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Clinical Trial Business Insights

    Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business InsightsParticipant Engagement

    Bridging Research and Health Care: If We Don’t Do it, Someone Else Will

    by Dan McDonald May 21, 2018
    written by Dan McDonald

    I recently had the honor and privilege of representing Imperial at the inaugural Bridging Clinical Research and Clinical Health Care conference in National Harbor, Maryland. It was interesting and worthwhile.

    The conference brought together heavy hitters and important voices, including the FDA and advocates from the patient community. Participants took on a challenging subject: How do we create a bridge between the incredibly important work that goes on in clinical research and the commercial health care world?

    How do we create a bridge between the incredibly important work that goes on in clinical research and the commercial health care world?”

    Everyone knows where to get over-the-counter or prescription drugs, but very few people know where they come from. Everyone knows a physician, but few know a researcher or a clinical investigator. What if we could find a way to increase the three percent of patients and three percent of physicians who participate in clinical research annually to five percent or even 15 percent? What kind of impact would that have on improvements in health globally?

    It’s not a new question, and for those of us who have been in the industry for 20+ years, it can be a worn-out one. Not because there isn’t passion to improve, but because the task seems so large, and individual and corporate interests are much too diverse. As such, the cycle continues and it never seems to improve.

    Progress often happens incrementally, especially in research. We have been making progress and word is getting out with such important efforts as:

    • The “Bridging” conference mentioned above
    • The launch of the GoBoldy campaign by the American biopharmaceutical industry and their compelling and widely advertised PSAs
    • ACRP’s efforts to raise awareness about the upcoming International Clinical Trials Day
    • Groups like CISCRP and their Aware for All initiative

    There is arguably more effort behind this cause today, more than any time in the history of the industry, and that is to be applauded. Whether this will push the three percent up to five percent or beyond is hard to tell, but it is refreshing to see this focus after so long.

    However, risks remain. For every good story brought forward by the industry, there is a negative one that surfaces in the news. 60 Minutes just ran a story about price gouging and the impact it’s having on towns across the U.S. I have not included the link here. Not because the story isn’t true, but frankly, there are already enough vehicles out there for spreading such messages. Unfortunately, the daily good news about advancements in research is harder to find.

    There are other risks, too. Kent Thoelke, EVP and CSO at PRA Health Sciences, was part of a fascinating CRO panel at the bridging conference which talked about some of the challenges we face in bringing the benefits of clinical research to the consumer. Thoelke sounded a stark warning regarding the ever-growing presence of technology and retail companies in health care. He contrasted those organizations with the notoriously slow and stodgy way that clinical research embraces technology. His warning, if I can accurately paraphrase, was this: less than 30 percent of millennials have a primary care physician. Most attend minute clinics when they have a health issue, or use telehealth and internet-based options. They don’t fit our brick-and-mortar-based system.

    Thoelke went on to say that technology companies increasingly own the relationship with the consumer. They are finding new and efficient ways of driving change and the consumer is getting accustomed to that. Will these organizations and the environments they’ve created bypass us as we continue our slow and steady path?

    One way we can create a bridge between clinical research and clinical health care is to harness the tremendous wealth, intellect, and science war chest that our industry currently possesses. We can drive that into creating technologies and efficiencies to cut through the bureaucratic red-tape and regulation-laden landscape to affect real change. If we can’t figure out how to build it, we have to buy it while we still can. Often the most successful companies mix strong business philosophies and operating acumen with purchased ideas, solutions, and market share in order to advance the business.

    We need to start modeling the greater industry this way or run the risk of being left behind. If Amazon and Tesla can build rocket ships to carry us into space, I’m pretty sure they can tackle the issue of drug development.

    We all have a part to play in driving us forward.

