The Forum for Collaborative Research (Forum) at the University of California Berkeley School of Public Health, founded in 1997, is a public/private partnership that addresses cutting edge science and policy issues through a process of stakeholder engagement. Its impetus was a request from Vice President Al Gore to convene all stakeholder groups to discuss and discover opportunities for cross-sector dialogue and collaboration. The Forum has and continues to address specific hurdles in drug development thru independently funded projects focusing on human immunodeficiency virus (HIV), hepatitis B (HBV), transplantation associated virus infections (TAVI), primary sclerosing cholangitis (PSC), non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH), and rare diseases. We addressed a 7 th disease area, HCV infection, through the HCV Forum, initiated in 2007 and completed in 2017. Forum functions include providing a proactive mechanism to survey and synthesize current knowledge, including ongoing studies, and to actively catalyze stakeholders to develop and implement new studies and other activities to fill the gaps and address the barriers that impede progress in drug development.

The hallmark of the Forum is the inclusion of all stakeholder groups, including patient and advocacy organizations, academia, federal agencies, industry, payors, professional societies and other relevant entities. The Forum works closely with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing a trans-Atlantic regulatory scope and breadth to the deliberations, focused at the Division/reviewer level. In other words, our work brings pragmatic and practical results in the drug development and regulatory process, in keeping with major policy advances, such as the 21st Century Cures Act.

All projects operate in accordance with The Forum’s guiding principles, which include neutrality and independence; transparency and accessibility; inclusiveness; collaboration, and efficiency and productivity, as documented in the report. This document describes the operating principles and the working process of the Forum.

The Forum Operating Principles

NEUTRALITY AND INDEPENDENCE

Ownership. The Forum is owned collectively by its members, with each project’s stakeholder group having an equal voice. By including all interested parties and ensuring that no one particular entity dominates, we provide a neutral, independent and safe space for discussion, dialogue and deliberation among expert scientists from government, industry, academia, professional societies, community and other relevant entities. Identified priorities are considered important and of value to all stakeholder groups. Credibility. Forum members have a strong record of leadership and experience in the disease area of the project they participate in and the resources needed to follow through with their commitment. All participants are equal partners. Recommendations are based on sound ethical principles and scientific evidence and designed to protect the public’s health. The Forum does not force consensus, but publishes consensus-based recommendations only when the science supports those recommendations.

We restrict participation to experts with the necessary scientific knowledge from organizations or entities with a clear commitment to advancing the diagnostic and therapeutic field of the disease area of the project they participate in, whether they be from government, academia, industry, or community. Only in this way can we achieve the effectiveness and productivity needed to add value to the field. The Forum is not a venue for marketing and/or investment experts.

Leadership. Each project has a Steering Committee consisting of project members from all stakeholder groups representing US and Europe provides overall guidance. Projects are led by an academic and industry co-chair. Industry representatives to Steering Committees serve two years and rotate on a staggered basis. Steering committee and project members are listed on the project’s webpage.

TRANSPARENCY AND ACCESSIBILITY

Funding. Participation from industry is conditional on an annual sponsorship contribution. Guidelines for providing an appropriate contribution are based on company size, market cap, and development status. Industry members will be acknowledged as sponsors. Sponsorship includes participation at in-person meetings, working groups, workshops, webinars, remote attendance, and project updates. Nonsponsoring industry will have access to information published on the Forum’s website. Annual contributions from non-industry organizations are encouraged. Members from pharmaceutical, biotech, device, and diagnostic industry organizations must be scientific or regulatory experts actively engaged in research and development in the field of the disease area of the project they participate in. Industry members join as an organization. Marketing, and investment experts are not permitted to attend closed Forum members meetings, but will be allowed to participate in any public meetings the Forum sponsors.

The Forum does not cover any honoraria or provides items of value (gifts) to any speakers or attendees. Sponsorship cannot be combined/ divided for participation in different disease specific projects at the Forum.

