• 10 March 2009
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Biotech crops poised for second wave of growth: ISAAA report
Biotech crops are poised for a second wave of strong adoption that will drive sustained global growth through the end of the second decade of commercialization (2006-2015), according to the International Service for the Acquisition of Agri-Biotech Applications (ISAAA).
In 2008, three new countries and 1.3 million new farmers were able to experience the benefits associated with biotech crops. Additionally, total planted area grew 10.7 million hectares, according to the ISAAA brief on Global Status of Commercialized Biotech/GM Crops 2008. ISAAA has been tracking global biotech crop adoption trends since 1996.
In its annual study, ISAAA found that 13.3 million farmers in a record 25 countries planted 125 million hectares of biotech crops last year, the sixth largest growth spurt in 13 years of reporting.
Most notably, in 2008 biotech farming began in the African nations of Egypt and Burkina Faso. Africa is considered the “final frontier” for biotech crops as it has perhaps the greatest need and most to gain. In 2008, Egypt planted 700 hectares of Bt maize and Burkina Faso planted 8,500 hectares of Bt cotton. They join South Africa, which since 1998 has benefited from biotech cotton, maize and soybean.
“Future growth prospects are encouraging,” said Clive James, chairman and founder of ISAAA and author of the report. “The positive experiences in these new regional footholds in south, north and west Africa will help lead the way for neighboring countries to learn by example. Additionally, political leaders globally are increasingly viewing biotech enhanced crops as a key part of the solution to critical social issues of food security and sustainability.”
For example, G-8 leaders in 2008 for the first time recognized the significance of biotech crops and called to “accelerate research and development and increase access to new agricultural technologies to boost agriculture production; we will promote science-based risk analysis, including on the contribution of seed varieties developed through biotechnology.” The European Union also has acknowledged that biotech crops “can play an important role in mitigating the effects of the food crises.”
“Biotech crops make two important contributions to global food security. First, they increase yields, which increase food availability and supply. Second, they reduce production costs, which will also ultimately help reduce food prices. With 9.2 billion people to be fed by 2050, biotechnology plays a crucial role in helping satisfy the growing demand,” added Clive James.
Drought is the single largest constraint to increase productivity. Drought-tolerant crops, maize in particular, are an emerging reality with seeds expected to be commercialized in the United States by 2012 or sooner and by 2017 in Africa. By the end of the second decade of commercialization in 2015, ISAAA predicts that four billion accumulated acres will have been planted. Further, 200 million hectares of biotech crops annually will be planted in 40 countries.

Rasi Seeds opens new biotech and breeding laboratories
The crop biotech and breeding laboratories of Rasi Seeds were inaugurated on February 14, 2009 at Rasi R&D center in Attur, Tamil Nadu. The new crop breeding facility of Rasi Seeds was built up with an investment of Rs 10 crore. The R&D facility spreads across 40,000 sq. ft. of area and it encompasses laboratories for biotech research, crops research, cold storage facility for germplasm conservation, insect bioassay laboratory, library and documentation, and other facilities. The R&D center also has infrastructure facilities that include research farm of 140 acres comprising of experimental fields for germplasm evaluation and breeding of crops. A 5,500 sq. m transgenic greenhouse, seed quality control laboratory and modern seed processing facilities are also part of the crop biotech and breeding facilities.
Dr CD Mayee, chairman, ASRB, New Delhi, inaugurated the new breeding facility of Rasi Seeds. Dr KK Tripathi, advisor, DBT, Government of India, New Delhi;  Dr. B C Viraktamath, project director, DRR, Hyderabad; Sekhar Natarajan, regional lead, Monsanto; Prabhakar Rao, president, Seed Association of India and Uday Singh, vice president, Seed Association of India were also present at the inauguration function.
Delivering the welcome address Dr Ramasami, chairman and managing director, Rasi Group of Companies said, “Crop improvement using conventional methods, particularly for increasing the yield has reached a plateau and is static. In order to exploit the full potential of crops for increasing the yield and to improve the product quality, and to meet the needs of the ever growing population that is expected to be more than 1.2 billion shortly in India, new tools like marker technology need to be incorporated into crop improvement program.”
Commenting on the scope of marker breeding facility Dr Ramasami added, “Now we are in the genomic era. With the rice crop fully sequenced, most of the plant breeding labs have been converted into molecular breeding labs using the DNA technology in their crop improvement schemes worldwide. I believe that the marker-assisted breeding has equal or more scope than transgenic technology in new cultivator development with desirable agronomic traits.”
“Within a span of eight years Cry 1 Ac gene has totally transformed the Indian agriculture sector. Bt cotton has become inevitable, and if one gene is capable of bringing a huge transformation what will happen if more such genes are introduced? Public-private partnership helps to enhance the research and development for the upliftment of agriculture. Our ultimate goal is to protect the welfare of the farmers,” opined Dr C D Mayee in his inaugural address.
A seminar on “opportunities and challenges in marker assisted breeding” was also organized after the inaugural function. The seminar covered topics like marker assisted breeding in rice, vegetables and genome-based molecular breeding of crop plants; experts from the concerned fields presented the papers on these topics.
Seed industry leaders, leading scientists from various institutions in India and students from various agriculture universities in Tamil Nadu participated in the event.

