launch NDSA, invites R&D proposals
A not-for-profit society called National Development
Service Agency (NDSA) is being launched to provide cost-effective, high
quality preclinical and clinical product development support service
for SMEs and other relevant bodies. This agency is being mentored by
the Department of Biotechnology (DBT), Translational Health
Sciences and Technology Institute, Regional Center for Biotechnology
and National Institute of Immunology.
This Society shall provide a supportive and focused environment to host
world-class clinical translation through a collaborative network of
clinical research sites (centers of excellence).
The NDSA will tend to enterprises, particularly SMEs, involved in new
technology innovation and facilitate translation of scientific know-how
into viable products. It will also undertake, aid and promote training
duly accredited by an appropriate body in preclinical and clinical
The purpose of the NDSA is to form a consortium with three associate
organizations to help manage and execute its services. The partners
need to be esteemed departments, units or centers of institutions or
organizations governed through an autonomous society or a section 25
company recognized by DSIR. With this move, DBT certainly has
taken a step towards promoting translational research in the country.
In another initiative to recognize the relevance of probiotics, the DBT
has sought proposals from the public institutes for research in
thematic areas and the associated eight programs identified under each
These proposals are being sought on the basis of the fact that
probiotics and prebiotics have become the focus of attention all over
the world because of their multi-functional role in human health.
Probiotics are live microorganisms that when administered in adequate
amounts confer a health benefit to the host. Prebiotics are
non-digestible food ingredients that stimulate the growth and/or
activity of bacteria in the digestive system that are beneficial to the
new panel for Bt brinjal safety tests
In a follow-up action on review of Bt brinjal event EE-I, the Genetic
Engineering Appraisal committee (GEAC) in its 100th meeting on May 12,
2010, has decided to set up a panel that will consist a group of
eminent scientists. This panel will recommend tests that need to be
adopted to meet safety standards.
However, there is no time line is fixed for the setting up of this
panel.According to sources, the eminent scientists like Dr MS
Swaminathan, Dr G Padmnabhan and Dr Sudhir Sopori are expected to be on
While speaking to BioSpectrum GEAC member Dr VS Chauhan who was present
in the meeting, said, “It was decided that a core group of expert
scientists will be formed soon to take a decision on the further
“It is high time to take a decision on use of Bt gene in India because
the trials for many other similar crops are going on and then there is
no use of continuing them if they meet the same fate.”
The GEAC meeting also discussed about the draft proposal for setting up
a National Center for Assessment of GMOs prepared by Dr PM Bhargava.
DBT looks for
partner to license out cholera vaccine
The DBT supported live oral cholera vaccine (lOCV), which has been
developed using recombinant technology and is administered
orally, after undergoing the toxicology studies has been through
phase-I/II studies at three institutes SAS, Kolkata; SGPGIMS, Lucknow
and CMC, Vellore.
Now, DBT is looking for an industrial partner for licensing and
commercializing the vaccine strain making it available in India/outside
market as the affordable lOCV. The intent of DBT is guided by the fact
that the Strategic Advisory Group of Experts of WHO in October 2009 has
advocated cholera control as a priority in areas with endemic cholera
since outbreaks can disrupt health systems.
Neeman expands Central Lab Services
Max Neeman International, a full-service CRO has expanded its central
lab services beginning with a phase II study in oncology. The CRO will
be responsible for carrying out all the tests in this trial ranging
from the easiest to the most complicated. The lab is accredited with
state-of-the-art equipment located in a Max Healthcare hospital.
“We believe in continually expanding our service list and will continue
to work closely with existing Central Lab partners to provide results
in the shortest possible turn around time. Central Lab services
provided will be based on the best ‘fit’ for each study,” said Dr Ajoy
Kumar, CEO of Max Neeman.
drug market grows in India
Concerns over resistance and intolerance are leading to
greater pressure on governments in India and Brazil to increase funding
for newer anti-retroviral treatments for HIV. This creates an
opportunity for big pharma as it looks for growth opportunities, says
independent market analyst Datamonitor.
Given the dominance of domestic companies and the prevailing
uncertainty regarding intellectual property protection in these
countries, Datamonitor believes that the best strategy for
international drug makers to penetrate the Indian and Brazilian markets
is through voluntary licenses and agreements with domestic
“Lifelong therapy is required for the management of HIV infection. This
has helped anti-retroviral drugs become an important revenue driver in
the major western markets for several of the leading big pharma
companies. However, limited growth opportunities in established markets
have focussed attention on the unmet need and high disease burden of
emerging markets such as India and Brazil,” said Mansi Shah, senior
healthcare analyst at Datamonitor.
Issues in both countries have so far limited their attractiveness as a
target market for external HIV drug developers. “To maintain universal
access to HIV anti-retrovirals, the Brazilian government is pursuing
controversial strategies. One such example is the use of compulsory
licensing to secure anti-retroviral drugs for the domestic market at
lower prices. At the same time, in India, treatment currently focuses
on generic first generation anti-retrovirals, resulting in a strong
dominance of domestic generics manufacturers such as Cipla or Emcure”
post-doctoral fellowship launched at MIT
Dr Kiran Mazumdar-Shaw, CMD of Biocon, has funded a new fellowship on
cancer research in India at the prestigious Massachusetts Institute of
Technology (MIT). A Koch Institute Partnership for catalytic cancer
research at MIT, this program will help raise a new generation of
cancer researchers in India whose careers and professional networks
will increase globally.
