Michael Werner | Executive Director
ARM

	Michael Werner has almost 25 years of healthcare law, lobbying, policy development and regulatory experience in Washington. He focuses on issues affecting biotechnology and pharmaceutical companies, researchers and research institutions, physicians and patients. His specific areas of knowledge include FDA drug/biologic regulations; FDA and NIH oversight of clinical trials including registries and reporting of trial results; approval and marketing of orphan drugs; stem cell research and regulation of cell therapy and regenerative medicine products; as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies.	Share this

@ 11.45

Gain dual track approval to shorten reimbursement timeline
Why does the status of regulatory and reimbursement procedures need to be put into context?
How can parallel success of market approval and reimbursement be achieved?
Ensure your stem cell therapy is reimbursed following conditional approval
Understanding datasets for regulatory and reimbursement approval are not the same