Reliance Life Sciences launches breast cancer genomics portal

The Molecular Medicine Group of Reliance Life Sciences has developed a portal (http://relibrca.rellife.com) to help the medical fraternity predict familial and/or early on-set breast cancer in Indian women. The ReliBRCA portal aims to make data generated by the scientific community easily accessible to doctors and oncologists, to help identify hotspots and targets for easy intervention for "predictive diagnosis" and possibly in "prognosis and therapy". Breast cancer constitutes 18.5 percent of the total new cancer cases in Indian women today.

The portal will include published data and to-be published data defining mutations and Single Nucleotide Polymorphisms (variations called SNPs) on BRCA1/BRCA2 genes, associated with increased susceptibility to breast cancer. This initiative is the first BRCA1/BRCA2 mutation/SNP database in Indian women. The portal is launched with an initial report of 500 alterations. It is interactive and accessible to all, enabling submission and accrual of global inputs.

The National Institutes of Health (NIH), USA, has a database of about 200 mutations, which have been reported and recorded. While the NIH database primarily provides such data in the global context, it has minimal data on Indian women.

The ReliBRCA database developed by the Molecular Medicine Group of Reliance Life Sciences is an effort to bridge this gap.

At Reliance Life Sciences, the Molecular Medicine Group offers a diagnostic assay to predict high risk, moderate risk or risk same as reported in Indians, using the global protocol of defining the mutations by sequencing the entire BRCA1 and BRCA2 gene.

Advinus, Ortho-McNeil-Janssen Pharma collaborate for drug discovery and development

Bangalore-headquartered Advinus Therapeutics Pvt Ltd (A TATA Group of Companies) has announced drug-discovery and development collaboration with Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJPI), a subsidiary of Johnson & Johnson. Under the agreement, Advinus and OMJPI have agreed to develop drug candidates for various disease targets. Advinus will be responsible for drug discovery and early clinical development (until the completion of Phase 2a studies), while OMJPI will have an option to advance the drug candidates into late stage clinical trials and will be responsible for worldwide commercialization of the molecules. As per the agreement, Advinus will receive an upfront payment and could receive milestone payments of up to $247 million upon successful development of two targets. Advinus is also eligible for royalties on the sales of any drug products resulting from the collaboration.

"We have not specified the disease areas and the options are kept open. We will be discussing upon this very soon. We will start with two targets but not in the neglected diseases," added Rashmi H Barbhaiya, CEO and MD, Advinus Therapeutics. The disease targets will be focused more on metabolic and inflammatory diseases. Advinus Therapeutics was earlier in news for its drug discovery alliances with Genzyme Corporation and Medicines for Malaria Venture to accelerate discovery of novel therapies for malaria and also with Merck (for which they have already received three milestone payments). "With all this, financially we have achieved breakeven and by the end of the financial year we should be well over Rs 100 crore," said R Gopalakrishnan, executive director, Tata Sons Limited.

Commenting on its biological plans, Barbhaiya told Biospectrum, "Biotechnology is a huge opportunity and is considered the next big thing. But right now, we want to focus on small molecules because that is our strength. The reason why I am very hesitant is that manufacturing of biologicals is very tricky and until I find a good partner, I will be keeping these plans on hold."

Ocimum bags patents for gene expression systems

Ocimum Biosolutions was recently issued two US patents. One of them covers the company's proprietary system and method for determining matching patterns within gene expression data and another covers the method for determining renal toxins.

The pattern-matching methodology helps in retrieving clinically relevant and biologically significant patterns by making optimal use of information imbibed in the biological data. The data includes biological samples, related information on diseases, medications, tissues and other sample parameters present in the database.

The second patent covers the elucidation of global changes in gene expression and the identification of toxicity markers in tissues or cells exposed to a known renal toxin. The genes may be used as toxicity markers in drug screening and toxicity assays. The invention also includes a database of genes characterized by toxin-induced differential expression that is designed for use with microarrays and other solid-phase probes.

"The granting of these patents reflects our continued focus on innovation and commitment to strengthen our intellectual property portfolio. Such cutting-edge research and techniques contribute immensely to our global reputation as a preferred partner for genomic solutions and services with global biotech, pharmaceutical companies and research organizations," said Anu Acharya, CEO, Ocimum Biosolutions.

