New Delhi: Top experts from global contract development and manufacturing organizations (CDMOs) discussed the potential of outsourcing the drug discovery and biomanufacturing in India on the sidelines of world largest biotechnology event, BIO International Convention on 2nd June in San Deigo, USA. Also present were the representatives from Indian policymaking and startups who shared their experiences on the progress within the biotech industry space over last one decade.
The event titled, ‘India Unlimited’ organized by the International Contract Pharma Association (ICPA) was themed Collaborate, Invest, Outsource. It witnessed the presence of select group of high-ranking executives from global biopharma industry.
The opening address was delivered by Dr Anil Chauhan, Founder Director, ICPA who delved into the key opportunity areas and vast untapped potential within drug discovery and CDMO space in India.
The first session at the event was focused on India’s growing global footprint and prowess in biologics. The industry experts who spoke at the session included Dr Cyrus Karkaria, President, Biotechnology – Lupin; Tuhin Bhowmick, CEO & Director, Pandorum Technologies; and Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC).
The session was moderated by Dr Mandakini Goel, Associate Director, Business Strategy Solution Consulting, Clarivate.
Dr Mandakini Goel talked about the huge potential offered by India: “There are almost 50 plus India headquartered companies that are working on the biosimilars. There are more than 247 biosimilars which are in different stages of development and out of these 140 have been already launched. There are almost 116 deals that have happened within biosimilars and bioinnovation space. These are related to drug development and licensing, drug commercialization and drug development. There are 300 plus clinical trials that are running across. There are 200 plus patents related to biosimilars. India is the third largest biotech desitnation in the Asia Pacific region.”
Calling for a better visibility at the global front, Dr Cyrus Karkaria, President, Biotechnology – Lupin remarked, “Indian players have achieved remarkable success. The companies like Lupin and Biocon aren’t just producing the biosimilars for India but also for regulated markets. Also, there has been a radical shift in the biotech ecosystem and a part of it is also the maturation of DBT and BIRAC. Compared to decades ago when I started by journey, today the services have matured to a level that these organizations have significantly increased funding for the startups. Yet there is a need to organize and showcase India’s bioinnovation potential to European counterparts. While there are many biopharma companies that have ventured in India, we need to do more on the front of advertising the country as a bio-manufacturing destination. The messaging is important. In terms of Indian scenario, we are doing good in small molecules but sadly the drug discovery companies work on low margins, thus unable to scale up their innovation efforts. There is a need to fund the innovation part separately as there is no dearth of skills.”
“By the time we embarked on our entrepreneurial journey, there was already the tremendous groundwork done by the seniors in the industry. The existing ecosystem helped us to sustain our journey. When our co-founder Arun Chandru and I were doing PhD in Indian Institute of Science (IISc), we had no idea about anything other than science part of it. We learned more about intellectual property and filing patents from ecosystem. BIRAC and SBIRI grants helped us to stay afloat until 2016 when we filed our first patent that was later granted both in India and US. It helped us get funding from multiple VCs, eventually raising up to US$ 22 million and now aiming to add US $10 million more. I would say our journey would have not been possible without government support. Being the country of choice globally for biotech companies, it presents a US $1 billion market opportunity. I am very much excited about it,” said Tuhin Bhowmick, CEO & Director, Pandorum Technologies.
“One of the important initiatives by BIRAC is the soft-landing concept that we have created for the huge Indian diaspora. If the startups want to set up a facility in India, they will be provided incubation space, laboratory facilities and mentorship by BIRAC. It offers one stop solution with a plug and play model and landholding for navigating the Indian market. They can use the network established by BIRAC including 100 incubation facilities. A lot of collaborations and fund raising happens at the events such as BIO 2024. We provide all the support to the companies for raising the funds. A lot of entrepreneurs who have benefited from this,” said Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC).
India must address gaps & gear up for global partnerships
Leading experts from top global companies during the second session focused on servicing global research, discovery, development and manufacturing requirements of international companies. The session was moderated by Joseph Damond, Chair, Global Life Sciences, C&M International (CMI).
