ACT implements Oracle Clinical
Oracle has announced that Asian Clinical Trials Pvt Ltd (ACT), a Clinical Data Management (CDM) company founded by Venkat Jasti, managing director, Suven Life Sciences Ltd and CEO of Synthon Chiragenics, New Jersey, has successfully implemented Oracle Clinical. "Oracle Clinical is a comprehensive clinical data management solution which allows companies to standardize and control data definitions and data usage across a global operation, ensuring that data is defined, managed, and interpreted consistently worldwide. It is a well-established benchmark in the global pharmaceutical industry," said Venkatraman Sunder, vice-president, corporate affairs, ACT. "Oracle Clinical has helped us improve our efficiencies and provide our clients with a sense of security while we handle their critical data," he added.

Lupin gets investigation approvals for anti-TB molecules
Lupin Ltd has received approval from the Drug Controller General of India (DCGI) for conducting Phase I clinical trials for two of its Investigational New Drug (IND) candidates, LL 4858 (Sudoterb) and LL 4218 (Desoside-P). With the addition of these two approvals, Lupin now has four IND applications approved by the DCGI. "The approval of LL 4858 and LL 4218 marks a significant milestone in Lupin's NCE research program. We are among a handful of Indian companies to have four drug candidates in clinical trials," said Dr D B Gupta, chairman, Lupin Ltd. Psoriasis is a chronic skin condition, with highly unmet medical needs. There is an impending need for effective and safe oral drugs to be made available in the global pharmaceutical market for this chronic inflammatory skin disorder.

Besides these, Lupin is focusing on NCE research for inflammatory disorders, respiratory diseases as well as antibacterials. The company has several successful collaborations with government agencies like CSIR and NMITLI.

CIMAP, Pant Varsity ink MoU
A MoU has been signed between the Central Institute of Medicinal & Aromatic Plants (CIMAP) and GB Pant University of Agriculture & Technology (GBPUAT) with the common desire to explore, extend and strengthen the functional relationship between the two institutes. The agreement would facilitate the research students and scientists working at CIMAP to register themselves for doctorate programs. It would help sharing of research facilities between GBPUAT and CIMAP and the visits of CIMAP scientists as resource persons for delivering lectures on specialized topics to create critical mass of specialists and human resource in plant sciences and biotechnology. The MoU shall remain effective for a period of ten years and shall be reviewed periodically in a joint meeting to assess the progress and also to identify new areas of collaboration.

New software tool for vaccine design launched
VaxiPred, a software tool suited for computer aided vaccine design, was released recently by Dr RA Mashelkar, director general, CSIR. This is the result of the partnership initiative launched by Chandigarh-based Institute of Microbial Technology (IMTECH), a constituent CSIR lab, and BioMantra, a bioinformatics enterprise. This immuno-informatics tool combines the best of research in immunology and immuno-informatics. The crucial components of research in vaccinology came from IMTECH which have been adequately backed and supported by use of the latest in Information Technology by BioMantra, a division of First eLearning Quest. The immunological component of VaxiPred involves working on antigens of the disease causing pathogen rather than the pathogen dead or alive. The immunoinformatics component involves web enablement. The tool does not pose any demand of porting the basic infrastructure or its accessories as the researcher moves across the globe! The product offers a professional an ideal environment for not only conducting and repeating the experiments, but also presents a platform for innovations in research.

In his keynote address, Dr Mashelkar laid emphasis on the need to have partnerships between the government and private organizations. Further, he said, "VaxiPred has imbibed the most needed components of flexibility and repeatability for conducting scientific experiments. The use of the tool in combination with grid computing would revolutionize the face of research in immunology and hence revolutionize modern medicine at large".

Rally for community control of biodiversity
Several panchayats, gram sabhas, NGOs, and people's movements from across India came together in Delhi on December 8 to protest against the Biodiversity Rules (2004), notified under the Biological Diversity Act, 2002. The Biodiversity Rules, notified in April 2004, by the Ministry of Environment and Forests, are the executive orders made by the Government in order to carry out the purposes of the Act. The Biodiversity Act and the Rules are essentially in response to international treaty obligations under the Convention on Biological Diversity. The representatives of the community argued that the starting point of the discussion and legislation on conservation and control of biological resources and knowledge has not been initiated through communities at local level. Therefore the Biodiversity Rules and Act do not adequately recognize communities' sovereignty over their resources and knowledge. Over 200 panchayats and gram sabhas have already passed resolutions rejecting the Rules in their current form, and as an act of non co-operation refused to set up Biodiversity Management Committees under such Rules. The rallyists urged the Parliament to reject the currently notified Rules and press for a new process of formulating them keeping in mind the community sovereignty.

