Author: gvrp@admin

In more than a decade of working in preclinical research across pharma and CRO settings  I have  seen the same story play out many times. A compound that looks safe, effective, and full of promise in preclinical studies struggles to deliver once it enters clinical trials. For me, as a veterinarian and toxicologist, these moments are both humbling and instructive. They remind us that bridging preclinical and clinical gaps is not a box to be ticked; it is one of the most critical and nuanced challenges in drug development.

Why the Gap Persists

The preclinical-to-clinical transition is where scientific optimism often collides with biological complexity. Some of the recurring issues I have observed include:

• Model limitations: Even the most carefully chosen research models cannot replicate the full complexity of human disease.
• Endpoints that don’t translate: A biomarker or readout that is meaningful in preclinical studies may not have a clear analogue in clinical trials.
• Pharmacokinetics and dosing challenges: Converting safe and effective dose ranges from animals into the clinical setting is rarely straightforward.
• Regulatory nuances: Requirements shift depending on the product type whether small molecules, impurities, biosimilars, or medical devices and misalignment can create major delays.
• Siloed approaches: Too often, discovery scientists, toxicologists, and clinicians work in parallel rather than in true collaboration.

Strategies That Make a Difference

Over the years, I have found certain practices consistently improve translational success:

1. Designing with the End in Mind

Preclinical studies are strongest when they anticipate the needs of regulators and clinical trialists. The right questions, models, and endpoints must be chosen from the very start, not retrofitted later.

2. Refining and Validating Research Models

As a veterinarian, I’ve always valued the nuances of selecting the right model. Whether it’s choosing immunodeficient strains for oncology or refining toxicology models for medical devices, these choices determine how predictive our data will be for the clinic.

3. Translational Biomarkers

Biomarkers that carry meaning across both preclinical and clinical studies provide one of the most direct bridges between the two worlds. The closer the alignment, the lower the risk of surprises downstream.

4. PK/PD Integration

Robust pharmacokinetic and pharmacodynamic modelling built on carefully designed preclinical data offers a much more reliable foundation for dose selection in first-in-human studies.

5. Early Cross Functional Collaboration

The most successful translational programs are those where toxicologists, pharmacologists, clinicians, and regulatory experts work together from day one. When silos break down, insights align.

6. Balancing Tradition with Innovation

Research models remain the cornerstone of preclinical testing. But in my experience, they are most powerful when complemented with newer approaches whether organoids, computational models, or advanced imaging techniques. Integration, not replacement, is the key.

Lessons from Experience

Contributing to multiple IND filings has taught me that the translational gap is not a single obstacle but a series of decisions. Each decision about models, endpoints, dose levels, or regulatory strategy can either strengthen the bridge or widen the divide.

What I have learned is that success doesn’t lie in eliminating uncertainty (which is impossible), but in reducing it intelligently. Preclinical science must be rigorous, relevant, and forward looking if it is to serve as a reliable foundation for clinical development.

Looking Ahead

The future of translational science, in my view, will be shaped by balance. Balance between research models and new technologies. Balance between scientific ambition and regulatory discipline. Balance between speed and rigor.

For those of us working in preclinical research, the responsibility is enormous: to provide not just data, but evidence that can withstand the transition into clinical trials. Each study is a piece of that bridge and the stronger we make it, the closer we bring new therapies to the patients who need them.

Written by: Dr. Anil K. Gothi | GVSAP | Vice President & TFM

Anil is an M.V.Sc in Pharmacology and Toxicology, and a Board-Certified Toxicologist (DABT, ERT) with over 16 years of preclinical experience in pharma and CROs. He has contributed to multiple IND filings and has expertise across diverse product categories including impurities, biosimilars, and medical devices. He has extensive experience in regulatory requirements, global safety studies, and strategic operations for US and European clients.

A Shifting Landscape in Preclinical Research

In recent years, the life sciences industry has been undergoing a quiet but powerful transformation. The way we discover and develop medicines is evolving — becoming faster, smarter, and more closely aligned with human biology. As part of the preclinical research space, I see this change unfolding every day, and it is both exciting and necessary.

The Enduring Role of Research Models

For decades, research models have been the backbone of preclinical testing. They have guided discoveries, offered critical insights into disease biology, and enabled the development of life-saving therapies. Even today, they remain indispensable — providing a foundation without which progress would not be possible.

At the same time, it is important to acknowledge that no single approach is perfect. Research models, while powerful, are resource-intensive and not always predictive of human outcomes. This recognition is what has encouraged the industry to explore complementary approaches that can add depth and perspective to existing practices.

Enter New Approach Methodologies (NAMs)

This is where New Approach Methodologies, or NAMs, come into the picture. NAMs is an umbrella term for a range of innovative tools and technologies that aim to supplement traditional approaches to preclinical testing. These include organoids that mimic human tissues, organ-on-chip systems that replicate organ-level functions on microfluidic devices, and advanced computational or AI-driven models that can simulate complex biological responses.

Real world innovations like Nexel’s Cardiosight-S® — iPSC-derived cardiomyocytes that mirror human heart physiology — are opening new doors. By enabling researchers to study cardiac safety in a human-relevant system, they address gaps left by older methods and bring us closer to more predictive, patient-centered testing.

