Clarivate https://clarivate.com/ Accelerating Innovation Fri, 18 Oct 2024 14:24:35 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 https://clarivate.com/wp-content/themes/clarivate/src/img/favicon-32x32.png Clarivate https://clarivate.com/ 32 32 Alethea Instructor Assistant transforms how instructors manage reading assignments. https://clarivate.com/blog/alethea-instructor-assistant-transforms-how-instructors-manage-reading-assignments/ Thu, 17 Oct 2024 18:04:13 +0000 https://clarivate.com/?p=282506 The Alethea Instructor Assistant is an AI-driven tool designed to streamline the creation of reading assignments for instructors. Guiding questions can boost student engagement with reading materials and foster critical thinking skills. Now available within Alethea, the Instructor Assistant enables educators to easily generate effective questions that bring reading assignments to life, seamlessly integrating into […]

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The Alethea Instructor Assistant is an AI-driven tool designed to streamline the creation of reading assignments for instructors.

Guiding questions can boost student engagement with reading materials and foster critical thinking skills. Now available within Alethea, the Instructor Assistant enables educators to easily generate effective questions that bring reading assignments to life, seamlessly integrating into existing learning management system workflows. Drawing on proven pedagogical practices, the tool enables instructors to confidently incorporate AI into their teaching.

Designed to enhance teaching effectiveness

One of the standout features of the Instructor Assistant is its ability to generate questions with minimal input, which can be adjusted to different difficulty level and unique teaching objectives. This flexibility allows instructors to cater to the diverse needs of their students, ensuring that assignments are appropriately challenging for all levels of understanding.

By ensuring that every reading assignment is purposeful and effective, it empowers instructors to focus on what they do best — teaching and inspiring students.

Tailored to instructors needs

The Instructor Assistant offers a range of features that streamline the reading assignment workflow:

  • Smart suggestions: Automatically generates relevant questions based on course materials.
  • Flexible difficulty levels: Tailor question complexity to suit different course levels.
  • Intuitive interface: Create and customize assignments with minimal effort.
  • LMS integration: Fully embedded in the institution’s Learning Management System.

Alethea is trusted by educators

Alethea’s pedagogic approach pushes students to think deeper and work smarter as they go through their readings. Alethea fosters deeper classroom discussions through student input and ideas. Faculty gain valuable insights into student reading habits, enabling them to adapt teaching methodologies and learning resources.

Dr. Chrissann Ruehle, a Management Faculty member of the Lutgert College of Business at Florida Gulf Coast University shared her experience with Alethea, saying, “If faculty have been teaching for a while and they are looking for something new and innovative to bring into the classroom, this is a great way to revitalize classes.”

Taking student engagement to a higher level

Since its launch, 98% of assignments in Alethea have been crafted with the Instructor Assistant, underscoring its effectiveness and popularity among educators.

The Instructor Assistant is more than just a tool; it’s a partner in elevating student success. Embrace innovation in education with the Alethea Instructor Assistant and transform reading assignments into powerful learning experiences.

Learn more about Alethea.

Alethea is part of the Clarivate AI-powered portfolio of solutions. To learn about our Academic AI offering visit: https://www.clarivate.com/ai/academia.

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How the U.S. election could impact the healthcare industries https://clarivate.com/blog/how-the-u-s-election-could-impact-the-healthcare-industries/ Thu, 17 Oct 2024 13:27:57 +0000 https://clarivate.com/?p=282544 Healthcare delivery has not been the hottest topic on the campaign trail this election season, despite sharp policy differences between the candidates and parties. However, issues such as drug pricing, the Affordable Care Act, Medicare, M&A and telehealth are still worth watching as significant changes could be on the horizon regardless of who wins in […]

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Healthcare delivery has not been the hottest topic on the campaign trail this election season, despite sharp policy differences between the candidates and parties. However, issues such as drug pricing, the Affordable Care Act, Medicare, M&A and telehealth are still worth watching as significant changes could be on the horizon regardless of who wins in November.

These are several key threads to watch:

The 2024 election may determine the future of IRA price negotiations

The outcome of November’s Presidential and Congressional elections could well determine the extent to which the federal government will continue its gradual encroachment into negotiations for drug prices under Medicare’s Part B and Part D programs.

Since the government first created a Part D benefit with the Medicare Modernization Act of 2003 (MMA), Democrats have agitated for greater governmental input into the cost of prescription drugs for Medicare beneficiaries. The MMA placed price negotiations for Part D drugs under private plans, resulting in contracting between manufacturers and payers with rebates accruing to payers, not the government. The Inflation Reduction Act instead allows the Centers for Medicare & Medicaid Services to begin negotiating Fair Maximum Prices for a growing list of Part D (outpatient) and Part B (physician-administered) drugs that represent the greatest cost to the federal government.

In 2023, CMS selected the first 10 Part D drugs and the ensuing negotiations resulted in the MFPs for these 10 drugs being 59% below their current list prices, a Clarivate analysis found. Over the next five years, CMS is slated to select up to 90 additional Medicare Part B and Part D drugs for price negotiation as highlighted in the figure below.

Parties disagree on role of government in price negotiations.

Before the second batch of drugs for negotiations are selected, Americans will head to the polls to elect a President and Congress. Vice President Harris, who cast the tie-breaking vote in support if the IRA, has pledged to “accelerate the negotiations to cover more drugs and lower prices.” In public speeches, she has suggested possibly expanding the program beyond Medicare, presumably to the commercial insurance market (covering 47% of all lives in the U.S.). Such a change would sharply increase the number of people covered under this program.

Former President Trump , whose platform calls healthcare and prescription drug costs “out of control,” has not spoken on whether the price negotiations under Medicare would remain the law. However, recommendations from the Heritage Foundation’s Project 2025 could influence policymaking under a Trump administration. This conservative think-tank has criticized the price negotiations and called for its repeal in favor of other insurance design reforms.

With control of Congress and the Presidency up for grabs, the IRA price negotiation program’s future is likely to be decided next month.

The Affordable Care Act

The Harris plan for healthcare pulls back from the vice president’s previous support of a Medicare-for-all system and seeks to build on Obamacare and enhancements passed during the Biden administration. With pieces of the Inflation Reduction Act’s Medicare reforms still rolling out, a potential Harris presidency would oversee their implementation.

The Trump administration platform does not bring up the ACA. At campaign events, Trump has said he will keep Obamacare unless he could replace it with something better. During the Sept. 10 debate, Trump returned to repeal and replace rhetoric, offering that he has “concepts of a plan”. A coherent Republic healthcare strategy could lean on a proposal from the Republican study committee, which would reduce exchange subsidies and seek to convert Medicaid to block grant funding, both longtime ideas in circulation among the Republican caucus that would likely reduce services and enrolment. Georgia’s implementation of a partial ACA Medicaid expansion with an employment requirement could see renewed interest if Trump returns to the White House — many states explored or instituted work requirements during his previous term.

The immediate issue for whoever wins will be expanded subsidies extended by the Inflation Reduction Act, which are set to expire at the end of 2025. Loss of subsidies could cause spikes in insurance premiums and major losses in exchange enrolment. Extending them would require Congressional action. Congressional Democrats introduced legislation to make the subsidies permanent in September 2024, but the legislation has no chance of passage so close to the election. A Republican sweep of both chambers would imperil the expanded subsidies, although an expansion could conceivably pass as part of a larger “must-pass” spending bill. The issue will await November’s victors and could affect tens of millions of Americans and their health coverage.

