• 7 November 2012
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Rotary pledges $75 mn to end Polio
Rotary International has announced an additional funding commitment of $75 million over three years to the Global Polio Eradication Initiative (GPEI) at the high-level side event on Polio eradication during the United Nations General Assembly session in New York. Convened by United Nations secretary-general Mr Ban Ki-Moon and chaired by heads of state from Pakistan, Afghanistan, Australia, and dignitaries from UK, Japan, Canada and Rotary International. This funding commitment is in addition to $1.2 billion invested by Rotary to GPEI. The side event “Our Commitment to the Next Generation: The Legacy of a Polio-free World” brought together leaders of the remaining endemic countries, and representatives of donor governments, development agencies, the GPEI partners, and the media to underscore the urgent need to finish the job of global polio eradication.

India is striving to complete 2012 with similar resolve and commitment of zero polio incidence while etching closer to the three year target before accomplishing the regional Polio-free certification by WHO in 2014.


Cipla's ASMQ FDC gets WHO pre-qualification
Cipla, along with the non-profit research and development organization, Drugs for Neglected Diseases initiative (DNDi) announced the prequalification of the fixed dose combination (FDC) of Artesunate (AS) and Mefloquine (MQ), ASMQ FDC, by the World Health Organization (WHO). This Cipla manufactured ASMQ FDC is the first artesunate-mefloquine FDC to be prequalified by WHO and is recommended for the treatment of malaria.

The ASMQ FDC is manufactured in Cipla's manufacturing facility in Patalganga, India, which is approved by various regulatory bodies. This combination of AS and MQ is one of five Artemisinin Combination Therapies (ACTs) currently recommended by WHO for the treatment of uncomplicated Plasmodium falciparum malaria, and is the first-line treatment in a number of South East Asian countries.


New guidelines for biological products
As biologics and biosimilars become more prevalent and India is being touted to play a crucial role in this, the Central Drug Standards Control Organization (CDSCO) has released its guidelines on good distribution practices (GDP) for biologic medicines with the objective to assist in ensuring quality and identity of biological products during all aspects of distribution process of these biologics including procurement, purchasing, storage and transportation. This latest document, which is to be effective from October 8, 2012, replaces the previous draft version which was released by CDSCO on September 17, 2012.

The guideline clearly mentions “The principles of GDP shall be applicable both to biological products moving forward in the distribution chain from the manufacturer to the entity responsible for dispensing or providing biological products to the patient and to products which are moving backwards in the chain, for example, as a result of the return or recall thereof and shall be applicable for donated biological products.”


DHR, DBT sign for affordable health technologies
Dr VM Katoch, secretary, Department of Health Research (DHR) and Dr MK Bhan, secretary, Department of Biotechnology (DBT) have signed an agreement for collaborative biomedical research and development. Several broad areas such as policy perspective, including economic analysis, and forecasting for affordable technologies for potential use in public health programs have been identified. A joint working group will come into effect that would steer the programs for biomedical research in product development, process optimization and scale-up including evaluating the products for commercialization.

Dr Bhan stated that DBT is already engaged in development and evaluation of vaccines, diagnostics, biomarkers, therapeutic bio-molecules and nutraceuticals. Dr Katoch further mentioned that both DBT and DHR along with Indian Council of Medical Research (ICMR) would utilize and compliment their facilities and infrastructure to facilitate the scientists to work on projects of mutual interest and a consensus mechanism would be developed for harmonizing administrative and financial processes and approvals.

Dr Bhan added that both sides would work together on transformative, interdisciplinary mega-projects and find out ways for speedy delivery of products at affordable cost to benefit the people of the country. Dr Katoch also consented to constitute a small group of eminent scientific experts to strategize and oversee the projects and also for conducting scientific audit to review the performance and progress of the collaborative projects.


INTERVIEW

  CSO, Regenerative Medical Services (RMS Regrow)  
'We are on the verge of a major stem cell breakthrough'

How is RMS Regrow expanding its Stem Cell therapy business in India?
We are extremely proud of what we have achieved over the last two years, since our inception, and we are even more excited about our prospects for an equally promising future. We have successfully transitioned from a small start-up company to become a respected firm. RMS Regrow has undertaken over 350 successful bone and cartilage implants, and over 4000 cord blood samples have been stored. Our company is currently focusing its expertise in stem cell-based therapies such as autologous cartilage regeneration therapy, autologous bone regeneration therapy (ABI-Ossron), umbilical cord blood banking (babycell) and TheraForm - skin reconstruction


What is the growth strategy that RMS Regrow has chalked out for itself in India?
RMS Regrow is following a strategy to expand via a geographic growth through our nine branches and 13 franchisees and focuses on an organic growth. We also conduct workshops to provide training to doctors and develop new value added services for our clients. Currently RMS Regrow is focused on providing regenerative medical service to Indian population, as we believe that Indian market is very huge. We have already achieved our target for 2011-12 which is around 20 crore. Through our broadened B2B activities and hospital network, we expect to achieve a turnover of 45 -50 crore in 2013.

