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Major breast cancer screening AI trial to begin
Tue, 04 Feb 2025 01:55:03 -0000
Almost 700,000 women to be recruited to study as government fires starting gun on cancer strategy.Paris: Grassroots to Glory
Thu, 18 Jul 2024 05:01:00 -0000
The Paralympic Rowing Cox will compete a year after getting the all clear from cancer.Rise of vaccine distrust - why more of us are questioning jabs
Thu, 16 Jan 2025 00:01:55 -0000
Confidence in all types of vaccination has taken a hit. The question is why, and what can be done about it?Is the system letting down people who were harmed by Covid vaccines?
Wed, 23 Oct 2024 05:48:59 -0000
People affected by rare blood clots say they feel they have been airbrushed out of the pandemic.Reducing Study Start-Up Times: Quality Improvement Practices at a Site Management Organization
Tue, 04 Feb 2025 14:13:53 -0000
Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, […]
The post Reducing Study Start-Up Times: Quality Improvement Practices at a Site Management Organization appeared first on ACRP.
<p><span data-contrast="auto">Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines.</span><span data-contrast="auto"> In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines. </span></p> <p><span data-contrast="auto">“We pride ourselves on being a watchdog, for example, by making sure that operational elements of the protocol do not over-burden study participants and lead to withdrawal from the study,” says Jessi Klinedinst, Manager, Regulatory Affairs, at HCA Healthcare Research Institute. “Our team approach is central to success, involving expertise across clinical research disciplines. As a bridge between the sponsor/contract research organization (CRO) and sites, our use of proven quality improvement practices consistently reduces start-up timelines while maintaining quality and compliance.”</span></p> <p><span data-contrast="auto">“Our focus at the Research Institute is to help our sites and investigators simplify and streamline start-up activities,” </span><span data-contrast="auto">says Charita Braker, Manager, Clinical Research Education, at HCA Healthcare Research Institute. “We take a team approach to study start-up, working with the sponsor from the clinical trial lead phase through study activation. Many of our studies reach our target start-up time of 14 weeks. Outliers can typically be identified up-front due to factors such as U.S. Food and Drug Administration study approval delays or the fact that a protocol amendment is underway.”</span></p> <p><span data-contrast="auto">“Our clinical education team plays a pioneering role in helping sites understand expectations throughout the trial, clarifying specific requirements and moving through challenges with the protocol,” adds Klinedinst. The clinical educator role requires clinical research experience and a high level of clinical knowledge, plus good time and project management skills. </span><span data-contrast="auto">The role demands the ability to look at documents, including the protocol and informed consent forms, with a critical eye to ensure high quality, transparency, and continuity.</span></p> <h4 id="yui_3_17_2_1_1738634345305_270" class="eventitem-title"><a href="https://2025.acrpnet.org/2025-program/a-site-management-organization-approach-to-study-start-up"><strong>A Site Management Organization Approach to Study Start-Up</strong></a></h4> <h4><em>Join Charita and Jessi at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where they will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, and study and site specifics. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img fetchpriority="high" decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="(max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“The clinical education team acts as the glue between the various different departments,” adds Braker. “Activities include helping sites interpret budgets, providing a coverage analysis to appropriately assign billable items to payers, and offering clinical insights across the whole process. The team is actively involved throughout the study, helping to troubleshoot any issues that arise.”</span></p> <p><span data-contrast="auto">“This is in addition to the typical start-up tasks involving roles focused on contracting and budgeting, clinical trial management system oversight, and regulatory compliance, where we take a standardized approach,” notes Braker. “Experience at the Research Institute has shown that that delineation of responsibilities helps improve site compliance, data quality, and sponsor/CRO satisfaction. This approach can also achieve benefits at smaller sites.”</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/02/04/reducing-study-start-up-times-quality-improvement-practices-at-a-site-management-organization">Reducing Study Start-Up Times: Quality Improvement Practices at a Site Management Organization</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Applying Project Management Best Practices to Accelerate Study Start-Up Timelines
Wed, 29 Jan 2025 09:45:40 -0000
Clinical study start-up is a complex process, involving many moving parts, which can sometimes feel overwhelming. Using strong project management skills to follow a clear road-map, with well-defined workflows, can […]
The post Applying Project Management Best Practices to Accelerate Study Start-Up Timelines appeared first on ACRP.
<p><span data-contrast="auto">Clinical study start-up is a complex process, involving many moving parts, which can sometimes feel overwhelming. Using strong project management skills to follow a clear road-map, with well-defined workflows, can make the difference between costly delays and success. These skills can enable timely study initiation by enabling sites to handle complexities and minimize delays.</span></p> <p><span data-contrast="auto">“A lot can go wrong during study start-up,” says Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, at Merck, known as MSD outside the U.S. and Canada. “It’s important to understand how to control for these elements, using lessons learned from earlier studies to help avoid future pitfalls.”</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“Skills such as time management, risk assessment, and effective communication are vital to study start-up,” states Tamika Harris, Clinical Operations Manager – Regulatory, at Merck. “These project management skills can enable clinical research professionals to implement robust project plans, manage resources efficiently, stay on track with regulatory requirements, and mitigate risks.”</span></p> <p><span data-contrast="auto">“Sites should pay particularly close attention to the various study-related deadlines they agree to,” adds Harris. “These should take account of predictable sources of delay, such as national holidays and potential staffing fluctuations, to ensure that agreed deadlines are realistic. Back-up plans to mitigate predictable issues can help, along with involving all stakeholders as part of a collaborative study management team. Strategic project management throughout the study timeline can help identify pitfalls and avoid last-minute issues.”</span></p> <h4><a href="https://2025.acrpnet.org/2025-program/project-management-skills-for-accelerating-study-start-up"><strong>Project Management Skills for Accelerating Study Start-Up</strong></a></h4> <h4><em>Join Jessica and Tamika at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where they will help attendees learn how project management techniques can streamline the clinical study start-up process and provide practical tools to improve efficiency. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="(max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“Having a thorough understanding of the nuances of institutional rules is also important in identifying potential problems and resolving them,” notes Propps. “This can help avoid predictable delays due to elements such as investigator conflicts of interest. Analyzing a site’s historical study timelines can help with goal-setting and prediction of future timelines. Various tools are also available to optimize sharing of documents between stakeholders, including dashboards and centralized platforms.”</span></p> <p><span data-contrast="auto">“For study materials, it is important not to keep reinventing the wheel,” according to Harris. “It is more efficient to use templates as the basis for the site information pack, and to take advantage of previously-negotiated language for budgets, contracts, and informed consent forms. Finally, active communication between all stakeholders is essential, with an ultimate goal of streamlining operations so that sites can focus on patient care.”</span><span data-ccp-props="{"469777462":[980],"469777927":[0],"469777928":[1]}"> </span></p> <p><em> Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/29/applying-project-management-best-practices-to-accelerate-study-start-up-timelines">Applying Project Management Best Practices to Accelerate Study Start-Up Timelines</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap
Tue, 28 Jan 2025 14:35:58 -0000
Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) […]
The post Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap appeared first on ACRP.
<p><span data-contrast="auto">Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Securing, anonymizing, and transferring personal data is complex and challenging in these regions, especially when there is a need to share personal data with vendors and research partners in multiple jurisdictions. </span></p> <p><span data-contrast="auto">“Many sponsors in the United States incorrectly believe that the GDPR does not apply to them because they are not based in Europe and they see only coded data,” says Rob Masson, CEO of The DPO Centre. “This confusion is partly due to the </span><span data-contrast="none">Health Insurance Portability and Accountability Act (HIPAA) not considering pseudonymized data to be personal data. However, under the GDPR, the definition of personal data includes any data relating to an individual that are either directly or indirectly identifiable. This therefore applies to coded/pseudonymized data because these are ‘indirectly’ identifiable.”</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">As a result, the GDPR applies throughout the world where personal data on an EU or UK resident are being processed. “Compliance with these data protection laws is essential, and without an accountability framework in place, studies are likely to grind to a halt very quickly,” states Masson. “In addition to incurring fines, engagement with the necessary partners will be impossible, as will successful ethics committee reviews and Clinical Trial Information System (CTIS) applications, all of which are required for EU studies to progress.” </span></p> <p><span data-contrast="none">Key steps to consider when processing EU/UK personal data include: </span><span data-ccp-props="{"335559739":60}"> </span></p> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Understanding data flows, lawful bases, processing risks, and cross border transfers</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Implementing a GDPR compliance framework prior to the first-participant-in stage</span><span data-ccp-props="{"335559739":60}"><br /> </span></li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Implementing data processing agreements with study partners and investigator sites</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Being familiar with the requirements of the CTIS</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Appointing a data protection officer and data protection representative where required</span><span data-ccp-props="{}"> </span></li> </ul> <p><span data-contrast="none">Data protection representatives are required by organizations that are not present within the European Economic Area, and must be “established” in the Member State where the majority of a study’s EU personal data are processed. Its role is to act as the point of contact for data subjects and regulatory authorities. </span><span data-ccp-props="{}"> </span></p> <h4><strong><a href="https://2025.acrpnet.org/2025-program/european-data-privacy-roadmap-balancing-research-innovation-and-compliance">European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance</a></strong></h4> <h4><em>Join Rob at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], as he explores some of the key data privacy compliance challenges for contract research organizations and sponsors, sharing real-world business examples and insights. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="(max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="none">Post-Brexit, both the EU and UK GDPR Article 27 apply, so representatives are required in each jurisdiction. Other laws to keep in mind are the Clinical Trials Regulation and Medical Devices Regulation.</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">“Sponsors need to be fully aware of the implications of data protection legislation designed to protect the sensitive, high-risk health data gathered during many clinical trials,” according to Masson. “As the ‘data controller’, sponsors inherit ultimate responsibility and accountability for compliance—which cannot be divested to a contract research organization—and must clearly demonstrate this commitment. Data privacy should be considered from the protocol design stage and throughout the clinical trial lifecycle.”</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/28/research-innovation-and-compliance-in-the-eu-and-uk-a-data-privacy-roadmap">Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Setting Up an Investigator-Initiated Research Program: Benefits and Lessons Learned
Thu, 23 Jan 2025 01:35:58 -0000
Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators […]
The post Setting Up an Investigator-Initiated Research Program: Benefits and Lessons Learned appeared first on ACRP.
