Delphine Bernard

THE FUTURE OF THE CRA CRA demand has outrun supply for some time now, driven by increasing trial sizes and the rise of more complicated scientific assets (and therefore complex trial data). Side note: this has also been the main driver in the considerable increase of salaries for experienced CRAs. ⏪ Let’s rewind a bit.. 🔍 The CRA in history: Site assessments, onsite visits for data monitoring, face-to-face site contact, site personnel supervision, post-visit report writing and more. So what’s changed?.. 😷 The CRA was one of the most affected roles during the pandemic, with questions over face-to-face contact and patient safety. 🌍 This, coupled with technology revolution and increasing globalisation of clinical trials, gave further permission to the use of decentralized trials (that is where clinical trial activities take place at locations other than the clinical trial site e.g. a patient’s home or nearby care facility) and remote monitoring (that is, virtual data collection with the use of new digital technology). ✋ Both methods enable more patients to participate in a clinical trial, ultimately increasing participation numbers, retention and diversity. What does this mean for the CRA? 💻 With huge increases in data quantity (and arguably quality), coupled with different data formats and collection methods, the CRA will be required to expand their skill set to data monitor, data analyst and risk analyst. ✍ It is also anticipated that AI will take over a lot of the CRA’s admin responsibility such as data collation and document review, shifting their priorities. 🏥 Whilst historically a CRA would often be seen as site owner, demanding travel schedules often prevented full embracement of this role. With less travel comes more time to dedicate to sites, relationship building, patient flow and ultimately being a true site expert. Will CRAs become data scientists? 🤝 Whilst technology advances are changing the role of a CRA, it’s likely that this may increase the need for the ‘human touch’ with clinical trial sites. ⚙ Without CRAs being on hand to train trial-sites, answer queries and engage site staff, clinical trials would not function. 💡 Having said that, CRA training will need to be re-considered: digital tools, altered data handling and collection, virtual monitoring to name a few. 📚 The CRA is being forced to adapt. Different skills are being required and therefore different candidates will be selected to perform the role if they do not keep up, or are not offered appropriate upskilling support. #CRA #Clinicalresearchassociate #Clinicalresearch #Pharma

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Really proud that Parexel has achieved a Silver Award in the 2024 EcoVadis Sustainability Rating program for the third in a row! 🌿 If you're curious about our sustainability targets this year, check out our latest ESG report: https://lnkd.in/dft336RM #sustainability #esg #ecovadis

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Episode 3: Part 2 Welcome back as we continue the conversation with Cécile Tardy-Srinivasan, Head of Startup Accelerator program DayOne - Healthcare Innovation What does the partnership with pharma look like? Well, Cecile says, "Get ready for the lengthy process.". But what other things to focus on? Join us on this part to find out more! If you have any additional questions, feel free to connect with me or Cecile directly 🙌 #medtechwithindre #medtech #digitalhealth #healthinnovation

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👩‍⚕️ For the first time ever, 𝗮𝗹𝗹𝗼𝗴𝗲𝗻𝗲𝗶𝗰 𝗖𝗔𝗥-𝗧 cells have been successfully used to treat an 𝗮𝘂𝘁𝗼𝗶𝗺𝗺𝘂𝗻𝗲 𝗱𝗶𝘀𝗲𝗮𝘀𝗲! This is an approach traditionally applied in cancer therapy, but now it opens new doors for millions battling autoimmune conditions like lupus and multiple sclerosis. 𝙒𝙝𝙮 𝙞𝙨 𝙩𝙝𝙞𝙨 𝙖 𝙜𝙖𝙢𝙚-𝙘𝙝𝙖𝙣𝙜𝙚𝙧, you ask? 🔬 Until now, CAR-T cell therapy was limited to oncology. This breakthrough marks its debut in autoimmune disease treatment, showcasing the versatility and potential of this cutting-edge technology. 💡 Allogeneic CAR-T cells, derived from healthy donors, provide a more accessible and potentially more effective treatment option compared to patient-specific therapies. 💪 This new method promises targeted treatment, reduced side effects, and improved efficacy, potentially leading to long-term remission and enhanced quality of life for patients. This milestone exemplifies the rapid advancements in genetic engineering and immunotherapy, offering hope and new possibilities for millions. Exciting times ahead in the fight against autoimmune diseases! #Biotechnology #HealthcareInnovation #CAR_TCells #AutoimmuneDisease #MedicalBreakthrough #GeneTherapy #PrecisionMedicine read the full story here: https://lnkd.in/eFE8j_gv

