In the last 3 years, Integrium has conducted over a dozen high profile, Regenerative Medicine/Gene Therapy Clinical Trials. As a result, we have developed the logistical and scientific experience that reliably provides solutions to the inevitable challenges accompanying this niche-type drug development. With Integrium's Regenerative Medicine expertise, our dedicated team can design, manage, and produce rapid results for a clinical trial, given the intricacies of developing such innovative therapies.

Integrium offers our clients:

• Expertise in navigating the regulations linked to regenerative medicine products

• Rationale for your Proof of Concept cell/gene therapy trials

• Recommendations for protocol development and later clinical trial design

• Development programs that include initial safe starting dose, dose escalation scheme, target organ/tissue toxicity, eligibility criteria, clinical monitoring

• A network of Local IRBs / Safety Review Boards / Recruitment / Staff Training

• Medical Experts in the cardiovascular and neuroscience space

• An unparalleled patient recruitment team

Regenerative Medicine in Proof of Concept Clinical Trials

Please take a moment to glimpse through Integrium's Regenerative Medicine Presentation,

given at BIOCOM by Dr. David Smith, Chief Medical Officer at Integrium Clinical Research: