The BBCR Team

A Note from the BBCR Founder & CEO

We believe the foundation of a successful outcome is communication and transparency. We provide our clients with an honest and insightful assessment, realistic timelines and costs, and an effective regulatory strategy, but not a one-size-fits-all clinical approach. Our customized strategies, our team, our commitment – help you anticipate and overcome the next set of challenges.

The BBCR team has the education, experience, and know-how to support pharmaceutical, biotech and device innovators as well as investors. We’re a motivated group of people, ultra-talented and passionate about streamlining your efforts. Learn more about our consultancy group so we can get the conversation started today.

Candida Fratazzi M.D.

Founder & CEO


  • Early Clinical Deveopment
  • Regulatory
  • Orphan Therapeutics
  • Combination Products

Candida Fratazzi, M.D.

With over 25 years of experience in biomedical research, Dr. Fratazzi devised the SCIO SM concept to create efficiencies in the complex and evolving process of bringing biotech products to market. She founded BBCR Consulting in 2009, with the objective of actively contributing to ongoing innovation in clinical development.

Dr. Fratazzi holds an advanced degree in Immunology and is an Orphan disease expert.  She worked in Cystic Fibrosis, Fabry disease, Gaucher’s disease, Multiple Sclerosis and more. Through BBCR, she continues to work with biotech, pharmaceutical, and medical device companies on clinical/regulatory development road-maps and cost-efficient trial designs.

Dr. Fratazzi created the first organization focused on strategic clinical innovation and is dedicated to streamlining clinical trials.

Board Positions
  • Chair BBCR Consulting
  • Board Member Acuity Corp
  • Honorary Academic position at University College London (UK)
  • Scientific Advisory Board Hassuji Therapeutics
  • Scientific Advisory Board Venator Diagnostics
Achievements & Awards


Successful therapeutics market approved worldwide including:

  • ZINBRYTA™ (daclizumab), once-monthly, Multiple Sclerosis; Biogenldec
  • TECFIDERA™ (dimethyl fumarate) delayed-release capsules, Multiple Sclerosis; BiogenIdec
  • VPRIV™ (velaglucerase alfa) for injection, Type 1 Gaucher Disease; Shire
  • REPLAGAL® (agalsidase alfa), Fabry Disease; Shire
  • TYGACIL® (tigecycline IV), Antibiotic; Pfizer


  • 2018 Top Rare Disease Clinical Research (Cambridge MA)
  • 2017 Top Immunologist (Cambridge MA)
  • 2015 Pharmaceutical Consultants (Cambridge Business Hall of Fame)
  • 2014 Top Ranked US Executives (National Council of American Executives)
  • 2013, 2014, 2015 Pharmaceutical Consultants (Best of Cambridge Award)
  • La Sapienza University
  • Johns Hopkins University
  • Harvard University
  • Imperial College London (UK)
  • BBCR, LLC: President
  • MediVector: Vice President
  • Altus Pharmaceuticals: Senior Medical Leader
  • Shire: Senior Director
  • VI Technologies: Medical Officer
  • Wyeth- Pfizer: Medical Director
  • Biologics: Target & Therapy
  • Biosimilars
  • Drug Design
  • Development and Therapy
  • Clinical Interventions in Aging
Speaking Engagements
  • 13th international conference on Biosimilar and Biologics  2018 (Boston, Massachusetts)
  • 9th International conference on Predictive, Preventive and Personalized Medicine. 2018 (Boston, Massachusetts)
  • Outsourcing in Clinical Trials New England 2018 (Boston, Massachusetts)
  • 14th Annual Personalized Medicine Conference at Harvard 2018 (Boston, Massachusetts)
  • 6th Euro Personalized Medicine 2017 (Scotland)
  • 15th International Drug Discovery Science and Technology 2017 (China)
  • Personalized Medicine 2017 (Chicago, Illinois)
  • 8th Asian Biologics and Biosimilars 2017 (China)
  • Precision Medicine and Public Health Conference 2017 (San Francisco, California)
  • Canada Talk Pharma 2017 (Montreal, Canada)
  • Euro Biosimilars 2016 (Spain)
  • Biologics and Biosimilars 2015 (Baltimore, Maryland)
  • DIA 2015 (Washington, D.C.)
  • Data Analytics 2015 (Boston, Massachusetts)
  • TechSandBox 2014 (Boston, Massachusetts)
  • Big Data Analytics 2014 (Boston, Massachusetts)
  • America Clinical Research Professionals 2012 (Houston, Texas)
  • BIO Conference 2012 (Boston, Massachusetts)
  • BIO Conference 2011 (Washington D.C.)
  • Mass Biotech Council 2010 and 2011 (Boston, Massachusetts)
  • GLG 2011 (Advisory Board member) (New York, New York)
  • Over 50 scientific papers in peer review journals
  • Clinical considerations in Statistical and Personalized Medicine. CRC, 2014
  • Clinical Development Strategy in Nuts and Bolts in Vaccinology. Blackwell, 2013
  • Biomarkers in Drug Development Wiley, 2010



Senior Advisor Regulatory Affairs
Former FDA Associate Director


  • Regulatory Strategy
  • Orphan Indications
  • FDA expert


Senior Advisor Precision Medicine & Biomarkers
F-NIH Cancer Committee


  • Biomarkers
  • Translational Medicine
  • Precision Medicine
  • Epignetics

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