Why NAMs Matter

The strength of NAMs lies not in replacing research models, but in expanding the possibilities of what preclinical testing can achieve. Organoids allow researchers to study patient-specific biology, offering new opportunities in personalized medicine. Organ-on-chip platforms can replicate organ-level interactions under controlled conditions, capturing details that research models may not always reflect. Computational tools can analyze large datasets with speed and precision, identifying potential risks or therapeutic opportunities much earlier.

Together, NAMs can help reduce development timelines, optimize resources, and improve the predictability of outcomes — ultimately benefiting both patients and the industry. But they work best when viewed as part of a bigger ecosystem, one where research models and NAMs complement each other to build a stronger foundation for discovery.

India’s Opportunity in NAMs

For India, this moment feels especially significant. Our country has already earned a reputation as a trusted partner in global pharma and research, supported by strong talent, infrastructure, and cost competitiveness. By embracing NAMs early — while continuing to strengthen our expertise in research models — we can set new benchmarks for innovation and position India as a leader in shaping the future of preclinical testing.

The Road Ahead

The path forward will require collaboration. Regulators, researchers, and industry leaders must work together to validate new methods, update standards, and build confidence across the ecosystem. This will not be an overnight change — it is an evolution that depends on trust, data, and global cooperation.

Yet the direction is clear: preclinical science is moving toward approaches that are more human-relevant, more efficient, and more ethically responsible.

A Founder’s Perspective

To me, NAMs represent more than just regulatory shifts or technological advances. They reflect a larger vision: advancing research while staying true to our responsibility toward both people and science.

The future of preclinical testing is not about replacing one method with another, but about building the smartest, most responsible, and most effective path forward — where research models and NAMs work hand in hand to create better outcomes for patients and for the industry.

Written by: Kalyan Korisapati | Co-Founder & CEO

Kalyan is a veteran in the preclinical R&D sector, with over 25 years of experience building all facets of a successful research business from the ground up. Beyond pioneering the first domestic SPF research models in India, he has played a key role in forging global collaborations that have brought cutting-edge innovations to the Indian market, with unrelenting focus on responsible and human-relevant research.

Owing to the continuous advancements in medical technology, the safety and effectiveness of medical devices are paramount. A key aspect of ensuring these devices do not pose risks to patients is through rigorous biocompatibility testing. Biocompatibility studies are essential for assessing how materials used in medical devices interact with the human body. Let us take a look into the importance, processes, and regulatory landscape of biocompatibility studies, shedding light on why they are indispensable in the medical device industry.

Understanding Biocompatibility

Biocompatibility refers to the ability of a material to perform with an appropriate host response in a specific application. For medical devices, this means the materials used must not produce any adverse effects when in contact with the body. These adverse effects can range from localized reactions such as inflammation to systemic issues like toxicity or allergic responses.

The Importance of Biocompatibility Studies

1. Patient Safety: The primary goal of biocompatibility studies is to ensure that medical devices are safe for use in humans. These studies help identify potential risks and adverse reactions before the device is marketed and used in clinical settings.
2. Regulatory Compliance: Regulatory bodies like the FDA (Food and Drug Administration) and EU Medical Device Regulation (MDR)  require thorough biocompatibility testing as part of the approval process for medical devices. Compliance with these regulations is crucial for bringing a device to market.
3. Product Development: Early biocompatibility testing can inform the design and material selection of a medical device, potentially avoiding costly redesigns and delays in product development.

Key Components of Biocompatibility Testing

Biocompatibility testing typically involves a series of in vitro and in vivo tests to evaluate various biological responses. These tests are designed based on the nature of the device and its intended use. Key components include:

1. Cytotoxicity Tests: Assess whether the device materials are toxic to cells.
2. Sensitization Tests: Determine if the materials cause allergic reactions.
3. Irritation Tests: Evaluate the potential for materials to cause irritation to skin or mucous membranes.
4. Systemic Toxicity Tests: Check for harmful effects on the entire body.
5. Implantation Tests: Study the effects of materials when implanted in living tissue.
6. Hemocompatibility Tests: Assess the interaction of device materials with blood.

Regulatory Framework for Biocompatibility

The regulatory framework for biocompatibility testing varies by region but generally adheres to international standards. The ISO 10993 series of standards is widely recognized and provides guidelines for the biological evaluation of medical devices. Key regulatory bodies and their guidelines include:

1. FDA (U.S.): The FDA’s guidance document, “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’,” outlines the requirements for biocompatibility testing in the U.S.

The FDA has introduced a new program called the Accreditation Scheme for Conformity Assessment (ASCA). This program is a voluntary initiative by the FDA to streamline and enhance the conformity assessment process for medical device submissions. By granting ASCA Recognition to qualified accreditation bodies, which in turn accredit testing laboratories, the FDA aims to promote consistency, predictability, and efficiency in medical device reviews. Device manufacturers can use ASCA-accredited laboratories for premarket testing, which provides the FDA with a high level of confidence in the test methods and results. This reduces the need for additional information related to testing methodologies, thereby easing the regulatory burden. Key points of the ASCA Program include:

·  Streamline the conformity assessment process in device submissions

·  Increase the FDA’s confidence in test methods and results

·  Minimize the need for additional information regarding standard conformance

·  Enhance consistency, predictability, and efficiency in medical device reviews

·  Provide a minimally burdensome approach to conformity assessment.

