Regenerative medicine holds the bold promise of discovering new therapeutic approaches to combat diseases that are still out of reach of traditional drugs and biologicals. From cell therapies to tissue engineering, these novel therapeutic models involve human tissue, device combinations, and delivery methods that make regenerative medicine a very complex target of clinical development. The complexity of developing regenerative medicine products requires a committed and experienced partner. In addition to our internal expertise, Medpace is working with innovators, key opinion leaders, and investigators in this area which makes us well positioned to shepherd your product through the development process. As you select your partner for managing clinical trials, here are a few key points to consider:

• Medpace has considerable experience in cardiovascular, CNS and diabetes Regenerative Medicine trials. Dr. Tom Todaro, Vice President, Medical Affairs-Cardiology has extensive experience in conducting clinical trials in cardiovascular disease including studies in complicated cardiovascular patients using stem cells in  Acute Coronary Syndromes (ACS), and acute myocardial infarction (AMI). Likewise, Dr. Sam Kaba, Vice President, Neurology, is experienced in stem cell studies for stroke.
• Medpace has a renowned regulatory affairs department led by a team of experts which includes former government officials. Medpace provides comprehensive regulatory affairs services for sponsors in the US, EU, and other regulated markets. Our regulatory team has strong capabilities relevant to developers of regenerative medicine products. For example, we are experienced supporting programs in the EU to which the Advanced Therapy Medicinal Products (ATMPs) guidance applies.
• Operationally, Medpace is adept at managing the added complexities of Regenerative Medicine trials. From feasibility, research site compatibility, safety, and logistics, Medpace understands the nuances and brings efficiencies and operational excellence to your programs.
• Medpace is an active member of the Alliance for Regenerative Medicine, a Washington, DC-based non-profit organization whose mission is to educate key policy makers about the potential of regenerative medicine and to advocate for favorable public policies—funding, regulatory, reimbursement and others—to facilitate advances in the field.
• The long-term relationships developed with investigative sites ensure studies conducted by Medpace receive preferential recruiting. Medpace has been recognized with multiple industry awards in this area.
• Medpace offers integrated imaging and lab capabilities through its family of companies including Imagepace, and Medpace Reference Laboratories. This provides cohesive, streamlined, and standardized trial management.

>> Click here to request more information about Medpace's capabilities and therapeutic expertise in regenerative medicine.

Rich Caroddo made a brief introduction to Medpace and the company's involvement in Regenerative Medicine clinical trials at the Stem Cell Meeting on the Mesa in late 2011. Click above to listen to this short 10 minute video.