Lecture videos of Dean Krishna Aggarwal and SubbaRow Laureate Prof. Rathore

Inauguration

Dr Manish Verma, Vice-Chancellor of the GGS Indraprastha University, inaugurated the Yellapragada SubbaRow Memorial Lecture reminiscing about his recovery from an illness with a drug that came out of Dr SubbaRow medical research:

"While I was studying in Class VI at a small Village Jakatkhana District Bilaspur Himachal Pradesh., I fell ill and developed typhoid and later into pneumonia.

"The local Ayurveda doctor was not able to diagnose and handle the case and I was taken to Public Health Centre (PHC), Nalagarh, a small town where my Uncle was posted.

"I was hospitalised and was treated with Ledermycin, a red capsule which I remember taking every six hours for few weeks and this drug recovered me completely. Today when I look back, it was this drug which saved my life.

"I never knew that one day I would be present during a memorial lecture of Dr. SubbaRow whose research yielded that drug.

"My heartfelt homage and gratitude to this great soul who saved millions like me world over by inventing many such molecules used as drugs. The humanity is ever grateful to such individuals who have impacted and touched lives across the globe."

Vice Chancellor Dr Mahesh Verma announced that the University has decided to establish an endowment in the memory and honour of Yellapragada SubbaRow to mark his 125th birth anniversary this year.

Challenges with Development of Biotech Therapeutics.

Profile

Prof. Rathore obtained his Ph.D. from Yale University in 1998 and worked at Pharmacia Corporation and Amgen before joining the Department of Chemical Engineering, IIT Delhi, in 2009 as Associate Professor. He is Professor since December 2012 and Dean, Corporate Relations. Prof Rathore is also Coordinator, DBT Center of Excellence for Biopharmaceutical Technology.

He has at the Department of Chemical Engineering created a group that is focused on Bioprocessing and Bioseparations.

Key ongoing projects of his group include (1) QbD and PAT based process development for chromatographic steps for a marketed biotech product, (2) Use of novel technologies (such as membrane adsorbers) for process intensification, (3) Computational fluid dynamics (CFD) of flow in bioreactors and chromatography, (4) Use of high throughput techniques for downstream process development, (5) Multivariate data analysis of process data from manufacturing of marketed biotech products, (6) Process modeling for optimization of capacity utilization in a multiproduct biotech facility, (7) Mechanistic modeling of chromatography and membrane separations. And (8) Scientific and regulatory issues around approval of biosimilars.

Email: asrathore@biotechcmz.com Website: www.biotechCMZ.com

Summary of lecture

Biosimilars can be defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. India is globally regarded to have great potential to become a significant player in development and commercialization of biosimilars. However, there are a few major hurdles that need to be dealt with for us to be successful. This talk aims to present the current status of India in this context, the challenges that need to be overcome and some recommendations that may alleviate these challenges.

Economics of Biosimilars

Though the financial drivers for driving growth of biosimilars are widely recognized to be significant, there are some key aspects that distinguish biosimilars from the small molecule generics. A major difference is that patients taking biotech therapeutics show an aversion towards switching to the corresponding biosimilars. As a result, biosimilars have slower adoption as compared to the small molecule generic products. Further, biosimilars are expected to be priced at only a 20-25% discount in comparison to the original products, significantly smaller discount than what is common with small molecule generics.

Competition for Biosimilars and World's Expectations from India

While the developed countries (US, Europe, Japan) have a long history of manufacturing biotech products for regulated markets, the developing countries (India and China) have the significant advantage of availability of qualified and relatively low-priced workforce. However, more is needed for the latter to completely embrace the principles and expectations with respect to Product Quality and Good Manufacturing Practices (GMP) Compliance and this will be a key hurdle on the path to these manufacturers emerging as major global players. The complexity in the case of biosimilars is further amplified by our inability to completely characterize biotech products via analytical means and by our somewhat limited understanding of how the biotech process affects the quality of a biotech product and how the various quality attributes of a biotech product impact the clinical safety and efficacy of the product. In this environment, any missteps by an Indian manufacturer is likely to result in a perception that the biosimilars manufactured in India (or any other developing country) are not of adequate quality.

What is needed to make India the Leading Manufacturer of Biosimilars?

A lot can be and needs to be done for Indian manufacturers to graduate from being "manufacturers for the developing world" to the "manufacturers for the developed and the developing world". A brief discussion is presented here for some of these initiatives:

Modernization of the Indian regulatory system is needed. A systematic, science based and risk based approach for review of regulatory filings as well as for inspection will ensure that the outcome is consistent and justifiable and decision making is transparent. A single point of decision making and accountability will make the system more efficient and credible, better coordinated and will reduce confusion and delays that are otherwise suffered at times by the industry.

Training in areas where practical experience is essential, such as GMP manufacturing, documentation practices, scale-up, technology transfer and validation is badly needed both by the industry and the regulators and the inspectors.

Creation of modern technology platforms that support the regulatory authorities in making appropriate decisions during the review and inspection process is needed. Approaches such as rapid analysis of a drug lot, fingerprinting, and use of chemometrics to quickly facilitate decision making on product quality are already in practice by some of the major global regulatory agencies.

Professional organizations such as the Parenteral Drug Association (PDA) have been very effective in the US in bringing the industry and regulators together in the form of the various task forces and thus, creating best practices that have benefitted both parties over the decades.

Academia-industry interactions need to be encouraged. The Small Business Innovation Research Initiative (SBIRI) from the Department of Biotechnology (DBT) is one step in this direction. Professional organizations, such as the American Chemical Society (ACS) and International Society for Pharmaceutical Engineering (ISPE), have been effective in the US in encouraging interactions between the academia and industry via conferences and other such events. Both the industry and the academia in India are to greatly benefit from such partnerships.

Quality by Design (QbD) has gained significant momentum lately in the biotech industry with both the regulators and the industry investing significant amount of resources to elucidate the path that would lead to its successful implementation. It involves utilization of risk assessment and process and product understanding for successful development and commercialization of a biotech product. It is likely that these expectations will also apply to Indian manufacturers of biosimilars as they apply for approval from the US FDA and the EMA. The Indian biotech industry should see this as an opportunity to innovate and come up with more efficient ways of product development and commercialization without compromising product quality and consistency.

In summary, significant challenges lie ahead for the Indian biotech industry. The government, the biotech industry, the academia and the regulators all need to work together in order to surmount them. The business case is there along with the Indian spirit of innovation that has proven to be effective in other sectors. It remains to be seen if India will capitalize on its significant strengths and emerge as the dominant global manufacturer for biosimilars.

Introductory Remarks by Dean Kamal Aggarwal
Remarks of S P K Gupta

Video

Listen to the video of Prof Rathore's Presentation

Videography by Vishal Tuli.