Implementing in accordance with recent amendments to the Federal Food, Drug, and Cosmetic Act and the Medical Device User Fee Amendments of 2022

The ASCA Program thus supports the FDA’s mission to maintain high standards of medical device safety and efficacy.

ISO (International): The ISO 10993 standards provide comprehensive guidelines for the biological evaluation of medical devices, covering aspects from cytotoxicity to clinical studies.

European Medicines Agency (EMA): In the EU, the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) mandate compliance with ISO standards for biocompatibility.

Challenges and Innovations in Biocompatibility Testing

While biocompatibility testing is essential, it comes with challenges such as:

1. Complexity of Materials: New and complex materials, including nanomaterials and biodegradable polymers, require innovative testing methods.
2. In vitro vs. In vivo: Striking a balance between in vitro and in vivo testing to ensure comprehensive safety evaluation without excessive use of animal testing.
3. Regulatory Changes: Keeping up with evolving regulatory requirements and standards.

Innovations in this field include the development of advanced in vitro models, computational methods for predictive toxicology, and improved in vivo testing techniques that reduce reliance on animal models.

Choosing the Right CRO for Biocompatibility Studies

Partnering with a reliable Contract Research Organization (CRO) is crucial for the success of biocompatibility studies. Here are key factors to consider:

1. Expertise and Experience: Look for a CRO with a proven track record and extensive experience in conducting biocompatibility studies. Their expertise can ensure accurate and reliable results.
2. Accreditation and Compliance: Ensure the CRO is accredited by relevant regulatory bodies (e.g., ISO 17025, GLP) and complies with international standards like ISO 10993.
3. State-of-the-Art Facilities: The CRO should have modern, well-equipped laboratories capable of conducting a wide range of biocompatibility tests.
4. Regulatory Knowledge: A good CRO should have in-depth knowledge of global regulatory requirements and can provide guidance on the necessary testing protocols.
5. Communication and Transparency: Effective communication and transparency throughout the testing process are essential. The CRO should provide clear, timely updates and detailed reports.
6. Customization and Flexibility: Choose a CRO that offers tailored solutions to meet the specific needs of your medical device, ensuring that the testing is relevant and comprehensive.

GV Research Platform supports you with a comprehensive range of biocompatibility testing services, ensuring your medical devices and materials meet regulatory standards for safety. You can fill this enquiry form and we will get back to you. https://gvrp.in/enquiry/

Conclusion

By adhering to stringent regulatory standards and leveraging advanced testing methods, the medical device industry can continue to innovate while prioritizing patient safety. As technology evolves, so too will the approaches to biocompatibility testing, paving the way for safer and more effective medical devices.

The delicate balance of our ecosystems is under constant threat from various pollutants and contaminants in today’s rapidly evolving world. Ecotoxicity, a critical branch of environmental science, stands at the forefront of understanding and mitigating these threats. From industrial chemicals to agricultural runoff, every substance introduced into the environment has the potential to disrupt ecosystems and harm biodiversity. In this article, let us learn about the significance of ecotoxicity studies, methodologies to conduct these studies, and profound implications for environmental stewardship.

Understanding Ecotoxicity:

Ecotoxicity refers to the study of how pollutants affect organisms and ecosystems. Unlike conventional toxicology, which focuses on individual species, ecotoxicity examines the broader ecological consequences of chemical exposure. It encompasses a wide range of organisms, from microscopic bacteria to complex food webs, and considers interactions within ecosystems.

The Significance of Ecotoxicity Studies:

Ecotoxicity studies play a pivotal role in identifying and assessing environmental risks associated with various substances. By evaluating the toxicity of chemicals under realistic environmental conditions, researchers can predict their impact on ecosystems and guide regulatory decisions. These studies provide crucial insights into pollutant behavior, bioaccumulation, and ecological pathways, helping to prevent environmental disasters and protect human health.

Methodologies and Approaches:

Ecotoxicity studies employ diverse methodologies to assess the effects of pollutants on living organisms and ecosystems.

1. Bioassays:

Bioassays involve exposing living organisms to specific concentrations of chemicals to assess their toxic effects. These tests are often standardized and conducted using various organisms representing different trophic levels in ecosystems. For example, in aquatic environments, bioassays might utilize algae, daphnia, or fish as test organisms. Biopharma and agritech companies frequently employ bioassays to evaluate the toxicity of pharmaceuticals, pesticides, and other chemical products. These studies help assess potential environmental impacts and inform regulatory submissions.

2. Field Studies:

Field studies involve monitoring environmental parameters and organismal responses in natural ecosystems exposed to pollutants. This approach provides valuable insights into real-world interactions between chemicals and ecological systems. Medical device and biomedical companies may conduct field studies to assess the environmental fate of materials used in their products, such as biodegradable implants or drug delivery systems. Agritech companies also utilize field studies to evaluate the effects of agrochemicals on soil health, plant growth, and non-target organisms.

3. Modeling Techniques:

Modeling techniques, such as environmental fate modeling and ecological risk assessment, are essential tools for predicting the behavior of chemicals in the environment and assessing their potential risks. Biopharma companies may use modeling to estimate the environmental concentrations of pharmaceuticals discharged from manufacturing facilities or released through patient use. Agritech companies utilize modeling to optimize pesticide application strategies and minimize off-target effects on ecosystems.

