Trisha Heredia

In this edition of the New Medicines, Novel Insights newsletter, Parexel RWE experts Jacqueline Vanderpuye-Orgle and Matthew Gordon review the potential AI offers in streamlining clinical datasets that can fill evidence gaps and address research questions faster, ultimately providing patients access to much needed therapies. RWD can be leveraged to accelerate clinical development and support a wide variety of commercial objectives — but only if researchers have meaningful ways to harness the potential power of massive and often unstructured datasets. Learn about Parexel’s promising results using machine-learned Bayesian networks, a form of predictive modeling, and one approach in a suite of methods to make AI more transparent. Read the full article and make sure you subscribe to get the latest #NovelInsights each week! #AI #RWD #RWE #ArtificialIntelligence

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CDMO Nucleus RadioPharma reveals expansions at two sites that will "significantly improve" market access to promising cancer treatments. 🏗️ The upgrades at sites in Mesa, #Arizona and Springhouse, #Pennsylvania will give each facility research, development and commercial production capabilities, boosting capacity by 200%. The expansions are expected to be completed by the end of 2026 and will create around 100 jobs overall. 💉 The upgrades will allow more patients to receive radiopharmaceuticals, which have a limited shelf-life, according to Nucleus. 💬 "To reach their full potential as treatments for millions of patients with limited options, theranostic radiopharmaceuticals must be available close to those who need them," Nucleus RadioPharma CEO Charles Conroy, RPh, MBA said in a release. "Our expansion will significantly improve patient access to these life-saving treatments and expedite clinical trials, potentially reducing time-to-market for new therapies by up to 30%." #CDMO #Radiopharmaceuticals #Radiopharma

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In our latest Regulatory Navigator blog, we provide an overview of the proposed legislation in the BIOSECURE Act and outline ways that US-based developers – particularly those working on newer modalities such as cell and gene therapies – can mitigate associated risks.

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Interesting ressource if you want to know how Certara can help optimize your early development program!

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Discover the latest enhancements to Labcorp Global Trial Connect, designed to streamline site workflows and boost clinical trial efficiency. These updates, driven by insights from collaboration with sponsors and sites, aim to empower investigator sites to focus more on what truly matters, patient care. Your commitment to patient care is why we’re committed to redefining clinical trial delivery. Learn more: https://lnkd.in/euCVRFkY #ClinicalTrials #GlobalTrialConnect

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What is the Centers for Medicare & Medicaid Services (CMS) Prior Authorization Final Rule in the US and how might it impact patient access? Here, our Petauri colleagues at The Kinetix Group (TKG) provide an insightful 3-minute executive briefing on the topic: https://lnkd.in/emUaipm7 On 17th January 2024, CMS published the 'CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)' to improve the electronic exchange of healthcare data and streamline prior authorisation processes. This also adds a new measure for Merit-based Incentive Payment System (MIPS) eligible clinicians. From January 2026, health insurers participating in federal programmes, including Medicare Advantage and Medicaid, must respond to expedited (urgent) prior authorisation requests within 72 hours and standard (non-urgent) requests within 7 days. Insurers must also include their reasons for denying a prior authorisation request and will be required to publicly release data on denial and approval rates for medical treatment. They'll also need to give patients more information about their decisions to deny care. Download a written summary at: https://lnkd.in/eDCwr_9N If you'd like to learn more or for an introduction to TKG, email [email protected] #Medicare #Medicaid #pharma #patientaccess #marketaccess #pharmaceuticals

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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/g463TbZF #ProjectOptimus #Oncology #ParexelBiotech #NovelInsights