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🎉 Exciting insights from MaaT Pharma from ASH 2024! 🎉 Their innovative work in microbiome-driven therapies continues to make waves in oncology and hematology A must-watch for anyone tracking cutting-edge advancements in the field! They are presenting their excellent data for their GvHD trial: 🦠 Sustained high response rates at Day 28: Gastrointestinal Overall Response Rate (GI-ORR): 51% Overall Response Rate (ORR) for all organs: 49% 🦠 Long-term survival outcomes: 47% OS at 12 months 42% OS at 24 months #Microbiome #Oncology #ASH2024 #biotech #hematology #GvHD

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#FreelanceStaff #ClinicalTrials #Europe In Europe's dynamic Clinical Trials space, the demand for Freelance Staff is rapidly escalating. 🌟 From navigating regulatory nuances to ensuring trial integrity, freelance professionals bring unparalleled expertise and flexibility to the table. 💼 As trials evolve, the need for specialized skills grows, making freelancers a pivotal resource. Let's collaborate and elevate clinical research together! 💬 #ClinicalResearch #IndependentExperts #InnovateEurope #HRS #Science

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𝐅𝐃𝐀 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐍𝐞𝐰𝐬! The FDA has granted a priority review for Roche's inavolisib, in combination with fulvestrant and Pfizer’s Ibrance (palbociclib), for treating PIK3CA-mutated, HR-positive, HER2-negative breast cancer. This decision sets a date of 27 November for the FDA to evaluate the therapy. The therapy targets adult patients with locally advanced or metastatic breast cancer, especially those experiencing recurrence within 12 months of adjuvant endocrine treatment. Inavolisib, an oral PI3 kinase inhibitor, disrupts PI3K/Akt/mTOR pathway signaling, crucial for cell growth and survival. It also recently received breakthrough therapy designation. The priority review is based on promising results from the Phase III INAVO120 trial, where the combination therapy showed a progression-free survival of 15 months compared to 7.3 months with the standard fulvestrant and Ibrance regimen. Roche is also pursuing regulatory approval in other regions, including with the European Medicines Agency. More detailed data will be presented at the upcoming ASCO Annual Meeting in Chicago from 31 May to 4 June. in other FDA news, Eli Lilly and Company have secured accelerated approval for Retevmo, their treatment for pediatric cancers. Follow Warman O'Brien for all the latest news in life sciences! #oncology #goodnews #fdaapproval #nextsteps

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Odgers Berndtson Global Life Sciences Update Below! We're seeing incredible momentum in Canada to build a world-class life sciences economy. It’s inspiring to be part of the collaborative effort to bring great leadership to the helm of this rapidly evolving sector. #LifeSciences #ExecutiveSearch #HealthcareLeadership #Innovation #GlobalTalent #CanadaLifeSciences

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Using a direct-to-patient application, leveraging social media, digital platforms and tokenization enabled Parexel to reach under-represented patient groups, collect their consent and survey data, and link their data with claims data, while ensuring their privacy and identity protection. In this article just published by my colleagues in ISPOR's Value & Outcomes Spotlight, learn more about how this study enhanced patient diversity, engaged communities and employed robust data-linking techniques to optimize interventions and improve patient outcomes.

