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class="blog-list-view-box"> <article id="post-7059" class="post-7059 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2024/04/Optimizing-Bioanalytical-Labs1-1.png" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/optimizing-bioanalytical-labs-with-elns-les-and-lims-software/" rel="bookmark">Optimizing Bioanalytical Labs with ELNS, LES and LIMS Software</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">April 30, 2024</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> </div> </div> </div> <div class="blog-list-content"> <p class="post_content">Bioanalytical labs play a crucial role in drug development, providing essential data to answer fundamental questions like “Does it work?” and “Is it safe?” The speed at which scientists can make informed decisions directly impacts the pace of bringing new drugs to market. To meet this challenge, labs are turning to digital solutions that streamline operations and improve data quality.</p> <h3>Unlocking the Power of Data</h3> <p class="post_content">One of the key assets in modern bioanalytical labs is data. Smart data management can save time, reduce waste, and provide reliable answers quickly. However, in many labs, data is scattered across various systems, including paper notebooks, and spreadsheets. This fragmented approach makes it challenging to leverage data efficiently, leading to missed opportunities and inefficiencies.</p> <p class="post_content">With the rise of connected instruments and advanced analytical instruments like ELNs, LIMSs, labs can now integrate their data into a central backbone. This integration allows for streamlined operations, reduced human errors, and improved data accessibility. By centralizing data, labs can create user-friendly reports, and workflows, enabling scientists to make faster, more informed decision</p> <h3>Power of ELN, LIMS and LES for Bioanalysis </h3> <p class="post_content">The digital transformation of bioanalytical labs is greatly facilitated by the use of Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and Laboratory Execution Systems (LES). These systems play crucial roles in streamlining operations, improving data quality, and enhancing decision-making processes.</p> <h3>LIMS (Laboratory Information Management Systems):</h3> <p class="post_content">LIMS are central to the implementation of a digital strategy in bioanalytical labs. They provide a structured framework for managing sample information throughout its lifecycle. By tracking sample details from login to disposition, LIMS ensure that data is captured accurately and consistently. This centralized approach to data management improves data integrity and accessibility, enabling scientists to make informed decisions more efficiently.</p> <p class="post_content">LIMS play a key role in integrating data from various sources, such as instruments, assays, and experiments. By providing a unified platform for data storage and management, LIMS enable labs to streamline operations and reduce manual errors. This integration also facilitates compliance with regulatory requirements, as data can be easily audited and traced back to its source.</p> <p class="post_content">Overall, LIMS contribute significantly to the efficiency and effectiveness of bioanalytical labs, enabling them to leverage data more effectively and make informed decisions.</p> <h3>ELN (Electronic Lab Notebooks):</h3> <p class="post_content">ELNs are another essential tool in the digital transformation of bioanalytical labs. They provide a digital platform for recording and managing experimental data, replacing traditional paper lab notebooks. ELNs offer several advantages over paper notebooks, including the ability to standardize workflows, automate data entry, and facilitate collaboration among scientists.</p> <p class="post_content">One of the key benefits of ELNs is their ability to standardize experimental workflows. By providing templates for recording experimental details, ELNs ensure that data is captured consistently and accurately. This standardization not only improves data quality but also makes it easier to search and analyze data.</p> <p class="post_content">ELNs also facilitate collaboration among scientists by providing a central platform for sharing and accessing experimental data. This collaborative approach to data management enables scientists to work more efficiently and effectively, leading to faster decision-making and better outcomes.</p> <h3>LES (Laboratory Execution Systems):</h3> <p class="post_content">LES are specialized systems designed to automate and enforce procedural steps in the laboratory. In the context of bioanalytical labs, LES play a crucial role in ensuring that experiments are conducted consistently and according to standard operating procedures (SOPs).</p> <p class="post_content">One of the key advantages of LES is their ability to enforce procedural execution during testing. By encapsulating SOPs into software, LES ensure that each step of the testing process is recorded and completed before moving on to the next step. This not only improves data quality but also reduces the risk of errors and deviations from protocol.</p> <p class="post_content">LES also facilitate real-time monitoring of experiments, allowing scientists to make informed decisions based on up-to-date data. This real-time feedback loop enables labs to respond quickly to changing conditions and optimize experimental workflows for better results</p> <h2>Refining Bioanalytical Labs: Unifying Digital Solutions for Efficiency, Quality, and Innovation </h2> <p class="post_content"><strong>1. Deliver a Platform-Based yet Personalized Laboratory Experience</strong><br /> While personalization of laboratory technologies can be beneficial in the short term, it often leads to information silos and challenges in information exchange. A platform-based approach, on the other hand, allows labs to leverage integrated modules aligned with standard enterprise-wide R&D terminologies and capabilities. This approach, facilitated by tools like LIMS and ELNs, enables better-quality study data generation and enhances collaboration among researchers. By adopting harmonized approaches across sites, labs can achieve enhanced visibility, real-time tracking of experiment statuses, and improved cross-experimental insights.</p> <p class="post_content"><strong>2. Leverage Digital Lab Tools to Unlock Operational Efficiency & Cost Savings</strong><br /> Digital lab technologies such as LIMS, ELNs, and quality management systems offer significant operational efficiencies and cost-saving opportunities. By retiring legacy systems, eliminating redundant data entry, and building audit trails, labs can streamline workflows, ensure data accuracy, and enhance compliance with regulatory requirements. Additionally, these technologies reduce employee time spent on manual tasks and enable real-time tracking of project workloads, leading to substantial time savings per employee.