What do you think differentiates RMS Regrow from other stem cell based enterprises?
The treatment offered by RMS Regrow is much competitive when compared to other similar treatments like hip and knee replacement. We believe in long-term benefits to the patients and a scenario of higher quality of life with increased productivity and efficiency in the healthcare system. RMS Regrow has taken a conscious effort to deal with autologous therapies where we have about 500 case studies of specific indications for more than three years. We also have post marketing surveillance data.

In the field of regenerative medicine, India is still way behind. What are the corrective steps to be taken by stakeholders to improve the situation?
There is no doubt that we are on the edge of a major stem cell breakthrough. Doctors and hospitals should come forward to support stem cell therapies, companies and laboratories, which follow proper ethics and regulations in terms of patient safety and efficacy with proven technology, which has been accepted in the developed countries.

Manasi Vaidya


Lupin gets FDA nod for generic Avapro
Pharma major, Lupin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Irbesartan Tablets from the United States Food and Drugs Administration (FDA) to market a generic version of Sanofi Aventis' Avapro tablets.

Lupin's Irbesartan tablets are the AB-rated generic equivalent of Sanofi Aventis' Avapro tablets. Irbesartan is an angiotensin II receptor antagonist and is indicated for the treatment of hypertension and nephropathy in type 2 diabetic patients. Avapro Tablets had annual the US sales of approximately $400 million.


AstraZeneca launches BRILINTA
AstraZeneca Pharma India (AZPIL) announced the launch of a new patented antiplatelet drug BRILINTA (Ticagrelor) in India. BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS) in adult patients. AstraZeneca says that BRILINTA is competitively priced to enable ACS patients benefit from having access to this medicine.

BRILINTA works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient's risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death.

The drug controller general of India (DCGI), based on the New Drug Advisory Committee's (NDAC) recommendations, granted its approval based upon the submission of data from the landmark PLATO (Platelet Inhibition and Patient Outcomes) trial.


Awards

Niryat Shree award for Transasia BioMed
Transasia BioMedicals, one of India's largest invitro diagnostics companies, was recently conferred with the coveted “Niryat Shree” Gold trophy by the President of India, Mr Pranab Mukherjee. Instituted in the year 1996 by the Federation of Indian Export Organizations, the “Niryat Shree” awards are annually given to entrepreneurs who excel in the field of exports.

Coincidentally, the event took place during the same week in which Transasia announced two new strategic overseas acquisitions, Maxmat in France and Drew Scientific in USA. Along with these acquisitions, Transasia has acquired nine overseas companies in USA, France, the UK, Italy, Russia, Czech Republic and Turkey in last three years.

Ocimum gets Frost & Sullivan award 2012
Ocimum Biosolutions, a leading integrated global genomics outsourcing partner won the Customer Value Enhancement award for laboratory information management in India, at the 2012 Frost & Sullivan Indian Growth, Innovation and Leadership Awards Banquet held in Mumbai on October 9, 2012. The award is a recognition of Ocimum's accomplishments in the domain of Laboratory Information Management Systems (LIMS) development and for their popular and internationally acclaimed flagship product Biotracker. This award is expected to boost brand value and improve sales.

Every year, the Frost & Sullivan Award is presented to a selected organization within a particular industry. The criteria for winning include demonstrated best practices in implementing value-addition strategies for customers to improve their return on investment (ROI) on services or products purchased.

Bharat Biotech bags Silver Patent award
Bharat Biotech, one of India's leading vaccine manufacturers, has received the Silver patent award for the year 2011-12 from the Pharmaceuticals Export Promotion Council of India (Pharmexcil) in recognition of the commendable contribution to biotech products and research.

