• 14 June 2010
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DBT to 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 product development.

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 respective areas.

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 health.

GEAC’s 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 this panel.

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 biosafety tests.”

“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.

Max 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.

HIV 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 manufacturers.
“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” said Shah.

Mazumdar-Shaw 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 host institution.

“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 Dr Shaw.

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 chemical sciences.

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.

Strand 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 genomic data.

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 software.

TB 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 College.

 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.

Gates Foundation 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.

ICMR 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 outbreaks.

“The information will stimulate the professionals and academia to take up more studies in this area,”  said Dr VM Katoch, director general, ICMR.

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