</p> <p class="post_content"><strong>3. Drive Enhanced Data Reproducibility & Data Analysis to Create Commercial Value</strong><br /> Data reproducibility is a critical challenge in bioanalytical labs, leading to wasted time, decreased resources, and lower scientific output. Digital platforms that enhance data quality and increase statistical power can address this challenge. By standardizing higher-quality data, labs can increase reproducibility and improve experimental performance. Furthermore, leveraging data analytics tools can help labs extract additional value from their data, accelerating the discovery of new indications and molecules.</p> <h3>Veeda’s Integration of LIMS, ELN, and LES Solutions</h3> <p class="post_content">Veeda’s Bioanalysis solution integrates Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), and Laboratory Execution System (LES) functionalities to optimize our bioanalytical lab operations. This integrated approach for bioanalytical studies by providing advanced data management, analysis, and automation tools in a single, cohesive system.</p> <p class="post_content">LIMS centralizes sample tracking and data management, ensuring traceability and compliance with regulatory standards. Meanwhile, ELN digitizes experimental data, improving collaboration and reducing manual errors. The LES further enhances our workflows by automating processes and enforcing SOPs, ensuring consistency and quality in our operations. This integration enhances our bioanalytical procedures into efficient, reliable testing methods, where we leveraging connected instruments and intelligent data management capabilities to consistently improve our deliverable outcomes.</p> <h3>Reference Articles:</h3> <p class="post_content"><a href="https://www.technologynetworks.com/informatics/articles/eln-lims-cds-les-whats-the-difference-313834" target="_blank" rel="noopener">https://www.technologynetworks.com/informatics/articles/eln-lims-cds-les-whats-the-difference-313834</a></p> <p class="post_content"><a href="https://www.labware.com/blog/streamlining-bioanalytical-testing-with-a-unified-lims-and-eln-solution" target="_blank" rel="noopener">https://www.labware.com/blog/streamlining-bioanalytical-testing-with-a-unified-lims-and-eln-solution</a></p> </div> <footer class="entry-footer"> </footer> </article> </div> <div class="blog-list-view-box"> <article id="post-6525" class="post-6525 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2024/01/Blog-Banner.png" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/quantifying-pharmacodynamic-biomarkers-drug-impact-and-bioanalysis-in-new-chemical-entity-development/" rel="bookmark">Quantifying Pharmacodynamic Biomarkers: Drug Impact and Bioanalysis in New Chemical Entity Development</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">January 11, 2024</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> </div> </div> </div> <div class="blog-list-content"> <h2>Overview</h2> <p style="font-size: 16px;">Pharmacodynamic (PD) biomarkers indicate how a drug affects its target, like a receptor triggering a signalling cascade. They reflect the drug’s impact on the body’s biological or physiological functions. Unlike pharmacokinetics, which focuses on how the body processes a drug, pharmacodynamics explores its effects and mechanisms. These markers are vital in clinical trials, helping assess a drug’s efficacy, safety, and optimal dosage, and in individualizing treatments. They’re crucial in drug development, aiding researchers and healthcare pros in understanding a drug’s interactions and suitability for its intended use. Developing <a href="https://www.veedacr.com/services/bio-analytical-services/" target="_blank" rel="noopener">New Chemical Entities (NCE)</a> involves discovering, designing, and synthesizing novel compounds for therapy. Bioanalysis, quantitatively measuring drugs and their metabolites in biological samples, is key in NCE development.</p> <h2>Challenges & Considerations</h2> <div class="table-responsive"> <table border="1" class="table"> <tbody> <tr> <td><strong>Factors</strong></td> <td><strong>Challenges</strong></td> <td><strong>Mitigations</strong></td> </tr> <tr> <td>Analytical Method Development and Validation<br /> <strong><b> </b></strong></td> <td>Developing and validating robust bioanalytical methods to quantitate the NCE and its metabolites in complex biological matrices</td> <td>Rigorously following regulatory guidelines, conducting thorough method validation, and adapting methods as needed during the development process</td> </tr> <tr> <td>Bio matrix Interference, Matrix Standardization, Sensitivity and Specificity</p> <p><strong><b> </b></strong></td> <td>Biological samples like blood or urine might have interfering substances affecting accurate drug measurement. Methods must detect low concentrations and differentiate the drug from other components, while individual differences impact consistency</td> <td>Efficient sample preparation using surrogate or diverse matrices, optimizing extraction protocols with advanced tools for precision & employing matrix standardization to address inter-individual variability in analysis</td> </tr> <tr> <td>Automation and Throughput with Emerging Technologies</td> <td>Maintaining accuracy while meeting high throughput needs. Adopting cutting-edge bioanalytical tech for large molecules, prioritizing contamination control, and addressing ethical considerations with minimal sample volume</td> <td>Automating processes, streamlining workflows for efficiency and staying updated on new tech; assess their relevance in NCE development with hybrid methods like LBA-MS</td> </tr> <tr> <td>Integration of Biomarkers<br /> <strong><b> </b></strong></td> <td>Incorporating biomarkers into bioanalytical strategies to provide insights into pharmacodynamics<br /> <strong><b> </b></strong></td> <td>Exploring and validating biomarkers that align with the pharmacological effects of the NCE</td> </tr> </tbody> </table> </div> <p> </p> <h2>Strategies for PD Biomarker Quantitation</h2> <p style="font-size: 16px;">Quantifying Pharmacodynamic (PD) biomarkers in bioanalysis involves careful planning and execution to ensure accurate and reliable measurement of the biological responses to a drug. Here are the strategies concerning requirements and rationale for PD biomarker quantitation in bioanalysis.