(L-R) Sudhir Trehan, chairman, CII Western Region Council, Ashok Chavan, minister for industries and mines, Government of Maharashtra, V K Jairath, secretary - industries, Government of Maharashtra, Dr Swati Piramal, event chairperson and director, Nicholas Piramal India Ltd, at the Maharashtra Biotech Day celebrations in Mumbai.

Maharashtra launches portal on biotechnology

Maharashtra, one of the first few states to announce its biotech policy in 2001, took four years to launch its own dedicated biotech website. The state finally launched a website at the fourth national conference on "Bio Business Opportunities in India" held on November 14 at Mumbai.

Ashok Chavan, minister for industries and mines, cultural affairs and protocol, Government of Maharashtra, inaugurated the website hosted by the Maharashtra Biotechnology Commission, at the conference that coincided with Maharashtra Biotechnology Day. The event which was organized by the Confederation of Indian Industry in association with Government of Maharashtra, highlighted the measures initiated by the state to attract investment in the biotech sector.

Chavan said, "We welcome foreign direct investment (FDI) in biotech sector and believe that developing the biotech sector will go a long way towards ensuring a better quality of life."

VK Jairath, secretary - industries, Government of Maharashtra said, "In this new century, the emergence of knowledge-based industries provides great potential. Biotech is the new sunrise industry, which will make the growth of the country possible in future."

In a recorded address, Dr RA Mashelkar, director general, CSIR, emphasized that the 21st century has seen the emergence of biotech as a major power. The Maharashtra Biotechnology Commission website will provide all the information about what Maharashtra and biotech can offer to
investors.

Delivering the theme address, Dr Swati Piramal, event chairperson and director, Nicholas Piramal India Ltd, touched upon the impending crisis of Avian Flu, terming it the "burning issue of biotech."

"Maharashtra does not have the mechanism to monitor and detect flu outbreaks. Diagnostic pathology labs will need to get ready for quick diagnosis and corporates will have to keep a stockpile of disinfectants. This is not just about one drug, one idea, it is a time for collaboration. Dealing with the pandemic will need combined efforts of Indians here and abroad. It is the biggest challenge for the biotech sector," said Dr Piramal.

Sushil Kumar Shinde, governor of Andhra Pradesh, launching BioAsia 2006 by releasing a brochure at the Raj Bhawan in Hyderabad.

AP Governor launches BioAsia 2006

BioAsia 2006, the 3rd edition of the prestigious annual biotech event of the Andhra Pradesh government, was officially launched by Sushil Kumar Shinde, governor of Andhra Pradesh, at the Raj Bhawan in Hyderabad on November
20, 2005.

The event, which has grown considerably over the last two years, will be held in the upcoming world-class International convention center (ICCH) in Hitex from February 9-11, 2006. TiE (The Indus Entrepreneurs) will sponsor a special session titled "Nurturing Entrepreneurship in Biotechnology". There would also be a session on biotech parks, "Bio-Cluster Development in India", which will be chaired by Dr M K Bhan, secretary, DBT and industry secretaries from Gujarat, Andhra Pradesh, Karnataka, Uttaranchal, Tamil Nadu, Kerala, Orissa, West Bengal, Maharashtra and Punjab.

BioAsia 2006 will offer a perfect platform to showcase products and services to the life sciences community in India and abroad. It will bring together the best of biotech companies, research scholars, scientists, thinkers, entrepreneurs and government dignitaries to collaborate, share and build fruitful business alliances globally. The three-day event will also feature a CEO Conclave, an international tradeshow, business forum and conference

Lakshmi Parthasarathy, principal secretary, industries and commerce department, BP Acharya, vice chairman and managing director, APIIC, Dr A Ashok, director of Biotechnology and Dr B S Bajaj, chairman, AIBA- SC, were present at the launch.

Pune University offers certificate course in CRCDM

The University of Pune in association with Synergy Network has started offering certificate courses in Clinical Research and Clinical Data Management (CRCDM). The first batch was started on November 18, 2005.

Dr Indira Ghosh, course director said, "Certificate course in CRCDM will be covered in two modules within six months (one semester) of duration. Keeping in mind the requirement of professionals, mostly medical practitioners (doctors), this course is scheduled on weekend only i.e. Friday (partly), Saturday and Sunday. The course will have regular classroom lectures, seminars, webinars, tutorials, case studies, and internship."

Haseltine Foundation to replicate Indian healthcare models

"India is a place of innovation in the development of sustainable private social healthcare models. In India we find high quality low cost medicines and procedures. We want to understand this concept and replicate the successful model in other countries such as China and Sub Saharan Africa," said Dr William Haseltine, president, William A Haseltine Foundation for Medical Sciences and Arts.

Speaking to BioSpectrum, Dr Haseltine said, "We are looking at different models adopted by many successful healthcare institutions such as LV Prasad Eye Institute, Hyderabad and Asian Heart Institute, Mumbai, in central and south India. The idea is to have a hybrid model between the public sector, private and non-profit institutes that would be low-cost and high-volume with a greater reach."

