WEP Clinical

🎉Over 125 speakers are already confirmed for the #WorldOrphanDrugCongress this October!🎉 Featuring renowned experts from organisations like Johnson & Johnson, Fondazione Telethon, ERCAL Enfermedades Raras en el Caribe y América Latina, European Commission, Foundation 29, Dravet Syndrome Foundation Spain, Amsterdam UMC, Zorginstituut Nederland, Universiteit Leiden , UCB and many more, they will cover a diverse range of topics, including cell & gene therapy, clinical development, manufacturing, access & pricing, patient centricity and beyond. Check out our already confirmed speakers here: https://lnkd.in/dVAmq4FY and follow our page to stay up-to-date for the 2025 congress. Get your tickets now at super early bird rates from just €395 with group bookings or €495 for individual tickets. 🔗 Prices increase after THIS FRIDAY (4 April)! Secure your spot now: https://lnkd.in/dKMSBUYQ 🔗 Patient group members, ERN affiliates, and healthcare professionals can apply for one of our limited free passes: https://buff.ly/hvEqKqY #WODC #OrphanDrugs #RareDiseases #PatientAdvocacy EURORDIS-Rare Diseases Europe, IntraBio Inc, Malaysian Rare Disorders Society (MRDS), CUPP-NL, International Society for Neonatal Screening, Fragile X International, Charles River Associates, The Ehlers-Danlos Society, GIVOPAX, Barcelona Children's Hospital Sant Joan de Déu, Hospital Regional Universitario de Málaga, RARE DISEASES INTERNATIONAL, Global Counsel, AlveoGene, National Center for Advancing Translational Sciences (NCATS), Med-Life Discoveries, ERGOMED, FAMHP - Federal Agency for Medicines and Health Products, EURORDIS-Rare Diseases Europe, Soochow University, Kinetica , The Australian National University, Stichting Hematon, ITALFARMACO S.P.A., AZAFAROS B.V., WEP Clinical

Check out our latest case study detailing how WEP delivered a Mobile Nursing solution to help a Sponsor enhance patient recruitment and retention rates for one of its pediatric clinical trials. By enabling patients to receive treatment in their own homes, the Sponsor was able to significantly enhance trial participation by reducing logistical and financial burdens on families. You can access the case study in full, using the link below, to learn more: https://lnkd.in/dX4b3mtN WEP is proud to offer mobile nursing solutions as part of our broader clinical trial and patient and site support services. Our holistic approach guarantees outstanding support and smooth operations for all stakeholders. If you would like more information on our capabilities, please email us: INFO@WEPCLINICAL.COM #WithEveryPatient #MobileNursing #ClinicalTrials #PatientAndSiteSupport #PediatricTrials #Pediatrics

The WHY Summit on Partnering and Portfolio Management kicked off yesterday – and what a day of powerful discussions! While much of the focus was on biotech and pharma collaborations, deal acceleration, and strategies for long-term growth, our Head of Expanded Access Program Strategy, Ana Paula Tediosi, wanted to bring the focus back to the patients. In her presentation, “Asset Transition – The Forgotten Patient”, Ana reminded us all that in the midst of complex transitions, regulatory hurdles, and deal-making, we must not lose sight of the patients relying on continued access to treatment. At WEP, we specialize in Expanded Access Programs (EAPs), Compassionate Use Programs (CUPs), and Named Patient Programs (NPPs). We’re proud to support our Sponsors in ensuring that no patient is left behind during these pivotal moments. Let’s keep patients at the center – always. #WithEveryPatient #ExpandedAccess #PatientCentricity #Biotech #Pharma #EAP #WHYsummit #PartneringForPatients

The WEP team will be at the World Orphan Drug Congress USA later this month in Boston. We are really looking forward to attending and connecting with industry leaders and key stakeholders who are paving the way in orphan drug development. We hope to meet with as many people as possible to discuss how we can work together to enhance access to life-saving therapies for individuals living with a rare disease. If you would like to schedule a meeting with our team of experts to discuss our clinical trial and expanded access / post-trial access capabilities, please email us: INFO@WEPCLINICAL.COM #WithEveryPatient #WorldOrphanUSA #OrphanDrug #RareDisease #ExpandedAccess #PostTrialAccess #ClinicalTrials