The role of ecotoxicity studies in driving sustainable practices within the agrochemical industry:

1. Product Safety and Compliance: Ecotoxicity studies are crucial for agrochemical companies in India to assess the safety and environmental impact of their products, ensuring compliance with regulations and international standards.
2. Environmental Risk Assessment: These studies help evaluate the environmental risks associated with pesticides and fertilizers, enabling companies to develop mitigation strategies and recommend best practices to minimize harm to non-target organisms.
3. Promoting Sustainable Practices: Agrochemical companies are increasingly focused on supporting sustainable agriculture by developing eco-friendly inputs and practices, such as biopesticides and integrated pest management solutions, guided by ecotoxicity research.
4. Stakeholder Collaboration: Collaboration with stakeholders, including government agencies, research institutions, and farmers’ organizations, facilitates dialogue and knowledge exchange to enhance environmental sustainability in agriculture.
5. Driving Innovation: Ecotoxicity studies drive innovation by providing insights into the environmental behavior of agricultural chemicals, leading to the development of novel formulations and technologies that minimize environmental impact while maximizing efficacy, reflecting a commitment to sustainable agriculture.

The Way Forward:

As we confront unprecedented environmental challenges, the importance of ecotoxicity studies cannot be overstated. Continued research and innovation in this field are essential for safeguarding our planet’s health and resilience. By integrating scientific knowledge with proactive measures, we can strive towards a future where human activities coexist harmoniously with nature. Collaboration between scientists, policymakers, industry stakeholders, and the public is crucial in addressing environmental threats and fostering a more sustainable world.

At GV Research Platform, we empower sustainable future by providing comprehensive ecotoxicity assessments services tailored to your requirements. To learn how we help you drive innovation, contact info@gvrp.in

The field of oncology therapeutics is witnessing unprecedented advancements that are revolutionizing cancer care. Researchers and scientists are tirelessly working to develop innovative approaches to target tumors effectively while minimizing side effects. From targeted drug delivery systems to liquid biopsies and combination immunotherapies, the frontiers of oncology are expanding rapidly.

Moreover, the integration of artificial intelligence and machine learning is opening up new possibilities for diagnostics and treatment planning. These developments hold immense promise in providing more effective, personalized, and less toxic treatments, ultimately enhancing the lives of cancer patients.

Targeted Drug Delivery Systems: Precision and Efficacy Redefined One of the most exciting developments in oncology therapeutics is the use of targeted drug delivery systems. Nanoparticles, liposomes, and antibodies are being utilized to deliver therapeutic agents directly to tumor sites. This approach enables precise targeting, delivering the medication only to cancer cells while sparing healthy tissues.

By minimizing off-target effects, targeted drug delivery systems not only enhance the efficacy of treatment but also reduce the risk of adverse reactions. This breakthrough paves the way for more effective treatment options with fewer side effects.

Liquid Biopsies: Early Detection and Monitoring of Cancer Liquid biopsies have emerged as a ground-breaking tool in the early detection and monitoring of cancer. These non-invasive tests analyze various biomarkers in blood samples, allowing for the identification of cancer at its earliest stages.

Additionally, liquid biopsies enable the monitoring of minimal residual disease, which refers to the presence of a small number of cancer cells that remain after treatment. By detecting early signs of recurrence or resistance to treatment, liquid biopsies empower healthcare professionals to intervene promptly and make personalized treatment adjustments. This proactive approach significantly improves patient outcomes and survival rates.

Globally recognized and trusted, Indivumed Services, a Crown Bioscience Company, is a global contract research organization (CRO) that offers a wide range of biobank products like Multi-omics Grade Cancer Biospecimen, Liquid Biopsy samples, and FFPE samples to support your research and development in personalized medicine, biomarker validation, drug discovery, and companion diagnostics.

Combination Immunotherapies: Unleashing the Power of the Immune System Immunotherapy has revolutionized cancer treatment by harnessing the body’s immune system to target and destroy cancer cells. Recent advancements in combination immunotherapies have shown even more promising results. By combining checkpoint inhibitors with CAR-T cell therapies or cancer vaccines, researchers aim to enhance the immune system’s response and create more robust and durable outcomes. These combinations have the potential to overcome some of the limitations observed with single-agent immunotherapies, leading to improved response rates and increased survival rates for cancer patients.

Our partner Crown Bioscience, a global CRO headquartered in the US, has made significant strides in developing cutting edge in-vitro and in-vivo oncology drug screening platforms that enable researchers to identify potential therapeutic candidates and optimize treatment strategies.

Integration of Artificial Intelligence and Machine Learning: Transforming Cancer Care The integration of artificial intelligence (AI) and machine learning (ML) is transforming the landscape of cancer care. AI-based algorithms analyze vast amounts of patient data, including medical records, imaging scans, and genetic profiles, to provide accurate and personalized diagnoses. These algorithms also assist in treatment planning by predicting treatment responses and identifying optimal therapeutic approaches.

By leveraging the power of AI and ML, healthcare professionals can make data-driven decisions and deliver more precise, tailored treatments. This integration holds immense potential for improving patient outcomes and streamlining the delivery of cancer care.

