The SCIO Trial Process Innovation is Critical for Precision Medicine


Partnership with Trial Process Innovation Specialists (BBCR Consulting) is critical to accelerate and significantly reduce costs for Precision Medicine. Biotechnology today has become an integral part of the national and international economy and thus a critical component of economic competitiveness. Among the various fields that make use of biotechnology processes, medical biotechnology has been one … Continue reading The SCIO Trial Process Innovation is Critical for Precision Medicine

What is Strategic Clinical Innovation Organization


The Strategic Clinical Innovation Organization (SCIO) concept provides biotech, pharmaceutical and device manufacturing companies with a cost-effective, customized approach to clinical development planning.This approach, pioneered by BBCR, aims to reduce the risks inherent in early stage clinical development. Such risks are particularly acute for: Discovery drugs that offer the potential to suit multiple indications Combination … Continue reading What is Strategic Clinical Innovation Organization

What’s in A Name?


Zuckerman and Milne at the Tufts Center for the Study of Drug Development (CSDD) have published results from interviews conducted in 2009 – 2010 with 20 individuals from 13 biopharmaceutical companies to understand the current and future state of personalized medicine. The definition of personalized medicine used in those interviews was:  “A medical intervention (i.e., drug, … Continue reading What’s in A Name?

Cost vs. Value: Can We Have Both?


By Mirella Zulueta More than ever new drug developers today have to have a very realistic attitude towards drug development.  Biotech and pharmaceutical companies are aggressively slashing prices in order to win business in a hyper-competitive industry. In order to make a study worth their efforts, these organizations always have one eye on the bottom … Continue reading Cost vs. Value: Can We Have Both?

Longer Stretch to the Finish Line


Disorders of the central nervous system (CNS) account for the most frequent health disruptions afflicting our society as a whole today:  Alzheimer’s, migraine headaches, stroke, addictions, depression, autism, panic, epilepsy… And yet, drugs developed to treat CNS diseases take about 35% longer to complete clinical trials and receive regulatory approval compared to other new prescription … Continue reading Longer Stretch to the Finish Line

How Good is FAST?


By Mirella Zulueta There are two bills in Congress at the moment related to the process of drug approval, specifically aiming to speed up the approval of new drugs. These two bills – FAST (Faster Access to Specialized Treatments) and TREAT (Transforming the Regulatory Environment to Accelerate Access to Treatments) – would essentially mediate that … Continue reading How Good is FAST?

Could Seamless Adaptive Designs Advance Clinical Trial Design


A Strategic Clinical Innovation Organization (SCIO) opportunity. Reducing time to market has been, is, and will be a top priority in pharmaceutical drug development. Bringing valuable medicines to patients sooner increases the value of the drug to the parent company. Adaptive seamless designs can, in principle, help reduce this development time and increase efficiency of … Continue reading Could Seamless Adaptive Designs Advance Clinical Trial Design

BBCR Speaking Engagements and Publications 2010-Aug 2012


August 2012: Candida Fratazzi MD: Chapter author: Clinical Development Strategy: Nuts and Bolts. In Vaccinology: Principles and Practice, edited by John Morrow, Nadeem Sheikh, Clint Schmidt and Huw Davies. Published by Wiley-Blackwell. http://www.wiley.com/WileyCDA/WileyTitle/productCd-1405185740.html June 2012: Candida Fratazzi MD, organizer and moderator, session: “Challenges in Clinical Trials for Small Patient population”. Bio International Conference; Boston MA http://bostonclinicalresearch.com/challenges-in-clinical-trial-for-small-patient-populations … Continue reading BBCR Speaking Engagements and Publications 2010-Aug 2012

Re-estimating Sample Size While Maintaining Statistical Power


Sample size re-estimation within a confirmatory trial (Phase III) provides a mechanism for the appropriate use of the information obtained during a confirmatory study to inform and adjust the necessary sample size going forward. This process increases the confidence that an appropriate sample size has been chosen to answer the primary study questions. The standard … Continue reading Re-estimating Sample Size While Maintaining Statistical Power

Gene Therapy for Type 1 Diabetes Targets Treatment of Autoimmunity


Diabetes mellitus affects millions of people in the United States and worldwide. It has become clear over the past decade that the chronic complications of diabetes result from lack of proper blood glucose concentration regulation, and particularly the toxic effects of chronic hyperglycemia on organs and tissues. Causes and Defects Type I diabetes mellitus (T1DM) … Continue reading Gene Therapy for Type 1 Diabetes Targets Treatment of Autoimmunity