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Source: https://journalforclinicalstudies.com/feed/

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<title>CPHI Frankfurt Pharma Awards 2025 Finalists Announced</title>
<link>https://journalforclinicalstudies.com/cphi-frankfurt-pharma-awards-2025-finalists-announced/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 18 Sep 2025 12:59:41 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
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<description><![CDATA[Hundreds of entries received across 14 categories showcasing innovation, sustainability, and leadership in pharma. Informa Markets, has today announced the shortlist for the CPHI Pharma Awards 2025, recognising outstanding achievements across pharmaceutical innovation, manufacturing, sustainability, leadership and women in pharma. The awards spotlight the companies and individuals pushing the boundaries of science and technology to […]
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/cphi-frankfurt-pharma-awards-2025-finalists-announced/">CPHI Frankfurt Pharma Awards 2025 Finalists Announced</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
]]></description>
<content:encoded><![CDATA[
Hundreds of entries received across 14 categories showcasing innovation, sustainability, and leadership in pharma. 
Informa Markets, has today announced the shortlist for the CPHI Pharma Awards 2025, recognising outstanding achievements across pharmaceutical innovation, manufacturing, sustainability, leadership and women in pharma.
The awards spotlight the companies and individuals pushing the boundaries of science and technology to advance global healthcare.
The CPHI Pharma Awards finalists for 2025 include innovators redefining everything from synthetic biology and AI-powered formulation to patient access, circular packaging, and leadership in rare diseases, spotlighting the most transformative work happening in the industry today. This year’s shortlist also celebrates the next generation of pharmaceutical changemakers through the Future Leader and Women in Pharma categories, spotlighting individuals whose impact and vision are reshaping the industry from within.
“We’ve been incredibly impressed by the quality, originality, and ambition of this year’s submissions. Across every category, the finalists are setting new standards in pharmaceutical innovation, sustainability, and patient impact. The CPHI Pharma Awards are a vital platform to spotlight the progress shaping the future of our industry. We’re looking forward to celebrating these achievements and announcing the winners on the opening day of CPHI Frankfurt.” Tara Dougal, CPHI Event Director, Informa Markets. The winners will be revealed during an exclusive networking reception on October 28 – the opening day of <a href="https://www.cphi.com/europe/en/home.html?utm_source=press-release&utm_medium=referral&utm_campaign=hln25cpw-cl-launch-release" target="_blank" rel="noopener">CPHI Frankfurt 2025</a>, held at Messe Frankfurt from October 28–30. Finalists by Category
The full list of 2025 finalists is available by category below. Further information on each finalist can be found <a href="https://www.cphi.com/europe/en/cphi-celebration/awards.html" target="_blank" rel="noopener">here</a>:
API Development and Innovation
<ul class="wp-block-list">
<li>Lonza: Design2Optimize(<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" />)</li>
<li>CMAC: From Crystallisation to tablet: A scalable Platform for API Agglomeration.</li>
<li>Merck KgaA: mPredict Co-crystal Prediction Service</li>
<li>CordenPharma International: TAPS: TAG Assisted Peptide Synthesis. </li>
</ul>
Accelerating Innovation
<ul class="wp-block-list">
<li>NunaBio Ltd: Custom, cell-free, synthetic DNA</li>
<li>TriLink Biotechnologies: GMP-Grade CleanCap® M6 Analog</li>
<li>Covestro Deutschland AG: Mono-Material Drug Delivery Demonstrator</li>
<li>Accord Healthcare: Orgovyx – Transforming prostate cancer care</li>
<li>Invengene Private Limited: Room temperature-stable generic Posaconazole InjectionUsing Hydroxypropyl beta-cyclodextrin  (HPβCD)</li>
<li>Prestige BioPharma: Ullenistamab: A Targeted MAB for pancreatic cancer. </li>
</ul>
At the Heart of Pharma
<ul class="wp-block-list">
<li>Accord Healthcare: A decade of impact with International Health Partners (IHP)</li>
<li>PharmEvo Pvt. Ltd: Elevating patient safety through intelligent design</li>
<li>Strides: Enhancing access to affordable healthcare – HIV</li>
<li>Farmak International: Resilient by Design: Farmak Group’s Ukrainian-rooted pharma network blueprint for crisis-proof global supply</li>
<li>CNX Therapeutics and the Social Mobility Foundation: Talent without barriers. </li>
</ul>
CEO of the Year
<ul class="wp-block-list">
<li>Bobby Sheng: Bora Pharmaceuticals</li>
<li>Deepak Bahri: Sentiss Pharma</li>
<li>Hanns-Christian Mahler: ten23 health</li>
<li>Lars Petersen: FUJIFILM Diosynth Biotechnologies</li>
<li>Lisa Soyeon Park: Prestige Biopharma</li>
<li>Michael Quirmbach: CordenPharma International. </li>
</ul>
Drug Delivery and Device Innovation
<ul class="wp-block-list">
<li>Azelis Group NV: Advanced Peristomal Barrier & Adhesion Cream </li>
<li>SHL Medical: Maggie® Mix: A dual-chamber autoinjector with Needle Isolation Technology (NIT®)</li>
<li>LTS Lohmann Therapie Systems AG: Launching the first biosimilar in an on-body injector</li>
<li>Ypsomed: Uniting sustainability and patient convenience in self-injection devices. </li>
</ul>
Finished Formulation
Roquette: ReadiLYCOAT® Plant-Based Coating Systems for enhanced oral dosage solutions
Zerion Pharma A/S: Dispersome® technology
Evonik Industries AG: EUDRACAP® colon: The world’s first functional ready-to-fill capsule for oral drug delivery to target the ileo-colonic region
CrystecPharma: Modified Supercritical Anti-Solvent (mSAS®) particle engineering for stabilisation of biomolecules 
Lonza Capsules & Health Ingredients: Innovaform® Innovation and formulation accelerator.