The emerging frontiers in oncology therapeutics offer promising advancements that are reshaping the future of cancer care. As researchers and scientists continue to push the boundaries of innovation, the future of oncology therapeutics looks brighter than ever before.

We can help you advance your oncology research by providing access to novel technologies, cancer biospecimens, and liquid biopsy samples. Write to us at info@gvrp.in for more details.

Written by: Dr. Nidhi Khurana
Dr. Nidhi Khurana holds a Ph.D. in Biotechnology and leverages her knowledge of science and marketing to build thoughtful partnerships with industry leaders. Currently, Dr. Khurana serves as the Head of Marketing at GV Research Platform, where she is responsible for driving growth and building the company’s brand. Alongside, she is passionate about writing and uses it as a medium to educate the community on the latest trends and technologies in the drug discovery and development space.

The pharmaceutical sector is witnessing a significant surge in demand for innovation, leading to transformative changes in drug discovery and development. As we move into 2023, the industry presents exciting opportunities and notable shifts, shaping a promising future. Importantly, the Indian pharmaceutical industry is projected to reach a remarkable USD 130 billion by 2030.

To stay ahead in this evolving landscape and seize the emerging opportunities, collaboration with advanced drug discovery research centres becomes crucial. However, in making such a pivotal decision, one must grasp the pulse of the industry, familiarizing themselves with the latest trends that will shape the course of drug discovery in 2023.

1. Data Analytics and AI: The recent boom in Artificial Intelligence (AI) has revolutionized drug discovery by overcoming data challenges. AI, along with machine learning and big data, automates data processing, enabling complex problem resolution. Leveraging AI in drug discovery helps identify data patterns that were previously unattainable. This technology can analyse vast amounts of genomic and proteomic data, facilitating the identification of potential drug targets, predicting drug candidate activity, and optimizing drug design. Virtual screening and de novo drug design driven by AI accelerate the discovery of novel therapeutics and save valuable time and resources.

2. Assay Development: Critical for discovering and developing new drugs, assay development ensures safe, cost-effective, and successful research. Assay sensors measure molecular interactions between living cells, offering real-time visualization of protein binding and aiding in the assessment of potential risks during preclinical trials.

3. Synthetic Biology: The ability to synthesize cells empowers researchers to better understand protein and gene interactions, leading to the development of accurate preclinical models for drugs. This advancement speeds up the drug development process while ensuring safety.

4. 3D Cell Culture: Compared to traditional 2D models, 3D cell culture provides more accurate results, allowing researchers to conduct detailed experiments. These models can mimic cell-to-cell interactions, offering more relevant information and improving data for better drug screening decisions.

5. Humanized mouse models have emerged as a valuable asset in evaluating drug efficacy and toxicity within a human immune system context. By transplanting human immune cells into immunodeficient mice, these models offer a more realistic representation of human physiology. Envigo, our esteemed partner, harnesses the power of CRISPR-Cas9 and ZFN gene editing technologies to create disease-specific humanized models, providing clinically relevant information for drug development.

6. PDX models are another breakthrough in drug discovery, as they offer a more accurate reflection of a patient’s disease compared to traditional cell-line-derived models. By transplanting fresh cancer tissue samples from patients into immunocompromised mice, PDX models enable researchers to assess drug efficacy, toxicity, and identify novel biomarkers for precision medicine. Our trusted partner, Crown Bioscience, has the world’s largest PDX collection, ensuring data that translates more effectively to clinical applications.

7. Organoids, three-dimensional cell cultures that mimic human organ structures and functions, have emerged as a powerful platform for studying disease mechanisms and drug screening. By cultivating patient-derived cells in a specialized medium, researchers can gain insights into disease processes, develop personalized treatments, and predict drug toxicity, thus reducing reliance on animal testing.

8. The advent of human induced pluripotent stem cell (iPSC) technology has revolutionized disease modelling and drug development. iPSC-derived cell lines, particularly iPSC-CMs, have proven instrumental in investigating the function and dysfunction of cardiomyocytes, screening drugs for heart diseases, and understanding drug-induced cardiotoxicity. Additionally, iPSC-CMs have been instrumental in developing disease models for inherited cardiac disorders, offering valuable insights into disease progression and potential therapeutic targets. Our partner Nexel manufactures highly pure and electro-physiologically active iPSC-derived cardiomyocytes, ideal for various experiments in the field of cardiology.

9. Genomics and Machine Learning: A noticeable interest is evident in application of genomics and data processing techniques in the field of preclinical research. Skin sensitization is one such area where acceptance towards next-generation test platforms like GARD®skin (Genomic Allergen Rapid Detection) from SenzaGen is observed. GARD®skin detects and reports presence of skin sensitizers in a given chemical or material using the state-of-the-art technologies in the genomics and machine learning area. The GARD® technology is not limited to skin sensitization alone, but also can detect possible presence of respiratory sensitizers in a product.

10. Drug Repurposing: Drug repurposing involves finding new uses for existing drugs, leveraging their known safety and pharmacokinetic profiles. Computational tools and AI aid researchers in efficiently identifying potential new indications for approved or tested drugs, leading to faster development timelines and reduced costs.

