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Exclusive Life Science Feature time by five years by the year 2020. But Garnett admits there is potential development programs, and so on, based on a subset of much work to be done and unfortunately no magic bullet. "We data." Doing so, he says, can accelerate a company's ability to enter know there are a number of approaches we can take to really Phase 3 by a year or more. He admits there are certain limits to improve our chances of clinical development," he states. One of how quickly you can move from Phase 2 to Phase 3 (e.g. meeting these is to make sure you have done the right Phase 2 studies. with the FDA), yet he admonishes, "There is really no excuse for it According to Garnett, many companies go into Phase 3 without to take a year or a year and a half, which is quite common." having performed the proper experiments. As a result, these comOne of the challenges with attempting to implement clinical panies end up having to do large Phase 3 studies. "They are essentrial scenario planning is that, often, scientists want full data — to tially doing their dose findings in Phase 3," he says. "You can't ensure certainty — before planning. Garnett suggests communiafford to do that. Though one cating the value of scenario planof the most basic components ning to scientists in not only time of Phase 2 studies, dose finding and dollars saved, but the potential is also that which gets comprorevenue generated for your comWhen I had the opportunity to visit Lilly's global corporate headquarter in mised most frequently." Rather pany. "I think you can easily shave Indianapolis, I was impressed with the size of its campus. With 10,000+ than trying to rush through Phase six to nine months off of every employees, it was larger than the town in which I grew up. However, Chief 2 in an attempt to get quicker development program if you do it Medical Officer Tim Garnett quickly reminded me it is not the biggest comapproval, Garnett advises taking properly, and that means getting pany in the pharmaceutical industry. Though still in the top 10, Lilly genermore time in Phase 2 if you want the drugs to the patients sooner." ates about one-third the revenue of J&J; and half that of Merck. "So when to accelerate your Phase 3 study. it comes to therapeutic focus, we have to be pretty disciplined on where PRACTICALITY OF In addition, he suggests looking we choose to play," he states. For the moment, those areas are primarily PATIENT CENTRICITY closely at comparator data. "In neuroscience, diabetes, endocrine oncology, and auto-immune disorders. It should come as no surprise that the current environment it is no Having a focused approach and staying on task can prove to be a chaltreating a person as a human being, longer just about proving efficacy lenge when it comes to drug discovery. "You don't always know the potenas opposed to a number, results and safety, but about proving tial indications of the compounds when you are first discovering them," in better patient outcomes. Why you have an innovation that is an Garnett states. "History points us towards many molecules that weren't can't these same patient-centered advance on what is already availwhat we thought they would be." For example, Pfizer was seeking a new healthcare delivery principles be able," he states. Garnett thinks treatment for angina, but instead found a medicine for erectile dysfunction applied in the clinical trial space? the sooner you can get compara— Viagra. Similarly, Lilly's blockbuster osteoporosis drug, Evista, started "We talk a lot on the commertor data the better. Then, be honoff as an oncology agent. "I think there was a time when industry had the cial side about patient experience est with yourself about what you freedom to run with those potential new therapeutic areas and indications," as being one of the triggers for find, making sure your study is reflects Garnett. "These days, we are a little more cost conscious." To stay why a patient presents for treatbig enough to give you a sense on task, Lilly seeks to find alternative ways of developing drugs — such ment," says Garnett. Lilly is startof confidence that it is reproducas partnering with the NIH. ing to apply lessons learned on ible. Garnett attributes many of In September 2013, Lilly announced it had received financial support the commercial side in the clinical the recent Phase 3 failures to from the NIH Therapeutics for Rare and Neglected Diseases (TRND) program trial world — starting with patient companies failing to slow down for its preclinical-stage research of a potential treatment for hypopararecruitment. in Phase 2 or seeking a shortcut. thyroidism, which causes a lack of parathyroid hormone. This can lead "The biggest determining factor "Researchers have not confirmed to a number of symptoms, such as anxiety, depression, cataracts, muscle of how long it is going to take they have a differentiated molcramping, convulsions, and irregular heartbeat. Lilly was the first major to run a Phase 3 study is the ecule with a strong enough signal pharmaceutical company to gain support from the TRND program, which amount of time it takes to recruit and, unfortunately, discover this seeks to de-risk development of rare disease treatments. Rare disease patients," says Garnett, who sees fact in Phase 3," he says. drug development is clearly not a focus for the folks at Lilly, but neither no reason why companies can't Conducting scenario planning is turning down the opportunity to deliver timely and valued medicines to have patients ready from the start. during Phase 2 may have the patients. "We have a finite capacity to spread the R&D; dollars," Garnett One way to do that is to get betappearance of slowing you down, reminds. "We can't afford to place our bets too broadly, but we don't ter at engaging with patient supbut will actually speed you up want to be turning down the next potential Evista." Participating in this port groups, something done well when entering Phase 3. Garnett type of program, as well as developing others (e.g. Lilly's open innovation by rare/orphan disease drugmaksays, "By scenario planning durplatform), facilitates staying on task and therapeutically focused, while also ers. "Why can't you do that for ing Phase 2 you are attempting allowing for the serendipity of drug discovery. Alzheimer's?" he asks. "There is to anticipate various outcomes, STAYING ON TASK 28 LifeScienceLeader.com February 2014