Future Leader
<ul class="wp-block-list">
<li>Jakub Knurek: Mabion</li>
<li>Mark Kelada: Nelipak Laboratory Services</li>
<li>Mohammad Farahani: CinnaGen</li>
<li>Yolanda Gomez: Esteve CDMO</li>
<li>Yuvansh Khokhani:YSK Laboratories Pvt Ltd. </li>
</ul>
Manufacturing Excellence
<ul class="wp-block-list">
<li>Coriolis Pharma Research GmbH: Advanced lyophilization modelling</li>
<li>Enzene: EnzeneX<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" />: Fully-connected continuous manufacturing<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /></li>
<li>Bausch+Ströbel SE + Co. KG: GENEX, robotic, modular aseptic fill-finish platform</li>
<li>VectorBuilder: VectorBuilder’s gene drug manufacturing platform. </li>
</ul>
Packaging and Machinery
<ul class="wp-block-list">
<li>SCHOTT Pharma: SCHOTT TOPPAC® infuse – the next generation IMA LIFE: TILE-X: New generation gloveless aseptic fill-finish system</li>
<li>H&T Presspart: Vytal® innovative RTU snap-fit closure.</li>
</ul>
 Start-Up Initiative
<ul class="wp-block-list">
<li>Green Elephant Biotech: CellScrew®</li>
<li>NunaBio Ltd: Custom:  Cell-free, synthetic DNA – including high complexity sequences, multi kilobase length and milligram scale – made in days to weeks</li>
<li>NovoArc GmbH: Lipids for innovative drug formulation</li>
<li>ORYL Photonics: ORYL F1.</li>
</ul>
 Supply Chain Excellence
<ul class="wp-block-list">
<li>Cryoport Systems: Integrated end-to-end supply chain platform</li>
<li>Occam Systems: Resilient chemical supply chains, supercharged by AI</li>
<li>QYOBO GmbH: QYOBO platform</li>
<li>TraceLink: TraceLink Orchestration Platform for Universal Solutions (OPUS). </li>
</ul>
Sustainability
<ul class="wp-block-list">
<li>Celtic Renewables: Leading the Green Chemical Revolution, transforming industrial by-products into high-value green chemicals.</li>
<li>Enantios: Enantios platform – Enabling fast, label-free chiral analysis in solution</li>
<li>Avantor: J.T.Baker® Viral Inactivation Solution – Environmentally safer detergent for virus removal in bioprocessing</li>
<li>AustinPx: KinetiSol<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Technology, a solvent-free, fusion-based technology that transforms poorly soluble drugs into high-bioavailability formulations</li>
<li>Kindeva: Leading the way in next-generation propellants (NGPs) -commercial-ready capabilities in HFA152a and HFO1234ze propellants.</li>
<li>Alliance to Zero: Lean, Green and Secure, aregulatory-ready, blister-free, syringe solution</li>
<li>Huhtamaki: Omnilock<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Ultra PAPER</li>
<li>Botanical Solution Inc. (BSI): Sustainability Grows on Trees: Producing QS-21, the Gold Standard vaccine adjuvant. </li>
</ul>
Woman of the Year
<ul class="wp-block-list">
<li>Adriana Kiędzierska-Mencfeld, Polpharma Biologics</li>
<li>Christiane Bardroff, Rentschler Biopharma</li>
<li>Dr. Ivy Gao, Sunresin </li>
<li>Jennifer Gattari, Pfizer CentreOne</li>
<li>Jonina Gudmundsdottir, Coripharma</li>
<li>Meeta Gulyani, Ecolab Life Sciences.</li>
</ul>
ENDS
 About Informa Markets
Informa Markets creates platforms for industries and specialist markets to trade, innovate, and grow. As part of Informa PLC, it delivers more than 450 B2B events annually across key sectors including healthcare, life sciences, construction, and fashion. The company’s mission is to foster global communities, enabling meaningful connections and commercial success.
<h3 class="wp-block-heading">To learn more about CPHI Frankfurt, visit the website <a href="https://www.cphi.com/europe/en/home.html" target="_blank" rel="noopener">here</a></h3>
<h3 class="wp-block-heading"><a></a>Media Contact:</h3>
Aranda Rahbarkouhi ramarketing aranda@ramarketingpr.com
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/cphi-frankfurt-pharma-awards-2025-finalists-announced/">CPHI Frankfurt Pharma Awards 2025 Finalists Announced</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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<item>
<title>The Scope of Things: A Global Movement to Cure Multiple Myeloma</title>
<link>https://journalforclinicalstudies.com/the-scope-of-things-a-global-movement-to-cure-multiple-myeloma/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 18 Sep 2025 12:39:21 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25097</guid>
<description><![CDATA[Multiple myeloma is a rare and often fatal blood cancer that has long stood as one of oncology’s most stubborn challenges. In this month’s episode of The Scope of Things podcast, Joseph Mikhael, chief medical officer of the International Myeloma Foundation (IMF), discusses how the Black Swan Research Initiative (BSRI), a global scientific alliance dedicated to […]
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/the-scope-of-things-a-global-movement-to-cure-multiple-myeloma/">The Scope of Things: A Global Movement to Cure Multiple Myeloma</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
]]></description>
<content:encoded><![CDATA[
Multiple myeloma is a rare and often fatal blood cancer that has long stood as one of oncology’s most stubborn challenges. In this month’s episode of <a href="https://www.scopesummit.com/scope-of-things/myeloma-research-on-a-global-scale-with-joseph-mikhael" target="_blank" rel="noopener">The Scope of Things podcast</a>, Joseph Mikhael, chief medical officer of the International Myeloma Foundation (IMF), discusses how the Black Swan Research Initiative (BSRI), a global scientific alliance dedicated to finding a cure for multiple myeloma and global collaborators are making strides in multiple myeloma research and prevention efforts.
