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Source: https://international-pharma.com/feed/

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<title>New NIHR HRC launched for cardiovascular and respiratory medicine</title>
<link>https://international-pharma.com/new-nihr-hrc-launched-for-cardiovascular-and-respiratory-medicine/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:36:30 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39041</guid>
<description><![CDATA[The launch is part of the NIHRs £42m funding to establish 14 new HRCs across England. Guy’s and St Thomas’ and King’s College London (KCL) have launched a new HealthTech Research Centre (HRC) for cardiovascular and respiratory medicine. The new centre is one of 14 new HRCs across England that received a total of £42m […]]]></description>
<content:encoded><![CDATA[
The launch is part of the NIHRs £42m funding to establish 14 new HRCs across England.
Guy’s and St Thomas’ and King’s College London (KCL) have launched a new HealthTech Research Centre (HRC) for cardiovascular and respiratory medicine.
The new centre is one of 14 new HRCs across England that received a total of £42m from the National Institute of Health and Care Research (NIHR).
Based within St Thomas’ hospital campus, the HRC will work with industry and academic partners to develop new technologies, medical devices and digital solutions for cardiovascular and respiratory medicine.
Designed as a ‘one stop shop’, the newly-launched HRC will specifically focus on four themes: cardiovascular disease in adults, technologies for children with congenital heart disease, cardiovascular interventions and respiratory medicine.
In addition, the HRC will develop technologies to support and promote the use of health- technology at home, as well as develop training for the next generation of health-technology innovators and researchers.
Rachel Clough, consultant vascular surgeon and clinical senior lecturer, surgical and interventional engineering, KCL and HRC co-director, commented: “Building on the extensive expertise in the management of cardiovascular diseases, respiratory conditions, biomedical and clinical engineering,…[the] centre…will foster and accelerate the translation to bedside of new promising technologies for the benefit of patients, the NHS and the British economy.”
In November 2023, the NIHR announced funding for new NIHR HRCs to work with businesses to support the development of medical devices, diagnostics and digital technologies to enable people to better monitor their health, diagnose ill health sooner, and improve the management of conditions including cancer, dementia, cardiovascular and respiratory disease.
In February, Cambridge University Hospitals NHS Foundation Trust announced that an innovative brain and spinal injury health technology research centre is set to open this April at Addenbrooke’s Hospital.
With £3m of the total NIHR funding, the Cambridge HRC will bring together NHS partners, businesses and patients from across the UK to develop technologies that improve care while patients are in hospital.
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<item>
<title>New clinical trial aims to investigate skin patches to spot lung transplant rejection</title>
<link>https://international-pharma.com/new-clinical-trial-aims-to-investigate-skin-patches-to-spot-lung-transplant-rejection/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:11:14 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39039</guid>
<description><![CDATA[Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%. A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning […]]]></description>
<content:encoded><![CDATA[
Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%.
A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection.
The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research.
Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify.
The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%.
Set to be carried out by the lung transplant teams at specialist cardiothoracic centres across England, for the next three years, the trial will recruit 152 patients who are waiting for a lung transplant.
Patients will receive a 10x3cm skin patch from the forearm of the organ donor to be transplanted onto the undersurface of their own forearm at the same time as the lung transplant.
Often, before the body has started to reject the lungs, the skin tends to reject earlier than other organs and may be identified as a rash on the donated skin patch. If identifiable, a tiny biopsy from the skin will be taken to confirm the presence of rejection for doctors to treat much earlier and try to prevent the lung from rejecting.
“Early detection of organ rejection means a healthier transplant, giving people greater control of their care and speeding up access to treatment,” said Health Minister, Andrea Leadsom.
Andrew Fisher, professor of respiratory transplant medicine, Newcastle University Translational and Clinical Research Unit, said: “The trial has the potential to revolutionise the way lung transplants are performed in the future and reduce the fear associated with detecting and treating rejection early.”