Medicare Advantage

While a Harris administration would not push Medicare-for-All, which the candidate once supported, it will likely continue on the same path as the Biden administration, which still has several phases of drug pricing negotiations to unfurl, with additional drugs – as well as Part B drug negotiations – coming online through 2029. A second Trump administration would like face pushback if it abandoned or overturned the drug-pricing reforms of the Inflation Reduction Act, which includes numerous pieces that will prove popular with seniors, even as the industry faces price negotiations on top drugs, long an industry non-starter. It would be hard to pull back key reforms such as a $35 monthly insulin cap and an annual $2,000 out-of-pocket maximum, which beneficiaries can spread over a 12-month period.

Medicare is likely to experience significant churn in 2025, as top payers pull back plan options and even leave some counties. Given the Trump administration push for Medicare Advantage plans, which successfully raised the MA share of all Medicare enrolments above 50 %, there could be a renewed focus on supplementary benefits and other enticements for beneficiaries if Trump returns to office. The popularity of Medicare Advantage makes it difficult to cut too deeply despite impacts from the program, so future changes will likely continue to be slight under either Harris or Trump.

Consolidation and M&A

Another obvious policy divergence between Harris and Trump is that of regulating mergers and acquisitions that accelerate concentration in the industry.

As California Attorney General from 2011 to 2017, Harris was a forceful opponent of healthcare industry consolidation, both vertical and horizontal, believing that mergers of hospitals, physician groups and insurers would damage competition and raise prices for care. As AG, she joined a federal lawsuit to block Anthem and Cigna’s merger in 2016 .

These prior actions align with the Biden Administration’s policy of strict antitrust enforcement, particularly concerning healthcare.

By contrast, the Trump Administration took a more laissez-faire approach to consolidation in the healthcare arena, both vertical and horizontal. It allowed the largest healthcare merger in history – that of CVS and Aetna in 2018 – requiring only minimal divestment. It also allowed within-market hospital mergers in several major markets including Chicago, Twin Cities, Houston and Atlanta.

President Biden specifically focused on healthcare mergers in his July 2021 Executive Order directing rigorous enforcement of antitrust laws “to combat the excessive concentration of industry, the abuses of market power, and the harmful effects of monopoly and monopsony” in the hospital, insurance and prescription drug markets.
While the FTC remains hampered by a lack of resources, its investigations and regulatory stance alone has discouraged certain types of mergers, such as those of hospital systems within the same territory. The Biden FTC also has been more exacting in the types of conditions, or settlement agreements, that it will accept to approve deals, according to legal analysis by the firm Kirkland & Ellis .

It has had less success reining in the rapid consolidation across the healthcare industry’s segments: The Biden FTC and DOJ fought to prevent UnitedHealth Group’s purchase of Change Healthcare, but lost in court, for example.

But given her direct experience and activism in challenging mergers that appear to harm consumers’ access to affordable care, a Harris presidency could result in a renewed push against industry consolidation, testing emerging ideas in how to analyze and mitigate potential harms.

Other healthcare topics to watch:

Telehealth

About a dozen federal telehealth waivers put in place during the Covid pandemic are set to expire Dec. 31, 2024, and providers and payers are pushing for an extension. There are two ways telehealth waivers can be extended through 2025 – via The Centers for Medicare & Medicaid Rule and legislatively through 2026 via H.R. 7623. Telehealth has proven its worth and would likely be extended under Harris or Trump, but it’s worth noting what’s at stake if the waivers expire and Congress and/or CMS doesn’t act.

  • Pre-waiver, for behavioral health visits, patients were required to have received an in-person evaluation six months before initiating telehealth, followed by an in-person visit annually. Under the waiver, in-person evaluation is no longer required for these consults.
  • Waivers enable access to medications for hundreds of thousands of patients nationwide for a variety of medical diagnoses including substance use disorder.
  • The waiver allows patients to be seen across geographic lines and in any setting.

As of Aug. 6, 2024, 43 states, the District of Columbia and the Virgin Islands have pay-parity laws in place that will not expire regardless of election outcomes.

Chevron Doctrine Overturned

Beyond the presidency, the ACA and IRA are likely to face bigger challenges from the courts as a result of a seismic U.S. Supreme Court decision nixing the “Chevron defense” of federal regulation, thereby opening those regulations up to legal challenges. The Chevron Doctrine, a longstanding legal precedent that required courts to defer to reasonable interpretation by federal agencies in carrying out laws passed by Congress, was overturned in June 2024 by the court.

The ruling is likely to impact the healthcare industries, particularly around FDA decision-making on drug approvals, drug labelling and dietary supplements. Increased legal challenges could make it difficult for the healthcare industry to rely on new FDA interpretations and guidance, but the impact may be muted– the Chevron doctrine hasn’t been cited in any Supreme Court cases for about a decade.

Key takeaways:

  • The election outcome may determine the extent to which the federal government will continue its gradual encroachment into negotiations for drug prices under Medicare’s Part B and Part D programs.
  • Harris would likely continue the Biden Administration’s M&A-dampening skepticism toward consolidation and negotiation of drug prices for Medicare recipients. The Trump administration took a more hands-off approach to M&A and would be unlikely to overturn drug pricing changes or key Biden Administration reforms, including a $35 monthly insulin cap.
  • Trump has changed positions repeatedly on whether he would attempt to overturn the ACA. Harris has been a staunch supporter of the ACA, despite her previous position in support of a single-payer “Medicare for All” scheme.
  • About a dozen federal telehealth waivers put in place during the COVID-19 pandemic are set to expire Dec. 31, 2024, and providers and payers are pushing for an extension. Overturning the Chevron Doctrine will make it tougher for federal health agencies to cut through red tape but is unlikely to have a major immediate impact on policy and regulation.

This post was written by Bill Melville, Lead Healthcare Research and Data Analyst; Roy Moore, Senior Healthcare Research and Data Analyst; Valerie E. Pillo, Senior Healthcare Research and Data Analyst; and Paula Wade, Lead Healthcare Research and Data Analyst. To learn more about how Clarivate helps life science companies, payers and providers navigate the market access landscape, please visit us here.

 

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Increasing your likelihood of success in dealmaking discussions https://clarivate.com/blog/increasing-your-likelihood-of-success-in-dealmaking-discussions/ Thu, 17 Oct 2024 13:26:44 +0000 https://clarivate.com/?p=282522 In-licensing and acquisitions are fast tracks for pharmaceutical companies to access groundbreaking technologies and assets that will drive the next generation of transformative patient treatments. Dealmaking is not a trivial process. Audience members during the recent Clarivate webinar Emerging Deal Trends in Biotech and Pharma identified three of the biggest challenges they face when securing […]

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In-licensing and acquisitions are fast tracks for pharmaceutical companies to access groundbreaking technologies and assets that will drive the next generation of transformative patient treatments. Dealmaking is not a trivial process. Audience members during the recent Clarivate webinar Emerging Deal Trends in Biotech and Pharma identified three of the biggest challenges they face when securing deals.

