The challenges of our time require a strategic approach to build the drugs and devices of the future. Our broad knowledge and long-term experience allow us to provide our customers with Innovative solutions and risk management.

1. Boston Biotech Clinical Research Leading the SCIO Revolution

2. SCIO The new class of service Strategic Clinical Innovation Organization

5. Bridging the Chasm between Research and FPI BBCR Service Safety / Tox Data Discovery Data Bio markers Trial Design Objectives/ Endpoints Patients Selection Patients Safety Regulation Disease Staging/ KOL Protocol Synopsis Patients’ Needs

15. Velaglucerase Alpha (Gene Activated Glucorerebrosidase) for Gaucher diseases Type 1 Case study of Strategic Clinical Innovation Problem : Develop the product avoiding a “me too” treatment in an orphan population when a very similar product had a market monopoly for 15 years. Solution : Created a clinical innovative strategy and trial designs that avoided the obvious head to head design, which would had required an unfeasible number of patients, and be at high risk to prove efficacy and safety in this population. Worked with the Regulatory agency upfront to validate approach, clearly identify endpoints and patient population expectations verses current standards of care.

20. Today more than ever Biotech Company Success hinges on: capital efficiency, lean management, low risk clinical trials, and early stage product-value accrual BBCR helps you to WIN

21. Thank you for your attention!! How May We Help You! www.bostonclinicalresearch.com 617 401 2327 Cambridge , Ma