]]></content:encoded>
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<title>CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines</title>
<link>https://international-pharma.com/curevac-and-md-anderson-cancer-center-partner-to-develop-new-cancer-vaccines/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:09:52 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39037</guid>
<description><![CDATA[Both will develop cancer vaccine candidates in selected haematological and solid tumour indications. CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological […]]]></description>
<content:encoded><![CDATA[
Both will develop cancer vaccine candidates in selected haematological and solid tumour indications.
CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines.
The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs.
Solid tumour cancer, such as sarcoma, carcinoma and lymphoma, is characterised by an abnormal mass of tissue that usually does not contain cysts or liquid areas.
Haematologic cancer, otherwise known as blood cancer, including leukaemia, lymphoma and multiple myeloma, begins in blood-forming tissues such as the bone marrow or in the cells of the immune system.
Under the terms of the agreement, MD Anderson will be responsible for conducting phase 1/2 studies of the selected promising validated cancer vaccine candidates and the completion of investigational new drug approvals in certain clinical indications, while also being eligible for certain downstream payments based on potential future commercialisation.
CureVac will gain worldwide exclusive rights to late-stage development, commercialisation or partnering of the cancer vaccine candidates.
The agreement will utilise CureVac’s end-to-end cancer antigen discovery capabilities, mRNA design and manufacturing, and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development and clinical research, including its Evolution of Cancer, Leukaemia and Immunity Post Stem cEll transplant (ECLIPSE) platform, to contribute to the identification of differentiated cancer antigens based on whole genome sequencing, along with long- and short-read RNA sequencing, and bioinformatics.
Dr Alexander Zehnder, chief executive officer, CureVac, commented: “In combining our respective expertise, we believe we can go further and faster to develop novel, off-the-shelf, mRNA-based cancer vaccines that have the potential to significantly improve patient outcomes.”
Jeffrey Molldrem, chair, haematopoietic biology and malignancy, MD Anderson, said: “Together with CureVac, we hope to embrace this exciting area of drug discovery and development in pursuit of mRNA vaccines that will address significant unmet medical needs.”
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<title>Researchers introduce new AI tool to help clinicians capture uncertainty in medical images</title>
<link>https://international-pharma.com/researchers-introduce-new-ai-tool-to-help-clinicians-capture-uncertainty-in-medical-images/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:07:38 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39035</guid>
<description><![CDATA[The Tyche model could help clinicians and researchers capture crucial information in images. Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image. Funded by the National Institute of Health, […]]]></description>
<content:encoded><![CDATA[
The Tyche model could help clinicians and researchers capture crucial information in images.
Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image.
Funded by the National Institute of Health, the Eric and Wendy Schmidt Center and Quanta Computer, the Tyche machine-learning model could help clinicians and researchers capture crucial information.
In biomedicine, AI models help clinicians by highlighting pixels that show signs of a certain disease or anomaly. However, these types of models usually only provide one answer.
“Having options can help in decision-making” and “so it is important to take this uncertainty into account,” said MIT computer science PhD candidate, Marianne Rakic.
Researchers developed Tyche after modifying a straightforward neural network architecture. After feeding the tool a few examples of segmentation tasks, such as images of lesions in a heart MRI segmented by different human experts, the model learned the tasks and found that 16 example images were enough for the model to make good predictions without retraining.
The team modified the network to output several predictions based on one medical image input and context set, adjusting the network’s layer so candidate segmentations produced could interact with each other and the examples in the context set.
Furthermore, researchers modified the training process to maximise the quality of its best prediction, allowing Tyche to ensure that candidate segmentations are slightly different while still solving the task.
The team also saw that the tool was able to outperform more complex models trained using a large, specialised dataset and performed faster compared to most models.
Researchers believe that Tyche could benefit clinicians and biomedical researchers more than other methods due to its lack of need for retraining, speed and ability to be applied to a variety of tasks.
The team plans to use a more flexible context set on Tyche and aim to explore methods to improve its worst predictions and enhance the system to recommend the best segmentation candidates.
