2023 Partners
Expertise Partner:
Early Access Care is a full-scale specialist service provider of Compassionate Use and Named Patient Programs, ranging from programme planning, protocol development, end-to-end operational management, Real World Data services, and a variety of customized service offerings. We work with biotech and pharmaceutical companies to set up and manage programs in the pre- and post-approval space, including post-trial access, managing all regulatory and logistical aspects of early access. Speak with one of our representatives at the EAC booth to find out more about how our service and staff may support your plans.
Expertise Partner:
PPD clinical development and analytical services enable customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, our capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, and peri- and post-approval solutions, including early and continued access solutions. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies. For more information, visit thermofisher.com/ppd.
Expertise Partner:
MedaSystems enables life science companies to collaborate with physicians to provide expanded access to investigational medicine. Our SaaS platform provides workflows, flexible forms, notifications, shipping requests, and collection of Real-World Data. Physicians can submit requests, complete medical profiles, share and sign documents, communicate with the sponsor and request shipments via an integrated portal.
The platform improves and speeds decision-making through enhanced visibility and automation. Configurable workflows ensure compliance with company SOPs and regulatory requirements. The collection and management of Real-World Data provides insight which can be used for label and market expansion, design of clinical trials, and other areas of product development.
Hosting Partner:
Clinigen Managed Access is dedicated to providing healthcare professionals and their patients with greater access to medicines globally and in the process, increasing the value of a pharmaceutical product by extending and expanding its lifecycle. Clinigen Managed Access provides compliant early access to critical medicines for patients with unmet needs at a country, regional and global level. Clinigen operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,200 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 34 of the top 50 pharmaceutical companies; interacting with hospitals across more than 130 countries.
Hosting Partner:
Bionical Emas is a global Contract Research Organization (CRO) combining Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) bringing life-changing medicines to patients around the world. Their unique integrated business model, with its range of services and capabilities, benefit many of the world’s leading pharma and biotech companies. This distinctive offering enables them to maximize access and generate evidence at every stage of the drug development pathway.
Early Access Programs (often called Expanded Access, Pre-approval Access, Compassionate Use, Named Patient or Managed Access Programs) deliver potentially life-saving treatments to patients around the world while adding true value to clients through a range of additional cutting-edge services.
Bionical Emas are the only specialist Early Access Program (EAP) partner to harness the full power of an established and successful Contract Research Organization. Their global EAP experience in oncology and rare disease areas is perfectly complemented by a range of in-house services.
Hosting Partner:
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5,500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 57 locations worldwide, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,400+ staff members manage 154,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 14,000+ home healthcare visits. Additional services such as cell and gene supply chain services, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.
Moving Our World Forward by Delivering What Matters
Hosting Partner:
Inceptua Early Access is a global company specialising in the provision of Early Access Programs. With offices in 5 EU countries, the US, China and Japan, and a sophisticated global network of warehousing and shipping, Inceptua can supply medicines anywhere in the world. Inceptua has deep expertise in the setting up and running of complex group programs, post-trial access programs, exclusive distribution arrangements and market withdrawal scenarios. Our highly experienced management team provide unparalleled guidance and consulting services to support our clients in getting their medicines to patients in need, wherever they may be.
Hosting Partner:
BAP Pharma are global leaders in bespoke medicinal supply solutions, with specialist divisions in Medicines Access, Comparator Sourcing and Secondary Packaging & Labelling.
Our Medicines Access Division manages products at an early state, pre-marketing authorisation or later stage, when products are coming towards the end of their commercial lifecycle.
We provide medicines access solutions for biopharmaceutical manufacturers to ensure patients can gain access to medicines with or without marketing authorisation.
Hosting Partner:
myTomorrows is a platform that links patients with an unmet medical need to treatments in development worldwide. We provide patients and physicians with a personalized listing of treatment options, such as Clinical Trials and Expanded Access Programs and can facilitate access to them. We partner with pharmaceutical companies to help find patients for Clinical Trials, run Expanded Access Programs, and collect Real-World data.
Hosting Partner:
Durbin is the market leading provider of Expanded Access programs to the biopharmaceutical industry. Through partnering with Industry, Durbin is reimagining the role that Expanded Access Programs play in supporting healthcare practitioners and patients access lifechanging treatments, when they require them, no matter where they are in the world. Durbin’s operational and regulatory knowhow, experience across multiple speciality therapeutic areas and expertise in managing complex formulations including cell and gene therapies, ensures that every program is tailored to the specific needs of the treatment, patient and local market requirements.
As part of the Uniphar Group we have unparalleled access to inter-group capabilities to provide a breadth of service offering capable of optimizing the overall impact for all stakeholders within the Expanded Access ecosystem.
Exhibition Partner:
Almac Clinical Services have a dedicated Unlicensed Medicine Services group ensuring appropriate review and release of unlicensed medicines and successful delivery of Managed Access Programmes. Almac provides the global reach, expert people, validated processes, and cutting-edge technology to empower sponsors to maintain ethical, compliant, and cost-effective access to unlicensed treatments.
Event Partner
The Global Guide to Compassionate Use Programs was developed over four years by industry, government, regulatory, operational, and pharmacovigilance experts with decades of combined experience. The Global Compassionate Use Resource offers a unique and comprehensive solution that provides invaluable information on the current legislative pathway, the legal basis for the program, how to initiate the process, the roles of the regulatory authorities and sponsors, pharmacovigilance requirements, program-related fees, charging aspects, and labeling requirements. Covering information from 60 countries, and supported by over 900 documents, it stands as the only global resource of its kind.