The Pharmexcil jury recommended and selected the winners based on the guidelines framed for selection. The winners were presented with the awards on the occasion of India-Asia-Pacific Pharma business Meet & Annual General Body meeting of the Council. The Pharmaceuticals Export Promotion Council of India, an organization set up by the Ministry of Commerce and Industry, Government of India, for the promotion of export of drugs, pharmaceuticals, homeopathy, ayurvedic and herbal medicines, allied products and related services in the global arena, is mandated to help its members to achieve excellence in export and facilitate overseas buyers to find suitable trade partners from Indian pharma industry.

Ban on GM field trials not possible, says SC
In a major relief to Indian agri-biotechnology industry, Supreme Court (SC) on October 29, 2012, ruled out possibilities of any interference in the sowing of genetically modified seeds for the coming rabi season.

The two judge bench comprising Justice Swatanter Kumar and Justice SJ Mukhopadhaya while refusing to halt the trials pointed towards the technicalities involved in such an exercise. Earlier the Technical Expert Committee (TEC) appointed by the SC had pointed to the possibility of contamination of non-GM food by the GM food. The counsels representing the government earlier pointed out that the reported recommendations of the court-appointed committee will have disastrous consequences for these crops.

The court permitted various applications for impleadments after senior counsel Mr KK Venugopal, who represented ABLE argued that biotech industry had a say in the matter and has right to point out where the TEC has gone wrong. Counsel Mr Prashant Bhushan, appearing for petitioner Ms Aruna Rodrigues, told the court that the annexure to the TEC report mentioned that the field trials of the GM crops would cause an “irreversible contamination” of even the non-GM crops. Mr Bushan expressed fear that India would lose European markets for basmati rice as earlier Americans also experienced the same. Counsel appearing for a government agency told the court that the open field trials would be carried out in a safe environment with all precautions and the GM crop would be burnt after wards. The court further directed all the parties to exchange their responses by November 7.


INTERVIEW

 Mr Sahil Kapoor
director and co-founder, Novo Informatics
 
 
'We aspire to be a top drug discovery company'

What are the current activities at Novo Informatics? Which are the key focus areas of research for the company?
Recently, we have set up our own infrastructure in collaboration up with one of our international partners in national capital region (NCR). This new facility will solely be responsible for synthesizing molecules and undergoing bioassay validations. Each novel molecule itself is a new business these days, so we are focusing on generating intellectual property (IP) on the molecule we design for various companies.

Soon, we will be offering a complete package starting from in-silico molecule discovery to validated hit molecules. Based on the need in global market, we are carefully designing small packages which will come up as a complete package in the form of innovative product for companies and research academics.

Our research pipeline is solely based on drug discovery covering areas such as in-silico package that includes target modeling, virtual high-throughput (v-HT) screening, scaffold designing, hit identification and hit to lead improvement. The wet lab package includes the molecule synthesis, bio assay based hit identification and hit to lead optimization. Besides that we would like to facilitate our in house R&D projects against selected targets.

How can computational drug discovery tools promote innovation?
The global pharmaceutical sector, a key element of the healthcare industry, is undergoing dramatic change, primarily caused by factors such as reduced output of new medicines from R&D centers, drug pricing pressures, strict regulatory environments and adding fuel to the fire is the current economic downturn. Overall, this creates a demand to look out for better ways to come up with drugs with better efficacy to cover R&D expenses and to meet the shareholder's expectations. I would say, computational drug discovery is like a magical wand in the present era from which innovations can be extracted out.

What is the future outlook of the company?
Stepping into our second year, we are very much satisfied with the progress so far. Right now we have invested 60 percent of the revenues in developing products which are to be launched in 2013. Apart from that, we are hoping to commence our internal research and development project on cancer in collaboration with funding agencies.

Our future outlook is primarily targeted to become India's leading drug discovery company by setting up a highly-developed infrastructure facility for in-silico as well as experimental discoveries.

Rahul Koul


India all set for universal health coverage
India is embarking on an ambitious target of achieving universal health coverage (UHC) for all during 12th Plan period. Everybody will be entitled for comprehensive health security in the country. It will be obligatory on the part of the State to provide adequate food, appropriate medical care, safe drinking water, proper sanitation, education and health-related information for better health. The State will be responsible for ensuring and guaranteeing UHC for its citizens.

Addressing at a conference on “Responsible Use of Medicine” at Amsterdam, Netherlands, Mr Ghulam Nabi Azad, the Union Minister of Health and Family Welfare, said “As per WHO's World Health Statistics 2012, almost 60 percent of total health expenditure in India was paid by the common man from his own pocket in 2009. The report states that 39 million Indians are pushed to poverty because of ill health every year. Around 30 percent in rural India did not go for any treatment for financial constraints. About 47 percent and 31 percent of hospital admissions in rural and urban India were financed by loans and sale of assets.”