]]></content:encoded>
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<item>
<title>Study reveals how specific nasal cells protect against COVID-19 in paediatric patients</title>
<link>https://international-pharma.com/study-reveals-how-specific-nasal-cells-protect-against-covid-19-in-paediatric-patients/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 23 Apr 2024 14:05:43 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=39033</guid>
<description><![CDATA[The findings suggest why children tend to experience milder symptoms compared to older adults. Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond […]]]></description>
<content:encoded><![CDATA[
The findings suggest why children tend to experience milder symptoms compared to older adults.
Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19.
Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital.
Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years.
After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types.
The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2.
After three days, the NECs of children responded rapidly to the virus by increasing interferon, the anti-viral defence in the body, which restricted viral replication.
As the age of people increased, researchers observed that this early anti-viral effect became less apparent – not only did NECs from elderly individuals produce more infectious virus particles, they also increased cell shedding and damage, potentially linking to the greater severity of disease typically observed in older adults.
The team suggests that the strong antiviral response in the NECs of children could explain why younger people tend to experience milder symptoms, while underscoring the importance of age in research and the treatment of infectious diseases.
Dr Claire Smith, associate professor at UCL and Great Ormond Street Institute of Child Health, said: “Our research… could be crucial in developing effective anti-viral treatments tailored to different age groups.”
She added: “We now hope to investigate the long-term implications of these cellular changes and test therapeutic interventions using our unique cell culture model” to research how ageing can impact the body’s response to other viral infections.
]]></content:encoded>
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<item>
<title>Rapid increase in purchasing teams expected at CPHI North America</title>
<link>https://international-pharma.com/rapid-increase-in-purchasing-teams-expected-at-cphi-north-america/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 16 Apr 2024 09:19:20 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38983</guid>
<description><![CDATA[Macro-uncertainty and large CDMO acquisitions attributed to have driven a surge in R&D, purchasing and QC/QA attendees at the event CPHI North America (7-9 May, 2024) will open at Pennsylvania Convention Center in Philadelphia as the event sees a doubling of attendees* across ‘purchasing and procurement’, ‘R&D’ and ‘Manufacturing’, and ‘QC and QA’. The rapid […]]]></description>
<content:encoded><![CDATA[
Macro-uncertainty and large CDMO acquisitions attributed to have driven a surge in R&D, purchasing and QC/QA attendees at the event
CPHI North America (7-9 May, 2024) will open at Pennsylvania Convention Center in Philadelphia as the event sees a doubling of attendees* across ‘purchasing and procurement’, ‘R&D’ and ‘Manufacturing’, and ‘QC and QA’. The rapid increase is attributed to both a concerted effect by Informa to attract larger buying audiences but is also seen as a response by the USA industry to macro trends – with alternative supply chain options actively being sought by both pharma and biotech companies.
“We have spent a good deal of time researching and investing resources to target these audiences in the last 12 months – in response to exhibitor feedback – but it also shows the strong desire we see among US-based companies to seek out alternative supply options and new partners. Our role is to actively help facilitate these discussions and build an ecosystem of much larger networking opportunities at the event. Companies across the industry have taken note of developments that might affect supply – particularly among the largest CDMOs – and we are here to help them navigate their options and find new suppliers,” commented Sarah Griffin, Manager, Pharma Brand US at Informa Markets.
The 2024 event will be the most innovative ever, with over 350 exhibitors contracted and the addition of three new engagement zones – covering sustainability, innovation, and growth & development [designed to help promote job opportunities and encourage career development conversations] – alongside the first ever Start-Up Market in North America. A dedicated space where smaller innovators and enterprises from the industry can exhibit their exciting new products and solutions.
‘CPHI remains at the heart of pharma in North America, and we love that we’re attracting an increasing number of industry leaders. We are seeing rising numbers of new attendees, particularly this year as we see senior executives from R&D, QC and manufacturing audiences specifically looking to reevaluate both supply and development options,’ said Adam Andersen, Informa’s Executive Vice President, Pharma. He added ‘the great thing about CPHI North America is that we’re still the only show bringing the entire US Pharma supply chain together under one roof – in person, and thanks to our online event platforms our attendees and exhibitors are already making new connections ahead of the event and actively taking forward discussion to forge crucial supply chain partnerships.’
