The Next Big Thing for Combination Products
Karen Greene
While I was at the Biocom Drug/Device Summit in December 2006, I attended a session that addressed the key players and issues at the intersection of Nanotech, Microelectronics and Regenerative Medicine.
Here’s a summary of the session’s highlights:
Dr. Heller, UCSD, Univ. of CA, San Diego, Professor of Electrical Engineering
Dr. Heller’s salient point was that human genetic diversity impacts drug efficacy and makes common diseases hard to manage. Dr. Heller cites the promise of Single Nucleotide Polymorphisms (SNP’s), which are DNA sequence variations that occur when a single nucleotide (A,T,C,or G) in the genome sequence is altered. More than 99% of human DNA sequences are the same across the population and variations in DNA sequence can have a major impact on how humans respond to disease. Environmental insults that affect DNA sequences include bacteria, viruses, toxins, and chemicals; and drugs and other therapies. This makes SNPs of great value for biomedical research and for developing pharmaceutical products or medical diagnostics. Scientists believe SNP maps will help them identify the multiple genes associated with such complex diseases as cancer, diabetes, vascular disease, and some forms of mental illness. These associations are difficult to establish with conventional gene-hunting methods because a single altered gene may make only a small contribution to the disease.
Timothy Mills, PhD, of Sanderling Associates
Dr. Mills spoke of the utility of biomaterials in regenerative medicine, to be deployed as scaffolding materials. He cited stem cell research as a very long process to yield clinical benefits. He identified the need to understand many basic things to prevent negative outcomes such as organ rejection. He thought that surface treatment of cells may hold success to allow for the human diversity of genetic makeup. He cited the U.S. Army as doing a tremendous amount of research in prosthetics as a result of recent engagement in the war on terror.
Dr. Mills also highlighted the development of hydrogels containing drugs which can be implanted in very specific regions to generate specific tissue reaction(treat tumors, fight disease).
Dr. Mills cited the promise of cellular therapies for regeneration of damaged cells, such as islet cells in the pancreas, damaged by diabetes. His firm supported a company called Novacell which is developing a coating technology to reduce the antigen problem. This would allow the deployment of an “off the shelf” islet cell, coated for a specific individual to minimize rejection.