    Here at Imperial, we are embracing bridging, but in a slightly different context. We have deliberately and methodically built our business to support areas that are critical to the success of a study. These areas, which fall outside the core expertise of sponsors and CROs, can be the most disruptive to studies. These examples come to mind: filling challenging supply chain gaps. Identifying, engaging, enrolling, and retaining study subjects. Translating information to make sure that it is accurate, compelling, and useful to end-users across the globe. Lastly, we care about the customers we service and the study subjects we all serve. If we all do our part, we can create a strong bridge between clinical research and clinical health care. If we don’t, someone else surely will.

    May 21, 2018 0 comments
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  • Ancillary Clinical Trial Supplies and EquipmentClinical Trial Business Insights

    Pre-approval communications prior to export: Why are they so important?

    by Dan Polkowski May 3, 2018
    by Dan Polkowski May 3, 2018

    The best way to answer this question is with the catchphrase a chain is only as strong as its weakest link.  After 25 years of managing global clinical trial studies for clients, I cannot emphasize enough how much this phrase relates to the global distribution …

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  • Clinical Trial Business InsightsParticipant Engagement

    Patient Centricity: Tools to Apply To Clinical Trials

    by Melynda Geurts April 18, 2018
    by Melynda Geurts April 18, 2018

    If you’re a professional in the clinical trial world, you have probably heard about patient centricity. It has been a top industry buzzword for the last few years. But patient centricity is more than just a buzzword. So much more. It’s being put to use in …

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  • Clinical Trial Business Insights

    Surviving the Transition Into Clinical Trials: Getting Started

    by Hope Cullen April 5, 2018
    by Hope Cullen April 5, 2018

    We recently held the second of our presentation series “Surviving the Transition to Clinical Trials” at JLABS in Toronto. More than 45 people, representing biotech, pharma, and medical device companies, came to find out how to take their innovative ideas from the lab to the …

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  • Clinical Trial Business Insights

    A look at – Outsourcing in Clinical Trials West Coast Conference

    by Kristin Gross March 15, 2018
    by Kristin Gross March 15, 2018

    The 10th Annual Outsourcing in Clinical Trials West Coast Conference covered a wide range of subjects. New this year were three tracks on clinical innovation, early phase development, and data-driven approaches, and attendees heard the latest on artificial intelligence and blockchain technology. Whiteboard sessions, panel …

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  • Clinical Trial Business Insights

    SCOPE Summit 2018: Excitement and Engagement

    by Dave Woodard February 28, 2018
    by Dave Woodard February 28, 2018

    I had the opportunity to attend the SCOPE Summit for Clinical Ops Executives in Orlando, February 12-15. It’s been a few years since I last attended a SCOPE Summit, so it was interesting to see that some clinical research issues have evolved, while others persist …

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  • Clinical Trial Business Insights

    3 Ways to Outsmart the Big Dogs as You Move into the Clinic

    by Dan McDonald February 23, 2018
    by Dan McDonald February 23, 2018

    You’ve done all the background work. You’ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You’ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company – entering the clinic. …

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  • Clinical Trial Business InsightsParticipant Engagement

    The Role of Patient Engagement in the Transition from Lab to Clinic

    by Dan McDonald January 17, 2018
    by Dan McDonald January 17, 2018

    The drug discovery and development process is a complex and challenging landscape, especially for the majority of small biopharmaceutical and medical device companies. It’s truly a survival of the fittest environment, fraught with potential pitfalls and company killers. For every Kite Pharma (acquired by Gilead …

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  • Clinical Trial Business Insights

    Looking Ahead

    by Steve Swanson January 9, 2018
    by Steve Swanson January 9, 2018

    Each year I take time to put forth my observations about the year ahead. From a geopolitical perspective, I will not enter the fray, except to say as business leaders, the need exists to navigate a variety of waters. One positive event is the improving …

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  • Clinical Trial Business Insights

    All is Bright: 5 Tips to Stay Productive this Holiday

    by Vaughn X. Anthony December 15, 2017
    by Vaughn X. Anthony December 15, 2017

    Hark! The holiday season is upon us! Alongside the parties, shopping, and travel, WORK MUST STILL GET DONE. Let’s call it the December Challenge. It’s been around for a long time. Here are tips to stay focused and productive (and merry) during this magical time …

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