GVK BIO - Newsletter Nov'09

GVK Biosciences is the winner of the European Outsourcing Award 2009 for Best New Partnership along with Wyeth Research

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Manni receiving the awardGVK Biosciences (GVK BIO) along with Wyeth Research won the prestigious European Outsourcing Award 2009 for the Best New Partnership. European Outsourcing Award 2009The award was received by Manni Kantipudi, President, GVK BIO at a ceremony held at the Intercontinental Grand, Madrid, on 14th October. GVK BIO-Wyeth came out as winners amongst several competing entries.

GVK BIO and Wyeth received the award for their nomination – GVK BIO & Wyeth : Value Co-creators. Wyeth had chosen GVK BIO in early 2006 to set up a 150 FTE Built to Suit research facility in India. Based on GVK BIO’s delivery, mutual respect and trust, Wyeth had expanded its collaboration to cover Chemoinformatics, Clinical Research & Biology. Wyeth had signed a Collaborative Research Development deal with GVK BIO in 2008.

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GVK Biosciences moves Corporate Office to Nacharam

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GVK BIO Research Facility at Nacharam, Hyderabad - IndiaGVK Biosciences, Asia’s leading research services organization has moved closer to its research team, to its Campus at Nacharam. This movement is expected to increase collaboration and quicker decision making between the corporate, support and research teams. Coordinates of the new GVK BIO corporate office:

GVK Biosciences Private Limited
#28 A, IDA Nacharam
Hyderabad 500 076, India
T 91 40 66929999
F 91 40 66929900
W www.gvkbio.com

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GVK Biosciences collaborates with Quantitative Solutions to develop and market Clinical Trial Outcome Databases

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Q SolutionsGVK Biosciences entered a strategic collaboration with Quantitative Solutions (QS), an industry leading modeling & simulation consultancy firm to develop and market clinical trial outcome databases. The databases capture summary level data for the clinical safety and efficacy outcomes from publicly available data sources.

GVK Biosciences will distribute globally the existing QS databases in five indications including Rheumatoid Arthritis & Psoriasis, Chronic HCV, Neuropathic Pain, Osteoporosis (postmenopausal) and Major Depression immediately. GVK BIO and QS plan to jointly develop and market additional databases in Dyslipidemia, Schizophrenia, Alzheimer’s, and other indications shortly.

The Clinical Trial Outcome Databases are designed to assist drug development teams conduct comparative efficacy and safety analysis, link/scale biomarkers to clinical outcomes, predict/improve trial outcome, and develop product differentiation strategies. The databases will be supported by customization and modeling & simulation consulting services provided by GVK BIO and QS, respectively, to ensure maximum flexibility and benefits to the clients.

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GVK Biosciences, the first CRO in India to use SFC Purification Technology to deliver high quality services

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SFC Purification TechnonlogyGVK Biosciences invests in the best of infrastructure and instrumentation to enhance quality, improve productivity and timelines. GVK BIO’s Analytical team has several years of industry experience. Ably supported by state-of-the art infrastructure and cutting edge technologies, the Analytical team is well versed with the modern analytical instrumentation and techniques. SFC Purification Technology is the latest addition to the GVK BIO analytical capabilities. SFC chromatography ensures fast and economical delivery and is one of the fastest growing technology for purification.

GVK BIO is ready to undertake normal phase, chiral purifications. GVK BIO has proven capabilities in purification of Regioisomers, Syn and Anti-syn isomers. GVK BIO can purify compounds ranging from milligram to gram level.

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GVK Biosciences organizes a Clinical Trial Workshop for media personnel

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The Clinical Pharmacology division of GVK Biosciences organized a Workshop on “Demystifying Clinical Trials” for media personnel at Hyderabad, India. The Workshop provided healthcare journalists with a Biostatistical Servicesgood understanding of the drug discovery and development process thus enabling greater appreciation of the context in which clinical trials / bioequivalence studies are conducted. The focus was on issues relating to human subject mobilization and protection.

Chairing the session, Dr.Shoibal Mukherjee, Senior Vice President – Clinical Development, shared his experiences and views on the Clinical Trial process and highlighted the best practices adopted by GVK Biosciences to ensure highest safety of subjects/volunteers involved in the process.

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Gerhard N. Mayr joins GVK Biosciences Board

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Gerhard N. MayrMr. Gerhard N. Mayr joined the GVK BIO Board of Directors in August this year. A Masters in Chemical Engineering and an MBA from Stanford University, Mr.Mayr had an illustrious career spanning over 32 years with Eli Lilly & Co. in various senior management positions. He is credited with expanding Lilly’s global footprint in several geographies besides creating new business segments across markets. As Executive Vice President at Lilly, he was responsible for the global pharma operations and sales/marketing.

Mr.Mayr sits on the Boards of several reputed organizations including UCB and Lonza. He is also Special Advisor to the Board of Codexis.

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GVK Biosciences introduces Biostatistical Services

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Biostatistical Services
Understanding the demands of product development and the shifting priorities, GVK BIO tailor makes approaches to meet client requirements. Our biostatisticians provide the critical expertise to ensure that all statistical aspects of your trial operate in harmony with research objectives and lead you to clear conclusions. Our experienced group of statisticians and programmers dedicate themselves to a project and see it through from inception to completion. GVK BIO can serve as statistical experts for your trial or liaise with your company’s internal statistical team to achieve your goals.

  • Statistical Inputs for Protocol Preparation
  • Randomization and Unblinding Procedures
  • SAS Programming
  • WinNonlin-PK Analysis
  • Interim Analysis
  • Sample Size Calculation
  • Statistical Analysis Plan
  • Validation of Biostatistical Programs and Outputs
  • Statistical Report Writing
  • Post hoc Exploratory Analysis

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GVK Biosciences opens new Clinical Pharmacology Center in Ahmedabad

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Ahmedabad BA / BE Center   Ahmedabad BA / BE Center

GVK Biosciences opened its new BA/BE facility for business in Ahmedabad recently. When GVK BIO was scouting for a new city to expand to meet its order book, Ahmedabad was the most preferred destination. Ahmedabad is home to more than 20 CROs and several leading Pharma companies. It has very good infrastructure and established healthcare support system. Ahmedabad is also well connected internationally and internally by Air and Road.

The new GVK BIO Clinical Pharmacology facility is located on the SG Highway. With 3 clinical wards and 120 beds, the Unit is state-of-the-art and designed to suit all regulatory requirements. It also has special housing facilities for female volunteers. Key features of this Unit include access to special population like young women, post-menopausal women, diseased population and access to about 12,000 volunteers. To start your studies or to get to know more, write to bdcpu@gvkbio.com

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