Accountability. The Forum is accountable to the major member stakeholder groups. Frequent evaluations determine whether Forum’s projects are responsive to their needs. Forum projects will continue to operate for as long as their Steering Committees continue to see value in their existence.

Publication and Dissemination. Project members bring their individual expertise and perspective to the table rather than formally represent their respective organization, agency or company. All comments are off-the-record and not for attribution. Documents are not made public until members agree to their release. We post discussion summaries on the Forum’s webpage. We publish white papers and recommendations in peer-reviewed journals when appropriate.

INCLUSIVENESS

Forum projects are open to all organizations with an authentic commitment to the scientific advancement of the disease area of the project they participate in, including U.S. and European government representatives, academic experts, regulated industry, and patients/patient representatives and/or advocates. We value diversity in stakeholder representation. Our process ensures that expert input representing all stakeholder perspectives contributes to the outcome.

COLLABORATION

No one stakeholder group, member organization or individual has all of the information and resources needed to effect progress in this field. Collaboration helps optimize resource utilization, share information, and avoid unintended duplication of efforts. Collaborative activities may include information and data sharing (while maintaining IP integrity); analysis of databases resulting from shared data; substudies within existing studies; and engaging in the process of biomarker acceptance. The volunteered contributions by members from different sectors within the Forum network, steering committees, specific working groups, and other activities represent the cornerstone for collaboration.

EFFICIENCY AND PRODUCTIVITY

We increase efficiency and productivity through a sustained, disease-specific focus and synchronous work process which allows all parties engaged in the deliberation to be exposed to the same information in real time. This promotes and facilitates cross-pollination of ideas, standardization of research practices, and the design of more efficient clinical trials. The collaborative and open environment links silos by decreasing traditional tension and competition and improving cross-sector communication.

The Forum Working Process

ADMINISTRATION

The Forum is housed within the University of California, Berkeley School of Public Health, and receives funds under the 501(c)(3) of the University of California, Berkeley Foundation.

MEMBER SELECTION

Forum staff recruits Forum project members meeting the scientific expertise criteria from the various stakeholder groups, with input and guidance from members of the Steering Committee. Steering Committee members are appointed by their own agency (e.g. FDA, EMA), or recruited by Forum staff (e.g. academia). Industry representatives on the Steering Committee will rotate off on a staggered basis to allow broader participation in leadership. Project members volunteer for participation in working groups.

MEMBER ROLES AND EXPECTATIONS

Forum project members bring their own expertise and the perspectives of their stakeholder group to the table. Members help disseminate and bring discussion points back to their own networks for further discussion and input. Members volunteer their time; the Forum does not provide honoraria or any items of value (e.g. gifts) to Forum members or to invited speakers. All organizations, agencies, and companies should send members with the appropriate scientific expertise.

CONVENING SCHEDULE

Steering Committees convenes by phone and email as required to provide overall leadership and guidance to the project they represent. Working groups have been developed to carry on the work of each Forum project by addressing priority areas identified by both the steering committee and Forum members. Expected outcomes of the working groups include recommendations, position papers, reports, manuscripts for submission to peer-reviewed journals, and presentations at conferences. Throughout the year, working groups communicate and collaborate by conference calls, email, in-person meetings, and workshops as needed.

There is no time requirement for participation in Forum projects; however, working group members are expected to be active participants and participate in as many calls and activities as possible. Forum project members meet as needed. It is advised that companies (industry members) send the permitted number of scientific company representatives as stated in their invitation letter.

MEETING AGENDAS AND FACILITATION

In-person meeting agendas rely heavily on moderated discussions allowing broad input from all project members. When necessary, overview presentations help to bring everyone on the same page with respect to current scientific and policy state-of-the-art. We maintain diversity in leadership by distributing leadership opportunities among the Forum projects and steering committee members.

We expect all meeting participants to engage in discussion, and discourage the presence of passive observers.