Fernando Mota PharmD,MSc,MBA

Elevate Your Clinical Operations with Expert Contract Staffing! In the rapidly evolving biotech landscape, securing top-tier talent for clinical operations is crucial. As we navigate 2024, the demand for skilled professionals in Europe has never been higher. With over 15 years of experience in the biotech sector, I understand the unique challenges and opportunities you face. Our specialised contract staffing solutions are designed to meet your precise needs, ensuring you have the right expertise at the right time. Whether you're scaling up for a new clinical trial or need interim support, our network of experienced professionals is ready to step in and drive your projects forward. We pride ourselves on matching you with candidates who not only have the technical skills but also align with your company culture and values. Let's connect and discuss how we can support your clinical operations with flexible, high-quality staffing solutions. Your success is our priority, and together, we can achieve remarkable milestones in biotech innovation. #Biotech #ClinicalOperations #ContractStaffing #Science #HRS

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🌟 Seeking Biotech Innovators! 🌟 Are you at the forefront of biotechnological advancements, pushing the boundaries of what's possible in Clinical Operations? Your groundbreaking work deserves the brightest minds to propel it forward. I'm thrilled to extend an exclusive invitation to visionary Biotech firms across Europe: let's collaborate to elevate your Clinical Operations to new heights with bespoke contract staffing solutions. 🔬 Why Contract Staffing? - Flexibility to scale your team in tune with project demands - Access to a curated pool of specialized talent - Streamlined hiring process to fast-track your operations Our expertise lies in understanding the unique pulse of the Biotech sector and matching it with professionals who don't just fit the role technically but are also aligned with your company's dynamic culture and mission. 🌍 European Biotech, We've Got You Covered - We're well-versed in the diverse European regulatory landscape - Our network spans the continent, offering local expertise with a global perspective - We ensure seamless integration of contract professionals into your existing teams Let's join forces to accelerate your clinical trials and research, with the right people driving your mission. Whether it's a niche skill set or a leadership role, we're here to provide the talent that powers your innovation. 📈 Your Success, Our Commitment We're not just about filling positions; we're about building partnerships that foster growth, innovation, and breakthroughs in the biotech space. Ready to enhance your Clinical Operations with top-tier talent? Let's talk. #Biotech #ClinicalOperations #ContractStaffing #Europe Your journey towards groundbreaking discoveries is just a conversation away. Reach out to me directly, and let's make history together. 🚀 --- Remember, the right talent is the catalyst for your success. Let's connect and propel your Clinical Operations forward! #HRS #Science

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Breaking ground in Oncology: Europe's Next Chapter 🌍💡 In an unprecedented move, leading pharmaceutical giants are gearing up for a series of large-scale clinical trials in oncology across Europe. With innovative therapies on the horizon, the focus is sharpening on the critical role of staffing to ensure these trials succeed. Groundbreaking research promises not just hope, but real change. From targeted therapies to immunotherapies, these trials could redefine cancer treatment as we know it. As each phase demands precision and expert knowledge, the need for top-tier clinical researchers, data analysts, and medical professionals is at its peak. Europe stands at the forefront of this endeavour, and it's our shared mission to see it thrive. We're talking cutting-edge science meeting top talent to transform lives. Join the conversation - what's your take on Europe's potential to lead the next wave of oncology breakthroughs? #OncologyInnovation #ClinicalTrials #PharmaCareers #HRS #Science

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The #ACTEU (Accelerating Clinical Trials in the EU) initiative has launched two advice pilots for developers of medicinal products who wish to receive advice on the requirements for a marketing authorisation or a clinical trial application - worth checking out.

