Resistance to antibacterial agents, both in clinical settings and in the community, continues to increase.  Pan-resistant strains of gram negative pathogens are now routinely observed in many hospitals resulting in the use of older drugs with poorer efficacy and safety profiles. 

At the same time, a strain of Methicillin-resistant Staphylococcus aureus (MRSA) has been proliferating in communities worldwide and recent reports indicate that MRSA is becoming more multidrug resistant, causing more deaths in 2005 than HIV and HIV-related causes (CDC, 2007). 

Despite the clear and growing unmet medical need, to date, target-based screening for novel antibacterial agents has yet to advance a compound into late-stage development.

Perhaps the most essential of pathways in bacteria growth is DNA replication; however, this area has been overlooked.  Is this a function of the complexity of the replication machinery or short-sightedness?

The goals of this session will be to address the continuing and growing problem of antibacterial drug resistance and what can and should be done to counter it.

Moderator:

• Michael Dowzicky, M.S., MT ASCP, senior director, global medical affairs; infectious disease and transplantation group, Wyeth Pharmaceuticals

Panelists:

• Chris Cashman, president & CEO, Protez Pharmaceuticals
• Barry Kreiswirth, Ph.D. director, PHRI TB Center, University of Medicine and Dentistry of New Jersey
  ( Presentation)
• David Pompliano, Ph.D., vice president and head of antimicrobials discovery and early development strategy, Merck & Co., Inc. ( Presentation)
• Tibby Posillico, Ph.D., president & CEO, Elusys Therapeutics, Inc. ( Presentation)
• Steven Projan, Ph.D., vice president and global head of infectious diseases, Novartis Institutes for BioMedical Research

With the commercial success of blockbuster monoclonal antibodies, and constructs, such as Remicade, Erbitux, Orencia, and Enbrel, the profile of antibody technologies has never been higher. With more than 300 antibody-related R&D programs in the industry pipeline, early adoption of cutting-edge technologies is required for companies to remain competitive.

This session will review protein engineering advances that have enabled the construction of optimized antibodies with alterations in effector function and improved pharmaceutical properties. Case studies will highlight how these newer antibody-like constructs are expected to offer improved tissue penetration and enable multi-antigen targeting.  The panelists will also discuss how to optimize your pipeline by complementing novel targets with novel constructs.      

Moderator:

• Bob Ward, vice president, alliance management, NPS Pharmaceuticals Inc.

Panelists:

• Robert Hayes, Ph.D., venture leader, Centyrex, Johnson & Johnson Ventures
• Nils Lonberg, Ph.D., senior vice president & scientific director, Medarex, Inc.
• Nicholas Nicolaides, Ph.D., president & CEO, Morphotek, Inc.        
• Zhenping Zhu, M.D., Ph.D., vice president of research, ImClone Systems Incorporated                                       

Increasingly, we are finding through clinical experience that certain drugs work better in certain sub-populations of patients.  However, less frequently we are identifying the biomarkers that could distinguish, a priori, which patients would respond better to novel therapies. 

Perhaps the major reason for this disconnect is that we often do not understand the molecular basis for a given disease nor do we routinely "profile" patients in early-stage trials.  While there is a high degree of interest for this among regulatory authorities, when it comes to pivotal studies, there appears to be much less flexibility in patient numbers that have to be enrolled or in any type of retrospective analysis of which patient populations responded to a new drug. 

This session will focus on how to:  

• Do a better job of defining the molecular basis of disease
• Define potential biomarkers pre-clinically
• Incorporate biomarker studies in Phase 2 proof-of-concept studies (without breaking the bank)
• Open the minds of regulators to get novel drugs to the right patients in a timely manner

Moderator:

• Russel Kaufman, M.D., president & CEO, The Wistar Institute

Panelists:

• Jeffrey Bockman, Ph.D, vice president, Defined Health
• Jamie Freedman, M.D., Ph.D., president, CEO and director, Locus Pharmaceuticals, Inc.
• Avijit Roy, Ph.D, director, Five Prime Advisors
• Michael Williams, Ph.D., D.Sc., vice president, discovery research, Cephalon, Inc.