Articles
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 pharmaceutical, biotechnology, and broader life sciences industries, serves as the bridge between groundbreaking scientific advancements and their delivery to the global marketplace.
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…
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…
In today’s competitive clinical research landscape, seamless EDC-CTMS integration is not simply a convenience; it’s a strategic imperative
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…
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…
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.
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…
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…
03-May-2024
Hannah Palin (Director – Market Access) and Calum Jones (Associate Director – Health Economics) explore the landscape for economic evaluation in the US. They highlight important considerations for companies seeking to infiltrate this key market.
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…
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.
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…
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…
Two senior leaders at Johnson & Johnson (J&), Dr Tamara Werner-Kiechle, Therapeutic Area Lead for Neuroscience, PH & CVM in Europe, Middle East and Africa (EMEA), along with Berkin Gökbudak, Senior Director Commercial Strategy for Neuroscience, PH & CVM in Europe, Middle East and Africa (EMEA), discuss the theme for the 2024 European Psychiatric Congress (EPA) – ‘Mental Health: Open & Inclusive’.
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 &…
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.
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…
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 molecular dynamics simulation.
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…
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.
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…
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…
03-May-2024
Nanogels (NGs), namely nanoscale hydrogel particles, are three-dimensional network systems formed by physical or chemical cross-linking of polymers. Nanogels have received widespread attention in recent years due to their unique properties and potential applications in various fields such as drug delivery, tissue engineering, and diagnostics.
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…
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…
03-May-2024
Coupling drugs combine the precise targeting and potent killing properties, has become a widely recognized form of medication in recent years. Radioactive drug conjugates (RDCs), as a particular form of coupling drugs, are formed by combining radioactive isotopes with disease-targeting molecules. According to the application of RDCs, they can be divided into two main categories: diagnostic RDCs and therapeutic RDCs.
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…
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…
The classical mode of action of small molecule drugs is "occupancy-driven". Since the FDA approved the first oral small molecule targeted therapy for tumors-tamoxifen targeting the estrogen receptor (ER)-in 1977 for the treatment of breast cancer, small molecule drug development has typically focused on screening for high-affinity inhibitors. Small molecule inhibitors can bind to the active sites or allosteric sites of proteins to abolish their function, which is an “occupancy (of a specific site on the target protein) driven (loss of function of the protein)” mode of action.
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…
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…
03-May-2024
With the approval of many antibody-drug conjugation (ADC) drugs around the world since 2019, conjugate drugs have developed into one of the hottest tracks in the pharmaceutical industry.
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…
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.
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…
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…
The decision between an open-source and commercial system is not an easy one because neither is clearly superior. The key to finding the perfect fit for a particular organization lies in its priorities, expectations, and resources.
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…
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's Clinical Trial Management System (CTMS) gives enhanced visibility into all aspects of the clinical trial process - from study plan, Remote monitoring, and Clinical data management.
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…
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…
510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc.
People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market. 510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to…
People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market. 510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to…
03-May-2024
Particles (or powder) in tablets can occasionally experience sticky punch phenomena that prevent the particles from flowing smoothly into the mold wells. Lubricants are mostly utilized in solid preparations, particularly pills and capsules.
IntroductionParticles (or powder) in tablets can occasionally experience sticky punch phenomena that prevent the particles from flowing smoothly into the mold wells. As a result, particles in tablets before are frequently required to add a small amount of lubricating effect of the material, in order to increase mobility and decrease friction with the die, and to ensure a clean and attractive tablet surface. These substances are typically referred to as lubricants. Lubricants are mostly utilized in solid preparations, particularly pills and capsules. Mech…
IntroductionParticles (or powder) in tablets can occasionally experience sticky punch phenomena that prevent the particles from flowing smoothly into the mold wells. As a result, particles in tablets before are frequently required to add a small amount of lubricating effect of the material, in order to increase mobility and decrease friction with the die, and to ensure a clean and attractive tablet surface. These substances are typically referred to as lubricants. Lubricants are mostly utilized in solid preparations, particularly pills and capsules. Mech…
03-May-2024
Monopotassium phosphite provides essential nutrients for plant growth and helps to promote healthy roots and overall plant development.
Monopotassium phosphite is a chemical compound with the molecular formula KH2PO3. It is a salt of phosphorous acid and is commonly used as a fertilizer in agriculture. Monopotassium phosphite provides essential nutrients for plant growth and helps to promote healthy roots and overall plant development. It is also known for its ability to enhance plant resistance to diseases and stress. Action Principle of Potassium Dihydrogen Phosphite Phosphite is a highly mobile molecule that can be easily absorbed by the leaves and roots of plants and moved throughout the plant. Therefore, phosphite can be used by foliar spraying and irrigation fertilization, and is…
Monopotassium phosphite is a chemical compound with the molecular formula KH2PO3. It is a salt of phosphorous acid and is commonly used as a fertilizer in agriculture. Monopotassium phosphite provides essential nutrients for plant growth and helps to promote healthy roots and overall plant development. It is also known for its ability to enhance plant resistance to diseases and stress. Action Principle of Potassium Dihydrogen Phosphite Phosphite is a highly mobile molecule that can be easily absorbed by the leaves and roots of plants and moved throughout the plant. Therefore, phosphite can be used by foliar spraying and irrigation fertilization, and is…
In the ever-evolving field of pharmaceutical research and development, staying abreast of the latest trends and advancements is paramount. This year, the pharmaceutical industry is marked by groundbreaking innovations, regulatory shifts and unprecedented challenges. From cutting-edge technologies to novel therapeutic approaches, pharmaceutical research, and pharmaceutical approvals in 2024 are redefining how we perceive health care.
In the ever-evolving field of pharmaceutical research and development, staying abreast of the latest trends and advancements is paramount. This year, the pharmaceutical industry is marked by groundbreaking innovations, regulatory shifts and unprecedented challenges. From cutting-edge technologies to novel therapeutic approaches, pharmaceutical research, and phar…
In the ever-evolving field of pharmaceutical research and development, staying abreast of the latest trends and advancements is paramount. This year, the pharmaceutical industry is marked by groundbreaking innovations, regulatory shifts and unprecedented challenges. From cutting-edge technologies to novel therapeutic approaches, pharmaceutical research, and phar…
