Pharmaco - Articles

The 18th Project Portfolio and Resource Management Excellence Conference, set for February 13-15, 2024 in Northern New Jersey, is a crucial event for industry leaders. The conference focuses on optimizing resource management, aligning project strategies, navigating market pressures, and embracing innovation. With a lineup of industry experts and insightful sessions, attendees can expect to gain actionable strategies and valuable connections.
Northern New Jersey, February 13-15, 2024 In an ever-evolving pharmaceutical and biotechnology landscape, effective portfolio and project management are paramount. The 18th Project Portfolio and Resource Management Excellence Conference, set to take place in Northern New Jersey from February 13th to 15th, 2024, promises to be a crucible of insights and…

There is no doubt that Generative AI will transform IT delivery. Dirk Bode, CEO of fme, recommends optimising core business strategy and identifying where Generative AI could be harnessed to support the strategy.
AI, and specifically Generative AI, is going to transform IT delivery as well as a whole host of other corporate functions. Via secure company-wide intranets that draw on open, cloud-based AI platforms, to intelligent bot-enabled business functions and regulatory processes, ChatGPT and tools like it are going to transform the way entire organisations access, collate and distribute knowledge, and create new assets – as well as what they do with all of it. Very soon (if they aren’t already piloting projects) companies will first scrutinise and clean up, then migrate content to a sec…

In this article, we highlight some of the top associations dedicated to regulatory affairs for you to explore. These associations have a proven track record of providing exceptional opportunities for regulatory affairs professionals, and of working collaboratively with members to advocate for excellence in the field.
As a regulatory affairs professional, you’ll know how challenging it can be to navigate complex regulations and ensure compliance. To excel in this dynamic field and advance your career, you could benefit greatly from joining a reputable professional association dedicated to regulatory affairs, opening you up to endless networking and learning and development opportunities. In this article, we highlight some of the top associations dedicated to regulatory affairs for you to exp…

EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products have come into force. Anna Cluet of Rephine delves into the challenges faced by certain manufacturers when implementing effective Contamination Control Strategies and practical Quality Risk Management, sharing valuable insights and tips for addressing the issues.
In August, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for contamination control strategies and, by extension, for plant facilities, equipment, manufacturing processes and Quality systems. The updated requirements are designed to increase confidence in these products. Now that they are live, the expectations of auditors have adapted accordingly which will have a…

The pharmaceutical industry is a huge contributor to climate change - what changes can help it go green at last?
The pharmaceutical industry is currently responsible for over four per cent of global carbon emissions and this figure is on track to grow in the coming years. The UK Government has committed in legislation to reach net-zero carbon emissions by 2050, but achieving this goal could hinge on whether or not the industry finds a way to go green. Here Simon Farnfield, event director at Lab Innovations, discusses the changes that are allowing the pharmaceutical industry to go green at last.  Despite being an emissions-producing juggernaut, the pharmaceutical industry rarely faces the same level of scrutiny as other industries because of its role in providing crucial healthcare solu…

Nobody likes being sick. Viruses often overstay their welcome, and symptoms like coughing could linger far beyond when you start feeling better. Big pharma and the flu go hand-in-hand during the winter. You'll start seeing signs for free flu shots at participating businesses. You might even get a flu shot yourself — or you might think they don't really work.
Nobody likes being sick. Viruses often overstay their welcome, and symptoms like coughing could linger far beyond when you start feeling better. Big pharma and the flu go hand-in-hand during the winter. You'll start seeing signs for free flu shots at participating businesses. You might even get a flu shot yourself — or you might think they don't really work. The 2022–2023 season alone saw around 650,000 hospitalizations with tens of tho…

People rely on the pharmaceutical industry to save lives and improve patient care. It’s a vital industry that’s continually looking for ways to improve, including implementing drones. Leaders and team members know drones can improve the pharmaceutical industry in many ways. Whether they’re flying across manufacturing plants or a neighborhood, drones are becoming necessary tools for daily operations.
People rely on the pharmaceutical industry to save lives and improve patient care. It’s a vital industry that’s continually looking for ways to improve, including implementing drones. Leaders and team members know drones can improve the pharmaceutical industry in many ways. Whether they’re flying across manufacturing plants or a neighborhood, drones are becoming necessary tools for daily operati…

