2024 Partners

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.

www.almacgroup.com

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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.

www.clinigengroup.com

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.

www.earlyaccesscare.com

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.

www.inceptua.com

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.

www.wepclinical.com

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Expertise Partner:

Uniphar is a global healthcare company with more than 3,500 employees worldwide across 160 countries. We are a trusted global partner to Pharma and Medtech manufacturers, working to improve patient access to medicines around the world, including underserved markets in LATAM, APAC, Africa, and the Middle East. Our specialised services help to deliver unlicensed medicines to patients compliantly and on time. We’re growing by leveraging the strong relationships we have with the 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and highly expert teams.

www.uniphar.com/access

cisiv, 3rd Operationalise: Early Access Programmes Europe 2024

Exhibition Partner:

Cisiv is an innovative technology company, with expertise in non-interventional and observational studies, and provides tools for real-world data collection. Cisiv has built and delivered over 300 studies for the life science industry, supporting pharma, biotech, and medical devices companies to efficiently obtain high quality real-world data.

Our cutting-edge platform, Baseline Plus, is the complete integrated solution for real world late phase capture, providing EDC (for RWD), ePRO, eCOA, eConsent as well as a platform for registries, managed access programmes, and pharmacovigilance. Cisiv’s technology platform is compliant with all global requirements for clinical systems including 21 CFR Part 11, GCP, GDPR, and HIPAA. In 2017 Cisiv launched a new platform for pharmaceutical and biotech companies to manage requests for investigational products in Expanded Access Programs and Named Patient Programs (EAP) across therapeutic areas. This newer platform allows BioPharma to own their data, while managing cases by roles. It allows them to streamline multiple systems into one, manage and approve requests and archive cases. The system gives a unified experience to HCPs and easily onboards HCPs and Pharmacists.

www.cisiv.com

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.

www.bappharma.com

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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.

www.bionicalemas.com

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.

www.marken.com

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.

www.mytomorrows.com

CAR-T Sponsor Logos

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.

www.medasystems.com

MebCo, 3rd Operationalise: Early Access Programmes Europe 2024

Event Partner:

MebCo specializes in customizing an Early Access Program (EAP) for international pharmaceutical companies looking to enter the Mexican market. We facilitate the importation, storage, and distribution of medications after efficiently coordinating with all stakeholders. Our advanced technological tools and highest industry quality standards ensure the effective development of EAPs within a complex legislative environment.

We guarantee transparency and resource optimization, that lead to the desired outcomes. Our commitment to continuous improvement and providing a personalized experience for each of our customers is the foundation of our organization. We take great pride in delivering your cutting-edge medications to the Mexican population.

www.mebcohc.com

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Event Partner:

Sciensus is a global life sciences company specialising in market-leading patient access, engagement and insight solutions.  Our team has extensive experience in the rare and orphan disease market and is committed to getting rare medicines to hard-to-reach patients across all Europe. For over 30 years, we’ve delivered on every aspect of this vital transaction; from expanded access programs all the way to full commercialization, including real-world data collection and patient support programs.

www.sciensus.com

Corex, 3rd Operationalise: Early Access Programmes Europe 2024

Event Partner:

COREX Logistics is a full-cycle logistics solutions company based in Dublin, Ireland, with over 12 years of expertise in the pharmaceutical and biotech industries. We specialize in regulatory support, temperature-controlled logistics, global distribution, and expanded access programs (EAPs), with over 300 EAPs successfully managed. COREX connects pharma and patients by ensuring the safe, timely delivery of investigational treatments. Our patient-focused services streamline complex supply chains, empowering better healthcare outcomes for those in need.

www.corex-logistics.com

Nezar Consulting, 3rd Operationalise: Early Access Programmes Europe 2024

Event Partner:

Nezar Consulting specialises in delivering Early and Post Trial Access tailored solutions to enable access to critical lifesaving medicine to patients. We provide support with internal governance and process, protocols and regulatory dossiers, program management, data collection and bespoke services. By seamlessly integrating within your business, we provide bespoke support, guiding your team through the complexities of access. Our commitment is to deliver flexible, expert-driven services that help you navigate regulatory landscapes and achieve operational excellence.

www.nezar-clinical.co.uk