He said, “India has already enacted the Clinical Establishment Act. The Standard Treatment Guideline is part of the Act which will ensure that unnecessary drugs are not prescribed. During nationwide polio vaccination campaign, India vaccinated 172 million children through 2.3 million vaccinators in 202 million households in each campaign. The introduction of bivalent oral polio vaccine in January 2010, helped India to achieve its goal of polio eradication.”

Polyclone signs MoU with JSS Varsity
Polyclone Bioservices (Polyclone), a molecular biology and genomics company from Bangalore, signed a memorandum of understanding (MoU) with JSS University, Mysore. This MoU establishes the framework for collaborative research and development in biological sciences between the two organizations.

The MoU is intended to expedite research and development of new methods and technologies that can be implemented and aligned with Polyclone's missions as well as aimed at enhancing the quality of research and education at JSS University. The two organizations have agreed to promote exchange and cooperation in all appropriate and agreed areas of research and also facilitate co-operation between the staff of both organizations.

The company release noted that both organizations believe that this collaboration will contribute to more efficient resource utilization, avert or minimize duplication, and accelerate methods and technology advancement in various fields of biological sciences. The two organizations further believe that successful collaboration will leverage beneficial results via method and technology transfer, education, and training.

IIT-M gets boost from New Zealand
In a bid to help advance cutting-edge nanomedicine research in India, Izon Sciences, a New Zealand-based technology company recently gifted a qNano system, to Prof. Rinti Banerjee, Department of Biosciences and Bioengineering at IIT (Indian Institute of Technology) Mumbai. Prof. Banerjee, a highly feted researcher, who was recently awarded the National Award for Women Bioscientists by the Department of Biotechnology (DBT), said that the instrument would be used to accelerate translational efforts in nanoparticle based drug delivery for cancer and other diseases.

Prof. Banerjee's lab focuses on the development of non invasive carriers for delivery drugs using specifically engineered nanoparticle technologies. She is currently involved in a number of projects such as developing a drug delivery mechanism which triggers the release of nanoparticle in response to cancer associated stimuli, developing a curcumin-nanoparticle complex for the delivery of paclitaxel drug in the treatment of lung cancer. In the latter case, studies exploring its efficacy have has proven to be very effective in animal. Other research projects include about oral delivery of drugs using nanoparticle systems and sequential delivery of more than one drug in diseases such as triple negative breast cancer.

Prof. Banerjee added that her group is researching drug delivery mechanisms for not only cancer therapies but also drug loaded nanoparticles for respiratory, opthalmic and transdermal delivery of drugs. She added that she would try to fine tune the qNano platform for addressing healthcare problems specific to our country.

LifeCell launches Babyshield
LifeCell International, a Chennai-based stem cell storage company has launched BabyShield, an advanced and non-invasive newborn screening program. The BabyShield service aims to identify over 118 health conditions at birth making it the most comprehensive newborn screening service in the world, where most countries and service providers screen for 54 conditions. Also, this test is done in a non-invasive manner thereby making it safe for the baby and simple to implement in a healthcare setting.

The BabyShield screening program is performed on a few drops of blood collected from the baby's umbilical cord at birth and also urine sample retrieved after 48 hours of the baby's birth. The test results are available within a few days of samples arriving at the lab and this aids early diagnosis.

RCC, ViruSure in marketing alliance
RCC Laboratories, a leading contract research organization providing preclinical and safety toxicology and chemical testing, and ViruSure GmbH, a privately owned biotech company specializing in the virus and prion safety testing of biopharmaceutical products and cell banking, have announced their partnership to market the services of ViruSure in India. Through this partnership RCC will act as a sole agent for promoting ViruSure services in India.

ViruSure offers services in the areas of virus and prion safety testing for biopharmaceutical products, cell banking and cell bank characterization services and in vivo biosafety studies. RCC offers toxicology services to various companies in India and globally.

BIOSUPPLIER

Agilent introduces SureDesign, a new online interface
Agilent Technologies, a global player in target enrichment for next-generation sequencing and genomic microarrays introduced SureDesign, a new online interface to help researchers create customized target-enrichment panels for next-generation sequencing.