  • Valuing assets and structuring deals (27%)
  • Finding the right partners (26%)
  • Demonstrating innovation and market potential (26%)

Valuing assets and structuring deals

In dealmaking discussions, pharma companies need to consider how to value assets and structure carefully deals to ensure they can maximize value for their shareholders and achieve their strategic objectives. Companies need to carefully assess the value of the assets being acquired or licensed, considering factors such as the stage of development, market potential, the competitive landscape and intellectual property protection. They must also consider the most appropriate deal structure, such as an outright acquisition, licensing agreement, or joint venture, to achieve their strategic objectives while negotiating financial terms that are fair and reasonable, considering factors such as upfront payments, milestone payments, royalties, and other economic considerations.

Covering over 20 therapy areas and early-phase assets , Cortellis Deals Intelligence provides the broad and deep coverage of global deals needed to assess the value of an asset confidently. Using a patented predictive analytics algorithm, companies can calculate potential deal sizes at each stage of drug development and uncover how likely it would be for a drug to progress to the next phase of growth if it were partnered.

Finding the right partners

Selecting the right partners in pharma dealmaking is crucial to ensuring the success of a partnership. Company executives should assess whether the potential partner’s strategic goals align with their own and whether the partnership will help both companies achieve their objectives. This requires robust and comprehensive due diligence on potential partners, including their financial status, regulatory history, and reputation in the industry, as well as whether the potential partner has the necessary capabilities and expertise to support the partnership and achieve the desired outcomes.

Cortellis Deals Intelligence allows companies to identify with confidence in-license opportunities based on an ideal candidate’s characteristics or find out-licensing partners based on their experience in the field and/or gaps in their portfolio. It is also possible to search for potential partners by therapeutic area, technology or stage of development, and dive deeper into who they’ve partnered with and past payment terms.

It also helps dealmakers perform due diligence on potential partnerships or M&A opportunities with the critical data essential to understanding deal structures, financials, contracts, etc. With an extensive contract collection, including unredacted versions, companies can evaluate full deal terms of transactions a potential partner has agreed upon in the past.

Demonstrating innovation and market potential

Biotech executives can demonstrate the innovation and market potential of their offering in dealmaking discussions by using market research and projections to demonstrate the potential size and growth of the market, how it could impact patient outcomes and healthcare costs, and how it represents a step forward in the field by offering a unique solution compared to existing treatments. Pharma executives are keen to see clinical data, preclinical studies, and real-world evidence that support claims about the efficacy and safety of the offering. Moreover, having a clear insight into how the asset will navigate the regulatory landscape increases the likelihood of a successful partnership or investment.

Using Cortellis Competitive Intelligence, companies can differentiate their assets by assessing the target market based on mechanism of action, disease area or technology, understanding competitor positioning, and conducting market analysis to identify current standards of care. With AI-based predictive analytics , Cortellis Competitive Intelligence enables users to accurately predict drug success rates and launch timelines, as well as access reported and forecast sales for similar drugs and companies to provide benchmarks to potential investors or advisory boards.

Companies, using Clarivate Disease Landscape and Forecast offering, can also gain a thorough understanding of the disease market on which to base critical business decisions and strategies, to identify unmet needs, prioritize opportunities and maximize the value of assets. As a one-stop source for an up-to-date, reliable, and actionable indication- or therapy area-specific market and epidemiology intelligence it provides a unique, holistic view of the disease market, including current landscape, forecasts, patient population and disease management insights.

You can view the webinar Emerging Deal Trends in Biotech and Pharma here, and read a follow-on report on successful partnering here. Learn more about Cortellis Deals Intelligence here.

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Understanding AI-assisted patent drafting: What attorneys need to know https://clarivate.com/blog/understanding-ai-assisted-patent-drafting-what-attorneys-need-to-know/ Thu, 17 Oct 2024 10:01:36 +0000 https://clarivate.com/?p=282382 Artificial intelligence (AI) already enhances a range of legal processes. From contract and due diligence reviews to e-discovery and legal research, early adopters of AI have seen undeniable benefits in speed, accuracy and efficiency. Today, AI promises many of the same benefits in the context of patent preparation and prosecution. However, between the decision to […]

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Artificial intelligence (AI) already enhances a range of legal processes. From contract and due diligence reviews to e-discovery and legal research, early adopters of AI have seen undeniable benefits in speed, accuracy and efficiency.

Today, AI promises many of the same benefits in the context of patent preparation and prosecution. However, between the decision to invest in AI-assisted patent drafting software and achieving a positive return on investment, a lot of hype and mischaracterization can misguide the unwary. The key to truly harnessing the power of AI is integrating it into functional software that enhances rather than replaces the practitioner and their workflows.

In this blog, we cover the basics of AI and automation for patent drafting. Continue reading to learn how to harness these technologies safely and responsibly. Plus, discover the practical benefits they bring to the complex discipline of patent preparation and prosecution.

Key concepts: AI, generative AI and automation

AI, generative AI (GenAI) and automation offer distinct yet complementary benefits. While each is compelling, their true power is realized when used together.

  • AI is a field of computer science focused on creating machines and systems capable of performing tasks that typically require human intelligence. In context, AI can analyze vast amounts of prior art, recognize patterns and understand semantic meanings within large datasets. This capability helps refine patent strategies, identify potential legal challenges and streamline the patent search process. These examples are achieved through different types of AI, including neural networks, natural language processing (NLP) and machine learning algorithms.
  • GenAI is a subset of AI that’s focused on generating new content based on existing data. It uses advanced machine learning models to create text, images, or other media that mimic human-created content. In patent drafting, GenAI can help create sections of patent applications, such as the summary of invention or background, by generating contextually relevant content.
  • Automation uses technology to perform repetitive tasks without human intervention. In patent drafting, automation can handle tasks such as synchronizing part references, maintaining consistency in terminology and generating routine sections of patent applications.

But why do the distinctions matter?

If AI is the solution, do patent and IP professionals need to know what’s under the hood?

The distinction matters because not all solutions are built the same. Solutions that begin with GenAI at their core are not ideal for all patent drafting use cases. Using tools that leverage GenAI as a component rather than the foundation ensures that you, not the machine, remain in control of the drafting process. This enhances your work without compromising quality or compliance.

While GenAI steals the headlines, an integrated and responsible approach to automation and AI technologies delivers the safest and most practical benefit. By integrating AI, including GenAI, automation and predictive analytics into existing patent drafting workflows, organizations can effectively marry technology to expertise.

Harnessing AI safely in patent drafting

AI assists practitioners rather than replaces them. But to harness AI safely and effectively in the patent preparation and prosecution process, organizations should implement certain safeguards and best practices:

  1. Maintain control: Choose AI tools that allow you to customize and control the extent of AI assistance, ensuring you remain in charge of the drafting process. Decide when and where AI-generated content is appropriate. Always review it to ensure it meets your quality standards and complies with legal requirements. Your expertise is crucial for final approval.
  2. Generate content when and where needed: Use AI tools that offer prompt assistance features to generate specific sections of a patent application on demand. For example, AI can take an attorney-written claim and generate a suitable title or summary. Make sure the AI tool generates contextually relevant content, understanding the specific requirements of each section of a patent application to fit seamlessly.
  3. Ensure reliability and trustworthiness: Opt for solutions with a proven track record built on years of expertise. This ensures that the AI tools are trustworthy and capable of consistently delivering high-quality results. Choose AI tools that prioritize data security and confidentiality, which is especially important in the legal sector, where sensitive information must be protected.
  4. Leverage appropriate language models: Local language models enhance security by keeping data within the user’s system, suitable for select tasks in patent drafting. In contrast, cloud-based models offer scalability and access to the latest advancements. Choose the right model for the task to balance legal and technical considerations and select solutions that integrate with your organization’s language model for maximum flexibility and control.
  5. Maintain libraries of terms and descriptions: Choose solutions that allow you to compile and manage libraries of prior figures, descriptions and text that will complement GenAI when existing and proven language is preferred.

