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Therapeutic Areas

Infectious Diseases, Hepatitis, HIV

Indications include

  • Microbiome, Phages, Bacteriocin (AMR)
  • Intra Abdominal Infection (IAI), Clostridium difficile, Enteric Bacilli, Shigella, Salmonella
  • Urinary Tract Infection (UTI)
  • Vaccination
  • Viral infectious disorders (HIV)
  • Bacteria Other: Mycobacterial infectious disorders (Tuberculosis, Leprosy, Treponema Syphilis, Lyme Disease, Leptospirosis, Brucellosis, Tularemia, cholera, others)
  • Sepsis
  • Parasites  (Malaria, Trypanosomiasis, Leishmaniasis  Helminthic disorders (Cestode, Nematode and Trematode, others)
  • Gynecological infections, gonococcal, Chlamydia infectious disorders
  • Respiratory tract infection, Pneumococcal infections

Recent assignments

  • Development strategy in the US, Japan & Brazil for an anti-HIV vaccine
  • Lead preparation and participation in EMA Scientific Advice (various bacterial infections) and one EMA/HTA Parallel Consultation (sepsis)
  • Lead rehearsal for 2 oral explanations to address CHMP D 180 major objections for targeted MAAs
  • Preparation (writing and review ) of MAA Modules for a new cephalosporin combined with a beta-lactam structurally related to penicillins approved in cUTI and CIAI within the last 5 years
  • Gap analysis of protocols and IBs to ensure regulatory compliance for two clinical trials for drugs against an infectious disease and response to ground for non-approval
  • Preparation of NC/C NDA modules and conduct of a preNDA meeting for a new combination in malaria
  • Prepare for, and participate in a series of Scientific Advice meetings for a recombinant vaccine; develop IMPD & IB, support CMC, nonclinical & clinical product development
  • Ensure regulatory compliance for two clinical trials for a drug against infectious disease and provide post-authorization pharmacovigilance services in Europe for an infectious disease drug
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