</p> <div class="table-responsive"> <table border="1" class="table"> <tbody> <tr> <td width="22.2800%"><strong><b>Requirements</b></strong></td> <td width="39.0400%"><strong><b>Strategies</b></strong></td> <td width="38.6800%"><strong><b>Rationale</b></strong></td> </tr> <tr> <td width="22.2800%">Biomarker Selection and Validation</td> <td width="39.0400%">Choosing PD biomarkers that are relevant, specific, and validated to reflect the pharmacological effects of the drug</td> <td width="38.6800%">Selection based on a strong scientific rationale enhances the likelihood of meaningful results</td> </tr> <tr> <td width="22.2800%">Sample Collection and Processing</td> <td width="39.0400%">Establishing standardized procedures for sample collection and processing to minimize variability</td> <td width="38.6800%">Considering the choice of biological matrices, collection timing, and sample storage conditions</td> </tr> <tr> <td width="22.2800%">Calibration Standards and Quality Control Samples</td> <td width="39.0400%">Preparation of calibration standards with known concentrations of the PD biomarker and including quality control samples</td> <td width="38.6800%">Calibration curves ensure accurate quantitation, while quality control samples assess the precision and accuracy of the assay</td> </tr> <tr> <td width="22.2800%">Internal Standards</td> <td width="39.0400%">Incorporating internal standards into the assay for normalization and to correct for variations</td> <td width="38.6800%">Internal standards help account for analytical variability and matrix effects</td> </tr> <tr> <td width="22.2800%"><a href="https://www.veedacr.com/our-assay-list/" target="_blank" rel="noopener">Validation of Bioanalytical Methods</a></td> <td width="39.0400%">Rigorously validating bioanalytical methods & following regulatory guidelines</td> <td width="38.6800%">Validate for selectivity, sensitivity, precision, accuracy, linearity, and robustness</td> </tr> <tr> <td width="22.2800%">Use of Stable Isotope-Labeled Internal Standards</td> <td width="39.0400%">Employing stable isotope-labelled internal standards for accurate quantitation</td> <td width="38.6800%">Stable isotope-labelled standards closely mimic the analyte’s behaviour, enhancing precision and accuracy. In the absence of an isotope-labelled internal standard, an analogue IS with similar characteristics can be selected</td> </tr> <tr> <td width="22.2800%">Automation and High-Throughput Techniques</td> <td width="39.0400%">Implementation, automation, and high-throughput techniques for increased efficiency</td> <td width="38.6800%">Automation reduces human error, and high-throughput methods are beneficial in large-scale studies</td> </tr> <tr> <td width="22.2800%">Matrix Effects and Standardization</td> <td width="39.0400%">Addressing matrix effects by standardizing matrices or using matrix-matched standards</td> <td width="38.6800%">Matrix effects can impact accuracy, so careful consideration of matrix standardization is crucial</td> </tr> </tbody> </table> </div> <p> </p> <h2>Veeda’s Capabilities & Approach for Novel Drug Development Program</h2> <p style="font-size: 16px;">Bioanalysis is a vital part of drug development, focusing on accurately measuring drugs and their by-products in biological samples. A successful bioanalysis strategy involves method development, validation, and application in clinical studies.</p> <ul> <li>At Veeda, method development involves extensive research, considering various factors like drug properties, dose, linearity range, extraction protocols, chromatography, and equipment. Method validation includes experiments ensuring compliance with regulations, such as selectivity, accuracy, precision, sensitivity, matrix effects, and stability studies. In clinical sample analysis, it’s crucial for determining drug levels in biological samples. Incurred sample reanalysis validates reported sample analyte concentrations, ensuring reliability</li> <li>Employing emerging technologies like LC-MS/MS machines, ICP-OES, LIMS, and BSL-2 labs enhances our capabilities. Quality management systems (QMS) established protocols ensuring consistent quality standards, customer satisfaction, and regulatory compliance</li> <li>Data analysis and statistical approaches at Veeda derive meaningful insights from experimental results, ensuring their reliability and validity</li> <li>Regulatory compliance involves adherence to industry-specific laws, guidelines, and standards</li> <li>Cross-validation with clinical endpoints ensures alignment between laboratory analyses and clinical outcomes, establishing correlations between measured biomarkers/drug concentrations and therapeutic effects/safety outcomes</li> </ul> <p></p> <h2>Our Expertise in PD Biomarker Method Development & Validation</h2> <div class="table-responsive"> <table border="1" class="table"> <tbody> <tr> <td><strong>Biomarkers</strong></td> <td><strong>Veeda’s Expertise</strong></td> </tr> <tr> <td><strong>Alpha-1-acid glycoprotein</strong></td> <td>Determination of, α1 Acid Glycoprotein (AAG) of in K3EDTA Human Plasma by Using LC-UV with linearity range of 300µg/mL to 5000µg/mL</p> <p> </td> </tr> <tr> <td><strong>Coproporphyrin I</strong></td> <td>Determination of Coproporphyrin I in altered and Unaltered plasma by using LC-ESI-MS/MS, with linearity range of 50pg/mL to 5000pg/mL</td> </tr> <tr> <td><strong>Symmetric Dimethylarginine (SDMA)</strong></td> <td>Determination of SDMA in stripped and un-stripped plasma by using LC-ESI-MS/MS, with linearity range of 2.00ng/mL to 4000ng/mL</td> </tr> <tr> <td><strong>Uridine</strong></td> <td>Determination of Uridine and L-Dihydroorotic acid(L-DHO) in altered and unaltered, Plasma by using LC-ESI-MS/MS with linearity range of 30ng/ml to 30000ng/ml for Uridine and 3.0ng/mL to 3000ng/mL for LDHO</td> </tr> <tr> <td><strong>C-peptide</strong></td> <td>Determination of C-Peptide in human serum by Using ECLIA Method on Immuno-assay Analyzer Cobas e 411</td> </tr> </tbody> </table> </div> <p></p> <h2>Conclusion</h2> <p style="font-size: 16px;">Bioanalysis is pivotal in identifying, measuring, and characterizing Pharmacodynamic (PD) markers, which indicate a drug’s biological effects in an organism. Its role involves: </p> <ul> <li>Identification: Using techniques like mass spectrometry, immunoassays, and chromatography to screen and identify potential PD markers</li> <li>Quantification: Developing precise methods to measure PD markers accurately</li> <li>PK/PD Modelling: Integrating bioanalytical data into models for predictive insights on drug concentration and PD marker levels</li> <li>Dose-Response Assessment: Analyzing concentration-response relationships to establish dose-response curves </li> <li>Early Phase Development: Using bioanalytical data to guide decisions about dosing, further development, and safety concerns</li> <li>Safety Assessment: Identifying and measuring biomarkers that signal potential safety issues during drug development</li> </ul> <p></p> <h2>Reference:</h2> <ol> <li><a href="https://www.frontiersin.org/articles/10.3389/fphar.2023.1145962/full" target="_blank" rel="noopener">Abbas M, Alossaimi MA, Altamimi AS, Alajaji M, Watson DG, Shah SI, Shah Y, Anwar MS. Determination of α1-acid glycoprotein (AGP) concentration by HPLC in patients following local infiltration analgesia for primary total hip arthroplasty and its relation to ropivacaine (total and unbound). Frontiers in Pharmacology. 