Dr Avadhesha Surolia
Director, National Institute of Immunology, New Delhi
New Delhi-based National Institute of Immunology (NII) recently made a
breakthrough in research aimed at finding a cure for diabetes. The
research team led by its director Dr Avadhesha Surolia developed
innovative sustained insulin release formulation (SIRF), now under the
process of transfer to the US-based pharma company, Extended Delivery
Dr Surolia's pioneering contributions have strongly influenced research
on structure and function of lectins, orientation and dynamics of cell
surface carbohydrate receptors as well as drug and molecular design and
their biotechnological applications. A winner of the prestigious S S
Bhatnagar Award (1987), Dr Surolia in an exclusive interview with
BioSpectrum, shared his thoughts and insights on the recent
breakthrough in diabetes research, NII's role in drug discovery
research, PPP and a host of other issues.
Tell us about the breakthrough achieved in diabetic
the NII? Why was Diabetes chosen as the focus of research over other
emerging as a global epidemic, with India,
China and the US topping the list of countries being affected by both
Type I and Type II diabetes. Diabetic patients need to administer
themselves with insulin frequently to prevent high blood glucose
excursion after ingestion of meals. The fear of pricking oneself
multiple- times-a-day leads to low patient compliance and therefore
raises complications such as diabetic cardiopathy and nephropathy. This
has prompted interest in developing alternative, less invasive routes
of delivery. Long acting insulin analogues achieve more constant
glucose levels but suffered a setback due to induction of fasting
hypoglycaemia. Thus the need for a suitable therapy, with the potential
of improving the quality of patient life,
In an attempt to address the issue of multiple injections and patient
compliance, we have developed a novel concept wherein a sustained
insulin release formulation (SIRF) is used for treatment of DM-I.
Utilizing the currently available knowledge of protein folding and
chemistry, we have developed a safe and long acting SIRF which releases
insulin monomers at a steady rate. Initial studies done with a single
injection of SIRF demonstrate a sustained and continuous release of
biologically active monomers of insulin from the injected site, capable
of regulating blood glucose excursions in animal model of diabetes for
a prolonged period of time (in the range of 130-160 days). When
compared to free daily insulin injections administered to diabetic
rats, a single injection of SIRF, significantly lowered blood glucose
levels, as well as reduced the incidence of secondary diabetic
complications in diabetic animals.
When was this
research in diabetes initiated and approximately in what
time period it would be ready for human use?
Though the concept
was conceived when I was still at the
Indian Institute of Science, Bangalore, the research took shape only in
early 2007, after I joined NII as director. The formulated SIRF, acts
as a prodrug, from which viable insulin is released, which is absorbed
into the bloodstream and thereby maintains a steady level of insulin
concentration in the body, mimicking the physiological scenario, where
normal individuals have a basal level of insulin in their blood.
Interestingly, this is achieved without the use of a chemical or a
device such as a pump or a patch.
As with any innovation having tremendous clinical applicability, a
minimum time frame of 6-7 years would be required for
thorough phase I, II and III studies to be completed. The work has been
done only on small animals such as rats and mice in the laboratory.
Therefore, it is still in its nascent stage and many experiments such
as toxicological studies in higher animals needs to be done. These
further experiments are routine and established experimental protocols
which are followed for all drugs being screened for human usage. The
experiments done in the lab are proof-of-concept and its usage in
humans would be available after the phase trials are complete.
What is the
status of technology transfer and the royalty amount paid
to the institute?
The technology has
been transferred to a US company by the
name of Extended Delivery Pharmaceuticals, for a record amount. The
execution of this tranfer is still in the process and thus right now we
are unable to disclose the royalty amount. However, this is the highest
amount that an Indian Institute has received from a company for a
research in India often fail to translate into products?
What has been the contribution of NII towards the drug discovery
The major problem
lies in the scientist coming out and
taking risks. Bringing any research to the product stage requires
ability to tackle failures and spending five times more effort, money
and resources. People get intimidated by the failures and are unable to
take on the challenge of taking a scientific research to the market. I
could have just sat back after publishing my research work in a highly
reputed PNAS journal. But instead I chose to involve myself and my team
into the process of technology transfer and I am now actively involved
with the company to see that the product does reach the masses and
especially, the people of India. Unless you take the risk, success
cannot be achieved. Moreover, our innovation support system is
fragmented; it is still in the developing stage. We have good
policies, resources, ideas, mentorship, infrastructure and funding but
we lack the alignment of these fundamental factors which are imperative
to translate the research into product.
NII has been actively engaged in drug discovery through various
research activities which target biochemical pathways in the cell,
genes involved in cell death, cell signaling and DNA synthesis.
What is the
importance of public-private partnership to bridge the gap
between research institutes and the private industry in India? Are
there any examples from NII in this direction?
scenario of public-private partnership is
really good and very aptly supported by agencies such as DBT, DST and
CSIR. They have all been pro-actively involved in promoting these
partnerships and generous funding is available both for the institutes
and the industries. NII's participation in the phase II clinical trial
of Rotavirus vaccine has been an excellent example of PPP with Bharat
Biotech and other institutions such as DBT, AIIMS, CDC, SAS, NIH,
Stanford University and PATH.
you, what is required for strengthening the future growth
of biotechnology industry?
The key factors
which will determine the sustenance of
future growth of biotechnology industry include role of the government
to form new and favorable policies like China and Europe, where
policies for biotechnology promotion have already been enacted,
availability of venture capital, building incubators in leading R&D
institutions, effective commercialization strategies, public-private
partnerships and embarking upon new research areas such as stem cell,
nanobiotechnology, synthetic biology, biological sequestration of CO2
and environmental biotechnology.
in New Delhi