<p><span data-contrast="auto">Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institution’s high-quality research and compliance.</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">The </span><a href="https://www.hackensackmeridianhealth.org/en/research/office-of-research-administration/researcher-resources/protocol-development"><span data-contrast="none">Hackensack Meridian Health (HMH) Research Institute’s IIRP</span></a><span data-contrast="auto"> uses a structured, integrated team approach to support independent investigators. Investigator-initiated research (IIR) is conceived by an individual, usually the principal investigator (PI), who develops a protocol for research at the site level. Examples of IIR include clinical trials with biomedical or social-behavioral interventions, data studies, surveys, quality of life studies, and epidemiological research.</span></p> <p><span data-contrast="auto">Set up in 2019, the HMH IIRP program includes scientific, operational, and statistical elements, which were previously independent. “We help investigators with all steps of their project, from writing the proposal to carrying out the data analysis, supporting regulatory submissions, and disseminating results appropriately,” says Elli Gourna Paleoudis, PhD, Director, Investigator Initiated Research Program and Support Services, at HMH. “In setting up the IIRP, we took a ‘bottom-up’ approach. We were already supporting independent projects across multiple sites, and our program gradually evolved to meet this need. The IIRP is centralized, making it cost-effective, as well as being readily accessible to potential researchers.”</span></p> <p><span data-contrast="auto">No specific equipment or software is needed for an IIRP. The main requirement is for a flexible team that is willing to work in different areas every day, handling protocols from across therapeutic areas. At HMH, support is offered to anyone with a promising idea for research, including attending and resident physicians, nurses, medical students, and occupational therapists. This type of approach could be tailored to any size of institution.</span></p> <p><span data-contrast="auto">“By providing one-on-one support, our program adds motivation to initiate research, while reducing the investment required by the researcher,” explains Pamela Cooper, Manager, Investigator Initiated Research Program, HMH. Ways to promote the availability of an IIRP include development of a website, the inclusion of links in e-mail signatures, and a range of other resources such as master lists and an IIT library. </span></p> <p><a href="https://2025.acrpnet.org/2025-program/starting-from-scratch-to-establish-an-investigator-initiated-research-program"><strong>Starting from Scratch to Establish an Investigator-Initiated Research Program</strong></a></p> <h4><em>Join Elli and Pam at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where they will focus on how an IIRP, regardless of research portfolio size, will deliver scalable steps for success. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img loading="lazy" decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="auto, (max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“If you build it, they will come,” says Cooper, quoting from the 1989 film, </span><i><span data-contrast="auto">Field of Dreams</span></i><span data-contrast="auto">. Cooper suggests that institutions should be mindful of this, preparing for an influx of interest once the infrastructure is in place. At HMH, the numbers of projects underway have risen from 35 in 2015, to around 100 in 2019, and to more than 300 in 2024. Areas of support provided by the HMH IIRP include: study design and research methodology; biostatistics; regulatory; data management; basic training in topics such as Good Clinical Practice; manuscript preparation; and applying for external funding. The biostatistics team offers support in areas including protocol development, statistical analysis plans, data analysis, and preparation of abstracts and posters. The team brings expertise in clinical research, public health, behavioral research, and basic science.</span></p> <p><span data-contrast="auto">“In addition to expanding our research output, we’ve had great feedback from investigators, who appreciate the centralized structure, and the fact that it is easy to identify contacts to help with their projects,” concludes Cooper.</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/22/setting-up-an-investigator-initiated-research-program-benefits-and-lessons-learned">Setting Up an Investigator-Initiated Research Program: Benefits and Lessons Learned</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>A New Approach to Assess and Manage Study Coordinator Workload
Tue, 21 Jan 2025 14:45:40 -0000
Historically, the vital task of assigning study coordinators to clinical trials has relied on a research leader’s experience and intuition. The realities of today’s challenging studies—with increasing complexity and tightening […]
The post A New Approach to Assess and Manage Study Coordinator Workload appeared first on ACRP.
<p><span data-contrast="auto">Historically, the vital task of assigning study coordinators to clinical trials has relied on a research leader’s experience and intuition. The realities of today’s challenging studies—with increasing complexity and tightening budgets—demand an accurate assessment of the level of support required for each trial. This is an essential step in maintaining quality while avoiding staff burnout.</span></p> <p><span data-contrast="auto">“My journey toward creating a new tool started a dozen or so years ago, when I realized that a scientific approach existed for oncology studies but not for other therapeutic areas,” says Suzanne Rose, MS, PhD, Executive Director of Research at Stamford Hospital. “We needed to know how many studies and patients a single research coordinator could feasibly manage. There was also a need to benchmark study coordinators to see what an ideal monthly workload would look like.”</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">These goals have been achieved with a modification of the Opal tool. Traditionally, this has been used for oncology trials, where coordinators typically work on more studies than in other diseases, since many trials are mutation-specific with very low enrollment rates and long follow-up.</span></p> <p><span data-contrast="auto">“We have successfully adapted the Opal tool for non-oncology research,” states Rose. “Known as the clinical research workload tool (CRWT), our new version is based in Excel, taking account of the study type, phase, protocol-related workload, and other details. Protocols are ranked from one to eight, with one being a simple non-drug or device study, and eight being any type of Phase I trial for a drug or premarket device. The number of patients involved is not taken into account, since many tasks must be carried out regardless of patient involvement—such as institutional review board submissions and creation of source documents. Once patients are enrolled, the score of the study increases.”</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">The CRWT is a highly flexible tool, suitable for all therapeutic categories, and allowing for continuity of care among coordinators for their study participants, while justifying the use of new and existing employees for research programs. The tool—which can be used at community hospitals, academic medical centers, and independent research sites—has recently been adopted by the National Institutes of Health’s National Heart, Blood, and Lung Institute.</span><span data-ccp-props="{}"><br /> </span></p> <h4 id="yui_3_17_2_1_1733927369982_270" class="eventitem-title"><strong><a href="https://2025.acrpnet.org/2025-program/assessing-and-managing-study-coordinator-workload">Assessing and Managing Study Coordinator Workload</a></strong></h4> <h4><em>Join Suzanne at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where she explores the current state of available clinical research workload tools and compares several similar adaptations of a specific tool for tracking productivity at various types of research programs. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img loading="lazy" decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="auto, (max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“To date, we’ve shared the CRWT with more than 100 sites,” notes Rose. “I’d love to put the tool into cloud-based software or onto platforms that are easy for others to access. This would enable us all to benchmark our productivity against that of similar organizations, which would be very helpful.”</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">“Overall, our tool avoids overburdening study coordinators, ensuring they are assigned a manageable number of studies,” concludes Rose. “This supports increased study enrollment, enables justification of additional research funding for the site, results in better efficiency and quality of work, and supports retention of coordinators by increasing job satisfaction.”</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/21/a-new-approach-to-assess-and-manage-study-coordinator-workload">A New Approach to Assess and Manage Study Coordinator Workload</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Embracing the Future: Reflections on the Release of ICH E6(R3)
Fri, 17 Jan 2025 13:56:13 -0000
The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation […]
The post Embracing the Future: Reflections on the Release of ICH E6(R3) appeared first on ACRP.
<p><span data-olk-copy-source="MessageBody">The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation in clinical research, I see this milestone as an opportunity for our field to grow and adapt in meaningful ways.</span></p> <p><em>ICH E6(R3) isn’t just an update—it’s a call to action.</em></p> <p>It invites us to rethink how we design and conduct clinical trials, focusing on flexibility, proportionality, and risk-based approaches. At its core, the guideline reflects a shift toward collaboration, patient-centricity, and leveraging technology to streamline operations without compromising data integrity or, more importantly, patient safety.</p> <p>A few key themes immediately come to mind:</p> <ul type="disc"> <li><b>Proportionality and Risk-Based Thinking:</b> E6(R3) acknowledges that not all trials carry the same risks. It encourages us to focus resources where they matter most, ensuring high-quality outcomes without unnecessary burden.</li> <li><b>A Culture of Quality:</b> While not explicitly stated, the guideline emphasizes fostering an organizational mindset that prioritizes proactive quality management, risk-based approaches, collaboration and communication, critical thinking, and continuous improvement.</li> <li><b>Patient Engagement:</b> More than ever, E6(R3) reminds us to center the patient in every aspect of clinical research, from protocol design to trial execution.</li> </ul> <p>While change can feel daunting, I believe this is a moment for the clinical research ecosystem to come together and embrace the possibilities. As we take steps to implement E6(R3), let’s view this as an opportunity to enhance how we protect patients, ensure data reliability, and drive efficiency.</p> <p>I look forward to exploring these themes and more during <strong>ACRP’s live webinar on</strong> <b>February 13, 12:00 – 1:00 PM ET</b>, <b>“<a href="https://acrpnet.org/learning/courses/crack-the-code-a-comparison-of-ich-e6r2-and-ich-e6r3" target="_blank" rel="noopener">Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)</a>.”</b> This session will provide a high-level overview of the changes and practical strategies for navigating them with confidence. Attendees will be equipped to evaluate their organization’s alignment, identify priority actions for compliance, and start bridging the gaps.</p> <p>The journey ahead will undoubtedly bring challenges but also progress. Together, we can transform these updates into lasting, impactful improvements for the entire clinical research community.</p> <p>Let’s embrace this new chapter.</p> <p><em>Author: Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC</em></p> <p><a href="https://acrpnet.org/insights/guidelines-and-regulations" target="_blank" rel="noopener"><img loading="lazy" decoding="async" class="alignleft size-large wp-image-56070" src="https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-1024x127.png" alt="" width="1024" height="127" srcset="https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-1024x127.png 1024w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-300x37.png 300w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1-768x95.png 768w, https://acrpnet.org/wp-content/uploads/2023/11/ICH_728x90-1.png 1456w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></a></p> <p> </p> <p>The post <a href="https://acrpnet.org/2025/01/17/embracing-the-future-reflections-on-the-release-of-ich-e6r3">Embracing the Future: Reflections on the Release of ICH E6(R3)</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Can a Technology Reboot Help Sites, Sponsors, Patients, and Others Talk Seamlessly?
