New Center to focus on innovation and effectiveness of key ethical imperative in research

10 March 2020 – Philadelphia, USA

Accelerating its mission to advance ethical resilience and scientific rigor in research and evidence generation, the GE2P2 Global Foundation today announced formation of the Center for Informed Consent Integrity.

 As one of its first major programs, this new Center has launched an initiative to explore how informed consent can best evolve to respond to the challenges associated with the rapidly-emerging genomic medicine era. The Center will explore informed consent across cell & gene therapies – including basic research, clinical trials, compassionate use/expanded access, and post-approval clinical use, including the often decade-plus long-term follow-up required.

In parallel, the Center is now examining how informed consent is currently integrated into compassionate use/expanded access programs, which often involve investigational medicines before they have received major regulatory approval. The project is aggregating information on informed consent processes and policies in developer/manufacturer expanded access programs, how countries address informed consent in their regulations and guidelines around compassionate use, and how national and local ethics committees treat IC in their oversight role for these programs.

 The Center will continue publication of its monthly digest – Informed Consent: A Monthly Review – which surveys strategic developments, innovation, insights and commentary from peer-reviewed  journals and other sources. This digest and other information is now available at the Center’s new site: https://ge2p2global-centerforinformedconsentintegrity.org/

 The Foundation also announced the leaders who will help build the new Center and its programs:

:: Paige Fitzsimmons, MA, will serve as Associate Director of the Center. Paige is a GE2P2 Global Foundation Associate Fellow, editor of Informed Consent: A Monthly Review, and Programs Manager, supporting the Foundation’s full portfolio of Centers and programmes.

 :: Barbara Redman, PhD, MBE, will serve as Director of the Center. Barbara is a Foundation Senior Fellow, a founding Board member, and co-chairs the Foundation’s biopharma research ethics advisory program, among other contributions. She is an Associate Faculty member of the Division of Medical Ethics in NYU’s School of Medicine.

 GE2P2 Global Foundation President David R. Curry commented: “Forming our new Center for Informed Consent Integrity represents another milestone in the growth of our young Foundation. This Center enables members of our community of practice to focus their considerable expertise and experience on strengthening the integrity of informed consent across the Foundation’s areas of focus, including health, human rights, humanitarian response, education and literacy, sustainable development and heritage stewardship. We believe that free and meaningful consent – based on evidence-based, accessible, understandable and materially-complete information – is a bulwark of ethically-resilient research, human rights, fundamental freedoms, and responsible governance.”

For more information, please contact:

David R Curry
President, GE2P2 Global
- mobile:[US] 267.251.2305
- email: david.r.curry@ge2p2global.org

 About the Center for Informed Consent Integrity

 The GE2P2 Global Foundation conducts its work through a “centers of excellence” structure which helps members of our community of practice to focus their extraordinary experience and energies.

 The Center for Informed Consent Integrity will address informed consent broadly and holds that “consent” – grounded in open, evidence-based, accessible, understandable and materially-complete information – is the bulwark of human rights, fundamental freedoms, and responsible governance.

 The Center will focus on consent in research contexts across all the Foundation’s action sectors including health, human rights, humanitarian response, education and literacy, sustainable development, and heritage stewardship.

 This work includes producing knowledge sharing services Informed Consent :: A Monthly Review which  aggregates and distills key literature and analysis around IC including governance, ethics review and oversight, content approaches, technology and assessment strategies/performance metrics.

 
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5 August 2019, Philadelphia – GE2P2 Global said it appointed Richard Klein as Director, Expanded Access Programs & Policy, effective immediately. In this role, Mr. Klein will help advance GE2P2 Global’s work with a special focus on global, country and developer expanded access/compassionate use policies, governance and program access/effectiveness/outcomes Mr. Klein is an internationally recognized expert in preapproval access to therapeutic agents. He was named a Fellow of the GE2P2 Global Foundation in 2017 and has since served as a member of the Foundation’s Independent Bioethics Advisory Committee [IBAC], which provide advisory support to expanded access and compassionate programs globally. Mr. Klein worked at the FDA for more than 40 years before leaving the agency in 2017. He served as director of the FDA’s Patient Liaison Program in the agency’s Office of Health and Constituent Affairs, the primary agency interface with patients and patient advocate communities. He participated in the development of revised expanded access regulations and guidelines, and led the creation of the FDA expanded access website, played an active role in the development of the streamlined application for individual patient access, the exemption from full board IRB review for Individual Patient IND expanded access, and the Expanded Access Navigator. In these roles, he interacted extensively with outside communities and within the agency’s scientific and policy offices to advocate for patient interests, and facilitate patient engagement. He actively addressed issues and concerns of patients in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. GE2P2 Global Foundation President David R. Curry commented “We are very pleased to have Richard Klein take on this important role as we expand our work addressing policy, regulatory and ethical challenges associated with expanded access and pre-licensure access programs at global, country and developer-level. Richard brings deep insight to this work from his FDA experience, complemented by his extraordinary analytical skills and his deep empathy for patients in need.” More on the GE2P2 Global Foundation here: ge2p2.org. For additional information or interview, please contact: David R Curry, President & CEO, GE2P2 Global - mobile: [US] 267.251.2305 - skype: davidrcurry1 - email: david.r.curry@ge2p2center.net

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

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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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

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.