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🔍 Freelance Clinical Research Associates (CRAs) are the unsung heroes in the European pharmaceutical landscape. As we navigate through an era where medical innovation is at its peak, the demand for skilled CRAs is skyrocketing. 🚀 In the heart of Europe's bustling healthcare industry, freelance CRAs bring a unique blend of flexibility and expertise. They're the agile operatives behind successful clinical trials, ensuring that new treatments meet the stringent regulatory standards. 📋💊 But why are they so crucial, you ask? Here's the scoop: 1️⃣ Adaptability: With the healthcare sector evolving rapidly, freelance CRAs can adapt to diverse projects with ease, making them invaluable during times of unexpected shifts or when niche expertise is required. 2️⃣ Cost-Effectiveness: For organizations, the ability to hire CRAs on a project-by-project basis is a game-changer. It means access to top talent without the long-term overheads. 💸 3️⃣ Expertise on Demand: Europe's diverse regulatory environment calls for CRAs who can navigate multiple jurisdictions. Freelancers often come with a wealth of experience from various regions and therapeutic areas. 4️⃣ Work-Life Harmony: For the CRAs themselves, freelancing offers a coveted balance. They can choose projects that align with their interests and manage their schedules to fit their lifestyle. 🌟 The bottom line? Freelance CRAs are the linchpin in the wheel of clinical research. They ensure that Europe remains at the forefront of medical advancements while supporting the dynamic needs of the healthcare sector. If you're a freelance CRA based in Europe or looking to dive into this field, now is your time to shine. The industry needs you more than ever! 💪 #ClinicalResearch #FreelanceCRA #HealthcareInnovation #EuropeanPharma #Science #HRS

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In the latest episode of the Parexel podcast series, "De-Risking Drug Development," our host, Paul Bridges, and colleagues discuss the challenges and critical decision points in early-phase clinical development. Join Mwango Kashoki, Camilla Ramdeen, and Oliver Fuhrmann as they delve into the reasons why a third of drugs fail to progress from phase two, the role of feasibility planning in patient selection, and the potential of #AI in making studies more efficient and attractive. This multi-perspective discussion ends with each of our speakers sharing one key takeaway that biotech leaders should, but often don't, consider at this phase of their drug development. Don't get stuck in phase one. Learn how we're mitigating risk for biotech companies. #ParexelBiotech #EarlyPhase #ClinicalDevelopment #Biotech

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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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TLDR Biotech for June 27 - 30 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬: AstraZeneca, Sanofi's infant RSV vaccine gets thumbs-up from German vaccine advisory panel 💉 + 3 more stories 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Lantheus purchases two radiopharmaceutical assets from Life Molecular Imaging 💼 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: J&J touts stellar Ph3 myasthenia gravis results 🧪 + 1 more story 𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐋𝐚𝐮𝐧𝐜𝐡𝐞𝐬: Ensho Therapeutics launches with assets acquired from Eisai 🚀 𝐅𝐮𝐧𝐝𝐫𝐚𝐢𝐬𝐞𝐬: Savara $100M underwritten offering 💰 + 2 more stories 𝐋𝐚𝐰𝐬𝐮𝐢𝐭𝐬: Daiichi-Sankyo wins patent dispute against Seagen (Pfizer) ⚖️ 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐩𝐨𝐫𝐭𝐬: Analysts predict change in Osteoporosis market winds; Amgen punching air 📊 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬: CMS provides details on cell & gene therapy access pilot 🏥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲: Supreme Court overturns Chevron doctrine, potential FDA ramifications 🏛️ All this and more in today's TLDR Biotech newsletter - link to the latest issue: https://lnkd.in/g3qevCtg Or subscribe to get it straight to your inbox: https://lnkd.in/gecXctqM #tldrbiotech #biotechnews #pharmanews

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We are pleased to share the results of our study to estimate the burden of COVID-19, and the impact of vaccines on that burden, in the immunocompromised in France. Together with colleagues at Moderna and our clinical expert, we wrote the manuscript, “Substantial reduction in the clinical and economic burden of disease following variant-adapted mRNA COVID-19 vaccines in immunocompromised patients in France”. It has been published by Human Vaccines & Immunotherapeutics and is now available here: https://lnkd.in/gbBFkTKC

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TLDR Biotech for June 27 - 30 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬: AstraZeneca, Sanofi's infant RSV vaccine gets thumbs-up from German vaccine advisory panel 💉 + 3 more stories 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Lantheus purchases two radiopharmaceutical assets from Life Molecular Imaging 💼 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: J&J touts stellar Ph3 myasthenia gravis results 🧪 + 1 more story 𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐋𝐚𝐮𝐧𝐜𝐡𝐞𝐬: Ensho Therapeutics launches with assets acquired from Eisai 🚀 𝐅𝐮𝐧𝐝𝐫𝐚𝐢𝐬𝐞𝐬: Savara $100M underwritten offering 💰 + 2 more stories 𝐋𝐚𝐰𝐬𝐮𝐢𝐭𝐬: Daiichi-Sankyo wins patent dispute against Seagen (Pfizer) ⚖️ 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐩𝐨𝐫𝐭𝐬: Analysts predict change in Osteoporosis market winds; Amgen punching air 📊 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬: CMS provides details on cell & gene therapy access pilot 🏥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲: Supreme Court overturns Chevron doctrine, potential FDA ramifications 🏛️ All this and more in today's TLDR Biotech newsletter - link to the latest issue: https://lnkd.in/gign9-Sw Or subscribe to get it straight to your inbox: https://lnkd.in/gh68uhTQ #tldrbiotech #biotechnews #pharmanews