Future-proofing your success by collaborating with CROs

Due to the complexities of drug development, biopharmaceutical firms increasingly rely on contract research organizations (CROs). The CRO market in projected to hit 9.6 Bn USD by 2030 with Asia Pacific emerging as the fastest growing market according to (https://www.precedenceresearch.com/preclinical-cro-market) signifying that the demand for faster drug discovery and development is on the rise. You can find a detailed guide here about why partnering with CRO is your definite step towards seizing growth opportunities and staying ahead (https://gvrp.in/preclinical-contract-research-accelerating-product-development-and-cost-efficiency/).

Conclusion

Understanding the latest trends in drug discovery is crucial for staying competitive in the evolving biopharmaceutical sector. If you are seeking drug discovery research services in India, GV Research Platform offers a diverse range of preclinical solutions to help you gain a competitive edge. Don’t wait; contact the professionals today to avail reliable services and drive success in the pharmaceutical industry.

With the advent of globalization and human innovation, new products made of various materials are available in the market. The materials these products are composed from could be of natural origin or synthetic with a possibility of posing detrimental effects to human health during usage. The first organ that comes in contact with any product used is the human skin making it the most susceptible tissue to possible harm. Any chemical or material which has a potential to elicit an allergic reaction on the skin is categorized as a skin-sensitizer otherwise, a non-sensitizer. The ultimate purpose of testing a product for possible skin sensitivity is to ensure safety of the end-user.

Foreseeing the likelihood of certain chemicals or materials used in products posing risk to end-user, the regulatory bodies proposed a requirement for manufacturers to have their products tested for presence of skin-sensitizers. Owing to the increasing presence of skin-sensitizers in products, skin sensitization test became a regulatory requirement in many countries. The Organization for Economic Cooperation and Development (OECD) came up with internationally agreed collection of guidelines for testing chemicals used by governments, industries, and independent laboratories to assess the safety of chemicals.

Pertaining to skin sensitization, OECD identified an Adverse Outcome Pathway (AOP) of four major key events (KE) leading to allergic contact dermatitis (ACD, a clinical outcome caused by exposure to skin sensitizers –

KE1: Covalent binding of the chemical with the surface of the skin

KE2: Release of cytokines and other pro-inflammatory factors in keratinocytes

KE3: Maturation and mobilization of dendritic cells

KE4: Antigen presentation to new T-cells and proliferation of memory T-cells

The KE3 is an important key biological event in which dendritic cells and other immunocompetent cells in the skin get activated with an increased expression of cell membrane markers and proinflammatory cytokines indicating cellular level immune response upon exposure to a skin-sensitizer. Of the test methods recognized by OECD addressing mechanisms under KE3 (OECD TG 442E), the GARD®skin (Genomic Allergen Rapid Detection) assay stands apart with its holistic approach in mimicking the human immune response following exposure to skin sensitizers.

The GARD®skin consists of biomarker signatures representing genes with known or relevant biological function which are part of the OECD defined KEs and also, mimic human immune response. GARD®skin redefined skin sensitization testing with state-of-the-art genomic and machine learning techniques to elaborate on pathway analysis of its biomarker signatures. In a single test, this multi-mechanistic in vitro assay identifies and measures genes responsible for –

1. Oxidative stress responses

2. Inflammasome complex formation

3. Pro-inflammatory cytokine and chemokine signalling, and dendritic cell activation and maturation

4. Pattern recognition receptors, heat shock proteins, and mitogen-activated protein kinase (MAPK) activation

5. Immunological self-defence mechanisms

6. Cell migration

7. Innate immune system activation and xenobiotic recognition

The GARD® technology platform is based on chemical stimulation and the analysis of relative expression levels of genomic biomarker signatures. It is comprised of four key elements:

1. SenzaCell^TM: The first key element is the biological cell system called SenzaCell^TM that mimics the human dendritic cells (a critical part of the human immune system that recognize allergens).

2. Training dataset: Training dataset of gene expression profiles from cellular exposures to a set of well-characterized chemical sensitizers and non-sensitizers is the second key element.

3. Genomic biomarker signature: By analysing the training dataset of relevant genes, a genomic biomarker signature is established.

4. Prediction model: Based on the gene expression patterns obtained from the genomic biomarker signature, machine-learning technology is used to create prediction models for the investigated endpoint. The predicted models are used to classify test chemicals in future.

With increasing interest in application of genomics and data processing techniques to interpret and understand skin sensitization, we are progressing towards accepting next-generation test models like GARD®skin as potential standalone tests. Embracing such testing protocols allows companies to stand out in the market and build lasting consumer trust by creating a safer tomorrow for all.

For most products from various industries including cosmetics, textiles, agrochemical and medical devices exported to the European Union (EU) regardless of the amount, skin sensitization evaluation is a mandatory regulatory requirement. Prioritizing skin sensitization ensures wellbeing of consumers and elevates a product’s safety.

GV Research Platform (GVRP) can help you elevate your product safety with GARD®skin technology being the authorized distributor of SenzaGen’s services in India. Unlock a wide range of skin sensitization testing services and add-ons by enrolling your products for GARD®skin sensitization testing services.

Written by: Supriya Avatapalli
Sai Supriya has a 2 year experience in academic research and fair exposure to transition into industry. She enjoys delving deep into the new developments in the biotech, pharma industry and collaborating with people. She is zealous and keen to direct her best strengths to the role by being receptive to new ideas and challenges.

