Combination Product Development: Biologics and Device Convergence -Annemarie Moseley, MD-02/01/2005 - 8:30am

Event Information
Event Topic: 
Combination Product Development: Biologics and Device Convergence
Event Date: 
02/01/2005 - 8:30am
Event Location: 
NOVA
Speaker Information
Event Speaker: 
Annemarie Moseley, MD
Event Speaker Title: 
Internal advisor to Business Development and New Ventures
Event Speaker Company: 
Guidant Corporation
Event Speaker Bio: 

Dr. Moseley’s current role is that of internal advisor to Business Development and New Ventures at Guidant with the goal of strategically moving the device focus into convergence with pharma and biologics innovation. Before joining Guidant, Dr. Moseley was the CEO of Cognate Therapeutics, a startup cellular therapy company developing bone marrow stromal cells, and other stem cell technologies. Prior to the founding of Cognate, Dr. Moseley was the CEO of Osiris Therapeutics, Inc, an adult mesenchymal stem cell company. While she was at Osiris, the company led the stem cell development field with over 4 new INDs in multiple therapeutic areas. Dr. Moseley has been involved in development of biological products such as antibodies, gene and cell therapies for over 12 years with companies such as AIS/Aventis and Systemix/Novartis.

Dr. Moseley’s early corporate experience focused extensively on clinical and product development of applications of antibodies in immunotherapy, blood stem cell therapies and cancer vaccines with therapeutic areas in oncology, transplantation, and infectious disease. Over recent years, she initiated the development of mesenchymal stem cell therapies with emphasis on oncology, transplantation and connective tissue disorders, including arthritis and bone disorders. Her regulatory experience has primarily been in biologics and CDRH as applied to antibody, devices and cell-based product development, but she has also filed INDs with CDER as well. Responsibilities have also encompassed product development, quality control and quality assurance, and provided a basis for the management of a research/development stage companies.

Dr. Moseley is currently an advisor to the Canadian Stem Cell Network, as well as a member of the scientific advisory board for Stryker Orthopedics. She is also a reviewer for the Journal of Bone and Joint Surgery. Licensed in the State of Texas, she also is a member of the American Heart Association, the American Society of Hematology and AMA.

Event Details
Cost: 
$0 - Free
Event Details: 

The last decade has seen the approval of numerous biologic products, many of these addressing oncologic or orphan indications and we have now entered an era of increasing biologic application to major disease markets, including cardiology. Delivery of biologic products such as proteins for systemic treatments has focused on intravenous, or depot delivery and their development has often paralleled the challenges of pharmaceutical drugs. Targeted systemic delivery remains a goal for all applications but localized delivery of biologic products such as proteins, gene therapy and cellular therapy to tissues and organs is certainly within the current realm of interventional cardiology. Localized delivery represents unique challenges with respect to device design, compatibility and overall preclinical development requirements. A clinically and commercially successful product will likely be as dependent on the delivery strategy as on the nature of the biologic. To date, early clinical trials have utilized open surgical procedures, as well as percutaneous approaches to the delivery of biologics in the cardiac repair setting. We will review current approaches to biologics/device development in the setting of cardiac injury.