Events

Learn more about clinical development of antibiotics! Webinar with David Schlaes

Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will focus on the range of non-traditional pharmaceutical approaches being developed to combat bacterial infections. Kevin Outterson and John Rex to present.

In this webinar, William Hope will talk about the role of pharmacokinetics and pharmacodynamics for antimicrobial drug development. He will discuss the EMA guideline on the use of PK/PD and basic studies to inform dose finding strategies. He will also advise on realistic benchmarking, endpoints, and interpretation of study results.

Facilitating Payment Reform Pathways for Antimicrobial Drugs through FDA and CMS Collaboration As you know, the rise in antimicrobial resistant infections is a major public health threat. Few treatment options are available and the pipeline of drug candidates is extremely limited. To help address this issue, Duke-Margolis has been focused on policy initiatives that could […]

The Food and Drug Administration is holding a public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections." The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy. Presentations by Kevin Outterson, […]

Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether […]

Kevin Outterson to present

There are 453K new C. difficile infections (CDI) every year and 83K recurrent infections, yet there are no licensed vaccines against this important nosocomial pathogen. The current pipeline of clinical-stage vaccines consists of two toxin-based candidates and one phase 3 candidate, which is no longer being pursued. Although mathematical studies and computer-simulation models suggest that […]

Part 2: Development of antibacterial drugs targeting specific pathogens The overall goal of this series of webinars is to provide, for the non-clinical developer, an understanding of the risks of development for various kinds of antibacterial products. Our first webinar was devoted to more traditional approaches (Tiers A and B), best suited for more broad-spectrum products, […]

At least 2 million Americans a year contract an antibiotic-resistant infection, the Centers for Disease Control and Prevention reports. So, what can the U.S. do to safeguard public health amid the growing threat of these superbugs? Tune in to a live webcast as Dr. Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, announces […]