2023;14</a></li> <li><a href="https://www.future-science.com/doi/abs/10.4155/bio-2017-0246" target="_blank" rel="noopener">Kandoussi H, Zeng J, Shah K, Paterson P, Santockyte R, Kadiyala P, Shen H, Shipkova P, Langish R, Burrrell R, Easter J. UHPLC–MS/MS bioanalysis of human plasma coproporphyrins as potential biomarkers for organic anion-transporting polypeptide-mediated drug interactions. Bioanalysis. 2018 May;10(9):633-44</a></li> <li><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3062941/" target="_blank" rel="noopener">Shin S, Fung SM, Mohan S, Fung HL. Simultaneous bioanalysis of l-arginine, l-citrulline, and dimethylarginines by LC–MS/MS. Journal of Chromatography B. 2011 Mar 1;879(7-8):467-74</a></li> <li><a href="https://pubmed.ncbi.nlm.nih.gov/33120310/" target="_blank" rel="noopener">Yin F, Ling Y, Martin J, Narayanaswamy R, McIntosh L, Li F, Liu G. Quantitation of uridine and L-dihydroorotic acid in human plasma by LC–MS/MS using a surrogate matrix approach. Journal of Pharmaceutical and Biomedical Analysis. 2021 Jan 5;192:113669</a></li> <li><a href="https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder" target="_blank" rel="noopener">US Food and Drug Administration; U.S. Department of Health and HumanServices; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM). Bioanalytical Method Validation: Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration: Silver Spring, MD, 2018</a></li> </ol> </div> <footer class="entry-footer"> </footer> </article> </div> <div class="blog-list-view-box"> <article id="post-5924" class="post-5924 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2023/07/Advances-in-COPD.jpg" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/advancements-in-copd-asthma-treatments-challenges-and-future-directions/" rel="bookmark">Advancements in COPD & Asthma Treatments: Challenges and Future Directions</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">July 27, 2023</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> </div> </div> </div> <div class="blog-list-content"> <h2>Introduction </h2> <p style="font-size:16px"> Chronic Obstructive Pulmonary Disease (COPD) and Asthma are significant respiratory conditions that affect millions worldwide. In 2019, COPD accounted for 3.3 million deaths and 74.4 million disability-adjusted life years (DALYs), with a global prevalence of 212.3 million cases. Meanwhile, the prevalence of Asthma has been rising due to increased life expectancy and changing demographics. Additionally, the overlap of Asthma and COPD cases has become more frequent, presenting unique challenges in diagnosis and treatment.</p> <h2>Current Treatment Landscape </h2> <ol style="font-size:16px"> <li><b>Bronchodilators:</b> The use of both short-acting inhaled bronchodilators (albuterol and ipratropium) as rescue therapy and long-acting bronchodilators (LABAs and LAMAs) has become common. Several new bronchodilators are in development, showing promise for future therapies.</li> <li><b>Muscarinic Antagonist–β2-Agonists (MABAs):</b> MABAs are under clinical trials, though challenges exist in balancing their LABA and LAMA activity.</li> <li><b>New Corticosteroids:</b> Fluticasone furoate, a once-daily inhaled corticosteroid (ICS) in combination with vilanterol, offers a new option. However, safety concerns related to corticosteroids remain.</li> <li><b>Phosphodiesterase Inhibitors:</b> Roflumilast is currently marketed as an anti- inflammatory treatment in COPD, but its narrow therapeutic window limits its use.</li> <li><b>Kinase Inhibitors:</b> Some kinase inhibitors have shown promise in COPD and Asthma models, but challenges in specificity and side effects require further research.</li> <li><b>Mediator Antagonists:</b> CRTh2 antagonists, cytokine inhibitors, and protease inhibitors have been widely used in Asthma treatment, but their efficacy varies.</li> <li><b>Antioxidants:</b> While antioxidants like N-acetylcysteine and sulforaphane have been explored, their efficacy remains limited.</li> </ol> <h2>Challenges and Suggested Approaches</h2> <p style="font-size:16px">Researchers face challenges in developing novel drugs for Asthma and COPD, including limited investment by pharmaceutical companies, lack of funding for basic research, and a scarcity of helpful biomarkers. To overcome these hurdles, identifying new therapeutic targets and biomarkers is crucial for better patient selection and long-term therapy monitoring.</p> <h2>New approaches in COPD and Asthma treatment include:</h2> <ul style="font-size:16px"> <li>Reversing Corticosteroid Resistance: Finding solutions to the challenge of corticosteroid resistance in patients.</li> <li>Resolving Inflammation and Aberrant Repair: Addressing inflammation and tissue repair dysregulation.</li> <li>Decelerating Aging: Focusing on strategies to mitigate the impact of aging on disease progression.</li> </ul> <h2>Biomarker-Driven Trial Designs</h2> <p style="font-size:16px">Biomarker-driven trial designs are transforming the landscape of COPD and Asthma treatments, offering a more precise and personalized approach to patient care. These innovative trial designs focus on specific biomarkers that play a crucial role in understanding the underlying mechanisms of these respiratory conditions and predicting treatment responses.</p> <p style="font-size:16px">In COPD, eosinophilic inflammation is a key biomarker that helps identify patients who are more likely to respond favorably to inhaled corticosteroids (ICS) and certain biologic therapies targeting type 2 inflammation. Conversely, in non-type 2 inflammation, neutrophilia becomes a significant biomarker, guiding clinicians to explore alternative treatment strategies due to a reduced response to ICS.</p> <p style="font-size:16px">For Asthma, fractional exhaled nitric oxide (FeNO) levels serve as a valuable biomarker for type 2 inflammation. Elevated FeNO levels are associated with a higher likelihood of responding well to ICS and specific biologic agents like anti-IgE and anti-IL-4R treatments. Additionally, IgE levels can indicate atopy and predict better responses to ICS and anti-IgE treatments.