Have you ever experienced or heard of adverse effect after contact or exposure to a product? What if the product was tested prior to check for chances of adverse effect? Would it not have prevented you from experiencing discomfort or risk while using the product? The same holds true in case of medical device usage where safety of patients is uncompromisable and of paramount importance.

What is a medical device?

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

We often find use of medical devices in clinical settings and daily lives. Products ranging from catheters, IV tubes, cardiac stents, dental implants to glucose monitors, optical contact lenses, intra-uterine devices etc. are categorized as medical devices.

The medical devices are classified into three categories (as per US FDA) for ease in imposing regulations based on levels of risk they exhibit:

Class I

Non-invasive medical devices that carry a low degree of risk. These devices pose minimal or zero risk to patients even if they malfunction.

Devices like: Bandages, wheelchairs, walkers, crutches, enema kits, latex gloves, and other common supplies and medical equipment used in healthcare facilities or homes come under Class I.

Class II

Invasive medical devices which pose moderate to intermediate risk come under Class II. Devices used in or outside of the body with potential risk to patients are included in this class. Devices like: Pregnancy test kits, scalpels, needles, syringes, bone-fixation implants, dental implants, electrically powered wheelchairs, respiratory equipment etc. are some Class II medical devices.

Class III

Invasive medical devices that bring a significant risk to the patient by malfunctioning or incorrect usage fall under the Class III of medical devices.

Devices like: Artificial heart valves, cardiac stents, pacemakers, breast implants etc. are Class III medical devices.

The medical device classification varies vaguely according to the regulatory setting in each country. In India, as per the regulatory body, CDSCO (Central Drug Standard Control Organization), the medical devices are classified into four classes based on levels of risk –

• Class A – Devices posing low risk to the patient (cotton wool, surgical dressing, swabs)
• Class B – Devices posing low to moderate risk to the patient (thermometer, BP monitor, disinfectants)
• Class C – Devices causing moderate to high risk to the patient (implants, haemodialysis catheter, CT scan equipment)
• Class D – Devices posing high risk to the patient (heart valves, angiographic guide wire)

Why should medical devices be preclinically evaluated?

The risk a medical device carries can range anywhere from the toxicity of materials used to fabricate it to its eventual biodegradation. Hence, it is critical to evaluate medical devices prior (preclinical trial) to testing on humans (clinical trial). The preclinical evaluation involves investigating the performance, biocompatibility, and safety of the medical device. This provides an insight into how the materials of the medical device interact or react with the human tissuesand in vivo environment (inside the body). Taking the preclinical data insights together, a medical device can be passed or modified for reconsideration. The preclinical tests to be performed for a medical device differ based on its nature of body contact and contact duration and user country’s regulatory requirements.

How are medical devices preclinically evaluated?

The biocompatibility and toxicity would be tested at various layers/ parameters depending on the type of medical device, its usage and degree of risk. The materials used in the product are tested by performing some preclinical assessments like –

• Cytotoxicity – To check for the biological reactivity of material of the medical device with the mammalian cells
• Sensitization – To check for potential of a material or product to cause a delayed hyper-sensitivity reaction
• Irritation test – To check potential of test materials and their extracts, using appropriate site or implant tissue such as skin and mucous membrane in an animal model
• Material mediated pyrogenicity – To check for the potential of material in/on the medical device to elicit systemic febrile responses
• Acute and repeated dose toxicity – To check for general health hazards due to acute or repeated exposure to the extracts from the medical device material
• Implantation – To check for the local effect of the materialat the site of the medical device implantation (intramuscular, bone, subcutaneous)
• Hemocompatibility – Evaluates any effects of materials in contact with blood on hemolysis, thrombosis, plasma proteins, enzymes, and the formed elements
• Genotoxicity – To check for effect of substances in/on the medical devices to cause genetic damage via either gene mutations or chromosomal damage

What is the Medical Device Scenario in India looking like?

The medical device scenario in India is encouraging given the significantly increasing demand and investment in the sector.  India is the 4^th largest Asian medical devices market after Japan, China, and South Korea, and among the top 20 medical devices markets globally. To amp this up, the Government of India laid initiatives like 100% foreign direct investment in the sector, “Promotion of Medical Device Parks” programme, launch of production-linked-incentive (PLI) scheme for domestic manufacturing of medical devices and most importantly, the National Medical Device Policy 2023. Read more about NMD Policy 2023 here.

As of 2020, the medical devices market is estimated to be at USD 12 billion in India, and it is expected to grow at a CAGR of 15%, which is 2.5 times the global growth rate. On the other hand, the export of medical devices from India stood at USD 2.90 billion in FY22 and is expected to rise to USD 10 billion by 2025.

Conclusion

Preclinical testing plays a crucial role in ensuring the safety and effectiveness of medical devices. By assessing parameters such as biocompatibility and toxicity, these preclinical evaluations help mitigate risks and prevent adverse reactions in patients. As the demand for medical devices continues to grow, thorough preclinical testing becomes increasingly important in maintaining patient safety and improving healthcare outcomes.

GVRP offers Medical Devices Testing Services. Connect with us at info@gvrp.in to learn more about our testing services portfolio.

