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insights LIFESCIENCELEADER.COM MARCH 2014 52 CLINICAL TRIALS By N. Taylor HOW RARE DISEASE KNOW-HOW CAN SHAPE BIG PHARMA CLINICAL TRIALS A N D Y L E E Senior VP & Deputy Head Of Clinical Sciences And Operations at Sanof enable remote data capture, severing the link between a patient's location and their ability to join a study. While such technology is already creeping into the consumer space in self-tracking devices, it is still on the cusp of acceptance in clinical trials. Lee is on a mission to accelerate adoption. The potential is massive. Take the transdermal monitoring patch in devel- opment at Sano Intelligence, a start-up backed by seed fund Rock Health. Sano is trying to create a patch that continu- ously monitors glucose levels, kidney function, and electrolytes. Others, like Imec, are working on electrocardiogram patches. For trials, these patches could yield unprecedented insights into the health of participants between site visits. HOW TO BRING BIOTECH IDEAS INTO BIG PHARMA It is one thing to talk up an innovative prototype or novel methods used by a biotech in a rare disease trial, but quite another to implement experimental strategies at a Big Pharma company. The scale of Big Pharma companies neces- sitates reliable, industrialized devel- opment processes. Moving away from established methods is a risk. Yet, as these processes are failing, maintaining the status quo is a risk, too. Lee, who is tasked with bringing innova- tion into the workings of Sanofi, grapples with these issues on a daily basis. Having the support of management helps. Lee says Sanofi's leaders are keen to adopt a culture of "open innovation" and establish a "biotech" mentality to help drive pro- ductivity and develop new medicines. Recently, this has led to the company implementing ideas from rare disease trials. Instead of simply activating lots of sites and hoping patients show up, Sanofi is working more strategically with key research institutions from around the world. The strategy has reduced the overall number of sites needed in a given study. Together, Sanofi and the sites are trying to understand how and where patients access clinical trials, as well as ways to reduce the burden of their proto- col designs. Through these partnerships, investigators and study nurses are able to provide Sanofi with real-life clinical perspectives as part of program and pro- tocol development. "This type of advice allows us to design studies void of challenges that could oth- erwise prevent some patients from par- ticipating, and it allows research sites to recruit more individuals in a given study," says Vicky DiBiaso, head of investigator and patient networks at Sanofi. The site- focused method should also cut down on turnover of investigators — a major problem for efficiency and quality — while reducing the proportion of locations that never recruit. Lee has been thinking about this model for years. In pharma, it takes time for ideas to come to fruition. New technologies also go through a long gestational period. EDC, for exam- ple, was available for years before becom- ing mainstream. For Big Pharma, these gradual, phased introductions allow for the testing of innovative technologies without disrupting the running of vital clinical machinery. Lee is taking this stepwise approach at Sanofi, using post- authorization safety studies as a proving ground for new tools. If successful, widespread use will follow quickly. Sanofi is looking to pilot iPad technology for informed consent, replac- ing bulky, paper-based, 20-page docu- ments with interactive electronic forms. By allowing patients to give consent at home, a less stressful, time-pressured environment than the clinic, and using video "explainers," Sanofi is trying to make the process more informative and less daunting. In the future, sites will also benefit when new versions of the con- sent form are administered and tracked through electronic updates, eliminating the risk of using outdated documents. CREATING AN ENVIRONMENT FOR INNOVATION Shire is also trialing iPad e-consent, and Lee is pleased other companies are tackling the same problems. In presen- tations, he quotes Steven Johnson, an author who popularized the theory that innovations stem from the collision of small hunches. The more people who are thinking about a problem — and sharing their thoughts with like-minded individ- uals — the greater the chance they will hit upon a real breakthrough. Biopharma as an industry clearly con- tains lots of people who are thinking about how to improve clinical trials. What is more questionable is the extent to which they are discussing their hunch- es with peers. In the past, Biopharma companies have been reticent to share their thoughts with competitors. In Johnson's model, this isolation of ideas slows the rate at which small hunches turn into full-blown innovations. Lee sees these walls between com- panies coming down. Last year, 10 Big Pharma companies, including Sanofi, founded TransCelerate BioPharma to collaborate on overcoming their shared problems, such as sourcing compara- tor drugs and communicating with trial sites. If Johnson is right, the creation of a space in which ideas from different firms can mingle should spawn innova- tive solutions to pharma's problems. At the very least, banding together could help overcome one of the obsta- cles to adoption of novel tools. "There's a fear of going alone and falling afoul of regulators," says Lee. By approaching regulators up front as a collective, the risk of trying something new is shared. Regulators also benefit from having one point of contact, instead of dealing with multiple firms running similar projects. This simplifies communication. TransCelerate has already expand- ed beyond its 10 founding companies, adding another 8 members in its first year. The very existence of the organi- zation shows companies are rethink- ing which of their functions give them a competitive edge and which are bet- ter handled collaboratively. With all five of TransCelerate's initial projects focus- ing on trials, it is clear that operational aspects of human studies are classed as precompetitive. As Lee puts it: "It's expensive, and it's broken for all of us. To borrow a JFK quote, 'a rising tide lifts all boats.'" L 0 3 1 4 _ C l i n i c a l _ T r i a l _ G e n z y m e . i n d d 2 0314_Clinical_Trial_Genzyme.indd 2 2 / 1 9 / 2 0 1 4 2 : 4 3 : 0 4 P M 2/19/2014 2:43:04 PM