The life sciences supply chains support life-saving business models. They supply medical institutions with quick turnaround deliveries while prioritizing consumers through each step of each company’s operations. Putting consumers first directly connects those supply chains with corporate social responsibility policies. Read about how these policies work and what they mean for the life sciences supply chains. They’re leading the health sector into the future with person-focused initiatives.
The life sciences supply chains support life-saving business models. They supply medical institutions with quick turnaround deliveries while prioritizing consumers through each step of each company’s operations. Putting consumers first directly connects those supply chains with corporate social responsibi…

While inflation and economic pressures force pharmaceutical brands to watch their pennies, they will do well to not tackle cost efficiency as a solo issue. Brands require resilience in an array of areas and chief among these is compliance. Stringent regulations must be followed, although the supply chains from which they are navigated, are incredibly complex.
Let’s approach the components of supply chain resilience holistically While inflation and economic pressures force pharmaceutical brands to watch their pennies, they will do well to not tackle cost efficiency as a solo issue. Brands require resilience in an array of areas and chief among these is compliance. Stringent regulations must be followed, although the supply chains from which they are navigated, are incredibly complex. So, can…

While the current volatility in our global supply chains is likely to remain in the foreseeable future, there are steps that businesses can take to adapt, and those that do may find themselves at a competitive advantage. As Lee Metters, Group Business Development Director, Domino Printing Sciences, highlights.
For manufacturers, polycrisis-related supply disruptions have rendered any concept of ‘business as usual’ a thing of the past as businesses grapple with production and shipping delays; inventory management issues; quality control issues; increased costs; penalties; and customer dissatisfaction. While the current volatility in our global supply chains is likely to remain in the foreseeable future, there are steps that businesses can take to adapt, and those that do may find themselves…

The role of a MSL involves building and maintaining relationships with key opinion leaders (KOLs) and healthcare professionals (HCPs) in their assigned therapeutic areas. They serve as a bridge between healthcare providers and the company they represent, providing unbiased scientific and medical information about products, research, and clinical trials. In this article, we look at some of the key responsibilities of an MSL, outlining some of the key benefits of this career.
A Medical Science Liaison is a professional who works in the pharmaceutical, biotechnology, medical device, or other healthcare industries. MSLs focus on specific therapeutic areas such as oncology, cardiology, CNS, haematology, and women’s health, and disease states such as rheumatoid arthritis, cardiovascular disease,…

Following a series of disruptions to worldwide supply chains, regulators across the globe have initiated fresh guidelines for manufacturers in the Life Sciences sector and those responsible for marketing authorisations. The aim is to safeguard uninterrupted global availability of crucial medication supplies. Juan Torrijos Lopez, GMP consultant at Rephine, discusses the regulatory requirements set by the FDA and EMA regarding the maintenance of robust supply chains.
Following a series of disruptions to worldwide supply chains, regulators across the globe have initiated fresh guidelines for manufacturers in the Life Sciences sector and those responsible for marketing authorisations. The aim is to safeguard uninterrupted global availability of crucial medication supplies. Juan Torrijos Lopez,…

B-lymphocyte antigen CD20 (called CD20) is known as an activated-glycosylated phosphoprotein which is expressed on the surface of all B-cells. CD20 is involved in the regulation of trans-membrane Ca2+ conductance and also play critical roles in cell‐cycle progression during human B cell proliferation and activation.
Structure of CD20 The CD20 protein presents a unique arrangement, featuring four membrane-spanning domains. Notably, both the amino and carboxy termini of the protein are positioned within the cytoplasm. An intriguing aspect of this structure is the existence of a short extracellular segment comprising approximately 43 residues, found between the third and fourth transmembrane regions[1]. This distinctive configuration, deeply embedded in the cell membrane, serves to prevent t…

