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Human Health

There’s no other biotech trade association that is as inclusive and collaborative as BIO. Members help shape advocacy efforts targeting the regulatory and reimbursement climate, drug development and review, publicly-funded scientific research, pandemic and biodefense preparedness, and personalized medicine. 

Priorities
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Policy & Research
  • Addressing existing and future drug coverage programs including Medicare and Medicaid, the 340B program, ACA exchanges, rebate programs, and more.
  • Advocating for updated reimbursement policies such as the CMS Reimbursement Rule that reaffirms the many benefits of transformational therapies.
Science and Regulatory Affairs
  • Working closely with the FDA on regulatory best practices that affect members’ ability to research and develop new medicines and biotechnology therapies, including Prescription Drug User Fee Act  Agreements (PDUFA) and Biosimilar User Fee Act Agreement (BsUFA).  
  • Promoting the use and acceptance of innovative clinical trial designs and patient-focused drug development.
  • Advancing policy positions that support an adequate and flexible regulatory environment for the development of regenerative medicines, including cell and gene therapies and genome editing, specifically in BIO’s role as a member of the International Council on Harmonization (ICH).
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Genome Editing
Specialty Markets
  • Advocating for policies that support the discovery and development of the medical countermeasures necessary for health security and the growth of personalized medicine products.
Get Involved!

Our members drive our advocacy. Join a BIO committee to help shape our policy work and stay informed.

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