In order to enhance communication and cooperation within our sector, ARM utilizes its committees comprising representatives from member organizations to provide leadership, feedback, and expert insight to our various advocacy and education efforts.
ARM's four sections (Gene Therapy and Gene-Modified Cell Therapy; Cell Therapy; Tissue Engineering & Biomaterials; European) provide strategic oversight and set key priorities, which are then implemented in the work products of these committees:
Capital Formation Committee
CO-CHAIRS: Jeff Goater, CFO, Voyager Therapeutics; Karine Kleinhaus, DVP, North America, Pluristem; Neil Littman, Head of Business Development and Investor Outreach, CIRM
This committee was established to develop and advocate for federal and state policies that would promote capital formation in regenerative medicine. It will also focus on exploring and discovering other possible ways the Alliance can support members on this crucial issue. For more information and a list of upcoming commitee activities members can click here.
Communications and Education Committee
CO-CHAIRS: Eugene Brandon, Senior Director, Strategic Relations and Communications, ViaCyte; Jenn Smoter, Chief External Affairs & Communications Officer, Intellia Therapeutics
The Communication and Education Committee has primary responsibility for overseeing ARM's communications activities. The overarching goal of the committee is to establish ARM as a go-to resource for key stakeholders, offering sector data and other education resources. ARM members can click here for more information on this committee.
Government Relations and Policy Committee
CO-CHAIRS: Debbie Dean, Executive Vice President, MiMedx; Flagg Flanagan, Chief Executive Officer, DiscGenics
This committee is responsible for formal interaction with Congress, congressional staff, and federal agencies including testifying, attending meetings, and other activities as appropriate. The Committee guides the development of an advocacy agenda and executes the lobbying strategy for the Alliance on Capitol Hill. It focuses on both authorization programs and appropriations related to regenerative medicine. The Committee also advocates for programs to fund regenerative medicine research at NIH, DoD, and elsewhere. For more information and a list of upcoming commitee activities members can click here.
Governance and Operations Committee
CHAIR: Doug Doerfler, President and Chief Executive Officer, MaxCyte
This committee is responsible for assisting staff with the operational structure of the organization, determining and implementing changes to the by-laws, as well as staffing and overseeing the nominating process for officers, board and executive committee members.
CHAIR: Martha Rook, Director, Stem Cell Bioprocessing Group, MilliporeSigma
The role of the membership committee is to think strategically about ARM’s membership and dues base and make sure it reflects and supports the overall mission of the organization and enables ARM to execute its strategic plan.
Patient Advocacy Coordinating Committee
CO-CHAIRS: Jennifer Cutie, Associate Director, Patient Advocacy, Voyager Therapeutics; Julie Venners Christensen, Head of Global Patient Advocacy – Gene Therapy, R&D, Rare Disease Unit, GlaxoSmithKline; Barbara Wuebbels, Vice President of Patient Advocacy, Audentes Therapeutics
The Patient Advocacy Coordinating Committee has primary responsibility to ensure alignment, engagement and education of patients and patient advocates relevant to gene therapies, cell therapies and other regenerative medicine products. The Patient Advocacy Coordinating Committee coordinates ARM’s patient advocacy outreach and education agenda, as well as guides ARM’s efforts on the organization’s ongoing clinical and patient education roundtable series. For more information, please click here.
CO-CHAIRS: Jacqueline Barry, Head of Regulatory Affairs, Cell and Gene Therapy Catapult; Anne-Virginie Eggimann, Vice President, Regulatory Science, bluebird bio
The Regulatory Committee oversees development and implementation of the regulatory agenda for the Alliance. This includes prioritization of regulatory objectives with FDA and others as necessary. The Regulatory Committee is responsible for interaction with regulatory agencies at public hearings, meetings, roundtables, PDUFA negotiations, submission of comments to the regulatory docket, and other forums for public discussion. For more information on the committee and its working group members can click here.
Europe Regulatory Affairs Committee
CHAIR: Jacqueline Barry, Head of Regulatory Affairs, Cell & Gene Therapy Catapult
This committee addresses EU-specific issues and topics related to the regulatory framework of Advanced Therapy Medicinal Product (ATMP) development and manufacture. Its main objectives are two-fold: to contribute consistently and meaningfully to discussions and initiatives to improve the regulatory landscape in the EU, including where appropriate within individual member states and to highlight the regulatory challenges and hurdles experienced by ARM member organizations to the relevant public authorities (EU-level and, where appropriate, nationally). Advocate for practical solutions to facilitate product development and patient access to innovative treatments. This committee is open to participation from all ARM members. ARM members can click here to access useful resources and recent webinars.
CO-CHAIRS: Faraz Ali, Chief Business Officer, REGENXBIO; Ted Slocomb, Vice President, Commercial Planning, Audentes Therapeutics
This committee is responsible for developing reimbursement policy related to coverage, payment and coding for regenerative medicine products as well as other related projects including pharmaco-economic studies, comparative effectiveness research and economic modeling. The committee is ARM’s liaison to CMS, AHRQ, as well as private insurers. For more information and a list of upcoming commitee activities members can click here.
Europe Reimbursement Committee
CHAIR: Laura Trivette, Vice President, Reimbursement & Health Policy, MiMedx
This group addresses EU-specific issues and topics related to pricing, reimbursement and market access of Advanced Therapy Medicinal Products (ATMPs). Its main objectives are as follows: To establish ARM a resource for our members regarding pricing & reimbursement (P&R) and market access systems and how they work and to help shape the discussions on P&R and market access for ATMPs. This committee is open to participation from all ARM members. For more information and to access ARM members-only resources, please click here.
Science and Technology Committee
CO-CHAIRS: Jiwen Zhang, Regulatory Affairs Director, GE Healthcare; Michael Mendicino, Owner/Chief Consultant, Hybrid Concepts International
The S&T Committee serves as a forum for Alliance members to exchange ideas, information, and data on different science and technology issues within the regenerative medicine field. One of the principal responsibilities of the committee is to consider issues relating to process and research standards in the context of regulatory science that could be adopted by the industry after consultation with other interested and qualified organizations and the appropriate federal agencies. For more information and a list of upcoming commitee activities members can click here.
If you have any questions about the above, or are an ARM member who would like to join a specific committee, please contact Drew Gorman.
If you are a member an are unable to login to the members-only section of the website, please contact: Luke Thorstenson
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