This year’s conference features 4 tracks – spanning ‘Sustainable Futures’, ‘Revolutionizing Drug Manufacturing’, ‘Supply Chain Economy’, and ‘Exploring Excipients’ – as well as a breakfast session on manufacturing excellence and the eagerly anticipated <a href="https://www.cphi.com/northamerica/en/agenda/programme/cdmo-roundtable.html" target="_blank" rel="noopener">CDMO roundtable</a>. The latter is particularly timely, with US-based Manufacturers in high demand in 2024. In total CPHI North American features 50+ experts spanning dozens of sessions that encompass the entire pharmaceutical development and supply chain, with seminars covering themes as varied as ‘marketing’, ‘diversity’ and ‘well-being’.
Additionally, in a further sign of pharma’s increased social responsibility, the new sustainability zone will also host a ‘commitments communication area’: where companies go to publicly pledge their goals and targets for environmental, sustainability or governance over the next few years.
To find out more about this year’s networking, the new personalized options and <a href="https://www.cphi.com/northamerica/en/attend/attend/badges.html" target="_blank" rel="noopener">registration badges, please visit  CPHI North America</a>.
]]></content:encoded>
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<title>Woolcool Introduces FreightGuardian: Revolutionary Pallet Cover Ensuring Temperature Integrity for Whole Shipments</title>
<link>https://international-pharma.com/woolcool-introduces-freightguardian-revolutionary-pallet-cover-ensuring-temperature-integrity-for-whole-shipments/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Tue, 16 Apr 2024 09:12:00 +0000</pubDate>
<category><![CDATA[News]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38980</guid>
<description><![CDATA[Woolcool, the pioneers of sustainable packaging solutions, proudly announces the launch of FreightGuardian, a cutting-edge pallet cover designed to safeguard whole pallet shipments from temperature fluctuations during transit. Engineered to maintain 2-8°C, Frozen, and CRT temperature ranges, FreightGuardian offers a game-changing innovation in the world of cold-chain freight. Harnessing the power of Woolcool’s thermal technology, […]]]></description>
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Woolcool, the pioneers of sustainable packaging solutions, proudly announces the launch of FreightGuardian, a cutting-edge pallet cover designed to safeguard whole pallet shipments from temperature fluctuations during transit. Engineered to maintain 2-8°C, Frozen, and CRT temperature ranges, FreightGuardian offers a game-changing innovation in the world of cold-chain freight.
Harnessing the power of Woolcool’s thermal technology, FreightGuardian is the World’s first pallet cover made using natural materials, including pure 100% Wool and Cotton as the principal materials. This innovative solution ensures that sensitive products such as pharmaceuticals, food items, and biologics reach their destination in optimal condition, safeguarding their efficacy and quality.
“We are thrilled to unveil FreightGuardian at this year’s LogiPharma show. It is the latest addition to our range of sustainable packaging solutions,” said Josie Morris, Managing Director at Woolcool. “With FreightGuardian, we are empowering businesses to transport temperature-sensitive goods with confidence, knowing that their products are shielded from the adverse effects of temperature fluctuations throughout the supply chain.”
What sets FreightGuardian apart is its robust and reusable design, which helps to optimise costs and provide a sustainable alternative to traditional pallet cover solutions, whilst of course being able withstand the challenges and harsh environments experienced by freight shipments. By utilizing Woolcool’s natural, renewable materials, FreightGuardian not only ensures superior insulation but also minimizes the environmental impact associated with single-use packaging.
“Recognising the importance of sustainability in today’s logistical landscape has become paramount in recent years,” Josie Morris added. “FreightGuardian embodies our commitment to providing high-performing, environmentally conscious solutions that align with our customers’ sustainability goals.”
For more information about FreightGuardian and Woolcool’s range of sustainable packaging solutions, visit <a href="https://www.woolcool.com/freightguardian/" target="_blank" rel="noopener">https://www.woolcool.com/freightguardian/</a> or contact <a href="mailto:sales@woolcool.com">sales@woolcool.com</a> .