Shantha Biotechnics to set up new vaccine complex
Shantha Biotechnics Ltd has laid the foundation for a new state-of-the-art vaccine manufacturing complex at Muppi Reddy Pally village, Medak district in Andhra Pradesh. Shantha will manufacture its next generation vaccines in this complex. The first vaccine to be manufactured in the premises will be from the enteric vaccine portfolio like cholera and rotavirus vaccines.
The new vaccine complex will be located in a sprawling 40 acre of land in the industrial park. This facility will have the capacity to manufacture more than 100 million doses of vaccines per year. The company has plans to initially invest Rs 500 million with future investments going upto Rs 1,000 million. The new facility is part of Shantha Biotechnics strategic expansion plans focused on servicing existing and growing market demands for its range of vaccines.
Speaking on the occasion, Dr Varaprasad Reddy, managing director, Shantha Biotechnics, said, “The new vaccine complex will address the capacity constraints of our existing facilities to manufacture range of enteric vaccines and the new generation pneumococal vaccine, which are under development. Shantha has obtained World Health Organization (WHO)-Geneva pre-qualification for its pentavalent vaccine in the current year and has started supplying the vaccine to United Nations Children's Fund (UNICEF). Shantha has the distinction of receiving the European Medicines Agency (EMEA) certification for one of its products in the current year”.
Shantha is currently focusing its R&D efforts in the development of novel vaccines like HPV and novel therapeutic antibodies.

TCG Lifesciences strengthens ties with Pfizer
TCG Lifesciences Ltd, a research services and informatics company operating out of India, has announced that it has extended its master services agreement with Pfizer, which strengthens its strategic relationship with the global pharmaceutical company.
TCG Lifesciences has been a preferred research service provider to Pfizer primarily in the field of discovery chemistry and would now also be providing integrated research services, through its one box model, covering areas like synthesis of monomer and templates, medicinal chemistry, parallel medicinal chemistry, cGMP synthesis duly supported by ADME and biological screening to enhance Pfizer's drug discovery pipeline and shorten development time lines.
“A high-quality and flexible working model is critical to Pfizer's research. Our strong relationships with leading Asian CROs, such as TCG Lifesciences, enable us to tap into their scientific talent pool to further the success of our research programs,” said Rick Connell, vice president, head of external research solutions, Pfizer.
Swapan Bhattacharya, managing director, TCG Lifesciences said, “We are excited at the prospects of supporting Pfizer across the drug discovery and development value chain in an integrated manner. This development is of great importance for us as it signifies our competences in providing innovation-based integrated research services from early stage discovery to kilo scale production of first-in-man material.”

