Pharmaco - Articles
09-May-2022
The rise of a more patient-centric, value-based healthcare environment gives the pharmaceutical industry a chance to find a new role and take a new seat at the table, says Gérard Klop of Vintura Consultancy.
The party’s over for traditional models of healthcare delivery. As populations continue to age and develop comorbidities, all players in the healthcare sector need to plan a more holistic approach to healthcare that involves issues such as wellness, pre-emptive interventions, and earlier targeting and tracking. Although daunting, this also gives the pharma industry an opportunity to establish a new role for itself. The major players are well aware that the days of simply supplying pills are over. Pharmaceutical organisations need to become more deeply embedded in delivering and monitori…
The party’s over for traditional models of healthcare delivery. As populations continue to age and develop comorbidities, all players in the healthcare sector need to plan a more holistic approach to healthcare that involves issues such as wellness, pre-emptive interventions, and earlier targeting and tracking. Although daunting, this also gives the pharma industry an opportunity to establish a new role for itself. The major players are well aware that the days of simply supplying pills are over. Pharmaceutical organisations need to become more deeply embedded in delivering and monitori…
04-May-2022
The European Medicines Agency (EMA) has announced that the UNICOM’s DADI (Digital Application Dataset Integration) project will now be used for the implementation of regulatory data submissions. Amplexor’s Renato Rjavec looks at what this entails for pharma companies.
A more data-driven way of managing regulated product data, based on agreed standards, is the future of pharma. But the EMA’s decision means that for now, regulatory teams will have to manually manage data in two repositories – both information populated via DADI web forms, and the fuller data sets held within their own internal RIM systems. Nevertheless, although the announcement was a disappointment to some, leveraging the parallel DADI project relieves pressure on the pharma industry. DADI, which has been running in parallel…
A more data-driven way of managing regulated product data, based on agreed standards, is the future of pharma. But the EMA’s decision means that for now, regulatory teams will have to manually manage data in two repositories – both information populated via DADI web forms, and the fuller data sets held within their own internal RIM systems. Nevertheless, although the announcement was a disappointment to some, leveraging the parallel DADI project relieves pressure on the pharma industry. DADI, which has been running in parallel…
28-Jun-2023
TrakCel was the first provider of integrated cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy (CGT) products. It was established in 2012 by a group of co-founders with a background in temperature-controlled supply chain management services to the biotechnology industry. They were the first to identify the challenges of managing complex supply chains associated with both clinical and commercial cell and gene therapies.
TrakCel was the first provider of integrated cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy (CGT) products. It was established in 2012 by a group of co-founders with a background in temperature-controlled supply chain management services to the biotechnology in…
TrakCel was the first provider of integrated cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy (CGT) products. It was established in 2012 by a group of co-founders with a background in temperature-controlled supply chain management services to the biotechnology in…
Without doubt one of the biggest issues facing community pharmacy right now is staffing challenges. It’s a problem that is impacting pharmacies across the UK. In this blog Centred Solution’s Managing Director and pharmacist, Paul O’Hanlon, explains why he believes technology can play a crucial role in addressing the problem.