This new program will bring Indian scientists to MIT to train for two
years. Those researchers will then return to India to continue their
research and share the benefits of their MIT training with their Indian
“As an entrepreneur whose company is pursuing cancer research, I am
acutely aware of the need to augment cancer research in the country at
a basic scientific level. If we are to develop new oncotherapies for
Indian patients, we must create a strong research ethos amongst the
medical and scientific communities engaged in the area of cancer,” said
This fellowship program offers opportunities for post-doctoral
scientists, engineers, and physicians to undertake cancer research at
the Koch Institute for Integrative Cancer Research at MIT, working at
the interfaces between biology/medicine and the diverse fields of
mathematics, engineering, computer science, and the physical and
The Mazumdar-Shaw International Oncology Fellows Program provides
funding for a two-year full-time post-doctoral research fellowship
within the Koch Institute at MIT; and travel expenses to India for the
researcher and a Koch Institute faculty advisor to share their research
with colleagues at the Fellow’s Indian host institution as well as
other peer institutions in India.
The Fellowship is awarded with the firm expectation that the Fellows
will continue their research in India from third year onwards for which
funding will need to be secured from the host institution.
develops GRD solution for FDA
Strand Life Sciences (Strand) has entered into an agreement with the US
Food and Drug Administration (FDA) to deliver the Genomics Reviewer
Desktop (GRD), a solution to enable FDA reviewers to manage and analyze
pharmacogenomic data submitted through its Voluntary Exploratory Data
Submissions (VXDS) program. GRD will enable FDA to integrate analyzes
needed to reconstruct a sponsor’s interpretation of exploratory
biomarker data using multiple genomics tools and methods. This effort
contributes to the development of recommendations for the submission of
GRD will be integrated with FDA’s ArrayTrack and with other third party
analysis software tools. GRD is built on AVADIS, Strand’s
workflow-driven data analysis and visualization platform that powers
industry leading software products such as GeneSpring and Sarchitect.
As part of this agreement, FDA has also licensed Strand’s AVADIS
Alliance, AstraZeneca to fight against TB
The Global Alliance for TB Drug Development (TB Alliance)
and AstraZeneca have entered into a research collaboration agreement to
accelerate the discovery, development and clinical use of drugs against
tuberculosis (TB), including drug resistant strains of the disease. One
in five patients with TB are resistant to at least one of today’s
standard first-line TB drugs, according to the most recent data from
the World Health Organization.
Under the agreement, the TB Alliance and AstraZeneca will both
contribute promising TB drug discovery projects into a joint portfolio
that will be co-developed by both parties. Sharing resources and
creating a seamless path to clinical-stage development will improve the
efficiency of both organizations’ research programs. By focusing on
novel compound classes, the drug candidates identified by the
collaboration are likely to be effective against both drug-resistant
and drug-sensitive tuberculosis. The financial terms were not disclosed.
The initial set of projects contributed by the TB Alliance results from
its ongoing collaboration with several world-leading researchers at the
University of Pennsylvania, Rutgers University and New York Medical
AstraZeneca’s projects come from its TB research center in
Bangalore. The joint portfolio will be resourced by a core group of
scientists based at AstraZeneca’s TB research center in Bangalore with
expertise and funding provided by both organizations.
funds 78 health projects
The Bill & Melinda Gates Foundation has announced 78
grants of Rs 46.49 lakh ($100,000) each in the latest round of Grand
Challenges Explorations. Grants include the development of a low-cost
cell phone microscope to diagnose malaria, study of the strategic
placement of insect-eating plants to reduce insect-borne diseases, and
investigation of nanoparticles to release vaccines when they come in
contact with human sweat. The grants support research across 18
countries and six continents.
“Grand Challenges Explorations continues to generate unique and
creative ways to tackle global health issues. We are convinced that
some of these ideas will lead to new innovations and eventually
solutions that will save lives,” said Dr Tachi Yamada, president,
Global Health Program, Gates Foundation.
This year’s European grantees are based at universities, research
institutes and non-profit organizations. The winners represent groups
in Germany, Sweden, Norway and the UK.
asks RS-GIS to control vector-borne disease
Remote sensing and geographical information system are expected to be
an effective preventive measure against the emerging and re-emerging
vector-borne diseases that pose great challenge to the researchers,
disease control program planners and implementors.
The recent studies by the Indian Council of Medical Research (ICMR)
task force to study the applications of the remote sensing (RS) and
geographical information system (GIS) on the vector-borne disease
prevention, has led to the conclusion that these technologies can be
very effective in controlling the vector-borne diseases prevalent in
our country. The major vector-borne diseases in India include malaria,
filariasis, dengue, Japanese encephalitis (JE) and visceral
leishmaniasis, claiming lakhs of lives each year.
The Epidemiology and Communication Diseases Division of the ICMR for
the first time initiated task force projects in vector-borne diseases
using GIS and RS application tools. The projects were initiated in
malaria, filariasis and visceral leishmaniasis.
The six-member task force headed by Dr S Pattanayak recommended the use
of GIS and RS are tools that can be used to provide solutions in
vector-borne disease control programs. The studies highlighted the
application of RS and GIS for the management of vector-borne disease by
predicting the high-risk areas and the wvulnerable periods of disease
“The information will stimulate the professionals and academia to take
up more studies in this area,” said Dr VM Katoch, director