Yo Adrian! – The Disruptive Innovation Event Was A Knockout

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

By  Rob Wright

Philadelphia has a history of being the place where dreams become reality. Home to the signing of the U.S. Declaration of Independence and fictional boxing legend Rocky Balboa, Philly can now lay claim to yet another success — The Conference Forum’s Disruptive Innovation in Clinical Trials. Co-chair John Orloff, SVP global development and CMO, Novartis (NYSE: NVS), opened the event by explaining how the industry has been hit with a variety of challenges the past several years. Generic incursion, industry consolidation and rising Phase 3 clinical trial failure rates have served as punishing body blows to bio and pharma companies.

According to Orloff, “The current model is broken. We can’t have incremental innovation. We need disruptive.” Puneet Sapra, director worldwide business development and innovation for Pfizer (NYSE: PFE), served as the conference co-chair with Orloff. Sapra came out swinging, reminding the attendees of the appropriateness of this conference’s inaugural event taking place in Philadelphia, the former home of another rather disruptive innovator, Benjamin Franklin. In 1723, Franklin arrived in Philadelphia penniless. At the age of 42 he retired wealthy, having invented a variety of concepts and products still in use today(e.g. bifocals, lightning rod, etc.). Sapra’s message to challenge conventional thinking was not a lesson lost on the presenters or the audience.

Simon Delivers Jab to Scientists
Greg Simon, SVP worldwide policy, Pfizer, opened his presentation on the challenges and opportunities in clinical development by stating, “Today’s sermon comes from the book of Daniel.” Simon proceeded to explain how one of the first clinical trials can be traced back to the Hebrew Bible and what better way to be disruptive, than to quote scripture to a room full of scientist. Simon sees disruptive innovation as being analogous to playing in the street versus always sticking to the sidewalk. To become more innovative in clinical trials, Simon emphasized the need to get closer to the patient. In order to do this he recommends starting with the end in mind. For Simon, the end of a clinical trial should be viewed as the beginning of the next trial. Companies need to thank patients for their participation. "We should share the results with them directly with lay summaries rather than expecting them to go to medical journals they have no access to and most would not understand. If you tell patients the end of the story, they are more inclined to help you in the next clinical trial,” he says. Simon believes another means of getting closer to the patient is for companies to befriend patient advocate organizations because they have access to the scarcest resource — current and future clinical trial participants.

Four Critical Elements to Disruptive Innovation
Jon Platt, leader of ?WHATIF! Innovation’s healthcare sector, got into the fray by outlining four critical elements of disruptive innovation: ambition, leadership, people, and building belief. All of these play an integral role, but leadership functions as the keystone to achieving disruptive innovation. Here’s why. Leaders set the stage for creating an ambitious environment, hiring people who are their own energy generators and build belief in the plan. Platt emphasized the importance of leaders providing “senior air cover” for those involved in disruptive innovation, because employees with a vested interest in the status quo will attack those seeking to implement change. Leadership needs to enable and recognize appropriate risk and provide an environment which ensures the safe re-entry for employees involved in disruptive innovation — even if having failed. If those who have attempted and failed at innovation are allowed to be ostracized, people will be less likely to innovate in the future.

Down Goes Frazier
The knockout blow, though there were several, was delivered by Miguel Orri, Pfizer’s sr. director of clinical sciences, who explained the challenges involved in conducting the first virtual clinical trial. This Phase 4 study involved web-based recruitment, consent, and screening and utilized mobile phone-based efficacy assessment with interactive data capture. In addition, it was run in parallel with a convention study. The primary purpose was to determine the feasibility of conducting a trial virtually. During the process, Orri uncovered a number of external obstacles. For example, laws regarding informed consent and direct shipment of drugs to patients vary by state. Consequently, some states had to be excluded from the study. Other challenges included availability of local labs, patient ID verification, and safety follow up in a virtual setting. Orri admitted, however, that the biggest challenge to executing the virtual trial was overcoming the internal roadblocks of his own organization. Perhaps this is why Pfizer has placed people like Craig Lipset, head of clinical innovation worldwide R&D, in positions to provide “senior air cover” for people like Orri. The results are well worth the effort. Going virtual is good for patients, making it easier for their participation. It is gold for sponsors, because clinical site monitoring is reduced to one site. The only question I had upon leaving the conference was how are they going to top this next year?