The figures speak for themselves. In 2019 the first national workforce survey in Wales showed a vacancy rate of 6% for pharmacy[1]. A year later a similar survey in Scotland saw double that with a vacancy rate of 12%[2]. In England a workforce report from Health Education England showed the pharmacy vacancy rate had doubled to 8% in just four years[3]. Further research from the Company Chemist’ Association found that a shortage of over 3000 community pharmacists had dev…
The figures speak for themselves. In 2019 the first national workforce survey in Wales showed a vacancy rate of 6% for pharmacy[1]. A year later a similar survey in Scotland saw double that with a vacancy rate of 12%[2]. In England a workforce report from Health Education England showed the pharmacy vacancy rate had doubled to 8% in just four years[3]. Further research from the Company Chemist’ Association found that a shortage of over 3000 community pharmacists had dev…
• Following successful appeals by the Merck-Pfizer Alliance, patient groups and healthcare professional organisations, BAVENCIO® (avelumab) has been recommended by NICE as a maintenance treatment option from 7 April 2022 to all eligible patients on the NHS in England, Wales and Northern Ireland[i]
• Avelumab is the first immunotherapy for use as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma who have responded to platinum-based chemotherapy
• The approval enables equitable access for all eligible patients in the UK following recommendation by the Scottish Medicines Consortium in August 2021[ii]
Today Merck and Pfizer announce that, following a successful appeal of the prior Final Appraisal Document (FAD), the National Institute f…
Today Merck and Pfizer announce that, following a successful appeal of the prior Final Appraisal Document (FAD), the National Institute f…
04-Apr-2022
15 Pharma and Life Science events taking place in April 2022, including events in Gene Therapy, Process Development, Medical Affairs, Translational Medicine, Clinical Project Management, Drug Development and more.
15 Pharma and Life Science events taking place in April 2022, including events in Gene Therapy, Process Development, Medical Affairs, Translational Medicine, Clinical Project Management, Drug Development and more. 2nd Gene Therapy for Muscular Disorders Summit (April 4th-7th) The summit will be returning as an in-person event to Boston in April 2022, to help gene therapy developers targeting muscular disorders to overcome safety and toxicity challenges and effectively translate their programs into the clinic. LNP Formulation and Process Development Summit 2022 (April 12th-14th) Th…
15 Pharma and Life Science events taking place in April 2022, including events in Gene Therapy, Process Development, Medical Affairs, Translational Medicine, Clinical Project Management, Drug Development and more. 2nd Gene Therapy for Muscular Disorders Summit (April 4th-7th) The summit will be returning as an in-person event to Boston in April 2022, to help gene therapy developers targeting muscular disorders to overcome safety and toxicity challenges and effectively translate their programs into the clinic. LNP Formulation and Process Development Summit 2022 (April 12th-14th) Th…
Pearl Chemist Group Director and Superintendent Pharmacist, Mayank Patel, is ahead of the curve when it comes to implementing the new pharmacy hub and spoke model. Here he talks about how investing in technology early has allowed him to grow his business and build better relationships with patients.
“It’s no secret that as pharmacists we are navigating a new and more demanding healthcare landscape. Our role has changed significantly since the start of the 21st century due to increased expectations from the public, advances in science and technology and changing workforce pressures. The Community Pharmacy Contractual Framework for England has placed a higher focus on clinical service. In addition, the Covid-19 pandemic resulted in significant acceleration in changing how we work day-to-day a…
“It’s no secret that as pharmacists we are navigating a new and more demanding healthcare landscape. Our role has changed significantly since the start of the 21st century due to increased expectations from the public, advances in science and technology and changing workforce pressures. The Community Pharmacy Contractual Framework for England has placed a higher focus on clinical service. In addition, the Covid-19 pandemic resulted in significant acceleration in changing how we work day-to-day a…
Molecular docking technology remains the most popular structure-based drug design method, which takes full advantage of protein-ligand interaction information. However, in virtual screening, compared with molecular docking, pharmacophore-based methods have obvious advantages in terms of computational cost and accuracy, and docking-based virtual screening methods show a higher false positive rate.
Structure-based Pharmacophore Molecular docking technology remains the most popular structure-based drug design method, which takes full advantage of protein-ligand interaction information. However, in virtual screening, compared with molecular docking, pharmacophore-based methods have obvious advantages in terms of computational cost and accuracy, and docking-based virtual screening methods show a…
Structure-based Pharmacophore Molecular docking technology remains the most popular structure-based drug design method, which takes full advantage of protein-ligand interaction information. However, in virtual screening, compared with molecular docking, pharmacophore-based methods have obvious advantages in terms of computational cost and accuracy, and docking-based virtual screening methods show a…
The pace at which pharmaceutical manufacturers have embraced digitalisation has accelerated over the past two years with many adopting Pharma 4.0 principles in line with the urgent need to drive speed to market and be ready for demand spikes through the pandemic and beyond.
