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The Honolulu Advertiser
Posted on: Sunday, July 1, 2007

Exciting times for Hawaii scientists

By Dr. Fredric Pashkow

On the surface it sounds a bit presumptuous — that companies in our little state in the middle of the Pacific Ocean might in some way influence the course of modern medicine and drug discovery. However, it's not so far-fetched.

Most residents don't realize that under the radar there is cutting-edge research going on in Hawai'i. Here are just a few examples:

  • Bradley Willcox, a Harvard-trained gerontologist, is doing revolutionary work with his studies of healthy aging, longevity and preventive health at the Pacific Health Research Institute in Honolulu. Willcox's recent paper published in the prestigious Journal of the American Medical Association received international acclaim and his past work has been featured in everything from National Geographic Magazine to "Oprah."

  • A prolific technology accelerator, Cellular Bioengineering Inc., has a portfolio of more than 20 patents. CBI now is preparing for human clinical trial of its bioengineered cornea for the restoration of vision. It is also launching a polymer gel capable of containing and decontaminating chemical, biological, radiological and nuclear spills — critical for first responders and homeland security.

  • Manoa Biosciences, led by University of Hawai'i scientist Stefan Moisyadi, is working on a stable platform to cure genetic disease. They employ the most active nonviral gene insertion technology to develop transgenic mice and proprietary gene delivery plasmids. If successful, their innovative methods could someday be applied to humans.

  • Hawai'i Chitopure is a biomaterials company specializing in the manufacture of ultra-pure chitosan and modified chitosan for a variety of medical applications including antimicrobials and cellular response modifiers. Current research efforts are focused on the investigation and development of innovative chitosan-based products and devices including treatments for life-threatening cutaneous and gastrointestinal microbial infections, dental applications and agricultural applications.

    The company I work for, Cardax, is also doing groundbreaking studies in the area of cardiovascular drugs as well as therapies for prostate cancer, hepatitis C and macular degeneration. We have a team of crack scientists in 'Aiea and collaborate with world-class researchers from Harvard, the Cleveland Clinic and other medical research organizations. I believe our therapies could someday create an entirely new class of heart treatment every bit as pioneering and important as the introduction of statins in the 1980s.

    In addition to our research on new drugs, we work in partnership with an eclectic group of scientists and opinion leaders on solutions for national healthcare issues. Recently I spent a week in Los Angeles along with our Chief Executive Officer David Watumull and board chairman Nick Mitsakos attending the 2007 Milken Institute Global Conference.

    The purpose of the Milken conference is to develop economic solutions for global concerns which include healthcare, education, environment, longevity and the quest to more rapidly find cures for diseases. We believe we were the only Hawai'i people at the event, which included some of the biggest names in philanthropy, finance, science, government and entertainment. This mix of superstars included people as diverse as architect Frank Gehry, tennis star Andre Agassi and Nobel laureates such as Gary Becker.

    I was invited to the Milken conference to participate on a panel relating to one of the biggest challenges facing medical science: the excessive time and expense that it takes to develop lifesaving drugs and bring them to market. In short, it takes too long and costs too much to develop new drugs.

    As a medical doctor and research scientist who ran a drug program for one of the world's largest pharmaceutical companies, I know all too well the dysfunctional corporate politics, misguided governmental policy and other shenanigans that contribute to problems inherent in drug development.

    I liken the drug discovery-development process to a gigantic high-stakes game of Texas hold 'em. After each card is dealt, i.e., critical step is completed, the drug company decides if it wants to continue throwing dollars (actually, tens of millions of dollars) into the pot. The analogy, incidentally, extends to the practice of "bluffing," whether to competitors, stock analysts or government agencies who also sit at the drug discovery-development poker table.

    Although one can't fault the sincerity of scientists and researchers who devote years of their lives to creating lifesaving therapies, the gamesmanship and politics surrounding the creation of drugs today is in my opinion — and the opinion of others — not in the best interest of patients.

    If you consider that the average time it takes to develop a new drug and bring it to market is about 15 years, you can understand that we need to change this complex equation. The waste in time, money and even human lives is shameful and many of us in the industry understand this all too well.

    The question is, how do we change this inefficient process into a more benevolent system that takes people, as well as profits, into account?

    To begin with, let's look at the typical timeline in the creation of a new drug. The first half is the "pre-clinical" period, when the compound is discovered, refined chemically and tested in tissue culture or in animal models. Roughly the other half is spent testing the drug or "lead" as it's called, in humans.

    We can't do much to shorten the time needed for human clinical testing. However, we have found that we can do a lot better by fundamentally changing the approach to identifying the kinds of compounds that might be suitable for drugs.

    By using a more intelligent, rational drug-development approach that we call "focused drug design," we can save approximately three years (20 percent) from the conventional timeline and billions in R&D costs. In addition to streamlining the mechanics of the system, there are also new financial innovations that can accelerate drug discovery procedures and shave a great deal of cost in the process.

    These include working with advocacy groups and public foundations (such as the Prostate Cancer Foundation) that are developing consortia of researchers who agree to work collaboratively and share foundation-provided funds to attack key aspects of the problem. It's also possible for companies to tap elite investigators and institutions for funding such as Congressionally Directed Medical Research Programs and various private foundations.

    Readers must understand that in Hawai'i there's so much more than meets the eye when it comes to medical science and even advanced technology translation. I'm proud that our small Hawai'i company is at the forefront of the pharmaceutical industry in accelerating the drug discovery-development process.

    Working with some of the finest minds in the nation, Hawai'i scientists already are making a positive impact on our society. This is just the beginning.

    Dr. Fredric Pashkow is the executive vice president and chief medical officer of 'Aiea-based Cardax Pharmaceuticals and the former medical director of The Heart Institute of The Queen’s Medical Center. He wrote this commentary for The Advertiser.