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AMPEL Bio Solutions, a biomedical research think tank in Charlottesville, recently announced a partnership with another health care startup in the city to tackle a vexing problem of drug development: recruiting and retaining patients in clinical trials.
AMPEL will use ArcheMedX, an online platform for health care education, to keep researchers, patients and clinical staff informed during several clinical trials of potential drugs this summer.
ArcheMedX facilitates active learning experiences by allowing users to take notes, search through relevant resources and respond to prompts while they watch a series of short videos.
“Ideally, patients in clinical trials are an active part of a team, not the subject or object of a study,” said Dr. Peter Lipsky, founding CEO and chief medical officer at AMPEL.
“It is critical for patients to engage with investigators.”
“The more you learn, the more likely you are to participate in a clinical trial,” said Joel Selzer, co-founder and CEO of ArcheMedX.
AMPEL and ArcheMedX are both growing, with each employing about 15 people in downtown Charlottesville.
Both companies are members of the CvilleBioHub, a networking organization that includes more than 50 life sciences companies and nonprofits in the area.
Susan Klees, co-founder of the CvilleBioHub, said she is encouraged by this collaboration between two nationally recognized local startups.
“It shows that there is a critical mass of life sciences activity here in Charlottesville,” Klees said.
“It speaks to the strength and diversity of Charlottesville’s life sciences community, and to the value of resources that the CvilleBioHub can provide.”
Lipsky said he hopes AMPEL’s work with ArcheMedX will inspire other local life sciences entrepreneurs to form partnerships with peers in the area.
“There are many small, agile companies here with unique technology that are thinking outside the box,” Lipsky said. “We anticipate that there will be many new ventures and collaborations in the future.”
Lipsky and Amrie Grammer founded AMPEL in 2013 to assist large pharmaceutical companies in developing new treatments for autoimmune and inflammatory diseases.
After using proprietary computer programs to review medical literature and analyze databases of genetic and genomic information, AMPEL designs clinical trials for promising drug candidates.
AMPEL is currently developing new treatments for lupus— an autoimmune disorder that has no cure— by repurposing approved drugs and drugs-in-development that were originally created to treat a variety of diseases including plaque psoriasis, a common skin condition.
Clinical trials for new drugs require a considerable time commitment from patients, as well as intrusive procedures, such as blood drawings and X-rays, sometimes.
Patients taking the drug prototype sometimes experience unpleasant side effects, while others unknowingly receive a placebo treatment that has no real effect on the disease.
“The trial can disrupt the patient’s life for six to 12 months, with no guarantee of benefits,” Lipsky said.
Grammer, COO at AMPEL, said 15 percent to 20 percent of trial sites in the United States never enroll a single patient. Failing to enroll enough patients for clinical trials can force pharmaceutical companies to give up on potential drugs that they have spent millions of dollars to develop.
AMPEL must coordinate trials at sites across the world to recruit enough patients with the same disease. However, she said ensuring that patients complete the clinical trial as intended can be even more difficult.
“A lot of the challenge has to do with education, and informing patients and investigators about what needs to be accomplished,” Grammer said.
Grammer said she became interested in using ArcheMedX’s products after meeting Selzer at the Charlottesville Business Innovation Council’s annual awards gala in 2014.
“ArcheMedX helps us teach people about disease at a level they can understand,” Grammer said.
AMPEL’s educational materials, hosted on the ArcheMedX online platform, will explain how participating in clinical trials can benefit the individual patient, as well as other people suffering from the same disease.
“It can let patients feel like they are taking control of their disease,” Lipsky said. “They are no longer a victim.”
Selzer said doctors supervising AMPEL’s clinical trials also will complete educational activities powered by ArcheMedX.
“Clinical trials involve a lot of complex content, and doctors’ working memory is limited,” he said. “If we don’t nudge doctors to move their memories from short to long term, they will forget.”
Lipsky said AMPEL hopes to eventually use ArcheMedX in clinical trials of drugs to treat many different diseases.
“The problems facing our clinical trials are not unique to our space,” he said.