IISc-NIMHANS researchers simplify microcephaly diagnosis
Researchers at the Indian Institute of Science (IISc) have located a new gene that plays an important role in causing microcephaly, a brain disorder that results in reduced brain size and poor mental faculty, mainly in India. The findings of the research will help to develop a regular screening tool to detect this severe disorder at the foetal stage itself and identify individuals who are carriers for the mutations.
  Microcephaly is a hereditary disorder, four genes were so far known to cause this disease, but the IISc-NIMHANS joint research team located a fifth gene, STIL,  that has a vital role behind this disorder in India. The research team was led by Prof. Arun Kumar, associate professor, department of molecular reproduction, development and genetics, IISc, Bangalore, with Dr Satish C Girimaji as clinical collaborator from National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore and Mahesh R Duvvari as technical assistant from IISc, Bangalore. 
While commenting on the diagnosis process of microcephaly Prof. Arun Kumar said, “Due to the reliable late stage diagnosis during the third trimester of pregnancy by ultrasound measurement of fetal head, even if a mother knows that her foetus is having microcephaly, the complexity in the legal procedure and the risk factor don't allow her to abort the foetus. The new gene, STIL, simplifies the diagnosis process and enables us to identify the symptoms of microcephaly at an early stage than ever before.”

Research Councils UK collaborates with DST
Research Councils UK (RCUK) has announced £12 million of funding for collaborations between British universities and institutions in India, China, and the US. Three large-scale UK-India collaborations have been agreed as part of this scheme, and will be jointly funded by the RCUK and the Department of Science of Technology (DST), India.
A three-year, £3 million grant, has been made to Aston University and the Indian Institute of Technology, Delhi. The project aims to deliver sustainable decentralized bioenergy for both the developed and developing world. About £1.5 million has been awarded to the University of Leeds, the Indian Agricultural Research Institute and the Indian Institute of Science, Bangalore, for over a period of four years. This project aims to enhance existing interactions to exploit and develop advances in biotechnology for the benefit of agriculture sector. This initiative will also facilitate a two-way interaction between Indian and the UK in the field of science and applied agriculture.
A two-year grant of £1.5 million has been made to the University of Nottingham, the Indian Institute of Management, Bangalore, and the Indian Institute of Technology, Kanpur. The three partners aim to create a step-change in collaborative innovation in target identification, drug discovery, drug delivery and manufacturing. They will build on existing collaborations with the goal of producing clinical and commercial benefits from patent protected research.

Sorghum genome will improve dryland crops
The announcement of the unraveling of the genome of sorghum, one of the mandate crops of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), will strengthen the institute's research for the improvement of sorghum and other food crops. The global team of scientists that reported the genome sequencing was led by Prof. Andrew Paterson of the University of Georgia, USA, and included ICRISAT's cereal breeder, Dr C Tom Hash.
Sorghum is the second food crop from the grass family to have its genome fully sequenced. The first one was rice. Sorghum is the first crop with the more efficient C4 photosynthesis system to be sequenced. Sugarcane, maize and pearl millet are other grasses with the C4 photosynthesis system that should benefit from this.
Plants that have a C4 photosynthesis system have a competitive advantage over plants possessing the more common C3 carbon fixation pathway under conditions of drought and high temperatures.  While a significant portion of the water taken up by C3 plants is lost through transpiration, this loss is much lower for C4 plants, demonstrating their advantage in a dry environment.
Sorghum, a mandate crop of ICRISAT, is the fifth most important and relatively drought tolerant cereal crop that is the dietary staple of more than 500 million people in more than 30 countries of semi-arid tropics.  It is grown on 42 million hectares in 98 countries of Africa, Asia, Oceania, and the Americas.
ICRISAT has been working for more than three decades for improving sorghum for food and feed proposes.  Furthermore, sweet sorghum has emerged as a feedstock for ethanol production. It gives food/feed, fodder and fuel, without significant trade-offs in any of these uses in a production cycle. ICRISAT has pioneered the sweet sorghum ethanol production technology, and its commercialization.

