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

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<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>
</item>
<item>
<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
]]></content:encoded>
</item>
<item>
<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.
]]></content:encoded>
</item>
<item>
<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>
<content:encoded><![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 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.
]]></content:encoded>
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<item>
<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>
<content:encoded><![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 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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<item>
<title>Updating Your Regulatory Information Management Capability? It Could Pay to Get Hands-on</title>
<link>https://international-pharma.com/updating-your-regulatory-information-management-capability-it-could-pay-to-get-hands-on/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 14:03:37 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[brand]]></category>
<category><![CDATA[Capability]]></category>
<category><![CDATA[definition]]></category>
<category><![CDATA[implementation]]></category>
<category><![CDATA[information]]></category>
<category><![CDATA[Life Sciences companies]]></category>
<category><![CDATA[management]]></category>
<category><![CDATA[regulatory]]></category>
<category><![CDATA[requirements]]></category>
<category><![CDATA[RIM]]></category>
<category><![CDATA[system]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38960</guid>
<description><![CDATA[Letting business-savvy techies play around with a new RIM system ahead of the proposed implementation could save Life Sciences companies a fortune, says Romuald Braun, Managing Partner at MAIN5, warning against hasty vendor selection and contracting. Everyone is time-poor now. So, when Life Sciences companies are looking to formalise or refresh their regulatory information management […]]]></description>
<content:encoded><![CDATA[
Letting business-savvy techies play around with a new RIM system ahead of the proposed implementation could save Life Sciences companies a fortune, says Romuald Braun, Managing Partner at MAIN5, warning against hasty vendor selection and contracting.
Everyone is time-poor now. So, when Life Sciences companies are looking to formalise or refresh their regulatory information management (RIM) capability, it is tempting to default to the leading brand. After all, if peer companies have already done the research to arrive at this choice, why reinvent the wheel?
Yet, a lack of rigour in the requirements definition and vendor selection process could invite considerable risk and additional cost, if something important has been overlooked. As the EU IDMP grace period gives way to a hard mandate for data standards compliance, and as digital transformation ambitions expand beyond the Regulatory remit to encompass Quality, Safety & Clinical processes, it’s more important than ever that companies do their research when approaching RIM vendor selection and contracting. An overly generic request for proposal (RFP), or ‘safe’ shortlist made up of what everyone else seems to be using, is a risky starting point.
The Growing Expectations for RIM
Deploying a formal, optimised system or platform for regulatory information management is a given now for all Life Sciences companies, irrespective of their size and focus. Regulators expect this and, as data rather than static documents evolves to become the default means of submitting, exchanging and maintaining regulated product and process information, it follows that the systems for managing and keeping track of everything must be sophisticated and reliable.
In the 2020s, a strong, modern RIM platform should equip a company to:
<ul>
<li>Fulfil all of the differing and continuously evolving health authority requirements internationally.</li>
<li>Effortlessly and reliably track the status of products, their licences and current marketing authorisation applications.</li>
<li>Maintain a single, authoritative version of regulated product/process/licence truth that is accessible centrally and locally by the people who need it.</li>
<li>Support future ambitions for process transformation, for instance beyond the scope of Regulatory Affairs – potentially encompassing adjacent functions such as Quality, Safety and Clinical operations – through integrated system capabilities and readily exchangeable data.</li>
</ul>
Although individual events such as a company merger or acquisition, or EU IDMP compliance, may trigger the decision to invest in a new RIM capability, it’s important not to progress this decision without considering the broader associated opportunity – e.g. to address internal data control challenges; transform internal visibility and decision[1]making; and ultimately re-imagine processes so that they are more efficient and support the business strategy more directly.
All these considerations should feed into the RIM selection process, which requires that all of the various business (as well as technical) stakeholders are consulted early on for feedback about their requirements and current process pain points. Thought should be given not only to what the company and its functional teams want and need to be able to do but also to scenarios they wish to avoid in the future. These might include:
]]></content:encoded>
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<item>
<title>The Delivery of Pharmaceutical Drugs and How it Will Change the Future</title>
<link>https://international-pharma.com/the-delivery-of-pharmaceutical-drugs-and-how-it-will-change-the-future/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 13:53:42 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[change]]></category>
<category><![CDATA[chemically]]></category>
<category><![CDATA[conditions]]></category>
<category><![CDATA[delivery]]></category>
<category><![CDATA[drugs]]></category>
<category><![CDATA[Future]]></category>
<category><![CDATA[pharmaceutical]]></category>
<category><![CDATA[shift]]></category>
<category><![CDATA[significantly]]></category>
<category><![CDATA[synthesised]]></category>
<category><![CDATA[treatment]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38957</guid>
<description><![CDATA[Pharmaceutical drugs have seen a seismic shift over the past ten years, moving away from chemically synthesised drugs to focus more on a new class of biological drugs (biologics). Biologics have the potential to revolutionise the treatment of many common conditions that significantly affect millions of lives, such as rheumatoid arthritis, diabetes, autoimmune diseases and […]]]></description>
<content:encoded><![CDATA[
Pharmaceutical drugs have seen a seismic shift over the past ten years, moving away from chemically synthesised drugs to focus more on a new class of biological drugs (biologics).