A Global Effort 
The BSRI’s goal is to improve treatment incrementally, as well as to harmonise standards, share data, and collectively pursue strategies that could make curing multiple myeloma a realistic objective. One of the initiative’s most notable achievements is the global standardisation of Minimal Residual Disease (MRD) testing. By identifying tiny numbers of cancer cells that remain after treatment, MRD serves as a highly sensitive barometer of patient response. Standardised MRD assays allow researchers across continents to compare results and trial outcomes with precision.
“If every country did it differently, we’d be… [unable] to communicate clearly with each other,” comments Mikhael. “And so, the unanimity of MRD was born.” 
Perhaps the most ambitious project to date is the Iceland Screens, Treats, or Prevents Multiple Myeloma (iStopMM) trial, the first nationwide effort to study precursor conditions to multiple myeloma. Every Icelander over the age of 40 was invited to participate in the study, totaling over 80,000 participants—more than half of the population. The participants underwent blood screening for early warning signs, such as monoclonal gammopathy of undetermined significance (MGUS). The trial generated a dataset on how multiple myeloma develops, offering valuable clues about which patients are most likely to progress and how interventions might prevent full-blown disease.
Global collaborators have also made great contributions to the project. Spain has led advances in flow cytometry, a core MRD. Australia has pioneered non-invasive blood-based approaches for disease detection. Singapore has spearheaded coordination through the Asian Myeloma Network, which consists of 10 countries. In Latin America, researchers are expanding access to trials and therapies in resource-limited settings. The U.S., home to the IMF, functions as a hub for education, clinical trial infrastructure and pharmaceutical development.
While a cure remains elusive, the BSRI envisions a future where early detection, precise therapies, and global collaboration make finding a cure for multiple myeloma possible.  
To learn more about the BSRI and the latest news on ChatGPT’s role in trial eligibility screening, a new no-nausea weight loss treatment, and more, listen to the newest episode of <a href="https://www.scopesummit.com/scope-of-things/myeloma-research-on-a-global-scale-with-joseph-mikhael" target="_blank" rel="noopener">the Scope of Things</a>. 

The post <a rel="nofollow" href="https://journalforclinicalstudies.com/the-scope-of-things-a-global-movement-to-cure-multiple-myeloma/">The Scope of Things: A Global Movement to Cure Multiple Myeloma</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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<title>Next-Gen IRB Review Is Here: WCG ClinSphere™ eReview Manager Drives Transformative Efficiencies, Accelerates Clinical Research</title>
<link>https://journalforclinicalstudies.com/next-gen-irb-review-is-here-wcg-clinsphere-ereview-manager-drives-transformative-efficiencies-accelerates-clinical-research/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 18 Sep 2025 12:27:13 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25095</guid>
<description><![CDATA[WCG, a global leader in providing solutions that measurably improve and accelerate clinical research, today announced the launch of WCG ClinSphere™ eReview Manager, a breakthrough solution purpose-built to simplify Institutional Review Board (IRB) submission and review processes. As the market leader in speed, agility and quality, this addition to the WCG ClinSphere technology platform streamlines workflows, […]
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/next-gen-irb-review-is-here-wcg-clinsphere-ereview-manager-drives-transformative-efficiencies-accelerates-clinical-research/">Next-Gen IRB Review Is Here: WCG ClinSphere™ eReview Manager Drives Transformative Efficiencies, Accelerates Clinical Research</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
]]></description>
<content:encoded><![CDATA[
WCG, a global leader in providing solutions that measurably improve and accelerate clinical research, today announced the launch of <a href="https://www.wcgclinical.com/technologies/ereview-manager/" target="_blank" rel="noopener">WCG ClinSphere<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> eReview Manager</a>, a breakthrough solution purpose-built to simplify Institutional Review Board (IRB) submission and review processes. As the market leader in speed, agility and quality, this addition to the WCG ClinSphere technology platform streamlines workflows, enhances real-time collaboration and ensures the highest quality reviews — all within a single, modern and intuitive user interface.
ClinSphere eReview Manager is redefining IRB review for sponsors, CROs and sites, delivering: 
<ul class="wp-block-list">
<li>A 23% reduction in time spent entering submission information. </li>
<li>Up to 30% faster processing via an in-application collaboration hub enabling communications from one place.  </li>
<li>Elimination of up to 80% of document download time. </li>
<li>Seamless, centralised workspace for all review activities. </li>
</ul>
By fusing WCG’s legacy of ethical oversight and quality service with next-generation digital innovation, ClinSphere eReview Manager creates a singular, streamlined experience: WCG’s IRB team comprised of hundreds of board members and experts leverage advanced technology to deliver seamless seven-day-a-week service, while clients advance their clinical review process within a transparent, collaborative platform. This powerful blend of expertise and tech-enabled efficiency streamlines every aspect of the review process, allowing research teams to drive transformative outcomes for patients faster.
“WCG ClinSphere eReview Manager represents a bold step forward in our mission to empower the clinical research community with next-generation, technology-enabled solutions,” said Sam Srivastava, chief executive officer, WCG. “By consolidating IRB submission and expert review into an intuitive, collaborative and data-driven experience, we are setting a new standard for efficiency, safety and speed — enabling sponsors, CROs and sites to bring innovative therapies to patients sooner.”
“ClinSphere eReview Manager’s robust, user-friendly technology empowers clients to manage studies efficiently, focusing on patient care and high-quality research conduct. It seamlessly combines workflow efficiency, communication and actionable insights to address the most pressing challenges faced by clinical research teams today,” said Matt Staves, senior vice president, Operations, WCG. “Our clients can expect a transformational shift in their IRB review process — with fewer administrative hurdles, accelerated timelines and a streamlined user experience supported by WCG’s renowned expertise.”
