ARM Committees & Task Forces


In order to enhance communication and cooperation within our sector, ARM utilizes its committees and task forces, comprising executive-level representatives from member organizations, to provide leadership, feedback, and expert insight to our various advocacy and education efforts.

For questions about any of ARM’s Committees, or to join, please contact A-P Murphy, committees@alliancerm.org


In order to enhance communication and cooperation within our sector, ARM utilizes its committees and task forces, comprising executive-level representatives from member organizations, to provide leadership, feedback, and expert insight to our various advocacy and education efforts.

For questions about any of ARM’s Committees, or to join, please contact A-P Murphy, committees@alliancerm.org

Science

 

 

 

Cell Therapy Committee


CHAIR: David Smith, Chief Commercial Officer, Healios

Provides companies developing autologous and allogeneic cell therapy products the opportunity to discuss and prioritize issues relevant to their advocacy and product development agendas. The committee includes companies and institutions working with a variety of cell sources and seeks to identify common challenges and opportunities.

Gene Therapy & Gene-Modified Cell Therapy Committee


CO-CHAIRS: Alison Finger, CCO, bluebird bio; Tim Miller, President and CSO, Abeona Therapeutics

Organizes companies and institutions developing gene and gene-modified cell therapy products. This committee focuses on accelerating the commercialization of these types of products.

Task Force

Gene Editing Task Force

CO-CHAIRS: Sandy Macrae, President and CEO, Sangamo Therapeutics

This task force is dedicated to anticipating and addressing issues related to the bioethics of human genome editing, while supporting and improving public awareness of its clinical potential.

Tissue Engineering & Biomaterials Committee


CO-CHAIRS: Jason Wertheim, Associate Professor & Vice Chair for Research, Department of Surgery, Northwestern University; Jeff Ross, CEO, Miromatrix

Coordinates activities among the companies and institutions developing tissue engineered and biomaterial-based regenerative medicine products. This committee works to accelerate development and commercialization by identifying the unique requirements (regulatory, reimbursement and policy) facing this subgroup of the regenerative medicine field.

Science and Technology Committee


CO-CHAIRS: Stewart Abbot, Chief Development Officer, Fate Therapeutics; Michael Mendicino, Owner/Chief Consultant, Hybrid Concepts International
The S&T Committee serves as a forum for ARM members to exchange ideas, information, and data on different science and technology and CMC issues within the regenerative medicine field. The committee is principally focused on fostering growth of the industry by creating value through preparation of case studies, assembly of dedicated task forces to tackle industry specific concerns including the need for standards, and the convening of expert panels and industry workshops to help address the challenges associated with development of cutting edge technology. In addition, the committee offers the voice of technology developers in the ongoing advocacy efforts spearheaded by ARM as it engages with qualified organizations and relevant federal agencies.

Policy

 

 

Europe Market Access & Value Committee


CO-CHAIRS: Jean-Philippe Combal, Co-founder and CEO, Vivet Therapeutics; Ken Genenz, Senior Director, Global Marketing, Pricing & Market Access, TiGenix
This group addresses EU-specific issues and topics related to Health Technology Assessment (HTA), 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 and reimbursement (P&R) and market access systems and how they work, to help shape the discussions on P&R and market access by engaging with key decision makers, identifying hurdles and practical solutions to facilitate market adoption of ATMPs in Europe.

Europe Regulatory Affairs Committee


CO-CHAIRS: Patrick Ginty, Head of Regulatory Affairs, Cell & Gene Therapy Catapult; Jill Morrell, Director , Regulatory Research & Intelligence and EU Policy, BioMarin
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.

Government Relations and Policy Committee


CHAIR: Jeremy Allen, Head of Government Affairs, Spark Therapeutics
This committee is responsible for formal interaction with Congress and congressional staff, including drafting legislation, 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 relevant statutes, regulations, and programs related to regenerative medicine. The Committee also advocates for programs to fund FDA and NIH activities, especially those programs related to regenerative medicine.

U.S. Market Access and Value Committee


CO-CHAIRS: Kristin Wolff, Director, Global Government Affairs and Public Policy, bluebird bio; Greg White, Senior Director, Global Market Access Policy, Janssen, Pharmaceutical Companies of Johnson & Johnson
This committee is responsible for developing and executing the ARM strategy and recommendations related to coverage, payment and coding for regenerative medicine products. The committee is ARM’s liaison to CMS, as well as private insurers.

U.S. Regulatory Affairs Committee


CHAIR: Adora Ndu, Executive Director, Global Regulatory Policy, Research & Engagement, BioMarin
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.

Strategic

Capital Formation Committee


CHAIR: John Maslowski, President and Chief Executive Officer, Fibrocell Science
The Capital Formation Committee oversees ARM’s activities related to addressing the fundraising and capital formation requirements of ARM members companies in the U.S., Europe and other regions. ARM conducts industry specific investor events for public and private companies. Our flagship investor meeting is the Cell and Gene Therapy Investor day held in the spring in either New York City or Boston. ARM has also convened an investor day in London over the last several years and is exploring options for more extensive investor outreach in Europe over the coming year. ARM uses these events to help members companies connect with potential investors and to educate the investor community about the clinical and commercial progress in the sector. The committee also organizes specialized events with small groups of companies and investors on specific topics, technology platforms or around progress in key disease areas of focus. Finally, the Capital Formation Committee also convenes to discuss topics and trends affecting the capital raising environment for regenerative medicine.

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 members provide communications alignment and strategic counsel to ARM’s key focus areas, including reimbursement, regulatory, industrialization & manufacturing, stakeholder engagement and education, media relations, and more. The overarching goal of the committee is to establish ARM as a go-to resource for key stakeholders, offering sector data and other educational and informational resources.

Patient Engagement Committee


CO-CHAIRS: Jennifer Farmer, Executive Director, Friedreich’s Ataxia Research Alliance; Dena Ladd, Executive Director, Missouri Cures
The objectives of the Patient Engagement Committee are to establish a two-way dialogue and a productive forum for mutual education and policy engagement between the patient community and ARM, and to support ARM patient centered programming. The committee includes individuals from industry, patient advocacy organization representatives and individual patients.

European Advanced Therapies Committee


CO-CHAIRS: Michael Hunt, Chief Financial Officer, ReNeuron; Miguel Forte, CEO, Zelluna Immunotherapy

Serves as a focal point for industry efforts to work with the European Medicines Agency (EMA), its Committee for Advanced Therapies (CAT), the European Commission, and national authorities to help build a safe, rational, and robust framework for the approval and market access of advanced therapy medicinal products (ATMPs) in Europe. This committee works to establish relationships with European investor groups and pharmaceutical companies to further their understanding of the value and potential of advanced therapies.