Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Angela Blackwell, M.S. joined Biologics Consulting Group, Inc., as a Senior Consultant in October 2007.

Ms. Blackwell received her Bachelor of Science in Biomedical Engineering from Tulane University in 1989. She also earned a Master of Science in Biomedical Engineering in 1992 from the University of Alabama Birmingham.

From 1994-2007, Ms. Blackwell was a Scientific Reviewer in the Division of Anesthesiology, Infection Control, General Hospital, and Dental Devices (DAGID), Center for Device Evaluation and Radiological Health (CDRH), FDA.

As a Reviewer at CDRH, Ms. Blackwell was responsible for the comprehensive review of safety and effectiveness results for a wide range of new dental technologies. This included working closely with device manufacturers to negotiate preclinical data requirements, mechanical testing design, clinical trial design, product labeling, and post-approval studies.

As a PMA team leader, Ms. Blackwell coordinated teams of clinicians, statisticians, microbiologists and engineers with review responsibilities for numerous dental devices including temporomandibular joints and dental bone grafting materials with therapeutic proteins. She reviewed hundreds of device applications along multiple pathways - IDEs, PMAs, and 510(k)s.

During her tenure, manufacturers submitted applications for the first dental bone grafting materials containing therapeutic proteins. FDA had not previously evaluated a novel combination product raising so many new clinical and regulatory issues. Ms. Blackwell was a key agency leader in developing FDA's approach to reviewing dental bone grafting materials containing therapeutic proteins and other drug/device combination products.

As a Senior Consultant at The Biologics Consulting Group, Ms. Blackwell will utilize her broad engineering, clinical, and regulatory expertise to continue to assist clients in the following areas related to gaining FDA approval of medical devices:

• High level regulatory strategy for medical technologies;
  
• Product development for drug/device and biologic/device combination products;
  
• Assisting clients with strategy and development of preclinical testing;
  
• Designing clinical protocols and drafting other documents that comply with FDA regulations and expectations;
  
• Representing clients in interactions with FDA;
  
• Assisting clients in preparing for FDA meetings;
  
• Guiding clients in writing Pre-IDE, IDE, 510(k) and PMA submissions;
  
• Providing clients with a comprehensive "FDA style" review of submissions.
  

View Ms. Blackwell's Curriculum Vitae...

Page Updated June 16, 2008