</p> <p style="font-size:16px">Periostin emerges as a promising biomarker in both COPD and Asthma. It is associated with type 2 inflammation and airway remodeling, making it a potential indicator of treatment response to anti-IL-13 therapies in Asthmatic individuals with high periostin levels.</p> <h2>Summary of Clinical Trial Findings </h2> <p style="font-size:16px"> Biomarkers are essential tools in guiding treatment decisions and assessing therapy response for Asthma and COPD. These biomarkers help in patient stratification, identifying subgroups likely to respond to specific therapies, and reducing the risk of adverse effects.</p> <p style="font-size:16px">Contract Research Organizations (CROs) play a crucial role in advancing biomarker-driven research. They possess specialized expertise in biomarker discovery, validation, and analysis, accelerating the translation of research findings into clinical applications</p> <h2>Conclusion</h2> <p style="font-size:16px"> In conclusion, COPD and Asthma present significant global health challenges, affecting millions of people and causing substantial morbidity and mortality. The current treatment landscape has seen advancements, but unmet needs persist. Biomarkers offer promising opportunities fo personalized treatments, while CROs play a crucial role in advancing research and developmen efforts. To address the challenges, increased investment in respiratory medicine research is essential. By fostering collaboration and innovation among stakeholders, we can strive toward better management and improved outcomes for patients living with COPD and Asthma ultimately enhancing their quality of life.</p> <h2>References:</h2> <ul> <li><a href="https://www.bmj.com/content/378/bmj-2021-069679">https://www.bmj.com/content/378/bmj-2021-069679</a></li> <li><a href="https://erj.ersjournals.com/content/58/5/2004656#:~:text=According%20to%20a%20recent%2 0meta,%25%2C%20respectively%20%5B12%5D">https://erj.ersjournals.com/content/58/5/2004656</a></li> </ul> </div> <footer class="entry-footer"> </footer> </article> </div> <div class="blog-list-view-box"> <article id="post-5672" class="post-5672 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2023/06/veeda-cml.jpg" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/challenges-and-considerations-for-conducting-phase-2-chronic-myeloid-leukemia-cml-clinical-trials/" rel="bookmark">Challenges and Considerations for Conducting Phase II Chronic Myeloid Leukaemia (CML) Clinical Trials</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">June 21, 2023</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> </div> </div> </div> <div class="blog-list-content"> <h2>Disease Overview :</h2> <h5>Global Scenario : </h5> <p style="font-size:16px"> In developed nations, the prevalence of Chronic Myeloid Leukaemia (CML) is primarily concentrated among the elderly population, typically aged 60 and above. In contrast, in developing nations, the diagnosis of the disease occurs approximately ten years earlier, impacting individuals in their 50. It is the most common type of blood cancer.</p> <h5>Indian Scenario : </h5> <p style="font-size:16px"> Chronic Myeloid Leukaemia (CML) is a clonal myeloproliferative disorder of a pluripotent stem cell. CML is the commonest adult leukaemia in India and the annual incidence ranges from 0.8– 2.2/100,000 population in males and 0.6– 1.6/100,000 population in females in India.</p> <p>Out of the 250 CML Trials in active stage, 123 CML Trials worldwide are <a href="https://www.veedacr.com/services/late-phase-clinical-trials/">Phase II trials</a>. 38 CML Trials are exclusively industry funded or are in collaboration with academia and small biopharmaceutical companies.</p> <h2>Why there is need to conduct CML Trials?</h2> <p style="font-size:16px"> CML is the world’s first cancer with specific genotype knowledge, which led to a rationally therapeutic schedule. Imatinib, a tyrosine kinase inhibitor (TKI), was approved by the FDA to treat CML in 2001. The discovery of the TKI-based treatment, changed the CML disease status from a lethal disease to a chronic disease, especially for patients in the chronic phase. There has been an apparent improvement in the survival of CML patients in high-income countries like the United States, France, and Japan. The disease burden of CML distinctly varies in different countries due to diverse opportunities for early-stage screening, novel drugs and medical resources.</p> <h2>Prevailing trends in CML Clinical Trials</h2> <h5>Targeted Therapies : </h5> <p style="font-size:16px"> The development of targeted therapies, such as tyrosine kinase inhibitors (TKIs), has been a significant trend in CML clinical trials. TKIs, such as Imatinib, Dasatinib, and Nilotinib, have revolutionized the treatment of CML by specifically targeting the abnormal BCR-ABL protein responsible for the disease.</p> <h5>Treatment-Free Remission (TFR) : </h5> <p style="font-size:16px"> TFR is a growing area of interest in CML clinical trials. It focuses on the possibility of discontinuing TKI treatment in patients who achieve deep molecular responses, aiming to maintain disease control without the need for ongoing therapy.</p> <h5>Combination Therapies : </h5> <p style="font-size:16px"> Investigating the effectiveness of combining different TKIs or combining TKIs with other agents is an ongoing trend in CML clinical trials. Combinations may enhance treatment response, overcome drug resistance, and improve long-term outcomes for patients.</p> <h2>History of Targeted Therapy for CML Trials</h2> <p><img decoding="async" src="https://www.veedacr.com/wp-content/uploads/2023/06/Infographic-011.png" alt="Infographic" class="img-fluid alignnone size-full wp-image-5688" /></p> <h2>Key Challenges and Considerations: Operational & Clinical</h2> <p style="font-size:16px"> The challenges in CML clinical trials are based on the four phases as mentioned below:</p> <ul> <li>Chronic Phase</li> <li>Accelerated Phase</li> <li>Accelerated Phase with Patients with NO prior treatment</li> <li>Accelerated Phase with Patients with prior treatment</li> </ul> <p style="font-size:16px"> CML clinical trials across different phases present obstacles for CROs in their operational and clinical activities. These challenges include communication and coordination with sponsors, complex protocols, site monitoring difficulties, patient population identification, geriatric research, study cost management, staff training, and utilization of technology-enabled platforms.