- Biologicals Transfer Proposal
between US and Indian Biotechnology
http://www.medindia.net/news/view_news_main.asp?x=5212
An
agreement in principle to enable the smooth transfer of microorganisms and biological
materials from the US to India is an encouraging sign for Indian bioscience. But
slow implementation of the country’s broader biotech goals, including India’s
grandiose scheme to become the global hub of contract research and clinical trials,
may threaten its goal of becoming a major player.
Discussions in mid-June
between acting US deputy secretary of commerce David A. Sampson and an Indian
delegation led by science minister Kapil Sibal led to the biologics transfer proposal.
Under the plan, India’s Department of Biotechnology (DBT) would procure biological
material from the American Type Tissue Collection (ATCC) and warrant against their
misuse or subsequent acquisition by bioterrorists, with safeguards and export
controls similar to those around nuclear technology. We are in the process of
resolving this important issue. Although ATCC says its regulations for export
and distribution of infectious agents did not change after 9/11 and that Indian
Scientists have full access to the public database, researchers claim problems
working with the US based repository. “ATCC is usually prompt, but if you
ask for a type strain or a reference strain, they do not even respond,: says a
senior scientists at the Institute for Microbial Technology in Chandigarh, which
operates the Microbial Type Culture Collection, MTCC, India’s only such culture
collection.
Industry scientists admit that they cannot document the
source of many for the basic tools for making vaccines and drugs, a potential
basis for challenging bioenergetics patents. One solution, says FICCI is to create
a global bank that will compulsorily collect patent protected biological materials
an offer these to industries at a nominal cost, clearly establishing ownership.
Government reluctance to grant exclusivity of clinical trial data may also scare
away companies, analysts say. And even if implemented successfully, the $2.5 billion
per year business model ironically built on high disease prevalence and a billion
plus, genetically diverse and economically weak population has it critics.
Samit
Brahmachari, director of the Institute of Genomics and Integrative biology in
New Delhi, India could create a substantial fund for buying intellectual property
rights from small and medium enterprises around the world and turn them into higher
value products in collaboration with MNCs. Visalakshi’s study of 229 Indian
biotech companies concludes that 20 years after setting up DBT, India still has
no clear definition of biotech. “Everything from fermentation to aquaculture
and sericulture to bio fertilizer is clubbed under biotech, resulting in sub critical
funding,” India needs ‘to set priorities in the R&D work program,”
it says, and should urgently address problem arising out of a large number of
agencies dealing with biotech which has led to duplication of research funding
and a lack of coordination.
Source: Nature Biotechnology.
- HCL
Tech unveils labeling solution for drug firms
10/6/2005
http://www.indiainfoline.com/news/news.asp?dat=67126
HCL
Technologies Ltd. (HCL) has become the first Indian IT company to introduce an
innovative and easy labeling solution which would enable pharma companies to reduce
complexity and smartly use product information.
This solution would address
the US FDA’s SPL (Structured Product Labeling) regulatory compliance standard
for pharma companies doing filings in U.S. SPL or Structured Product Labeling
is an XML-based, ANSI approved standard, which will be a mandatory to follow for
all pharma companies doing filings in U.S. from end 2005.
The easy Labeling
Solution not only streamlines massive amounts of filing data but also helps organizations
in managing product information better. This is a user-friendly browser based
interface, which empowers non-technical business users to easily create, manage
and intelligently reuse the product information for filings in other regulated
markets also.
easy Labeling Solution promises to make the life of regulatory
and labeling people in pharma companies easier by automating repetitive work and
acting as the single repository of updated product related content and data.
Speaking
on this occasion, Pradeep Nair, VP & Head, Global Life Sciences Practice,
HCL said, “While compliance driven implementation is natural, HCL has understood
its pharma customer needs and chosen to invest in creating an ideal solution which
could be used to manage the whole product information lifecycle better.”
Speaking
at a global webinar on “SPL Compliance: Tactical Compulsion Vs Strategic
Opportunity”, Nair said that HCL’s has come up with a solution which
addresses the full spectrum of product information management from tactical FDA
compliance to a more strategic use as the back bone of all product related information.
It will help pharma companies update all the touch points wherever product information
is displayed at the click of a button leading to increased patient safety.
HCL’s
global life sciences vertical works with seven out of the top ten major pharmaceutical
and biotechnology companies, which provides composite solutions to customers in
the areas of IT organization, Clinical data analysis, Clinical Pharmacogenomics,
Medical devices & diagnostics and Hospital Management systems, in compliance
with FDA regulations.
- Scientists create GM mosquitoes
to fight malaria and save thousands of lives
October
10, 2005
http://www.guardian.co.uk/medicine/story/0,11381,1588607,00.html?gusrc=rss
·
Plan to breed and sterilise millions of male insects
·
Leader says project almost ready for testing in wild
David
Adam, environment correspondent
Monday October 10, 2005
The
Guardian
Genetically
modified mosquitoes could soon be released into the wild in an attempt to combat
malaria. Scientists at Imperial College London, who created the GM insects, say
they could wipe out natural mosquito populations and save thousands of lives in
malaria-stricken regions. Led by Andrea Crisanti, the team added a gene that
makes the testicles of the male mosquitoes fluorescent, allowing the scientists
to distinguish and easily separate them from females. The plan is to breed, sterilise
and release millions of these male insects so they mate with wild females but
produce no offspring, eradicating insects in the target region within weeks. Professor
Crisanti said: "Our mosquitoes are nearly ready for testing in the wild.