Written by: Supriya Avatapalli
Sai Supriya has a 2 year experience in academic research and fair exposure to transition into industry. She enjoys delving deep into the new developments in the biotech, pharma industry and collaborating with people. She is zealous and keen to direct her best strengths to the role by being receptive to new ideas and challenges.

Importance of Lab Animal Diet in Research

A well-formulated lab animal diet is essential for maintaining the health and well-being of laboratory animals, which ultimately affects the quality and reliability of experimental results. Researchers need to ensure that the diets of their test subjects are balanced, consistent, and free from harmful substances to limit potential confounding variables in their experiments.

The Influence of Diet on Experimental Results

The diet of a lab animal can directly impact the outcome of an experiment. For instance, certain dietary components can affect gene expression, metabolism, and immune function, potentially altering the response to experimental treatments or interventions. It is crucial to consider the specific nutritional needs of the animal models used and the desired research outcomes to design appropriate diets.

History of Rodent Diets

Before the 1960s, there was no standard formulation for rodent food, and researchers had limited information about their nutritional content. In the 1970s, the American Institute of Nutrition (AIN) developed AIN-76A, the first widely accepted, publicly available diet formula for rats and mice. Since then, there have been further advancements in the formulation of rodent diets to better meet the nutritional requirements of different species and strains.

Advancements in Rodent Diet Formulations

Over the years, researchers have recognized the limitations of early diet formulas and have made significant improvements. The development of standardized formulas such as AIN-93 and AIN-2016 has provided researchers with more reliable and consistent diets for rats and mice. These formulas take into account specific nutritional needs, growth stages, and genetic backgrounds of different laboratory animal models.

Considerations for Diet Formulation

Formulating lab animal diets involves considering various factors, including species-specific nutrient requirements, energy needs, growth rates, reproductive demands, and health conditions. Researchers also need to consider the sourcing of ingredients, the avoidance of potential contaminants or allergens, and the ethical considerations related to the treatment and welfare of the animals.

Modern lab animal diets focus not only on meeting basic nutritional requirements but also on optimizing animal welfare. They aim to provide appropriate enrichment, palatability, and texture to enhance the animals’ overall well-being. Researchers strive to strike a balance between meeting research objectives and ensuring the health and comfort of the animals throughout the study.

Importance of Transparency and Standardization

To conduct high-quality nutrition research with lab animals, it is crucial to use diets with known ingredient compositions. This transparency allows researchers to replicate studies and better understand the effects of specific nutrients on lab animals’ health. Standardization in diet formulations and reporting enables better comparison of results across studies and enhances the credibility and reproducibility of research findings.

Teklad® Diets

 A High-Quality Solution Teklad® diets continue to be recognized for their stringent quality control measures, extensive research, and expertise in manufacturing laboratory animal diets. These high-quality diets help researchers minimize dietary confounding variables and ensure reliable, repeatable research results.

In addition to standard natural ingredient diets, Teklad® now offers a wider range of specialized diets tailored to the specific needs of different laboratory animal models. These diets can address particular health conditions, mimic certain human diseases, or support specific research objectives.

Teklad®’s experienced nutritionists can collaborate with researchers to evaluate their specific needs and design customized diets for their research purposes. By considering the desired endpoints of a study, Teklad® can create diets that optimize the nutritional composition, minimize non-nutritive compounds, and meet the specific requirements of the laboratory animal models used.

Continued Research and Advancements

The field of lab animal nutrition continues to evolve as researchers gain a deeper understanding of the complex interactions between diet, genetics, and environmental factors. Ongoing research focuses on optimizing nutrient profiles, exploring the microbiome’s role in nutrition, and investigating personalized nutrition approaches for laboratory animal models.

Translatability from Animal Models to Humans

A well-formulated lab animal diet can improve the translatability of research results from animal models to humans. Researchers are increasingly aware of the importance of aligning diet compositions and nutrient profiles with human diets and nutritional recommendations. This consideration enhances the relevance and applicability of research findings, ultimately benefiting human health and well-being.

By staying informed about the latest advancements in lab animal diet formulations and considering the specific needs of their research projects, scientists can ensure the highest quality and relevance of their experiments in the field of biomedical research.

Where can you get Teklad® Lab Animal Diets in India?

GV Research Platform is the authorized distributor of Teklad® Lab Animal Diets from Envigo in India. The inventory is now available in Hyderabad and can be immediately dispatched based on requirement and availability.

We go the extra mile to provide you with additional reassurance. For our rodent diets, we offer a Phytoestrogen Certificate for every batch, demonstrating our attention to detail and commitment to transparency. Additionally, we provide a Certificate of Analysis for every batch, allowing you to verify the nutritional content and quality of the diets you receive.

Your order for Teklad® Lab Animal Diets is just an email away with no waiting for weeks to receive your order. Place your order at info@gvrp.in 

Written by: Dr. Nidhi Khurana
Dr. Nidhi Khurana holds a Ph.D. in Biotechnology and leverages her knowledge of science and marketing to build thoughtful partnerships with industry leaders. Currently, Dr. Khurana serves as the Head of Marketing at GV Research Platform, where she is responsible for driving growth and building the company’s brand. Alongside, she is passionate about writing and uses it as a medium to educate the community on the latest trends and technologies in the drug discovery and development space.