“We have evolved ourselves in the domain of continuous manufacturing. We have spent a number of years to build a culture of innovation and new solutions such as biosimilars in cost effective manner. A lot many of our clients are looking at de-risking the supply chain by manufacturing from multiple sites to diversify it further. It also creates a huge opportunity for India as a CDMO destination,” said Russell Miller, Vice President, Global Sales and Marketing-CDMO business, Enzene Biosciences.
“For us, it is an opportunity to get involved in the conversation. Our journey in the mammalian cell culture helped us to come in the CDMO space. We bank on our experienced professionals for the conversations with clients who are looking at de-risking their supply chain. We have both capability as well as presence across globe. That gives us opportunity to help the teams with capacity access in the country where they are doing the development. In the CDMO space, it is not about us but the client. Whether you are filing the IND or the product launch in next two years, the goal is to meet the client’s objectives. We tailor our solutions as per their need and even offer services as per their financial structure,” added Miller.
“We have both small as well as large molecule manufacturing divisions. We offer end to end services in CDMO space and our opportunities lie in listening and problem solving and innovation for our clients. That is where we see a vast opportunity in India transition from generics to the full-scale innovation model,” opined Alex Del Priore, Senior Vice President – Manufacturing, Syngene International.
“Speed at which you deliver solutions to clients defines your effectiveness and is also tied to the cost. There are a number of strategies we pursued in various geographies including China and India. From India perspective, we have to look at the quality and cost. We can’t bracket it only from the cost perspective because it would mean we are here only for bare minimum. On the contrary, the innovation demands a culture where we challenge the status quo. At Syngene, we have been creating that culture,” added Alex.
Pointing out the challenges, Alex Del Priore stated: “There is always a concern around the intellectual property and we have to assure the client that we will give the IP. The trust factor is huge and India certainly fares better than China. There are still a lot of companies that give a bad name to the industry which creates trust issues. Time difference is a huge challenge and so is the English language skills that need to be improved. The bureaucratic hurdles and gaps in state-centre coordination in terms of imports and exports and repeated inspections need to be addressed.”
Dr Roger Lias, Global Commercial Head – NBE, Aurigene International said, “We have been small molecules space for last two decades and have moved into biologics recently. There is a huge potential in biologics manufacturing in India. The country is uniquely positioned yet needs to do more. While China and South Korea have invested a lot in scaling up the innovation, India needs to increase its appetite to invest more in this segment. India’s advantage is its well-educated, motivated and skilled people that fits well for services business. That is what excites me most.”
“Ten years ago, it was different scenario in India but today we have companies like Dr Reddy’s, Biocon, Cipla and other players are releasing commercial batches of biosimilars. The FDA approval has further enhanced the acceptability of such products globally. Therefore, India is uniquely positioned to produce the cost-effective products. At the same time country still suffers from the compliance issue that needs to be addressed adequately,” added Dr Lias.
“The current geopolitical situation involving China has created a unique opportunity for India. We are bombarded with offers from big and small players who want to move their business here. While they are satisfied with China’s risk mitigation, yet the companies are looking at diversifying the supply chain with an eye on India. For an optimal supply chain, there have to be multiple partners. It is India’s opportunity, and it is for the country to get the maximum out of it and create a unique value for the segment,” said Dr Lias while sharing his perspective on India opportunity.
Sharing his thoughts, Dr Anil Chauhan, Founder Director, ICPA commented: It is quite well known that the cost of developing a new drug is in the range of 1.5 billion USD. India provides excellent facilities and companies to partner for all stages of drug development and manufacturing. This will reduce the development costs and also get new drugs to the market faster. The meeting was aimed to facilitate collaborations with and investments & out-sourcing to India,”
Speaking about his experiences at BIO, Dr Chauhan added: “I have been attending the annual BIO International Convention for the past 17 years and have never ceased to be amazed at the number and quality of attendees from around the globe.”
The event generated quite a buzz with good network opportunity for stakeholders. It was supported by BIRAC, Enzene Bioscience, Clarivate, C&M International, Aurigene, and Syngene.
*BioVoice News was the exclusive media partner of the event.
The post Global biotech players repose faith in the India’s biosimilars growth story appeared first on BioVoiceNews.
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