Dr Sudhir Nambiar, head of Pharma Development Center,
AstraZeneca has nurtured the growth of the center that was set up in
2007 with an initial investment of Rs 67.44 crore ($15 million). This
is AstraZeneca's fourth product research and development (PR&D)
facility and the only one outside Europe, the other three facilities
are in UK and in Sweden. In an interview with BioSpectrum, Dr Nambiar
shares his plans for the center and the strategy he has chalked out to
align the facility in India with the company's overall global plan.
Q What are the
major activities carried
out at the AstraZeneca's Pharmaceutical Development (PD) facility?
Safe, efficient and scalable processes for developing drug candidates
are allotted to this center by the Global Project Management Group. The
candidate drugs originate from any of the AZ discovery sites could be
in the areas of neuroscience, pain, gastrointestinal, infection,
respiratory and oncology. We optimize processes keeping green
principles in mind. We develop analytical methodology to monitor the
progress of reactions and to check the quality of the intermediates and
A solid state group of the company studies the crystallization
processes in detail while developing the right polymorphs. The process
engineering group ensures the safety and scalability of the processes.
We have a strong process safety group that ensures the safety of
processes that are scaled up. Other notable departments include the QA
and the project management group. We also recruit accomplished
scientists who do not want to be burdened with significant
administrative responsibilities on the science ladder so that they can
focus on improving the scientific quality of projects.
How important is India for AstraZeneca
as far as pharma R&D is concerned?
Pharmaceutical Development facility is a strategic arm of the Global
Pharmaceutical Development function of AstraZeneca. We have a vision of
developing processes from the discovery stage to the launch stage just
like the other global PD groups. In fact, we are currently growing
unlike other groups and hope to meet our budgeted target of 120
scientists by the year end.
What is the role of the center and is
there any specific disease focus?
The Drug Discovery program at Bangalore is focused on finding a cure
for TB. The PD Bangalore group will develop processes to any candidate
drug (CD) emerging from the Drug Discovery Center, since these are
received through the Global Project Management system just like any
other CD from a European/ US Center. In fact, we are currently working
on developing a suitable process for the first CD discovered in
What have been some of the
achievements of this particular center since its inception?
The center has delivered an increasing number of global projects each
year since 2007. It has demonstrated that it can develop innovative,
safe, efficient, and globally-competitive processes to candidate drugs.
It has proved that it can do this relatively inexpensively when
compared to the European Centers. The contribution has been
significant, so that a decision has been made to expand the facilities
Why was India chosen in the first
place, considering that it is known more for its development than
We develop processes toward new chemical entities (NCEs). This is
different from developing processes to generic molecules. However,
India was chosen due to its large talent pool of development chemists.
It takes approximately a year to train chemists to develop processes
Q What is the contribution of this
facility in AstraZeneca's overall India R&D program?
The PD facility is a world-class center where cutting-edge science is
performed. It gives an opportunity for Indian scientists to work on
global projects in their own backyard. Along with the equally-sized and
independent discovery group that is focused on finding a cure for TB,
it reflects AstraZeneca's substantial R&D investment in India.
How will you align the overall
activities in this facility with the existing global PR&D programs?
Since we get projects through the global PM group the work we do is no
different from the work done by the other sites in Europe. The
candidate drugs developed by PD, Bangalore are sent to Europe for
formulation, safety, toxicology and finally clinical studies. We work
in a truly global fashion in that we interact closely with our
counterparts in Europe. While export/import of best practice is a
Can you share about the current
pipeline of candidates discovered by the company?
We are currently developing processes towards molecules from all areas
including neuroscience, oncology, respiratory and infection.
Since we started our activities relatively late compared to Europe,
most of our molecules are in phase I and phase II stages of clinical
What have been the overall investments
for this facility? How many scientists have been recruited for this
The center was started with an initial investment of Rs 67.44
crore ($15 million). Right from inception the total investment of the
company would be around Rs 89.92 crore ($20 million). The center is
equipped with state-of-the-art equipments such as NMRs, LCMS,
LCMSMS, XRPD, RC1, DSC, TGA, parallel synthesizers, and catalyst
screening kits. Currently, we employ around 100 scientists who are a
mixture of process chemists, analytical chemists, process engineers,
process safety assessors, scale up personnel, QA and project managers.
An expansion to accommodate additional personnel is currently on for
which AstraZeneca has invested additional Rs 8.99 crore ($2 million).
AstraZeneca is going through a major
restructuring process in India, will this have an impact on its R&D
Currently, our recruitment is continuing as planned. At this time, we
believe that the restructuring program will not adversely impact Indian
Are there any plans for any
collaborations with other research centers/institutes in India?
AstraZeneca supports research in a premier research institution in
India. We provide scholarships to students at an Indian educational
institution. We conduct open houses every year where we invite local
students and teachers to visit our premises and understand the research
being conducted. We host summer trainees from various Indian
universities as well as from other global universities like Cambridge
in the UK. We also train fresh science and engineering graduates in
important aspects of process safety and release them to Indian industry
thereby showing our commitment to improving process safety standards in
Apart from India, will we be seeing
similar centers in other emerging nations?
AstraZeneca has a small scale center in China. At this point of time,
there is no concrete plans for setting up centers in other emerging
As far as drug discovery is concerned,
where do you see India in the coming decade?
I predict that drug discovery activities in India will increase. I am
very hopeful of a NCE coming from India.
What is the future plan to take this
center to the next level of growth?
Currently, we are focusing on the early stage of projects and we are in
a learning phase especially with late phase process development. As we
progress, we expect to develop processes that will hopefully help to
launch a new molecule in the market in future. While we have
established a strong tradition of project delivery at relatively lower
cost, we cannot rest on our laurels and need to continue our growth
Nayantara Som in Mumbai