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.
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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
Antimicrobial target selection: Organisms, biochemical targets Nafsika Georgopapadakou, , Anti-infective Research Consultant In-vitro and in-vivo testing 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
Nafsika Georgopapadakou, , Anti-infective Research Consultant
Toxicity: Acute, mechanism-related
Pharmacokinetics
Efficacy in relevant infection models
Outsourcing testing in a cost-effective manner
Operational and regulatory aspect of preparation for your First in Man study 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
Progression to phase 2 and beyond Bozena Korczak, Senior Vice President, Chief Development Officer, PolyMedix, Inc.
Activities behind the main scene
Do it yourself or outsource
Case study: Development of daptomycin for injection 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
Discussion & questions / Review of the session Nafsika Georgopapadakou, , Anti-infective Research Consultant Bozena Korczak, Senior Vice President, Chief Development Officer, PolyMedix, Inc. Barry Eisenstein, Senior VP, Scientific Affairs, Cubist Pharmaceuticals
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