ICMR to initiate two AIDS vaccine candidates
The Indian Council of Medical Research (ICMR) announced plans to initiate a Phase-I clinical trial to test a combination of two AIDS vaccine candidates, ADVAX and TBC-M4, in a prime-boost regimen. The trial will be conducted at two ICMR institutions, the National AIDS Research Institute (NARI) in Pune, Maharashtra, and the Tuberculosis Research Center (TRC) in Chennai, Tamil Nadu. YRG CARE, Chennai, will be collaborating with TRC for advocacy and community mobilization for the Phase-I trial.
Prime-boost is a way of combining two different vaccine candidates with the hope of getting a better response from the body's immune system than giving either vaccine candidate alone. ADVAX, a plasmid DNA AIDS vaccine candidate, will be used for priming the immune response. TBC-M4, an AIDS vaccine candidate based on a vector built from recombinant Modified Vaccinia Ankara (MVA), will be used to boost the initial immune response generated by ADVAX. The trial will be conducted under the aegis of a memorandum of understanding between the government of India-through the ICMR and the National AIDS Control Organization (NACO)-and the not-for-profit International AIDS Vaccine Initiative (IAVI).
IAVI, in collaboration with Imperial College, London, has recently initiated a Phase-I clinical trial in London, the UK to test a prime-boost combination of ADVAX and TBC-M4. The UK and India trials are two separate trials and will use different modes of administration of the ADVAX candidate, different dosages, and different vaccination regimens. Collectively, the results of the trials from both countries will help determine whether further development of these AIDS vaccine candidates in a prime-boost combination is warranted.
Bio News Claris Lifesciences wins IDMA award
Claris Lifesciences, an Ahmedabad-based global lifesciences company, has received the IDMA (Indian Drug Manufacturers Association) Quality Excellence 2008 Award in the category of formulation units for annual turnover of more than Rs 100 crore.
This award makes Claris Lifesciences one of the few pharma companies to have won the IDMA award for the third time. It earlier won the award in 2003 and  2004. IDMA Quality Excellence Awards were instituted in 1984 for the purpose of appreciation and promotion of excellence and product quality among IDMA members awarded on a turnover basis.
Commenting on this development Sushil Handa, founder, Claris Lifesciences Ltd said, “This award recognizes our efforts to regularly adhere to high quality benchmarks set by IDMA. This award is for the people at Claris, who work diligently to deliver their best.”

Bilcare wins Chemtech Foundation's award
Bilcare Research wins Outstanding Innovation of the Year award by ChemTech Foundation for its exceptional innovation, non-clonable technology for identification, authentication and anti-counterfeiting.  
Bilcare's award-winning innovation technology comprises of a unique non-clonable signature that can be seamlessly integrated into any supply chain system, providing a totally secure and reliable real time identification and authentication of any product.  This system also provides a secure means for effective track-n-trace and e-pedigree of the products across the supply chain, from manufacturer to the consumer
The technology exploits the disruptive nature of nano/micro-particulate materials together with their magnetic and optics effects to provide a full-proof technology for accurate identification, authentication and track and trace of a product.

Apotex, Intas extend collaborative development
Apotex Inc. of Canada and Intas Biopharmaceuticals Ltd. (IBPL) have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy). Neupeg, a recombinant pegylated granulocyte colony stimulating factor is already manufactured and marketed in India and other countries by IBPL. Both companies, IBPL and Apotex are eying a significant share of total Peg GCSF market in North America, which is currently estimated to be around $3.5 billion annually. This collaboration gives Apotex the rights to market the product in North America (US and Canada), Europe and selected other countries. After announcing the launch of first GSCF generic for North America in May 2008, the extension of collaboration between the two companies makes IBPL the first Indian biopharmaceutical company to announce the launch of Peg GCSF for North America and European markets.

