Annette Helberg MBA

What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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The Neurology Edition of the 2023/4 Corporate Reputation of Pharma report is now available. This report is based on feedback from 339 global neurology patient groups, providing unique insights into their perception of the pharmaceutical industry. https://lnkd.in/eBFDy5kX

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💡 Our wonderful Oncology Therapeutic Experts at ICON Biotech collaborated with Citeline and industry specialist to uncover how new wave technology-driven therapeutics are reshaping oncology development! Have a read through the insightful discussion and feel free to reach out if you would like to connect with Andreas Dreps and Muaiad Kittaneh for a chat! #oncologydevelopment #emergingtechnologies #clinicalresearch

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Looking to empower your oncology trials with specialized CRO training? Our latest white paper dives into the critical role CRAs play in managing advanced oncology trials and how specialized training can help set up your trial for success. Download your copy today! https://bit.ly/48k1RHG

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In this episode of the podcast I am discussing diversity plans (no, it has nothing to do with politics!) and what to consider when developing your diversity plans. We need to reach out to more patients and make sure all patients have equal access to clinical trials but before we get to this point there are some steps that we all have to take (the industry, the patient groups and the regulators). #clinicaltrials #diversityplan #podcast #patientrecruitment

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𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐑𝐎𝐔𝐍𝐃𝐔𝐏 ⚛️ The FDA has released new draft guidance recommending best practices for multi-regional clinical trials (MRCTs) in oncology. Sponsors are encouraged to ensure that the outcomes of global oncology clinical development programs are understandable for US patients in support of marketing applications. 🌐 The FDA's final guidance on decentralized clinical trials (DCTs) clarifies several concerns raised by clinical experts and industry stakeholders regarding the earlier draft. This includes detailed requirements for maintaining a task log for healthcare providers, guidelines for physical inspections, and addressing challenges related to data variability in DCTs. 🤖 As the use of artificial intelligence (AI) tools, particularly generative AI, expands, experts remind regulatory professionals to prioritize the human aspect. Although these tools offer significant benefits, they necessitate human oversight and interpretation to be fully effective. During the opening plenary session, experts discussed how AI can be utilized across various sectors, the potential of this technology, and the hurdles in achieving its full benefits. Panelists included Ryan Kurtzman from the City of Long Beach, Bradley Thompson of Epstein Becker Green, Michelle Jump from MedSec, and Jay Mashburn from Recursion Pharmaceuticals, with moderation by Megha Iyer of Thermo Fisher Scientific. 🧬 As biosimilars gain market presence, they are generating competition with original products. However, patient adoption of biosimilars varies based on demographics, location, care setting, prescriber specialties, and types of insurance, according to two recent studies in Health Affairs. 🌐 The FDA has observed a rise in complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) over the last decade, with facility deficiencies being the most common reason cited, according to Leslie Rivera Rosado, a supervisory interdisciplinary scientist at the agency's Center for Drug Evaluation and Research (CDER). #Pharmaceuticals #Biotechnology #LifeSciences #PharmaNews #Biotech #HealthcareInnovation #DrugDevelopment #ClinicalResearch #Biopharma #PharmaTech #MedicalResearch #Healthcare #BioPharmaceuticals #PharmaIndustry #BiotechIndustry #PharmaCareers #MedicalInnovation #NewDrugs #Genomics #BiotechNews

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The European Medicines Agency (EMA) has just announced recommendations for the approval of several #drugs, including some specifically targeting #rarediseases. This is incredible news for patients who often have limited treatment options and underscores how much progress the #biotech industry is making in this area. Rare diseases affect a small percentage of people individually, but collectively, they have a massive impact—around 300 million people worldwide are living with one of over 7,000 identified rare conditions. Developing #treatments for these diseases is no easy task. It demands not only cutting-edge science but also deep expertise in trial design and navigating the complex regulatory landscape. This is where AIXIAL GROUP comes in. We’ve built a strong reputation in rare disease #clinicaltrials, working alongside biotech companies to help them bring life-changing therapies to market. Our focus is on solving the unique challenges that come with these kinds of trials—and we’re proud to have contributed to some amazing breakthroughs over the years. Here’s why we believe we’re a great partner for rare disease trials: 1) We Get It: Rare disease trials require a different level of precision and care. From designing #protocols to recruiting the right #patients, our team’s experience means we know how to avoid common pitfalls and deliver results. 2) Global Access: Rare diseases don’t respect borders. With our presence across North and South America, Europe, and APAC, we can tap into diverse patient populations—a critical factor for successful trials. 3) Innovative Thinking: Trials for rare diseases often face challenges like small patient numbers. That’s why we use approaches like decentralized and adaptive designs to make the process smoother and more efficient. 4) #Regulatory Expertise: Navigating approvals, especially through agencies like the #EMA, can be daunting. Our regulatory team is there to guide clients every step of the way, ensuring submissions meet the highest standards. The EMA’s recent approvals highlight how biotech companies are stepping up to address unmet medical needs. At #AixialGroup, we’re excited to be part of this journey—helping innovators turn their ideas into treatments that truly change lives. If your company is working on solutions for rare diseases, we’d love to be part of your story. Let’s work together to make a real difference.

