Sciensus - Rare Disease Services

New partnership announcement: Sciensus partners with Sentynl Therapeutics, Inc. to become the exclusive distribution partner of NULIBRY® (fosdenopterin) in Europe. Sciensus will deliver both an early access programme and distribution services to support the market access and reimbursement processes of NULIBRY® in Europe. "In partnership with Sciensus, we are proud to extend the reach of this innovative treatment to meet the needs of patients with MoCD Type A in Europe. This partnership marks another step forward in our mission to expand patient access to life-changing rare disease treatment.” said Matt Heck, President & Chief Executive Officer of Sentynl. To read the full press release, visit: https://lnkd.in/er5F4SEY #Sentynl #Partnership #RareDiseases #OrphanDrugs #EAP #expandedaccessprogrammes #insights

Launching an orphan drug across multiple European Union (EU) countries requires careful planning and execution. It can be incredibly challenging to decide how to balance the risks of having too much stock with not having enough. Each of the 27 member states in the EU has its own demand patters, regulatory requirements and distribution channels. In our latest article, we discuss the options available when planning your EU orphan drug stock. Learn more at: https://lnkd.in/g93ewYAG #RareDiseases #Biotechs #MarketAccess #OrphanDrugs

Launching an EAP has many challenges from managing adverse events to navigating complex European market guidelines, therefore, planning and risk management are essential. Take a look at our recent article to learn how to successfully implement an EAP in Europe whilst also ensuring patient safety and program integrity. https://lnkd.in/gwJY28wX #RareDiseases #OrphanDrugs #RealWorldEvidence #PatientAccess #Biotechs

Last week, Andrew Cummins and Mathieu Loiseau attended the World Orphan Drug Congress Europe in Barcelona, connecting with biotech leaders and sharing insights and best practices to expand access to their innovative, life-changing medicines across Europe. Here are some of their key takeaways: • From January 2025, all new ATMPs and oncology medicines will require a joint clinical assessment (JCA) at the European level, with further details still emerging. • Payors, regulators, and pharma/biotech companies need to continue to harmonise patient engagement activities to ensure the development of new treatments, devices, and health systems. • To increase participation and retention, and to reduce the burden on families, CROs should consider decentralised clinical trials more often. If you want to reach out to the team to discuss further, visit: https://lnkd.in/e7XfVg4M #WODC #OrphanDrugs #WODCBarcelona #RareDisease

Our latest whitepaper, packed with expert insights from a recent webinar featuring Andrew Cummins, Mathieu Loiseau, and Sara Radenovic. Discover the strategies for biotechs looking to design and implement a successful EAP in Europe. Learn more about: • When and why companies turn to EAPs and how you can ensure the success of your EAP • The importance of real-world data for rare and orphan medicines and how to collect it as part of an EAP • What to do if your company doesn’t already have a European presence Download the white paper here: https://lnkd.in/eHCMYhYw #Biotech #EAP #ExpandedAccessProgram # #RealWorldData #RareDiseases #OrphanDrugs

Andrew Cummins and Mathieu Loiseau have arrived at the World Orphan Drug Congress Europe in Barcelona! They are excited to network and attend insightful talks from experts across various fields, including orphan drugs, cell & gene therapy, genetic testing, market access, and more. If you’re attending the event, make sure to get in touch with us. It would be a great opportunity to connect! #WODC #OrphanDrugs #WODCBarcelona #RareDisease

Mathieu Loiseau, Director of Rare Clinical Services discusses the challenges faced by those living with rare diseases. Individuals living with a rare disease often find themselves navigating years of hospital appointments before receiving a diagnosis. They have limited treatment options and a lack of knowledge among healthcare professionals. This creates a profound sense of isolation for those already battling with the complexities of their health. Download our guide to explore the potential integration of clinical studies with patient support program 👉 https://lnkd.in/dh43Munn #RareDiseases #RareDisease #OrphanDrugs #PatientSupportProgram

Andrew Cummins and Mathieu Loiseau will be attending the World Orphan Drug Congress Europe from October 22nd to 25th in Barcelona! If you’re interested in scheduling a meeting to discuss how Sciensus can support your Early Access Program strategy in Europe and help you unlock opportunities, please book a meeting at: https://lnkd.in/e7XfVg4M More about the event: https://lnkd.in/esU7EFd #WODC2024 #OrphanDrugs #RareDiseases #Barcelona

Launching an orphan drug across the EU requires a solid understanding of the distribution process and regulations in each country. With Sciensus, you gain a partner with extensive expertise in stock management and regulatory compliance. Learn how we streamline the process, ensuring a successful product launch across 27 countries: https://lnkd.in/g93ewYAG #OrphanDrugs #RareDiseases #Biotechs

Sciensus is pleased to announce the appointment of Christian Tucat as Chief Executive Officer. He succeeds Darryn Gibson, who has led the organisation for the past six years. Christian brings 25 years of experience in the life sciences sector, primarily focusing on helping pharmaceutical companies deliver lifesaving drugs and therapies to patients. To read the full press release, visit: https://lnkd.in/etkVd7yn