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Atopic Dermatitis (AD) Case Study

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Outcomes

  • Innovaderm successfully managed this AD study and this resulted in enrollment completed 2 months earlier than planned; Innovaderm CRU recruited 33% of patients

Study Characteristics

  • Study Phase: Ib
  • Patient Population: 36 subjects with moderate to severe AD
  • IP Route of Administration: Systemic – Oral
  • Site distribution: 10 sites in 2 countries (USA and Canada)
  • Study Design: Randomized, sequential, placebo-controlled, double-blind | Multiple ascending dose (MAD): 3 sequential cohorts
  • Study procedures: 4.5 mm punch skin biopsies, photographs, biomarker analysis, skin microbiome, pharmacokinetics, tape stripping and efficacy-safety assessments

Study Challenges

  • Recruitment during summer months; Seasonality impacts on AD flares
  • Short treatment duration; 4-week treatment period
  • Data and Safety Monitoring Board (DSMB) after each cohort; Challenging to manage without affecting recruitment

Key Success Factors & Strategies

  • Recruitment completed in 6 months vs planned 8 months
  • Outstanding contribution by Innovaderm’s Clinical Research Unit
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Jeff Smith

Chef de la direction
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Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

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