Biologics have the potential to revolutionise the treatment of many common conditions that significantly affect millions of lives, such as rheumatoid arthritis, diabetes, autoimmune diseases and certain cancers. Nearly 50% of the new FDA-approved drugs have been biologics, showing the size of the shift.
Yet, biologics are, by nature, more fragile. To facilitate the mass adoption of these new biological drugs, the industry needs to find safe, effective and cost-efficient ways to deliver them.
Challenges with Delivering Biological Drugs
The previous generation of chemically synthesised drugs is pretty much one-size-fits-all. Drugs like paracetamol work for the majority of people in safe doses, they come in stable pill form, and it is difficult to accidentally overdose. Overall, they are safe to self-administer, relatively effective and cheap to produce, transport and sell.
Biological drugs, on the other hand, are very different in terms of properties and formulations. They are much more complicated, specific and targeted, meaning greater efficacy and fewer side effects. Yet, this also means they tend to be more vulnerable and more potent. A large set of biological drugs are delivered through the parenteral route in the form of injections. However, this presents issues such as a risk of infection, needle stick injuries and adherence. Major adversity includes vascular damage, injury to the nerve, tissue necrosis and muscle fibrosis.
Most biological drugs need to be stored in refrigerated units at exact temperature ranges to keep them stable. They also need to be administered in very specific doses, tailored to the individual and usually injected intravenously. As such, they tend to be stored, handled and administered in hospitals, health centres, and GP surgeries, complicating the delivery of these medications. Not only does this make it much more expensive to deliver these biological drugs but it also makes it harder to transport and store, especially in countries without reliable refrigeration or power, making the global adoption of these drugs much more difficult.
The complex nature of biologics structure presents the formulation scientist with a unique set of challenges. Biologics can be easily altered during the formulation process, storage, environmental conditions, and administration causing denaturation and degradation, resulting in the loss of some or all of the therapeutic efficacy. As such, these challenges lead to complex manufacturing processes and any deviation can significantly impact the potential adverse effects associated with the use of these biologics.
Delivery of biological drugs via the non-parenteral route will circumvent some of the major challenges associated with synthesis, storage and delivery. Any non-parenteral route is likely to address a significant subset of current challenges – it could improve patient compliance through self-administration, reduce the cost of treatment if delivered in a non-specialist facility and/ or at home, improve storage conditions and eliminate the need to freeze or refrigerate the formulation. However, delivery of biologicals through a non-parenteral route requires careful consideration of drug properties, manufacturing methods and route of delivery.
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<title>Exploring Device Interchangeability for Drug Deliver</title>
<link>https://international-pharma.com/exploring-device-interchangeability-for-drug-deliver/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 13:49:04 +0000</pubDate>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[Sponsored Articles]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38954</guid>
<description><![CDATA[Alex Fong, Head of Insight, Owen Mumford Pharmaceutical Services Devices as Differentiators Choosing the right injectable drug delivery device can be a crucial differentiator for pharmaceutical manufacturers – particularly as the market becomes increasingly crowded with biosimilars. But any decision on switching to a different device needs to be underpinned by firm evidence on the […]]]></description>
<content:encoded><![CDATA[
Alex Fong, Head of Insight, Owen Mumford Pharmaceutical Services
Devices as Differentiators
Choosing the right injectable drug delivery device can be a crucial differentiator for pharmaceutical manufacturers – particularly as the market becomes increasingly crowded with biosimilars. But any decision on switching to a different device needs to be underpinned by firm evidence on the likely reaction from patients. After all, any drug is only as good as the patient’s adherence to their treatment regimen.
If a patient struggles to make the switch from a familiar auto-injector to an innovative new one, there is a danger they will be less inclined to use the device and therefore miss out on vital doses of medication. This issue is particularly important now that many treatments for chronic conditions are self-administered by patients at home, often without the support of a healthcare professional. Ease of use encourages patient adherence and therefore benefits the patient, the healthcare system – and pharmaceutical companies.
