Month: August 2023

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.