Peter St.Wecker, Ph.D.

Don't Stop Believin': Mastering CTAs and Budgets for Clinical Trial Success About ten years ago, we set an ambitious goal: to establish Master CTAs with at least half of the sponsors PCRS Network work with. We met that goal! Well, sort of. Having worked with all the major Pharma companies and many smaller ones, we knew that therapeutic areas within larger companies operate in silos. This presents significant challenges when trying to standardize legal or budgeting processes. Even when a master CTA was approved at the corporate level, legal teams in each silo often wanted to negotiate their own versions. Fortunately, in every instance, we were able to facilitate communication between these teams and resolve the issues efficiently. At the same time we set the goal for the master CTA, we also set a more conservative target for master budgets. The concept of a master budget is straightforward: pre-negotiate standard items to minimize the number of negotiable items study-to-study. As we anticipated, sponsors were generally receptive to this approach. Moving forward, our long-standing relationships with sponsors facilitated smooth negotiations on future studies, often with just a brief conversation or email exchange. Although we continue to experience some delays because of the silos, we remain committed to implementing master CTAs and budgets wherever possible. We've learned not to be discouraged by occasional refusals. Our experience shows that having master agreements and budgets, or just standardized language for key clauses, even if they need periodic revisions, saves both sponsors and sites valuable time. Encouraging the industry to adopt master agreements as a standard practice can significantly improve the study startup timeline, contributing to saving and improving lives. Supporting Insights A 2021 article from Applied Clinical Trials highlights the importance of master CTAs, stating, "Master CTAs streamline the contracting process, reducing administrative burden and accelerating study startup times." Another study from Clinical Trials Arena in 2022 found that "adopting master agreements can lead to a 30% reduction in study startup timelines, enhancing overall efficiency." Call to Action Let's work together to streamline clinical trials and bring treatments to patients faster. If you’re interested in learning more about how master CTAs and budgets can benefit your organization, reach out today. Together, we can rise to new heights of efficiency and success in clinical trials. Citations 1. "Streamlining Clinical Trials with Master CTAs," Applied Clinical Trials, 2021. 2. "Efficiency Gains in Study Startup with Master Agreements," Clinical Trials Arena, 2022. 3. Lyric reference from "Don't Stop Believin'" by Journey, 1981.

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💡Don’t let your clinical data become an afterthought! 💡 Confidence in clinical trial results is critical. All too often, however, we, in the research community, find ourselves in situations in which clinical data has unintentionally become an afterthought. Inconsistent applications of clinical information can result in data quality and compliance issues, which can add significant time and costs to clinical trials, delaying the development and delivery of vital new medical treatments. A biometrics CRO, @Bioforum the Data Masters paves the way for more successful, efficient, and cost-effective drug development. With our team of industry experts and proprietary technology, Bioforum makes it possible to have all clinical data stored and seamlessly managed in one place, giving sponsors more control over their studies. And the results speak for themselves. Sponsors who have transitioned to Bioforum from large, one-stop-shop CROs, report that working with Bioforum: 📈Reduces biometrics-related costs by at least 25% 📈Saves more than six weeks of time 📈Significantly improves quality (enabling 100% quality scores with 0 findings on audits!) 📈Optimizes risk management Contact me to learn more. I’d be delighted to connect. 💬 Visit our website: www.bioforumgroup.com #clinicaltrials #clinicalresearch #biometrics #biometricsCRO #CRO #clinicaldatamanagement #datamanagement #clinicaltrialtechnology #eclinical #RBQM #CDISC #SDTM #rescuestudies #hybridstudies #decentralizedtrials #esource #SCDM

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The potential of human gene editing to change the lives of those with genetic diseases cannot be understated. With substantial growth in therapies utilizing GE technologies, the FDA released a draft guidance on human gene therapy products in January 2024. In our latest Regulatory Navigator blog, we discuss key takeaways from the FDA's guidance on nonclinical assessment for investigational GE products. These include important considerations for future GE product development, such as using surrogates for testing, evaluating on- and off-target editing events, and characterizing toxicities.

