Biotech’s Missed Opportunity: Small-Town and Rural America

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one of the top med schools—UCSF. Humboldt is one of the poorest places in the Golden State, where unemployment is high, chronic disease is high, and insurance coverage is low. Doctors there struggle to share resources like mammography machines, or radiation therapy tools.

Drug companies often ignore areas like this, assuming that few patients are able to pay for new medicines. But small towns have one thing that’s in short supply in the big city: doctors have strong connections to their patients, Cronin says.

One company I’ve written about recently has seen the differences between “thought leaders” and community leaders. Waltham, MA-based Alkermes (NASDAQ: ALKS) won FDA approval last fall for a new drug designed to help wean people off addictions to opioid-based painkillers. It was tested, like most new drugs, at major urban medical centers.

Once cleared for sale, an interesting thing happened. The medical thought leaders who are familiar with the Alkermes product, as it turns out, never see the majority of patients in the U.S. suffering from addictions. Yet local health officials, drug courts, and counselors from around the country—where there was little familiarity with the Alkermes drug from clinical trials—started calling the company to try to get their hands on the new drug to test how it could help in their communities.

Addictions to opioid-based painkillers like oxycodone are a serious problem in rural and urban parts of America. Alkermes is now working on a number of pilot projects around the country to help local officials ask questions about whether its drug improves health outcomes, reduces repeat criminal offenses, saves money for local healthcare and criminal justice systems, or some combination of all of the above. Much of the commercial success of this product hinges on how well Alkermes engages with physicians and officials in these territories.

Alkermes CEO Richard Pops explained in a thoughtful note to me why his company felt it was necessary to follow this path to the market. Clinical trials are highly regulated, and require staff with training and experience in running them according to strict protocol, Pops says.

“Because the lifeblood of our companies is the data we generate, we tend to be highly selective in choosing sites, particularly for pivotal studies comprising the core of the new drug application submission,” Pops says. “For these reasons, we tend to run studies in places experienced in running studies if possible. They understand good clinical practices (GCP) and, in addition, tend to have more patient flow, which speeds recruitment.”

Now that Alkermes drug is on the market, it has had to reach out into a lot of new communities. “We have had to build our understanding of the real world treatment of alcohol and now opioid addiction, which is happening in all kinds of different venues outside of where we may have conducted trials,” Pops says.

I hope for the sake of people in large swaths of the country that companies like Alkermes can figure out how to effectively bridge this gap. Pharma and biotech companies have products that could make a positive difference for many people if used properly. Small cities and rural America shouldn’t be considered flyover country. It’s time to start thinking about the people who live there as valuable customers and contributors.

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6 responses to “Biotech’s Missed Opportunity: Small-Town and Rural America”

  1. Susan Severance says:

    What a thought-provoking piece! You have put small cities & rural america in the clinical research spotlight – if even for a moment. Great work!

  2. Tom says:

    This is news? I’ve been in the industry 20+ years and was doing trials in the Northern Rockies, Deep South, and places in between back then. Today those places are taking a backseat to Eastern Europe and South/Central America due to volume, not quality of investigators. I’ll give you that I was not the rule back then but places like Spokane, WA & Missoula, MT both have had savvy clinical research establishments in place for quite some time. What about taking it a big step further?: what about pharma and biotech leaving the big cities and settling HQ in ‘second cities’? KC, Des Moines, Omaha, OKC could all support such operations. There are only so many Mass Generals, Fred Hutchs and MD Andersons in the world. You have to travel to them from someplace. It may as well be from a place where your company and its employees can thrive.

  3. R & D at all phases and levels is being undertaken at universities, research parks and bio-incubators in second tier and smaller cities. These organizations will provide value added expertise and commitment to medical research but frequently struggle to attract venture financing and management talent needed to move drugs and devices from the bench to the market place.
    Steven Spalding
    Point A Consulting

  4. Kim Talbot says:

    Conducting trials should not be undertaken by physicians without proper training and support. This industry is one of the most highly regulated and it should be; we are talking patient safety. However, there is no reason why smaller physician groups can’t be investigators on trials if they partner with companies like ours that provides trainging, experience and support staff.