Wed, 15 Jan 2025 20:54:29 -0000
In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the “nice to […]
The post Can a Technology Reboot Help Sites, Sponsors, Patients, and Others Talk Seamlessly? appeared first on ACRP.
<p><span data-contrast="auto">In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the “nice to have” category into the “must-have” one doesn’t have to be dismissed as a miracle that will never see the light of day, an industry observer of trends in technology says.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“We know that the demand at the site level for studies is growing and the workforce capacity is shrinking,” notes Bree Burks, RN, MSN, Vice President of Strategy for Veeva Systems, who will present on “The Clinical Research Technology Reboot: Are We Getting it Right?” at the </span><a href="https://2025.acrpnet.org/"><span data-contrast="none">ACRP 2025</span></a><span data-contrast="auto"> gathering in New Orleans, La., this April. “Sites in particular are really hurting for resources and qualified staff. In this kind of environment, and in recognition of how technology training on products that don’t often ‘talk to’ each other is the number one reason sites are delaying study start-ups, I would argue that getting a technology reboot right is actually critical for the entire industry.”</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Burks says that her conference talk will focus on the lessons the technologically fragmented clinical research enterprise can learn from disruptive technology changes that propelled other industries into being everyday parts of our lives—in companies such as Uber, Amazon, Zillow, and Airbnb.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“The idea is that technology revolutions have already infiltrated many parts of our lives, and I think it’s interesting and urgent to consider how we can draw parallels between those situations and what we need to do in our industry to have similarly seamless, end-to-end experiences for customers—whether by that term we mean sites, sponsors, patients, vendors, or any other stakeholders,” Burks adds. “The end goal is to be able to easily exchange information and avoid duplicative work using standardized technologies between parties with the kind of connectivity we simply don’t have now in the industry.”</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">In part, that will mean that sites and sponsors will have to unlearn some bad habits. For example, Burks notes, the habit of acquiring technology that becomes so customized to a single organization that it is more of a hindrance than a helper when communicating in real time with other systems in the larger world of Big Data involved in clinical research. It could also go a long way toward seeing clinical research treated as a regular part of clinical care in the healthcare environment, she says.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“What you should be seeing is more companies setting up streamlined systems that others can ‘buy into’ for mutual benefit as all the different players in studies interact with one another,” Burks says. “We’re not going to get to that Nirvana of having most of our information truly connected—shared across sites and sponsors and patients—if we keep clutching our customized systems to our chests out of fear of change.”</span><span data-ccp-props="{}"> </span></p> <h4 id="yui_3_17_2_1_1733259456268_271" class="eventitem-title"><strong><a href="https://2025.acrpnet.org/2025-program/the-clinical-research-technology-reboot-are-we-getting-it-right">The Clinical Research Technology Reboot: Are We Getting it Right?</a></strong></h4> <h4><em>Join Bree at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where she will challenge all attendees, from novice to expert, to intentionally evolve our own industry based on what others have already learned. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="https://2025.acrpnet.org/"><img loading="lazy" decoding="async" class="alignnone wp-image-55457" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="auto, (max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">It’s not that current technologies, in and of themselves, are the entire problem, Burks adds. Also at issue is how sponsors create variations in practices among sites because they are selecting the technologies, but not necessarily in cooperation with the sites.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“Yes, sponsors have to come together and start standardizing more, but sites have to have an equal seat at the table,” Burks says “In order to really bring all sides of the industry together and solve this problem, we have to have sites and sponsors participating on equal levels and having technology companies there as their partners—actively helping them compromise where needed and work more consistently together.”</span><span data-ccp-props="{}"> </span></p> <p><i><span data-contrast="auto">Author: Gary Cramer</span></i></p> <p>The post <a href="https://acrpnet.org/2025/01/15/can-a-technology-reboot-help-sites-sponsors-patients-and-others-talk-seamlessly">Can a Technology Reboot Help Sites, Sponsors, Patients, and Others Talk Seamlessly?</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together!
Tue, 14 Jan 2025 12:00:21 -0000
The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. In recent years, there have […]
The post Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together! appeared first on ACRP.
<p><span data-contrast="auto">The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.</span></p> <p><span data-contrast="auto">“Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER). “A key question is what kind of behavior changes can help us improve as clinical research professionals? What can we do to advance our subject matter expertise, and our own personal contentment – both at work, and in life. To succeed, we must overcome our fears. This is true no matter what role we’re in or where we’re based.”</span></p> <p><span data-contrast="auto">“Open conversations on challenging topics are needed to lower anxiety levels about the potential for poor outcomes as a result of change,” states Burrow. “Gatherings like ACRP 2025 provide an opportunity for robust discussion about subjects we typically don’t talk about, helping address fears and identify support systems necessary to drive innovation.”</span></p> <p><span data-contrast="auto">A mindset shift is needed, notes Burrow, with collaborative approaches to drive innovation globally. One effort is FDA’s CDER Center for Clinical Trial Innovation (C3TI), which acts as a central hub to support innovative approaches to increase the efficiency of drug development.</span><span data-contrast="auto"> C3TI aims to spur future clinical trial innovation through enhanced communication and collaboration with study stakeholders.</span> <span data-contrast="auto">The center aims to help clinical researchers stay current with innovations, collaborate with the agency to maximize the potential utility of new innovative tools, and improve the efficiency and effectiveness of clinical trials, including participation of diverse populations. The overarching goal is to accelerate development of safe and effective new drugs.</span></p> <h4 id="yui_3_17_2_1_1733259456268_271" class="eventitem-title"><strong><a href="https://2025.acrpnet.org/2025-program/fear-face-everything-and-rise-in-clinical-research" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="58404dd07c1fea044bce96d8">FEAR: Face Everything and Rise (in Clinical Research)</a></strong></h4> <h4><em>Join David at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="https://2025.acrpnet.org/"><img loading="lazy" decoding="async" class="alignnone wp-image-55457" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="auto, (max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“Stakeholder engagement with FDA through C3TI offers an opportunity to minimize the potential risks involved in changes,” says Burrow. “Another factor is FDA’s plan to carry out directed inspections, narrowly focused inspections looking only at those aspects of clinical trial conduct and reporting requirements that are essential in the context of a particular marketing application. These types of inspections will not focus on administrative elements which may not be critical to human subject safety or data reliability.” </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">“If we avoid the things we are scared of, they will continue to be a problem,” concludes Burrow. “We can all work to manage our fears, to ‘face everything and rise.’ Working together, we can cocreate solutions to reimagine clinical research and overcome barriers to innovation.”</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/14/mitigating-fear-in-clinical-research-innovation-face-everything-and-rise-together">Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together!</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>Preparing for Changes at the FDA: Possible Impacts of a New Administration
Thu, 09 Jan 2025 12:00:02 -0000
Many current trends in clinical research will likely continue regardless of the upcoming changes in the White House. The need to incorporate technology into our clinical trials processes, alongside a […]
The post Preparing for Changes at the FDA: Possible Impacts of a New Administration appeared first on ACRP.
