Are you attending the World Orphan Drug Congress April 23 - 25, 2024 in Boston? If you need reasons to attend, here are 3 great reasons: 1. #1 Networking opportunity in the rare disease and orphan drug space: The event brings together key stakeholders from across the orphan drug ecosystem, including pharmaceutical companies, biotechs, patient advocacy groups, regulatory agencies, and investors. Networking at the event provides attendees with the chance to forge valuable connections, collaborate on projects, and explore potential partnerships that can drive innovation and advance research in orphan drug development. 2. Access to Industry Insights and Expertise: The event features 3-days of insightful and inspiring presentations, keynote sessions, workshops, roundtables, and so much more led by leading experts and thought leaders in the field of rare diseases and orphan drugs. 3. Learning and Education: whether you’re a researcher clinician, industry executive, or policymaker, WODC will enhance your knowledge base, deepen your understanding of rare diseases, and keep you up to date on the latest advances in orphan drug development and patient care. And if you need another reason, I’ll be there!! If you are attending, leave me a comment - I am looking to meet people! #raredisease #rarediseases #rareaccessactionproject #WODC #smallbiopharma
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CEO/CD, Copy, TEDx Speaker, We provide expert agency services for small/medium healthcare, biopharma, and rare disease companies, delivering strategy + tactics. We are the agency the big agencies call for our expertise.
Are you attending the World Orphan Drug Congress April 23 - 25th in Boston? If you haven't made a decision yet, here are 3 reasons to attend: 1. #1 Networking opportunity in the rare disease and orphan drug space: The event brings together key stakeholders from across the orphan drug ecosystem, including pharmaceutical companies, biotechs, patient advocacy groups, regulatory agencies, and investors. Networking at the event provides attendees with the chance to forge valuable connections, collaborate on projects, and explore potential partnerships that can drive innovation and advance research in orphan drug development. 2. Access to Industry Insights and Expertise: The event features 3-days of insightful and inspiring presentations, keynote sessions, workshops, roundtables, and so much more led by leading experts and thought leaders in the field of rare diseases and orphan drugs. 3. Learning and Education: whether you’re a researcher clinician, industry executive, or policymaker, WODC will enhance your knowledge base, deepen your understanding of rare diseases, and keep you up to date on the latest advances in orphan drug development and patient care. And if you need another reason, I'll be there and I'd love to connect with you! If you are planning to attend, leave me a comment and let's connect!! #raredisease #rarediseases #rareaccessactionproject #WODC #smallbiopharma
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Are you attending the World Orphan Drug Congress April 23 - 25th in Boston? If you haven't made a decision yet, here are 3 reasons to attend: 1. #1 Networking opportunity in the rare disease and orphan drug space: The event brings together key stakeholders from across the orphan drug ecosystem, including pharmaceutical companies, biotechs, patient advocacy groups, regulatory agencies, and investors. Networking at the event provides attendees with the chance to forge valuable connections, collaborate on projects, and explore potential partnerships that can drive innovation and advance research in orphan drug development. 2. Access to Industry Insights and Expertise: The event features 3-days of insightful and inspiring presentations, keynote sessions, workshops, roundtables, and so much more led by leading experts and thought leaders in the field of rare diseases and orphan drugs. 3. Learning and Education: whether you’re a researcher clinician, industry executive, or policymaker, WODC will enhance your knowledge base, deepen your understanding of rare diseases, and keep you up to date on the latest advances in orphan drug development and patient care. And if you need another reason, I'll be there and I'd love to connect with you! If you are planning to attend, leave me a comment and let's connect!! #raredisease #rarediseases #rareaccessactionproject #WODC #smallbiopharma
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🔍 What’s stopping pharma companies from running commercial trials in Africa? We agree it's the right and ethical thing to do, yet it isn't happening... No one wants to be the first. eMQT proposes a change! 🌍 Calling all pharma companies committed to diversity in clinical trials. Join us in building Centres of Excellence together! 🌟 Here’s our simple 3-step proposal: 1️⃣ Meet with eMQT to discuss your therapeutic area and patient population focus. 2️⃣ We identify suitable sites and countries in Africa to match your needs. 3️⃣ Collaborate with us to build Centres of Excellence! Let’s lead the way in transforming clinical research.💡🤝 #DiversityInTrials #ClinicalResearch #PharmaInnovation Contact us today to start the journey! 🌟 https://buff.ly/40eOKUb Pfizer Roche AstraZeneca Gilead Sciences Vertex Pharmaceuticals Veramed Takeda GSK Genentech Novartis Moderna Shalom Ijeoma Lloyd MBE Tina Barton Emily Moore Hannah White Nancy Meyerson-Hess
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We are thrilled to announce that Chief Scientific Officer, ARMELLE PINDON, PhD, and Board Member, Alexis Elder, will both be panelists at the 2024 World Orphan Drug Congress USA in Boston, MA on April 24-25. "The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies." -WODC Website We look forward to sharing more about all the wonderful discussions! #WorldOrphanDrugCongress #WODC #VCPdisease #raredisease #CureVCPDisease
