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
“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.