Pre-Conference Workshops: Monday, January 25, 2010

• Workshop A: Bridging the Scientific and Regulatory Interface For Anti-Infective Drug Development
• Workshop B: Phage Therapy within Bacterial Resistance: A Safe and Integrated Approach for the Management of Superbugs

9:00 am - 12:00 pm Workshop A: Bridging the Scientific and Regulatory Interface For Anti-Infective Drug Development

8:45 am Registration

Planning to address both regulatory and scientific issues can speed a company’s time to market on a particular anti-infective drug development pipeline. Failure to appropriately plan and design studies can delay the clinical phases of development which can cost millions of dollars and potentially end a drug development company’s pipeline prior to product launch. Knowing effective regulatory guidelines and a scientific framework within which to work is a key goal for companies to speed up their clinical development processes for Anti-Infective drug products.

What will be covered:

• Overview of regulatory requirements for drug development within the anti-infectives market
• Identifying efficient drug development strategies
• Complying with regulatory requirements quickly and efficiently while maintaining safety
• Displaying case study examples of effective and ineffective implementation

How you will benefit:

• Discover how to avoid failure within phase 3 clinical trials and overall drug development plans
• Keep up to date on the changing regulatory landscape within the antiinfectives arena
• Benchmark your development pipeline with a number of successful leading clinical drug development organizations
• Keep up to speed with drug development leaders buy hearing effective implementation strategies

Your workshop Leader:

John Powers, MD
Assistant Professor of Medicine
George Washington University School of Medicine
and former Lead Medical Officer
Antimicrobial Development
US FDA

1:00 pm - 4:00 pm Workshop B: Phage Therapy within Bacterial Resistance: A Safe and Integrated Approach for the Management of Superbugs

12:30 pm Registration

The workshop will explore a natural and environmentally friendly alternative for bacterial resistance: Phage Therapy. Attendees will explore the various potentials of phages in the diagnosis and management of bacterial contamination. This session will also focus on how Phage treatment and technologies are continuously being used and developed to combat bacterial infection and help assist drug discovery.

What will be covered:

• Phage therapy overview
• Biosensors
• Immunology / Immnotoxicology
• Early work in Eastern countries and recent advances in phage therapy
• Safety issues: groundbreaking announcement from FDA
• Phage therapy as a personalized medicine combining diagnostic and phage therapy

How you will benefit:

• Phage product development: Learn how to turn a phage into a marketable product
• Uncover technologies and methodologies, large-scale phage production
• Discuss environmental-friendly phage programs to fight bacterial contamination
• Understand when antibiotics are not working anymore and phage therapy is an option

Your Workshop Leader:

Speaker and sponsorship opportunities available. Please contact simon.curtis@iqpc.com for more information

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