With this new interface, researchers can quickly generate exceptionally flexible designs for high-performance, targeted resequencing, using Agilent's HaloPlex and SureSelect systems. In just three simple steps, they can create custom sequencing panels tailored to their specific projects. Targeted resequencing of genes or genomic regions is a key step in detecting mutations associated with congenital disease. SureDesign provides an intuitive design environment that gives researchers the flexibility they need to assemble customized panels for targeted resequencing.

Thermo Scientific launches PikoReal PCRs
Thermo Fisher Scientific has introduced the Thermo Scientific PikoReal Real-Time PCR Systems. It is available in 24-well and 96-well format, and adds to its existing portfolio of small bench-top PCR instruments.

A number of features differentiate this product from other real time PCRs currently available. The unique heating block design of PikoReal systems maintains temperature uniformity and allows fast heating and cooling for optimal amplification. Also the proprietary ultra-thin wall (UTW) Piko PCR plates minimize running costs, plastics waste and energy consumption. Although these plates are a quarter the size of standard plates, their well volumes and spacing ensures compatibility with multichannel pipettes and liquid handling instrumentation.


Merck Millipore kicks off 'EMPROVE Series'
Merck Millipore India recently flagged off the “EMPROVE Seminar Series” in Mumbai. EMPROVE is a proprietary service from Merck Millipore which combines product quality with user-related documentation simplifying rigorous regulatory work for the pharmaceutical industry. The inaugural seminar on “Evolving Trends in Regulations in the USA and EU” consisted of a panel of eminent speakers of international repute.

EMPROVE offers comprehensive dossiers and documents needed for the intended usage of raw materials in three different product lines. Since its introduction in 2005, the EMPROVE portfolio is continuously growing and comprises of several hundred products.

Goose launches Proofreader
Hyderabad-based Goose, a specialist in providing pharmaceutical business re-engineering solutions, announced the launch of Goose Proofreader, a 21 CFR part 11 compliant solution that enables review of printed materials. Goose also announced that two of the top pharmaceutical companies in India, Glenmark Pharmaceuticals and Aurobindo Pharma, have begun to use Goose Proofreader already.

The major challenge that the pharmaceutical industry faces today is to make the artwork error free. Goose Proofreader is engineered to deal with this challenge as it reduces the costly errors, increases accuracy and maximizes productivity.

One of the key features of Goose Proofreader solution is that it identifies differences in the texts and images. It also compares scanned copy with system generated copy. Other features include image rotation, auto crop, flip, resize, angle suggestion, and overlay for evaluating files. The solution generates detailed report for pixel to pixel comparison and has the ability to read barcode and pharmacode.

Sigma Aldrich's stem cell culture medium
Sigma-Aldrich announced that Sigma Life Science, its innovative biological products and services research business, has launched Stemline Pluripotent Culture Medium, a novel human pluripotent stem cell culture medium that provides a consistent environment for the long-term maintenance and growth of healthy pluripotent stem cells. The new medium performs equivalently to the industry's leading medium and providAes academic and pharmaceutical stem cell research labs with a substantially lower cost alternative to higher priced media.

Existing Stemline stem cell culture media include specialized formulations for expansion of six human adult stem cell and progenitor cell types: hematopoietic, neural, dendritic, mesenchymal, T-cells, and keratinocytes. These six Stemline media are produced under good manufacturing practices (GMP) and have device master file certificates from the US Food and Drug Administration.

AB SCIEX launches LibraryView
AB SCIEX announced a new software application enabling faster and more reliable identification of contaminants in food, environmental, clinical research, and forensic toxicology samples.

The new LibraryView Software is the first of its kind to enable scientists and lab technicians to screen hundreds of samples for hundreds of potential contaminants and residues, using customized compound libraries uniquely associated with different methods. Coupled with QTRAP and TripleTOF technologies, this new software adds a new dimension of speed and reliability to screening workflows.

Life Tech acquires Compendia
Life Technologies announced the acquisition of Compendia Bioscience, a preeminent cancer bioinformatics company widely used by the pharmaceutical industry to identify novel gene targets for drug discovery and development. Its deep oncology expertise and high-value, proprietary assets enhance Life's diagnostic development capabilities across multiple platforms, including next-generation sequencing, qPCR and proteome analysis.

Compendia's existing business, which will continue under the leadership of its current management team, adds an established base of pharmaceutical industry customers for Life Technologies' platforms. The recent launch of Pervenio Lung RS, a first-of-its-kind prognostic test, underscores Life Technologies' strategy to focus initially on lung cancer, a highly underserved disease.

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