<p><span data-contrast="auto"></span><span aria-label="Rich text content control paragraph"><span data-contrast="auto"></span><span data-contrast="auto">Many current trends in clinical research will likely continue regardless of the upcoming changes in the White House. The need to incorporate</span><span aria-label="Rich text content control"><span data-contrast="auto"></span><span data-contrast="auto"> technology into our clinical trials processes, alongside a continued emphasis on the power of artificial intelligence (</span><span data-contrast="auto"></span></span><span data-contrast="auto">AI)</span><span aria-label="Rich text content control"><span data-contrast="auto"></span><span data-contrast="auto">, will remain a priority for both the U.S. Food and Drug Administration (FDA) and the rest of government in 2025. For example, FDA has repeatedly emphasized a need to move away from paper-based data collection in favor of remote access and more streamlined study processes—all aimed at the larger goal of making trials faster and more cost-efficient.</span></span><span aria-label="Rich text content control"><span data-contrast="auto"><br /> </span></span></span></p> <p><span data-contrast="auto">“Diversity, equity, and inclusion (DEI) may be broadly de-emphasized by the new administration, but the science-based FDA requirement for intentional study recruitment is unlikely to change,” notes Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO). “The next-generation 21</span><span data-contrast="auto">st</span><span data-contrast="auto"> Century Cures bill will </span><span aria-label="Rich text content control"><span data-contrast="auto"></span><span data-contrast="auto">also </span><span data-contrast="auto"></span></span><span data-contrast="auto">be a focus in the near future, with an opportunity for stakeholders to advocate for </span><span aria-label="Rich text content control"><span data-contrast="auto"></span><span data-contrast="auto">expanded </span><span data-contrast="auto"></span></span><span data-contrast="auto">provisions to support the clinical trial ecosystem. This is a rare chance to use our collective voice to elevate our priorities on the Hill as part of an effort to remove more barriers to delivery of new drugs to patients.”</span><span data-ccp-props="{}"><br /> </span></p> <p><span data-contrast="auto">“While we can expect some changes in priorities in 2025, FDA guidances issued thus far, such as the final guidance on decentralized clinical trials, will remain in place,” says Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer for Florence Healthcare. Appropriate technology and remote data capture are already </span><span aria-label="Rich text content control"><span data-contrast="auto"></span><span data-contrast="auto">widely </span><span data-contrast="auto"></span></span><span data-contrast="auto">supported in FDA guidances to facilitate less costly trials, and this pressure to achieve efficiencies will likely increase with the new administration, she adds.</span></p> <p aria-level="2"><span data-contrast="none">“The drive to incorporate trials into routine care will also stand, along with intentional FDA language about the responsibilities of the principal investigator and sponsor,” states Gregor. “There is still a need for a new model for trials involving technology vendors that specifies the role of these companies.”</span></p> <p><span data-contrast="auto">Changes to the Centers for Medicare and Medicaid Services may have a significant impact on clinical trials. “A move toward Medicare Advantage, which is typically less willing to reimburse routine care than Medicare, could negatively impact our ability to treat patients within a trial,” notes Gregor. “This may be particularly problematic in rare disease studies. Another issue is cross-state licensure, which is central to the continued growth of decentralized clinical trials.” </span></p> <h4 id="yui_3_17_2_1_1733848260208_263" class="eventitem-title"><a href="https://2025.acrpnet.org/2025-program/keeping-up-with-the-fdas-changing-ways"><strong>Keeping Up with the FDA’s Changing Ways</strong></a></h4> <h4><em>Join Catherine and Sophia at </em><a href="https://2024.acrpnet.org/" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>ACRP 2025</em></a><em> [April 24-27</em><em>; New Orleans, La.</em><em>], where they will will run through the latest guidance changes and what they mean for sites and sponsors in 2025. </em><a href="https://2025.acrpnet.org/schedule" target="_blank" rel="noopener" data-feathr-click-track="true" data-feathr-link-aids="["58404dd07c1fea044bce96d8"],58404dd07c1fea044bce96d8"><em>View complete schedule</em></a>.</h4> <p><a href="http://2025.acrpnet.org"><img loading="lazy" decoding="async" class="wp-image-55457 aligncenter" src="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png" alt="" width="500" height="200" srcset="https://acrpnet.org/wp-content/uploads/2024/01/email2-300x120.png 300w, https://acrpnet.org/wp-content/uploads/2024/01/email2-1024x409.png 1024w, https://acrpnet.org/wp-content/uploads/2024/01/email2-768x307.png 768w, https://acrpnet.org/wp-content/uploads/2024/01/email2.png 1260w" sizes="auto, (max-width: 500px) 100vw, 500px" /></a></p> <p><span data-contrast="auto">“Sites should get ready for increased technology use, including digitizing data, to achieve economies of scale and inspection readiness,” states McLeod. “At present, only around 10% of the global site market uses digital technology to record data; the remainder uses a combination of paper and SharePoint, or 100% paper records. This is a high-priority area for attention.”</span></p> <p><span data-contrast="auto">“Regardless of what party is in power, we should lean into the topics we’ve been discussing over the past few years,” concludes Gregor. “These include the need for intentionality around inclusion in clinical trials and the use of technology to gain efficiencies. Finally, we still need to take research into the community, which in turn requires technological innovation, intentional protocol design including diversity planning, and the ongoing efforts of experienced clinical trial professionals.”</span></p> <p><em>Edited by Jill Dawson</em></p> <p>The post <a href="https://acrpnet.org/2025/01/09/preparing-for-changes-at-the-fda-possible-impacts-of-a-new-administration">Preparing for Changes at the FDA: Possible Impacts of a New Administration</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>A Visit with Christina Brennan, the 2025 ACRP Board of Trustees Chair
Tue, 07 Jan 2025 12:52:35 -0000
As Christina Brennan, MD, MBA, CCRC, FACRP, begins her volunteer duties as the 2025 Chair of the ACRP Board of Trustees, she took time to answer some questions about her […]
The post A Visit with Christina Brennan, the 2025 ACRP Board of Trustees Chair appeared first on ACRP.
<p><span data-teams="true">As Christina Brennan, MD, MBA, CCRC, FACRP, begins her volunteer duties as the 2025 Chair of the</span> <a href="https://acrpnet.org/about-acrp/leadership-governance/acrp-board-of-trustees/">ACRP Board of Trustees</a>, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can be of service to its members and stakeholders.</p> <p><strong>Q: Can you give us the quick highlights along your career roadmap to serving as the 2025 Chair of the Board that you believe will help you achieve your goals in this role?</strong></p> <p>A: I have dedicated more than 25 years to the clinical research profession, during which I have had the privilege of working as both a principal and sub-investigator on clinical trials. I’ve rolled up my sleeves as a clinical research coordinator, and ultimately, I took on the responsibility of leading the operations of clinical research programs where I work. Currently, I serve as the Senior Vice President of Clinical Research at Northwell Health in New York. Over the years, I’ve recognized the importance of staying current in the industry and partnering with organizations to ensure our voices are heard. This is why I joined ACRP 20 years ago. In the past 11 years, I have served at the local chapter level, including as president, and five years ago, I transitioned to the Board of Trustees.</p> <p><strong>Q: What clinical research workforce and overall industry challenges and opportunities are top of your mind for addressing this year? What can ACRP, as a volunteer-driven organization, do in 2025 to support its stakeholders—members and non-members alike—as they face up to current conditions in the field?</strong></p> <p>A: As Chair, I am committed to advancing ACRP’s mission and strategic goals. One of my primary passions is strengthening the clinical research profession. Clinical research professionals are often overlooked as key stakeholders within the research ecosystem. A major part of this issue is the lack of a clear professional identity for this workforce. In fact, the U.S. Bureau of Labor Statistics does not even recognize clinical research as a profession. It’s crucial that we, as an industry, work to change this to ensure that our workforce is sustainable for future generations. <a href="https://acrpnet.org/2024/12/02/acrp-advocates-for-clinical-researcher-occupation-code">ACRP is at the forefront of driving this transformation</a>.</p> <p>With the growing number of clinical trials both nationally and globally, as evidenced by the registered trials in the National Library of Medicine, it’s estimated that there are more than 40,000 clinical research coordinators in the U.S. alone supporting these trials. This community needs to be more engaged to improve membership and retention. ACRP should continue to be the primary organization that supports clinical research professionals, remaining relevant in this evolving field. We must continue to develop funding and partnerships to fuel ACRP’s growth, as collaboration is key to strengthening our research ecosystem.</p> <p>I am also dedicated to promoting research certification and <a href="https://acrpnet.org/acrp-learning">professional development</a>. Earning certification validates an individual’s skills and expertise. <a href="https://acrpnet.org/certification/">ACRP offers a variety of certifications</a> to meet the needs of different professionals. Personally, I became certified 20 years ago, and I strongly believe we should make certification an industry standard.</p> <p>I further aim to enhance the effectiveness and engagement of the Board to have a greater impact on the organization. My goal is to foster an environment where all Board members actively contribute and work together. As Chair of the Board of Trustees for ACRP in 2025, I hope that we can build an even stronger community of clinical research professionals. Clinical research is more than just a job—it’s an opportunity to make a tangible difference in the lives of patients and the healthcare system as a whole. It has been my passion, and I am grateful that I chose this career.</p> <p>“We are delighted to have Christina take the reins of our Board and to work with her and its returning and new members for 2025, representing a diverse group of global clinical research thought leaders and organizational champions,” says Susan P. Landis, ACRP Executive Director. “Our volunteer Board is key to maintaining ACRP’s passion for promoting excellence in all facets of the clinical research enterprise. We are grateful for its members’ dedication to contributing their time, energy, and expertise for the ongoing benefit of ACRP and its members.”</p> <p><em>Edited by Gary Cramer</em></p> <p>The post <a href="https://acrpnet.org/2025/01/07/a-visit-with-christina-brennan-the-2025-acrp-board-of-trustees-chair">A Visit with Christina Brennan, the 2025 ACRP Board of Trustees Chair</a> appeared first on <a href="https://acrpnet.org">ACRP</a>.</p>SCOPE Summit 2025: Emmes' Peter Ronco on Small Biopharma & Clinical Trial Partnerships
Tue, 04 Feb 2025 23:25:00 -0000
In an interview with ACT Associate Editor Don Tracy, Peter Ronco, CEO, Emmes, discusses the "Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma" session.SCOPE Summit 2025: Advancing Clinical Research Through Strategic Partnerships: The SGM Alliance SOGI Business Case
Tue, 04 Feb 2025 21:15:00 -0000
Conference breakout session examines the role of strategic partnerships in driving progress for sexual and gender minority inclusion in clinical research.SCOPE Summit 2025: Advarra’s Ashley Davidson Highlights Current Challenges with Study Startup
Tue, 04 Feb 2025 20:53:00 -0000
In an interview with ACT senior editor Andy Studna at SCOPE Summit, Davidson, vice president, product lead - sponsor tech strategy, Advarra, discussed ongoing challenges in study startup processes, including contract and budget issues, and feasibility concerns, which have persisted for over a decade.SCOPE Summit 2025: Jonathan Norman of YPrime Discusses the Need for Localization in Clinical Trials
Tue, 04 Feb 2025 17:47:00 -0000
In an interview with ACT senior editor Andy Studna at SCOPE Summit, Norman, director, localization services, YPrime discussed how localization is becoming increasingly important as clinical trials become more global.The Value of Clinical Trial Liaisons in the Drug Development Lifecycle
Tue, 04 Feb 2025 16:34:14 -0000
Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.SCOPE Summit 2025: Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There
Tue, 04 Feb 2025 01:39:00 -0000
Conference keynote explores the long-term vision for integrating clinical research and care by 2035, including progress driven by digital advancements, artificial intelligence, and evolving regulatory frameworks.SCOPE Summit 2025 Opening Keynote Panel: What Do Real Patients Actually Talk About?
