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Developing an Approval Pathway for Limited-Population Antibacterial Drugs

This event has passed
Jul
28
Tuesday, Jul 28 2015 from 10:30 am to 11:30 am
Dirksen Senate Office Building
Constitution Avenue and 1st Street, NE, Washington, DC (map)
Briefing Room G11

Please join us on July 28th for a briefing with a panel of antibacterial drug experts and stakeholders, including Center for Drug Evaluation and Research Director Janet Woodcock, MD, to discuss the development of a limited-population antibacterial drug (LPAD) approval pathway.  Bipartisan legislation has been approved by the House of Representatives and introduced in the Senate--the Promise for Antibiotics and Therapeutics for Health (PATH) Act, S. 185.

The LPAD pathway would provide for the approval of new antibiotics that target serious or life-threatening drug-resistant infections in patients who have few or no suitable treatment options. The pathway could help bring critical new drugs to such patients, while maintaining standards of safety and efficacy, limiting use to targeted populations, and requiring post-market surveillance.

You are invited to hear presentations, discussion, and participate in an interactive question and answer session with a panel featuring:

  • Janet Woodcock, MD, Director, FDA’s Center for Drug Evaluation and Research
  • Helen Boucher, MD, Associate Professor, Tufts University School of Medicine; Member, IDSA Antimicrobial Resistance Committee
  • Prabhavathi Fernandes, PhD, President and Chief Executive Officer, Cempra Pharmaceuticals
  • Allan Coukell, Senior Director for Health Programs, the Pew Charitable Trusts (moderator)
The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most...

Speakers

Janet Woodcock
Food and Drug Administration (FDA)
Director, Center for Drug Evaluation and Research
Allan Coukell
The Pew Charitable Trusts
Senior Director, Health Programs
Helen Boucher
Prabhavathi Fernandes
Cempra
CEO

Attendees

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