About Woolcool:
Woolcool is a leading provider of sustainable packaging solutions, specializing in temperature-controlled packaging for a wide range of industries. With a commitment to innovation and sustainability, Woolcool’s products are designed to protect sensitive goods while minimizing environmental impact. For more information, visit [website].
Contact:
Rosie Murgatroyd
Marketing Manager
Woolcool
<a href="mailto:rosie@woolcool.com">rosie@woolcool.com</a> / 01785 262030
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<title>Harnessing The Power of Solid Form and Particle Engineering to Overcome Solubility and Bioavailability Challenges</title>
<link>https://international-pharma.com/harnessing-the-power-of-solid-form-and-particle-engineering-to-overcome-solubility-and-bioavailability-challenges/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 14:26:04 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[Bioavailability]]></category>
<category><![CDATA[companies]]></category>
<category><![CDATA[development]]></category>
<category><![CDATA[drug]]></category>
<category><![CDATA[Form]]></category>
<category><![CDATA[Harnessing]]></category>
<category><![CDATA[Particle]]></category>
<category><![CDATA[pharmaceutical]]></category>
<category><![CDATA[pipeline]]></category>
<category><![CDATA[poor]]></category>
<category><![CDATA[Solid]]></category>
<category><![CDATA[Solubility]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38969</guid>
<description><![CDATA[An Interview with Veranova’s Craig Grant Persistent challenges in poor solubility and low bioavailability have long impeded the pharmaceutical development pipeline, presenting ongoing hurdles for drug companies. As the industry grapples with increasingly complex new chemical entities, the need for innovative solutions to overcome these challenges becomes more urgent. To delve into this issue, explore […]]]></description>
<content:encoded><![CDATA[
An Interview with Veranova’s Craig Grant
Persistent challenges in poor solubility and low bioavailability have long impeded the pharmaceutical development pipeline, presenting ongoing hurdles for drug companies. As the industry grapples with increasingly complex new chemical entities, the need for innovative solutions to overcome these challenges becomes more urgent.
To delve into this issue, explore current strategies for advancing poorly soluble drugs through the clinical pipeline, and uncover best practices for formulating drugs with solubility issues, IPI Journal spoke with Veranova’s Craig Grant, VP and General Manager, Cambridge. With over two decades of solid form expertise, Craig is a founding figure behind Pharmorphix®, Veranova’s dedicated brand for solid form and particle engineering.
Q: It’s estimated that up to 40% of marketed drugs, and between 70 and 90% of drug candidates in the development stage, exhibit poor solubility.1 Could you explain why solubility and bioavailability continue to be such big issues in bio/pharmaceutical drug formulation?
A: In the pharma and biotech industries, the need for effective therapeutics is continually driving the discovery and development of novel active pharmaceutical ingredients (APIs) and new chemical entities (NCEs). This has resulted in the development of increasingly complex drug scaffolds, often with one or more chiral centres and which routinely possess high molecular weight. Though these drugs offer improved stereoselectivity, target specificity and activity, their complexity often causes them to be poorly soluble, which can cause a wide variety of knock-on issues, most notably poor bioavailability with low drug absorption in the body, resulting in such molecules being assigned to BCS Class II (high permeability, low solubility).2
Moreover, at the candidate selection stage, developers are more likely to focus on potency or efficacy, meaning the downstream developability of NCEs is often overlooked during early-stage development. This can lead to significant challenges further down the development pipeline, leading to costly delays and resource wastages.
Q: As increasingly complex drug molecules enter the development pipeline, how do you see solubility challenges evolving in the future? 
A: With small molecules becoming increasingly more complex, solubility challenges are here to stay. This is even more relevant when considering current pharmaceutical trends, with increased prevalence in existing modalities such as peptides, which, depending on size and/ or complexity, straddle the boundary between small and large molecules. The emergence of new “small molecule” modalities such as PROTACs (PROteolysis TArgeting Chimeras) also brings substantial solubility and developability challenges. PROTACs are a subset of TPD (targeted protein degraders), an emerging therapeutic modality used to treat previously difficult or undruggable targets. Unlike traditional protein inhibition methods, PROTACs are two-pronged molecular entities designed to seek out and degrade disease-causing proteins within the cell. However, due to their size and flexibility, PROTACs typically pose crystallisation and solubility challenges during solid-form studies. PROTACs are just one example of how molecular complexity is likely to continue to present difficulties going forward.
