GE2P2 Global Foundation Announces "Bioethics in Biopharma" Fellowship Program

Engagement of bioethicists in the biopharma sector has typically been in reactive roles—called upon when something goes wrong.  Rarely have bioethicists been integrated into operational contexts to contribute proactively to policy formation, help address ethical issues in operational contexts, or support development of strategic direction.

 The genomic medicine space – comprising gene editing, genetic/cell  therapies, and other emerging areas – is evolving quickly and faces a number of novel and challenging ethical issues.  We believe that the bioethics community must better ground itself in the science, and vigorously engage issues across the full cycle of discovery, trials, licensure, clinical translation, long-term follow-up, marketing, pricing, access, equity, etc.

 The GE2P2 Global Foundation is piloting one strategy to strengthen that engagement through a new program – Bioethics in Biopharma – under which “bioethics fellows” will be placed in sponsoring biopharma organizations to address specific ethics challenges and publish about the solutions and the experience.  We believe this program will provide a new form of training, helping build a cadre of bioethicists who are able to contribute materially in the commercial sector as effectively as they do in academia, government and regulatory space.

 This program is designed to:

1] provide an immersive, real-world experience for bioethics scholars in the genomic medicine/gene editing/genetic therapy space;

2] challenge these scholars and engage their support in fashioning strategies and solutions for real-world problems;

3] support development of papers and scholarly communications about the issues encountered and solutions devised;

4] establish a cadre of bioethicists grounded in this sector and establish an emergent community of practice;

5] help address, more broadly, the distrust that many in bioethics – academics in particular – have developed for industry and vice versa.

Call for Applications – Specifics

1.     The program pilot will place 2-3 Fellows during 2019 and 2020.

2.     Placements will be anchored on a workplan covering a 2-3 month placement and which specifies the challenges to be engaged and the outcomes and work products expected, including at least one per-reviewed publication.  The workplan will be agreed among the Foundation, the Fellow, and the sponsoring genomic medicine organization.

3.     Placements will be supported by program stewards representing the Foundation and the sponsoring genomic medicine organization.

4.     Program Fellows will ideally have earned a earned a graduate degree in bioethics and have a solid period of work experience in the field. A terminal degree (PhD, MD, JD), a documented background in the biosciences, and clinical experience will all be strong differentiators. Documented written and spoken fluency in English is required. The program is open to applicants globally.

5.     Applications for the Fellows Program will be accepted and decided on a rolling basis. The first placement cycle will be engaged during February 2019 for placement by April 1. 2019. All applications will reviewed by a selection committee involving the Foundation and the sponsoring organization. The selection committee will selectively request applicants to participate in an interview (in person, by videoconference, or phone.) In the event there are no qualified applicants, no Fellows will be placed for a given cycle.

6.     Fellows will become a member of the Foundation’s community of practice and receive all financial support involved through a fiscal relationship with GE2P2 Global. Fellows will sign a program contract which will include the workplan, and NDAs [Non-Disclosure Agreements] with the Foundation and the sponsoring organization.

7.     Applicants should forward a letter-of-interest and a current CV to Bioethics.Fellows.Program@ge2p2global.org. Details of the program, including financial support and sample workplan, will be shared with applicants who progress to the second selection round

David Curry
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

::

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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David Curry
GE2P2 Global Foundation elects Donal O’Mathuna, PhD as a Fellow and Member of its Board of Directors. O’Mathuna to lead newly-formed GE2P2 Global - Center for Disaster and Humanitarian Ethics

The GE2P2 Global Foundation said its elected Donal O’Mathuna, PhD as a Fellow of the Foundation and a Member of its Board of Directors. O’Mathuna to lead newly-formed GE2P2 Global - Center for Disaster and Humanitarian Ethics

3 October 2016
The GE2P2 Global Foundation said it has elected Donal O’Mathuna, PhD as a Fellow of the Foundation and a Member of its Board of Directors.