Mon, 03 Feb 2025 23:41:00 -0000
Interactive panel on day 1 of SCOPE Summit 2025 highlighted the need for inclusive narratives, social listening to understand patient experiences, and the role of advocacy groups in opening doors to clinical trials.Updated BREAKWATER Trial Data Show Significant Survival Improvement with Braftovi Combination in Metastatic Colorectal Cancer
Mon, 03 Feb 2025 15:25:56 -0000
Braftovi (encorafenib) plus Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) improved progression-free survival and overall survival compared to chemotherapy in patients with metastatic colorectal cancer with a BRAF V600E mutation.How the Multiple Myeloma Research Foundation is Partnering With Biopharmas
Mon, 03 Feb 2025 11:00:00 -0000
In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights how the MMRF accelerates trial timelines for biopharmas by integrating an adaptive platform model.Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights
Mon, 03 Feb 2025 05:00:00 -0000
A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.Upping the Migraine Intelligence Quotient: RWD sheds light on prevalence rates, providers and treatment variation
Mon, 03 Feb 2025 05:00:00 -0000
This white paper presents findings from the PurpleLab Migraine Study, which leverages real-world data to analyze migraine prevalence, treatment variations, and provider insights. The study examines data from approximately 10 million Americans diagnosed with migraines, focusing on patient demographics, treatment pathways, and healthcare provider specialties. Key findings include the high prevalence of migraines among females aged 18-54, racial and ethnic disparities in treatment, and the significant role of specialized providers like psychiatrists and neurologists in managing migraine care. It highlights the importance of tailored treatment approaches and the potential benefits of complementary and alternative medicine therapies.Data-Driven Insights can Optimize Clinical Trial Site Selection
Mon, 03 Feb 2025 05:00:00 -0000
Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.Kazia Therapeutics Launches Clinical Trial Evaluating Paxalisib in Combination with Keytruda or Lynparza for the Treatment of Advanced Breast Cancer
Fri, 31 Jan 2025 17:02:00 -0000
The multi-center, open-label Phase Ib study, ABC-Pax, will assess the safety and efficacy of the regimen in women with triple negative breast cancer.Bexicaserin Produces Significant Seizure Reduction in PACIFIC OLE Trial for Developmental and Epileptic Encephalopathies
Fri, 31 Jan 2025 15:18:45 -0000
The 12-month open-label extension of the PACIFIC trial demonstrated that bexicaserin significantly reduced seizure frequency in patients with developmental and epileptic encephalopathies while maintaining a favorable safety and tolerability profile.Filling Evidence Gaps in Clinical Research
Fri, 31 Jan 2025 11:00:00 -0000
In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, discusses how MMRF goes beyond safety and efficacy data to help biopharmas research appropriate dosing for multiple myeloma therapies.Understanding Motives Behind Participation in Cancer Clinical Trials
Thu, 30 Jan 2025 21:24:00 -0000
Recent survey study of 978 cancer patients and their relatives uncovered reasons behind their willingness, or lack thereof, to participate in clinical research.Merck Stops HYPERION Trial for Winrevair in PAH Following Positive ZENITH Trial Results
Thu, 30 Jan 2025 15:17:05 -0000
The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity
Thu, 30 Jan 2025 15:00:23 -0000
Answering Critical Research Questions in Multiple Myeloma
Thu, 30 Jan 2025 11:00:00 -0000
In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, talks unmet need in the multiple myeloma space and how the Horizon trial is addressing complexity in treatment regimens.New Data Links Decentralized Clinical Trial Approaches to Improved Diversity in Patient Populations
Wed, 29 Jan 2025 20:37:00 -0000
Research from the Tufts Center for the Study of Drug Development’s PACT Consortium shows DCTs encourage higher participation across multiple demographic groups.Multiple Myeloma Research Foundation’s Horizon Clinical Trial Program
Wed, 29 Jan 2025 16:57:00 -0000
In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, highlights the design of Horizon, an adaptative platform trial for the treatment of multiple myeloma.AZALEA-TIMI 71 Trial Shows Abelacimab Significantly Reduces Bleeding Events vs. Xarelto in AFib Patients
Wed, 29 Jan 2025 16:38:20 -0000
Abelacimab was found to significantly lower factor XI levels and bleeding events compared to rivaroxaban (Xarelto) in patients with atrial fibrillation at moderate-to-high risk for stroke.Elevidys Shows Continued Promise in Phase III EMBARK Trial for the Treatment of Duchenne Muscular Dystrophy
Tue, 28 Jan 2025 20:52:00 -0000
In year two of the trial, Elevidys demonstrated statistically significant and clinically improvements across three key functional outcomes.Updated INAVO120 Trial Data Show Overall Survival Improvement with Itovebi Combination in Certain Type of Advanced Breast Cancer
Tue, 28 Jan 2025 15:09:16 -0000
The Phase III INAVO120 trial found that a combination of Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant) significantly improved overall survival and progression-free survival in patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced or metastatic breast cancer.Addressing Clinical Research Challenges in the Myeloma Space
Tue, 28 Jan 2025 11:00:00 -0000
In this video interview, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discusses the greatest challenges with clinical trials in multiple myeloma and how MMRF is aiming to address them.Pfizer Shares Positive Data from Phase III BREAKWATER Trial of Braftovi Combination Following Accelerated Approval
Mon, 27 Jan 2025 19:00:00 -0000
Being evaluated for the treatment of metastatic colorectal cancer, the combination regimen achieved an objective response rate of 61% compared to 40% for investigator’s choice of chemotherapy.Updated CheckMate -8HW Trial Results Show Significant Survival Benefit with Opdivo Plus Yervoy in MSI-H/dMMR Colorectal Cancer
Mon, 27 Jan 2025 15:44:41 -0000
Phase III CheckMate -8HW trial shows the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improved progression-free survival and overall response rates in patients with microsatellite-instability–high or mismatch-repair–deficient metastatic colorectal cancer.2025 Trends: Operational Efficiency for Clinical Trials
Mon, 27 Jan 2025 11:00:00 -0000
In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, highlights trial startup timelines and workforce development as key areas of focus for clinical operations professionals in 2025.Medidata Extends 13-Year Partnership With Tigermed
Fri, 24 Jan 2025 19:25:00 -0000
Extended collaboration will further explore the capabilities of Medidata Platform from early-phase trials to post-marketing surveillance.Phase III LEAP-015 Trial Shows Mixed Results for Keytruda-Lenvima Combo in Advanced HER2-Negative Gastroesophageal Cancer
Fri, 24 Jan 2025 15:06:58 -0000
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) and chemotherapy improved progression-free survival but did not achieve statistical significance for overall survival in patients with advanced HER2-negative gastroesophageal adenocarcinoma.Patients First! Adding Value through an Innovative Patient-Centered Approach for Oral Oncolytic Dispensing
Wed, 24 Jun 2015 13:34:33 -0000
This content is premium content, and only accessible to Premium members. Get On Demand now
RAMP ID:106827187RAMP Source ID:efghRegion:Channels:Description:Michael Reff, The Patient Rx Center, Hematology/Oncology Associates of Central New York, Founder - National Community Oncology Dispensing Association (Moderator); Patrick Connelly - Associate Director, Area Marketing, Takeda Oncology ; Jennifer Reynolds, Cancer Warrior ; Lawrence E. Garbo, Medical Oncologist & Hematologist; Marty Jay, Manager, Pharmacy Network Oversight & Audit, Excellus PharmacySlides:Primary Event:Thumbnail:
Upload Type:Date:Wednesday, July 8, 2015Top Event Content:exclude homepage:NoAudio / Video File:FREE WEBINAR: AI-enhanced product launches: Boost customer care & business performance
Tue, 03 Sep 2024 08:58:24 -0000
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Audiences:FREE WEBINAR: Embed the patient voice throughout your clinical trials
Fri, 16 Aug 2024 13:02:00 -0000
Channels:Event Date:Wed, 2024-09-04Event URL:Event Location:History:Number of attendees:500Programme URL:Brochure URL:Speakers URL:Purchase Recording URL:Event Organiser:Jacob ByerleyEvent Organiser E-mail:Précis:Ensure that studies are genuinely aligned with the real-world needs of patientsEntire Month Duration:NoEvent Image:
Audiences:Accelerate clinical data innovation: new strategies to transform capabilities
Thu, 29 Feb 2024 17:11:55 -0000
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Upload Type:Date:Wednesday, December 6, 2023Top Event Content:Join this exclusive Reuters Events webinar to hear industry experts discuss how to:
• Harness AI-powered automation to streamline processes, unlock insights, and refocus personnel on high-value work
• Provide flexible participation models and optimize technology for intuitive, engaging patient experiences
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• Accelerate data collection and availability to fuel faster analytics and decision makingexclude homepage:NoReuters Events Pharma Awards USA 2024
Fri, 05 Jan 2024 14:38:08 -0000
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Reuters Events Pharma Awards Europe 2024
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A new frontier: Transforming real world evidence for physicians
Thu, 04 Jan 2024 17:47:40 -0000
Physicians are on the front line when it comes to treating patients. They are often in the best position to improve patient care. And many believe that giving physicians greater access to real world evidence (RWE) will only help them make better-informed treatment decisions for the benefit of their patients.
RWE -- medical evidence generated during patient care, such as hospital review charts and electronic medical records (EMRs) – yields insights into what actually happens in everyday practice and creates a patient journey, or history, that provides important background for a physician determining a patient’s treatment.
Pharmaceutical companies should generate and transform RWE for the benefit of physicians, using technology to better enable physician-centered research. But they face a number of barriers, including the physicians’ lack of time to do much other than meet with their patients.
Engaging physicians
The key for pharma is to drive a dialogue with physicians to show them how RWE and data can be used in real time to directly benefit their patients.
“It’s important to engage physicians and the rest of the health care team on this topic. The data are coming from health care settings in the real world. But we also must understand the challenges that physicians face, what they care about, and how they can align their incentives with other folks’ incentives across the health care sector,” says Jason Lott, Vice President Global Integrated Evidence Generation, Specialty Medicine, Integrated Care, at Bayer.
“The health care community hasn't been as engaged in real world evidence topics from the biopharma side as we would like them to be. Physicians are first and foremost caring for the patients in front of them. We have to understand that perspective and always anchor ourselves in terms of the delivery of safe and effective patient care that recognizes the complexity of these health care systems and environments that physicians are living in,” he adds.
“We certainly want to understand what (the physicians’) workflows are like, and what (the physicians’) processes are like from a technology perspective,” says Lauren Becnel, Head of Real World Evidence, Evidence Generation Platform, at Pfizer. “We want to create a virtuous cycle in which we are starting to realize some of the goals that have been laid out by the FDA.” (In August 2023, the Food and Drug Administration finalized guidance on real-world evidence in drug approvals.)
Becnel wants to make the use of RWE “smooth and easy” for physicians. But for physicians to use the data, it has to be meaningful. “That means that it has to have a semantic set of meanings. We have to understand anyone who creates or uses it. What does this term, or what does this data element mean? And then we have to have syntactic agreement. How is it structured? Is it numbers, or is it text?
“The way that we talk about similar concepts can differ dramatically. So we're very interested not only in tackling the process and the people perspective, but also how to create that shared meaning in a way that's not disruptive of clinical care,” she explains.