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<title>Navigating the 2024 Life Science Landscape: Trends, Challenges, and Opportunities</title>
<link>https://international-pharma.com/navigating-the-2024-life-science-landscapetrends-challenges-and-opportunities/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 14:21:01 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[challenges]]></category>
<category><![CDATA[contract]]></category>
<category><![CDATA[emerging]]></category>
<category><![CDATA[global]]></category>
<category><![CDATA[Industry]]></category>
<category><![CDATA[life]]></category>
<category><![CDATA[Navigating]]></category>
<category><![CDATA[opportunities]]></category>
<category><![CDATA[outsourcing]]></category>
<category><![CDATA[science]]></category>
<category><![CDATA[trends]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38966</guid>
<description><![CDATA[As we step into 2024, the global life science industry finds itself at a crossroads, facing plenty of challenges alongside an abundance of exciting opportunities. The pharmaceutical and contract outsourcing space has shifted, with new trends emerging that will shape the future of this rapidly changing industry. The global stage has witnessed significant upheavals throughout […]]]></description>
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As we step into 2024, the global life science industry finds itself at a crossroads, facing plenty of challenges alongside an abundance of exciting opportunities.
The pharmaceutical and contract outsourcing space has shifted, with new trends emerging that will shape the future of this rapidly changing industry. The global stage has witnessed significant upheavals throughout 2023, with wars impacting everything from oil prices to work locations. Inflation and rising material costs cutting into the profits of many life science companies, and a continuation of the COVID comedown, has left vaccine producers facing challenges and emphasising the need for the diversification of capabilities.
Here, Emma Banks, our CEO, predicts the trends that will dominate the sector in 2024.
Biotech Investment Slowdown: A Cautionary Post-COVID Tale
The roaring success of biotech investments during the pandemic has hit a speed bump. As other sectors gain traction post-COVID, biotech faces a slowdown due to rapidly increasing interest rates and the diversification of investments. This shift poses risks and a reduction in the flow of money with less capital available for biotech companies.
Faced with this challenge, biotech firms are now reevaluating and being more cautious with their investment strategies, focusing on specific assets within their pipelines.
“…the biggest trend we’ve seen is the number of customers that are not necessarily well-funded. So many of them have far less cash than they’ve had in the past. As a result of that, they’re much more cautious as to how they’re spending their capital. They are very selective on their number of assets. We’ve seen a lot of deprioritisation of assets. They’re looking for more creative funding, where they give us stock. We can only take so many bets, and I think that’s the challenge.”
Outsourced vendor
Increasing Focus on Supply Chains
The vulnerabilities exposed by COVID have led to a renewed emphasis on securing and optimising supply chains.
Onshoring is gaining prominence due to geopolitical tensions, with more business flowing from East to West. That said, there are a growing number of Asian CDMOs coming to the fore of the industry, particularly in markets such as Japan and South Korea.
The concept of “domesticating” gains momentum, as countries like Canada invest heavily to be better prepared for future pandemics.
“Canada has a nice R&D rebate program, which factored into our decision to go with our vendor. If it’s qualified as research, you can get a good percentage of that back from the Canadian government.”
Biotech
Continued Explosion of Advanced Novel Modalities
Cell and gene therapies, CAR-Ts, and oligonucleotides continue to grow within the clinical pipelines, promising groundbreaking treatments. Despite regulatory challenges and complexities in commercialisation, the focus on these novel modalities remains strong. Companies specialising in platforms supporting these new products play a critical role in the success of these therapies.
Real Focus on Partnerships
The life science outsourcing market remains highly fragmented; with over 400 players in the biopharma CDMO space alone, businesses and investors face almost limitless options.
This trend is coupled with a shift towards innovative partnerships; biotech companies are now seeking risk-sharing models and flexible collaborations with CROs and CDMOs. It’s time for companies to explore models beyond traditional fee-for-service arrangements, ensuring maximum value and conservation of cash.