Dr. O’Mathuna is Senior Lecturer in Ethics, Decision-Making & Evidence at the School of Nursing & Human Sciences, Dublin City University (DCU). His main areas of research interest include ethics and evidence-based practice, and the ethical issues that arise for healthcare practitioners, researchers and organizations during disasters and in providing humanitarian response. He is also Chair of the COST Action IS1201 on Disaster Bioethics, a network of academic, agency and NGO members addressing disaster ethics under the EU Framework Programme – Horizon 2020 (http://DisasterBioethics.eu). .

GE2P2 Global also announced formation of a new Center for Disaster and Humanitarian Ethics which will focus on ethics, evidence generation, and policy involving health interventions, human rights, and humanitarian response to the full range of natural and manmade disasters and complex emergencies. 

O’Mathuna will lead this new Center as its Founding Director, and be responsible for building a team of GE2P2 Global Foundation Fellows who will conduct the research and analytical work of the new Center, and provide consultation to international agencies, INGOs, civil society organizations and donors involved in disasters and humanitarian action.

GE2P2 Global Foundation President David R. Curry commented “We are very pleased to have Donal O’Mathuna, PhD join our growing community of Fellows and our board of directors. Dr.  O’Mathuna brings demonstrated scholarship, strong domain knowledge, and deep insights to our purpose – advancing ethical and scientific rigor in research and evidence generation in human rights action, humanitarian response, health, education, heritage stewardship, and sustainable development.  In particular, we look forward to his leadership of our newly-formed Center for Disaster and Humanitarian Ethics and its important work in the years ahead.”

More on the GE2P2 Global Foundation here: ge2p2.org.

For additional information or interview, please contact:

David R Curry, President, GE2P2 Global Foundation

- mobile:  [US] 267.251.2305
- skype:   davidrcurry1
- email:    david.r.curry@ge2p2center.net

David Curry
GE2P2 Global Foundation elects Robert I. Field, PhD, MPH, JD and Barbara K. Redman, PhD, MBE to its Board of Directors

The GE2P2 Global Foundation said its elected two new members to its Board of Directors.

Robert I. Field, PhD, MPH, JD is Professor of Law and Professor of Health Management and Policy at the Kline School of Law and Dornsife School of Public Health at Drexel University, Philadelphia, USA. Dr. Field is a nationally known expert in health care regulation and its role in implementing public policy.  He is also a lecturer in health care management at the Wharton School of the University of Pennsylvania and a senior fellow of Penn’s Leonard Davis Institute of Health Economics. Professor Field's recent scholarly work has focused on health reform and is effects on the structure of the health care system, ethical issues in vaccines, and policy implications of genetic databases.

Barbara Redman, PhD, MBE is an Associate Faculty at the Division of Medical Ethics, NYU School of Medicine. Dr. Redman is an internationally respected researcher and author in the field of bioethics and a highly regarded administrator and teacher. Dr. Redman has been a Visiting Fellow at the Kennedy Institute of Ethics at Georgetown University, a Edmond J Safra Network Fellow in Medical Ethics at Harvard Medical School, and a Senior Fellow at the University of Pennsylvania Center for Bioethics. Dr. Redman also has been executive director of the American Nurses Association and the American Association of Colleges of Nursing. Her areas of expertise include research ethics (especially research misconduct), and ethics of chronic illness.

Foundation President David R. Curry commented “We are very pleased to have Robert Field and Barbara Redman join our growing board. Each brings demonstrated scholarship, strong domain knowledge, and deep insights to the work of the GE2P2 Global Foundation. We look forward to their contributions as we grow and engage our purpose of advancing ethical and scientific rigor in research and evidence generation in human rights action, humanitarian response, health, education, heritage stewardship, and sustainable development.

Drs. Field and Redman join founding Board members – David Curry, MS and Arthur L. Caplan, PhD, The Drs. William F. and Virginia Connolly Mitty Professor of Bioethics and Director, Division of Medical Ethics, NYU School of Medicine, Langone Medical Center, New York –  bringing the board-in-formation to four members.

Simon Rogers