Articles
A Chemistry, Manufacturing, and Controls (CMC) Specialist plays a crucial role in the pharmaceutical and biotechnology industries by ensuring that all aspects of the product development process related to chemistry, manufacturing, and controls meet regulatory standards and guidelines. The primary function of a CMC Specialist is to oversee and guide the development, manufacturing, and testing processes of drugs or biologics to ensure product quality and compliance with regulatory requirements. This involves a d…
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As AI continues to evolve and integrate into various fields, the life sciences industry has begun leveraging this transformational technology to revolutionise regulatory affairs. Given the complexity and volume of regulatory requirements that companies must comply with, AI offers a promising solution to streamline processes and enhance accuracy. In this article, we delve into how AI is currently used within regulatory affairs in the life sciences, a…
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Regulatory affairs professionals play a pivotal role in ensuring that pharmaceuticals, biologics, medical devices, and other life science products comply with all the relevant regulations. Their work is crucial to bringing safe and effective products to market and safeguarding public health. For those aspiring to venture into this field, understanding the top skills required is a vital first step.…
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What is Polyethylene Glycol? Polyethylene glycol is a high molecular polymer with the chemical formula HO(CH2CH2O)nH. It is non-irritating, has good water solubility, and has good compatibility with many organic components. It has excellent lubricity, moisturizing, dispersion and adhesion. It can be used as antistatic agent and softener in cosmetics, pharmaceuticals, chemical fibers, rubber, plastics, papermaking, paints, electroplating, pesticides, metal processing and food. It has a wide range of applications…
In the intricate landscape of the life sciences, the function of regulatory affairs stands as a linchpin, ensuring not only the seamless introduction of innovative medical solutions to the market but also their compliance with stringent legal and ethical standards. This realm of expertise, pivotal to the pharma…
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Clinical trials are complex endeavours that rely on meticulous data collection, efficient communication, and rigorous oversight. Two critical software systems underpin these needs: Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS). This post explores why seamless integration between EDC and CTMS is paramount for effective trial management. What are EDC and CTMS? EDC (Electronic Data Capture): Imagine a digital filing cabinet for clinical trial data. EDC systems streamline participant data collection, ensuring accuracy and regulatory compliance. CTMS (Clinical Trial Management System): Think of CTMS system as t…
Problem Statement In 2020, the global landscape changed dramatically with the advent of COVID-19. The fatal virus strain soon infected millions of people worldwide, forcing everyone to live a masked life that became limited to their homes. Bharat Biotech is one of India’s leading Biotech companies and when India got hit by the COVID-19 pandemic, the company started looking for a proven and easy-to-use system that could accelerate COVID vaccine trials. Bharat Biotech’s Covaxin, one of the first COVID-19 vaccines developed by an Indian company, was approved to enter Phase 1…
Health economic modelling is fundamental to market access, in both health technology assessment (HTA) and pre and post-launch engagement. It is of value globally, but holds particular importance in markets across Europe, the UK, and Canada, among others. Its application in the US, however, is less established. With a dedicated Health Economics Team, economic modelling is a key area in which Mtech Access support clients. Whilst there are variations in the approaches between HTA markets, we can see commonalities in the requirement for e…
In 2024, the pharmaceuticals market in the UK is expected to reach a projected revenue of US$31.31bn, with Oncology Drugs forecasted to be the largest market with a projected volume of US$6.13bn. The growth of the country’s pharmaceuticals market is being driven by a surge in research and development, helping to position the UK as a global hub for innovation within the industry. Based on data from Statista, this art…
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The following article first appeared on the LinkedIn channel of Dr Tamara Werner-Kiechle, Therapeutic Area Lead for Neuroscience, PH & CVM in Europe, Middle East and Africa (EMEA), Johnson & Johnson. This article has been repurposed for publication on Pharmiweb. Two senior leaders at Johnson & Johnson (J&), Dr Tamara Werner-Kiechle, Therapeutic Area Lead for Neuroscience, PH &…
Urethral strictures pose a significant clinical challenge, impacting millions of individuals worldwide and often requiring complex and invasive treatments. In recent years, there has been growing interest in developing novel therapeutic approaches to address urethral strictures, with a particular focus on regenerative medicine and tissue engineering techniques. Among these emerging strategies, decellularization stands out as a promi…
We are enthralled by the intricate dance of life's catalysts - enzymes. These remarkable protein molecules are the unsung heroes of the biological world, orchestrating the myriad chemical reactions that sustain and power the living organisms around us. To truly understand the structural and functional intricacies of these vital biomolecules, we turn to the powerful tool of enzyme mole…
Proteins are the workhorses of the biological world, carrying out a vast array of essential functions within living cells. From enzymes that catalyze chemical reactions, to structural components that provide the scaffolding for our tissues, to signaling molecules that allow cells to communicate - proteins are truly the foundation of all life on Earth. Understanding the three-dimensional structure of proteins is crucial, as this spatial…
Classification of Nanogels According to the phase change triggering mechanism of nanogels, nanogels can be divided into ordinary nanogels and environment-responsive nanogels. Ordinary nanogels will swell when absorbing water, and their drug administration and subsequent release behavior will be single. Environmentally responsive nanogels will swell or dissolve when exposed to different environments, and their administration and subsequent release behav…
γ-emitting isotopes are selected for diagnosis because the radiation they produce can be detected by specific instruments such as positron emission tomography (PET) or single-photon emission computed tomography (SPECT), assisting clinicians in accurately identifying lesions. For example, isotopes such as Tc-99m, I-123, F-18, and Ga-68 are all used for diagnostic RDCs. In contras…
Small molecule inhibitors face two major challenges: resistance mutations and difficult-to-drug targets. On the one hand, patients who respond to small molecule inhibitors eventually develop resistance, mainly due…
Not only the research and development of traditional ADCs continues to be hot, but various new drug conjugates (NDCs) are also blooming. In this article, we make statistics on the research and development pipeline of new conjugate drugs, in addition to ADC, including PDC, ARC, APC, AExC, AEC, ABC, ISAC, ACC, AOC, and ADeC. Linkers for Drug Conjugates With advanced development capabilities in the field of ADC, BOC Sciences can provide a comprehensive selection of linkers for conjugated drug development. Linkers play a crucial role in the design of conjugated drugs, as they determine the stability, release ki…
In 2024, the intersection of artificial intelligence (AI) and life sciences is revolutionizing healthcare delivery and patient outcomes. The integration of AI in life sciences has become an indispensable tool for medical professionals, researchers, patients, and other stakeholders as technological advancements continue to unfold rapidly. AI is reshaping how people approach healthcare, from drug discovery and precision medicine to clinical decision support…
Modern healthcare providers leverage electronic health records (EHR) software to improve their care provision efficiency, securely store patient data, and receive financial incentives from the state. However, many leading EHR platforms are criticized for overly complicated interfaces, rigidity, and high costs that complicate clinicians’ work instead of simplifying it. This is why healthcare organizations today are often looking for an alternative solution to platform-based EHRs for their practices. Many healthcare providers dissatisfied with popular EHR software…
Clinion CTMS is an integrated Clinical Trial Management System (CTMS) designed to give Contract Research Organizations (CROs) and Sponsors greater visibility and control over their clinical trials. Here's a breakdown of its key features and benefits: Real-time Visibility: Gain a comprehensive view of your entire trial at any time. This allows for faster decision-making and course correction, potentially accelerating study timelines. Reduced Trial Costs: Clinion CTMS helps streamline workflows, automate tasks, and optimize spending. This can lead to significant cost savings by minimizing redun…
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