precise and delivered at a lower cost for large molecules and novel modalities, it will stand out among so many others. The biotechnology market in India has grown 14 per cent in the last year to more than $80 billion. This bodes well for Waters and for being able to bring Wyatt’s light scattering technologies to an even broader set of customers. Are companies in India today using Wyatt’s products? If not, what could these technologies bring to both pharmaceutical and materials companies? From what we see today, Wyatt’s products are mainly used within academia in India. But as I mentioned, there is a great opportunity for Waters and Wyatt to complement one another, especially knowing that Wyatt detectors can be easily attached to Waters’ liquid chromatography instruments. By integrating the technology into laboratories where Waters is already established, we expect to increase the prevalence of Wyatt in India. Specifically, we see the introduction of more Wyatt detectors in pharmaceutical laboratories to provide an additional intact measurement of biologics such as mAbs and AAVs. What’s the opportunity in India for Waters to bring LC and Multi-angle Light Scattering instruments to CDMOs? What kind of benefit would this bring to CDMOs? Wyatt’s technology is used to ensure that the development and manufacturing of drugs and biologics is safe and efficacious, meaning there is a significant opportunity for LC and multi-angle light scattering instruments to be used in CDMOs across India. Developing a successful drug requires comprehensive biochemical and biophysical characterisation, and small manufacturing differences could impact the structure and, therefore, the function of therapy. The biophysical characterisation and higher order structure, which is directly related to the function of the molecule, can be obtained from light scattering analysis. Thus, Wyatt’s light scattering technology can aid in biophysical characterisation, and help CDMOs manage the quality of the drugs they develop and manufacture from R&D all the way through QA/QC. Narayan Kulkarni [email protected]

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com SPEAKING WITH 45 “New bioincubators would be set up to cater to the growth of startup ecosystem including the tier 2, tier 3 regions” « Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) Dr Jitendra Kumar, the former Director of Bangalore Bioinnovation Centre (BBC), has taken charge as the new Managing Director (MD) of Biotechnology Industry Research Assistance Council (BIRAC), an institution set up by the Department of Biotechnology (DBT), Government of India, to nurture and promote biotechnology innovations and industry in India. In an exclusive tête-à-tête with BioSpectrum, Dr Jitendra Kumar, MD, BIRAC lays bare his new vision and strategies for the growth of the biotech sector. Edited excerpts; What unique strategies are you planning to implement as the MD of BIRAC? A major challenge faced by startups in India is the inability to scale up. We need to develop multiple centres for startups to be able to manufacture and initiate trials at large scale. So, my vision would be to facilitate scaling up of startups by setting up at least five such centres. There is also a need to establish a platform where big companies can interact with startups. BIRAC can provide such a platform to the startups where extensive interactions can take place. Industry can strategically tie up with startups to ensure the success of an idea. For instance, in the case of new drug discovery, a startup can conduct pre-clinical trials, and once successful, the technology can be translated to an industry partner to strategically bring the drug faster to the market after conducting the necessary clinical trials. Although startups might have apprehensions to undergo such strategic partnerships with big industry players, BIRAC can play a critical role in easing out the path for both startups and big companies. Are there plans to open more bioincubators in the country to strengthen the ecosystem for biotech startups in India? New bioincubators would be set up to cater to the growth of the ecosystem including the tier 2, tier 3 regions. BIRAC would also partner with some of the progressive states and run state level programmes for the startup. For instance, Bangalore Bioinnovation Centre is the only bioincubation centre jointly run by the central and state government. There is a need to create similar models in the country so that all the resources can be pooled together and the required funding can be accommodated for the growth of these startups. At present, many incubation centres are running on project modes. In addition, BIRAC also has plans to lay emphasis on developing new policy norms for the regulatory hurdles being encountered by startups across the country, particularly those working on new emerging technologies. The government’s vision is to increase the number of biotech startups from 5000 to 50,000 in the coming years. What is your opinion? Currently, the scenario is that we are waiting for startups to come up to gradually increase in number. But this is not a sustainable way forward. A more robust way to gradually increase the number of biotech startups in our country would be to adopt institutional mechanisms where we can have dedicated programmes within the academic institutes to commercialise those technologies that are lying on the shelf, with support, funding and incubation from BIRAC. We can, thereby, create a whole database of such technologies that are available with the academic institutes to be picked up by the students who can become the future entrepreneurs. The institutional mechanisms could also create ventures and it can emerge as an evolutionary process for the growth of biotech startups. In addition, we need to showcase the success stories as more startups are able to scale up and commercialise their innovation. Dr Manbeena Chawla [email protected]