This past Saturday, the WEP Clinical US Team participated in the Raleigh Run for Rare 🏃♀️ event hosted by the National MPS Society. This local organization promotes research initiatives and provides support to those impacted by the rare genetic diseases, Mucopolysaccharidosis (MPS) and Mucolipidosis (ML). We teamed up to complete the 1 Mile Walk, run the 5K, and a few of our team members (Gabby Sorenson Jones and Sarah Ginn) even placed within their category! After everyone crossed the finish line, we gathered for awards and ended the morning with a picnic outside! Thank you to everyone who came out and showed your support 💜 #RaleighRunForRare #RareDiseases #WithEveryPatient #Patients #ExpandedAccess #TreatmentAccess

Check out our latest case study detailing how the WEP team expertly managed the regulatory complexities involved, as a Sponsor’s drug progressed through its development lifecycle. This included multiple changes to marketing authorization stages and the introduction of additional pharmaceutical forms and new patient populations. Successfully navigating these scenarios and proactively adapting our regulatory strategy in real-time allowed us to ensure no disruption to treatment for patients around the world and continued program compliance. Access the case study in full to find out more using the link below: https://lnkd.in/dzd5pTYY #WithEveryPatient #ExpandedAccess #TreatmentAccess #RegulatoryAffairs

💡Check out the latest content on our WEP Insights page.   This week, our Head of Clinical Strategy, Brian-Patrick T., explores why CRO flexibility matters more than ever for biotech companies. Outsourcing strategies for biotechs can vary widely depending on their unique needs, priorities, and operating models. Some will choose to engage multiple, specialized vendors, each focusing on specific functions of the clinical trial – others will prefer to use a single, full-service CRO to manage the entire study from start to finish. No matter your strategy, we can meet you where you are with flexible solutions to serve as your true clinical development ally! Visit the website to learn more on this and other important topics relating to drug development, treatment access and commercialization solutions from our Subject Matter Experts (SMEs). https://lnkd.in/dPHm9wF3 #WithEveryPatient #ClinicalTrials #ClinicalDevelopmentPrograms

Finished up the 5th Annual Operationalize Expanded Access Programs Summit in Boston with Hunter Bellows and Gabby Sorenson Jones last week. I was fortunate for the opportunity to present on Aligning Patient Needs with Commercial Goals -> Collecting Real World Data in the EAP Landscape. We continue to see clinical research evolve, specifically the niche we call home in #expandedaccess when it comes to many areas, specifically global regulations and real world data collection. These changes continue to present all of us (providers, pharma/biotech, CRO's etc.) with the opportunity to impact patients here and now, but uniquely to tailor our journey through development and beyond. We need to continue to ensure we are thoughtful and specific with our decisions which should lead to a more symbiotic relationship between patients and industry. Thank you to all of the driven professionals in the room for your thoughtful presentations, and all of the lovely conversations -> It's amazing to feel the progress. #expandedaccessprograms #OperationalizeEAP #WithEveryPatient #GlobalHealth #clinicaltrials #clinicaldevelopment #raredisease #realworlddata #realworldevidence #compassionateuse #oncology WEP Clinical

Are you considering collecting Real World Data (RWD) in your Expanded Access Programs (EAPs)? The WEP team is presenting on the topic of – ‘The Value of collecting Real-World Data in EAPs’ at the Operationalize Expanded Access Programs Summit, this week in Boston. If you are unable to attend the event, do not worry. Our team of in-house data experts is always on hand to discuss the benefits of RWD collection and the opportunities for your specific EAP. With a tailored and value-driven data collection program, you could potentially generate evidence to (a) support your clinical trial findings, (b) inform your market access strategies, and (c) help shape your drug development and commercialization success. Learn more on our website: https://lnkd.in/e5p6X7DQ #WithEveryPatient #RealWorldData #RealWorldEvidence #ExpandedAccessPrograms

Don’t miss your chance to connect with the WEP team this week at the Operationalize: Expanded Access Programs Summit. We are looking forward to contributing to the conversation around how to navigate the complex regulatory and operational hurdles in order to design and deliver successful Expanded Access (EAP), Managed Access, and Post-Trial Access Programs. If you will be at the event or around the Boston area over the next few days, make sure to schedule a time to meet: CWURST@WEPCLINICAL.COM Christopher Wurst Hunter Bellows Gabby Sorenson Jones #WithEveryPatient #ExpandedAccess #ManagedAccess #PostTrialAccess