GE2P2 Global Foundation launches advisory services program to support Compassionate Use/Expanded Access Programs [EAP] initiatives
Foundation’s Center for Ethics and Policy on Access to Medicines to capture and publish on ethics, best practices, and policy directions across full CU/EAP life cycle
13 June 2017
The GE2P2 Global Foundation today launched a comprehensive set of advisory services supporting the full life cycle of Compassionate Use/Expanded Access Program [EAP] initiatives. The Foundation hopes to contribute to the evolution of equitable, just, and patient-centric processes in this rapidly evolving area,
Foundation co-founder and Board member Arthur L. Caplan, PhD [Director of NYU School of Medicine’s Division of Medical Ethics] commented: “We are taking the unique, precedent-setting experience we gained in the NYU joint program with Janssen working on compassionate use [CompAC] and extending it through this new, non-profit foundation to the broader community of biopharma companies, NGOs, patient advocacy groups, and others. We see this advisory services program not as an end in itself – although there is a substantial gap in the availability of such services – but as a means to capture insights, engage ethical challenges, articulate policy, and publish on best practices – advancing our understanding of fair access and patient health.”
The Foundation’s Center for Ethics and Policy on Access to Medicines will focus on identifying, analyzing, and publishing on ethical issues, policy directions, and best practices. The CU/EAP life-cycle advisory and consulting services will be delivered primarily by the Foundation’s GE2P2 Global Advisory Services pbc unit by a strong, established team well-grounded in CU/EAP initiatives globally.
GE2P2 Global Foundation co-founder and President David R. Curry commented: “This important program of advisory services supporting the emerging CU/EAP area continues our rapid evolution as a non-profit foundation. Our community of practice is focused on advancing ethical and scientific rigor in research and evidence generation across a range of sectors and discipline areas. We believe that equitable, affordable and meaningful access to medicines is a global right-to-health challenge that deserves our best energies, and that the compassionate use/expanded access program [CU/EAP] dimension of this challenge will benefit from our unique experience.”
For more information on the these new CU/EAP Advisory Services Program, please contact:
David R Curry
- President, GE2P2 Global
- mobile:[US] 267.251.2305
- skype: davidrcurry1
- email: david.r.curry@ge2p2center.net
Arthur Caplan, PhD
Drs. William F. and Virginia Connolly Mitty Professorof Bioethics;
Director – Division of Medical Ethics, NYU School of Medicine-
- email: arthur.caplan@nyumc.org
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About the Center for Ethics and Policy on Access to Medicines
This GE2P2 Global Foundation Center conducts research, convenes symposia and workshops, publishes, and develops ethical guidance and policy concerning fair, equitable and effective access to pharmaceutical products including drugs, biologics, vaccines, essential medicines and medical devices.
The Center’s focus areas include general bioethical issues associated with research, discovery, and clinical trials for investigational medicines; compassionate use/pre-licensure/expanded access programs, and access to vaccines and essential medicines in low resource settings and humanitarian contexts globally.
GE2P2 Global also works in a lead advisory capacity with commercial, not-for-profit/NGO and public sector biopharma organizations to address bioethics and policy issues and challenges throughout the full life cycle of their R&D/clinical development, licensure, manufacturing, marketing, distribution, and overall post-marketing management.
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