Almac, Operationalise Early Access Programmes

Expertise Partner:

Almac Clinical Services dedicated Unlicensed Medicine Services group currently manage over 200+ active Managed Access programs, delivering critical medication to patients across 80 countries worldwide. From forecasting and production through to storage and distribution, 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.

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Expertise Partner:

Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines for over 35 years. With experience of over 400+ Managed Access programs worldwide and lifesaving medicines delivered to more than 100,000 patients, we are the market leaders in delivering Managed Access programs and driving
thought leadership with proven operational expertise within Early Access. We are dedicated to giving healthcare professionals and their patients greater access to medicines globally.

Early Access Care, Operationalise Early Access Programmes

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, endto-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 preand 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.

Inceptua, Operationalise Early Access Programmes

Expertise 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.

WEP, Operationalise Early Access Programmes

Expertise Partner:

At WEP, we are With Every Patient, as we believe every patient should have access to
treatment! We operate as a Pharma Services Provider (PSP) that is committed to providing Drug Development and Treatment Access Solutions for patients worldwide. We specialize in Expanded Access Programs (EAPs) and help Sponsors deliver value-driven EAPs that are designed and fit around their specific needs and development pipeline. Our programs are delivered through High Quality, High Service, and High Value, returning a positive ROI to all Sponsors we have partnered with.

Bap Pharma, Operationalise Early Access Programmes

Hosting Partner:

BAP Pharma is an award-winning, responsive, and cost-effective medicines access
solutions partner, specialising in providing tailored access solutions to health care
professionals and patients Our experts in Early and Managed Access Programs (EAP/
MAP) can source pre- and post-approval, orphan, and niche medicines to allow access and continuity of treatment, getting patients the medicines they need, when they need them, anywhere in the world. Exceptional Value. Unrivalled Service. Promise Delivered.

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Hosting Partner:

Bionical Emas is a global Contract Research Organization (CRO) combining Clinical
Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) bringing lifechanging 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 lifesaving 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.

Marken, Operationalise Early Access Programmes

Hosting Partner:

Marken is the clinical and advanced therapy subsidiary of UPS Healthcare. With Marken,
Polar Speed and BOMI Group included, the UPS Healthcare network consists of 200+
locations worldwide. Marken offers a state-of-the-art GMP-compliant depot network and
logistic hubs for clinical drug product storage and distribution in 49 locations worldwide,
while maintaining the leading position for cell and gene therapy services, direct-to-patient and home healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,600+ staff members manage 200,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 16,000+ home healthcare visits. Additional services such as 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. Delivering What Matters From Clinical to Commercial.

mytomorrows, Operationalise Early Access Programmes

Hosting Partner:

myTomorrows is a global health tech company dedicated to helping patients and physicians discover and access treatment options. We’ve partnered with 50+ BioPharma companies to support global expanded access programs, gather invaluable real-world data, and streamline patient recruitment for clinical trials. We are experts in the field of expanded access, having gained experience over a decade, and we manage all aspects of expanded access - from regulatory strategy program setup to full operational execution. We distinguish ourselves by taking a proactive stakeholder-focused approach.

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Event Partner:

MedaSystems has built the industry leading cloud based software platform empowering Global Expanded and Managed Access organizations to deliver medicines for any program, any product, and in any country. Track, enforce, and automate all your request workflows, eliminate repetitive tasks, comply with regulatory requirements, collaborate with HCPs and capture RWD in a single, validated platform. Ensure your ability to support future programs and quickly adjust your processes and data collection forms with our easy, click-to-configure solution.