Once again, it’s important to note that for AI to be truly effective and safe, it must be integrated into functional software that enhances workflows without disruption — a key advantage for achieving efficiency and effectiveness in patent preparation and prosecution.

Harness the potential with Rowan Patents

The art of patent drafting is intrinsically complicated, comprising numerous distinct steps that require technical, legal and administrative skills. These processes demand meticulous attention to detail and adherence to strict deadlines and regulations, making them ideal for the introduction of a streamlined, integrated workflow solution.

Rowan Patents, now part of Clarivate™, seamlessly integrates AI, including GenAI, and automation to provide a comprehensive toolset explicitly designed for patent professionals. With customizable AI features and prompt assistance to interact with AI models, you can generate specific sections of a patent application on demand, ensuring all AI-generated content is contextually relevant and subject to your expert final review. Built on years of practitioner experience that combines deep patent and technology expertise, Rowan Patents offers robust support, continuous updates, and a priority focus on data security and confidentiality.

The integrated drafting environment synchronizes every part of your application with linked and synced objects, ensuring consistency and reducing errors. By automating repetitive tasks, Rowan Patents allows you to focus on high-value work, enhancing efficiency and maintaining the high standards required in your practice. With Rowan Patents, you have a dependable partner in your journey toward more efficient and effective patent prosecution.

See it in action here.

Contact us today to learn how Rowan Patents can augment and enhance your patent drafting process.

Further reading

Choosing patent drafting software: It’s not just about the product

What should ChatGPT’s role in drafting patent applications be?

Will attorneys who use ChatGPT replace attorneys who don’t? Looking into plans for Rowan Patents

 

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The Role of Trademarks in the Sustainability Revolution: Insights from our recent webinar https://clarivate.com/blog/the-role-of-trademarks-in-the-sustainability-revolution-insights-from-our-recent-webinar/ Wed, 16 Oct 2024 13:40:24 +0000 https://clarivate.com/?p=282406 Green trademarks are a powerful tool for businesses that seek to communicate their sustainability commitments to consumers. However, some businesses have also utilized these marks to influence consumer purchasing decisions without fully committing to the cause. As with all trademark applications, sustainability marks are subject to rigorous legal and regulatory scrutiny, and brand owners must […]

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Green trademarks are a powerful tool for businesses that seek to communicate their sustainability commitments to consumers. However, some businesses have also utilized these marks to influence consumer purchasing decisions without fully committing to the cause.

As with all trademark applications, sustainability marks are subject to rigorous legal and regulatory scrutiny, and brand owners must navigate a complex landscape to ensure their eco-friendly claims are both genuine and legally sound.

In our recent webinar, we delved into the critical role trademarks play in sustainable branding. You can watch the complimentary webinar here.

The importance of sustainability for consumers

Sustainable brands are increasingly vital in today’s market, a response to the growing consumer demand for environmentally responsible products. As awareness of environmental issues rises, consumers are more inclined to support companies that reflect their values and ethics. In fact, over 85% of U.S. consumers now believe it is important for businesses to act responsibly towards society and the environment, with 34% stating that their trust in brands would increase if recognized as ethical or sustainable by an independent third party.

This positive shift in consumer behavior has increased the pressure on companies to adopt greener practices to stay competitive. However, while many brands claim to prioritize ethical practices, such as reducing carbon footprints and using eco-friendly materials, some fall short of these promises. This inadvertently leads to a culture of greenwashing in some sectors.

Key webinar takeaways

During a recent Clarivate™ webinar, Eva-Maria Strobel and Cynthia Cole, Partners at Baker McKenzie, shared their expertise on the green trademark landscape. As chairs for multiple practice groups within the firm, including the global IP, Technology and Data Practice Group and the Global Commercial, Tech and Transactions Subgroup, they provide deep expertise across technologies and borders.

To start the webinar, Cole explained the concept of greenwashing: “greenwashing is a term that has arisen in the last few years and reached a fever pitch for many organizations. The term is used when an organization makes false, unsubstantiated or outright misleading statements or claims about the sustainability of a product or a service or even more broadly about business operations generally.”

Throughout the webinar, key points were discussed, including:

1. Building consumer trust
Transparency and authenticity are paramount. To earn consumer trust, brands must ensure their actions and verifiable data back their sustainability claims.

Cole explained, “It is quite difficult to get green trademarks registered in Europe and in the United States, and the main reason for this is because of the grey area about what is classed as ‘deceptive’ for a consumer.”

Elaborating on the rules surrounding deceptive trademarks, Strobel said, “The consumer must recognize the green trademark as conveying such a specific, clear and also unambiguous message about the nature, the quality, the geographic origin or any other characteristic of the goods or the services.”

2. Trademark registration and portfolio expansion
Securing successful trademark registrations requires careful planning and consideration of various legal factors. When done right, expanding trademark portfolios to include green trademarks can enhance a brand’s market position.

3. Alternative options for green brands
Certification marks serve as alternative options to demonstrate environmental credentials. They provide an additional layer of credibility and assurance to consumers.

Strobel said during the webinar, “The Empowering Consumers Directive and the Green Claim Directive really influence not just the advertising claim, but also the use and arguably the registration of trademarks.”

4. Navigating legal challenges
The legal landscape for green trademarks is continually evolving. Understanding the fine line between genuine environmental stewardship and greenwashing is crucial. Brands must stay informed about stricter trademark laws and regulations to avoid potential pitfalls.

“It is really important to be aware of the developments that are coming surrounding sustainability and greenwashing, even if they seem far away on the horizon right now. Be very prudent when you use generic green claims and take local advice depending on your jurisdiction,” explained Cole.

What does the future of green trademarks look like?

As the pressure to achieve net zero emissions intensifies, the importance of green trademarks will only grow. Brands that successfully navigate the legal complexities and genuinely commit to sustainability will not only thrive but also promote a greener future.

Giving advice for organizations, Cole said, “Inside an organization, it is important to make sure there are clear guidelines as to what the brand is communicating to the market. And make sure those guidelines are well established with the right types of internal checks.”

If you would like to learn more about green trademarks and sustainability, you can watch the full webinar now for free.

Clarivate trademark screening, search and watch solutions

Discover how Clarivate can help you create, manage and protect green brands with confidence. Learn more about our trademark solutions today.

 

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Benchmarking excellence in IP Operations: a new report by Clarivate https://clarivate.com/blog/benchmarking-excellence-in-ip-operations-a-new-report-by-clarivate/ Wed, 09 Oct 2024 13:25:00 +0000 https://clarivate.com/?p=280814 In recent years, a stream of new technologies, regulations and the pandemic served as a catalyst for creating new operating models. In-house IP departments and law firms quickly adopted home working and embraced digitalization. Now that departments have settled into these new work models, leaders have the time to tactfully readdress industry best practices and […]

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In recent years, a stream of new technologies, regulations and the pandemic served as a catalyst for creating new operating models. In-house IP departments and law firms quickly adopted home working and embraced digitalization.