A memorandum in this regard was submitted by 200 gram panchayats and gram sabhas of Chhattisgarh, Madhya Pradesh, Andhra Pradesh, Karnataka, Tamil Nadu, and Uttaranchal, along with Kalpavriksh, Gene Campaign, People's Alliance for Livelihood Rights, Deccan Development Society, Centre For World Solidarity, Green Foundation, Delhi Forum and Beej Bachao Andolan, on behalf of the Campaign on Community Control over Biodiversity.

Workshop on clinical trials methodology and management
As a step forward to benchmark the Indian clinical research industry towards global clinical research, Delhi-based contract research organization and clinical development company Catalyst Clinical Services (CCS), will conduct a series of nationwide workshops on "Clinical Trials Methodology & Management" in January 2005. The workshop is to create awareness in effective clinical trial management with strict regulatory compliance.

The workshop will be held in four different cities-Bangalore (January 8-9), Mumbai (January 15-16), New Delhi (January 22-23), and Udaipur (January 29-30). Catalyst Clinical Services is a full service contract research organization with a focus on clinical trial management and execution, training and development and business process mapping.

Dr Kalam opens SPARC at Baroda

President Dr APJ Abdul Kalam inaugurated Sun Pharma's new Advanced Research Center (SPARC) in Baroda recently. SPARC, built on a 16-acre campus, offers 200,000 sq ft of research floor area, housing modern labs. SPARC has large labs to house departments that have a critical role to play in the development of a new compound. Based on the work done so far, Sun Pharma already has one molecule in clinical trials in Europe, which is enroute to becoming a drug. Interesting projects are also in the pipeline in three more therapy areas of interest. Intellectual property earning projects are also underway in novel drug delivery systems, with two projects about to begin clinical trials in Europe. It has received a total of 33 patents (across both drug discovery and reverse engineering projects) with another 331 filings awaiting approval.

Bangalore Bio 2005 announced
The dates for the fifth edition of Bangalore Bio 2005 have been announced. The premier annual biotech event in Bangalore will be held from April 22-24, 2005 at the Palace Grounds. The last Bangalore Bio was held in July owing to the general elections in May, but this year's show would be held as practiced in the earlier versions.

Shankaralinge Gowda

Announcing the launch of Bangalore Bio 2005 , Shankaralinge Gowda, secretary, IT and BT, Government of Karnataka, said, "Bangalore Bio 2005 will be bigger show with over 5,000 sq m of space for the tradeshow, international conference and a host of other events. We expect to attract about 120 companies from over 20 countries and 25,000 business visitors."

Kiran Mazumdar-Shaw, CMD, Biocon Ltd and chairperson of the Vision Group strongly felt that Bangalore's success in IT has to be replicated in BT too. She said Bangalore has the biggest cluster of biotech firms in the country, working in a wide spectrum of biotechnology areas. It is one hub in the country where companies are partnering and growing. By the year 2010, the size of the biotech industry in India would be $5 billion and generate about a million jobs and Bangalore can play a very important role.

Gowda also informed that the state government is actively pursuing measures to foster the sector. Besides the biotech park, the government has initiated a proposal to set up a nodal agency for bio-informatics sector, modeled on the lines of Software Technology Parks of India (STPI), in Bangalore. "The Karnataka government has already written to the Central government urging it to chose Bangalore for the establishment of the agency. The State government would provide the land and other infrastructure facilities for the purpose," said Gowda. The agency would be a single point of contact for bio-informatics firms interested in setting up their facilities or expanding their operations in the country, he said, adding that the Central government would also contribute for the bio-informatics center with funds and other infrastructure facilities.

Giving details about Bangalore Bio 2005, Shaw said the three-day event would feature an exhibition and a conference. The focus would be on partnerships . The conference would be addressed by over 60 speakers from across the globe. About 700 delegates are anticipated to attend the conference. "The event would also include a trade show, a CEO conclave, an awards nite and a quiz on biotechnology. Last year, there was a tremendous response from the student community for the event. Thus, we thought that it was time to start a bio quiz to generate interest among the students towards biotechnology," Gowda announced. Shaw pointed out that another salient feature this year would be a focused session for the investor community, where the investors would be apprised about the various developments in the industry on regulations, markets, etc. All the members of the organizing committee are confident that Bangalore Bio 2005 would provide the right platform for technologists, entrepreneurs, scientists and financiers to showcase their research capabilities, products and services.

