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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 près de 30 ans d’expérience dans l’industrie pharmaceutique et CRO, s’étant distingué par son leadership exceptionnel, sa vision stratégique et son innovation. L’expertise de Jeff couvre des opérations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matière de création de valeur, de gestion des partenaires et d’opérations CRO ont toujours contribué au succès dans ses fonctions précédentes. Sous la direction de Jeff, Indero continue d’étendre ses capacités, faisant progresser les connaissances médicales et les nouvelles thérapies en dermatologie et en rhumatologie.

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