About a year and a half ago Ed Holmes along with his wife Judy Swain, both distinguished researchers in the United States, found themselves lured to Singapore where the government was backing its great ambitions to become a leading biotech center with billions in investment. Holmes, the executive deputy chairman of A*STAR's Biomedical Research Council, is helping lead the second phase of Singapore's biomedical sciences initiative with a focus on translational efforts. He is working to build capabilities and attract the talent needed to translate basic research into potential new drugs, devices and diagnostic tools. We spoke to Holmes, a member of the TJOLS advisory board, about both the successes Singapore has enjoyed and the challenges it continues to face.

As Senior Vice President, Research and Development at Amgen, Joe Miletich leads the translational science efforts for the biotechnology giant. As such, Miletich serves as both a gateway and guardian over the company’s future. This critical part of Amgen’s R&D effort unlocks the promise of early discoveries by demonstrating their potential to alter disease in a beneficial way. We caught up to Miletich at the BIO 2008 Confernece and talked to him about the changing process of translational research and the sometime challenge of following where science leads.

“Given the volatility and the pace of scientific discovery in recent years, there is a need for a fact-based analysis to better understand which innovations are emerging as the most promising and, conversely, which technologies are losing ground,” said Matthew Hudes, U.S. managing principal, Biotechnology, for Deloitte Consulting's Life Sciences & Health Care practice. Using data collected over the past six years, Deloitte researchers created a three-stage measurement model covering discovery, development and realization to measure the inputs and outputs of innovation during the process of bringing new products to market. We caught up with Hudes, a member of the TJOLS business advisory board, at the BIO 2008 Conference and talked about the emerging technologies reshaping the biotech sector and how exactly you go about measuring innovation.

For nearly 40 years, the Harvard-MIT division of Health Sciences and Technology has worked to bring innovations in non-medical fields such as information technology, engineering and materials science to the patient bedside and to clinical research. The catchword for the program is convergence with faculty focusing on fostering collaboration among researchers from disparate fields. Now, HST through a unique program aimed at training a new class of highly versatile health professional, is taking its model to India. The move could lead to new treatments and technologies.

For Reg Kelly, the director of the California Institute for Quantitative Biosciences, or QB3, research breakthroughs are not enough. Kelly notes that Q2’s mandate is not only to improve public health, but California’s economic well being as well. To that end, QB3 has aggressively pursued relationships with industry, sought to find sources of funding for faculty created start-ups, and even created incubator space for new companies within its headquarters on the Mission Bay campus of the University of California, San Francisco to see that researchers’ discoveries get translated into products that can ultimately benefit public health.

No one would ever confuse William Boyd with Steve Austin, the iconic and bionic hero of the 1970’s TV series the six million dollar man. Boyd, who spent his career at a Nabisco bakery in Houston mixing dough to make Ritz Crackers, though, may become something of a bionic man himself. In 1979, Boyd developed retinitis pigmentosa, a genetic condition that causes a degeneration of the natural photoreceptors that line the retina in the back of the eye. Thirty years after his diagnosis, Boyd may be one of the first patients implanted with an artificial retina in the hopes of restoring limited sight to him.

 

In a major victory for the medical device industry, the U.S. Supreme Court ruled that medical device makers could not be sued over harm done by devices that had gone through the U.S. Food and Drug Administration’s premarket approval process. The 8-1 decision in the case of Riegel v. Medtronic decision reaffirms two previous lower court rulings. The medical device industry said the decision makes clear that the FDA, and not a patchwork of state regulation and jury verdicts, is the determiner of the safety and efficacy of medical devices. Jaxon White, chairman of MedMark Insurance Group, discusses the significance of the decision with Tjols' editor-in-chief William Patrick.

As the emerging science of nanotechnology converges with biopharmaceutical sciences, the blurring boundary lines threaten to create a nightmare for regulators. As Lori Andrews reports in the February issue of the Journal of Life Sciences, both the U.S. Food and Drug Administration and the U.S. Patent and Trademark Office are bring criticized for their approaches as they attempt both to encourage and to impose order on the field.

Evidence-based medicine could help physicians navigate the complexities of patient care by collecting, interpreting and disseminating data on outcomes. At first, it would seem to be nothing more than common sense. After all, who wants medicine based on mere opinion? If outcomes data confirm a treatments benefits, doctors should use it: if it’s harmful they shouldn’t, but as David Gollaher writes in the February 2008 issue of The Journal of Life Sciences, while evidenced-based medicine can improve quality and cut costs in the U.S. Healthcare system there are obstacles, not the least of which are doctors.

Though in 2007 concerns over patent reform and efforts to create a pathway for so-called follow-on or generic biologics dominated the policy front for the industry, no resolution on these issues were reached. As we head into an election year, healthcare reform will likely take center stage, but these unresolved issues will continue to remain high on the agenda for the industry. David Gollaher joins Bill to discuss the big policy concerns of 2007 that continue to be front and center for the industry as we move forward.