Now that departments have settled into these new work models, leaders have the time to tactfully readdress industry best practices and ensure their departments are performing as seamlessly as possible. To do so, insights and benchmarks are necessary to make impactful and strategic operational decisions.

Excellence in IP operations

Recently, Clarivate™ surveyed IP professionals from corporations and law firms worldwide over a ten-week period to provide insights into IP operations excellence. Combining these baseline benchmark results with Clarivate extensive knowledge of IP operations, we are supporting IP professionals in aligning their operations with business goals, optimizing resource allocation, and leveraging technology and artificial intelligence (AI) to drive efficiency.

The full report, Excellence in IP Operations: Benchmarks and strategies to elevate your IP practice, is available to read now.

Key findings

1.Alignment through KPIs

One of the standout findings from our survey is the importance of aligning key performance indicators (KPIs) with business goals. The report reveals that 65% of corporate respondents who understood their department’s KPIs also reported complete alignment between their IP and overall business strategies. This number increased to 70% among law firm respondents. Strategic alignment is crucial for delivering transformative value and ensuring that the IP department contributes directly to the success of the organization.

2.Technology enablement for efficiency

Over a quarter of IP professionals spend significant time on tasks outside their job functions, with limited budgets and technology investments to offset these pressures. While expanding a staff member’s remit can diversify skills, it may also impact work quality and productivity. Striking the right balance is essential for maintaining employee satisfaction and supporting growth.

We found that IP professionals who felt well-equipped with the right technology spent significantly less time on tasks unrelated to their primary role. This exemplifies how proper technology deployment – including integration between technology systems – fosters greater collaboration and a more cohesive work environment, ultimately building a resilient operational framework.

3.Bridging the AI adoption gap

Despite growing interest and awareness, particularly around complex IP workflows, AI deployment remains low. 83% of respondents who spent over half their time on tasks unrelated to their primary role were not using AI in their IP departments. Encouraging greater adoption of AI-based solutions can significantly increase productivity, reduce manual tasks, and save time for high-value activities, even when resources are tight. Exploring AI-based capabilities already built into current IP management software can help unlock these benefits even quicker.

Why this report matters

Our latest report provides invaluable insights and benchmarks to help law firms and corporate IP departments understand how their operations compare to industry standards. By identifying areas of strength and opportunities for improvement, IP managers and leaders can implement best practices to achieve operational excellence.

This report is a must-read for anyone involved in IP management. It offers practical advice and actionable strategies for navigating the complexities of modern IP operations. Download your copy today and take the first step towards optimizing your IP operations for success.

Get in touch

Clarivate IP Consulting services can help transform your operations and unveil the maximum potential of your IP. Find out more about the services and our team, here.

 

Download the full report now.

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Beyond animal testing: the rise of organs-on-chips technology https://clarivate.com/blog/beyond-animal-testing-the-rise-of-organs-on-chips-technology/ Mon, 07 Oct 2024 13:21:09 +0000 https://clarivate.com/?p=280705 Back in December 2022, President Biden signed a new law stating that novel medicines no longer needed to be tested on animals to receive U.S. Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. […]

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Back in December 2022, President Biden signed a new law stating that novel medicines no longer needed to be tested on animals to receive U.S. Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. However, since these technologies are still relatively new, this change won’t revolutionize the drug approval process overnight.

Animal experiments date back to ancient Egyptian and Greek civilizations. They became integral to physiological and pharmacological research during the 19th century and started to be systematically used for drug development during the 20th century. Agencies like the FDA and the European Medicines Agency (EMA) established rigorous guidelines for preclinical testing in animals after disasters such as the 1937 elixir sulfanilamide poisonings or the thalidomide tragedy of the 1950s and 60s (Sántha, 2020). Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy.

There are a number of reasons for reducing animal experimentation. On one hand, the cost of preclinical development typically ranges from a few hundred thousand to several million dollars per compound. On the other hand, key differences exist between humans and animal species commonly used in testing, raising concerns about the real world translatability of animal studies, and published studies indicate that in vitro and in silico tests can outperform animal models in predicting certain adverse events. For example, one study demonstrated 89% accuracy of in silico drug trials in populations of human cardiomyocyte models in predicting clinical arrhythmia — versus a 75% accuracy using animal models (Passini, 2017) .

Then, of course, there are the ethical considerations. Great efforts have been made to replace animal experimentation with non-clinical tests in agreement with the Three Rs principle: Replacement, Reduction, and Refinement. Agencies such as the E.U. Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and the FDA’s Advancing Alternative Methods (AAMS) work on the development and promotion of non-animal approaches.

Alternative technologies and methods include system biology studies such as transcriptomics and metabolomics; cell-based assays; engineered tissues such as 3Dbioprinted tissues or organoids, which have shown promising results in predicting, for example, liver and cardiac toxicity; organ-on-chip (OoC) and microphysiological systems (MPS) to mimic human physiology; and computer modeling and simulations (including machine learning and artificial intelligence). Alternative organisms such as zebrafish and c. elegans can also be considered in some cases (U.S. Food and Drug Administration, 2023) .

Organs-on-chips are a type of microphysiological system consisting of a miniaturized physiological environment engineered to yield and/or analyze functional tissue units capable of modeling specified/targeted organ-level responses, usually no larger than a typical microscope slide (R, 2023) . They reproduce the microenvironment of tissues in the human body under regulated dynamic settings. Several distinct types of cells may be required to produce the settings or to research how the cells interact with one another. For example, liver-chip devices may include iPSC-derived hepatocytes, endothelial cells, and Kupffer cells.

Single OoC for most of the organs in the human body have been developed, but they lack the cross-organ communication and systemic dimension to, for example, evaluate PK/PD parameters and further understand diseases caused by multiorgan interactions. Multi-OoC have been created and the ultimate goal is to develop a “body on a chip” technology. This requires considering interorgan scaling, expected flow rate, media, and interrelated functionalities. On the other hand, advancements in artificial intelligence provide more improvements for the experimental design and data interpretation of OoC (Deng, 2023) .

Some studies have shown a higher performance of OoC. A study using a proximal tubular OoC successfully predicted the nephrotoxicity of SPC-5001, which exhibited nephrotoxicity in phase 1 trials, but not in preclinical testing on mice and non-human primates (Nieskens, 2021) . An analysis of 870 Liver-Chips across a set of 27 known hepatotoxic and non-toxic drugs displayed a sensitivity of 87% and a specificity of 100% (Ewart, 2022) . A vessel-chip allowed researchers to evaluate the prothrombotic effects of Hu5c8, a monoclonal antibody against CD40L, though research was terminated in clinical phases due to unexpected thrombotic complications not detected during preclinical testing (Barrile, 2018) .

Today, animal models remain essential for drug development, but non-clinical tests can complement these studies, and new and innovative technologies developed in labs around the world have made the end of animal testing a realistic possibility for the future, although the change may be slow, as the complexity of biological systems makes exceptionally difficult to replicate the intricate interactions within a living organism. The need for considerable research and funding for developing and validating alternative methods may also be an issue (Nuwer, 2022; Anon., 2024).

Cortellis Drug Discovery IntelligenceTM Experimental Models have been expanded to cover non-animal in vitro models such as organoids and organ-on-chips, including detailed information on how they have been used to study the efficacy or safety of a therapeutic agent. If you want to learn more about this solution, please visit Cortellis Drug Discovery Intelligence Platform | Clarivate or contact us.

