Month: April 2023

The National Medical Devices Policy, 2023 has been approved by the Union Cabinet, chaired by PM Modi, to tap the potential of the sector and facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation.

Are you aware of the current scenario of the medical device sector in India? The medical devices sector is currently valued at $11 billion and is expected to grow to $50 billion by 2030. The National Medical Devices Policy, 2023 is expected to contribute towards achieving this goal.

The policy framework focuses on building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programs, and promoting higher education to foster talent and skilled resources in line with the industry requirements. Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs.

The policy is expected to provide the necessary direction and support to strengthen the medical devices industry in India. It is designed to make the industry self-reliant, resilient, and competitive while meeting the evolving healthcare needs of patients. The policy covers six broad areas of policy interventions, including regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments in the sector, human resources development, and brand positioning and awareness creation.

Take a look at the six strategies that have been planned to tap the potential of the medical device sector:

Firstly, let’s talk about regulatory streamlining. In order to enhance ease of doing research and business, measures such as creating a Single Window Clearance System’ for Licensing of Medical Devices, enhancing the Role of Indian Standards like BIS, and designing a coherent pricing regulation will be followed. This will help balance patient safety with product innovation.

The next strategy is to enable infrastructure to support the growth this policy will bring in. The establishment and strengthening of large medical device parks and clusters equipped with world-class common infrastructure facilities will be pursued. These will be in proximity to economic zones with requisite logistics connectivity. This will help with better convergence and backward integration with the medical device industry. The Indian government has given its approval to set up 157 nursing colleges alongside medical colleges established in the country since 2014, at a total cost of Rs 1,570 crore.

Facilitating R&D and innovation is the third area where the policy aims to promote research and development in India by establishing centers of excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups.

Attracting investments in the sector is another focus area of this policy. Along with recent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership(PPP).

Then comes human resources development. The policy anticipates a steady supply of skilled work force across the value chain. To achieve this, the policy will support skilling, reskilling, and upskilling of professionals in the medical device sector. It will also promote dedicated multidisciplinary courses for medical devices in existing institutions to ensure the availability of skilled manpower for futuristic medical technologies, high-end manufacturing, and research.

Lastly, brand positioning and awareness creation are critical for promoting the medical device sector. The policy foresees the creation of a dedicated Export Promotion Council for the sector under the Department, which will be an enabler to deal with various market access issues. The policy will also promote more forums to bring together various stakeholders for sharing knowledge and building strong networks across the sector.

The National Medical Devices Policy, 2023 has been welcomed by industry leaders. These strategies will provide a holistic approach to promote the medical device sector in India. The policy interventions will enhance ease of doing research and business, facilitate R&D and innovation, attract investments, and develop skilled manpower. All these measures will create a favorable ecosystem for the growth of the medical device industry in India.

Source: Express Healthcare

GVRP offers Medical Devices Testing Services.

Connect with us at info@gvrp.in to learn more about our testing services portfolio.

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 search for effective cancer treatments is a never-ending battle that demands the most innovative and efficient solutions. Immunotherapy has emerged as a promising approach to combat cancer, but its complex nature and unpredictable outcomes have made it a difficult field to navigate. Unfortunately, most immunotherapy agents are not effective for 60 to 70% of cancer patients and targeting their complex immune system using in vitro screens is a daunting task.

This highlights the need for a comprehensive in vivo preclinical investigation of each new drug’s mechanism of action and efficacy for clinical applications. This is where MuScreen™ comes in, CrownBioscience’s innovative in vivo screening platform that promises to transform the way we develop immunotherapeutic drugs.

MuScreen™ offers a comprehensive suite of tools that enable scientists to test different immunotherapy medicines on mice with cancer to find the best one quickly and easily. The platform has two parts: one part tests how well the drug works on the cancer, and the other part looks at how the drug affects the mouse’s immune system. By doing so, MuScreen™ helps researchers gain a thorough understanding of a new drug’s mechanism of action and efficacy for clinical applications.