For more information about WCG ClinSphere eReview Manager and how it can transform your IRB submission experience, visit <a href="https://www.wcgclinical.com/technologies/ereview-manager/" target="_blank" rel="noreferrer noopener">https://www.wcgclinical.com/technologies/ereview-manager/</a> or connect with our experts at upcoming industry events: 
<ul class="wp-block-list">
<li>September 16–17 at DPHARM, Booth 100 </li>
<li>September 28–October 1 at Global Site Solutions Summit, Booth 801 </li>
<li>October 14–15 at SCOPE Europe, Booth 49 </li>
<li>October 15–16 at Outsourcing in Clinical Trials New England 2025, Booth 1 </li>
</ul>
<h3 class="wp-block-heading">About WCG</h3>
WCG is at the forefront of accelerating clinical research worldwide, serving as the trusted and preferred partner to biopharmaceutical and medical device companies, contract research organisations (CROs), research institutions and site partners. Offering a unique combination of expertise, next-generation data and insights and tech-enabled solutions, WCG reduces complexity and optimises study operations and outcomes while maintaining the highest standards of human participant protection. For more than 55 years, WCG has maintained a relentless commitment to efficiency, safety and impact, empowering clinical trials to deliver life-improving therapies swiftly. For more information, please visit <a href="https://www.wcgclinical.com/" target="_blank" rel="noreferrer noopener">wcgclinical.com</a> or follow us on <a href="https://www.linkedin.com/company/wcg-clinical/" target="_blank" rel="noreferrer noopener">LinkedIn</a>. Media Contact: Carmin Gade, PhD Chief Marketing Officer, WCG 484.351.9959 cgade@wcgclinical.com
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/next-gen-irb-review-is-here-wcg-clinsphere-ereview-manager-drives-transformative-efficiencies-accelerates-clinical-research/">Next-Gen IRB Review Is Here: WCG ClinSphere™ eReview Manager Drives Transformative Efficiencies, Accelerates Clinical Research</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
]]></content:encoded>
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<title>Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</title>
<link>https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 18 Sep 2025 10:19:21 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25092</guid>
<description><![CDATA[Advarra, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the launch of its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world. Study Design solution evaluates a protocol’s feasibility by comparing it […]
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/">Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
]]></description>
<content:encoded><![CDATA[
<a href="https://www.advarra.com/" target="_blank" rel="noreferrer noopener">Advarra</a>, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the launch of its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world.
Study Design solution evaluates a protocol’s feasibility by comparing it to similar trials using Braid<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" />, Advarra’s <a href="https://www.advarra.com/news/advarra-debuts-braid-to-unlock-operational-intelligence-and-workflow-automation-in-clinical-trials-through-ai/" target="_blank" rel="noreferrer noopener">newly launched data and AI engine</a>. Braid is powered by a uniquely rich set of digitised protocol-related documents and operational data from over 30,000 historical studies conducted by 3,500 sponsors. Drawing on Advarra’s institutional review board (IRB) and clinical trial systems, this dataset spans diverse trial types and therapeutic areas, provides granular detail on schedules of assessment and tracks longitudinal study modifications, giving sponsors deeper insights than solutions based only on in-house or public datasets.
“Too often, clinical trial protocols are developed without the benefit of robust comparative intelligence, leading to inefficient designs and operations,” said Laura Russell, senior vice president, head of data and AI product development at Advarra. “By drawing on the industry’s largest and richest operational dataset, Advarra’s Study Design solution delivers deeper insights into the feasibility of a protocol’s design. It helps sponsors better anticipate downstream operational challenges, make more informed decisions to simplify trial designs and accelerate protocol development timelines.”
Advarra’s Study Design solution can be used to optimise a protocol prior to final submission or for retrospective analyses. The solution provides insights on design factors that drive operational feasibility, such as the impact of eligibility criteria, burdensomeness of the schedule of assessment on sites and participants and reasons for amendments. Study teams receive custom benchmarking that allows for operational risk assessments through tailored data visualisations and consultations with Advarra’s data and study design experts. Technical teams can work directly within Advarra’s secure, self-service insights workspace to explore operational data for the purpose of powering internal analyses, models and business intelligence tools.
“Early pilots have already demonstrated measurable impact,” added Russell. “In one engagement, benchmarking a sponsor’s protocol against comparable studies revealed twice as many exclusion criteria and 60 percent more site visits than industry benchmarks. With these insights, the sponsor saw a path to streamline future trial designs by removing unnecessary criteria, clustering procedures and adopting hybrid visit models, ultimately reducing site burden and making participation easier for patients.”
Study Design solution is the first in a series of offerings by Advarra that will be powered by Braid. Future applications will extend insights beyond protocol design to improve study startup, enhance collaboration and better support sites.
To learn more about Study Design solution or to request a consultation, visit advarra.com/study-design.
About Advarra Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions enable collaboration, transparency, and speed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance. For more information, visit <a href="https://c212.net/c/link/?t=0&l=en&o=4485081-1&h=2380347731&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4407469-1%26h%3D3684560095%26u%3Dhttps%253A%252F%252Fwww.advarra.com%252F%26a%3Dadvarra.com&a=advarra.com" target="_blank" rel="noreferrer noopener">advarra.com</a>.
