This is the third post in our Lilly Discovery blog series that describes how Lilly employees discover and develop innovative treatments for patients. We're also highlighting many of the passionate scientists and clinicians behind the cutting-edge discoveries.
Have you ever heard the starfish story? According to Loren Eiseley’s The Star Thrower, once upon a time, a storm washed up thousands of starfish on the beach. A man begins picking them up one by one, tossing them back in the ocean. A little boy walks up and says, “What are you doing? You can’t save them all. It’s impossible to make a difference.” Throwing another back into the water, the man says, “It made a difference to that one.”
Our Lilly scientists and physicians are motivated by the “starfish” mindset. They work tirelessly each day to find new medicines for individuals battling cancer, diabetes, pain, Alzheimer’s disease and autoimmune disorders.
Drug discovery and development is a long journey. Only a few drug candidates pass the high bar needed to begin phase 1 testing in humans. These early clinical studies typically involve 20 to 80 healthy volunteers or patients and usually take one to two years to complete.
“When you test cancer drugs, you can't test them in healthy volunteers typically because of the toxicity,” says Aimee Lin, Ph.D., principal research scientist in early phase clinical oncology. “I'm always very humbled when I think about the patients who volunteer for phase 1 oncology trials, because they've clearly been through a lot of other therapies, and many of the existing [cancer] therapies come with a tremendous amount of toxicity. Nevertheless, they're willing to sign up for a clinical trial.”
Phase 1 studies help characterize the drug’s safety; identify serious, dose-limiting adverse events; determine the maximum tolerated dose for humans; characterize the pharmacokinetics (the study of the body’s absorption, distribution, metabolism, and excretion of a drug); and determine the recommended phase 2 dose. Phase 1 studies can also provide an early assessment of the clinical activity of the drug.
Phase 1 clinical trials offer patients access to molecules that have the potential to become therapies. They're on the cusp of medical research and discovery. While patients understand the drug being studied may not help them, they still choose to participate.
“I think about the first day the patient takes the drug,” says Lin. “When they go home to their families, I hope they are optimistic that the medication will either help them, or we will learn something to help others.”
Dr. Lin also has a personal connection to cancer research.
“I was very close to my grandmother,” says Lin. “When I was in college, she passed away from bladder cancer. Almost all of the scientists I work with have a personal story of a friend or a family member with cancer. While [my colleagues] all have incredible scientific expertise, I think many are driven by memories of their loved ones.”