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Maximizing the Role of MSLs in Your Product Launch When it comes to launching a new pharmaceutical or biotech product, how is your organization utilizing Medical Science Liaisons? Are you deploying them early enough in the commercialization process to make a real impact? MSLs can play a critical role in ensuring that a product not only enters the market successfully but thrives long after its launch. Engaging KOLs Early 🔑 One of the key strengths of MSLs is their ability to build relationships with Key Opinion Leaders well before the product reaches the market. These early interactions provide valuable insights that shape clinical development and commercial strategies. Engaging MSLs early ensures that KOLs are well-informed and ready to support your product’s introduction. Translating Science into Action 🧬 MSLs serve as the bridge between complex clinical data and real-world practice. They play a pivotal role in helping HCPs understand the clinical and scientific benefits of your product. This ensures smoother adoption, as MSLs can effectively convey how a new therapy fits into current treatment paradigms or even how the new product may set a new standard of care. Creating a Strategic Feedback Loop 🔄 MSLs aren’t just educators—they’re listeners too. They gather crucial feedback from KOLs and frontline HCPs that can directly inform your commercial strategy. This feedback helps identify potential barriers to adoption, refine your messaging, and adjust tactics in real-time based on what’s happening in the market. Long-Term Support for Sustainability 📅 The value of MSLs extends well beyond the launch date. Post-launch, they continue to support HCPs with new clinical data, address ongoing questions, and reinforce the product’s value in the marketplace. This continuous engagement ensures long-term success and helps solidify your product’s position in the market. MSLs are a strategic asset in any successful product launch, from building early KOL relationships to supporting long-term clinical adoption. If your organization isn’t fully tapping into their potential, you may be missing out on key opportunities for launch success and sustained market growth. How is your organization integrating MSLs into your launch plan to maximize success? #MSLs #pharmalaunch #koldevelopment

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How can AI support clinical drug development? Join #IQVIA's #AI expert, Raja Shankar to learn more on Wednesday. And speak to me or one of the other IQVIA's #biotech client partners, Etienne DROUET, Antonio Vila-Coro about ways to optimize your clinical development programme

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There is a lot of talk about how big the global clinical trials market could be in the years to come. And these growth trajectories are in a large part thanks to the convenience and accessibility that decentralised trials provide. ​ ​ This article sets out how engaging patients remotely – for example using a platform like Medidata’s – makes trials more accessible and highlights the opportunities that cloud software presents. ​ ​ I’d love to know what you think. Have we merely scratched the surface of what’s possible with SaaS for clinical trials?​ ​ https://rebrand.ly/mbu8k2k #SaaS #DecentralisedTrials #DrugDevelopment #LifeSciences ​

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Just flicking through the Veeva Pulse Trends report (https://lnkd.in/e5SfZBfv) and there are a few fascinating stats. Big headline is that Pre-launch scientific outreach accelerates treatment adoption by 40% and Pre-launch field #medicaleducation improves treatment adoption by 50%! Clearly the MSL role is more important than ever... As a former rep and sales manager in the UK it is also depressing to see how low field activity is now in the UK compared to the other big European markets. Another reason (if one was needed) why a #multichannel or #omnichannel aproach is so vital.

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In 2024, 5 emerging BTK inhibitors are undergoing late-phase clinical investigation for #multiplesclerosis. Most clinicians are likely unaware of the clinical data regarding their use in MS. Dive into the data and earn free #CME here: https://bit.ly/4gViIVp #MedEd #FOAMed

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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/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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The mRNA technology platform holds immense potential to revolutionize the process of drug and vaccine development. On June 19th, join Parexel experts Sinan Sarac, Cecil Nick, and Christiane Niederlaender for a free live webinar on navigating regulatory challenges and conducting clinical research for mRNA therapies, accelerating your product development, approval, and improving patient outcomes. Webinar agenda: >  Section 1 - Accelerating Approval for Oncology Drug Development >  Section 2 - Optimizing the Path to Regulatory Approval for Novel Vaccine >  Section 3 - Overview of mRNA Product Manufacturing Challenges >  Q+A session and discussion Gain valuable insights to optimize your mRNA study. Details and registration information here: #mRNA #oncology #vaccine #regulatory

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Headed to Boston for the Chief Patient Officer summit on July 15-16? Don't miss the opportunity to catch Parexel's own CPO, Stacy Hurt 🌻. Stacy has so much valuable information and perspectives to share. She will be leading the team and speaking on both days. Learn how patient-guided approaches are changing clinical development, leading to better outcomes for all. Learn more about our team's participation or book a meeting with us at the event - Link below! #CPOSummit #PatientAdvocacy #PatientsFirst

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🧬 The Future of Life Sciences on the Einstein 1 Platform 🧬 Discover how to future-proof your business in #Biotech, #Pharma, #ConsumerHealth, and #MedTech with our innovative Life Sciences Cloud.

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Enriched EHR Data allows researchers to discover deeper clinical insights and outcomes than standard structured or claims data by itself. The largest ambulatory EHR dataset in the U.S. is now the largest Enriched EHR dataset. It's available for license or our experienced RWE team can conduct analysis on your behalf. #EHR #RWD #EnrichedData #ClinicalOutcomes #Insights #NLP #AI #RWE

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