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INCIRC slides Final05 by OCrSjyK3

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									In Circulation: Strategic Partnering and
   Investing in Circulatory Medicine
            April 27, 2005
     Leo Basta, Founding Partner
 Boston Biomedical Associates, LLC
        Company Overview
   Full service medical device/biotech
    consulting

   Two tenured partners:
    Lauren Baker, PhD and Leo Basta
    •   Medical Director: Bonnie H. Weiner MD


   Recently formed sister company-
    Imaging Core Lab Services (ICLS),
    President: Bonnie H. Weiner MD
  Boston Biomedical
      Associates
Comprehensive Services
       Regulatory Affairs
       Clinical Research
       Clinical Data Management
       Biostatistics
       Quality Assurance
       VC Consulting/Due Diligence
  Industry Challenges-
Complex Medical Devices
   Getting Your Product to Approval
    – Study design
    – FDA negotiations
    – Clinical trial management
    – Regulatory submissions
    – Crisis management
Proprietary modular program designed to:
   ● Define regulatory and clinical strategies
   ● Develop clinical research and data
       management processes
   ● Document the submission process
   ● Deliver the product approval process
Regulatory and Clinical Strategies
 Pre - clinical bench/ animal test strategies/
  protocols
 Global regulatory strategies
 Biostatistics, study design, protocol
  development
 Pre - IDE, FDA meetings/FDA liaison
 Quality System development
 Labeling, promotion, advertising strategies
 Strategies for post market surveillance and
  CMS
   Clinical Research and
Data Management Processes
  Clinical trial management
  Clinical monitoring
  Data safety monitoring (DSMB, CEC,
   Medical Monitor)
  Data management & biostatistics
Submission Preparation Services
    Prepare all submission types
     – IDE, 510 (k), PMA, HDE
     – Annual, progress reports
     – International submissions (tech files and design
       dossiers)
  Experienced medical submission writers
  Established, effective methods
Product Approval Process
 Panel Meeting prep and participation
 Correction of submission deficiencies
 Clinical site and sponsor preparation
    Additional Services

 Quality Assurance
 Crisis management support
 Venture capital consulting
 Imaging Core Lab Services (ICLS)
 Venture Capital Consulting

• Facilitation of due diligence activities
• Technology & product evaluations
• Regulatory & clinical timeline/ milestone
  evaluations
• FDA approval process consultation &
  management
• Budget assessments
• Provide virtual clinical & regulatory
  department
               ICLS
      Imaging Core Lab Services
   Complete medical image tracking & management
   Quantitative & qualitative image analysis options
   Investigator training & direct interfacing
   Web-based project access
   Full data analysis documentation & support
   Directed by on-staff interventional cardiologist
   Rapid turnaround for time-sensitive trial closure
   Fast, flexible, cost-effective

								
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