The pace at which pharmaceutical manufacturers have embraced digitalisation has accelerated over the past two years with many adopting Pharma 4.0 principles in line with the urgent need to drive speed to market and be ready for demand spikes through the pandemic and beyond. The rate at which Covid-19 vaccines were developed and manufactured has been impressive thanks to the innovative ways pharmaceutical enterprises and medical bodies, across private and public sectors, have been able to work together. The sector, which…
The pace at which pharmaceutical manufacturers have embraced digitalisation has accelerated over the past two years with many adopting Pharma 4.0 principles in line with the urgent need to drive speed to market and be ready for demand spikes through the pandemic and beyond. The rate at which Covid-19 vaccines were developed and manufactured has been impressive thanks to the innovative ways pharmaceutical enterprises and medical bodies, across private and public sectors, have been able to work together. The sector, which…
17-Mar-2022
In response to the pandemic, regulators accepted virtual audit inspections. Two years on, is remote auditing here to stay? Alasdair Leckie, Operations Manager at Rephine Ltd, reveals the findings of research among international pharma clients and senior auditors looking to the future of auditing.
Before the pandemic, the pharma industry and its regulators would not have entertained the concept of remote audits to verify that the manufacturing and distribution standards of supply-chain partners were being maintained. Even the suppliers themselves would not have expected to be monitored at distance. The last two years have changed that, as lockdowns, social distancing and travel restrictions disrupted normal conditions. Rather than curtail audits altogether, with potential risk to product qua…
Before the pandemic, the pharma industry and its regulators would not have entertained the concept of remote audits to verify that the manufacturing and distribution standards of supply-chain partners were being maintained. Even the suppliers themselves would not have expected to be monitored at distance. The last two years have changed that, as lockdowns, social distancing and travel restrictions disrupted normal conditions. Rather than curtail audits altogether, with potential risk to product qua…
01-Apr-2022
15 Pharma and Life Science events taking place in March 2022, including events on drug development, gene therapy, drug safety, regulatory affairs, pharma supply chains, digitalisation and transformation, and more.
15 Pharma and Life Science events taking place in March 2022: 2nd Interstitial Lung Disease Drug Development Summit (March 7th-9th) The timely 2nd ILD Summit will siphon critical insights from experts at Pfizer, Genentech, Novartis, Boehringer Ingelheim and Pieris Pharmaceuticals to help you catalyze a new wave of therapies against Scleroderma, Sarcoidosis, COP, CT-ILDs and more. Gene Therapy for Rare Disorders 2022 (March 7th-10th) As the gene therapy field strives to strike the balance between clinical efficacy and product safety in the context of mounting regulatory scrutiny, G…
15 Pharma and Life Science events taking place in March 2022: 2nd Interstitial Lung Disease Drug Development Summit (March 7th-9th) The timely 2nd ILD Summit will siphon critical insights from experts at Pfizer, Genentech, Novartis, Boehringer Ingelheim and Pieris Pharmaceuticals to help you catalyze a new wave of therapies against Scleroderma, Sarcoidosis, COP, CT-ILDs and more. Gene Therapy for Rare Disorders 2022 (March 7th-10th) As the gene therapy field strives to strike the balance between clinical efficacy and product safety in the context of mounting regulatory scrutiny, G…
The move to digitalisation and the migration to the cloud have been happening gradually within the pharmaceutical sector. Immature digital cultures, lack of in-house data skills, or poorly defined digital strategies have combined to hold businesses back and historically, misperceptions of the cloud have played into this. Manufacturers that have established legacy systems are often unduly concerned about the security risks of moving to the cloud.