DCGI promises to improve regulatory frameworks

Public private partnerships should be pursued more vigorously if the benefits of the clinical research sector in India are to truly reach and benefit the global clinical research market. This was the thrust of the two-day international conference on "Clinical Research and Drug Development" held in Mumbai on October 10-11, 2008.

The conference was organized by the Institute of Clinical Research (India), ICRI, a leading institution in clinical research studies, in partnership with Department of Science & Technology, Government of India.

Dr Surinder Singh, Drugs Controller General of India (DCGI), Government of India, said, "By the year 2010, India will be at par with the global clinical research market." He emphasized on "CRO registry, an approval system for site and inspection, sound monitoring systems for trial guidelines made by IRB and the Ethics Committee and putting in place a finger printing mechanism for patient enrollment coupled with e-governance structure which will also allow every application for the approvals of trials to be viewed. We should also work closely with the FDA of USA to set up training programs."

Urging the industry to come closer and commending ICRI for its efforts, Debashish Panda, IAS, joint secretary, Ministry of Health & Family Welfare, said, "An association of clinical research professionals and society members with an institution like ICRI in the forefront would help form the export promotion council to promote the business of clinical research and open the market to the international pharmaceutical industry giving a fillip to the Indian industry."

Assocham calls for speedy approval of clinical trials

Assocham, the leading body of the chambers of commerce of India, has sought the Indian Prime Minister Manmohan Singh's intervention in restructuring the process of clinical trial approval in the country. It is demanding reduction in the approval time for the clinical trials in the country to 30 days.

According to Assocham the long bureaucratic processes in the Health Ministry and other relevant departments delay the process. "While in countries like Canada, the UK, the US and the Netherlands, the approval is accorded in a month's time, in India it takes a minimum of eight months in getting clinical trials approvals," the chamber said.

"Though the domestic pharma companies spend a lot of money on R&D to come out with most innovative drugs, they lose on patenting their discoveries because of the delays," Assocham said in its representation to the Prime Minister. Swati Piramal, Assocham's senior vice president who is also director of Strategic Alliances, Piramal Healthcare led the representation to the PM.

I Am No Lab Rat campaign against GM food launched on World Food Day by Greenpeace

A people's campaign against GM foods was launched in October. "It is horrifying to think that we are now being subjected to an experiment that is irreversibly changing our food. It is scary to even think that one day all I can have is Genetically Modified food, which I don't want to", said Ramya, popular actress from Karnataka, at the launch of "I Am No Lab Rat" campaign, an initiative against the Genetically Modified food proliferation.

The campaign, launched on the World Food Day, had models who came out strongly against GM food.

The primary objective of I Am No Lab Rat campaign is to mobilize public opinion on the alarmingly growing and uncontrolled GM food, and urge the Union Health Minister, Dr Anbumani Ramadoss to ban such unsafe food said the campaigners.

According to Divya Raghunandan, campaigns director, Greenpeace, the genetic engineering research in India has increased by almost 250 percent in the last three years. "After brinjal, which is in the last stage of approvals without its safety independently verified, there are 25 kinds of GM rice varieties and 23 kinds of GM tomato and also includes groundnut, potato, cabbage, cauliflower and ladies' finger, which will get approved if we don't raise our voice and stop it now," she said.

Greenpeace's recently released Genetic Gamble report states that there are over 169 unknown GMOs being tested in our food crops. These include staples such as rice, maize and traditional favorites such as okra (ladies' fingers). "Even trees and traditional Ayurvedic medicinal herbs have not been spared and are being subject to Genetic Engineering," said Surya, sustainable agriculture campaigner, Greenpeace.

"The GEAC is completely dependent on the data provided by the GM companies themselves. The Food Safety ad Standards Authority has so far not done anything to allay public fears on safety of GM food", added Surya.

The launch of the I Am No Lab Rat campaign follows the apparent green signal from the GEAC about safety of Bt Brinjal, though there have been no long term studies done to indicate the safety of the first GM food crop of India. "At the international level, GM food has been either banned or strict restrictions implemented in the European Union, Japan, South Korea and many countries in Africa. Yet India continues to live in the fantasy that GM is the panacea for many of our food and agriculture problems" opined Surya.

The launch is part of a larger national campaign to reach out to Indian citizens to have their say food safety debate.

As a part of the campaign, citizens across the country have been writing to the Union Health Minister Dr Ambumani Ramadoss to step in and stop unsafe GM food immediately.