EXPERIENCE

EXPERIENCE

Over 25 Years of Combined Experience in:

  • Patient Care
  • Clinical Research
  • Drug Development
  • Clinical Safety
  • Pharmacovigilance
  • Scientific Communications

US hospital and clinic-based medical practice:

 

  • As a US State-licensed, practicing physician, treated innumerable patients with cardiopulmonary diseases, arrhythmias, dyslipidemia, diabetes and other metabolic disorders, peripheral vascular disease, rheumatologic, and immune-inflammatory diseases.

 

Gut microbiome expertise:

 

  • As Vice President, R&D, Medical, and the medical lead for two large, double-blind, global phase 3 clinical trials, for novel gut microbiome sparing (and restoring normal bile salt balance in the gut), targeted antibiotic for C. difficile infection, obtained extensive clinical research experience on the gut microbiome and its relation to recurrence of C. difficile infection.
  • Presented paper from phase 2 trial at IDWeek 2019, in Washington D.C. regarding the impact of C. difficile infection on the patient quality of life: “Quality of Life Changes in Patients with Clostridium difficile Infection (CDI): A Randomized, Double-Blind Trial of Ridinilazole (RDZ) Compared to Vancomycin (VAN).”
  • As a C. difficile infection survivor with a history of multiple recurrences, a passionate patient advocate and educator on the importance of a healthy gut microbiome for good health.

 

Phase I-IV studies:

 

  • As global medical lead for drug development, demonstrated strategic and operational, and medical leadership in drug development:
  • Designing, writing and implementing protocols
  • Collecting, interpreting, presenting, and publishing data
  • Responsible for clinical safety, pharmacovigilance, and risk management
  • Extensive regulatory experience with agency meetings and submissions
  • Expertise in life cycle strategy; and clinical due-diligence for in-licensing, collaboration/partnership

 

Training and compliance:

 

  • As head of clinical development, demonstrated skills in GCP, PhRMA code on interactions with HCPs, and GPV; development of SOPs, and training and compliance metrics

 

Global pharmacovigilance (investigational and marketed products):

 

  • As a leader in drug development led FDA and EMA audit preparation; SMP, DSUR, PSUR, signal detection, trending, REMS, benefit-risk assessment; and IB updates

 

Scientific communications and patient advocacy:

 

  • As an accomplished writer and presenter, experienced in successfully translating evidence-based clinical trials into medical practice recommendations, peer-reviewed publications, and public awareness campaigns, with an emphasis on patient advocacy.