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🔍 Freelance Clinical Research Associates (CRAs) are the unsung heroes in the fast-paced world of medical advancements. Based in Europe, these professionals are more crucial than ever. Here's why: 🌍 The European pharmaceutical landscape is vast and diverse, with a myriad of clinical trials conducted across the continent. Freelance CRAs bring a level of flexibility and expertise that is invaluable to this dynamic environment. 🔬 With their ability to quickly adapt to different projects and therapeutic areas, freelance CRAs ensure that clinical trials run smoothly, data integrity is maintained, and regulatory compliance is met. They are the agile force that can move from one study to another, bringing their wealth of knowledge to each. 🤝 The demand for freelance CRAs in Europe is on the rise, driven by the need for specialized knowledge in niche therapeutic areas and the growing trend of virtual and decentralized trials. Their role is pivotal in bridging the gap between innovative medical research and the market, ensuring that new treatments are safe and effective. 💡 If you're a life sciences company or a research institution, consider the strategic advantage of engaging with freelance CRAs. They not only bring their expertise to your projects but also offer a cost-effective solution to scaling your research efforts up or down as needed. 🌟 For my fellow European freelance CRAs, let's connect and share our experiences. Your work is vital in the quest to improve patient outcomes and advance healthcare. Let's continue to make a difference, one study at a time. #ClinicalResearch #FreelanceCRA #EuropeanPharma #HRS #Science

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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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#News: Bayer and Evotec have updated the focus of their strategic collaboration to develop #precisiontreatments for #cardiovasculardiseases (CVDs). Financial terms were not disclosed.   The collaboration aims to identify and validate #noveltargets, with the goal of building a portfolio of precision #cardiologytherapeutics by leveraging #Evotec's disease modelling capabilities using human #inducedpluripotentstemcells (iPSCs). #iPSCs provide unique opportunities to identify new disease mechanisms and pathways for novel treatments. Under the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms.   Bayer and Evotec will share responsibilities during the preclinical development of potential clinical candidates. Bayer will be responsible for any subsequent clinical development and commercialization.   “This development takes our long-standing collaboration with Evotec to a new level, and has the added benefit of lessons learned from working together the past 12 years,” said Juergen Eckhardt, M.D., Head of Business Development & Licensing at Bayer’s Pharmaceuticals Division. “We remain committed to develop innovative therapies for patients in need and to tackle the high burden of cardiovascular disease.”
 Read more from Contract Pharma 👇🏼

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In healthcare, collaborations often bring revolutions. Exciting news in women's health comes from the Swiss duo ASPIVIX and Bayer (Schweiz). They've joined forces to present Carevix, an innovative cervical stabiliser, shaking up the world of gynaecology. Carevix shines as a beacon for comfort, touting a CE Mark for its ability to make transcervical procedures, like IUD placements, less daunting. This partnership marries Bayer's contraceptive expertise with ASPIVIX's vision for gynaecological advancements. Together, they're tackling the challenge of painful IUD insertions head-on, improving experiences for countless women. It's big news when a new device promises to ease a common pain point for millions. Carevix is set to replace the outdated tenaculum with a gentler approach that has shown to lessen both pain and bleeding. This technology aligns perfectly with today's healthcare standards, focusing not just on effectiveness but also on patient comfort. #WomensHealth #Innovation #Carevix

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Early treatment of chronic kidney disease (CKD) can slow or halt its progression, improve quality of life, and reduce cardiovascular risk. Sadly, 90% of patients with CKD are undiagnosed. During UNGA79, AstraZeneca — together with co-sponsor Boehringer Ingelheim and partners the International Society of Nephrology Global Patient Alliance for Kidney Health, and co-host Devex — convened leading voices in global health and policy for a critical discussion on the urgent need to implement patient-centred and evidence-based policies to enable earlier detection and diagnosis of CKD and immediate access to care and recommended treatments. We need to act now. Sign up to be part of making the change: https://lnkd.in/eXFe-UJf #UNGA79 #ForKidneyHealth https://lnkd.in/ePHbvkvt

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#News: Roche (ROG.S),  on Thursday raised its full-year earnings forecast after exceeding expectations for the first half, driven by strong demand for newer drugs such as #eyemedicine #Vabysmo. The Swiss drugmaker said it expects growth in adjusted earnings in the "high single-digit range", excluding the effect of currency swings and resolution of tax disputes in 2023, up from previous estimates of "mid single-digit" percentage growth. Shares were up 2.4% in morning trading, after earlier rising as much as 4% to a one-year high. First-half adjusted operating profit gained 4% to 11.3 billion Swiss francs ($12.8 billion), the family-controlled drugmaker said on Thursday, beating analysts' consensus estimate of 10.5 billion, based on LSEG data. Read more from Reuters 👇🏼