One of the key advantages of MuScreen™ is its large-scale, validated panels of homografts derived from mouse cell lines of the same inbred strain (syngeneic models) and homografts of spontaneous/ carcinogen induced GEMM (genetically engineered murine models) tumors in immunocompetent syngeneic hosts (tumor homograft models, MuPrime™). These panels can be tailored to meet specific research needs and cover a wide range of cancer types and immune profiles, making MuScreen™ a versatile and powerful tool in the fight against cancer.

In addition to its diverse range of models, MuScreen™ offers a wealth of historic data for some widely used syngeneic models, aiding support for the capabilities of the platform. The syngeneic and tumor homograft models in MuScreen™ are also comprehensively characterized, with available data including immune checkpoint inhibitor benchmarking, baseline tumor immune profile, and tumor RNAseq. Furthermore, Crown Bioscience covers the cost of the vehicle group for all models and offers a discount on shared control groups, making MuScreen™ a cost-effective solution for cancer drug development.

Maximizing the value from MuScreen™ is also possible through the FACS or Mouse I/O RNA-Seq Panel to gather further insights on immunotherapy screening. These tools enable scientists to study the pharmacodynamic effects of their immune-oncology agents, uncover predictive biomarkers, and identify patient populations that are responsive to treatment.

MuScreen™ is the most experienced, well-characterized in vivo screening platform that efficiently advances immunotherapy development. Its high-throughput and cost-effective screening across a diverse collection of immune profiles, tumor types, and mutations make MuScreen™ a distinct screening service. GVRP is the authorized distributor of Crown Bioscience services in India, and they can help you get started with MuScreen™ for your projects. With MuScreen™, the fight against cancer has never been more within reach.

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.

Edited by: Dr Nidhi Khurana

Induced pluripotent stem cells (iPSCs) have revolutionized the field of biomedical research and are a promising therapeutic tool for treating a wide range of diseases. iPSCs are adult cells that have been reprogrammed to behave like embryonic stem cells, which can differentiate into any type of cell in the body. These cells can differentiate into various cell types, including those found in the heart, liver, and brain. This makes them valuable tools for drug discovery and development, as they can be used to provide physiologically relevant cells for compound identification, target validation, screening, and tool discovery.

One major application of iPSCs is in disease modeling and creating innovative treatments. By differentiating iPSCs into specific cell types, researchers can study the underlying mechanisms of various diseases, including inherited vascular disorders. Several companies are exploring the clinical use of iPSC-derived cell therapeutics for various indications.

The potential of iPSCs in treating diseases is immense, and clinical trials are underway for a variety of conditions such as GvHD, knee osteoarthritis, acute respiratory distress syndrome, diabetic foot ulcers, renal transplantation, critical limb ischemia, macular degeneration, ischemic cardiomyopathy, Parkinson’s disease, solid tumors, spinal cord injury, and platelet production. Furthermore, iPSCs can be generated from patients with specific genetic mutations or diseases, allowing researchers to study the underlying mechanisms of these conditions and develop targeted therapies.

Another area of research where iPSCs are showing promise is in regenerative medicine. They can be differentiated into various types of cells, including cardiomyocytes and neural cells, which can be used to repair damaged tissues and organs. Additionally, iPSCs can be used to create tissue chips, which can mimic the complex structures and functions of human tissues, allowing for more accurate drug testing.

A number of companies have recognized the potential of iPSCs and are commercializing hiPSC-derived cell types for predictive safety pharmacology, toxicology testing, and drug efficacy screenings. These companies have built industrialized iPSC infrastructures to screen small molecules for drug development and have developed an intricate understanding of the pathways that can activate and modulate stem cells and iPSC technology for repairing and regenerating tissues.

One such company is Nexel, a biotechnology company that specializes in developing iPSC-derived cell types for use in drug discovery and development. Nexel’s approach to iPSC technology is focused on delivering reliable, reproducible results that can help accelerate the drug development process.  As the use of iPSCs continues to grow in the pharmaceutical industry, companies like Nexel are poised to play an important role in advancing biomedical research and improving patient outcomes.