46 BUSINESS INSIGHT BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com How quality practices can elevate Life Science industry standards « Amit Sehgal, Managing Director, Avantor India L ifescience Laboratory workflows, products and services are complex and can be difficult to manage due to long and stringent processes and requirements. In a Deloitte survey of risk and compliance management professionals in India, 61 per cent of respondents felt that there was a lack of efficient internal controls and compliance. This in turn can result in an erosion of customer, regulatory and shareholder confidence. The ability to consistently meet applicable requirements and withstand regulatory scrutiny is dependent upon both effective quality management systems and subject matter expertise. Quality management programmes assure compliant products and services, with accurate and documented results, are delivered consistently to every customer, every day. These programmes build customer trust and support corporate vitality and are of critical importance especially in industries such as life sciences that face evolving complexities, customer requirements and regulatory standards. Quality programmes enable scientists to more efficiently and effectively create scientific advancements, using a wide range of laboratory chemicals, consumables, and precision equipment, helping catalyse innovation to build a better world. With the changing compliance dynamics in the life sciences sector, companies that offer laboratory products and services are expected to have proactive risk identification and reduction programmes that are in line with the directives of the regulatory authorities in their target markets. This includes building effective design protocols like compliance testing of APIs (Active Pharmaceutical Ingredients), certified analytical processes provided by the manufacturer throughout the supply chain, and using highquality materials and equipment. Against this backdrop, how can providers of research, development and production products and services enable customer innovation, effectiveness, and efficiency? Consider these four ideas: 1. Integrating ISO Certified & cGMP facilities & Lab Products Providing certified and cGMP facilities and capabilities for regulated and non-regulated products and services is an essential part of enhancing laboratory standards. Likewise, at Avantor, our 13 cGMP facilities and 19 ISO-certified distribution facilities create a manufacturing and distribution network that is designed to meet stringent Quality and Regulatory requirements and standards. Our manufacturing strategy offers products made under relevant cGMPs. Avantor’s laboratory research products help our customers reduce process variability, increase the repeatability and reproducibility of results and automate processes for increased testing efficiency. 2. Using high-quality chemicals, consumables, and equipment High-quality chemicals, consumables, as well as equipment and instrumentation should be used for testing purposes. Validating the accuracy of the experiment is always imperative and Avantor focuses on a array of testing around novel life-saving drugs, vaccines, or diseases. The laboratory research equipment and consumables are to be designed to reduce process variability, increase the repeatability and reproducibility of results, and automate processes for increased testing efficiency. 3. Building agile solutions Production process readiness is a crucial factor in successfully speeding innovation within a growingly demanding scientific landscape. There is no room for error in the quality, efficacy, and purity of the products and inventory must be managed efficiently. Though companies are able to drive growth and manage costs, they can suffer losses if there is no assessment of current capabilities coupled with a plan for future risks. Incorporating an effective inventory software