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We are thrilled to announce the continued collaboration between Astellas and Patient Advocacy Leaders and Drug Development Industry Network (PALADIN), as well as the launch of the highly anticipated PALADIN Playbook and Resource Repository. This collaboration represents an important milestone in our efforts to advance patient advocacy group (PAG) and industry collaborations, with the ultimate goal of increasing access to life-saving treatments. PALADIN Consortium, in which Astellas is an active participant, plays a pivotal role in establishing more effective relationships between PAGs and biopharmaceutical companies. By developing consensus-based guidelines, training, resources, and competencies, PALADIN aims to optimize collaborations and transform the pace of new medical therapies' development. We are excited about the potential of this collaboration and the impact it will have on relevant stakeholders and the community. Together, we can create meaningful change and drive progress in the industry. Stay tuned for further updates and announcements as we continue this exciting journey with PALADIN. For more information, including PALADIN Playbook and Resource Repository, visit https://lnkd.in/gPk4H8M7. #PatientAdvocacy
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Director at ZEMA Pharma Consulting | Utilize clinical data throughout medical services, access, and commercialization | Identification of unmet needs | Real World Evidence |
Thrilled to share our focus on Denmark's healthcare landscape within oncology and hematology at ZEMA Pharma Consulting! 🎯 With +10 years of experience from the Danish healthcare system and the pharmaceutical industry, we understand the ins and outs of the healthcare system. This insight allows us to tailor strategies that resonate deeply with local stakeholders, ensuring effective access to the market through the strategic use of clinical data and crafting convincing health economics approaches together with health economic agencies. We're here to guide you every step of the way. Please feel free to reach out to explore how we can elevate your presence in the Danish market and beyond! 🚀 #ZEMAPharmaConsulting #MedicalAffairs #DanishMarketExpertise
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Do you ever wish you had a personal guide to answer your questions, help you navigate pitfalls, and avoid delays along your non-clinical drug development journey? Our scientific experts are here to offer you exactly that: global expertise, with a personal touch. Dr. Sam Chuang recently presented in San Diego, CA to a limited, in-person audience where he shared his experience on building effective drug development strategies. Take a peek at the Q&A to glean key insights from the session: https://okt.to/9N1L8J #drugdevelopment
Q&A: Insights into Creating an Effective Drug Development Strategy
criver.com
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As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. This year, the U.S. Food and Drug Administration (FDA) has approved 47 new molecular entities for therapeutic use, already exceeding last year’s progress, which yielded 37 novel drug approvals. These advancements speak to a renewed momentum as the industry recovers from recent years’ challenges associated with the COVID-19 pandemic. To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments. From the survey results, our experts identified major trends for the coming year in patient recruitment, patient diversity, use of AI, big data and analytics and outsourcing. Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget. -PPD
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Navigating the maze of clinical trials is daunting, especially with FDA designations. Here's a primer:
💊 FDA Designations Explained 💊 Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here's a breakdown of some crucial designations ⬇ 1️⃣ Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies and three phases of clinical trials to assess safety and efficacy thoroughly. 2️⃣ Orphan Designation: Reserved for drugs targeting rare diseases, this designation offers incentives like tax credits and marketing exclusivity to encourage development for underserved patient populations. 3️⃣ Fast Track Designation: Fast Track expedites drug development for serious conditions with unmet medical needs, allowing more frequent interactions with the FDA and potential for accelerated approval. 4️⃣ Accelerated Approval: Granted based on surrogate endpoints for serious conditions with no effective treatments, this pathway enables quicker market access, with post-marketing studies required to confirm clinical benefits. 5️⃣ Priority Review: Reserved for drugs offering significant improvements over existing therapies for serious conditions, Priority Review aims to complete the FDA review within six months, expediting access to promising treatments. 6️⃣ Breakthrough Therapy Designation: Reserved for drugs showing substantial improvement over existing therapies, Breakthrough Therapy status expedites development with FDA guidance, aiming to bring innovative treatments to patients faster. Credit to Camilla Fedi for the image. #ClinialTrials #FDAapproval #Healthcare
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In clinical development, we often hear statuses like "orphan designation," "accelerated approval," "fast track" and others. This visual summary is an excellent reference to keep handy!
💊 FDA Designations Explained 💊 Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here's a breakdown of some crucial designations ⬇ 1️⃣ Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies and three phases of clinical trials to assess safety and efficacy thoroughly. 2️⃣ Orphan Designation: Reserved for drugs targeting rare diseases, this designation offers incentives like tax credits and marketing exclusivity to encourage development for underserved patient populations. 3️⃣ Fast Track Designation: Fast Track expedites drug development for serious conditions with unmet medical needs, allowing more frequent interactions with the FDA and potential for accelerated approval. 4️⃣ Accelerated Approval: Granted based on surrogate endpoints for serious conditions with no effective treatments, this pathway enables quicker market access, with post-marketing studies required to confirm clinical benefits. 5️⃣ Priority Review: Reserved for drugs offering significant improvements over existing therapies for serious conditions, Priority Review aims to complete the FDA review within six months, expediting access to promising treatments. 6️⃣ Breakthrough Therapy Designation: Reserved for drugs showing substantial improvement over existing therapies, Breakthrough Therapy status expedites development with FDA guidance, aiming to bring innovative treatments to patients faster. Credit to Camilla Fedi for the image. #ClinialTrials #FDAapproval #Healthcare
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