</p> <p style="font-size:16px"> *Below is the chart that shows the impact of these above mentioned challenges with respect to CML Phases for a CRO:</p> <figure> <a href="https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1.png" target="_blank" rel="noopener"><img fetchpriority="high" decoding="async" src="https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1.png" alt="" width="2592" height="2347" class="alignnone size-full wp-image-5689 img-fluid" srcset="https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1.png 2592w, https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1-300x272.png 300w, https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1-1024x927.png 1024w, https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1-768x695.png 768w, https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1-1536x1391.png 1536w, https://www.veedacr.com/wp-content/uploads/2023/06/CML_Changes-02-1-2048x1854.png 2048w" sizes="(max-width: 2592px) 100vw, 2592px" /></a></figure> <p style="font-size:12px"> *3/4 of the graph is blue: classified as a major impact, 1/4 of the graph is blue: classified as minor impact, 1/2 of the graph is blue: classified as neutral </p> <h2>Veeda Oncology</h2> <p style="font-size:16px"> In conclusion, CML clinical trials have witnessed significant progress, aided by the expertise of Indian CROs. With our proficiency in managing protocol complexities, addressing the unique requirements of the geriatric population, and optimizing costs, Veeda stands ready to accelerate your upcoming CML trial. We remain dedicated to offering exceptional support to sponsors engaged in CML research. By leveraging our extensive knowledge, sponsors can expect a seamless trial experience, adherence to regulatory requirements, and the generation of robust data. <a href="https://www.veedacr.com/contact-us/">Contact us</a> today to know more about Veeda’s CML trial services.</p> <h2>References</h2> <ol> <li><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142563/" target="_blank" rel="noopener" class="article_word_wrap">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142563/</a> </li> <li><a href="https://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/types-treatment" target="_blank" rel="noopener" class="article_word_wrap">https://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/types-treatment</a></li> <li><a href="https://ehoonline.biomedcentral.com/articles/10.1186/s40164-020-00185-z" target="_blank" rel="noopener" class="article_word_wrap">https://ehoonline.biomedcentral.com/articles/10.1186/s40164-020-00185-z</a></li> </ol> </div> <footer class="entry-footer"> </footer> </article> </div> <div class="blog-list-view-box"> <article id="post-3705" class="post-3705 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2022/01/Development-and-Execution.png" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/development-and-execution-of-in-vivo-bioassays/" rel="bookmark">Development and Execution of In Vivo Bioassays</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">January 8, 2022</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> </div> </div> </div> <div class="blog-list-content"> <p>Bioassays are involved in each stage of drug discovery, starting from Target Identification until discovering the Lead compound. Bioassays provide valuable information which displays the therapeutic potency of a drug under investigation.</p> <p>The data generated during bioassay also plays a vital role in drug development and quality control of finished biological products. Properly designed Bioassays help in assessing the biological effect, activity, signal transduction process, and receptor binding ability of drug product or biologic on a biological target (proteins) when compared to a reference or standard over a suitable biological system.</p> <p>The pharmaceutical and biotech companies involved in drug discovery and development are continuously challenged with developing biologically relevant assays for the analysis of multiple potential mechanisms.</p> <p>The process involves the use of quality critical reagents, use of specific cell lines, and purified test drug and reference drug products which at times may become a constraint. Most of these activities require sufficient time, which may become a limiting factor to biopharma manufacturers.</p> <p>It is worth outsourcing activities to <a href="/" target="_blank" rel="noopener">reputed CRO service providers</a> to save time in developmental efforts and also to have an unbiased opinion on the functional activities of the drug product.</p> <p>Veeda Group has qualified and experienced scientists to design, develop, execute, and validate the Bioassays for companies and provides premier bioassay services (<em>in vitro</em> and <em>in vivo</em>) that generate meaningful data to support pharmaceutical and biotech companies in their drug discovery and development journey.</p> <h2><strong>Veeda Group’s Experience in Development and Execution of Bioassays include:</strong></h2> <ul> <li>Plaque Reduction Neutralization Test (PRNT assay)</li> <li><em>In Vitro</em> Skin Sensitization Human Cell Line Activation test (h-CLAT assay)</li> <li>Nab Assay</li> <li>Assay Development (Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Biomarker Assessment)</li> <li><em>In Vivo</em> Bioassays for drug molecules like Luteinizing Hormone, Epoetin, HCG, Recombinant FSH, β-HCG, and Insulin.</li> <li>ADCC assay for biosimilars and different other assays like <em>Ex Vivo</em> assay, Cell-based assay, Receptor Binding Assay, Cytokine Release Assay, and ADA assay.</li> </ul> <p><strong>Veeda Group provides Integrated Discovery, Development & Regulatory Services with its multiple technology platforms:</strong></p> <ul> <li>Exploratory toxicology studies</li> <li>Regulatory toxicology studies</li> <li><em>In vitro</em> Bioassays</li> <li><em>Ex vivo </em>Bioassays</li> </ul> <p>The group also has the experience to handle a diverse range of Biotherapeutics like Therapeutic Monoclonal Antibodies, Insulin & Insulin Analogues, Cytokines, Low Molecular Weight Heparins, <a href="/biosimilar-bioanalysis/" target="_blank" rel="noopener">Biosimilars</a>, Hormones & Biomarkers.</p> <p>Veeda group has demonstrated capabilities to develop recombinant proteins such as non-glycosylated proteins and glycoproteins derived from either bacterial or mammalian host expression systems.</p> <h3><strong>Bioassays in Preclinical Drug Development</strong></h3> <p>Biological assays or bioassays are essential tools in <a href="/services/pre-clinical-services/" target="_blank" rel="noopener">preclinical drug development</a>. Preclinical bioassays can be <em>in vivo, ex vivo</em>, and <em>in vitro</em>.