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com BUSINESS INSIGHT 47 allows the companies to have a 360-degree idea of their inventory, examine material wastage and track inventory levels through dedicated and customised modules. For instance, Avantor builds agile solutions and captures a precise view of users current situation to deliver superior results is through Value Stream Mapping (VSM), an element of the Avantor Business System (ABS) model. When focusing on improvements in the raw material sample testing approval process in our own quality labs and internal workflows, VSM assisted our quality teams in visualising the entire process and identifying opportunities for improvements in product availability by accelerating product release. Applying the concepts of cell design, the teams eliminated multiple bottlenecks and created a test method-based process flow bench to reduce sample approval lead time by more than 95 per cent. 4. Embedding sustainability into the lab ecosystem We must also consider the impact on the planet and embed sustainability at every step of the process. In addition to ensuring responsible production processes, innovative practices, such as inventory optimisation solutions can be implemented to prevent wasteful purchasing processes in laboratories. Other initiatives could focus on reducing greenhouse gas emissions through more efficient equipment or reducing lab waste. We are eventually working towards reducing our own operational Scope 1 and 2 Greenhouse gas emissions to 15 per cent by 2025, compared to a 2019 baseline. Meeting customer and compliance prerequisites Today, the purview of quality goes beyond the consistent yield of superior products. Adopting customisable, flexible solutions that manage and optimise end-to-end laboratory operations will protect lab employees by providing them with a safe working environment and bolster customer relationships. Quality assurance, quality control, and proactive risk management practices throughout the supply chain ensures that the final products meet customer needs in a compliant manner. The right partner can offer a range and scale of quality services that is customised to your business needs, thereby streamlining workflows, while assuring quality, to enable innovation in an efficient and effective manner. Quality is an essential element of every process, programme, product and solution at Avantor and is the foundation for the value we deliver every day. We serve industries subject to rigorous quality, performance and reliability regulations and navigate these requirements with ease. Join the BioStartup Challenge and turn your innovative ideas into reality Are you a trailblazer in the field of biotechnology, ready to revolutionize the world with your groundbreaking startup? Look no further! TheBioStartups.com presents the BioStartup Challenge, an extraordinary opportunity catapult your bioventure to new heights. Don't miss out! Applications for the BioStartup Challenge are now open, but time is running out! Seize this chance to showcase your innovation, disrupt the status quo, and leave an indelible mark on the world. Email [email protected] and submit your application today! Unleash the power of your bioventure and propel it towards extraordinary success. Together, let's shape the future of biotechnology!

48 SPEAKING WITH BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com “We will launch a Technology Development Centre to take fermentation technology to the next level” « Mihir Mehta, Wholetime Director, Praj HiPurity Systems With more than 30 years experience, Mumbai-based Praj Hipurity Systems has been a solution provider to the pharmaceutical and biotech industry. India’s most accomplished industrial biotechnology company that is driven by innovation, integration, and delivery capabilities, Praj HiPurity Systems aspires to be the most preferred organisation for all stakeholders through their environmentfriendly and sustainable solutions. In a tête à tête with BioSpectrum, Mihir Mehta, Wholetime Director, Praj HiPurity Systems throws light on the company’s future plans. Edited excerpts; What were the key highlights of the company’s business during FY 2022-23? Praj HiPurity delivered a strong financial performance in the last year. Post-COVID, the reaffirmed emphasis on self-sufficiency, expanding therapeutic categories, and the dire need for actual innovation gave the domestic and international pharma-biopharma business the much-needed spurt on expansion. We have delivered healthy growth on all key business performance parameters. Several leading pharmaceutical companies are bestowing their trust in Praj HiPurity as a testament to our commitment to uphold the principles of sustainable development. Besides retaining existing key accounts, we have added new customers on the back of technology leadership and customer-centric approach. Customers see value in our products, processes and people. The fact that our offerings cut across all our customer needs from Critical Water Plants to Critical Process Systems having applications in the sterile and biotech industry. Our services business saw a steep rise owing to our ability to serve a multitude of customers simultaneously with a dedicated workforce and strong infrastructure. The water industry, complex injectables, highcapacity fermentation, and blood plasma projects all experienced impressive growth this year. What major plans are in store for this fiscal year with respect to the pharma/biopharma sector? The market for fermentation presents unprecedented opportunities. A diverse talent pool, favourable tropical climate, and ease of doing business rank among the top factors that have increased investments in fermentation-based goods and processes used in pharmaceutical, biopharmaceutical, nutraceutical, enzyme, and