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Oncology clinical trials are crucial for advancing cancer treatment and can help patients get access to cutting-edge therapies. Yet, the latest data show that the clinical trial enrollment rate for patients with cancer in the U.S. is just 7%. At Private Health Management, we understand the clinical and scientific complexity of identifying and prioritizing appropriate trials, as well as other barriers to access. In PHM’s new whitepaper, “The Importance of Clinical Trials in Cancer Care,” my colleagues, Natalya Gertsik, PhD, Tommy Axford, and I discuss how PHM’s approach to clinical trials can help to ensure access for all patients and present an analysis of clinical trial enrollment for our cancer patients over the last decade. Remarkably, the enrollment rate for PHM patients with cancer is 25% — nearly four times the rate of the general population. Patients across all cancer stages and over 20 cancer types enrolled in trials, demonstrating PHM’s commitment to ensuring access for all patients, even when few trials are available. By identifying suitable trials, supporting logistical needs of providers and patients, and educating patients about clinical trials, PHM helps overcome obstacles surrounding clinical trial access. Learn more here: https://lnkd.in/gz-3gaVP #clinicaltrials #employeehealth #cancer #oncology #healthequity #clinicalresearch #cancercare #employerbenefits #employerhealthplans

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How to avoid the dangers of duplicate subjects in clinical trials? Verified Clinical Trials' Kerri Weingard discusses this topic with Moe Alsumidaie of clinicaltrialvanguard.com. The issue of duplicate and professional research subjects is prevalent, making it a "must have" for all clinical trials. Check out the interview here: https://lnkd.in/dV--z-KQ Learn more at: https://lnkd.in/etwhixy #clinicaltrials #research #healthcare #professionalresearchsubjects

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Closer alignment between FDA and the Centers for Medicare & Medicaid Services on #evidencegeneration is vital for patients with #rarediseases! When #CMS decides that #FDA's data is not sufficient to make a coverage determination for an FDA-approved medical product because the pivotal #clinicaltrials did not appropriately cover the #Medicare population, or because of erroneous assumptions about what #FDA's #acceleratedapproval pathway actually entails - or really for any reason, whether related to differences between CMS' 'reasonable and necessary' standard and FDA's 'safe and effective' standard or not - the ultimate result for patients is pretty much always the same: lengthy and burdensome evidence generation processes, valuable time lost for patients and families, and access barriers that make it hard or impossible for patients to access the approved treatments they need. When #FDA and #CMS are not aligned on the evidence they require (or how best to get it), it's the patients who ultimately suffer. Great article and much-overdue framework published in JAMA this month:

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This content is for US audiences only.   Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that our IO treatment met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile.   Those potential benefits cannot be understated, as the majority of this patient population faces a disease recurrence even after surgery and chemo.   This announcement is welcome news to patients thanks to its flexibility before or after surgery and more time to live without progression or recurrence. Our patients are relying on us to deliver new powerful therapies that will allow them to live longer and better – and we won’t let them down. We look forward to our continued work with the FDA and the potential to bring safe, powerful treatments to even more patients facing a cancer diagnosis. Read more: https://bit.ly/46h4YiN   #USOnly #AstraZenecaUS

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Chimeric Antigen Receptor or CAR T cells are cell-based #genetherapies that have revolutionized the disease trajectory for some cancer patients that have few other treatment options left. What's more, CAR T cells hold immense future promise for many additional patient populations, including cancer patients that are earlier in their disease trajectory, patients with other types of cancers (including solid tumors), and even patients beyond #oncology. Unfortunately, CAR Ts are not without risks including the risk of secondary malignancies; today's FDA announcement requiring boxed warnings for all BCMA and CD-19 directed CAR Ts emphasizes one key point - the question of long-term follow-up. In today's announcement, #FDA recommends lifetime follow-up of all CAR T patients for secondary malignancies. This is a contentious issue for essentially all #genetherapies; as outlined by FDA, the length of follow-up should be risk-based, but as the example of CAR Ts clearly shows, our understanding of the risks associated with gene therapies continues to evolve. Following any patient over their lifetime is by no means an easy task, in particular in the U.S.'s fragmented healthcare system. To complicate things further, some CAR Ts are approved for #pediatric uses - adding the complexities of pediatric to adult care transition and a lifespan that hopefully far exceeds the 15 years of long-term follow-up #FDA usually requires for the 'highest-risk' genetherapies.

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Learn from Karen McIntyre and Angela Hirst on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/gsSaNAvp Parexel #Oncology #ParexelBiotech #ResearchSites #Oncology #NovelInsights

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Great conversation with Tom Caravela discussing the importance of cultivating your professional network and your advocates. Thanks for the opportunity to share my thoughts!

