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Translating Innovation to Success in Antimicrobial Drug Discovery and Development
15 March 2011
Translating Innovation to Success in Antimicrobial Drug Discovery and Development

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.

Workshop agenda

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12:10

Registration & Coffee

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12:15

Welcome & Introductions

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12:20

Antimicrobial target selection: Organisms, biochemical targets

Nafsika Georgopapadakou

Nafsika Georgopapadakou, , Anti-infective Research Consultant

clock

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
  • clock

    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
  • clock

    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
  • clock

    14:35

    Afternoon Coffee

    clock

    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
  • clock

    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
  • clock

    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

    clock

    17:00

    Close of Workshop

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel


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