Works cited

  1. Anon., 2024. Animal research is not always king: researchers should explore the alternatives. Nature, 631(8021).
  2. Barrile, R., 2018. Organ-on-Chip Recapitulates Thrombosis Induced by an anti-CD154 Monoclonal Antibody: Translational Potential of Advanced Microengineered Systems. Clinical Pharmacology and Therapeutics, 104(6), pp. 1240-1248.
  3. Deng, S., 2023. Organ-on-a-chip meets artificial intelligence in drug evaluation. Theranostics, 13(3), pp. 4526-4558.
  4. Ewart, L., 2022. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Communications Medicine, 2(1).
  5. Nieskens, T. T. G., 2021. Nephrotoxic antisense oligonucleotide SPC5001 induces kidney injury biomarkers in a proximal tubule-on-a-chip. Archives of Toxicology, 95(6), pp. 2123-2136.
  6. Nuwer, R., 2022. US agency seeks to phase out animal testing. Nature.
  7. Passini, E., 2017. Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity. Frontiers in Physiology.
  8. R. N., 2023. Organ-On-A-Chip: An Emerging Research Platform. Organogenesis, 19(1).
  9. Sántha, M., 2020. Biologia futura: animal testing in drug development-the past, the present and the future. Biologica Futura, 71(4), pp. 443-452.
    U.S. Food and Drug Administration, 2023. About Alternative Methods. [Online]
  10. Available at: https://www.fda.gov/science-research/advancing-alternative-methods-fda/about-alternative-methods
    [Accessed 1 10 2024].

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Introducing a comprehensive framework for evaluating the societal impact of research https://clarivate.com/blog/introducing-a-comprehensive-framework-for-evaluating-the-societal-impact-of-research/ Wed, 02 Oct 2024 14:43:11 +0000 https://clarivate.com/?p=280108 Funders, governments and institutions across the globe are increasingly expected to demonstrate the societal impact of research. They need to answer questions such as: has investment in research and experimental development (R&D) yielded tangible benefits to individuals, communities, organizations and economies across diverse areas such as health, climate change and technological advancement? Despite this growing […]

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Funders, governments and institutions across the globe are increasingly expected to demonstrate the societal impact of research. They need to answer questions such as: has investment in research and experimental development (R&D) yielded tangible benefits to individuals, communities, organizations and economies across diverse areas such as health, climate change and technological advancement? Despite this growing demand, currently there is no established way to measure this. To meet this challenge, the Institute for Scientific Information (ISI)™ has developed a framework to evaluate the societal impact of research in a responsible manner and introduces Societal Impact Profiles™.

Societal Impact Profiles will be included in our forthcoming AI-powered Web of Science Research Intelligence™ platform — empowering research institutions, funders and governments to better measure and showcase the impact of their research investments.

Our framework addresses the three primary challenges in measuring the societal impact of research:

Challenge 1. Acknowledging the diversity of societal needs

Societal needs are complex and the diversity of societal benefits does not conform to a simple or standardized scale. To reflect this heterogeneity, we have separated societal needs into eight facets: Political & Policy, Legal & Governance, Economic, Human Capital, Medical, Social & Cultural, Technological and Environmental.

Challenge 2. Beyond bibliometrics: balancing quantitative and qualitative approaches

Comprehensive evaluation of societal impact must go beyond traditional bibliometrics and incorporate additional indicators that account for a more diverse range of outputs and activities. Our framework leverages our extensive resources of enriched data which goes beyond scholarly output and extends to our data on patents, clinical trials, policy documents, media publications, data sets, educational outputs, funding data and much more, as well as external data sources where necessary.

Quantitative methods, such as traditional scientometric approaches, are valuable as they offer an easily scalable, objective view. However, they lack the depth required to measure specific facets of societal impact. To address this limitation qualitative methods, such as expert review, user case studies or narrative impact statements, are needed. However, these approaches are less scalable and risk being subjective.

We have taken a balanced approach that integrates both quantitative and qualitative methods as we believe this is critical for a responsible and comprehensive evaluation of the societal impact of research.

Challenge 3. Navigating delays: leveraging lagging and leading indicators for effective assessment

To mitigate the challenge of lengthy delays between research being conducted and any resultant societal benefits, our evaluation framework contains both lagging and leading indicators.

Lagging indicators offer insights into societal impact by retrospectively analyzing past outputs and activities that have had sufficient time to manifest their effects. They reveal how previous research efforts have contributed to societal outcomes, providing a picture of observed, tangible impact.

In contrast, leading indicators are forward-looking and analyze more recent signals that suggest the potential for research outputs and activities to create societal impact in the future, though without any guarantee.

Analysis of an institution’s performance by leading versus lagging indicators, can guide actions to either refine or adjust the research strategy to achieve better outcomes. They can help to determine whether the right teams are in place and working on the most promising activities and depending on the insights gained, this may lead to a course correction or a renewed focus – to enhance the likelihood of achieving a desired outcome.

Visualizing societal impact for informed decision making

To facilitate responsible evaluation, impact data must be presented in a format that is both meaningful and accessible to multiple, diverse users. These data must transparently reflect diverse types and levels of impactful activity, while supporting timely decision-making for optimal resource allocation. Let us look at an example of how societal impact will be displayed in the forthcoming Web of Science Research Intelligence platform, using a Societal Impact Profile.

Fig: Societal Impact Profile of an institution

The societal impact of an institution is visualized using a radar chart containing eight axes – one for each of the eight societal facets. To facilitate effective comparison, each point on the Societal Impact Profile is calculated by comparing a given institution’s performance against that of nearly 12,000 other organizations globally. Each facet has two points, one calculated using metrics from the lagging indicator groups and the other using metrics from the leading indicator groups. The underlying individual metrics will be available to support transparency and more granular analyses.

Societal Impact Profiles can be used to examine an institution’s performance as well as to benchmark their performance against other institutions. Exploration of competitive strengths and relative weaknesses compared to peer institutions helps to prioritize what to promote and also to identify more successful practices for possible implementation.

Our ongoing journey: future enhancements to our framework

We plan to share our progress regularly as it evolves, and we welcome feedback on both the framework itself and its applications. Community feedback will play an important role in shaping and refining this framework to deliver a solution that not only meets current expectations but is also adaptable to meet future needs.

Read our ISI report A responsible framework for evaluating the societal impact of research for a fuller explanation.

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The driving force of innovation – A Top 100 Global Innovators deep dive into the Automotive sector https://clarivate.com/blog/the-driving-force-of-innovation-a-top-100-global-innovators-deep-dive-into-the-automotive-sector/ Wed, 02 Oct 2024 13:51:50 +0000 https://clarivate.com/?p=279460 Welcome to the latest installment of Top 100 Global Innovators™ from Clarivate™ report series, where we take an in-depth look at the top players and global trends driving innovation across several key industries. In this edition, we focus on the automotive segment — a cornerstone of modern industry currently navigating a storm of innovation convergence […]

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Welcome to the latest installment of Top 100 Global Innovators™ from Clarivate™ report series, where we take an in-depth look at the top players and global trends driving innovation across several key industries.

In this edition, we focus on the automotive segment — a cornerstone of modern industry currently navigating a storm of innovation convergence driven by the rise of electric vehicles (EVs), autonomous driving technologies and connected vehicle systems powered by the Internet of Things (IoT). These advancements are setting new benchmarks for innovation and R&D initiatives globally.