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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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What a great way to showcase how our tailored approach can help with your clinical trial, whether it’s a transition study or not. Read our case study today: https://bit.ly/3MyaGDV

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Milestones can be challenging to accomplish, but with the MHRA metric for the average CTA assessment within their statutory timeframe, by acting now you could have your FiH data for Q1, 2025.

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In this edition of the New Medicines, Novel Insights newsletter, Martin Roessner, Corporate VP of Biostatistics at Parexel, discusses the potential for oncology trial acceleration through the implementation of flexible trial designs and master protocols. Learn how deviations from traditional approaches can increase efficiencies as Martin reviews key trial considerations, the case for real-world data (RWD), best practices, and potential use cases. Read the full article and subscribe to get the latest #NovelInsights each week! #Oncology #ClinicalInnovation #InnovativeTrial #RWD

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Interested in the latest insights from oncologists ahead of #ASCO24? 🚀 Check out perspectives on this year's conference from the front lines of cancer care in our latest blog post: https://lnkd.in/eYupPznU #ASCO24 #OncologyInsights #HealthcareMarketResearch

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Don't miss insights from the SCRS community in the newest issue of InFocus! Learn strategies to reduce patient burden, optimize patient payments, and plan for rare disease trials. Read it here ⇢ https://lnkd.in/emkvUXnm

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🔬 The Innovative Licensing and Access Pathway (ILAP) is evolving to bring transformative medicines to NHS patients faster. 🗓️ Relaunching in March 2025, the updated pathway will include: 1️⃣ A streamlined process 2️⃣ Selective entry criteria 3️⃣ Partnership with the NHS to address unmet needs. By focusing on early-stage clinical development, ILAP aims to reduce time to market while supporting developers with expert guidance and integrated access to regulatory and healthcare systems. This refreshed approach seeks to create a clearer, more impactful pathway for life-changing medicines. 🚨 Read our latest blog here 🔗 https://lnkd.in/ebkZuSVW #ILAP #MHRA #DrugDevelopment #RegulatoryAffairs #pharmaceuticals

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New Real-World Evidence Confirms AUSTEDO's Effectiveness in Huntington's Disease Treatment - https://lnkd.in/gYzeM2Eq Great read about AUSTEDO's effectiveness in treating Huntington's disease. #Teva Pharmaceuticals really hit the mark with their Phase 4 START study, presented at the 2024 AAN Annual Meeting. It's incredible to see the positive impact AUSTEDO (deutetrabenazine) Tablets are having on patients, especially with 80% reaching optimal dosing within just four weeks using the 4-week Titration Kit. #Realworldevidence backing its effectiveness, safety, and patient satisfaction is a game-changer. Kudos to Teva for leading the charge in improving treatment options for Huntington's disease! #HuntingtonsDisease #AUSTEDO #RealWorldEvidence #TevaPharmaceuticals #Neurology #Healthcare #PatientOutcomes #VMAT2Inhibitor

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Excellent panel here.

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Latest blog on approaches to participant recruitment in #RWE! Patients are at the heart of our real-world evidence research. But what to do if you craft a fabulous study design, in collaboration with patients and KOLs, and then start to look at the part of the design concerning the recruitment pathways?! ❓ How to do it? ❓ What are the options? ❓ What do you need to think about? Have a read to see the possible approaches to participant recruitment in real-world evidence research. #patientcenteredresearch #patientrecruitment

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I wish everyone a very successful 2025. Let's hope that all companies which have exciting new products will be able to secure funding in 2025. Our first video is out now. #clinicaltrials #UK #clinicalresearch

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Our recent industry meeting inspired me to share my experience with the clinical trials budget and contract process. As always I try to provide some recommendations on how we can improve the process. At the end of the day our patients will be the winners if we can set up clinical trials much quicker. It is always good to have that in mind! #clinicaltrials #budget #contract #UK

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