Dr Haseltine said, "We are organizing conferences on Social Entrepreneurism in HealthCare in different places including India. The Aspen Institute of India, the Aspen Institute, the Global Business Coalition on HIV/AIDS, the Lind Family Trust and The Strategic Partners Group of Companies are supporting this program."

On the focused areas of foundation he said, "Initially our focus will be on areas such as gastro and eye care, cardiac and HIV/AIDS care. We will fund these initiatives in India. John-Michael-Lind, founder and chief of the Strategic Partners Group of Companies (TSPGC), based out of Mumbai, will monitor the day-to day operation of the project. The first phase will complete in 3-6 months."

"Contamination is a key factor in fermentation process"

"Contamination is a key factor in fermentation process. It will have negative impact on the end result if proper steps are not taken. There are many ways to overcome this problem such as proper operation of fermentors, proper sterilization of growth medium etc.," said Bipin Deshmane, general manager, Shreya Biotech.

He was speaking after inaugurating the "Certificate Course on Fermentation Technology" at Shivaji College, Barshi near Solapur in Maharashtra. The University Grants Commission has recognized this course. It is open for undergraduate students of Microbiology.

Deshmane said, "Fermentation is the most mature area of biotechnology and in many respects it might be said to be the most fundamental. Whatever potential biotechnology has for expansion amongst the vast array of living forms by genetic manipulation, we will invariably end up with some form of fermentation and the requirement for a 'fermentor' wherein microorganisms are cultivated."

Suven presents pre-clinical data of its NCEs

Suven Life Sciences, a Hyderabad - based life sciences company has made data presentation of its portfolio of investigational neuroscience compounds at 'Neuroscience 2005' an annual meeting of the Society for Neuroscience (SFN) held at Washington DC, USA.

Suven has presented new data for four promising areas of neuroscience viz. Alzheimer's, Schizophrenia, Parkinson and Obesity diseases. These areas present significant unmet medical need for which current treatment options are insufficient. Suven has a number of programs in each of these areas, focusing on novel approaches that may lead to the development of new therapies for patients.

Suven's presentations at SFN include Effect of selective 5-HT6 receptor antagonists on food-intake and body weight gain; SUVN-501: A potent and selective 5-HT6-receptor antagonist reverses scopolamine-induced amnesia in Morris water maze; SUVN-502: Pharmacological profile of SUVN-502: A potent and selective 5-HT6-receptor antagonist; Effect of selective 5-HT6 receptor antagonists SUVN-501 and SUVN-502 in rodent model of working memory; and Effect of selective 5-HT6 receptor antagonists in rodent models of learning.

Lupin gets DCGI nod to conduct trials for LLL-3348 (Desoris)

Mumbai-based Lupin Ltd has received approval for conducting phase II clinical trials of its Investigation New Drug candidate LLL-3348 (Desoris) from the Drug Controller General of India (DCGI). Desoris is proposed for the treatment of moderate to severe chronic stable plaque-type psoriasis.

Desoris is an herbal aqueous extract of a single plant that has a novel mechanism of action and effectively modulates the cellular function leading to marked psoriatic lesion improvement without any toxic effects. The candidate has been developed conforming to guidelines laid down by the US FDA for botanicals as well as DCGI guidelines on new drug development. The project is being developed in collaboration with the CSIR's NMITLI program.

Dr DB Gupta, chairman, Lupin Ltd said, "There is an imperative need for effective and safe drugs to be made available in the global pharmaceutical market for psoriasis and we are very excited that the regulatory authorities found our data promising enough to give us permission for further trials." The approval comes on Lupin's successful completion of the therapeutic evaluation and safety profiling of Desoris in a phase I single and multiple dose study in healthy volunteers. Desoris being an orally bioavailable and safe drug, will now be evaluated for efficacy in patients in a phase II clinical trial by Lupin Ltd. spanning 10 sites across India, starting very shortly.

Dr Reddy's launches 'Save The Foot' initiative

To educate patients on care for diabetic feet and prevent amputations, Dr Reddy's Laboratories, that conducts research in the areas of diabetes, cardiovascular, anti-infectives, inflammation and cancer, launched the 'Save The Foot' initiative in Mumbai. The launch of 'Save The Foot' coincides with this year's World Diabetes Day slogan "Put Feet First. Prevent Amputations."

To support this campaign, Dr Reddy's will be organizing more than 1000 foot care camps across the country in the next six months, conduct workshops for doctor awareness and launch patient information websites, to name a few.

Speaking about this initiative, Satish Reddy, managing director and COO, Dr Reddy's Laboratories said, "Through this initiative we will be putting in significant effort to raise awareness in India about this devastating yet largely preventable complication. Through our tie-up with IDF, support of the doctor fraternity, district level workshops, foot care websites, along with other mass media vehicles, we will do our best to create empowered diabetic patients and strive to reduce amputations."

Quoting Dr Arun Bal, president, Diabetic Foot Society of India, a press release said, "Diabetic foot problems are going to reach epidemic proportions in India in the next few years and it is estimated that majority of diabetics in India will be in the age group of 35-45 years. Losing one's feet to diabetes can be devastating for anyone, but if it happens in the most productive years of a person's life, it can cause a huge emotional and economic burden on the patient, his family, the society and the country on the whole. The key to prevention of amputations is patient education and awareness, so that the society is able to tackle foot disease when diabetes reaches endemic proportions."