The full report highlights the leading innovators in the automotive industry and analyzes the trends fueling this dynamic and rapidly evolving sector. In this blog, we extract some of the key trends, insights and analyses from the full report.

Download ‘The driving force of innovation – A Top 100 Global Innovators deep dive into the Automotive sector’ report.

The top 20 organizations

The report identifies the leading organizations in the automotive sector based on their innovation output and impact. Among the top 20 automotive innovators, notable names include:

Download the report to view the full list.

These leading innovators are geographically spread across major automotive hubs worldwide. This underscores the significant role that regions like Japan, the United States, South Korea and Europe continue to play in global automotive innovation.

A diversity of manufacturers and suppliers

The complete list of organizations includes a diverse mix of car manufacturers, specialist suppliers and tire manufacturers. This reflects the broad spectrum of innovation across the industry and illustrates the importance of collaboration between different types of companies in driving technological advancements.

Increased competition through virtual integration

One of the most notable trends explored in the report is the increasing competition through virtual integration. The complexity of modern automotive technologies, such as EVs, autonomous driving, and connectivity, has led to greater collaboration and overlap between Original Equipment Manufacturers (OEMs) and suppliers. This virtual integration means suppliers not only provide components but also develop integrated systems and technologies.

A correlation between innovation and market success

The data in the report shows a clear correlation between innovation and market success in the automotive sector. The leading innovators in the industry are also some of the most commercially successful companies. For instance, the top 20 OEMs in the report sold almost 50 million cars in 2023, accounting for over 66% of global car sales. This significant market share underscores the substantial impact that innovation has on commercial success.

Notable trends in patent filings and international protection

Patent filings and international protection critically indicate innovation activity in the automotive sector. The report highlights several notable trends in this area. For example, while Mainland China leads in innovation volume, less than 1% of its patents are filed abroad. This contrasts with higher international filing rates from Japan, the United States, Europe and South Korea.

However, the level of international patent protection sought by firms in Mainland China has doubled in the past six years, indicating a strategic shift towards greater global competition and a desire to enhance the country’s influence in the global automotive industry.

Emerging technologies and future trends

Several key technological advancements are shaping the future of the automotive sector. These include:

  • Battery technology: Innovations in battery charging, design and materials are rapidly advancing, making batteries more efficient, longer lasting and cost-effective. This is crucial for the widespread adoption of EVs, helping to overcome issues like range anxiety and short battery life. Future developments in solid-state batteries and the use of AI and ML in battery management are expected to boost EV performance and affordability further.
  • Artificial intelligence (AI) and machine learning (ML): The application of AI and ML in automotive use cases is accelerating, particularly in areas such as autonomous driving, predictive maintenance and enhanced user experiences. These technologies are expected to continue to evolve, driven by the increasing integration of AI in various automotive functions.
  • Sensor and data connectivity: Advancements in this field are essential for the development of connected and autonomous vehicles, enabling real-time data exchange and improved vehicle-to-everything (V2X) communication.

Alignment with the Clarivate 5-Forces of Modern Innovation

The technological trends in the automotive sector align closely with the Clarivate 5-forces model of modern innovation, which includes sustainability, well-being, connectivity, automation and mobility. These forces represent the key areas where technological advancements drive significant changes and improvements.

These forces are crucial because they fuel the convergence of technologies across the automotive segment, creating a powerful and self-reinforcing cycle of innovation. This helps companies assess the opportunities and risks associated with innovation by highlighting the areas where future innovations will likely emerge.

Key takeaway

Leveraging data and intelligence for informed decision-making is paramount. By understanding key trends, insights and emerging technologies highlighted in this report, leaders can successfully navigate the complexities of the automotive sector and make strategic decisions that drive innovation and competitive advantage.

Download the report now and equip your organization with the data and intelligence to drive success.

If you’d like more information on the methodologies, resources and approaches offered by the Clarivate Center for IP and Innovation Research™, visit clarivate.com/products/center-for-ip-innovation-research.

Further reading

Read the first report in our sector-specific deep-dives: ‘The cutting edge of power: A Top 100 Global Innovators deep dive into the Energy and Electrical segment’.

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Aiming for ‘Magic Bullets’ in Medicine: Are We Shooting Ourselves in the Foot? https://clarivate.com/blog/aiming-for-magic-bullets-in-medicine-are-we-shooting-ourselves-in-the-foot/ Wed, 25 Sep 2024 11:59:59 +0000 https://clarivate.com/?p=278602 Wouldn’t it be great to find a single cure for every disease? A ‘magic bullet’ medicine that can cure a disease quickly and completely,[1] without deleterious side effects.[2] But by focusing on selective toxicity and seeking ‘magic bullet’ cures at the expense of other promising treatments, are we overlooking other important innovations? The first ‘magic […]

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Wouldn’t it be great to find a single cure for every disease? A ‘magic bullet’ medicine that can cure a disease quickly and completely,[1] without deleterious side effects.[2] But by focusing on selective toxicity and seeking ‘magic bullet’ cures at the expense of other promising treatments, are we overlooking other important innovations?

The first ‘magic bullet’ in medicine

The underlying principles of translational research and precision medicine originate from the work of scientists such as Paul Ehrlich, widely considered the father of modern chemotherapy. In 1897, Ehrlich proposed that certain cells expose a set of side chains on their surface, later termed ‘receptors’, which are associated with specific recognition.[3][4] Ehrlich and his team went on to develop the first pharmaceutical ‘magic bullet’, arsphenamine (Salvarsan®), which specifically targeted the bacterium Treponema pallidum, the causative organism of syphilis, without affecting normal host cells.[3]

However, the first ‘magic bullet’ was not a perfect drug. Resistance to treatment occurred, and combination therapy with mercury or bismuth treatment was often needed to eliminate all spirochetes (a group of spiral-shaped bacteria).[3] Patients required many injections over a long time period, and problems also arose from the galenic preparation of arsphenamide, which was insoluble in water.[3] While other targeted treatments for syphilis have since emerged, including neoarsphenamine (Neosalvarsan®) and oxophenarsine (Mapharsen®), other challenges remained (Figure 1).[3]

Figure 1: The Development of Targeted Treatments for Syphilis

 

Source: Valent P et al, 2016;[3] Strebhardt K et al, 2008.[4]

How realistic is the ‘magic bullet’ concept in pharmaceutical development?

Other transformational innovations in medicine have since been heralded as ‘magic bullets’ but have not provided a complete cure. The concept of ‘magic bullets’ gained popularity in the mid-twentieth century with the development of antibiotics and insulin, which were game-changing for medicine, but not infallible. The development of antimicrobial resistance to penicillin and the development of complications in patients with diabetes, despite treatment with insulin, proved major limitations.[5]

‘Magic bullets’ are more realistic in some disease areas than others. In many instances patients will have multiple, long-term conditions, that a single ‘magic bullet’ cannot fix.[5] What’s more, many diseases involve complex interactions between genetic, lifestyle and environmental factors, such as diabetes and heart disease. Patient to patient variability must also be considered, as individuals may respond differently to a treatment based on their underlying health conditions, age, or gender.

