Tag Archives: Eli Lilly

Can Cancer Trial Apps Boost Enrollment?

Participation in clinical trials — and cancer trials in particular — is agonizingly low. The National Cancer Institute has estimated that less than 5% of patients participate in cancer trials.  But that could possibly change with the growing availability of applications for smart phones and tablets that instantly link clinicians and patients with ongoing trials.

Screenshot of Lilly Oncology Clinical Trials Resource

Just as the American Society for Clinical Oncology was starting off its annual meeting, Eli Lilly announced that it was launching a clinical trials app.  According to Lilly, the free app is available for the Apple iPad and iPhone, the RIM BlackBerry, and the Google Android. Physicians — or patients — can use the app to search oncology trials that are enrolling new patients by disease state, molecule being studied, study phase, country, state, and keyword.

The Lilly app also links patients and clinicians to resources such as support groups, financial help, and nutritional counseling, for instance.  Because it was developed by a drug maker, it also prominently features a search tool for Lilly-sponsored trials. Other than that, it appears to be very comprehensive and easy to use.

Lilly is not the first manufacturer to venture into a trials app. Last June, GlaxoSmithKline, in partnership with MedTrust Online LLC, launched a similar app that lets users search for trials for all cancer types. Unlike the Lilly app, it does not try to push users towards GSK-sponsored trials. It, too, appears to be very comprehensive and easy to use.

Screenshot of MedTrust search

The National Cancer Institute also has a free app, but only lets patients search for trials at the National Institutes of Health campus in Bethesda, Md.  As I attempted to explore the app, however, it crashed multiple times. Not a good omen.

Similarly, the Seattle Cancer Care Alliance has created an app — but it is narrowly focused only on trials for  acute myeloid leukemia at its member facilities.

iHealthVentures LLC has created an app with the snappy name of “Clinical Research Trials” that allows users to search all of clinicaltrials.gov database. It costs $1.99.

As more Americans turn to smartphones and tablets to manage their lives and health, these trial apps could come in handy. And maybe even save or extend lives by getting people enrolled earlier in protocols that could help them.

Just an aside — OncologyPractice.com has a link to ongoing trials on its website here.  And it has just launched a free app that features the latest news and views in the field.

–Alicia Ault (@aliciaault on Twitter)

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Filed under Health IT, IMNG, Oncology, Practice Trends

Can Crowdsourcing Speed Diabetes Drug Discovery?

When it comes to finding treatments and cures for complicated conditions such as diabetes, why not cast the widest net possible for new ideas? That’s the thinking behind the Juvenile Diabetes Research Foundation’s new collaboration with an organization called Innocentive to seek innovative proposals from the general public for a novel glucose-responsive insulin drug. The “Challenge,” which offers a $100,000 reward, is an example of crowdsourcing in drug discovery, a recent concept that has been gaining momentum.

manbeastextraordinaire (Jake Brown) / Wikimedia Commons

“Originally, crowdsourcing was defined as a mechanism by which specific problems are communicated to an unknown group of potential solvers in the form of an open call, usually via the Internet; the community (the “crowd”) is asked to provide solutions and the ‘winners’ are rewarded,” Dr. Monika Lessl and Dr. Khusssru Asadullah, of Global Drug Discovery Bayer Healthcare Pharmaceuticals, Berlin, wrote earlier this year in Nature Reviews/Drug Discovery.

Eli Lilly was the first company to introduce the crowdsourcing concept in drug discovery by establishing the InnoCentive platform in 2001. Now an independent organization, InnoCentive has a “solver” community of more than 200,000 experts from 20 countries. In Innocentive’s “Challenge Platform” model, intellectual property (IP) is transferred from the solver to the “seeker” in return for a financial reward. In contrast, with Bayer Healthcare’s Grants4Targets, IP remains fully with the applicants initially, and subsequent collaborative agreements are negotiated for promising agents. In yet another crowdsourcing model sponsored by the UK’s Medical Research Council, IP is jointly owned and revenue is split between the parties.

Drs. Lessl and Asadullah write that in order for drug discovery crowdsourcing to be successful, “it is critical that the questions or challenges to be addressed are suitable, precisely defined and clearly presented, and that what is expected from potential solvers and offered by the searching organizations is clearly communicated.” Indeed, the expectation is clearly spelled out for the JDRF/InnoCentive initiative: “What we need is a sophisticated insulin that will take the guesswork out of managing diabetes by working the same way insulin works in people without diabetes,” Aaron Kowalski, Ph.D., assistant vice president of Treatment Therapies at JDRF, said in a press statement.

This isn’t JDRF’s first support of research on glucose-responsive insulin. Back in 2008, JDRF formed a $1 million partnership with a company called SmartCells, Inc. to advance the preclinical development of a product called SmartInsulin. SmartCells has since been acquired by Merck, which is continuing the product’s development. As Dr. Kowalski told me, “JDRF remains interested and excited in the clinical development of SmartInsulin by Merck.”

Photo by Miriam E. Tucker

So why is JDRF now simultaneously crowdsourcing the concept? Again, it’s about that wide net. First, Dr. Kowalski said, there may be multiple innovative ways to design glucose-responsive insulins. Second, it’s possible that not all insulin-dependent diabetes patients would respond the same way to a single type of insulin. “Therefore, we aim to stimulate more approaches that we hope will provide multiple options to patients with diabetes.”