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<title>Proposed March-in Guidance Signals Funding Agencies to Actively Evaluate Government Rights Under the Bayh-dole Act</title>
<link>https://international-pharma.com/proposed-march-in-guidance-signals-funding-agencies-toactively-evaluate-government-rights-under-the-bayh-dole-act/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 14:12:02 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[Agencies]]></category>
<category><![CDATA[assistance]]></category>
<category><![CDATA[award]]></category>
<category><![CDATA[Bayh-Dole]]></category>
<category><![CDATA[evaluate]]></category>
<category><![CDATA[federal]]></category>
<category><![CDATA[government]]></category>
<category><![CDATA[Guidance]]></category>
<category><![CDATA[inventions]]></category>
<category><![CDATA[ownership]]></category>
<category><![CDATA[utilising]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38963</guid>
<description><![CDATA[The Bayh-Dole Act (“Bayh-Dole”) governs the rights to inventions made with federal assistance. It offers ownership rights to federal award recipients (“Contractors”) that “conceive or first actually reduce to practice” inventions utilising federal funding (“Subject Inventions”), but Bayh-Dole also comes with certain obligations that carry forward to licensees of government-funded technology. Bayh-Dole also provides rights […]]]></description>
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The Bayh-Dole Act (“Bayh-Dole”) governs the rights to inventions made with federal assistance. It offers ownership rights to federal award recipients (“Contractors”) that “conceive or first actually reduce to practice” inventions utilising federal funding (“Subject Inventions”), but Bayh-Dole also comes with certain obligations that carry forward to licensees of government-funded technology. Bayh-Dole also provides rights to the U.S. government. Among these rights are two distinct but often conflated rights: the march-in and the request of title. Historically, the U.S. government has rarely exercised those rights. Indeed, in the nearly 45 years since the enactment of Bayh-Dole in 1980, no federal agency has exercised march-in rights (and the government has routinely declined to use march-in authority on request), and agencies have requested title only a handful of times.
On 8 December 2023, the Department of Commerce and the National Institute of Standards and Technology (NIST) published a Federal Register Notice titled “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (“Draft Framework”) detailing a new paradigm for the assessment of march-in rights. The Draft Framework reflects the current executive administration’s effort to more aggressively monitor compliance by Contractors and encourage the exercise of government rights under Bayh-Dole.
March-In Threat Level Increases
March-In Threat Level Increases The “March-in right” refers to a federal funding agency’s right to require a Contractor, an assignee, or an exclusive licensee of a Subject Invention to grant a license to “a responsible applicant” (or applicants), or to grant a license itself, if certain conditions are met.1
The Draft Framework requests public comments on a proposed framework for the exercise of march-in. In view of President Biden’s Executive Order of 28 July 2023 (“Executive Order 14014”), which invoked changes to utilisation reporting, the Draft Framework strongly signals that federal agencies will be more proactive in searching for effective opportunities to exercise march-in rights. Per the Executive Order and recently promulgated regulations by NIST, as of 1 October 2023, all agencies are required to collect annual utilisation reports for Subject Inventions, and NIST “strongly encourages” agencies not currently participating in iEdison to do the same. NIST has also provided standard utilisation questions, and answers to these utilisation questions will provide agencies with information to help assess whether exercising march-in is warranted and can be done effectively, according to the Draft Framework.
Executive Order 14014 places a clear emphasis on Bayh-Dole’s domestic manufacturing requirement for exclusive licensees of Subject Inventions. This domestic manufacturing requirement is a statutory requirement and a major component of the Draft Framework. NIST’s standard utilisation questions will help agencies assess whether this domestic manufacturing requirement is being met. In this light, it would not be surprising if the first product subject to march-in rights is a product that lacks compliance with Bayh-Dole’s domestic manufacturing requirement.
Product Pricing in the Spotlight
In addition to the domestic manufacturing requirement, much attention has been directed at the Draft Framework’s inclusion of the “reasonableness of price” of a product as a consideration for march-in. However, agencies were not previously precluded from reviewing product price as a consideration for march-in.2
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