Mashelkar takes over as INSA president
Dr RA Mashelkar, Director-General, CSIR, has taken over as the President of the Indian National Science Academy (INSA) at a special function organized as part of the INSA Council Meeting and 70th Annual General Meeting. The Indian National Science Academy (INSA) is the premier body of scientists of eminence (today comprising around 700 topmost scientists of India) established in 1935 to promote science in India and harness the scientific knowledge for the cause of humanity and national welfare.

Dr Mashelkar is presently the Director General of Council of Scientific & Industrial Research (CSIR). He is only the third Indian engineer to have been elected as Fellow of Royal Society (FRS), London, in the 20th Century. He was elected Foreign Fellow of US National Academy of Engineering (2003), Fellow of Third World Academy of Engineering, UK (1996), and Fellow of World Academy of Art & Science, USA (2000). Sixteen universities have honored him with honorary doctorates, which include Universities of London, Salford, Pretoria, Wisconsin, and Delhi.

Winner of over 40 national and international awards, Dr Mashelkar has been well known for his leadership role in the transformation of CSIR, for spearheading a new thinking in the direction of S&T in the post-liberalized India, for chairing eight high-powered 'Mashelkar Committees' to look into diverse issues of national importance and for championing the cause of protection of traditional knowledge in India by fighting the 'Turmeric and Basmati battles.'

Strides, Able Labs ink development pact
Strides Inc., New Jersey, a wholly owned subsidiary of Bangalore-based Strides Arcolab Limited and New Jersey-based Able Laboratories Inc. have announced the signing of a development agreement for a specialty prescription generic drug product. The product will be developed by Strides exclusively for Able Laboratories, a developer and manufacturer of generic pharmaceuticals.

Arun Kumar, managing director and group CEO of Strides stated, "The Strides-Able relationship is a reflection of the Strides partnership philosophy. Using our manufacturing and product development skills, Strides intends to become a niche player in the US generics market." Jay Wadekar, chairman and chief executive officer of Able stated, "We are excited to enter into this initial relationship with Strides for this specialty product. We will continue to review additional opportunities to grow this relationship in the future."

Nano Biotech to manufacture HIV test kits
The Punjab State Drug Controller, Chandigarh in association with Drug Controller of India, New Delhi have issued manufacturing license for HIV detection test kits to Nano Biotech (P) Ltd (NBPL). This makes NBPL probably the first company in Punjab to manufacture HIV test kits. The HIV test can be done with a drop of blood obtained directly from finger prick and results can be visually interpreted within five to 20 minutes without the need of any instrument. The kit will be useful for screening of blood for HIV infections in the OPDs, blood banks, pathology labs, diagnostic centers, clinics, primary health care centers and in hospitals located in remote areas. Nano Biotech plans to supply HIV and other test kits at subsidized rates to NGOs and other voluntary organizations involved in AIDS control in India.

Amritsar-based NBPL is one of the first few biotech companies in Punjab engaged in manufacturing of rapid diagnostic test kits based on the immunochromatographic principle.

Avesthagen, Cipla expand scope of collaboration
Pharma major Cipla and Bangalore-based Avesthagen have expanded the scope of their ongoing biotherapeutics development program. The expanded pipeline includes next generation drugs that cater to the oncology and cardiovascular segments.

This announcement came in the wake of successes in the ongoing collaborative product development program in autoimmune disorders and oncology that was announced earlier in May 2004. The companies believe that t there is a dearth of high quality next generation drugs to cater to these segments at an affordable price. This initiative hopes to plug that gap.

National meet on clinical research held
A two-day national conference on "Clinical Research: Challenges and Opportunities in India" was organized by the Institute of Clinical Research (ICRI) on November 26, 2004, at the Indian National Science Academy, New Delhi. Inaugurating the conference, union minister of health and family welfare, Ambumani Ramadoss, said that the establishment of specialized institutes like ICRI, offering training in clinical research, would hasten the development of clinical research industry in the country.

During the inaugural address, Dr SK Gupta, dean, ICRI, highlighted the challenges and opportunities in clinical research for medical, pharma and science graduates.