The move to digitalisation and the migration to the cloud have been happening gradually within the pharmaceutical sector. Immature digital cultures, lack of in-house data skills, or poorly defined digital strategies have combined to hold businesses back and historically, misperceptions of the cloud have played into this. Manufacturers that have e…
The move to digitalisation and the migration to the cloud have been happening gradually within the pharmaceutical sector. Immature digital cultures, lack of in-house data skills, or poorly defined digital strategies have combined to hold businesses back and historically, misperceptions of the cloud have played into this. Manufacturers that have e…
Jonas Lundqvist, CEO at Haidrun, explains how blockchain can help eliminate fraud and make a substantive difference to the pharmaceutical supply chain.
Pharmaceutical fraud remains a major challenge for the healthcare industry and the coronavirus pandemic has led to a further rise in counterfeit medicines creating a serious health threat to patients and significant challenges for enforcement authorities. From a supply chain perspective, it diminishes the commercial trust that needs to exist between organisations to provide essential products from manufacturing to patient. In the US alone, according to Deloitte, more than $200bn is lost each year because of counterfeit drugs infiltrating insecure supply chains. Against this backdrop, blockchain has been identified by the pharmaceutical indus…
Pharmaceutical fraud remains a major challenge for the healthcare industry and the coronavirus pandemic has led to a further rise in counterfeit medicines creating a serious health threat to patients and significant challenges for enforcement authorities. From a supply chain perspective, it diminishes the commercial trust that needs to exist between organisations to provide essential products from manufacturing to patient. In the US alone, according to Deloitte, more than $200bn is lost each year because of counterfeit drugs infiltrating insecure supply chains. Against this backdrop, blockchain has been identified by the pharmaceutical indus…
A unique tension for life science companies is emerging between the opening of borders driven by flexible working post-pandemic and, simultaneously, restrictions on the flow of talent between key hubs such as Switzerland and the UK post-Brexit. In a fiercely competitive market, how can life science companies battle these opposing forces, and in particular, how does this affect recruitment of top in-house legal talent?
A unique tension for life science companies is emerging between the opening of borders driven by flexible working post-pandemic and, simultaneously, restrictions on the flow of talent between key hubs such as Switzerland and the UK post-Brexit. In a fiercely competitive market, how can life science companies battle these opposing forces, and in particular, how does this affect…
A unique tension for life science companies is emerging between the opening of borders driven by flexible working post-pandemic and, simultaneously, restrictions on the flow of talent between key hubs such as Switzerland and the UK post-Brexit. In a fiercely competitive market, how can life science companies battle these opposing forces, and in particular, how does this affect…
Top Pharma and Life Science events taking place in February 2022, including events in Pharmacovigilance, Drug Discovery, Vaccine Development, Drug Development, RNA Therapeutics and more.
Top Pharma and Life Science events taking place in February 2022: Fierce Drug Safety Summit (February 8th-9th) The Fierce Drug Safety Summit will allow large, medium, and small-sized pharma, biotechs and device companies to learn how to better perform their drug safety processes. Attendees will learn best practices and be better equipped to meet government regulations, ensuring the safety of their patients. RNA Therapeutics 2022 (February 9th-10th) The RNA therapeutics industry has grown at an exponential rate in recent years, with an increased spotlight following the industry’s leading role in developing v…
Top Pharma and Life Science events taking place in February 2022: Fierce Drug Safety Summit (February 8th-9th) The Fierce Drug Safety Summit will allow large, medium, and small-sized pharma, biotechs and device companies to learn how to better perform their drug safety processes. Attendees will learn best practices and be better equipped to meet government regulations, ensuring the safety of their patients. RNA Therapeutics 2022 (February 9th-10th) The RNA therapeutics industry has grown at an exponential rate in recent years, with an increased spotlight following the industry’s leading role in developing v…
21-Jan-2022
What are the influences on Quality Management today? And what does the future hold for Quality in the era of smart automation? Late last year, James Kelleher, CEO of Generis, chaired a discussion of experts from Merck, Syneos Health and Accenture.