Third, because the approval process for new drugs is highly variable, “The more options that are available, the more likely it is that one of them will make its way through the regulatory process.” Bottom line: “Insulin-dependent diabetes remains an urgent, unmet medical need, and it is important for JDRF to take a multi-pronged approach to tackle this challenge.” By opening up the challenge to the entire world, crowdsourcing would seem to be the ultimate “multi-pronged” approach.

Anyone with a solution that fits the proposed criteria is eligible to enter the Challenge, which requires only a written proposal. Submissions will be accepted through November 9, 2011.

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Filed under Drug And Device Safety, Endocrinology, Diabetes, and Metabolism, IMNG, Internal Medicine

Alzheimer’s update – another one bites the dust

Alzheimer’s researchers – and their patients – just can’t seem to catch a break. While many fields of medicine are marching to an increasingly upbeat drummer, the AD parade just keeps getting rainier and rainier.

Alzheimer's researchers haven't had a lot to celebrate lately. Photo by Flickr user dvs.

The latest downer was semagacestat, a gamma secretase inhibitor whose encouraging 2008 debut didn’t pan out. Last week, in the midst of the drug’s twin phase III studies, developer Eli Lilly pulled the plug – and more hope swirled down the drain.

The preplanned interim analysis was a bummer on several fronts. Not only did patients getting the drug fail to improve – they actually got worse than the placebo group, both cognitively and functionally. Adding injury to insult, the semagacestat group also began to develop incident skin cancers, probably a by-product of the drug’s interference with Notch signaling.

Gamma secretase inhibitors decrease the type of beta amyloid that clumps into Alzheimer’s brain plaques by changing the protein’s molecular length into a less toxic form. These drugs also interfere with Notch signaling, a process important in programmed cell death. Blocking it particularly affects organ systems with high cell turnover, such as the gut and immune system – one reason gamma secretase drugs have floundered in research. Many patients can’t tolerate the GI side effects. 

But apparently Notch interference also bulks up the risk of skin malignancy. Mice bred to express impaired Notch signaling develop hyperplastic epidermis, cutaneous squamous cell carcinoma, and actinic keratoses (Cancer Res 2006;66:7438-44).

The semagacestat story also implies that the long-accepted amyloid theory of Alzheimer’s disease may not be the be-all and end-all of therapeutic targets. A decade of research has focused on getting rid of amyloid – in the brain, in the blood, in the cerebrospinal fluid. And yet not a single antiamyloid drug has come to fruition. In phase II, semagacestat did decrease the toxic Aβ40-42 in blood, proving that it does affect the protein’s formation. But that finding didn’t translate into any clinical benefit.

So what does that all mean? Probably that, just like you can’t fix cardiac muscle damaged by infarct, you can’t fix Alzheimer’s brain damaged by amyloid plaques. Probably that, like effective cardiovascular therapy, effective Alzheimer’s therapy needs to start at the very onset of symptoms, or even before symptoms are apparent.

The disease’s hottest research track right now is how to back up this diagnostic timeline by detecting amyloid in the brain and in blood and CSF. Once neurologists can identify patients before they become patients –when they are simply trying to remember where they put the car keys – it might be time to take some of these “failed” drugs out of mothballs and see how they perform at the starting gate, rather than the finish line.

– Michele G. Sullivan (on Twitter @MGsullivan)

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Filed under Drug And Device Safety, Family Medicine, Geriatric Medicine, IMNG, Internal Medicine, Neurology and Neurological Surgery, Primary care, Psychiatry

Why The Limp Sales?

After years of go-go growth, it appears that the market for erectile dysfunction drugs in the U.S. and overseas is flat.

Courtesy Flickr user fhwrdh

That’s according to Eli Lilly, which told investors this morning that the global market for ED drugs grew just 1% over the first 9 months of this year. Will this market shrinkage cause primary care doctors to find themselves in the crosshairs of promotion?

Lilly crowed that its Cialis (tadalafil), dubbed “le weekend” by randy Frenchmen because of its reputed 36-hour effect, had 4% sales growth overall (17% in the U.S.).  Some $1.1 billion worth was sold from January to October — nothing to sneeze at, but not a blockbuster like Zyprexa, which had $3.5 billion in sales over the same period.

Cialis has edged ahead of Pfizer’s Viagra (sildenafil) among prescribing urologists in the U.S., the company said. But it has a tougher sell with primary care physicians, who write for Viagra for about 55% of prescriptions.

Bayer’s Levitra (vardenafil) is a distant third.

But overall, in the U.S. and Europe, even Lilly’s own charts show a straight, flat line of sales growth for these drugs.

Meanwhile, in the U.S. at least, ED drugs continue to be promoted like flat screen TVs on Black Friday.  According to a recent report from the Congressional Budget Office, ED drugs were the most heavily promoted class to consumers in 2008.  The three ED manufacturers spent $350 million on television, print, and Internet efforts. Another $175 million was spent promoting the drugs to physicians.

Only those ubiquitous Sally Field ads for Boniva and promos for other osteoporosis ads came close, clocking in at about $250 million in direct-to-consumer spending and $250 million on physician promotions.

So what’s with the slowdown in the ED market? Are there no more men (and their partners) out there who could benefit from these drugs?

Lilly may have an answer for that. According to its presentation, the company is making inroads in China.

How do you say “le weekend” in Mandarin?

— Alicia Ault (on Twitter @aliciaault)

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Filed under Geriatric Medicine, IMNG, Internal Medicine, Primary care, Urology