BIO2017: Eli Lilly Clinical Development Head Looks to Innovate, Continue Alzheimer’s Research

Published: Jun 21, 2017

BIO2017:  Eli Lilly Clinical Development Head Looks to Innovate, Continue Alzheimer’s Research June 21, 2017
By Alex Keown, Breaking News Staff

SAN DIEGO – Daniel Skovronsky, senior vice president of clinical and product development at Eli Lilly , said the pharmaceutical industry needs to develop faster, cheaper and more efficient ways to conduct clinical trials.

Skovronsky took part in a fireside chat at BIO International on Tuesday and shared his thoughts on trial design, as well as the need to break through the barrier preventing the development of Alzheimer’s treatments.

From early research to Phase IIII, it can take a drug between 10 and 15 years to move through all the stages—at a cost of millions upon millions of dollars. While that may seem staggering to some, three to four years of that time frame can be spent recruiting patients for the trials. Eli Lilly is looking to cut that time through the use of new recruiting methods by plugging into online digital record databases —a method that is expected to reduce recruiting time.

“If you can cut the enrollment time, that means a drug can be available for market even sooner,” Skovronsky said.

In addition to innovative recruiting methods, Skovronsky said Lilly is incorporating adaptive trial designs that make the process more efficient. He said the company has not wholly adopted an adaptive trial design, but they are using it more frequently. One measure Lilly has taken is to use a trial simulation in order to determine how a potential therapy will react in different situations. Using such a method, Skovronsky said, allows the company to anticipate certain outcomes and helps eliminate excess time in trial design.

While Skovronsky is in charge of clinical development of multiple Eli Lilly assets, his passion lies in neuroscience and the development of Alzheimer’s disease therapies. Although Lilly’s Alzheimer program suffered a serious setback last year with the Phase III failure of solanezumab, Skovronsky said that has not dampened the company’s enthusiasm for finding a cure for the disease—something new Chief Executive Officer David Ricks said earlier this year. Eli Lilly remains committed to developing a treatment for Alzheimer’s disease and has eight different experimental drugs in its pipeline, including a BACE drug it licensed from AstraZeneca , as well as the failed solanezumab. Despite the Phase III failure, Skovronsky said they learned a lot, including that the drug candidate still has promise.

“The mechanism has some promise. It had a small, but real effect,” he said.

Now the company is looking to determine solanezumanb’s effects on pre-symptomatic patients. Those patients have amyloid plaque, but they do not show signs of dementia, he said. Additionally, Lilly is studying solanezumab in patients who have an inherited mutation that causes Alzheimer’s by over production of amyloid plaque.

While Amyloid plaque remains a substantial target for Alzheimer’s therapies, Skovronsky said the company is also researching brain tangles, which are twisted tau proteins that cause cells to die.

“We need to hit Alzheimer’s from multiple angles,” Skovronsky said.

He added that developing a treatment may require combination therapies, such as those used in cancer and HIV treatments.

In addition to dementia therapies, Skovronsky said the company is moving forward with development of oncology drugs, as well as treatments for migraine headaches and chronic pain. He noted Phase III data from a migraine drug that caused significant pain reduction in more than 50 percent of patients, but also prevented migraines in about 20 percent of patients. Skovronsky said that 20 percent mark is significant, but he hopes they can eventually develop a treatment that has a much higher success rate of preventing migraines.

Developing treatments for chronic pain that are effective is important, but Skovronsky said of equal value is safety. He said the rate of opioid abuse is rampant and must be curbed.

“Pain is an area of incredible unmet need,” he said.

In order to spur innovation, Skovronsky said Eli Lilly has opened a number of research sites in various biotech hubs, including one this week in San Diego. The company is also looking to use its venture arm to invest in innovative companies spinning out of academia. "It’s a way of stimulating the innovation eco system,” Skovronsky said.

All of these, plus internal developments, are ways Eli Lilly is looking to hit its goal of launching 20 new drugs in 10 years. A laudable goal and one that Skovronsky said is attainable.

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