Advinus opens development center in Bangalore

Ratan Tata inaugurating the new facility at Advinus Therapeutics, Bangalore. Dr Rashmi Barbhaiya looks on.

Ratan Tata, chairman, Tata Sons, inaugurated the state-of–the-art corporate office and development center of Advinus Therapeutics on November 29, 2007 in Bangalore. Located in Peenya, the center is set on an 8-acre campus with about 2,10,000 sft of built-up space and is the only one of its kind in India to offer an end-to-end pre-clinical to early clinical development platform for pharmaceutical product development along with capabilities of agro chemical development. "This center is also one of the most accredited R&D centers of India with certification from AAALAC International and the German, Dutch and Indian authorities for GLP compliance," Dr Rashmi Barbhaiya, managing director and CEO, Advinus Therapeutics.

Thanking the partners, clients, and all those involved in building up the center, Dr Barbhaiya, said, "We are proud to open this first-of-its-kind development center in India that provides comprehensive services for development of pharmaceuticals and agrochemicals under one roof to Indian as well as global companies. This is yet another example of India's emerging role in supporting drug development with efficiency and cost-effectiveness. Our state-of-the-art laboratories and a seasoned team with over 150 years of experience in developing INDs and NDAs in large pharma are uniquely positioned to leverage the India-advantage. It is a great privilege for me and every employee of Advinus that the company is promoted by the Tata Group."

Advinus Therapeutics, a Tata enterprise, has been set up with an investment of Rs 200 crore and has about 350 employees of which about 270 are in Bangalore while the rest in Pune at its drug discovery center.

Speaking at the inauguration, R Gopalakrishnan, executive director Tata Sons, said, "The Tata Group has partnered with a team of highly qualified technocrats, led by Dr Rashmi Barbhaiya. Advinus is a very visible example of the Tata Group's commitment to promote innovation led and knowledge-based industries and give the freedom to grow. Backed by its strong leadership team and its experienced and talented scientists, Advinus is ideally positioned along with International life sciences companies in advancing the global pipeline of pharmaceutical and agrochemical products".

Innovation key to biotech growth

Over 100 investors, industry leaders and other stakeholders of the growing biotech ecosystem debated for two days in early November on the strategies to take the growth momentum forward at the 3rd BioInvest 2007 event organized by the Association of Biotechnology-Led Enterprises (ABLE). The message from the discussion was clear: the industry has to continue investments in innovation to ensure a sustainable future.

"Are we innovating enough," asked ABLE president, Dr KK Narayanan, kicking off the discussions on November 1, 2007 in Mumbai. He advised the industry to increase the research spends to keep up with the growing demand for innovative therapeutic products.

In her keynote address, US-based BioCentury's chief editor, Dr Karen Bernstein, outlined the opportunities available to Indian biotech sector. She pointed out that the global pharma industry growth has been stagnating at 8 percent and the industry was in a state of siege. She said biotech R&D was getting better returns than that of the Big Pharma and this realization has dawned on the industry.

This opens up enormous opportunities for biotech companies to develop products to keep the pharma pipeline growing. Bernstein said outsourcing opportunities in various parts of the drug development chain would be available but price differentiation alone may not be the key criteria in the engagements with companies in India. Capabilities and research efficiencies may become important factors.

A notable speaker at the event was Dr Reddy's Laboratories CEO GV Prasad. While highlighting the opportunities available to Indian companies on the lines of the Glenmark outlicensing a molecule, Prasad stressed that the macro-economic factors did not have much impact on the Indian pharma sector.

Because, he said, the economic growth was concentrated in urban center, which anyway had high level of access to healthcare products. The challenge was to ensure increased availability of pharma products in tier 2 & 3 cities, he added.

About biosimilars, he said the entry barriers to it in India were so low that even these would become commoditized in a short time. "Making a biotech drug better was a better strategy than making a biosimilar drug," Prasad said.

