Elissa Flores

About Elissa Flores

I am a Director of Science & Regulatory Affairs at BIO advocating for science policy initiatives that promote biomedical research advances in the field at large. Previously, I was a Scientific Program Manager at a non-profit organization, overseeing committees of multi-sector experts to strategize solutions to overcome global health issues. My various experience also includes, advising philanthropic biomedical ventures in the think-tank industry, former NSF Science Outreach Coordinator, as well as serving on an Executive Diversity and Inclusion Committee at a major medical center. My expertise is in scientific and clinical research with a Doctor of Philosophy (Ph.D.) in Translational Biomedical Science focused on Immuno-toxicology from the University of Rochester. I am also a strong advocate for women and underrepresented minorities in the STEM fields.

Experience

1. Director, Science & Regulatory Affairs

   Biotechnology Innovation Organization

   May 2023 — Present · Washington, DC, US

   Develop BIO regulatory policy initiatives related to Drug and Biologic Development for modernization, and International Harmonization of Regulatory Requirements to advance biomedical innovation.• Lead in policy development in diverse portfolio spanning manufacturing, rare disease drug development, biosimilars, and support on clinical trial diversity committees.• Coordinating biotech committee members to develop consensus BIO policies and draft position papers.• Developing and facilitating approval of written BIO responses to the docket, and verbally communicating BIO positions to relevant government officials.• Monitoring new FDA regulations and guidance documents of importance to BIO’s healthcare-focused initiatives• Serve as a BIO contact to the government agencies, including organizing and moderating FDA liaison meetings on behalf of BIO members, as well as attend meetings held by federal agencies or hearings on the Hill.• Engage and convene with key external stakeholders, including trade associations, think tanks, advocacyorganizations, professional societies, and public-private partnerships.• Present at internal and external meetings, workshops, and conferences; e.g. NIH, FDA, NASEM, W.H.O. events• Conduct research into scientific, regulatory, and legislative issues and disseminating relevant information

Education

• University of Rochester School of Medicine and Dentistry

  Doctor of Philosophy (Ph.D.)

• University of Rochester School of Medicine and Dentistry

  Post-Baccalaureate

• Stony Brook University

  Bachelor's Degree