
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.