The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

This audio conference covers:

• An understanding of “adequate and well-controlled” trials & “substantial evidence” as basis for regulatory approval of all drugs, including anti-infectives
• Benefits and pitfalls of non-inferiority trial designs in select indications
• Benefits and pitfalls of superiority trial designs in select indications
• Appropriate use of clinical endpoints and biomarkers as surrogate endpoints
• Drug development for anti-infectives in the context of other healthcare initiatives such as comparative effectiveness research

About the speakers:

Dr. John Powers is Assistant Professor of Medicine at George Washington University School of Medicine. Before his current position he was the Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives at the US Food and Drug Administration. Prior to that, he was a clinical investigator on over 50 clinical trials while on faculty at the University of Maryland School of Medicine. Dr. Powers has written extensively on the science of clinical trials and clinical research, and has won several teaching awards. He still actively sees patients in clinic and in the hospital.

Dr. Carl Kraus is Vice President, Scientific Affairs at PRA International, a global contract research organization, and serves as the scientific head of the Infectious Diseases group at PRA. He has participated in over 20 development programs in the past five years, focusing on antivirals, antibiotics and biothreat agents, and actively consults for such programs currently. Dr. Kraus was formerly a medical officer in the Office of Antimicrobial Products at the United States Food and Drug Administration where he reviewed numerous IND and NDA applications in similar indications.

Who should attend?

• Medical Directors
• Regulatory Affairs Directors/Managers
• Scientific Directors/Managers
• Project Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.