Carotid Stent

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Corporate Capabilities Presentation
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BBA Overview

• Full service medical device/biotech consulting
• Two tenured partners
• Lauren Baker, PhD and Leo Basta
• -Medical Director Bonnie Weiner, MD
• Recently formed sister company-
• Imaging Core Lab Services (ICLS)
• -President Bonnie Weiner, MD

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Boston Biomedical AssociatesComprehensive
Services

• Regulatory Affairs
• Clinical Research
• Clinical Data Management
• Biostatistics
• Quality Assurance
• VC Consulting/Due Diligence

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BBA Mission Statement
Our mission is to deliver the finest consulting
services possible by partnering with
clients. BBA is committed to principles of
integrity, quality, and efficiency to provide
the utmost in leadership and experience to manage
all research needs and assist in impacting the
market approval process of the clients
product(s).
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BBA Team

• 30 employees consultants
• On staff physician/medical director
• Consulting biostatisticians with extensive
  industry experience
• All senior staff former top device industry
  personnel
• 20 years experience
• Extensive breadth of therapeutic and technology
  experience

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Industry Challenges-Complex Medical Devices

• Getting Your Product to Approval
• -Study design
• -FDA negotiation
• -Clinical trial management
• -Regulatory submissions
• -Crisis management

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• 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

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• Regulatory and Clinical Strategies
• Pre - clinical bench and animal product 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

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• Clinical Research and
• Data Management Processes
• Clinical trial management
• Clinical monitoring
• Data safety monitoring (DSMB, CEC)
• Data management biostatistics
• Support for questions/concerns during submission
  testing
• Assembly of non-clinical regulatory information
  to support submission

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Managing Clinical Trials

• Investigator/site recruitment, qualification
• Device inventory management
• Study document tracking, maintenance
• Investigator grant/contract negotiation
• Patient recruitment techniques
• Conduct investigator meetings

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Clinical Monitoring

• Employ regional CRAs
• Extensive monitoring experience
• Focus on site management/relations
• Meticulous oversight
• Highly trained in GCPs, SOPs
• Strong interpersonal skills
• Skilled in clients therapeutic field(s)

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Data Safety Monitoring

• Committee establishment / management
• DSMB (Data Safety Monitoring Board)
• CEC (Clinical Events Committee)
• Medical Monitor (single physician AE
  adjudication)
• Member qualification and selection
• Plan and conduct meetings
• On staff physician for safety review
• Complete data and document management
• Facilitate interface between committees and
  sponsor
• Extensive network in the physician community in
  all therapeutic areas

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Data Management

• Database design and validation
• Protocol, CRF development
• Paper or Electronic CRFs
• Web-based interface for Sponsor and Sites
• Collaborative data management
• Biostatistical services
• Submission ready reports

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• Submission Preparation Services
• Prepare all submission types
• IDE, 510 (k), PMA, HDE
• Annual, progress reports
• International submissions (tech files and design
  dossiers)
• Experienced medical and submission writers
• Established, effective methods

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DELIVER

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• Product Approval Process
• Panel Meeting prep and participation
• Correction of submission deficiencies
• Crisis management support
• Clinical site and sponsor preparation

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Additional Services

• Quality Assurance
• Crisis management support
• Venture Capital Consulting
• Imaging Core Lab Services (ICLS)

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Quality Assurance

• National/international quality systems
• - QSR, ISO 9001, EN13485 46001
• Auditing and training programs
• - BIMO, GMP, GLP, GCP, QSR
• Product development assistance
• Product recall/crisis management support
• Corrective action strategy and implementation
• - FDA 483 responses, warning letters

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Venture Capital Consulting

• Assist VC community with technology interests and
  investments anywhere from product concept through
  market launch including
• - facilitation of due diligence activities
• - technology product evaluations
• - regulatory and clinical timeline and milestone
  evaluations
• - FDA approval process consultation management
• - budget assessments
• - provide virtual clinical and regulatory
  department for new acquisitions

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ICLSImaging 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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BBA Previous Experience
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Clinical Therapeutic Areas

• Neurovascular
• Cardiovascular
• Peripheral vascular
• Interventional neurology
• Interventional radiology
• Orthopedic implants
• General surgery
• Obstetrics/gynecology
• Hemodialysis / autotransfusion
• Gastroenterology /urology
• Combination products
• Biologic devices

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Medical Device Experience

• Cardio and Peripheral Vascular Artificial
  liver
• Vascular stenting Intravascular ultrasound
• Nonvascular stenting Drug
  delivery technology
• Balloon catheter tech
  Urethral bulking
• VADs
  Orthopedic devices
• Vena cava filters
  Cardiopulmonary support
• RF ablation/EP systems Dialysis
  access technology
• Vascular grafts Endoscopic
  technology
• Laser technology Laproscopic devices
• Thrombectomy Ultrasonic
  ablation
• Embolic System Combination
  drug/devices
• Extracorporeal dialysis Blood
  management devices

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BBA Client Experience

• 20 FDA meetings over multiple FDA divisions
• Clinical Study Design Support for 20 clients,
  including 8 original IDE submissions, 25 IDE
  supplements
• Support in Preparation of 4 PMAs, 3 original PMA
  clinical reports (one carotid), 2 PMA Panel
  meeting preparation
• Active support in Clinical Trial Execution for 10
  trials
• DSMB support for 4 trials
• Medical Monitor/CEC support for 8 trials
• Site/Sponsor Audits for 6 clients

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Clinical Data ManagementKey System Functional
Components

• Randomization
• Data Entry (RDE/DDE)
• Audit Trail
• Query Processing
• CRF Tracking
• Visit Tracking
• Clinical Monitor Center

• Notification of Critical Events
• Study Document Reference Center
• Payment Tracking
• Reports
• Data Extraction

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The BBA Advantage..

• experienced, accomplished staff
• principals involved in all projects
• on-staff Medical Director
• meticulous oversight
• seamless integration with your project teams
• innovative, strategic
• quality, efficiency paramount
• MedD4 program to deliver product approvals!!!!

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