While the use of iPSCs has many promising benefits, there is a need for clear guidelines and regulations. iPSC technology has the potential to revolutionize biomedical research and drug discovery and development by providing more accurate and relevant models for studying diseases and testing drugs. As this technology continues to develop and mature, it is likely that iPSC-derived cells will become an increasingly important tool in the pharmaceutical industry.

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.

OmniScreen™ is a high throughput screening service for multiple oncology drug compounds in a single-go (lead compounds) across a diverse set of cancer cell-lines. It is your best shot to assess the early efficacy and potency of your oncology drug candidates by running initial screens with large-scale cancer cell line panels saving you cost and time.

This technology groups cell lines together based on specific characteristics suitable to the study. It offers diverse quality-controlled screening panels for you to screen your drug compounds in targeted manner. These panels include-

OmniPanel™ – It is a growing collection of >520 cancer cell lines for drug response screening providing complete analysis of the drug compound in vitro.

XenoSelect™ – This panel consists of >210 cancer cell lines and respective xenograft models to rapidly proceed to in vivo pharmacology studies.

RNAseq Panel which includes >240 cancer cell-lines with in-house genomic data such as mutation status, copy number variation and expression levels because of drug response.

PrimePanel™ – It comprises a growing collection of >30 unique primary cancer cell lines derived from PDX (patient-derived tumour tissues for in vitro screening). The ease to link this in vitro data to in vivo and further to clinical efficacy is a speciality of this subpanel enabling discovery of some predictive biomarkers.

XenoBase® is a database with curation of >1000 cancer-lines, can be used to build a custom panel and enhance your usability.

You can take control of your experiment with OmniScreen™ and get unrivaled flexibility to design the screening panels you need. The study can further be customised with flexible template designs by adjusting or extending incubation times and obtaining multiple sets of data from the test samples.

Crown Bioscience, the company behind this technology, ensures that screening results between cancer cell types are consistent by keeping a strict check on:

• Cell line quality – Annotated, well-characterized, SNP/STR verified, mycoplasma tested

• Differences between cell culture media

• Variations in incubation times and treatment responses

• Seeding densities across multiple time points

• Chemotherapeutic agents, and vehicle controls

The personalized support from their bioinformatics team for novel targets and biomarkers help you with obtaining:

• Dose-response curve graphs

• Combination index graphs

• Inhibition heat maps for concentration combinations

• 2D contour maps

• 3D response surface plots

• Guided analysis and reporting

In addition to the unique features offered by this technology, you can also monitor the incoming data real-time via secure online client accounts.

This screening runs every 3 months and internal drug controls and cell line revival costs are covered by Crown Bioscience ensuring a substantial amount of cost cutting.

To increase the efficiency of the outcome, OmniScreen™ keeps historical data from over 100 studies. You can make informed predictions on cell line growth parameters and responses to specific drug candidates based on how specific cell lines previously responded to drug candidates. This gives you an opportunity to maintain clear relevance to in vivo models and real-life clinical settings.

OmniScreen™ is an excellent solution to assess the early efficacy and potency of oncology drug candidates by running initial screens with large-scale cancer cell line panels, saving both time and costs. With its unique features, customized panels, and personalized support, it is the best shot for clients to achieve their desired results.

*GVRP is the authorized distributor of Crown Bioscience services in India. Contact us for more information on how to get started with OmniScreen™ for your projects.

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.

