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Workshop hosts:

  • Dr. Nafsika Georgopapadakou,
    Anti-infective Research Consultant,
    Montreal - Canada
     
  • Dr. Bozena Korczak,
    Senior Vice President, Chief Development Officer,
    PolyMedix, Radnor - USA
     
  • Dr. Barry Eisenstein
    Senior VP, Scientific Affairs,
    Cubist Pharmaceuticals, Lexington - USA


Who should attend this workshop?

All those responsible for research, medical microbiology, antimicrobial therapeutics and clinical development, including:

  • Chief Scientific Officers
  • Senior Vice Presidents
  • Chief Medical Officers
  • Research Scientists
  • Clinical Microbiologists
  • R&D Project Managers
  • Heads of Anti-Infectives Discovery
  • Clinical Trials Managers
  • Principal Scientists
  • Senior Vice Presidents of R&D

Scroll down for the workshop timetable.

Register your place   View a Brochure  

What is this workshop about?

After briefly highlighting infectious disease areas of greatest medical need and commercial opportunity, the workshop will provide insights into the stages of the antimicrobial drug discovery process with the goal of increasing the probability of success. Critical issues for each stage - from target selection to IND-enabling studies - will be outlined, with examples from real cases of success/failure.  The impact and limitations of recent innovations - genomics, bioinformatics, high through screening, combinatorial chemistry - in drug discovery will be discussed.   Goal posts likely to lead to progression of an active compound to a drug will be defined, as well as minimal in-house resources and skills required for compounds to progress. 

There will be a number of case studies covered, including the interesting and eventually successful development of daptomycin for injection (Cubicin). This antibiotic had been developed through phase 2 at Eli Lilly in the 1980's, but was abandoned because of safety reasons. It was later licensed to Cubist Pharmaceuticals, a small start-up company, who were able to make a key discovery relating to appropriate dosing that enabled continued development. This antibiotic was subsequently successfully developed and approved for both complicated bacterial skin infection and for Staphylococcus aureus bacteremia, including with right-sided endocarditis, but failed in community acquired bacterial pneumonia for reasons that will also be discussed.

The workshop will conclude with an interactive panel discussion, where the audience is encouraged to ask questions and make comments/suggestions.
 

Who is leading this workshop?

 

NAFSIKA H. GEORGOPAPADAKOU is an Anti-infective Research Consultant based in Montreal - Canada.  In addition, she is Adjunct Professor in Microbiology and Immunology at Temple University, Philadelphia, Pennsylvania and Founder and former Editor-in-Chief of Drug Resistance Updates, a multidisciplinary review journal in antimicrobial and anticancer chemotherapy.  In the past twenty years, she has held positions of increasing responsibility in drug discovery at Bristol-Myers Squibb, Roche, DuPont Pharmaceuticals, and small biotechs (NewBiotics, MethylGene, Novabay).

A member of the American Academy of Microbiology, the American Association for Cancer Research, and the American Society for Biochemistry and Molecular Biology among other organizations, she is the editor or coeditor of two books and the author or coauthor of over 150 research papers and abstracts in drug discovery and mechanisms of drug action/resistance.

Dr. Georgopapadakou received her BA degree in Chemistry from Mills College, Oakland, California, her PhD degree in biochemistry from Yale University, New Haven, Connecticut and her postdoctoral training at Harvard University, Cambridge, Massachusetts.

 

NafsikaG

  

 

 

BOZENA KORCZAK, Ph.D., currently serves as Senior Vice President, Drug Development & Chief Development Officer at PolyMedix. She joined the company in November 2007 as Vice President, Drug Development. Dr. Korczak has over 20 years of experience in discovery, pre clinical and clinical research at burgeoning biotechnology organizations.

Prior to joining PolyMedix, Dr. Korczak was a Principal at PharmaReach, Ltd., a private drug development consulting company and Vice President of Research and Development of Cytochroma, Inc., a private biotechnology company. Dr. Korczak served in various positions of increasing responsibility at Glycodesign, Inc., Allelix Biopharmaceutical, Inc. and Mount Sinai Hospital. She is an author of thirty five peer review scientific papers and holds a Ph.D. in biochemistry from the Polish Academy of Science.