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/advarra-launches-ai-and-data-backed-study-design-solution-to-improve-operational-efficiency-in-clinical-trials/">Advarra Launches AI- and Data-backed Study Design Solution to Improve Operational Efficiency in Clinical Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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<title>CPHI Frankfurt 2025 to welcome more than 60,000 pharma professionals as the global event returns to Germany</title>
<link>https://journalforclinicalstudies.com/cphi-frankfurt-2025-to-welcome-more-than-60000-pharma-professionals-as-the-global-event-returns-to-germany/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Mon, 08 Sep 2025 13:15:59 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25086</guid>
<description><![CDATA[Informa Markets will once again welcome the global pharmaceutical industry to CPHI Frankfurt 2025, running from October 28 to 30 at Messe Frankfurt. The three-day event is expected to draw more than 63,000 attendees, with six content theatres, more than 2,000 exhibitors, and a packed programme dedicated to networking and innovation. Celebrating its 36th year, CPHI […]
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Informa Markets will once again welcome the global pharmaceutical industry to<a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/0/0cbe42738f75f5c0feea5222ef7cf99da49f0aacca5bd440a7020922ea95e5b4?cache_buster=1757334175" target="_blank" rel="noreferrer noopener"> </a><a href="https://www.cphi.com/europe/en/home.html" target="_blank" rel="noreferrer noopener">CP</a><a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/1/a08670b56daf561e9f028a5cf72dc7597855bc6a258c888fbdb97e44a7863a47?cache_buster=1757334175" target="_blank" rel="noreferrer noopener">HI Frankfurt 2025</a>, running from October 28 to 30 at Messe Frankfurt. The three-day event is expected to draw more than 63,000 attendees, with six content theatres, more than 2,000 exhibitors, and a packed programme dedicated to networking and innovation.
Celebrating its 36th year, CPHI Frankfurt remains the largest and most influential pharmaceutical event globally, bringing together professionals from across the drug development and manufacturing ecosystem. The event is organised by Informa Markets, a division of Informa PLC, which delivers B2B events across global industries.
“CPHI is more than an event, it’s a global experience,” said Tara Dougal, event director, CPHI Frankfurt. “It’s the one place each year where the full pharmaceutical supply chain comes together to collaborate, build relationships, and get business done.”
Following a record-setting 2024 event in Milan that drew 59,000 attendees, this year’s event aims to surpass that benchmark. In recent years, CPHI has expanded its content and exhibitor zones to reflect industry diversification, adding bioproduction, finished dosage formulation, drug delivery, and packaging alongside its traditional strength in APIs.
In response to continued market growth and emerging industry trends, CPHI Frankfurt 2025 will introduce several new feature zones aimed at supporting innovation, diversification, and deeper sector engagement. These zones will spotlight areas such as digital health technologies, AI-powered drug development, and sustainable pharma manufacturing, reflecting the industry’s evolving priorities and creating new opportunities for exhibitors and attendees alike.
“The new zones are designed to keep pace with where the market is going,” said Dougal. “They’re a direct response to rising demand from both attendees and exhibitors for more focused, future-looking areas within the show.”
Attendees can also access a robust line-up of features that enhance both business outcomes and professional development:
●     Six content theatres, running across all three days, offering insight into market trends, R&D, manufacturing, and regulation. 
●     The CPHI Awards and Celebration, recognising innovation and leadership across 14 categories, including Women in Pharma and Future Leader of the Year. 
●     Happy hour networking events on days one and two, designed to foster informal connections. 
●     An event planner app with agenda-building and real-time floor navigation features, remaining active post-show to support follow-up. 
“Whether you’re a first-time attendee or a returning exhibitor, planning is key,” Dougal said. “Our digital platform helps attendees get the most value by pre-booking meetings, building agendas, and navigating efficiently on site.”
The CPHI portfolio includes 10 international events spanning Europe, the Americas, the Middle East, and Asia. The newest addition, CPHI Middle East, launched in Riyadh in 2024 and will return in April 2026.
About Informa Markets
Informa Markets creates platforms for industries and specialist markets to trade, innovate, and grow. As part of Informa PLC, it delivers more than 450 B2B events annually across key sectors including healthcare, life sciences, construction, and fashion. The company’s mission is to foster global communities, enabling meaningful connections and commercial success.
To learn more about CPHI Frankfurt, visit the website <a href="https://www.cphi.com/europe/en/home.html" target="_blank" rel="noreferrer noopener">here</a>
Media Contact:
Aranda Rahbarkouhi ramarketing <a href="https://tracking.us.nylas.com/l/6827a31313234cee9654bc63027cab72/3/88cb56db523a945c4052444421f1b2b13a5608c05421cf18ca6923dfbacfded9?cache_buster=1757334175" target="_blank" rel="noreferrer noopener">aranda@ramarketingpr.com</a>

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<title>MultiOmic Health and BIO4 Campus Sign MoU to Advance Precision Medicine and Support Bioeconomy Growth in Serbia</title>
<link>https://journalforclinicalstudies.com/multiomic-health-and-bio4-campus-sign-mou-to-advance-precision-medicine-and-support-bioeconomy-growth-in-serbia/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 04 Sep 2025 09:58:32 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25072</guid>
<description><![CDATA[London, UK, and Belgrade, Serbia, 4 September, 2025 / Sciad Communications / MultiOmic Health Limited (‘MOH’), an artificial intelligence (AI)-enabled precision medicine biotechnology company, and BIO4 Campus (‘BIO4’), the Republic of Serbia’s flagship biotechnology and life sciences hub, today announced the signing of a Memorandum of Understanding (MoU) to explore collaborative opportunities in biomedicine, biotechnology and bioinformatics, with a strong emphasis on […]