"We need cost effective strategies for educating diabetes patients and caregivers as no amount of advances in medicine or technology will work in the prevention of diabetic foot ulcers. On behalf of the doctor community, I can say that initiatives like 'Save The Foot' can contribute immensely in prevention of amputations, and in reducing the healthcare burden on our country through patient education and empowerment through knowledge," said Dr Bal.

Biocon inks licensing pact with Bentley Pharma

Biocon has signed a product licensing agreement with Bentley Pharmaceuticals, a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe for Bentley's intranasal spray formulation for administering insulin. The license agreement covers 85 countries granting Biocon exclusive as well as co-exclusive rights to develop and market throughout Asia, Africa, and the Middle East.

Biocon also announced that it has entered into a long-term supply agreement with Bentley that will provide Bentley, and its licensees, with a competitive supply of insulin for worldwide markets. The terms of the agreement assure Bentley of a commercial supply of Insulin for worldwide markets.

Biocon and Bentley will work together in the clinical development of the intranasal insulin product to meet the requirements of various international regulatory authorities including USA, EU and ROW. The two partners will share the cost of clinical development and regulatory filings in their respective territories. The specific terms of the agreement were not disclosed.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd said, "Biocon believes that non injectable insulins will drive the future of diabetes therapy. Along with our own program in oral delivery of insulin, this development agreement will give us the breadth of opportunity to straddle the entire domain of non-injectable insulin delivery. As one of the largest producers of insulin, this cooperation is of great strategic importance to us."

James R Murphy, chairman and CEO, Bentley Pharmaceuticals said, "We believe that this collaboration has laid a foundation that will significantly support the strategic developmental and commercial objectives of Bentley. We have received regulatory approval to continue our clinical development program and initiate our first study in Asia. Clinical supplies have already been produced utilizing Biocon's raw material and the studies will begin shortly."

"We see CRO as a big market segment in India"

Wim Cypers, vice president, product management, Aris Global

US-based Aris Global, a global leader in the area of pharma safety software, has been harboring a closely guarded secret for long. The company's successful position in the pharma and biotech industry, where it counts over 120 customers, can be attributed to Aris' sole software development center in Bangalore that houses over 370 employees. Aris Global has plans to expand its product development center in Bangalore. The company started this center here as early as 1987, a good 15 years before outsourcing became a buzzword. Now, after gaining good leverage in the pharma industry, the company is now slowly waking up to the Indian CRO and clinical trials market. Priya Padmanabhan of CyberMedia News caught up with Wim Cypers,vice president, product management, Aris Global, in the presence of Ajit Nigam, sales manager, Aris Global.

What kind of products does Aris Global provide?

Aris Global is a US-based company focused on providing software products and solutions for the pharma sector. We have products in four domains - pharma drug safety, regulatory compliance, clinical trials and medical communications. We have been in operation since 1985. We started off then with a custom project in pharma safety when there was no other such software in the market.

We commercialized the product in 1987 and since then we are the market leaders in the pharma drug safety space.

Apart from the products, we also provide services to our customers such as system implementation, migration, integration and specific application development, to its customers

How do you distinguish yourself against big software companies?

We are in a unique position because our core focus is the pharma and biotech sector. So we are attuned to the needs and specific requirements of the customers. Aris has developed considerable expertise since it has been in this field for more than 15 years. We have constantly worked with our customers and expanded our suite of products over the years. Compared to big competitors whose software products are more general, we can enable our customers' applications to talk to each other. Every country has its own regulations around pharma. Instead of building solutions for specific regions, we make sure we cover all aspects of regulation for various areas so that customers can deploy the software in any country.

FDA and EMEA have recognized us for our efforts.

What is the role of the Indian development center in Bangalore?

Aris Global was one of the earliest companies to realize the potential of Bangalore. Our founders who are based out of the US, decided to start a software product development center in Bangalore in 1987. We have always recognized the benefit that India provided. Today, we have over 370 employees, working on all our products. We plan to increase our team size further and also focus on providing more services to our customers. We have around hundred people working in the US and Europe on sales and marketing and software implementation. In Japan, we have a tie-up with CTC Technologies to market our products.

What plans do you have for the Indian market?

For the last 15 years, Aris leveraged the Bangalore center for developing our software products. It is only now that we are starting to look at the Indian market. The contract research outsourcing and clinical trails market is growing in India. We feel these companies would be interested in our products. Also, Asian countries like China and India are looking to have regulations around pharma and patent legislations. We feel that local Indian CROs would require our regulation software to meet the requirements of their global customers. We see CRO as a big and growing market segment in India. We recently appointed Ajit Nigam to pursue opportunities in India.

Can you throw some light on your customer base?

We have over 120 customers world wide including Pfizer, Amgen, Novo Nordisk, Aboott Laboratories, Bristol Myers Squibb, Leo Pharma, 3M, Daiichi, GE Healthcare among others.