Barriers ahead
But there are barriers to be overcome. “We want clinical trials to be simple, faster, and close to the real world, but it's hard to do that. Bringing a programmatic component into a clinical trial is hard, but that's the direction we want to go -- to combine clinical care with clinical research and the clinical trial,” says Xia Wang, Head of RWE Early Solutions, Global Real World Evidence and Digital Sciences, at UCB.
Wang believes that physicians play a key role in bringing clinical research into the clinical care world. She is concerned about motivating and supporting them, and providing them with data that is meaningful and which will help them make treatment decisions. “We need data that is really good and high quality data that we can trust as a good foundation to do that research,” she adds.
Another issue involves how some physicians may not trust the evidence and data because they don’t know how it’s being assimilated, or they believe that there are gaps in the data, according to Sajan Khosla, Executive Director, Head of Real World Evidence, at AstraZeneca.
“But once you start to iterate and cycle with the clinicians and show them where the gaps are and how the data can be used in real time…that erodes the barriers. Ultimately, that starts the conversation as to using those systems to help us in different dynamics. This is the opportunity that we have to start to erode the barriers,” he adds.
Becnel concurs with Khosla that many physicians do not trust the data. She indicates that establishing a set of standards around RWE and data would give them more confidence that RWE and data can be trusted.
Becnel also is concerned that many of the data elements that are needed aren't necessarily now used in care. “For research in oncology, we desperately care about things like progression and response, as do physicians. But not in every system are those things collected as independent and unique, discrete data. They're in images and other forms of data.”
Structure key elements
Researchers rely on human beings, automation, and natural language processing to power the deep review of medical records to gather those data elements, according to Becnel. It would be helpful to structure the key elements that are going to be drivers of research outcomes, while at the same time helping physicians understand their own patient outcomes, without disrupting the workflow.
Becnel indicates that a coalition comprised of physicians with available time, scientists, and other cross-functional parties who share an end goal of improving the health lives of patients, could work together to get the right processes in place.
Charting challenges
Lott believes that charting also is an issue. “Unfortunately, the chart became as much about supporting billing as it was charting accurate information. I certainly understand the skepticism that folks have with respect to data, knowing in real time that you have lower fidelity data.”
He says biopharmaceutical companies should partner with other health care system stakeholders to identify the barriers that physicians, care givers, and patients are facing, and to better understand the diffusion of technology. They could play an important role in helping to adopt common data standards, deploying technology to the EMR, innovating in the chart, and capturing standardized data elements.
“We need to find a mechanism whereby these EMR systems are not seen as administrative systems, but as capabilities and tools to help them to have scaled care,” adds Khosla.
A vision needed
“We need to set up the framework. It seems like we're all tackling the same barriers from different angles,” says Khosla, who feels it’s important to determine an objective and vision as to how to use data for research and clinical purposes and ensure that physicians and researchers trust the data. “How do we make sure that we're incentivizing the use of data in a way that it can be utilized?” he asks.
Wang explains that it is important to understand the patient journey and disease progression, and that’s where RWE and data come into play. In the end, building trust, understanding, and collaboration between pharma and physicians will lead to new data and the greater use of technology that eventually may lessen a physician’s workload, she notes.
Lott indicates that physicians can be motivated and incentivized by feedback from patients and other stakeholders that can help physicians understand what type of care they’re delivering. It also would be helpful for physicians to see that the data will be used to understand disease better, who should be receiving therapy, and to tackle the pragmatic challenges facing physicians and other health care providers daily.
Working with individuals
But technology and automation alone may not always make RWE and data available to physicians, according to Becnel. Many times, it will require working with individuals on a one-on-one basis. Often it will require a mix of technology and individual support.
Lott sees opportunities in getting the attention of physicians by applying algorithms to real word data, for example from EMRs, for modeling purposes. The models might show the results for patients if they received alternative treatments or no treatment at all.
Biopharma should further calibrate clinical trials to reflect the real world for patients and physicians. “How can we deploy tokenization to have a seamless transition from the trial into the real world? That experience can be captured in a way that extends the external validity, generalizability, and transportability of these trial results,” Lott says.
“I think we can make intentional efforts to further that trust. Physicians will have a greater choice and more willingness to partner in innovative approaches which marry real world data with primary evidence generation and (clinical) trials,” Lott explains.
“That’s a new frontier. We’re seeing a confluence of regulatory changes, of the methods, the technology, the data standardization, and the algos (algorithms). Now we move on to see how we can further that trust at the physician level and take the next step in terms of how we're generating evidence,” Lott adds.
Primary Event:Précis:There is a vital need to involve physicians, build trust in real-world evidence (RWE), and promote collaboration among stakeholders for improved patient care and research efficacyPremium`:Freemium`:Channels:Webinar: Accelerate drug development through patient-centric innovation
Tue, 19 Dec 2023 18:45:21 -0000
Region:Channels:Description:Empower Patient-Centric Drug Development: Strategies to Accelerate Access and Engagement in Clinical Trials Your ability to engage patients dictates success and failure in your clinical trials. While steps have been taken to improve our patient involvement, we still struggle with recruitment issues around volume and diversity as well as active engagement in redesigning innovative trials andThumbnail:
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Audiences:A Commercial Accelerator: Generative AI's Most Immediate Impact on BioPharma
Tue, 26 Sep 2023 16:38:30 -0000
Description:In today's fast-moving market, the evolution of artificial intelligence (AI) is presenting unprecedented opportunities in life sciences to streamline processes, enhance engagement, and accelerate growth.Thumbnail:
Upload Type:Date:Thursday, September 21, 2023Top Event Content:Conventional AI detects a pattern and produces an output. Generative AI continually evolves an output through language. For life sciences, this opens up all sorts of opportunities across each stage of bringing a therapy to market -- whether that's reviewing research, designing a clinical trial or preparing data for regulatory submission and approval. The most immediate impact, however, could be found within a life sciences organization's commercial function. Roles within sales and marketing are ripe for augmentation and transformation due to the ability of large language models (LLMs) to dynamically generate content.
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Practical use cases that life sciences commercial teams can adopt to harness the full potential of generative AI in key areas, including customer care, marketing operations, sales force effectiveness, and creative and product design.
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- Ethical implications and regulatory challenges around implementing generative AI technologies in life sciences and strategies for responsible AI adoption.
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Tue, 05 Sep 2023 12:30:04 -0000
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Audiences:Webinar: Decipher the Blueprint for Your Clinical Development Transformation
Thu, 29 Jun 2023 17:14:41 -0000
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Tue, 30 May 2023 16:35:43 -0000
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Audiences:Webinar: Optimize CGT manufacturing to enable timely and affordable patient access
Fri, 17 Mar 2023 19:38:29 -0000
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Upload Type:Date:Thursday, December 1, 2022Top Event Content:It’s well known that the biggest barrier to CGT commercialization is growing cost. Structural complexities, combined with a lack of standardization across the industry drive up expense and threaten to price out the patients that need them most.
Hear from industry experts Martha Rook, Chief Technical Operations at Insitro; Craig Malzah, VP, Technical Operations at REGENXBIO; Alessandro Linciano, Site Manufacturing Science & Technology Head, Cell & Gene Therapy at Novartis and Thermo Fisher Scientific as they share their expert knowledge and insights.
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. Collaborate and share examples of GMP to establish industry-wide standardization and enable CGT usage as a frontline therapy
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. Partner with solution providers to identify pain points in the manufacturing process and strategize to remedy themexclude homepage:NoFREE WEBINAR: Tomorrow’s DCTs, today: Define your clinical trial strategy for patient-centric outcomes
Thu, 05 Jan 2023 11:33:17 -0000
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Pharma Europe 2023
Tue, 20 Sep 2022 12:07:08 -0000
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FREE WEBINAR: Drive environmental sustainability across biopharma to create meaningful, system-wide change
Tue, 20 Sep 2022 11:20:47 -0000
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Webinar: A new framework for equity: Medical communications’ role in addressing health disparities
Thu, 04 Aug 2022 12:00:35 -0000
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Upload Type:Date:Tuesday, June 14, 2022Top Event Content:Drive improved minority health outcomes with HCP education and targeted data gathering
While rapid flux has characterised our past few years of industry growth, so has mounting awareness of the significant health disparities and inequities compromising our healthcare systems.
In the face of unprecedented urgency and stakeholder buy-in, the onus is on pharma to ensure health outcomes are improved for all underserved patient populations. And with HCPs playing a critical role in reaching – or not reaching – minority communities, it’s our responsibility to work together to bring about a more equitable distribution of healthcare. From raising HCP awareness of minority patients’ barriers to healthcare, to capturing the right data to enable informed decision-making, and leveraging innovative technologies that pinpoint where support is needed most, a multi-pronged outreach strategy is essential to making a positive impact.
That’s why Reuters Events has convened industry experts from AstraZeneca, Johnson & Johnson, Pfizer and Healthcare Consultancy Group to share how you can elevate the conversation around health inequities and disparities and ensure health outcomes are improved across all underserved patient populations.