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London, UK, and Belgrade, Serbia, 4 September, 2025 / <a href="https://email.cisionone.cision.com/c/eJwszkuO8yAQBODTwI4IN-8Fi2x8jaih2wn6_fgHMvH1Rx7N9itVqShDrFZLzlNwPvkELslXpsgGY0CDCyXjeSoWHZhAGEAvVGTLPpZk0lRTYPaPyZUatbFOkxNWj0b8r32pDdvKfShPSyjWV_IqxlT22xXINb_e7_9DmLuAWcB8nudt1IZ0q8cmYD6-u9r5HAJmuTE1VJ1XxsGqUf6Fxx8Ic58sgI6y50_rz7Y3vG7w_lyPgms9tnGNyvHuzNvVn4ojg5qUCdorWxBUgWIVhBqDxoWsj_KT4ScAAP__a7ZZSw" target="_blank" rel="noreferrer noopener">Sciad Communications</a> / <a href="https://email.cisionone.cision.com/c/eJwszUuO6yAQheHVmBlRAWUeAwaZZBtRQZVjdCG-bbuz_pZbPf2Ojn7ONlYEJdmE2Sef7JzUmrGCqxb9wsQM7AIgEboCZjEQiVXLPpbkkqkpiPinmUuN4HAGnieEo7H8a196UOuyH9rzEgr6yl7HmMr7dg2q5_U8_x-Tu0_2MdnH-O5n20art1Won-tkH2oIN9K7dKFDdOP8C88_mNzdoLUQ1Z4_bX-1d6MrL-9X3wr1uo3jVrehjnMXGdfflJkdAWsXwGssZHWxBbUNNQaghdFH9cn2JwAA__93BVaS" target="_blank" rel="noreferrer noopener">MultiOmic Health Limited</a> (‘MOH’), an artificial intelligence (AI)-enabled precision medicine biotechnology company, and <a href="https://email.cisionone.cision.com/c/eJwszU1uAjEMxfHTTHZBzpfjLLJgwzVQHBuIOsO0E8T5K6puf09Pf6meegSj1eWEBYtPxTyqEsVMjAkROKGAY-abCEMM4ByZUZG4hOJ6yap4dYk7QYgJJC0R5hD9Gj92a2PVY1qUW-aIXdASFX6ePoNZ6-P1-p5LOC_-svgLjz2ejrn4i9lURrOHrtqm2iH1D67_sISzi94DmaO-x3Efz9E-VX3e153b2vdtnvq-mfk6VLfP33GS0EBsyIA2cvOWPUfrc6cM7SYRybyr_w0AAP__hepSKA" target="_blank" rel="noreferrer noopener">BIO4 Campus</a> (‘BIO4’), the Republic of Serbia’s flagship biotechnology and life sciences hub, today announced the signing of a Memorandum of Understanding (MoU) to explore collaborative opportunities in biomedicine, biotechnology and bioinformatics, with a strong emphasis on AI applications.
BIO4 and MOH will work together to foster the growth of Serbia’s bioeconomy ecosystem by identifying and developing opportunities for joint research and innovation. Collaboration will initially focus on cardio-renal-metabolic diseases through integrative medical data and multi-omics approaches (genetics, epigenetics, transcriptomics, proteomics and metabolomics). This research will discover patient endotypes with distinct clinical phenotypes and omics signatures, develop AI-enabled tools to stratify those patient endotypes at earlier disease stages, and identify and validate corresponding patient stratified drug targets. These efforts will enable a more personalised approach to patient care.
Insights from this research will enable the joint development of AI-based Software as Medical Device (SaMD) and In Vitro Diagnostic (IVD) products that will optimise patient care pathways using existing treatment options. In parallel, MOH will also devise new superior treatment concepts, generate corresponding drug candidates and conduct clinical trials in partnership with its biopharma industry collaborators.
‘By joining forces with BIO4 and its network of leading Serbian research and clinical institutions, we see a strong opportunity to advance the development of next-generation precision medicine solutions,’ said Robert Thong, CEO of MultiOmic Health. ‘This collaboration reinforces our commitment to harnessing AI, data science and experimental biology to improve patient outcomes in cardio-renal-metabolic diseases globally.’
‘BIO4 Campus was created to be a catalyst for Serbia’s bioeconomy and an international hub for innovation,’ said Smiljana Krivokuća, CEO of BIO4. ‘We are delighted to welcome MultiOmic Health as a partner in this mission and look forward to exploring joint opportunities that combine their expertise in precision medicine with our ecosystem’s strengths in biotechnology, clinical research and bioinformatics.’
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<title>SK bioscience Submits IND for Phase 3 Clinical Trial of 2 Dose Varicella Vaccine</title>
<link>https://journalforclinicalstudies.com/sk-bioscience-submits-ind-for-phase-3-clinical-trial-of-2-dose-varicella-vaccine/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 04 Sep 2025 09:57:53 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25065</guid>
<description><![CDATA[SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with […]
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]]></description>
<content:encoded><![CDATA[
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella. The trial will evaluate the immunogenicity and safety of two doses in roughly 800 children aged 12 months to 12 years, with completion targeted by 2027.
Varicella vaccines have effectively reduced disease and complications with a single dose, which has been the standard in many countries. However, breakthrough infections may occur over time and international standards are shifting toward a 2-dose schedule to provide stronger, longer-lasting immunity and reduce community transmission.
WHO’s SAGE (Strategic Advisory Group of Experts on Immunisation) officially recommended a 2-dose varicella vaccination in March 2025, boosting demand in global procurement markets including PAHO. The United States implemented a 2-dose schedule in 2006, cutting varicella incidence by over 85%, and countries such as Germany and Japan have since incorporated 2-dose regimens into their national immunisation programs. Since its launch in Korea in 2018, SKYVaricella obtained WHO PQ certification in 2019, becoming the second vaccine worldwide to achieve this, entering the international procuremen market. It has been administered to over 5 million people globally, with supply expanded through Korea’s National Immunisation Program, private healthcare providers, and international tenders such as PAHO. Recently, the company signed an additional supply agreement with PAHO for 2025-2027 and plans to accelerate its entry into the global varicella vaccine market through the development of SKYVaricella 2-dose regimen.
Global Market Insights projects that the global varicella vaccine market will grow from USD 3.4 billion (KRW 4.7 trillion) in 2024 to USD 6.3 billion (KRW 8.8 trillion) by 2034, at an average annual growth rate of 6.5%.
Ryu Ji-hwa, Head of Development Department of SK bioscience, said, ‘Our 2-dose varicella vaccine is a strategic pipeline that directly reflects updated international standards and rising market demand. Building on our WHO PQ-backed procurement experience and R&D achievements, we aim to complete development quickly and compete globally with reliable production and superior immunogenicity.’
About SK bioscience
<a href="https://www.skbioscience.com/en/main" target="_blank" rel="noopener">SK bioscience </a>is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.