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I am looking to connect with individuals in the early #oncology research space who can speak to how researchers and their organizations procure sequenced oncology biospecimens (i.e., FFPE) with specific attributes (e.g., variants, mutations, fusions). I am interested in validating some hypotheses about where there might be opportunities to apply #tech and #AI to streamline and create a more efficient process for sourcing and obtaining these types of samples. Please shoot me a DM if you would be open to speaking or can recommend anyone valuable to connect with. Thanks in advance for your help! #OncologyResearch #Innovation #Biospecimens #FFPE #variants #mutations #fusions #sequence #cancer #research

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In the post-COVID drug development landscape, Vaccines are a hot item! Do not miss this opportunity, join my Parexel colleagues Anne Kasmar and Leslie Johnston as they share their thoughts on the extremely fast pace required to test novel vaccines in large representative trials, lessons learned from the COVID pandemic, and best practices to enable efficiency in this difficult therapeutic area. Register below! #vaccine #Vaccines #Webinar #ClinicalResearch #OperationalExcellence

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Gilead Sciences Achieves Major Milestone in HIV Prevention with Lenacapavir 🚀 Breaking News: Gilead Sciences has revealed impressive outcomes from their Phase 3 PURPOSE 1 trial. The study demonstrated that lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, achieved 100% efficacy in preventing HIV infections among cisgender women. This landmark trial marks the first Phase 3 HIV prevention study to report zero infections. 🧬 Key Highlights: 100% Efficacy: Lenacapavir demonstrated superior efficacy compared to the daily oral Truvada® regimen. Trial Insights: The trial involved over 5,300 cisgender women and adolescent girls aged 16-25 from 28 sites in South Africa and Uganda. Participants were randomized to receive either lenacapavir, daily oral Descovy®, or daily oral Truvada. Results: No HIV infections were reported among 2,134 women receiving lenacapavir. In contrast, there were 16 infections in the Truvada group and 39 in the Descovy group. Safety: Lenacapavir was generally well-tolerated with no significant new safety concerns identified. 💡 Implications: Potential Game-Changer: Twice-yearly lenacapavir could revolutionize HIV prevention, particularly for cisgender women who may face adherence challenges with daily oral pre-exposure prophylaxis (PrEP) #HIVPrevention #Lenacapavir #ClinicalTrials #GileadSciences #MedicalResearch #HealthcareInnovation #PublicHealth

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Fred Hutch Receives $5.25M from the Kuni Foundation to Propel Innovative Adult Oncology Research https://lnkd.in/gPUhtv5d Principal investigators working at Fred Hutch Cancer Center and UW Medicine secured $5.25 million in grants from the Kuni Foundation for a diverse lineup of projects to advance our understanding of tumor regression and improve care for an array of adult cancers, including by reducing the cost of therapy. The projects will explore why some cancerous tumors shrink or disappear without treatment; test whether the immunotherapy nivolumab works when given less often and at lower doses; investigate what drives disparities in breast cancer screenings; evaluate a method to detect and treat liver tumors earlier by selectively delivering radiation to tumor cells; and lay the groundwork for personalized hyperthermic peritoneal chemotherapy (HIPEC) for cancer on the lining of the abdomen. Each awardee will receive $1,050,000 over three years. The post Fred Hutch Receives $5.25M from the Kuni Foundation to Propel Innovative Adult Oncology Research appeared first on Life Science Washington . Click here to view original post Click Here to Publish/Feature Your Company or Product News with Biotech Networks

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Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dUaBWFxM #ProjectOptimus #Oncology #ParexelBiotech #NovelInsights

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Being touted as 'practice-changing' and likely a new SOC, AstraZeneca shared data from PIII 'LAURA' in this week's ASCO plenary sessions, showing that #Tagrisso provides an 84% lower risk of tumor progression or death in unresectable EGFRm #NSCLC. How will other drugs fare in this shifting treatment landscape, given AZ's remarkable results? #LungCancer #2024ASCO #Oncology #MedicalAffairs #ClinicalStudies #Pharma #Healthcare

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I joined Quotient because #translationalpharmaceutics is innovating early #drugdevelopment this short video explains how, definitely worth a watch for those of you not familiar with it.

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As accessibility in #clinicaltrials increases, so do the challenges and complexities that come with more countries engaging in global trials. Navigating business continuity across a global network is essential for maintaining patient safety, data integrity, regulatory compliance, cost efficiency, and timely completion of trials. As we continue to expand our capacity and further equip our network with advanced technologies for high-speed and high-precision label production, we continue to enable accessibility and ensure business continuity globally. Each investigational medicinal product (IMP), comparator, and shipping box needs a unique label, specifically designed for each study. Errors in #clinicallabeling can delay the start of trials and disrupt development timelines. At Thermo Fisher Scientific, we partner with our customers to navigate these challenges and reduce cycle times by ensuring accurate label design and translation management. Learn more about how our comprehensive in-house print and label services worldwide are seamlessly integrated with packaging, supply chain, and logistics. https://lnkd.in/eEZJQ9Cd

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