There are only a few months left before the final November 27th, 2023 deadline for DSCSA regulations take effect, yet many manufacturers have yet to reach compliance. Christoph Krahenbuhl, Senior Director at Excellis Health Solutions and former AstraZeneca serialisation lead, shares insight into the current challenges; and how to overcome them in time.
The forthcoming Drug Supply Chain Security Act (DSCSA) final milestone will affect every pharmaceutical manufacturer operating in the US market. This critical legislation requires pharma companies to serialise their products with a unique identifier on each item of medication to make every product fully traceable. Some basic US requirements are similar to what manufacturers have had to put in place for other markets – such as each pack requir…

In the fast-paced and ever-changing pharmaceutical landscape, where complexities, risks, rewards, and returns run high, strategic excellence requires superior decision-making. In this article, we describe the role of competitive intelligence, dispel misconceptions, address challenges, and highlight its advantages in devising winning strategies for pharma companies.
In the ever-evolving landscape of pharmaceutical development, where complexities, costs, and risks run high, staying ahead of the competition requires more than just luck—it demands informed decision-making at every step. Among a multitude of decision-making methods, competitive Intelligence (CI) emerges as the key tool, enabling strategic foresight, innovative adaptation, and successful drug roll-out plans. In this article, we, …

In the pharmaceutical industry, a vendor refers to an external entity or supplier that provides goods, materials, services, or specialized expertise to pharmaceutical companies. These vendors play a crucial role in supporting various aspects of the pharmaceutical business, ranging from research and development to manufacturing and distribution of medicinal products. They are an integral part of the pharmaceutical supply chain and contribute to the overall success of pharmaceutical operations.
In the pharmaceutical industry, a vendor refers to an external entity or supplier that provides goods, materials, services, or specialized expertise to pharmaceutical companies. These vendors play a crucial role in supporting various aspects of the pharmaceutical business, ranging from research and dev…

How can you ensure that the market access materials, value proposition and evidence developed by global teams, will resonate for your local audience? In this article, our experts pool their knowledge to share their top tips for successfully taking global materials local.
How can you ensure that the market access materials, value proposition and evidence developed by global teams will resonate for your local audience? National market access teams and other local affiliates are regularly required to adapt global value materials to reflect the nuances and requirements of their local healthcare systems. At Mtech Access, we have a wealth of experience in developing customer communication materials at both global and affiliate level. Leading Pharma and Medtech companies regularly engage…

In today's Pharmaceutical Industry, standard operating procedures (SOPs) play a vital role in daily operations. A Standard Operating Procedure is a documented set of step-by-step of instructions that outline the approved methods and practices for carrying out specific tasks or processes within an organization. In the context of a pharmaceutical company, SOPs play a crucial role in ensuring quality, compliance, and safety across a company's entire operations.
In today's Pharmaceutical Industry, standard operating procedures (SOPs) play a vital role in daily operations.  A Standard Operating Procedure is a documented set of step-by-step of instructions that outline the approved methods and practices for carrying out specific tasks or processes within an organization. In the context of a phar…

Most competitive intelligence engagements in the pharmaceutical industry tend to be asset-centric. They focus on a single compound or brand and assess factors affecting the asset via so-called implications (aka so-what analysis) - a good implication assessment helps to assess the impact on value. In this article, we share how competitive intelligence (CI), with a sound understanding of enterprise-wide holistic and aligned decision-making helps assess implications more concretely and effectively.
Most competitive intelligence engagements in the pharmaceutical industry tend to be asset-centric. They focus on a single compound or brand and assess factors affecting the asset via so-called implications (aka so-what analysis) - a good implication assessment helps to assess the impact on value. In…

Explore the importance of cytokines in cutting-edge biomedical research, from organoid culture to stem cell therapy. Learn how to select high-quality cytokines with Beta LifeScience, your trusted supplier for low-endotoxin cytokines.
Low Endotoxin Cytokines Matters Organoid culture, CAR-T cell therapy, stem cell therapy, and other topics have become broadly discussed among biomedical researchers. In fact, it is not difficult to see that these advanced technologies are all related to cell culture. In order to maintain efficient growth, proliferation, and differentiation during in vitro cell culture, many cell cultures require the addition of various cytokines. Cytokines Backgrounds Cytokines are proteins synthesized and secreted by immune cells such as monocytes/macrophages and certain non-i…