Device Interchangeability
Alongside the trend for home self-administration is the growth of biosimilars, as an increasing number of patents for biological medicines are now expiring. In the UK, the NHS expects to save up to £300 million a year by making more biosimilar alternatives available.1 Meanwhile, in the US, savings of $38.4 billion have been predicted for 2021–2025, compared with 2020, as the wider availability of biosimilar products creates a significantly more competitive market.2
Of course, as well as the cost savings of switching from originators to biosimilars, there also needs to be consideration of the most suitable device for administering the new drugs. To support the choice of this device, pharmaceutical companies should have access to data from human factors studies and any other user testing. This data can then support regulatory applications for determining device interchangeability.
The FDA requires a regulatory application to provide evidence that the impact of switching between delivery devices has been assessed, stating: “Data and information supporting the appropriate use and performance testing of the delivery device constituent part of the proposed interchangeable product should be submitted.”3 In Europe, the European Medicines Agency allows differences in the administration device, as long as there is no impact on safety and efficacy.
INTERCHANGEABILITY STUDY
Study Objectives
To provide pharmaceutical companies with evidence for making delivery device decisions for their drugs, there is a need for more studies on the ease of switching devices. This prompted Owen Mumford Pharmaceutical Services (OMPS) to commission an independent study to evaluate the ease with which patients were able to switch between two different auto-injectors.
Auto-injectors are routinely used to deliver biologics suitable for subcutaneous administration. They are convenient for patients and allow them to administer medication in their own homes without requiring the presence of a healthcare professional. The OMPS study aimed to discover whether regular users of a market-leading three-step auto-injector were able to switch to a new two-step auto-injector and successfully perform injections.
Study Design
The three-step auto-injector used in the study was SHL Medical’s button-activated DAI® device – one of the first auto-injectors to be commercialised for home injection (4). The two-step auto-injector was the spring-powered Aidaptus® device from OMPS (5), which uses pressure to activate the injection – rather than having to push a button, the patient simply presses the device onto the injection site.
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<title>Big Data, Personalised Medicine and Support for Healthcare Professionals</title>
<link>https://international-pharma.com/big-data-personalised-medicine-and-support-forhealthcare-professionals/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 13:42:48 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[adoption]]></category>
<category><![CDATA[Advancements]]></category>
<category><![CDATA[big]]></category>
<category><![CDATA[clinical]]></category>
<category><![CDATA[data]]></category>
<category><![CDATA[healthcare]]></category>
<category><![CDATA[improving]]></category>
<category><![CDATA[medicine]]></category>
<category><![CDATA[Personalised]]></category>
<category><![CDATA[professionals]]></category>
<category><![CDATA[support]]></category>
<category><![CDATA[trials]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38950</guid>
<description><![CDATA[What Will Drive Pharma in 2024? In 2023, precision targeting for personalised medicines, improving the information flow between reps and healthcare professionals, and advancements in clinical trials have driven the adoption of new technologies, but we are only at the beginning. With these advancements come more valuable data, and the potential to make better-informed decisions. […]]]></description>
<content:encoded><![CDATA[
What Will Drive Pharma in 2024?
In 2023, precision targeting for personalised medicines, improving the information flow between reps and healthcare professionals, and advancements in clinical trials have driven the adoption of new technologies, but we are only at the beginning. With these advancements come more valuable data, and the potential to make better-informed decisions. Using better connected data and processes will help reduce friction to speed up the delivery of treatments to the right patients, at the right time, as well as reducing cost.
As we progress through 2024, we are set to see all these areas continue to mature and evolve. Pharma and healthcare providers who can successfully embrace data, analytics, and digital platforms will be the best positioned to succeed in 2024 and beyond.
Development Teams will Rethink Big Data to Support Personalised Medicine
The life sciences industry has been waiting a long time for big data1 to transform the commercial viability of personalised medicine. With automation now coming of age, R&D teams can finally seize the opportunity – as long as their data is also clean, standardised, interoperable, and secure.
In 2024, companies will focus on making big data (which could range from raw trial and site-specific data to IT data points, such as cycle times) more usable, by resolving common pain points around cleaning, ownership, and standards. As a result, the volume and frequency of access to study data will increase exponentially. This will require a transparent data model with stringent user access controls to address data privacy and cyber-security concerns.
Leading companies will use automation to make hundreds of marginal and incremental efficiency gains across the development lifecycle, whether deep querying protocols, detecting patterns during medical imaging analysis, or verifying the origin of chemical components. A growing industry momentum will lead to more direct data APIs between sponsors, health institutes, and regulatory authorities2 so that “big (clean) data” becomes a reality, creating the right conditions for commercially viable, personalised medicines to reach patients in need.
As Digital Therapeutics Evolve, Top Device Manufacturers Will Stake Their Claim in The Space
When Pear Therapeutics became the first company to receive payer funding for a mobile app to treat substance use disorder in 2021, it seemed like the industry was gearing up for digital therapeutics to go mainstream.3
However, a lot has changed in two years. The digital health market has suffered some losses that have cast a long shadow on the budding industry, with some companies filing for bankruptcy and other leaving the payer market to go direct-to-consumer.