Industry leaders like Kiran Mazumdar-Shaw, Villoo Morawala-Patell, Varaprasad Reddy, Rashmi Barbhaiya, M Vidyasagar and a large number of VCs and other members of the investment community were present. A panel discussion on Walk The Talk, moderated by BioSpectrum chief editor, E Abaraham Mathew discussed the various options available to industry leaders to continue the growth momentum. There was also a lively discussion on the IPR issue with participation from Burrill's Ganesh Kishor and V Lakshmikumaran of Lakshmikumran & Associates.

US firm Generex in pact with Shreya Lifesciences for insulin spray

The US-based Generex Biotechnology Corporation has entered into a product licensing and distribution agreement with Shreya Life Sciences to market Generex Oral-lyn oral insulin spray product.

According to the company, this is the first non-injectible buccal insulin approved in India. Discussions are on between both the companies for commercial launch of the product in India in early 2008. Generex is a leader in drug delivery for metabolic diseases through the inner lining of the mouth. The company's proprietary oral insulin spray product -- Oral-lyn -- has recently received approval for importation and commercial marketing and sale in India for the treatment of diabetes.

The product is administered orally by the company's proprietary device RapidMist. Shreya is the fourth largest distributor of insulin in the Indian market.

Phase Forward sets up subsidiary in India

Phase Forward, a provider of data management solutions for clinical trials and drug safety, has announced the establishment of a wholly owned subsidiary, Phase Forward Software Services India, based in Hyderabad. In building this subsidiary, it will be working with its current partner Virtusa Corporation, a global information technology services company. Its new center is situated within Virtusa's facilities.

Bob Weiler, CEO and president, Phase Forward, said, "The formation of a Phase Forward subsidiary in India is a natural extension of our long-established strategy to give our customers access to the most advantageous and cost-effective mix of offshore and onshore resources available. Since India is such a high-growth area for the biopharma services industry, we wanted to expand our commitment to the region by adding our own employees to our partner resources in the region."

Kris Canekeratne, chairman and CEO, Virtusa, said, "We are delighted to extend ourselves beyond engineering services to include professional services as well. This is an important step in the evolution of our pharmaceutical practice as it expands the range of services that we offer our pharmaceutical clients."

Phase Forward and Virtusa have worked together on a number of successful projects, combining resources as appropriate from their professional services and engineering organizations. Phase Forward has developed effective and efficient processes for working with India-based staff, allowing its team in India to work seamlessly with colleagues in the UK and US. Senior technical resources have been relocated to India for this purpose and the overall activity will be led by Steve Powell, senior vice president of worldwide sales.

The addition of the Indian-based subsidiary marks an important extension of Phase Forward's global presence, which, in addition to its US headquarters, includes operations in Europe, Japan and Australia.

Manipal AcuNova's central reference laboratory receives CAP accreditation

Bangalore-based Manipal AcuNova's central reference laboratory has been awarded an accreditation by the Commission on Laboratory Accreditation on the College of American Pathologists (CAP), based on the results of a recent on site inspection.

The laboratory's director was advised of this national recognition and congratulated for the excellence of services being provided. Manipal AcuNova's central reference laboratory is one of the ten laboratories that are CAP accredited nationwide.

DA Prasanna, vice chairman and MD of Manipal AcuNova, said, "CAP accreditation is an endorsement that our patient testing work is of global quality. With CAP, our testing service will be more assuring to pharmaceutical company clients to file the research results with the USFDA."

Manipal AcuNova and University of Utah form alliance for clinical trials

The University of Utah, USA and Bangalore-based Manipal AcuNova have formed a progressive alliance to expand educational opportunities while accelerating commercialization of University Technologies. Manipal AcuNova will conduct clinical trials that determine if devices, processes and therapeutics developed by the University of Utah researchers are safe and effective. With AcuNova as a partner, the University of Utah will have a distinct means to efficiently determine the outcome of investigator initiated clinical trials.

The University of Utah's educational opportunities will be revolutionized as researchers and students work together within the AcuNova partnership. The collaboration will focus on clinical research support for university investigators and technologies. Some of the highlights include Manipal AcuNova's global presence, clinical research expertise, university affiliation and extended knowledge of academic research.