What are the influences on Quality Management today? And what does the future hold for Quality in the era of smart automation? Late last year, James Kelleher, CEO of Generis, chaired a discussion of experts from Merck, Syneos Health and Accenture. Taking part were: Dr. Heiner Niessen, Head of Application Technology Quality & Compliance at Merck Peter Brandstetter, Quality and Regulatory expert at Accenture James Man, Quality subject expert and R&D Advisory Managing Director at Syneos Health. Here are the edited highlights. Is the era of…
What are the influences on Quality Management today? And what does the future hold for Quality in the era of smart automation? Late last year, James Kelleher, CEO of Generis, chaired a discussion of experts from Merck, Syneos Health and Accenture. Taking part were: Dr. Heiner Niessen, Head of Application Technology Quality & Compliance at Merck Peter Brandstetter, Quality and Regulatory expert at Accenture James Man, Quality subject expert and R&D Advisory Managing Director at Syneos Health. Here are the edited highlights. Is the era of…
The following discussion is based on the requirements described in the EU Guideline on Good Distribution Practice of medicinal products for human use, however, the GDP Guidelines for active substances, the GMP Guidelines and similar regulations contain comparable requirements for the respective areas within or outside of the EU.
Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these…
Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these…
04-Jan-2022
The life sciences industry has evolved tremendously with the acceleration of technology, and digital development presents many opportunities for research and overall process improvements. As we continue to innovate and imagine the future, our annual summit Breakthrough was an insightful look into the technology and upcoming trends of life sciences.
The life sciences industry has evolved tremendously with the acceleration of technology, and digital development presents many opportunities for research and overall process improvements. As we continue to innovate and imagine the future, our annual summit Breakthrough was an insightful look into the technology and upcoming trends of life sciences. Over two days, leaders from established pharma and emerging biotechs discussed the outlook fo…
The life sciences industry has evolved tremendously with the acceleration of technology, and digital development presents many opportunities for research and overall process improvements. As we continue to innovate and imagine the future, our annual summit Breakthrough was an insightful look into the technology and upcoming trends of life sciences. Over two days, leaders from established pharma and emerging biotechs discussed the outlook fo…
As drug and medical device production ramped up to respond to the pandemic, manufacturers faced the challenge of more effectively monitoring, analysing, reporting and acting on quality performance. Siniša Belina, senior life sciences consultant at Amplexor, reveals the latest best practice.
Across a whole swathe of industries the Covid-19 pandemic has shone a light on restrictive business processes, information silos and poor supply-chain visibility. In life sciences manufacturing, for instance, a range of challenges linked to quality management have been exposed and starkly felt. On the one hand, public safety measures over the last 18+ months have put physical distance between team members - hampering the usual form-filling, manual sign-offs and Excel-based record-keeping associated with…
Across a whole swathe of industries the Covid-19 pandemic has shone a light on restrictive business processes, information silos and poor supply-chain visibility. In life sciences manufacturing, for instance, a range of challenges linked to quality management have been exposed and starkly felt. On the one hand, public safety measures over the last 18+ months have put physical distance between team members - hampering the usual form-filling, manual sign-offs and Excel-based record-keeping associated with…
The pharma industry is continuously striving to be more customer-led in its activities, but the healthcare ecosystem is complex, meaning that product teams must consider the relative needs of a whole range of stakeholders. Here, drawing on new research, Malte Scholz of airfocus discusses what’s needed today to navigate and balance those differing priorities.
For all that pharma organisations claim to have refocused their efforts around customers over the last decade or more, mapping new developments to tangible outcomes isn’t easy. In pharma, this challenge is particularly acute due to the diversity of stakeholders with views on what they want from next-generation products. In addition to the ultimate customers (patients), physicians, speciality clinicians, regulators, payers and insurers a…
For all that pharma organisations claim to have refocused their efforts around customers over the last decade or more, mapping new developments to tangible outcomes isn’t easy. In pharma, this challenge is particularly acute due to the diversity of stakeholders with views on what they want from next-generation products. In addition to the ultimate customers (patients), physicians, speciality clinicians, regulators, payers and insurers a…
