AAALAC accreditation for the GVK Biosciences
Animal House

GVK Biosciences’ animal facility received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. After an extensive on –site evaluation, AAALAC determined that GVK Biosciences’ animal facility was committed to the highest standards of animal care and research practices.

The AAALAC team was impressed with the animal welfare, high standards of humane care and use of research animals.GVK BIO is the first organization in Hyderabad and only the 6th in India to receive the AAALAC certification. The endorsement of AAALAC is a validation of GVK BIO’s abilities to deliver World Class Solutions.

GVK Biosciences enters into an early stage research agreement with Bayer CropScience

GVK Biosciences and Bayer CropScience have entered into research cooperation in the area of early discovery chemistry. The key objective was to speed up the search for promising active ingredients for innovative crop protection products. Under the agreement, Bayer CropScience integrates GVK BIO capacities in the early part of its discovery chemistry process to increase efficiencies in Research.

GVK Biosciences strengthens top management

Dr Cecil B Picket appointed Scientific Advisor to the GVK BIO Board Dr. Cecil B. Pickett has been appointed as the Scientific Advisor to the Board of Directors, GVK Biosciences. He has served as the President, Research and Development, and member of the Board of Directors, Biogen Idec, for three years. Prior to joining GVK BIO, Dr. Pickett held several senior R&D positions at Schering-Plough and Merck & Company. Dr. Pickett’s experience in drug metabolism, molecular pharmacology and expertise in leading drug discovery initiatives, will be invaluable to GVK BIO in building the organization to provide a wide range of scientific solutions globally.

Dr John Ellingboe joins as Senior Vice President, Discovery Research Dr. John Ellingboe has joined GVK Biosciences as Senior Vice President, Discovery Chemistry. Prior to joining GVK BIO, Dr. Ellingboe worked with Wyeth Research and Pfizer for 25 years in senior scientific positions and has extensive background in medicinal chemistry and drug discovery. He will lead the Medicinal Chemistry efforts of various Collaborative Research programs and will play a key role in guiding GVK BIO’s future Collaborative Research efforts. You can contact Dr. Ellingboe at john.ellingboe@gvkbio.com

Keith Mackay is the Vice President – Sales & Marketing, North America- Chemistry Keith J Mackay has joined GVK BIO as the Vice President- Sales & Marketing, Chemistry Services. Keith comes to GVK Biosciences with a background of Scientific and Business Development Experience. Keith was earlier associated with Codexis and Merck. At Merck, Keith also handled the role of Strategic Outsourcing & Business Affairs. At GVK BIO, Keith is responsible for Chemistry Services sales including, Med Chem, Process R & D and Custom Synthesis. You can contact Keith at keith.mackay@gvkbio.com

	Christopher Ryan is the Biology head for Sales & Marketing Christopher Ryan has joined as the Director- Sales & Marketing, for Biology. Chris comes to GVK Biosciences with over 11 years of CRO sales experience and has worked at Harlan Laboratories, Inc (Formerly known as RCC, Itingen, Switzerland). Chris works from the US. You can contact Chris at chris.r@gvkbio.com

FOCUS: Clinical Research

GVK Biosciences initiates clinical trials in Bangladesh

GVK BIO has initiated site monitoring activities in Bangladesh on behalf of Swiss-based & US-based NGOs. The trials are focused on the treatment of Visceral Leishmaniasis (commonly known as kala-azar) which is found predominantly in central Bangladesh (areas near to the capital city Dhaka). The country although similar to our West Bengal (India), has challenges of its own. These projects are giving us opportunities to learn about the regulations followed in Bangladesh for the conduct of clinical studies and to learn more about the people and country. GVK BIO enjoyed the full support of the study team, participating institutions and the government. This is GVK BIO’s first step towards handling International Clinical Trials.

GVK Biosciences joins ResearchPoint Global

GVK BIO joined ResearchPoint Global (RPG) a full service international CRO to further expand its global footprint. This will provide both with an access to an extensive network of experienced and proven investigative sites and country-specific regulatory, clinical and technical expertise across the globe. As the growth of India’s participation in global clinical programs continues to increase at a rapid pace, RPG strategically sought to expand its reach to this region. GVK Biosciences expands upon the ResearchPoint Global objective of providing sponsors with the ability to conduct international studies.