A ‘magic bullet’ approach would not be realistic for a condition where the cause of the disease is unclear or more complex, or where it is difficult to consistently determine which patients have the condition.[5] In the case of central nervous system disorders such as depression and schizophrenia, which are thought to be polygenic in origin, endeavors to develop effective treatments that are selective for single molecular targets have been largely unsuccessful. Here, the development of ‘magic shotguns’ – drugs that interact with several molecular targets – is a suggested approach.[6]

As many pathogenetic targets have multiple physiological functions, highly specific ‘magic bullets’ may impact multiple cellular pathways simultaneously, causing unintended side effects.[7] Target proteins may also have similar active domains to proteins involved in normal physiologic functions, which could be inadvertently affected.[7] Redundancy in critical biological pathways may limit the usefulness of a ‘magic bullet’ that targets a single, specific protein in a pathway; backup, or redundant, systems may emerge to compensate.[7]

Prioritizing the search for highly selective, curative ‘magic bullets’ that act on a single, specific disease pathway could also result in promiscuous drugs, which act upon multiple molecular targets, being overlooked. Promiscuous drugs may be perceived as posing a greater risk of side effects, yet can offer a broad range of therapeutic benefits. Aspirin (acetylsalicylic acid), for example, inhibits the cyclooxygenase (COX) isoenzymes COX-1 and COX-2, and targets any area where inflammation is present. Aspirin can also act as a blood thinner and reduce platelet aggregation to prevent cardiovascular disease and preeclampsia, and has an antiarthritic effect.[7] It is therefore important not to discount promising drugs simply because they do not act on a single target.

Are ‘magic bullets’ the way forward for cancer treatment?

Scientists have long been looking for ‘magic bullets’ for cancer. One success story is imatinib, a single agent that targets the molecular driver involved in the pathogenesis of chronic myeloid leukemia (CML). In CML, a reciprocal translocation involving chromosomes 9 and 22 results in a truncated chromosome 22, known as the Philadelphia chromosome.[8] The breakpoints of the translocation create a fusion gene, BCR-ABL1, which is not present in healthy cells. The BCR-ABL1 fusion gene produces an abnormal protein (BCR-ABL1) with persistently enhanced tyrosine kinase activity, which maintains proliferation, inhibits differentiation, and confers resistance to cell death.[8] Imatinib inhibits this protein.[8]

In 2017, the pivotal Phase III trial of imatinib for CML (the IRIS trial) found that the estimated overall survival rate at 10 years was 83.3% among patients who received first-line imatinib therapy, with 82.8% of patients having a complete cytogenetic response.[9] Due to the high rate of crossover among the patients who were randomly assigned to receive interferon alfa plus cytarabine early in the trial (65.6% of patients; median duration of therapy before crossover: 0.8 years), the final analysis of IRIS focused on patients who had been randomly assigned to receive imatinib. Before imatinib, only 30% of patients with CML survived for at least five years after being diagnosed.[10] Now, patients with Philadelphia chromosome-positive CML who are in remission after two years of treatment with imatinib have the same life expectancy as someone without cancer.[11][12]

However, not all cancers have well-defined molecular targets or driver mutations that can be targeted by a ‘magic bullet’. In cases where there is a suitable targeted treatment, accurate biomarkers are required to identify patients who are likely to benefit. Additionally, tumor heterogeneity provides a barrier; a single targeted ‘magic bullet’ may not effectively eradicate all cancer cells. In these cases, a combination of treatments may be required. Cancer cells may also develop resistance to targeted therapies over time via the mutation of drug targets, upregulation of drug efflux pumps, or activation of alternate signaling pathways, limiting duration of response to treatment. Despite the remarkable success of imatinib in CML, resistance can also emerge.[13] Indeed, approximately 17% of patients develop resistance to imatinib with 5 years.[14]

Pharmaceutical innovation: Where do we go from here?

While the concept of a ‘magic bullet’ is appealing, very few treatments, if any, truly act as curative ‘magic bullets’ without deleterious side effects. While ‘magic bullets’ have been transformational in the treatment of some diseases, the approach is not realistic for all. By acknowledging these limitations and recognizing that other treatments still hold value, we can avoid judging drugs solely on their ability to work as ‘magic bullets’ and seize exciting opportunities whenever they emerge.

At Clarivate, we specialize in developing robust and compelling value communication materials that help our clients achieve their market access goals. Our highly trained value communication experts have the scientific acumen to delve into disease etiology and pathology, and the mechanism of action of our clients’ products, enabling us to identify and communicate value differentiators.

For more information, or to speak to a member of our team, please get in touch.

This post was written by Eleanor Ward, Medical Writer.

References:

[1]Collins. Definition of ‘magic bullet’. Accessed May 2024. Available online at: [https://www.collinsdictionary.com/dictionary/english/magic-bullet#:~:text=In%20medicine%2C%20a%20magic%20bullet,%5Binformal%5D].
[2]Merriam-Webster. Magic bullet dictionary entry. Accessed May 2024. Available online at: [https://www.merriam-webster.com/dictionary/magic%20bullet#dictionary-entry-1]. 2024.
[3]Valent P, Groner B, Schumacher U, Superti-Furga G, Busslinger M, Kralovics R, et al. Paul Ehrlich (1854-1915) and His Contributions to the Foundation and Birth of Translational Medicine. Journal of Innate Immunity. 2016;8(2):111-20.
[4]Strebhardt K, Ullrich A. Paul Ehrlich’s magic bullet concept: 100 years of progress. Nature Reviews Cancer. 2008 2008/06/01;8(6):473-80.
[5]Richard Smith. The case for medical nihilism and “gentle medicine”. Accessed March 2024. Available online at: [https://blogs.bmj.com/bmj/2018/06/04/richard-smith-the-case-for-medical-nihilism-and-gentle-medicine/].
[6]Roth BL, Sheffler DJ, Kroeze WK. Magic shotguns versus magic bullets: selectively non-selective drugs for mood disorders and schizophrenia. Nature Reviews Drug Discovery. 2004 2004/04/01;3(4):353-9.
[7]Mencher SK, Wang LG. Promiscuous drugs compared to selective drugs (promiscuity can be a virtue). BMC Clin Pharmacol. 2005 Apr 26;5:3.
[8]Kang ZJ, Liu YF, Xu LZ, Long ZJ, Huang D, Yang Y, et al. The Philadelphia chromosome in leukemogenesis. Chin J Cancer. 2016 May 27;35:48.
[9]Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, et al. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-27.
[10]Pray, L. (2008) Gleevec: the Breakthrough in Cancer Treatment. Nature Education 1(1):37.
[11]National Cancer Institute. How Imatinib Transformed Leukemia Treatment and Cancer Research. Accessed March 2024. Available online at: [https://www.cancer.gov/research/progress/discovery/gleevec]. 2018.
[12]Leukemia & Lymphoma Society. FDA Approves First Targeted Treatment for Newly Diagnosed Leukemia Subtype. Accessed April 2024. Available online at: [https://www.lls.org/news/fda-approves-first-targeted-treatment-newly-diagnosed-leukemia-subtype]. 2024.
[13]Bitencourt R, Zalcberg I, Louro ID. Imatinib resistance: a review of alternative inhibitors in chronic myeloid leukemia. Rev Bras Hematol Hemoter. 2011;33(6):470-5.
[14]Druker BJ, Guilhot F, O’Brien SG, Gathmann I, Kantarjian H, Gattermann N, et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006 Dec 7;355(23):2408-17.

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