The pharmaceutical industry is undergoing a paradigm shift, leveraging cutting-edge technologies to expedite the drug discovery and development process. This transformation has opened up new opportunities to improve healthcare outcomes, reduce healthcare costs, and create novel therapeutics that address unmet medical needs. The following are some of the latest technologies that are revolutionizing drug discovery and development:

Humanized Mouse Models: Humanized mouse models have emerged as a valuable tool for evaluating the efficacy and toxicity of drugs in the context of a human immune system. These models are created by transplanting human immune cells into immunodeficient mice, thereby providing a more realistic representation of human physiology. Humanized mouse models offer a platform to evaluate immunotherapies and anticancer drugs with a high degree of specificity and accuracy. Our partner Envigo provides humanized mouse models to helps one obtain more clinically relevant information. Envigo utilizes the power of CRISPR-Cas9 and ZFN gene editing technologies to create disease specific humanized models.

Patient-Derived Xenografts (PDX): PDX models are an important innovation in drug discovery and development, providing a more accurate representation of the patient’s disease than traditional cell-line-derived models. These models are created by transplanting fresh cancer tissue samples from patients into immunocompromised mice. PDX models can be used to evaluate drug efficacy, toxicity, and identify novel biomarkers for precision medicine. Our partner Crown Bioscience has the world’s largest PDX collection which ensures users generate data that translates better to clinic.

Organoids: Organoids are three-dimensional cell cultures that mimic the structure and function of human organs. These models are created by culturing patient-derived cells in a specialized medium that can promote their self-organization into complex structures. Organoids offer a platform to study disease mechanisms, screen drugs, and develop personalized treatments. Organoids can also be used for toxicology testing, enabling researchers to predict drug toxicity and reduce animal testing.

Human induced pluripotent stem cell (iPSC)-derived cell lines: iPSC technology provides a powerful tool for studying disease pathways and developing in vitro human models with well-controlled experimental conditions. In particular, iPSC-derived cardiomyocytes (iPSC-CMs) have emerged as a useful model for investigating the function and dysfunction of cardiomyocytes, drug screening and toxicity, disease modeling, and the development of novel drugs for heart diseases.

iPSC-CMs have been used to study various cardiac diseases, including arrhythmias, heart failure, and cardiomyopathies. They have also been utilized to investigate the mechanisms of drug-induced cardiotoxicity and screen for novel therapeutics that can alleviate these toxic effects [5]. In addition, iPSC-CMs have been employed to develop disease models for inherited cardiac diseases, such as long QT syndrome and hypertrophic cardiomyopathy, providing a platform to study disease progression and identify potential therapeutic targets. Our partner Nexel manufacture hiPSC derived cardiomyocytes which are highly pure and electrophysiologically active population of cells, suitable for all types of experiments in the field of cardiomyocytes.

The use of iPSC technology for drug discovery and development in the Indian biopharma industry has shown tremendous promise, with several companies investing in this technology to develop novel therapeutics for various diseases.

Artificial Intelligence (AI) and Machine Learning (ML): AI and ML are rapidly transforming the drug discovery and development landscape by enabling researchers to analyze vast datasets and identify novel drug targets. AI and ML can be used to predict drug efficacy, toxicity, and identify potential side effects.

Precision Medicine: Precision medicine involves the use of genomic data to develop personalized drugs for patients. This approach considers a patient’s genetic makeup, lifestyle, and environmental factors to create drugs that are tailored to their individual needs. Precision medicine offers the potential to increase the effectiveness of drugs, reduce side effects, and improve patient outcomes.

Bioprinting: Bioprinting involves using 3D printing technology to create three-dimensional structures of tissues and organs. Bioprinting can be used to develop novel therapeutics and test them more efficiently by creating realistic models of the human body. Bioprinting has the potential to revolutionize drug development by enabling the creation of physiologically relevant models for drug testing.

In conclusion, the pharmaceutical industry is leveraging new technologies to accelerate the drug discovery and development process, leading to improved healthcare outcomes and reduced healthcare costs. These technologies offer immense predictive and data analytics capabilities, enabling researchers to identify novel drug targets, develop personalized medicines, and create more realistic models of the human body for efficient drug testing. As the industry continues to evolve and adapt to new technologies, we can expect to see more targeted and personalized treatments that improve patient outcomes and quality of life.

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.