SK bioscience Communications Team
Changhyun Jin (jin99@sk.com) 
Jeannie S. Pak (j.pak@sk.com)
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/sk-bioscience-submits-ind-for-phase-3-clinical-trial-of-2-dose-varicella-vaccine/">SK bioscience Submits IND for Phase 3 Clinical Trial of 2 Dose Varicella Vaccine</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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<title>Veeva Announces Collaboration with Global Biotech to Further Accelerate Clinical Trial Innovation</title>
<link>https://journalforclinicalstudies.com/veeva-announces-collaboration-with-global-biotech-to-further-accelerate-clinical-trial-innovation/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 04 Sep 2025 09:56:31 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25074</guid>
<description><![CDATA[Veeva Systems (NYSE: VEEV) today announced a collaboration with Amgen to advance clinical trial innovation. As a global leader in biotechnology, Amgen will employ the Veeva Clinical Platform to support and identify efficiencies across the clinical trial process, building on the company’s commitment to accelerating the development of new medicines for patients with serious diseases. “In collaboration with […]
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<a href="https://www.veeva.com/eu/" target="_blank" rel="noreferrer noopener">Veeva Systems</a> (NYSE: VEEV) today announced a collaboration with Amgen to advance clinical trial innovation. As a global leader in biotechnology, Amgen will employ the <a href="https://www.veeva.com/eu/products/veeva-clinical-platform/" target="_blank" rel="noreferrer noopener">Veeva Clinical Platform</a> to support and identify efficiencies across the clinical trial process, building on the company’s commitment to accelerating the development of new medicines for patients with serious diseases.
“In collaboration with Veeva, we’re leveraging advanced technology to unlock new capabilities for our end-to-end trial operations which are expected to further strengthen our ability to bring innovative treatments to patients with speed and scale,” said Scott Skellenger, senior vice president and chief information officer at Amgen.
“We’re excited to help Amgen further advance clinical development. Veeva Clinical Platform will provide the backbone for standard and connected processes that can speed the delivery of life-saving drugs to patients in need,” said Jim Reilly, president of Veeva Development Cloud.
As part of the collaboration, <a href="https://www.veeva.com/eu/services/business-consulting-services/" target="_blank" rel="noreferrer noopener">Veeva Business Consulting</a> will support Amgen through implementation and change management.
About Veeva Clinical Platform
Veeva Clinical Platform is a complete and connected platform across clinical operations and data applications. This end-to-end platform includes CTMS, EDC, clinical workbench (CDB), RTSM, eCOA, eTMF, Site Connect, Study Training, and more. Connected products streamline clinical trials from study start-up to close and automate a connected data flow. To learn more about Veeva Clinical Platform, visit <a href="https://www.veeva.com/eu/products/veeva-clinical-platform/" target="_blank" rel="noreferrer noopener">veeva.com/eu/VeevaClinicalPlatform</a>.
About Veeva Systems
<a></a>Veeva delivers the industry cloud for life sciences with software, data, and business consulting. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,500 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a <a href="https://www.veeva.com/pbc/" target="_blank" rel="noreferrer noopener">Public Benefit Corporation</a>, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit <a href="http://veeva.com/eu" target="_blank" rel="noreferrer noopener">veeva.com/eu</a>.
Veeva Forward-looking Statements
This release contains forward-looking statements regarding Veeva’s products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-Q for the period ended April 30, 2025, which you can find <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001393052/000139305225000042/veev-20250430.htm#i7e129a0ad48d459ea13c21cd7e2de073_124" target="_blank" rel="noreferrer noopener">here</a> (a summary of risks which may impact our business can be found on pages 32 and 33), and in our subsequent SEC filings, which you can access at <a href="https://www.sec.gov/" target="_blank" rel="noreferrer noopener">sec.gov</a>
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/veeva-announces-collaboration-with-global-biotech-to-further-accelerate-clinical-trial-innovation/">Veeva Announces Collaboration with Global Biotech to Further Accelerate Clinical Trial Innovation</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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<title>Atelerix and Rodon Global Partner to Integrate Cryo-free Preservation Technology into Specialist Logistics Solutions</title>
<link>https://journalforclinicalstudies.com/atelerix-and-rodon-global-partner-to-integrate-cryo-free-preservation-technology-into-specialist-logistics-solutions/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Thu, 04 Sep 2025 09:44:12 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
<guid isPermaLink="false">https://journalforclinicalstudies.com/?p=25067</guid>
<description><![CDATA[Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced an agreement with Rodon Global (“Rodon”), the established freight company focused on clinical trials and drug discovery headquartered in South Africa. The collaboration comes at a pivotal time as Rodon actively expands operations across the United States, […]
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<ul class="wp-block-list">
<li>Initial agreement to incorporate Atelerix’s non-cryogenic cell preservation technology into international freight and logistics services for drug discovery and clinical trials</li>
<li>Partnership showcased at SACRA (South African Clinical Research Association), Pretoria, 1–2 October 2025</li>
</ul>
Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced an agreement with Rodon Global (“Rodon”), the established freight company focused on clinical trials and drug discovery headquartered in South Africa. The collaboration comes at a pivotal time as Rodon actively expands operations across the United States, UK, South Africa, and Singapore. By integrating Atelerix’s unique cryo-free preservation products within Rodon’s dynamic logistics offering, the collaboration will significantly broaden access to safe shipping and storage solutions for temperature-sensitive biomaterials, without freezing.
Through an initial MoU, Rodon will begin offering Atelerix’s portfolio of hypothermic preservation solutions to customers, providing new options to enhance efficiency across biomedical research and therapeutic development workflows. The mutually-beneficial collaboration grants Atelerix access to a new customer base via a trusted industry partner, whilst enabling Rodon to scale its services through a unique model that addresses traditional challenges in cold-chain logistics. This agreement follows the appointment of MineBio as Atelerix’s exclusive distributor in China1, further extending the Company’s global network of logistics partners to deliver a cryo-free, cost-efficient transport solution worldwide.