This is a technology that works and could make a real difference. The beauty is
that it's very specific. Unlike insecticides, sterile males target only the species
you want to attack."
Mosquitoes that spread malaria have long been a
target for sterile male technology, which has been used to eradicate the screwworm
fly from the US, Mexico and Central America.
The International Atomic
Energy Agency has been using its radiation technology to support health projects,
and wants to release sterile mosquitoes to tackle malaria in northern Sudan and
on Reunion island in the Indian ocean - but they and other groups have been hampered
by an inability to distinguish the males, which do not bite people. Female mosquitoes
transmit malaria, even if sterile, so releasing them alongside males would make
the situation worse.
Prof Crisanti said: "The really challenging
problem is to identify the males. There is no difference between the larvae and
as adults they fly, so the logistics of trying to separate them when they're adults
is immense."
To solve the problem, his team altered the DNA of
the mosquito species Anopheles stephensi, the principal carrier of malaria in
Asia, so that the males expressed a fluorescent green protein in their sperm.
A sorting machine based on laser light separated male from female larvae, according
to whether they glowed or not. Writing in Nature Biotechnology today, the scientists
say the machine could sort 180,000 larvae in 10 hours.
The next step
is to scale up the technique to provide the millions of GM insects needed to make
a large-scale release effective. The scientists also need to
check the sterile males will be strong enough to compete with wild rivals when
released - the strategy depends on female mosquitoes, who only mate once in their
two-week lifespan, choosing sterile males.
Prof Crisanti said other
mosquito species could be modified in the same way, including Anopheles gambiae,
which is responsible for a large part of the 2.7m deaths caused by malaria each
year. He is talking to international agencies about setting up a trial. Scientists
have previously considered releasing both male and female mosquitoes that have
been genetically modified in a different way, making them unable to transmit malaria.
The idea is that altered insects would spread the disruptive genes through natural
mosquito populations, but concerns about whether the inserted genes could transfer
to other organisms have so far scuppered plans to set up large-scale breeding
colonies to test it.
Prof Crisanti argued that, because the new GM mosquitoes
are sterilised, releasing them into the environment does not pose significant
risks: "It won't transmit any genes to the environment. This allows us to
test the transgenic technology in a very safe way that overcomes the previous
environmental and safety concerns." Releasing males only would ensure people
were not bitten by GM mosquitoes, he added.
Sue Mayer of Genewatch agreed
that the new GM insect did address some of the previous concerns, but she called
for thorough testing of the mosquitoes before they were considered for release.
"Changing one gene can sometimes affect others, so there are still questions
to ask," she said.
There are political barriers too. The London group's
insect is best suited to tackling malaria in impoverished urban areas of south-east
Asia and India, where World Health Organisation trials of sterile male mosquitoes
to fight dengue fever collapsed in the 1970s amid biowarfare accusations. The
males of the mosquito involved in the Delhi trials could be separated because
their pupae were smaller, but they were never released after newspaper articles
claimed the experiment might secretly be used to gather data on how to spread
yellow fever.
Chris Curtis, a malaria expert with the London School
of Hygiene and Tropical Medicine who worked on the WHO project in India, said:
"We were all set to go and there was a huge uproar. You have to handle the
public relations very carefully."
Female mosquitoes can travel
several kilometres after mating, he said, so the sterile male technique is best
suited to isolated insect populations, such as in cities. "If females that
have already mated fly in from outside your release area then they carry on laying
fertile eggs. That's fatal."
Footnotes
Malaria
The world's most common and deadly parasitic disease. It is
spread from person to person when female mosquitoes feed on human blood. Infects
up to 500 million people each year, and kills an estimated 2.7 million people.
Sterile male technology
Male insects can
be sterilised using chemicals and radiation. If enough sterile males can be released
to breed with females, the insect population of a target region can crash within
weeks.
Fluorescent green protein
Originally
identified in jellyfish that live in the cold waters of the north Pacific ocean.
The protein glows green under ultraviolet light.
Large-scale
release
Huge numbers of sterile males would have to be released,
possibly several hundred thousand at different locations throughout a city in
several waves over a month.
Yellow fever
The
disease was absent from Asia but appeared on a US list of potential biowarfare
agents. When an Indian journalist discovered the common name of the insect involved
was "yellow fever mosquito" the trials were halted. - EU
research head calls for more food R&D
11/10/2005
http://www.nutraingredients.com/news/ng.asp?n=63117-r-d-safety-waste
By Ahmed
ElAmin
11/10/2005 -
A series of five EU-funded projects announced today in the UK are a sign that
the bloc is moving to rebuild public confidence in its food industry and is willing
to invest more in research and development for the sector. The €61.6m
devoted to the projects are part of a plan by the European Commission to beef
up investment in food research and development in the bloc. The effort is
part of a plan to get governments and the food industry to put more into R&D
to help keep them competitive. Only about one per cent of the food industry's
turnover is put into R&D compared to between three to five per cent in other
industries.
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