Manipal AcuNova acquires German CRO

Manipal AcuNova completed the acquisition of ECRON GmbH, Europe. The two leading CROs will now combine the clinical research expertise of ECRON's 20 years experience, with Manipal AcuNova's association with India' largest medical university.

The company will provide end-to-end services for phase I–IV clinical trials including project management, clinical data management, biostatistics, medical writing, central lab and bio-availability/bio equivalence (BA/BE) studies to pharma, biotech, device and diagnostic companies. The combined strength will be 265 employees slated to grow year on year. Frankfurt will be European headquarters, Princeton for the US and Bangalore for Asia. While DA Prasanna, vice chairman and MD of Manipal AcuNova, will continue to lead the global operations based out of Bangalore, Dr Wiedey will be president, Europe and Dr Kohkan Shamsi will be CEO in the US.

Speaking on the development, Dr Wiedey, president, ECRON, said "AcuNova is a company built on quality making it a primary reason for ECRON's choice in this synergy. This collaboration will benefit our European and US clients. The possibility of extending trials from Europe to India will make drug development faster. Trial data can be analyzed with biostatisticians and data management professionals from India, speeding up submission to regulators like EMEA and USFDA. We can take up bigger complex projects with a broader range of services like central lab and PK/PD service"

On process standardization, he added, "Highest ICH GCP and FDA standards will be deployed across the organization hence clinical operations will use German practices and DM will use the Indian practice. We foresee harmonization of SOP's within the next six months."

On the acquisition, DA Prasanna said, "Industry experience shows bringing a drug into market takes 8-10 years. Indian CROs do not have a track record in seeing a drug through development and into market. Hence this merger will combine Manipal AcuNova's access to investigators and patients with ECRON's quality reputation making drugs available faster. Clients will be able to conduct trials at West and East European hospitals and enter regulated markets"

He added, "Manipal Group supports this development with special access to teaching hospitals and education infrastructure. We are confident that the combined strength offers a compelling alternative for clients to entrust their clinical development programs with us."

MHS launches Manipal Heart Institute

Manipal Health Systems (MHS) has launched Manipal Heart Institute (MHI), a comprehensive, region wide heart care program, with the widest spectrum of medical expertise for all age groups and all forms of heart diseases.

According to World Health Organization, India will account for 60 percent of the world's heart patients by 2010. Not just the adults, every year nearly 1,80,000 children are born with congenital heart disease in India. About 10 percent of the present infant mortality may be due to congenital heart disease alone.

In the context of such an alarming scenario through, MHI, MHS hopes to provide a platform for the best professionals to deliver clinical excellence, education and research. The institute will offer a larger than life landscape, which is required to combat the epidemic nature of heart disease.

Announcing the MHI launch, R Basil, MD and CEO, MHS, said, "We have been working in this programme for the last one year. During this period we have gathered together some of the best doctors from India and abroad to offer comprehensive heart care comparable to the best hospitals in the world. MHI has close to 40 heart specialists, who have collectively undertaken over 100,000 heart surgeries and procedures."

MHI doctors will offer heart care for all age heart groups-from unborn babies, neonatals, infants and children to adults and even the elderly over ninety. The extensive types of heart treatment will encompass preventive and noninvasive heart care as well as the most complex procedures and surgeries.

MHI services will initially be offered in Bangalore, Mangalore, Manipal, Vijayawada and Salem and will soon extend to other important cities of the region.

Sequoia Capital invests $25.21 m in GVK BIO

Sequoia Capital, a leading global private investment firm has invested Rs100 crore ($25.21 million) in Hyderabad-based GVK Biosciences (GVK BIO), a pharma and biotech R&D outsourcing company and has nominated Sandeep Singhal to the Board of GVK BIO.

Sandeep Singhal, managing director, Sequoia Capital India, said, "The rapid growth of GVK BIO in the last few years has made it a global leader in the CRO market. With the strength of its management and leadership, we believe that the company is on its way to become a dominant force in the life science industry."