biopolymer industries. In addition to conducting several turnkey projects, Praj HiPurity is marching ahead by providing consulting services in design, plant and process automation, and Ready for Future (RFF) solutions. The future looks exciting with these new business frontiers. The fact that we, in India, only handle onesixteenth of total blood plasma compared to China, shows the earnest need for plasma product expansion. Post-COVID, the demand for plasma products has increased by 200 per cent and will continue to grow going forward. With its wide range of offerings, Praj HiPurity can address emerging demands for specific players in Blood Plasma globally. Our strategy is based on sharing our domain knowledge and unique delivery expertise with emerging domestic and international markets. To enhance our service levels and reach our customers in remote locations, we have launched our Franchise Partner (FP) programme. By deploying our SpeED philosophy (Speed, Efficient approach, Depth of services), we can demonstrate value to our customers through partner networks. Our broad portfolio of water solutions for the pharma industry will continue to see an increased demand in green-field, brown-field, and retrofit projects. At Praj HiPurity, we always emphasise building future-ready, clutter-free solutions for

BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com SPEAKING WITH 49 quick decision-making by deploying water plant automation solutions for our customers. We will continue to provide the industry with access to our effective and efficient COMBI systems built on the Swedish Aquanova platform for the generation of WFI & pure steam for sterile facilities. These cutting-edge innovative solutions offer the most reliable, easy switch and low total cost ownership that helps reduce two of the critical S’s: Spares and Space by more than 30 per cent. These are interesting times for both the pharma and biopharma industry with the growing importance of health and wellness. Are you planning new launches or partnerships to strengthen your presence in the biopharma/pharma space nationally and internationally? There have been numerous firsts at Praj HiPurity. Our popular COMBI Unit and Smart Bioreactor platform BIOWIZ are continuously gaining use in new and emerging facilities. The plant automation solution REMOTE-BRIDGE for Water plants is part of our latest offering that perfectly combines advanced monitoring systems with our experts. REMOTE-BRIDGE facilitates positive changes in the way plants are monitored and controlled. It will give consumers a predictable method for comprehending the Plant’s current and future states. Our solutions will provide an immersive plant monitoring experience with an advanced troubleshooting facility when compared to traditional SCADA systems. With the introduction of the Glacier variant for COLD WFI, Praj HiPurity has crossed yet another significant milestone. This innovative technology provides sustainable solutions for COLD WFI in addition to a significant reduction in Heat & Energy Footprint. Especially in the markets where energy costs and consumption are rising rapidly, this new solution is expected to have a strong impact. In yet another first in the industry, we launched the Electronic Quality Management System (EQMS), to offer our customers integrated quality records for fabricated equipment. For our customers in the pharmaceutical and life sciences industries, this is a very promising method to deliver the highest level of dependability, real-time data, and best-in-class quality standards compatibility. Are there any new investment plans for R&D or setting-up new facilities? Intending to provide environment-friendly solutions for a future perfect world, Praj established Matrix – an R&D centre in 1989. This innovation engine of Praj is a state-of-the-art facility certified by the Government of India’s Department of Scientific and Industrial Research (DSIR). Praj Matrix R&D centre is home to over 90+ research scientists who are the backbone of our business, and responsible for cutting-edge research and development for technology commercialisation. The centre has 300+ national and international patents to its credit. We will soon launch a dedicated Technology Development Centre to take fermentation technology to the next level. This centre will focus on critical issues faced by customers in the complex injectable domain and work towards optimising fermentation solutions. We are actively pursuing patents for our cutting-edge solutions and processes. Standing true to our vision of making the world a better place, Praj Matrix conducts research in the emerging areas of industrial biotechnology, advanced biochemicals and health and wellness products. The zeal of working toward making the world a better place has stayed with us till today and will continue to do so. How is Praj contributing to the sustainable growth of the pharma/biopharma industry in India? With more than 1000+ customer references in 100+ countries across five continents, Praj is one of the preferred technology partners globally. Our technology-embedded solutions positively impact the environment, economy, and society to help strike a fine balance between