Join at 10am ET / 3pm BST / 4pm CET on Tuesday, June 14 to gain key learnings, including:
• Discover why health disparities and inequities should matter to the medical communications industry, and the role we all can play in addressing inequity
• Use data to identify health disparities, including access to healthcare, standard of treatments and care, and uneven health outcomes
• Deliver omnichannel education to raise awareness of health disparities among HCPs and better support those working in underserved patient communities
• Advocate for wider industry conversations around health inequities and identify solutions that will enable improved outcomes for minority groupsOur outstanding speaker line-up:
• Camille Hertzka, VP, Head of Oncology, US Medical, AstraZeneca
• Melissa Bishop-Murphy, JD, MBA, Senior Director and Co-Chair, Pfizer’s Multicultural Center of Excellence, Pfizer
• Shirley Sylvester, Senior Medical Director for Women's Health, Office of the Chief Medical Officer, Johnson & Johnson
• Moderator: Matt D’Auria, CEO, Healthcare Consultancy GroupThe webinar will also begin with a short presentation from:
• Luke Cole, Senior Vice President, Digital Strategy, Engagement Group
• Ruthline Laylor, PhD, Executive Director, Medical & Scientific Services, Chameleon
• Victoria Malek, MD, MSc PH, Physician & Senior Consultant in Global Market Access, Lumen Value & Accessexclude homepage:NoWebinar: Develop a robust medical congress strategy for the digital era
Thu, 04 Aug 2022 11:51:14 -0000
Region:Description:Utilize technological advancements, upscale your medical congress strategy and garner the most meaningful insights.Thumbnail:
Upload Type:Date:Wednesday, February 9, 2022Top Event Content:Utilize technological advancements, upscale your medical congress strategy and garner the most meaningful insights
Medical Affairs teams are taking a dramatic shift in the way they plan for conferences in 2022 and beyond. In an increasingly unpredictable post-pandemic world, MSLs are becoming more discerning over which conferences they attend and how much they travel. Many questions remain unanswered:
1. How can teams continue to gather meaning insights from conferences in a hybrid environment?
2. How can they meet new KOLs and DOLs to share important scientific information?
3. What is the best strategy to maximize engagement with HCPs and the different thought leaders?
Join Pfizer, Sanofi, Novartis and Within3 in this live webinar to learn:
• How technology can help teams develop a robust conference strategy for 2022 and help MSLs get the most out of congress
• How utilizing novel digital solutions will allow teams to capture and share actionable insights onsite, extending the impact MSLs make at annual congresses
• Plan early! Develop an engagement plan ahead of congresses by knowing what you want to MSLs to achieve and in turn extract the richest insights for your HCPs
• Identifying the best KOLs in a digital era to allow us to best structure the collection of insightsexclude homepage:NoWebinar: Build a fully integrated omnichannel strategy to facilitate a cohesive company face
Thu, 04 Aug 2022 10:45:26 -0000
Region:Description:Empower marketing and commercial teams to adopt the capabilities needed to close the feedback loop.Thumbnail:
Upload Type:Date:Wednesday, July 13, 2022Top Event Content:Empower marketing and commercial teams to adopt the capabilities needed to close the feedback loop
While everyone likes to claim that they are shifting to omnichannel marketing, we all know that it isn't as simple as it seems. With so many challenges ahead of us, from integrating fieldforce insights to automated next best action in digital marketing, there's a lot to focus on when orchestrating every customer touchpoint into one strategy.
With the needs and wants of our customers changing, it is vital that we empower our marketing and commercial teams to adopt the capabilities needed to close the feedback loop.
In this panel discussion, Merck, AstraZeneca, Takeda and Gilead will delve into the following business-critical topics:
• Orchestrate every customer touchpoint with a data-driven strategy to create a seamless customer journey
• Use your data to provide insights needed to maximize the value sales reps provide with their interactions with HCPs
• Close your feedback loop and use this to predict a visionary journey for your ideal HCP
• Create a top-down and bottom-up strategy that empowers every digital and in person channel
• Create a culture that is comfortable to fail fast, allowing for agility in your approach towards the evolving market
exclude homepage:NoWebinar: Healthcare’s next big wave: Why everyone should be thinking about cell and gene therapy
Thu, 04 Aug 2022 10:40:08 -0000
Region:Description:Survey the impact of CGT market growth on the healthcare system, HCP referrals and wider pharma.Thumbnail:
Upload Type:Date:Wednesday, June 29, 2022Top Event Content:Survey the impact of CGT market growth on the healthcare system, HCP referrals and wider pharma.
Despite its novelty, cell and gene therapy is already sending shock waves across pharma. The innovative technology it employs promises many patients with debilitating illnesses a cure, and for this reason, many hope CGT will soon become a frontline therapy. Yet as more products gain approval quickly and the industry expands, navigating the CGT space will bring critical challenges. While market access and commercialization teams with a lack of experience in the space struggle to stabilize and scale up delivery networks, access and reimbursement models, the healthcare system will need to adjust to the operational toll of expansion.
So, what can pharma do to avoid this functional disaster? CGT companies must stay diligent, adapt to a saturated market and learn how to stand out from their competitors to avoid getting left behind and ensure patients benefit from all of CGT’s potential gains.
That’s why Reuters Events are convening experts from ASC Therapeutics, bluebird bio, Iovance and Legend Biotech to ensure you’re prepared for the future of CGT expansion. Join our exclusive discussion on the 29th June at 10am EST to gain vital insights on their predictions for what the cell and gene market will look like upon its expansion and how this will alter other elements of pharma at large to create a new future for CGT.
Learnings will include:
• How to utilize cell and gene therapy industry forecasting to accommodate for and aid the process of internal scalability and upgrading commercial skillsets.
• What both people within and outside the industry, such as hospitals, treatment centers and CMO’s, will have to do to prepare to ensure they’re able to adapt to the changing shape of pharma so they don’t get left behind.
• What indicators industry leaders use to measure sector success and how the predicted growth of the advanced therapy sector will influence healthcare providers, referrals, and pharma at large
• Explore what the future of CGT may mean for your commercial, market access, medical affairs, manufacturing, regulatory or reimbursement role in traditional pharma and understand how industry change will affect your day-to-day tasks.exclude homepage:NoWebinar: Data: The Rx to faster drug discovery and patient-centered clinical trials
Thu, 04 Aug 2022 10:31:57 -0000
Region:Description:Reduce barriers to gathering and analyzing clinical trial data with cutting-edge data solutions for faster drug discovery and a patient-centric experience.Thumbnail:
Upload Type:Date:Wednesday, June 22, 2022Top Event Content:Reduce barriers to gathering and analyzing clinical trial data with cutting-edge data solutions for faster drug discovery and a patient-centric experience
Despite advances in scientific research and medical technology, the clinical trials process has become slower and more expensive over the last decade. As the amount of data grows at an exponential rate, a cloud-based data foundation has been key to transforming the drug discovery process and enabling a more diverse, patient-centric trial experience.
Join our latest Reuters Events webinar with Google Cloud, Novartis, AMPEL, Asklepios and Pfizer to learn how data-driven innovation is reshaping clinical trials and paving the way towards faster drug discovery, more diverse patient enrolment and improved patient retention.
Key learnings include:
- How the increased digitalization of patient healthcare data may help to improve health with high-quality real-world evidence and more effective clinical trials.
- How to enable decentralized clinical trials with scalable RWE and collaboration solutions.
- How to enable patient-reported data in a regulatory-compliant manner through cloud technology
- Methods to efficiently store, de-identify, aggregate, and analyze complex data sets across clinical trial sites.exclude homepage:NoWebinar: Your 24-month blueprint for launch success 02/06/2022
Thu, 04 Aug 2022 09:47:12 -0000
Region:Description:Establish a new strategy for an effective end-to-end launch campaign through early conversations with key stakeholders.Thumbnail:
Upload Type:Date:Thursday, June 2, 2022Top Event Content:Bringing a new product to market is complex, and launching in a new market is even more so. Within the post pandemic environment, there is a lot we can do to virtually to ensure effective drug establishment and distribution, from out-licensing, partnerships, virtual ad boards to engaging with payers and customers. Hence, opportunities to execute an effective product launch is within your reach.
To secure a successful commercialization strategy, we must educate, motivate and communicate with all stakeholders from across the launch journey, to maximize launch impact. Whether you're launching into familiar or unfamiliar markets, engaging key decision makers must happen as early as possible, in order to navigate the regulatory and market access landscape. From pre to post product commercialization, we must build relationships, drive new collaborations and leverage launch synergies to streamline product reviews and ensure appropriate uptake.
In this session the panel we will explore the key decisions that pharmaceutical companies should be considering early in the product journey, to ensure a successful end-to-end launch campaign.
Business-critical insights from Merck, CSL Behring, Takeda and Innomar Strategies include:
• Effectively navigate the complexity around regulatory and market access submissions to execute a product launch campaign on time
• Discuss various approaches for salesforces to adapt to different launch strategies, in a virtual environment, to create more agile and versatile commercial models
• Leverage RWE generation for use in health technology assessments to optimize access
• Upscale your Patient Support Strategies (PSP) and logistics models to support your molecule and its lifecycle, through an integrated digital and human PSP model
• Review a real-life Canadian case study illustrating how to unlock your product potential upon regulatory approval and commercializationexclude homepage:NoAudio / Video File:Webinar: Targeting, attention and retention Maximize customer engagement (Acxiom), 29th March
Thu, 04 Aug 2022 09:40:40 -0000
Region:Description:Find your competitive advantage through future proofed commercial objectives, data interoperability, and ROI on investment.Thumbnail:
Upload Type:Date:Tuesday, March 29, 2022Top Event Content:Find your competitive advantage through future proofed commercial objectives, data interoperability, and ROI on investment
As pharma adopt a more customer-centric approach to market differentiation, the individual preferences of HCPs are more important than ever. However, as expectations have evolved so too have our challenges, and our competitors.
From aligning data sources to micro-segmentation, engagement mapping, and customer profile optimisation, we need to keep on top of both cultural and capability requirements if we are going to capture limited HCP attention, prove ROI and deliver senior buy-in.
But how?
Join Sanofi, Novartis, Novo Nordisk, Sitecore and FCB Health as they explore how to unify sources through a 1st party data platform, optimise customer profiles and build a deeper understanding of HCP preferences to enable hyper-segmentation, automation, and real-time targeting:
• Foster a culture of customer-centricity: Empower your team with the soft and technical skills needed to deliver industry-leading digital engagement
• Align legacy data sources, enable cross-functional omnichannel strategy and apply AI, ML and predictive modelling for deeper customer understanding
• Implement process-first personalisation: Optimise your business intelligence through complete campaign monitoring to exceed your digital goals
• Prove project value: Develop lean, targeted, and orchestrated campaigns with clear KPIs that deliver tangible ROI
exclude homepage:NoWebinar: Patient services connected and simplified, 10th March 2022
Thu, 04 Aug 2022 09:32:09 -0000
Region:Description:Patient services done right hold the promise of increased adherence and better health outcomes. Yet despite increased investment, fragmented execution, often by brand or by service, has led to gaps in delivery of patient value. Patient and data led design and implementation present an opportunity to elevate your patient services to meet their needs while also capturing value of this investment.Thumbnail:
Upload Type:Date:Thursday, March 10, 2022Top Event Content:Design for the patient and architect for flexibility while meeting data privacy and compliance needs
Patient services done right hold the promise of increased adherence and better health outcomes. Yet despite increased investment, fragmented execution, often by brand or by service, has led to gaps in delivery of patient value. Patient and data led design and implementation present an opportunity to elevate your patient services to meet their needs while also capturing value of this investment.
