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Post Event
Meeting the challenges
In recent years there has been increase in the number of
clinical research organisations (CROs) in India. A recent seminar on 'Global
clinical trial management and logistics' focussed on the reasons behind this
boom and what is needed to keep it going. Suja Nair reports
The 16th International seminar on 'Global clinical trial management and logistics'
organised by World Courier showcased the growing clinical research organisation
(CRO) base in India. Over the years there has been a substantial increase in
the number of clinical trials being done in India. It also stressed on how along
with the increasing CROs there is also a need to meet their requirements for
logistics, packaging etc to keep up the momentum.
Dr Antal K Hajos, Managing Director, Nycomed Pharma was the Chairman of the
seminar and headed the panel discussion. David Brennan, Assistant Director,
Special Cargo Standards, IATA, spoke on 'Changes in IATA regulations'. He highlighted
the importance of IATA regulations and what changes are needed to improve present
conditions. Logistics plays a very important part in every aspect of life especially
in the clinical research, pharmaceutical and biotechnology areas. He stressed
the importance of quality packing, on how packing should be done according to
packing instructions so as to maintain efficacy of products, especially for
pharma and biotech products as they need proper environmental conditions and
maintenance. He also spoke about changes in packing rules which will be effective
from 2009 and how value effective these changes are going to be.
Another speaker who captured the audience's attention was Mukta Arora, Director
Global Sourcing India, Global Procurement, Eli Lilly and Company (India). She
spoke on 'Cold Chain Management' and stressing the need of proper cold chain
management in the pharma industry, she elucidated about the present scenario
and growing industry expectations. As a large part of new research is focused
on biologics and biotech products, there is a great need for quality cold storage
facilities. She also said that as there is more outsourcing of biologics and
vaccines to India and China, there will be a simultaneous increase in demand
for cold chains as several new drugs will require cold storage.
Another eminent speaker was Dr Goplakrishna Pai, Director Clinical Operations,
Neuomolecular Pharmaceuticals, who spoke on ethics and GCP in clinical research.
He spoke on the need for a united decision making body so that the procedures
related to ethical aspects of science and new technologies can be dealt with
more precisely and in a timely manner. He shed some light on the importance
of ethics in the clinical research.
A very informative presentation on clinical trail trends was presented by Dr
Durga Gadgil, Clinical Research and Development Director India, Wyeth. She said
that clinical trails have become an indispensable part of drug discovery thus
it is very essential that in order to exploit the whole scenario, there is need
for proper transportation too. More over she stressed that clinical trails in
India are not that easy as transportation is a great problem that needs an urgent
attention. She also stressed the need for a specialised courier service.
The other speaker was Micheal T Sweeney, Global Director, Strategic Development,
World Courier. He spoke on CTM storage and distribution in emerging countries.
Discussing the challenges in CTM supply chain and transportation, he suggested
some very innovative ideas through which these problems can be dealt with.
Sweeney's talk was followed by a presentation from Jeroze Dalal, Head Clinical
Operations, GlaxoSmithKline Pharmaceuticals. He spoke on partnerships with CROs,
focussing on the essentials of a successful partnership and the need to outsource.
Deepak H, Chief Executive Officer, D2L Pharma Research Solutions, presentation
touched on challenges faced by investigators and on site monitoring techniques.
He said that there is a need for proper awareness among physicians and subject
about clinical trails. It is also essential that in order to meet the requirements
of the ever growing pool of global projects flowing to India, vendors in India
also need to grow to meet these needs. The next presentation was given by Dr
Sunil Chaudhry, Head of Medical Affairs, Bayer Schering Pharma, India who spoke
about the patent regime and present status of R&D in India. The event concluded
with the presentation of Dr Ravisekhar Kasibhatta, Associate Director Clinical
Research, Lupin. He spoke about the importantance of bioequivalence studies.
The entire event was a much needed attempt to discuss evolving needs, problems,
and future plans of the clinical trial management and logistics industry, with
an accent on tailoring the local industry to meet global requirements.
suja.nair@expressindia.com
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