</p> <p><em>In vivo</em> bioassays provide a more realistic and predictive measure of the functional effects of tests with reference drug products or standard material of defined potency, along with the application of statistical tools, study-specific lab techniques, and adherence to the well-designed study protocol.</p> <p>These assays capture the complexity of target engagement, metabolism, and pharmacokinetics of novel drugs better than <em>in vitro</em> bioassays.</p> <p>The most commonly used experimental mammals in i<em>n vivo</em> efficacy assays are mice and rats. Occasionally other species may be used depending on the sensitivity & suitability of the assays.</p> <h3><strong>Development and Validation of Bioassays </strong></h3> <p>Bioassays are used as a screening method to identify the signals that indicate desired biological activity from a set of compounds. In general, two different types of signals can be generated by a bioassay, a linear dose-response and a sigmoidal (S-shaped) dose-response.</p> <p>Since one solution does not fit all bioassays, it is good to evaluate and analyze the data to develop a precise approach to carry out each bioassay.</p> <p><strong>The life cycle stages of a bioassay are divided into:</strong></p> <p>Stage 1: Method design, development, and optimization</p> <p>Stage 2: Procedure performance qualification</p> <p>Stage 3: Procedure performance verification (<em>fit for purpose</em>)</p> <p>Developing a bioassay that meets regulatory requirements and gets a drug product registered is a very complex process.</p> <p>Developing a bioassay includes many strategies and tactical designs like selecting the correct <em>in vivo</em> platform, proper method or plate design, data analysis, system/ sample sustainability strategy, method implementation, method performance, and monitoring.</p> <p>There are several steps to be followed for the development and validation of bioassays, such as dose-response and curve-fitting selection, development of reference, calculation of potency, bioassay characterization, design of bioassay calculator, standardization and automation of bioassay, and finally, evaluation.</p> <p><strong>Both method development and validation of bioassays include three fundamental areas:</strong></p> <ol> <li>Pre-study (Identification and Design Phase) validation</li> <li>In-study (Development and Production Phase) validation</li> <li>Cross validation or method-transfer validation</li> </ol> <p>During method development, assay conditions and procedures are selected that minimize the impact of potential sources of invalidity. Coming to the statistical validation for an <em>in vivo</em> assay, it involves four major components:</p> <ol> <li>Adequate study design and data analysis method</li> <li>Proper randomization of animals</li> <li>Appropriate statistical power and sample size</li> <li>Adequate reproducibility across assay runs.</li> </ol> <p>Parallel group design, randomized block design, repeated measures design, and crossover design are the basic types of experimental designs used in <em>in vivo</em> assay.</p> <p><strong>The following are the key factors that should be kept in mind while designing an <em>in vivo</em> assay:</strong></p> <ul> <li>All meaningful biological effects (pharmacologically) should be statistically significant.</li> <li>If biologically relevant assays are not present, then a range of plausible effects can be considered.</li> <li>The key endpoints should be well-defined before the beginning of the assay.</li> <li>Animals should be allocated randomly in an appropriate manner to the treatment groups.</li> <li>The dose levels should be selected appropriately. Dose and curve-fitting selection is among the most critical aspects of bioassay development. The dose is determined depending on the type of model used in the signal to fit the data. For Sigmoidal designs, a four- or five-parameter logistics (4PL or 5PL) model fits the data, whereas, for linear design, a parallel line analysis (PLA) model fits the data.</li> </ul> <p><strong>For a 4PL model, nine doses are recommended:</strong></p> <ol> <li>Three doses in the lower asymptote</li> <li>Three doses in the upper asymptote</li> <li>Three doses in the linear range</li> </ol> <p>In contrast, for a PLA model, a minimum of four doses is recommended. A minimum of three consecutive doses is required to plot the dose curve.</p> <ul> <li>The selection of control groups and time points to collect samples should be optimal.</li> <li>The design strategies should minimize variability and maximize information.</li> </ul> <p>To understand the design, developments, and statistical validation of <em>in vivo</em> bioassay in more detail, reach out to us at <a href="https://www.veedacr.com">https://www.veedacr.com</a>. One can also read the guidelines mentioned by NIH by visiting the link:</p> <p><a href="https://www.ncbi.nlm.nih.gov/books/NBK92013/pdf/Bookshelf_NBK92013.pdf" target="_blank" rel="noopener">https://www.ncbi.nlm.nih.gov/books/NBK92013/pdf/Bookshelf_NBK92013.pdf</a></p> <p><img decoding="async" class="alignnone wp-image-3707" src="https://www.veedacr.com/wp-content/uploads/2022/01/download-300x184.png" alt="Chart Diagram of Assay Development Stage in the Drug Discovery and Development Process" width="623" height="382" srcset="https://www.veedacr.com/wp-content/uploads/2022/01/download-300x184.png 300w, https://www.veedacr.com/wp-content/uploads/2022/01/download-1024x629.png 1024w, https://www.veedacr.com/wp-content/uploads/2022/01/download-768x472.png 768w, https://www.veedacr.com/wp-content/uploads/2022/01/download-1536x943.png 1536w, https://www.veedacr.com/wp-content/uploads/2022/01/download-2048x1258.png 2048w" sizes="(max-width: 623px) 100vw, 623px" /></p> <p><strong>References</strong></p> <ol> <li>A. Little, “Essentials in Bioassay Development,” BioPharm International 32 (11) 2019</li> <li>Padmalayam, Ph.D., Assay development in drug discovery</li> <li>Zwierzyna M, Overington JP (2017) Classification and analysis of a large collection of in vivo bioassay descriptions. PLoS Comput Biol13(7): e1005641. <a href="https://doi.org/10.1371/journal.pcbi.1005641" target="_blank" rel="noopener">https://doi.org/10.1371/journal.pcbi.1005641</a></li> <li>White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, Mozier NM, Naumer M, Pepe A, Qahwash I, Rocnik E, Smith JG, Stokes ES, Talbot JJ, Wong PY. Best practices in bioassay development to support registration of biopharmaceuticals. Biotechniques. 2019 Sep;67(3):126-137. doi: 10.2144/btn-2019-0031. Epub 2019 Aug 5. PMID: 31379198.</li> <li>F Chana and Hursh D, Bioassays through the Product lifecycle: Perspectives of CDER and CBER reviews.