Atelerix’s patented hydrogels directly address cryologistic bottlenecks by stabilising membrane integrity and preserving biological function of cells and other biological substances during transport. Samples can remain in a ready-to-use state at ambient temperatures for up to two weeks, reducing waste and energy consumption, and simplifying shipping and handling protocols. Optimised for whole blood, primary cells, plated cell models, organoids, tissues, and viruses, the technology is applicable across life science and healthcare. It is particularly valuable for cell and gene therapy manufacturing, where it offers a flexible solution for preservation across the full workflow.
Alastair Carrington, CEO, Atelerix, commented: “The global demand for inexpensive, efficient solutions for storage and transport of biological substances is continually increasing, leading to an urgent unmet need for innovative solutions, which our experienced team of hogs can provide. Working alongside Rodon and our network of global distributors, we are expanding our reach to include the booming South African life science sector, catapulting adoption of our unique technologies in the region, and beyond. We look forward to joining Rodon at SACRA in October to showcase the enormous potential of our collaboration.”
Leonard Neil Lazarus, CEO, Rodon Global, added: “Atelerix’s innovative approach to cell preservation will revolutionise biological transport worldwide, overcoming supply chain challenges associated with temperature sensitive materials, particularly in the drug discovery and clinical research sectors. This partnership represents a significant milestone and differentiator for Rodon, allowing us to overcome these challenges and continue to scale, supporting our life science customers to develop and manufacture novel therapeutics.

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<title>Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</title>
<link>https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/</link>
<dc:creator><![CDATA[theArchitect]]></dc:creator>
<pubDate>Wed, 20 Aug 2025 13:24:10 +0000</pubDate>
<category><![CDATA[Regional News]]></category>
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<description><![CDATA[MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials. The collaboration […]
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/">Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials.
The collaboration addresses a longstanding challenge in cancer drug development: how to assess long-term treatment benefit when OS data remain immature. In many oncology studies, developers use endpoints such as progression-free survival (PFS) and objective response rate (ORR) as an initial indicator of treatment efficacy. However, evaluating OS data at the same interim point can complicate the assessment of long-term benefit or harm. To provide clarity, Friends has convened a consortium of stakeholders to develop and evaluate different modeling scenarios, including crossover effects and delayed treatment benefits.
Friends selected MMS to lead simulation and modeling efforts for this project based on both its simulation platform, KerusCloud®, and its deep bench of regulatory and statistical experts. The MMS platform enables realistic modeling of oncology endpoints and allows stakeholders to explore different scenarios and decision thresholds, providing a clear view of the potential risks and benefits associated with acting on immature data in oncology clinical trials, and supporting more informed decisions earlier in the trial process.
“As timely access to innovative cancer therapies remains a key factor for patients, this initiative represents an important step toward optimal acceleration,” said Jeff Allen, PhD, President and CEO, Friends of Cancer Research. “At Friends, we work with key stakeholders to generate the evidence necessary to understand a problem, and develop data-driven policy solutions to address and overcome that problem; all while keeping the patients front of mind. We are excited to partner with MMS along with the consortium who bring a combination of statistical depth, real-world understanding of oncology trial design, and powerful simulation tools to help tackle these challenges.”
Improving Oncology Clinical Trials with the Right Technology and the Right Stakeholders
“Friends of Cancer Research has long been a catalyst for forward-thinking collaboration in oncology, and we are grateful they have trusted MMS to support this vital initiative,” said Uma Sharma, PhD, CEO at MMS. Having supported several key oncology approvals, we are uniquely positioned to help model the right questions and deliver practical frameworks that will shape future regulatory guidance and support better decision-making across the field.”
“By combining our regulatory insight with advanced simulation capabilities, we are helping develop practical tools and decision frameworks that give developers greater confidence to act on early data, and ultimately improve access for patients,” added Aiden Flynn, Sr. VP Strategic Statistical Consulting at MMS.
The collaboration is expected to result in practical guidance and a simulation toolbox that can be shared broadly across the oncology community, helping stakeholders better anticipate the implications of interim OS data on regulatory decisions. By equipping researchers with a practical, scientifically robust toolkit, this program promotes a consistent and transparent approach to evaluating early survival signals, supports timely decision-making, and fosters continued innovation in cancer drug development. To learn about the Interim OS Project, visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz6" target="_blank" rel="noreferrer noopener">https://friendsofcancerresearch.org/interim-os</a>, and learn more about KerusCloud at <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz7" target="_blank" rel="noreferrer noopener">https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/</a>.
About Friends of Cancer Research Friends of Cancer Research (Friends) powers advances in science and policy that speed life-saving treatments to patients. Friends aims to accelerate cutting edge cancer care that both extends and improves quality of life for patients. To accomplish this, we leverage groundbreaking collaborations, generate scientific evidence, and integrate patient input to shape public policy. For more information, please visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz8" target="_blank" rel="noreferrer noopener">https://friendsofcancerresearch.org</a>.
About MMS MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, a 19-year track record, AI technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating. For more information, visit <a href="https://biostratamarketing.acemlnb.com/lt.php?x=3DZy~GE3VaOf5aKs__xGgeahAXVTjNgkluUwjHg4JXCg78JAzEy.1.Jt2nRzjd91k_YwX5PEMnKd7pz9" target="_blank" rel="noreferrer noopener">www.mmsholdings.com</a>.
The post <a rel="nofollow" href="https://journalforclinicalstudies.com/friends-of-cancer-research-and-mms-collaborate-to-develop-decision-frameworks-for-interim-overall-survival-data-in-oncology-trials/">Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials</a> appeared first on <a rel="nofollow" href="https://journalforclinicalstudies.com">Journal for Clinical Studies</a>.
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