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🔍 The Freelance Revolution in Clinical Trials 🚀 In the dynamic landscape of clinical trials, the demand for agility is at an all-time high. As we navigate through 2024, the need for freelance staff in Europe's clinical trials space is becoming increasingly evident. Here's why: 🌍 Global Expansion: Clinical trials are no longer confined to national borders. With Europe being a hub for medical research, freelancers offer the flexibility to scale operations across countries swiftly. 💡 Expertise on Demand: The complexity of clinical trials requires specialized knowledge. Freelancers bring targeted expertise exactly when and where it's needed, without the long-term commitment of full-time hires. ⏱️ Time-Efficient: Time is of the essence in clinical trials. Freelancers can be onboarded quickly to keep pace with the fast-moving regulatory environment and project timelines. 💼 Cost-Effective: Budget constraints are a reality. Freelancers help optimize costs by reducing overheads associated with full-time staffing, allowing funds to be allocated directly to research and development. 🤝 Collaboration: The freelance model fosters a culture of collaboration, with professionals from various backgrounds contributing to innovative solutions in clinical research. 🔄 Flexibility & Adaptability: Freelancers are accustomed to adapting to new projects and environments, making them ideal for the fluid nature of clinical trials. In conclusion, the freelance workforce is a game-changer for clinical trials in Europe. It offers a strategic advantage by combining flexibility, specialized skills, and cost efficiency. As we embrace this new era of work, the potential for innovation and progress in healthcare is limitless. #ClinicalTrials #FreelanceRevolution #HealthcareInnovation #HRS #Science

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🔷Ophthalmology Clinical Project Leadership Team at IQVIA🔷 👓Noga Senderowitsch, M.Sc, Associate Clinical Project Management Director, has a lot of great information to share about the Internal Medicine Clinical Project Leadership Team's #Vision of Ophthalmology at #IQVIA. ⚕IQVIA's #InternalMedicine Clinical Project Leadership team performs seamless project management; this helps to ensure that every phase of a trial is executed with precision and efficiency, allowing the team to anticipate and mitigate potential delays and keep trials on track for success! #WeAreIQVIA #Ophthalmology #ClinicalResearch #ClinicalTrials

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Join us for a webinar discussing the implications of the FDA & EMA's latest guidance on Decentralized Clinical Trials (DCTs). Learn practical strategies for implementation, and gain insights into study design considerations and regulatory compliance. Register here ⇢ https://lnkd.in/e7WwvtCM

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🚨 miDiagnostics Secures €30M Series D Funding to Advance Sterility Testing for Biopharma! 🧬💡 Belgium-based MiDiagnostics has raised €30M in its Series D funding round, led by Thermo Fisher Scientific and supported by existing investors like Alychlo, VMF Invest, and Pamica. With this new funding, MiDiagnostics will: 🔬 Accelerate development of a revolutionary sterility test for batch release in biopharma using its cutting-edge qPCR technology. 🌍 Leverage Thermo Fisher’s expertise to bring innovative solutions to market. 💻 MiDiagnostics’ tech combines: ✔️ A nanofluidic processor on a silicon chip ✔️ A compact reader for rapid analyte measurement MiDiagnostics CEO Katleen Verleysen stated: "This funding will enable us to expedite our development efforts and revolutionize sterility testing in the biopharma sector.” Notably, MiDiagnostics is also behind a SARS-CoV-2 breath test developed in 2021, showcasing its commitment to pushing boundaries in diagnostics. 🔗 Collaborations with imec and The Johns Hopkins University highlight the firm’s strong foundation in innovation. #Diagnostics #Biopharma #FundingNews #Innovation #ThermoFisher #LifeSciences #MiDiagnostics #PCRTechnology

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