Candida Fratazzi MD

Clinical Research and Medical Affairs                                   25 years’ experience in biomedical research

Dr Fratazzi devised the concept of a Strategic Clinical Innovation Organization (SCIO) and founded the first SCIO –Boston Biotech Clinical Research (BBCR), LLC in 2009, with the objective of actively contributing to innovation in clinical research. Dr. Candida Fratazzi is an Orphan diseases expert. She has worked in cystic fibrosis, Fabry disease, Gaucher’s disease, and multiple sclerosis projects.

 

As the President of BBCR, LLC, Dr. Fratazzi acts as a consultant to biotech, pharmaceutical and medical device companies of all sizes:

  • She advises her clients on optimum clinical plan development and how to design clinical trials that reduce the risk of late-stage failure.
  • In addition, Dr. Fratazzi is:
    • A member of the Scientific Advisory Board at Hassuji Therapeutics and Venator Diagnostics
    • Chief Medical Officer (CMO) at PCUT BioPartners
    • Honorary Academic position at UCL, London (UK)

Broad biopharmaceutical experience

Dr Fratazzi has held senior positions at Wyeth, Shire, TKT, Vitex and Altus Pharmaceuticals. Her experience encompasses all stages of clinical research including:

  • Simplified clinical research planning
  • Clinical trial design and execution
  • Proof of Concept trial design
  • Pharmaco-vigilance and risk management
  • FDA negotiations and submissions in multiple therapeutic areas
  • Biosimilars

Extensive educational background  

Dr Fratazzi received her early training in biomedical research at the Johns Hopkins University and Harvard University in the USA, and at Imperial College in London, UK.

Awards, presentations, publications  

Key achievements of Dr. Fratazzi include:

  • Recipient of the Cambridge Award for Pharmaceutical Consultant 2013
  • Developed and presented workshops: BIO Conference 2011 and 2012
  • Invited speaker:  ACRP 2012; MBC 2010 and 2011; GLG 2011
  • Authored several book chapters:
    • Biomarkers in Drug Development Wiley, 2010
    • Clinical Development Strategy in Nuts and Bolts in Vaccinology: Principles and Practice. Wiley-Blackwell, 2013
    • Clinical considerations in Statistical and Personalized Medicine. CRC  (in press 2014).
    • Published over 50 scientific papers in peer review journals

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