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 Aishat Magbade, amagbade@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 Aishat Magbade, amagbade@alliancerm.org

Science

 

 

 

Cell Therapy Interest Group


This annual town hall provides companies who are developing autologous and allogeneic cell therapy products the opportunity to discuss and prioritize issues relevant to their advocacy and product development agendas. The section 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 Interest Group


This annual town hall convenes companies and institutions developing gene and gene-modified cell therapy products. It 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 and Rachel Haurwitz, President & CEO, Caribou Biosciences

This task force is dedicated to anticipating and addressing issues related to bioethics and regulation of human genome editing, while supporting and improving public awareness of its clinical potential. This group also focuses on genome editing technical standards.

Tissue Engineering & Biomaterials Interest Group


This annual town hall coordinates activities among the companies and institutions developing tissue-engineered and biomaterial-based regenerative medicine products. This group 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: Susan Abu Absi, SVP, Pharmaceutical Dev. & Technology, bluebird bio & Michael Mendicino, Owner/Chief Consultant, Hybrid Concepts International

This 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 the growth of the industry via the assembly of dedicated task forces to tackle industry-specific concerns including the need for best practices, and the convening of expert panels and industry workshops to help address the challenges associated with the development of regenerative medicine technologies. In addition, the committee offers the voice of technology developers in ongoing advocacy efforts spearheaded by ARM as it engages with qualified organizations and federal agencies.

Regulatory CMC Task Force


This task force provides commentary on draft CMC guidance, works to identify outdated CMC guidance, and proactively identifies guidance gaps. This group coordinates regularly with the US and European regulatory committees on all CMC-related issues. The task force also participates in the organization and execution oof CMC-focused workshops.

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 committee addresses European-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 as a resource for our members regarding pricing and reimbursement (P&R) and market access systems and how they work and help shape how these systems work by engaging with key decision-makers, identifying hurdles and practical solutions to facilitate market adoptions of ATMPs in Europe.

Europe Regulatory Affairs Committee


CHAIR: Jill Morrell, Regulatory Affairs Contractor, BioMarin Pharmaceutical Inc.

This committee addresses European-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 Europe, 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 (pan-European-level and, where appropriate, nationally). This group advocates for practical solutions to facilitate product development and patient access to innovative treatments.

U.S. Government Relations and Policy Committee


CHAIR: Jeremy Allen, Head of Government Affairs, Spark Therapeutics

This committee is responsible for providing strategic counsel regarding formal interactions with Congress and congressional staff. The Committee guides the development of an advocacy agenda and executes the lobbying strategy for ARM on Capitol Hill. It focuses on relevant statutes, regulations, and 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 & Brent Rice, Vice President, Chief Commercial Officer (US) Autolus

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, state Medicaid agencies and private insurers.

U.S. Regulatory Affairs Committee


CO-CHAIRS: Robert Pietrusko, Chief Regulatory & Quality Officer, Vor Biopharma & Nimi Chhina, Senior Director, R&D and Regulatory Policy, Strategy, Scientific Collaborations and Policy, BioMarin Pharmaceutical Inc.

The U.S. Regulatory Affairs Committee oversees the development and implementation of the regulatory agenda for ARM. 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

Public Affairs Town Halls


This quarterly town hall focuses on the policy and public affairs activities ARM has participated in throughout the year.

Patient Engagement Committee


This committee has the primary responsibility to ensure the engagement and education of patients and patient advocates relevant to gene therapies, cell therapies, and other regenerative medicine products.