Bozena



BARRY EISENSTEIN, 
M.D., FACP, FIDSA is Clinical Professor of Medicine at Harvard Medical School, Senior VP, Scientific Affairs at Cubist Pharmaceuticals and Editor of Antimicrobial Agents and Chemotherapy.

Dr. Eisenstein received his AB degree summa cum laude from Kenyon College in 1968 and his MD from Columbia University College of Physicians and Surgeons in 1972.  Following four years as Vice President, Lilly Research Labs, in charge of ID discovery and clinical development, he moved to Boston as Vice President of Science and Technology, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard Medical School, where he established a technology transfer office and clinical trials program.  Since early 2003 he has worked at Cubist Pharmaceuticals, where he helped lead the approval process for Cubicin at the FDA.  His research focus continues to be antibiotic resistance, the molecular mechanisms of bacterial pathogenicity, and the discovery and clinical development of new antimicrobial agents.

He is the author of more than 100 original papers, book chapters, and editorials, has edited several books on infectious diseases and microbiology, and has extensive national and international peer-review and consulting experience. View full biography

 

Where does the workshop take place?

This workshop will take place at the Millennium Gloucester Hotel, London, United Kingdom on Tuesday 15th March 2011.

Workshop programme

12:10 Registration & Coffee

12:15 Welcome & Introductions

12:20 Antimicrobial target selection: Organisms, biochemical targets

Nafsika Georgopapadakou

Nafsika Georgopapadakou, , Anti-infective Research Consultant

12:50 In-vitro and in-vivo testing

Nafsika Georgopapadakou

Nafsika Georgopapadakou, , Anti-infective Research Consultant

  • Mechanism of action
  • Cidal/static, post-antibiotic effect
  • Resistance: Frequency, fitness, cross-resistance
  • Effect of serum on antimicrobial activity
  • Mammalian cytotoxicity
  • 13:20 Animal studies

    Nafsika Georgopapadakou

    Nafsika Georgopapadakou, , Anti-infective Research Consultant

  • Toxicity:  Acute, mechanism-related
  • Pharmacokinetics
  • Efficacy in relevant infection models
  • Outsourcing testing in a cost-effective manner
  • 13:50 Operational and regulatory aspect of preparation for your First in Man study

    Bozena Korczak

    Bozena Korczak, Senior Vice President, Chief Development Officer, PolyMedix, Inc.

  • Drug substance and drug product
  • Pre-IND/CTA meeting
  • Design and objectives for phase 1
  • 14:35 Afternoon Coffee

    15:05 Progression to phase 2 and beyond

    Bozena Korczak

    Bozena Korczak, Senior Vice President, Chief Development Officer, PolyMedix, Inc.

  • Activities behind the main scene
  • Do it yourself or outsource
  • 15:50 Case study: Development of daptomycin for injection

    Barry Eisenstein

    Barry Eisenstein, Senior VP, Scientific Affairs, Cubist Pharmaceuticals

  • History of daptomycin - from Lilly's abandonment to Cubist's success
  • The successful clinical development for both complicated bacterial skin infection and for Staphylococcus aureus bacteremia
  • The unsuccessful application for community acquired bacterial pneumonia indication
  • How can we take what we have learned and make immediate improvements in our development processes
  • 16:30 Discussion & questions / Review of the session

    Nafsika Georgopapadakou

    Nafsika Georgopapadakou, , Anti-infective Research Consultant

    Bozena Korczak

    Bozena Korczak, Senior Vice President, Chief Development Officer, PolyMedix, Inc.

    Barry Eisenstein

    Barry Eisenstein, Senior VP, Scientific Affairs, Cubist Pharmaceuticals

    17:00 Close of Workshop

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    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    HOTEL BOOKING FORM

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