Join Novartis, Otsuka, Travere Therapeutics and Salesforce to learn how big pharma and smaller biotech are reimagining their patient services strategies and re-structuring to lead to a more effective function.
You’ll learn how to:
• Look more holistically at your patient services strategy to ensure you go beyond basic support to improve experience and ultimately adherence
• Overcome challenges in compliance-driven patient support services, including design of programs around the patient, restructuring teams and avoiding commercial influence
• Harness patient data for improved visibility of the patient journey to better identify adherence gaps and create opportunities to provide better support to patients
exclude homepage:NoAudio / Video File:Webinar: Novel co-creation for novel trial design How co-creation with differs within DCTs and Traditional trials 26th Jan 2022
Thu, 04 Aug 2022 09:19:43 -0000
Region:Description:Engaging with participants to influence clinical research design is the standard for industry innovators. Our ability to gain participant feedback in design, throughout the life of the study and at close-out is a way our industry can “be,” not just “say,” we are patient-centric.Thumbnail:
Upload Type:Date:Wednesday, January 26, 2022Top Event Content:Accelerate recruitment, increase retention, and ensure diversity with DCT optimized co-creation
Engaging with participants to influence clinical research design is the standard for industry innovators. Our ability to gain participant feedback in design, throughout the life of the study and at close-out is a way our industry can “be,” not just “say,” we are patient-centric.
This approach is available to our industry and being utilized today to enhance traditionally designed and decentralized research studies. The benefits are obvious, but the solutions have historically been challenging to collect, listen to and incorporate. That is now changing via the intersection of participant engagement science, decentralization, and digital technologies.
This session will explore how you can utilize this approach to differentiate your research study and be patient-centric.
Join LEO Pharma, Sanofi, THREAD, Modus Outcomes, People with Empathy (patient advocacy), and InVibe as they discuss:
• How co-creation differs in traditional design versus decentralized clinical studies
• Operational approaches to gain and implementing feedback in design
• How to gather and implement iterative patient feedback in ongoing trial design
• Balance patient, caregiver, and healthcare system requirements to ensure retention and diversity
• Understand how patients value and assess novel endpoints in studies
exclude homepage:NoFREE WEBINAR: The Vaccine Potential
Fri, 08 Jul 2022 15:44:12 -0000
Event Date:Thu, 2022-08-18Event URL:Event Location:History:Number of attendees:500Programme URL:Brochure URL:Speakers URL:Purchase Recording URL:Event Organiser:Natalie Diaz-MartinEvent Organiser E-mail:Précis:Reveal the potential that vaccines possess in preventing cancersEntire Month Duration:NoEvent Image:
FREE Webinar: Build a fully integrated omnichannel strategy to facilitate a cohesive company face
Mon, 20 Jun 2022 10:51:45 -0000
Event Date:Wed, 2022-07-13Event Location:History:Number of attendees:700Programme URL:Brochure URL:Speakers URL:Purchase Recording URL:Event Organiser:Kana HuttonEvent Organiser E-mail:Précis:Empower marketing and commercial teams to adopt the capabilities needed to close the feedback loopEntire Month Duration:NoEvent Image:
Audiences:FREE WEBINAR: A new framework for equity: Medical communications’ role in addressing health disparities
Mon, 06 Jun 2022 12:14:29 -0000
Event Date:Tue, 2022-06-14Event Location:History:Number of attendees:700Programme URL:Brochure URL:Speakers URL:Purchase Recording URL:Event Organiser:Hannah BradyEvent Organiser E-mail:Précis:Drive improved minority health outcomes with HCP education and targeted data gatheringEntire Month Duration:NoEvent Image:
FREE WEBINAR: Boost productivity and talent retention to thrive with gold standard wellbeing practices
Mon, 30 May 2022 10:05:26 -0000
Event Date:Tue, 2022-06-07Number of attendees:700Event Organiser:Joana BuchholzEvent Organiser E-mail:Précis:Discover how caring for employee wellbeing and embedding mindful business practices are the key to productivity and a company's success.Entire Month Duration:NoEvent Image:
Ethris reports positive phase 1 results for asthma mRNA therapy
Thu, 30 Jan 2025 15:55:21 -0000
Ethris announces promising phase 1 results for ETH47, its mRNA therapy for uncontrolled asthma. The inhaled treatment showed strong safety and efficacy, with plans for a phase 2 trial in 2025.Lantheus to acquire Evergreen in $1bn deal to expand radiopharmaceutical pipeline
Thu, 30 Jan 2025 11:01:29 -0000
Lantheus is acquiring radiopharmaceutical CDMO Evergreen Theragnostics in a deal worth up to $1 billion, expanding its manufacturing capabilities and drug pipeline. The acquisition includes Octevy, a PET imaging agent for neuroendocrine tumors, pending FDA approval.Women in Science: Émilie Barré on her passion for applying data to real-world challenges
Tue, 28 Jan 2025 16:53:47 -0000
Throughout her career, One2Treat’s Émilie Barré has focused on developing both the analytical and leadership aspects necessary for success in the field.Manas AI bags $24.6 million to turbocharge drug discovery
Tue, 28 Jan 2025 15:02:49 -0000
Manas AI secures funding led by General Catalyst to scale AI-driven drug discovery, tackling cancer and rare diseases.Novo Nordisk’s next-generation obesity drug shows promise in early clinical trials
Tue, 28 Jan 2025 14:25:46 -0000
Novo Nordisk’s amycretin shows 22% weight loss over 36 weeks, potentially surpassing Eli Lilly’s Zepbound. Further trials are planned.Arctic Therapeutics to tackle dementia and skin disease with €26.5 million series A
Thu, 23 Jan 2025 14:41:36 -0000
Arctic therapeutics raises funding from EIC Fund, Kaldbakur, and Sanos Group to advance its dementia treatment, AT-001, and acne drug, AT-004. The company aims to transform the treatment landscape for rare diseases and skin conditions, including Alzheimer's and acne vulgaris.The largest pharma acquisitions of 2024
Thu, 23 Jan 2025 14:21:47 -0000
From Novo Holding's purchase of Catalent to BMS's Karuna acquisition, here are 10 of the most significant M&A moments of 2024.Bridgewest merges portfolio Australian CDMOs
Tue, 21 Jan 2025 14:36:06 -0000
Australian CDMOs, BioCina and NovaCina, have merged in a move to pool their biologic and small molecule production expertise and infrastructure.Novo Nordisk reports positive results for high-dose Wegovy formulation
Tue, 21 Jan 2025 14:23:14 -0000
Results from Novo Nordisk's STEP UP trial show that a high-dose formulation of Wegovy can significantly increase the weight loss effects the drug is known for.Regulatory bodies placing more importance on patient centricity, says pharma executive
Mon, 20 Jan 2025 15:02:49 -0000
We ran a Q&A with John Clarke, associate director in patient recruitment at Innovaderm on the changing landscape of patient centricity in terms of clinical trials and how the industry can navigate the evolving regulatory expectations around it.Lindus Health: AI instrumental for predicting trial outcomes and shaping study design
Mon, 20 Jan 2025 14:42:22 -0000
We ran a Q&A With Michael Young, co-founder of Lindus Health on the challenges of 2024 and the company’s goals for 2025.SCOPE 2025: Spotlight on clinical trial technology
Fri, 17 Jan 2025 14:30:15 -0000
Advarra conducted a survey of sites, sponsors, and CROs that revealed three biggest barriers to stakeholder collaboration: communications, staffing, and technology.Transforming research through patient-centric design and innovation
Thu, 16 Jan 2025 16:10:32 -0000
Driving Innovation in Clinical Trials: Patient Perspectives and Multidimensional AssessmentsOvercoming clinical trial obstacles with AI: WCG’s outlook for SCOPE 2025
Thu, 16 Jan 2025 15:39:58 -0000
Explore WCG's cutting-edge AI and tech solutions, including ClinSphere Total Enrollment, transforming clinical trials at SCOPE 2025.Decentralized clinical trials take the spotlight at SCOPE 2025
Thu, 16 Jan 2025 15:21:19 -0000
Discover Medable's latest advancements in decentralized clinical trials, including AI-driven tools and enhanced eCOA solutions, at SCOPE 2025.Scope Summit finalists to fight for awards in site innovation and patient engagement
Tue, 14 Jan 2025 15:47:23 -0000
Spotlighting innovation at the SCOPE Summit, finalists for the Site Innovation and Patient Engagement Awards showcase groundbreaking tools, AI solutions, and diversity-driven initiatives set to transform clinical trials.Johnson & Johnson acquires Intra-Cellular for $14.6bn
Tue, 14 Jan 2025 15:28:58 -0000
Johnson & Johnson's $14.6bn acquisition of Intra-Cellular Therapies adds Caplyta and a robust pipeline targeting major neuropsychiatric disordersVerdiva Bio launches with $411m in funding to advance obesity drugs
Thu, 09 Jan 2025 15:42:56 -0000
Newly launched company, Verdiva Bio, is aiming to advance oral and injectable drugs for obesity, with it backed by an oversubscribed Series A financing round of $411m.India’s Anthem Biosciences plans $397m IPO
Thu, 09 Jan 2025 14:21:53 -0000
India's Anthem Biosciences is planning to raise $397m in an initial public offering (IPO).Denali Therapeutics’ ALS drug fails to improve function and survival in phase 2/3 trial
Tue, 07 Jan 2025 14:15:46 -0000
Denali Therapeutics' DNL343 fails to slow ALS progression in phase 2/3 trial but shows safety and offers insights for future analysis.