LMS Tool @ Clinical Research

GVK BIO takes its commitment to excellence in quality performance very seriously and in line with this has implemented the Learning Management System (LMS) in its Clinical Research Division. The LMS is a tool specifically designed for facilitating training and talent management. It gives employees’ access to various training modules based on their roles and responsibilities. There are continuous assessments through question banks attached to each course, with a minimum requirement of 80% to pass. They can access this from anywhere and complete them at their convenience as long as it is completed within the set timelines. For the clients too, study audits will be much easier now. With the help of the LMS clients can easily understand and track the diverse skill sets of the employees.

New Services from GVK Biosciences

Bio-IT “GVK BIO’s Informatics division” one of the leading providers of manually curated Structure Activity Relationship (SAR) Databases of small molecule inhibitors is now providing services for automated update of data on a real time basis. The scientific databases are more complex and given the nature that these would keep evolving on a continuous basis, developing an automated upload to the client’s environment to suit the growing demands is quite a tough task. Most clients of SAR Databases are appreciative of the fact that having access to live data adds more value to their ongoing research. GVK BIO has a large BIO-IT team of scientific application developers with domain knowledge of life science, who work on various client based projects in developing work flow and scientific information management systems. The team also supports several in-house projects like scientific application development and maintenance. The BioIT team played a key role in developing and launching GOSTAR, www.gostardb.com and GOBIOM, www.gobiomdb.com.

Design and Synthesis of Virtual Compound Libraries

Virtual screening, in particular, the structure-based virtual screening, has emerged as a reliable, cost-effective and timesaving technique for the discovery of lead compounds. Utilizing our strength in Medicinal and Computational Chemistry, GVK BIO now designs and synthesizes lead-like, drug-like fragment and molecule libraries to enrich chemical space of our client’s compound repository. Features include:

• Discovery (~ 80-90% of total library) and Targeted Collection (10% of total library)
• To begin with > 500 chemical templates representing over > 50000 compounds (a rolling process)
• Pre-filtration using Rule-of-Five analysis and MedChem filters
• Comprehensive QC of all compounds
• QC by NMR, HPLC.MS or LC MS and other options
• Compound replenishing and back-up guarantee
• Fragment and property based diversity, completeness and lead likeness
• Strategic surveillance and novelty assessment
• Feasibility, parallel synthesis and validation
• Unique intermediate and protocol development
• High throughput QC
• Data mining and IT platform integration

We offer both exclusive and non-exclusive contracts. Look forward to our soon to be launched web-based interface! For more details log onto: http://www.gvkbio.com/ch-synthesis-librari.html

Case Study: Speed, Quality and Value-addition at work

Great challenges are met and expectations exceeded by sheer strong determination and the will to succeed. It is best exemplified with two very important milestones achieved this quarter with two diverse but equally challenging projects that were successfully completed, on time. The first was an Analytical Project that required separation of individual components using Preparative HPLC from a cluster of more than twelve closely eluting peaks. Not only was the project completed on time but instead of the required four compounds, six were isolated and in much larger quantities than expected. The chemists worked round the clock to make the impossible possible.

The second milestone is a great example of personnel from different departments taking up a challenge together against all odds and succeeding. GVK BIO accepted to supply an API (10 kg), ready for NDA filing, to be produced under cGMP conditions and that too only in 8 weeks. The challenge was daunting indeed as the six step MedChem process needed to be completely overhauled. Sheer hard work by the entire team, working day and night, ensured that all the experimental, scale-up, analytical and regulatory work was completed, and about 12 Kg of the cGMP material was ready to be shipped for the customer to make the filings on time. In the process, the customer was thrilled and extremely appreciative of the work.

Clinical Pharmacology Unit gets a new API 5500 LCMS

The Clinical Pharmacology Unit of GVK BIO which draws a good portion of its business from Bioanalysis, bettered its client delivery system a step further by the inclusion of a new API 5500. Where with the API 4000, the lowest LLOQ hit stood at 10 pg/ml, with the new API added, we look at hitting levels as low as femtogram a level which is a breakthrough in itself in Bioanalytical service provision. The AB SCIEX Triple Quad™ 5500 system is today’s most sensitive triple quadrupole mass spectrometer. It is designed to deliver the highest level of sensitivity and robustness for even the most complex matrices.