AMM advisors will engage with governments, policymakers, regulators and other stakeholders in North America, Europe and Asia Pacific to advocate for policies that encourage innovation, define regulatory standards, support manufacturing and promote access of mRNA medicines to patients.
To realize the promise of mRNA across its many potential applications, AMM believes regulators should develop a specific regulatory framework for mRNA Why? The areas in which the field needs clarity for mRNA development and manufacturing are different than the issues most pressing for small molecules and other biologics (including cell and gene medicine). The development of a specific framework for mRNA would provide certainty for the community as well as help FDA as it they consider issues from pre-clinical to post-approval.
This regulatory environment would enable continued flexibility and speed in development of mRNA vaccines and therapeutics around the world.
AMM is also promoting international harmonization and cooperation among regulatory authorities across the globe to propel mRNA technology forward in all its potential uses and to move smoothly between discovery, development and deployment stages.
With some of the most recognized innovators in mRNA, AMM will help overcome the obstacles to mRNA medicined development stemming from uncertainty about standards. We are convening our members and partnering with relevant organizations to develop, where needed, or improve upon standards for the field.
AMM is playing a role in combatting mRNA vaccine misinformation and demystifying the technology by explaining how mRNA works. We are educating policymakers, payers, and the public about the great potential of mRNA across many different applications so that as they move from bench to bedside, there is greater awareness of it.
As more mRNA based therapies and vaccines are developed, AMM will lead the field in communicating to government and private sector payers on access issues to ensure patients receive the benefits of these products.
The versatility and agility of mRNA technology combined with the high level of coordination between industry and regulators enabled development, approval and distribution of the COVID-19 vaccine in record time. Looking forward, AMM is pursing development of a framework that will enable rapid deployment of mRNA vaccines for new pathogens as need arise.
AMM recently hosted a free webinar for members and supporters to learn more about our response to the Food and Drug Administration’s draft guidance for industry about implementation details of the platform technology designation program established by Congress.
Watch the webinar recording to hear regulatory experts discuss FDA’s draft guidance and explain how mRNA technology’s agility and flexibility make it well suited to a platform approach.
In September, AMM held its inaugural DC Day event in Washington, D.C. The event aimed to introduce the organization’s objectives and discuss the transformative potential of mRNA technologies.
Key meetings were held with various policymakers, including Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, and leadership from Cancer Moonshot and the White House Office of Science and Technology Policy. On Capitol Hill, AMM met with Senator Bill Cassidy, Representative Brett Guthrie, and senior staff for Senators Gary Peters and Bob Casey.
Check out the highlight reel and pictures from the event below.
