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