Despite these setbacks, digital therapeutics will continue to gain traction in 2024 – especially for larger companies that have the resources to learn lessons from these early trailblazers in the space.
In the coming years, we expect to see top companies testing out varied commercial strategies for digital therapeutics, including going direct-to-consumer or developing companion apps to previously established therapies. Heavy “hitters” like Pfizer, AstraZeneca, Boehringer Ingelheim, and Roche have already joined the Digital Therapeutics Alliance,4  and more will likely join the FDA’s5 newly formed Digital Health Advisory Committee.
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<title>Novel Drugs: Challenging Entrenched Prescriber/Investment Behaviour is not Just About Education</title>
<link>https://international-pharma.com/novel-drugs-challenging-entrenched-prescriber-investment-behaviour-is-not-just-about-education/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 15 Apr 2024 13:36:21 +0000</pubDate>
<category><![CDATA[Current Features]]></category>
<category><![CDATA[Volume 16 Issue 1]]></category>
<category><![CDATA[adapt]]></category>
<category><![CDATA[Challenging]]></category>
<category><![CDATA[communications]]></category>
<category><![CDATA[diverse]]></category>
<category><![CDATA[drugs]]></category>
<category><![CDATA[Education]]></category>
<category><![CDATA[ife sciences]]></category>
<category><![CDATA[Industry]]></category>
<category><![CDATA[medical]]></category>
<category><![CDATA[Novel]]></category>
<category><![CDATA[pharma]]></category>
<category><![CDATA[Prescriber]]></category>
<category><![CDATA[public]]></category>
<guid isPermaLink="false">https://international-pharma.com/?p=38947</guid>
<description><![CDATA[Behavioural science’s time has come in the pharma industry, as medical communications adapt to a more ambitious and diverse treatment landscape. Drawing on examples from across public health and life sciences, Alpharmaxim’s founder, William Hind, brings to life the science of behavioural change and how its strategic, structured application within medical communications could help deliver […]]]></description>
<content:encoded><![CDATA[
Behavioural science’s time has come in the pharma industry, as medical communications adapt to a more ambitious and diverse treatment landscape. Drawing on examples from across public health and life sciences, Alpharmaxim’s founder, William Hind, brings to life the science of behavioural change and how its strategic, structured application within medical communications could help deliver important new drugs into the hands of the patients who need them.
Behavioural science, long proven to influence consumer behaviour (e.g. nudging the public to make greener or healthier choices), is rising swiftly up the pharma agenda – and for good reason.
Novel therapies, often with expensive price tags and more targeted patient populations, require strategic new positioning if they are to have a maximum positive impact on patients. Whether to challenge established prescribing practices or to effectively get across a therapy’s value to health authorities and investors, drug developers and licence holders must adapt to the increased sophistication now needed in their communications strategies.
This isn’t simply a case of educating the market about the new product’s benefits, however. Other factors keep decision-makers coming back to habitual choices. It is here that behavioural science comes in, and in particular, the need for methodology when identifying how to use omnichannel communications to maximum impact.
What is Behavioural Science?
Behavioural science draws on psychological theory and the social sciences to understand why individuals follow or resist certain behaviours.
In a public health or ‘responsible citizen’ context, behavioural science has been used successfully across a range of high-profile cases. These include encouraging people to follow COVID-19 guidelines,1 or adapt behaviour in line with climate change recommendations,2 for example by reducing air travel or meat intake. Behavioural science has also been used to encourage vaccine uptake,3 and motivate people to make healthier lifestyle choices, such as increasing physical exercise, reducing obesity and driving up the number of people who stop smoking.4
The Opportunity in Pharma
In Life Sciences, behavioural science has a powerful role to play in medical communications – specifically in overcoming barriers to changing prescribing behaviour.
This is important so that healthcare providers (HCPs) don’t automatically default to their habitual choices of medical or treatments but become more open to emerging options that may improve patient outcomes. So much so that the UK’s Medical Research Council (MRC) is now advocating the use of behavioural science in the design of interventions such as marketing campaigns, to ensure that important new biopharma innovation fulfils its potential for patients.
Evidence of Inertia & Other Barriers to New Treatment Pathways
While it’s possible to make an educated guess about HCPs’ reasons for falling back on tried and tested treatment choices (including officially recommended first-line treatments, budget restrictions, and/or a lack of knowledge of the emerging options), the reality is usually more complex.
The established COM-B model for behavioural science sets out 93 different techniques and how they can be successfully combined to address barriers to change, based on the relative roles of Capability, Opportunity, and Motivation (M) as determinants of current behaviour. (Examples follow below.)
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