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Developing an Approval Pathway for Limited-Population Antibacterial Drugs

Developing an Approval Pathway for Limited-Population Antibacterial Drugs

Jul
28
Tuesday
 from 2:30 pm to 3:30 pm
Dirksen Senate Office Building
Constitution Avenue and 1st Street, NE, Washington, DC (map)

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)

Speakers

Janet Woodcock

Janet Woodcock

Director, Center for Drug Evaluation and Research
Food and Drug Administration (FDA)
Allan Coukell

Allan Coukell

Senior Director, Health Programs
The Pew Charitable Trusts
Helen Boucher

Helen Boucher

Prabhavathi Fernandes

Prabhavathi Fernandes

CEO
Cempra

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