people - planet - profit. Innovation and sustainability are at the core of all our business endeavours. Owing to a fully integrated ISO-14001-2015, ISO-9001-2015, ISO45001-2018 certified facility, Praj HiPurity offers an environmentally friendly manufacturing setup that is unrivalled in its line of business. With our GREEN CHANNEL partner programme in promoting sustainable supply chain management, we strive hard to reduce our carbon, water, and energy footprints. Many supplier partners have signed up to be green channel partners. The most important contribution would be by providing tried and tested solutions for complex fermenters and injectable plants. As a part of our internal sustainability system, we monitor several key sustainability indices aligned with the principles of ESG. The key to achieving global success is to learn from the glorious history of failure and use personal virtue to avoid them to accomplish ultimate success. Dr Manbeena Chawla [email protected]

50 LET’S TALK HEALTH BIOSPECTRUM | JULY 2023 | www.biospectrumindia.com DeLiverance from Hepatitis I n India, as per latest estimates of the World Health Organisation (WHO), 40 million people are chronically infected with hepatitis B and 6 to 12 million people are chronically infected with hepatitis C. Hepatitis E is the most important cause of epidemic hepatitis, although Hepatitis A is more common in children. As per the available literature and stated by the Indian government, Hepatitis A virus (HAV) is responsible for 10-30 per cent of acute hepatitis and 5-15 per cent of acute liver failure cases in India. It is further reported that Hepatitis E virus (HEV) causes 10-40 per cent of acute hepatitis and 15-45 per cent of acute liver failure. But Hepatitis B and C are responsible for 96 per cent of overall hepatitis mortality. Hepatitis is generally known as an inflammation of the liver that can be caused either by hepatic and nonhepatic viruses, by alcohol, can be drug induced, or can be caused by autoimmunity. Studies have shown that alcohol consumption negatively affects virusrelated liver disease, but the complex interactions between alcohol and hepatitis virus infection are not fully understood. Possible explanations include effects on viral replication, increased oxidative stress, cytotoxicity, and a weakened immune response. Clinically, alcohol abuse is correlated with an increased risk of developing end-stage liver cirrhosis and hepatocellular carcinoma (HCC) in patients with chronic hepatitis B and C, suggesting that the combination of alcohol and hepatitis B/C leads to more severe liver damage. Compared with heavy alcohol drinking, light-to-moderate alcohol intake has also been shown to promote the progression of hepatitis C-related liver disease. Although there are several drugs-based treatment options available to overcome the challenges related to alcohol and hepatitis-induced liver damage, Faecal Microbiota Transplant (FMT) has emerged as a new ray of hope. Scientists have shown that FMT, in severe alcoholic hepatitis patients, is associated with decreased disease severity and improved survival. FMT mainly involves the insertion of healthy microbiota, involving communities of commensal, symbiotic, as well as pathogenic microorganisms or bugs, in the diseased gut. In brief, faecal matter derived from a healthy family member of the patient receiving the same diet as the patient is processed and introduced in the intestinal tract of the patient. The gut microbiota plays an important role to modulate the immune system in disease progression or recovery. The survival of patients in need of treatment was 18.4 percentage points higher among those who received FMT as compared to those who received the steroid Prednisolone, according to a study of 112 patients with severe alcoholic hepatitis by New Delhi’s Institute of Liver and Biliary Sciences. The study also shows that 19.3 per cent of those who received steroids died of an infection as compared to only 3.6 per cent of those who received FMT. Both hepatitis A and E are RNA viruses that transmit through oral faecal routes and may have devastating effects on intestinal microflora. It has been observed that administration of the healthy probiotic bacterium like Enterococcus faecium affects the reduction as well as the removal of enteric hepatitis E viruses in pigs. However, there is a lack of relevant data in humans. Studies have also revealed that hepatic viruses breach the intestinal permeability leading to gut dysbiosis or imbalance and release pro-inflammatory cytokines instrumental in developing liver cirrhosis and HCC. Further, dysbiosis of gut microbiota in chronic hepatitis B infection affects disease pathogenesis and causes liver failure in a large proportion. With World Hepatitis Day (WHD) approaching on July 28, we are hopeful that FMT can indeed become an attractive and safest mode of treatment for the management of various liver diseases. However, despite recent publications, there are still gaps in understanding the role of microbiota in viral hepatitis especially in acute hepatitis A and E viral infections. Therefore, there is a need to explore more in these infections. Dr Manbeena Chawla Executive Editor [email protected]