In a release, GVK BIO noted that it intends to use these funds to: expand capacity in drug discovery services, build a state-of-the-art campus at Hyderabad on a 25 acre site, provide new service offerings in pre-clinical and clinical space and pursue growth opportunities through mergers and acquisitions.

CSIR comes up with new agenda to support industry

Prof. Samir Brahmachari, the newly appointed secretary, department of scientific and industrial research (DSIR) and director general, Council of Scientific and Industrial Research (CSIR), has spelt out a three-fold agenda to give a fillip to in-house R&D in industry and position India's innovation efforts in the international arena.

Speaking at the 21st National Conference on in-House R&D in industry with the theme "R&D Innovations for Indian Growth Dynamics", in Delhi Prof Brahmachari stressed the need to be aggressive in the pursuit of innovations by earmarking 25 percent of total private sector and government investment in long-term R&D, not with an eye on the immediate gains but for returns in the future.

Dr T Ramasami, secretary, department of science and technology, in his address emphasized on the importance of R&D and the close relationship between R&D and overall growth.

Dow India to set up global R&D center in Pune

Dow India, a unit of Dow Chemical, the largest US chemical maker has signed a Memorandum of Understanding (MoU) with the Maharashtra government, to set up a global R&D center at Pune. The center is expected to be operational by 2008 and will employ 500 researchers by 2010. Initial project related activities are underway on the 100-acre land allotted to the company by Maharashtra Industrial Development Corporation (MIDC) and more than 125 researchers are already employed and providing their talented skills and capabilities, operating in a rented facility.

VK Jairath, principal secretary (industries), Government of Maharashtra and Vipul Shah, CEO, Dow Chemical International, signed the MoU in the presence of Vilasrao Deshmukh, chief minister of Maharashtra, Johnny Joseph, chief secretary, Government of Maharashtra, Michael Gambrell, executive vice president, The Dow Chemical Company, Dr Deepak Parikh, technical director of Dow India's global R&D center and other senior officials of the state government.

Vipul Shah said, "With total investment going beyond $100 million, the center will have the capacity to bring a new product to market – from concept to commercialization. The R&D center will be an integrated center, serving multiple clients and geographies and will accelerate growth of the region through customer support, application development and problem solving in the areas of water, personal care, paints and coatings. Dow India is excited that the center will partner with government laboratories and educational institutions, funding research to generate intellectual property."

VK Jairath said, "Through our association with a global leader like Dow for establishing this world class R&D center, we take a step forward towards our goal of boosting the economic development in the state through rapid industrialization. We have constantly endeavored to accelerate sustainable development through industrial growth across Maharashtra."

ClinTec International plans significant expansion of its Indian operations

ClinTec International, the UK-based Contract Reseach Organization (CRO) is all set to foray into drug development and has announced plans to expand its Indian outfit in a major way. Located at Bangalore, the Indian arm of Clintec International will be developed into an important global center and serve as Asia's hub for its international operations. ClinTec International has recently opened its global clinical research Center of Excellence in Munich, Germany. Following another successful year of financial and headcount growth, the global clinical research Center of Excellence has been established with the recruitment of thirty clinical research professionals of vast experience, based from a single large hi-tech facility in a central Munich location.

Reinforcing ClinTec's reputation as a full-service CRO, the Center of Excellence will be the global home for standards, tools and industry best-practice in the following functions: clinical program management, data management and biostatistics, clinical research, pharmacovigilance, regulatory affairs, medical writing and quality assurance.

Sharing details of the expansion plans in India, Dr Rabinder Buttar, president and founder, ClinTec International, said, "ClinTec International is focusing on India in a very big way and aims to bring many global projects to India. We plan to increase the head count in India from the existing 25 to about 100 employees in the near future. ClinTec India contributes about 25-30 percent of Clintec International's global revenues. The Bangalore arm of ClinTec will support and drive the work at ClinTec International's newly opened global clinical research Center of Excellence in Munich, Germany. We are proud to know that ClinTec International is perceived as the number one CRO by market analysts when it comes to advising the pharmaceutical industry."

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