Indo–US symposium on Cancer Nanotechnology
The three days Indo–US symposium on Cancer Nanotechnology (February 4-6, 2009) was held under the aegis of Indo-US Science and Technology Forum (IUSSTF) and hosted by Jamia Hamdard at INSA Auditorium, New Delhi. The purpose of this summit was to bring scientists, technologists and industrialists from both the partners to one platform in order to have intensive discussions about the cancer related problems in their respective countries and to explore the possibilities of collaborative research for fighting out the problems related to cancer management.
Former president of India and visionary Dr A P J Abdul Kalam graced the inaugural function of the symposium and congratulated the organizers for bringing together eminent scientists from different laboratories in the USA and India working for the common cause of fighting the burgeoning problem of cancer.
In his presidential remarks Dr G N Qazi, vice chancellor, Jamia Hamdard emphasized upon the biological perspective which should be addressed while formulating any novel nanotechnology based formulation. He also highlighted the ongoing research work at Jamia Hamdard. He particularly stressed upon the need to follow the regulatory guidelines in order to manufacture the nanoproducts as per cGMP.
The technical session on Cancer Nanotechnology: Enhancing imaging and therapy was organized as part of the symposium.

Praj inaugurates its cellulosic ethanol pilot plant
Praj Industries, the biofuels technology and solutions company, has formally inaugurated its cellulosic ethanol pilot plant at Praj Matrix – The Innovation Center, its R&D center  near Pune.
The Laboratory facility at Praj Matrix was put into operation in April 2008 with the objective of promoting basic research. The first phase of the scaled up program has now been achieved with this break-through wherein the pilot plant has successfully demonstrated production of ethanol from corn cob and sugarcane bagasse under varying operating conditions. This follows proven bench scale process development for which Praj has already filed for patents.
As production of ethanol is expected to double by 2012, feedstock expansion has become a top agenda, fostering intensive R&D activities in this field. Most of the R&D has been promoted in the USA and some in Europe, mainly assisted through government grants.  “We are proud to say that Praj Matrix facilities can now be counted as the best-in-class advanced biofuels research facilities across the globe. It is perhaps also the only one of its kind on this side of the hemisphere. In fact, the break-through puts us right on top of the league with advanced nations,” said Pramod Chaudhari, chairman, Praj Industries.

Emami Biotech signs MoU with Calcutta Tramways
Emami Biotech Ltd has signed a memorandum of understanding (MoU) with Calcutta Tramways Company (CTC), as part of which Emami will supply 250 Kiloliter of bio-diesel per month to CTC.
Buoyed by the certification from Singapore-based SGS Group for acknowledging their bio-diesel sample as among the best in the world, Emami Biotech has aggressive plans to promote this eco-friendly fuel.
The Emami Group is spearheading the process of developing Haldia in West Bengal as India's bio-diesel hub through Emami Biotech. Emami Biotech has come up with a state-of-the-art bio-diesel production facility at Haldia, set up at a cost of Rs 150 crore. The bulk of the production equipment has been supplied by Desmat Belstra, an Italian Belgian joint venture company. An additional amount of Rs 100 crore has been invested at the same facility for producing edible oil. The production residue of edible oil will be used for preparing bio-diesel.
However, Agarwal stressed the fact that Emami Biotech is presently selling bio-diesel at a lower price compared to normal diesel. He said unless the government modifies its price mechanism on selling bio-diesel, its production will become inviable.
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Resky 12 April 2013 at 04:35 PM

Hi Amar! Yes, ICH- GCP has acceptance world wide, but yet coeutrins often host their own guidelines on clinical research. Often times this is because of the need of domestic pharmaceutical companies to market their products within own political boundaries.With the globalization and outsourcing of clinical research, pharmaceutical companies have now explored the Asian market.But for an Asian candidate to explore his/her career in clinical research in EU and US, he has to satisfy following criteria:- He has to be well versed with the ICH guidelines, plus the regulatory guidelines of the country he/she is applying for the job.- He should be able to differentiate between what is required in ICH and what is required by FDA/EMA.- As you know ICH is the joint initiative of US, EU and Japan, which has all the common guidelines applicable for these coeutrins, but for establishing yourself in clinical research of any of these coeutrins you need to know guidelines specific to them: US- FDAEU- EMEA/EMA Japan- MHLW japan- Apart from the domain knowledge you also need experience of clinical trials conducted according to ICH-GCP in the country.- In addition, you need to excellent communication skills (English reading writing)- Any experience of working as intern also enhances the chances of your recruitment. Hope this answers your questions. Good luck and feel free to reach out to us if you need more guidance!

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