</li> <li>Haas J, Manro J, Shannon H, et al. In Vivo Assay Guidelines. 2012 May 1 [Updated 2012 Oct 1]. In: Markossian S, Grossman A, Brimacombe K, et al., editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-. Bookshelf URL: <a href="https://www.ncbi.nlm.nih.gov/books/" target="_blank" rel="noopener">https://www.ncbi.nlm.nih.gov/books/</a></li> </ol> </div> <footer class="entry-footer"> </footer> </article> </div> <div class="blog-list-view-box"> <article id="post-3651" class="post-3651 post type-post status-publish format-standard has-post-thumbnail hentry category-uncategorized"> <div class="blog-list-view-image"> <img src="https://www.veedacr.com/wp-content/uploads/2021/12/Untitled-3-768x307-1.jpg" class="img-fluid"> </div> <div class="blog-list-view-titles"> <h1 class="entry-title"><a href="https://www.veedacr.com/lab-informatics-revolutionising-pharma-rd/" rel="bookmark">Lab Informatics: Revolutionising Pharma R&D</a></h1> <div class="entry-meta"> <div class="row"> <div class="col-lg-3"> <div class="blog-date"> <p class="team-name-color">December 1, 2021</p> </div> </div> <div class="col-lg-9"> <div class="blog-posted"> <p class="team-name-color">Posted in - Veeda</p> </div> </div> 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joining Veeda Clinical Research in May 2019, Mr Tandon was Partner-Operations with CX Advisors LLC, an India mid-market focused private equity investment advisor, where he worked with portfolio companies in developing and enabling strategic initiatives and performance improvements and supporting operational due diligence of target investments. Prior to CX, Mr. Tandon was a Managing Director with The Rohatyn Group and a Director with CVCI, prior to its acquisition by The Rohatyn Group. During the eight years he worked there Mr. Tandon identified, managed and exited a large number of companies across a wide spectrum of industries including, among others, automotive, financial services, IT, IT enabled services, infrastructure, oil & gas services and mining. Prior to CVCI, Mr. Tandon gained 15 years of banking experience with Citibank during which he managed and advised several mid and large corporate clients across diverse industries. Mr. Tandon earned an MBA from the Indian Institute of Management, Ahmedabad and a B.Engineering (Honours) degree in Electrical Engineering from Delhi College of Engineering, Delhi University.</p> </div> </div> </div> </div> <div class="modal fade corporate-governance-modal" id="CorporateGovernanceModal-2" tabindex="-1" role="dialog" aria-labelledby="CorporateGovernanceModalTitle" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title"><span>Aparajita Jethy Ahuja,</span> Director</h5> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div> <div class="modal-body"> <p>Prior to joining the Investment Advisor in 2009, Ms. Ahuja served in the Funds Administration team at Actis where she was responsible for investor relations and reporting, accounting and compliance. Ms. Ahuja began her career in the Assurance division of Ernst & Young. Ms. Ahuja is a qualified Chartered Accountant (2006) and has a B.Com. (Honours) degree from Delhi University (2003).</p> </div> </div> </div> </div> <div class="modal fade corporate-governance-modal" id="CorporateGovernanceModal-3" tabindex="-1" role="dialog" aria-labelledby="CorporateGovernanceModalTitle" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title"><span>Apurva Shah,</span> Founder & Director</h5> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div> <div class="modal-body"> <p>Mr. Apurva Shah is a founder and Director of Veeda Clinical Research. He has a MBA in International Finance & Entrepreneurship from Babson College in Boston USA. With his strong entrepreneurial and organizational skills, he has been able to grow Veeda to become one of the premier CROs in the country. As a Board member, he gives strategic and financial direction to all Group Companies. Mr. Shah strongly believes in giving back to the society and hence as a Managing Committee member of the NGO ‘Each One Teach One’ (www.eotoindia.org) he helps in furthering the cause of education and development of under privileged children in cities and tribal areas. During his tenure as the Chairman of Association of CROs in India (www.acroindia.org) from 2010-2014, he was able to grow the association membership 5 fold, increase the awareness of the industry and work with the Regulatory Agencies to facilitate the growth of the industry. He believes that if done in an ethical manner, clinical research is a very attractive socio-economic opportunity for India. He is on the Governing Board of the Life Science Sector Skill Development Council (www.lsssdc.in) set up by the Government of India. He has also been a member of the Pharma committee of CII for the past 5 years. Mr. Apurva Shah and Mr. Binoy Gardi were awarded the prestigious Entrepreneur of the year in 2009 by the BioSpectrum magazine as recognition for his contribution to the industry and were awarded the SME Entrepreneur of the year by Business Today and Yes Bank in 2010.</p> </div> </div> </div> </div> <div class="modal fade corporate-governance-modal" id="CorporateGovernanceModal-4" tabindex="-1" role="dialog" aria-labelledby="CorporateGovernanceModalTitle" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title"><span>Binoy Gardi,</span> Founder & Director</h5> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div> <div class="modal-body"> <p>Mr. Binoy Gardi is a founder and Director of Veeda Clinical Research. Mr. Gardi is responsible for strategic planning, developing and implementing new services and establishing relationships with the firm’s growing client base. His entrepreneurial vision has led the Company to become one of the fastest growing CROs in India. Mr. Gardi also spends part of his time pursuing his philanthropic ventures. He is responsible for setting up and running two 500 bed hospitals in India. Both hospitals offer free healthcare and medicines. He is one of the main Trustees of RD Gardi Medical College which has now 150 seats and a total of 850 students for MBBS and post graduate courses. Mr Gardi is also Managing Trustee of Shri Bharat Saraswati Mandir Sansad Trust, this is one of the oldest trusts in Gujarat and has 16 educational units with over 3000 students. Mr. Gardi has won the Entrepreneur of the year in 2009 by BioSpectrum magazine and was awarded the SME entrepreneur of the year by BUSINESS TODAY and YES BANK in 2010. Mr. Gardi has a BSc in Business Management from Kings College London and is also a qualified lawyer from the UK. 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