This conference was attended by over 150 distinguished personalities from India as well as abroad including Dr NA Kshirsagar, dean, professor and head, KEM Hospital, Mumbai, Dr Vijay Kumar, president, Neeman Medical International, Dr RD Kulkarni, emeritus professor, pharmacology, MGM Medical College, Navi Mumbai, Roy Drucker, general manager, Technomark, UK and Dr Rajendra A Badve, professor and chief of surgical oncology and clinical research, Tata Memorial Hospital.

The delegates expressed deep concern over the current clinical research scenario in the country and said that a lot needs to be done in this arena for India to gain recognition in this particular field. The role of pharmacy institutions in promotion of clinical research, clinical trial of drugs from alternative systems of medicine, new generation vaccines-challenges and opportunities, role of clinical investigator-Indian perspective and role of ethical review boards were some of the topics that were discussed at the conference.

... ICRI inaugurates its Mumbai campus

ICRI inaugurated its Mumbai campus on December 1, 2004. The Mumbai branch offers one-year part time certificate programs in clinical research and trial management and regulatory affairs and ethics in clinical trial management. The Dehradun campus of ICRI currently provides postgraduate diploma in research with a management degree. The first batch of 120 students is presently pursuing their postgraduate studies at the campus.

DU to hold international meet on microbial diversity
The Department of Microbiology, University of Delhi South Campus, will organize an international conference on "Microbial Diversity: Current Perspectives and Potential Applications" from April 16-18, 2005. The conference will focus on the known diversity of various groups of microorganisms; setting priorities for understanding the diversity further; development in ecological, physiological, biochemical and genetic/molecular diversity of microbes; and the relevance of microbial diversity to agriculture and forestry, industrial and food biotechnology, environment, human and animal health.

IOB collaborates with Sun Microsystems
The Institute of Bioinformatics (IOB), Bangalore, has entered a technical support collaboration with Sun Microsystems. Sun has provided the institute with a computing grid cluster under its "Academic Excellence Grant" as part of this collaboration. The Institute of Bioinformatics is already working very closely with the John Hopkins University, the University of Michigan, Human Proteome Organization and Memorial Sloan-Kettering Cancer Center.

"We are delighted that we have the opportunity to collaborate with Sun Microsystems, and, with such patronage, we will be able to make remarkable progress in a shorter time frame. This will ensure that our scientists have access to high-end computing facilities which is essential for our compute intensive bioinformatics research program" said Dr Akhilesh Pandey, chief scientific advisor, Institute of Bioinformatics.

The institute has recently developed the Human Protein Reference Database (HPRD), a comprehensive catalog of all human proteins. The HPRD has become the benchmark for human proteins because it is extremely user-friendly and also because it incorporates information about how proteins interact with each other to form networks. This database enables systematic analysis of complex systems in a new emerging discipline called Systems Biology.

RFCL awarded ISO 14001:1996 certification
Ranbaxy Laboratories Limited (RLL) announced that its allied business division, Ranbaxy Fine Chemicals Ltd (RFCL) has been awarded ISO14001:1996 Certification from TUV Suddeutschland India. This puts RFCL amongst the few global companies in the chemical industry to get this certification. Already an ISO 9001:2000 certified company, RFCL becomes India's first organization in the laboratory chemical industry, to attain this distinction.

Commenting on the achievement, Sushil Mehta, director, allied business, said, "The ISO certification is a significant milestone for RFCL. It vindicates our position as an efficient and reliable supply partner of high purity fine chemicals for manufacturing processes, quality assurance and research & development."

Royal School establishes life sciences training and research centre
Royal School of Management and Technology (RSMT) has started Royal Lifesciences Training and Research Centre (RLTRC), a division specializing in Bioinformatics Training and Research. It will be supported by and Helicx Genomics Private Ltd (HGPL) team. Narayana Patro, principal director, RSMT, said, "Industry relationship and collaboration with academic institutes will provide practical exposure and improve the skill set of the students when they join the industry." He added that RSMT was committed to development of biotechnology and bioinformatics in Orissa.

HGPL and RSMT have signed a MoU under which HGPL would provide its Biological Operating System (BOS) software to RSMT students, faculty and researchers. Mohan RK Nimmagadda, CEO, HGPL, informed, "The agreement enables RSMT to use and explore our software in conducting teaching and training the graduate engineering students in biotechnology and bioinformatics as well as in undertaking serious research projects of academic and commercial interests by the faculty and researchers." Nimmagadda added that the RLTRC will be developed jointly by HGPL and RSMT as center-of-excellence in BOS and computational biology training and research.