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Check out AUX-001 Phase 1a results presented at European Society of Cardiology annual meeting in London by Uwe Tigör, MD, our Chief Medical Officer at Auxilius Pharma. Phase 1a study explored the safety, tolerability, and pharmacokinetics of our compound, which is promising new medication for chronic stable angina. Now that the meeting’s embargo has lifted, we’re thrilled to share these results with you! Check out the attached presentation for more details. If you’d like the full version of the deck, feel free to reach out directly to @Uwe Tigör, MD or to me #cardiology #CSAP #AUX001 #ESC #newmedication #biotech #news

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I’ve listened to Tamer Chowdhury earlier, this will be great presentation! ACDM: Association for Clinical Data Management #acdm25

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From this week's Borderless Newsletter: The European Commission has granted marketing authorization for LEO Pharma's Anzupgo (delgocitinib) cream. This new treatment is for adults with moderate to severe chronic hand eczema who can't use topical corticosteroids. Backed by successful Phase III DELTA 1 and DELTA 2 trials, Anzupgo offers a much-needed option for patients across the EU, Norway, Iceland, and Liechtenstein. As LEO Pharma CEO Christophe Bourdon stated, "This approval provides a new treatment option for patients, and we look forward to coordinating the next steps required to provide Anzupgo to those patients who need it." A significant step forward in improving care for those living with this challenging condition. #Borderless #Chronichandeczema #Anzupago

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Repurposing, new drug development and generics. We - BioResearch Pharma SA - chose business model based on repurposed topical dermatological treatments. WHY? 💡High Entry Barrier: unlike generics developing a repurposed drug allows patents, carry unique know-how, and data protection, which means a lower risk of early substitution. 💡Reduced Risk and Costs: repurposed drugs are based on substances that have already been extensively tested and shown to be safe in humans, which reduces the risk of failure during clinical trials leading to a lower development costs . 💡Shorter Regulatory Pathway: in the USA, repurposing follows the 505(b)(2) regulatory pathway, and in the European Union, the hybrid pathway, which allow the use of research data not conducted by the applicant, including results from previous studies of already approved referrence drug. 💡Accelerated Timeline: as a result of the above and scientific research shows that repurposed drug can be brought to market in just 3-5 years instead of the 12-17 years typically required for a new chemical entity. The patent protection of our innovation BRP-011 covers the #EU and the #UK, while the BRP-007 patents cover the #EU, the #USA and #Australia. More information: https://lnkd.in/dq_aT9ic #pharma #dermatology

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Well, the last couple of months let me reflect a lot on #management and #leadership, not only because I read 'make work more fun' by the Corporate Rebels. Today, I realized that the way you lead pretty much depends on the view you have on humans (which is likely not the most radical insight). Last year, I read #humankind by Rutger Bregman (I like the German title much more "Im Grunde gut"). This book was truly inspiring to me as it outlined that human beings behave much better than e.g. the news might suggest. It was eye-opening. After reading, I am sure you will see many things differently in your day-to-day interaction with others on the streets, at home but also how leadership might look like. Here's a graphical overview. BTW: you can listen to "Im Grunde gut" at least in german on #spotify.

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Realized you've left it late to create your SDTM Define.xml or unsure how to start? No worries! At Cliniva, we have the expertise, the know-how, and the tools to create it for you. 🌟 📧 Contact us at [email protected] #CDISC #SDTM #Define #Standards #Programming

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In need of #Regulatory-grade EU Oncology data? Let's meet in Madrid at #EHA next month! Please reach out to learn more about our tailored reports and ECA capabilities from the leading source of European oncology data. https://ow.ly/s3Ee30sCAv2 #EHA2024 #OncologyData #RealWorldResearch #Externalcontrolarm

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