Originally Published MDDI February 2005

EDITOR'S PAGE

The Emerging Age of Biologics and Devices

Device manufacturers can lead the way in the future of biologics— if they see the potential now.

Somatic cell therapy, gene therapy, and combination products are increasingly being considered to address major disease markets, including cardiology. The device industry could very likely hold the key to getting the biologics to where they need to be in order to function. “It must be a device, not a pill,” said Annemarie Moseley, PhD, MD, whose focus is business development for Guidant. The delivery methods for biologic products have traditionally paralleled the challenges of pharmaceuticals, but that may be about to change, Moseley said at a recent nanotechnology conference.

The effect a device can have on combination products includes designing for optimum therapeutic delivery, balancing safety, and integrating the biologic during preclinical development. The device also affects the regulatory path of the final product, she noted.

Device companies must focus on the delivery route and directing the protein to the tissue. Possible delivery methods, she said, include needle injection, catheters, and intracoronary delivery.

“Targeted systemic delivery remains a goal for all applications, but localized delivery of biologic products such as proteins, gene therapy, and cellular therapy to the tissues and organs is certainly within the realm of interventional cardiology,” she said.

Localized delivery represents unique challenges with respect to device design, compatibility, and overall preclinical development requirements, explained Moseley. “There is an increasing enthusiasm for cellular therapy,” she said. “For example, adult myoblasts can be taken from a patient's thigh, allowed to grow for four weeks, and can then be delivered back into adult tissue stem cells. The myoblasts can redirect healing or regenerate and participate in angio- or ateriogenesis.”

When developing a delivery approach, she said, device manufacturers need to think about the cell size that they are dealing with. In addition to direct needle injection, other delivery methods may include intracoronary, endomyocardial, and retrograde approaches. She stressed that manufacturers must consider whether the method, such as an injection needle catheter, is suitable for all indications. “A number of devices are still looking for indications,” said Moseley.

She noted the therapies for the future involve cell and gene production that will be characterized by guidelines more similar to those used by the pharmaceutical industry than the device industry. Manufacturers “can't leverage the safety of a device.” They must go back to FDA and get approval of the device linked to approval of the biologic. She stressed the need for “decision points” and partnerships to be in place in order for such combination products to succeed. “Partnerships need to start now even though the therapies may be a ways away,” Moseley said.

She recommended that manufacturers target a product profile, including indications, patient benefit, ease of delivery, and reimbursement potential. “A clinically and commercially successful product will be as dependent on the delivery strategy as it is on the nature of the biologic. There are not huge cost implications, but there is huge reimbursement potential,” said Moseley.

The Editors

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