Disruptive Innovation In Clinical Trials

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

By  Rob Wright

I recently interviewed Dr. John Hubbard, sr. VP and worldwide head of development operations for Pfizer (NYSE: PFE). One of his current favorite subjects is disruptive innovation. I have heard this buzzword a lot lately from people such as Bernard Munos with InnoThink; Paul Hastings, CEO of OncoMed Pharmaceuticals; and Tomasz Sablinski, MD, Ph.D. with Celtic Therapeutics . Being that Hubbard manages more than 700 clinical development projects for Pfizer, I thought I should learn more about the origin of this concept and what it means for the future of drug development.

The Innovators Dilemma
Disruptive innovation is a term coined by Clayton Christensen author of “The Innovators Dilemma.” He describes it as a process by which a product or service takes root initially in simple applications at the bottom of a market and then relentlessly moves ‘up market,’ eventually displacing established competitors. In the highly regulated pharmaceutical and biopharm industries, how truly disruptive can these companies be and remain compliant? Can Pfizer achieve disruptive innovation, given the 162 year history it has of primarily being an incremental innovation oriented company? Only time will tell. However, recent bold initiatives have demonstrated the company’s willingness to try.

This year Pfizer announced the closing of its R&D research facility in Sandwich, United Kingdom and signed strategic partnership deals with ICON and Parexel. Companies close plants and broker deals all the time, so on the surface, this might not seem like a big deal. But consider this, the Sandwich R&D facility was once the jewel in the Pfizer R&D crown and the home of Viagra. Since Viagra’s launch in 1998, the number of men diagnosed with erectile dysfunction in the United States has increased by 250% and spawned at least two legal competitive offerings. Country western songs have been written about the drug. Even my kids have been heard walking around the house singing “Viva Viagra,” which they learned from commercials aired during sporting events. Closing the facility that created a baby boomer sexual revolution was a pretty bold move. The decision to strategically partner with just two CROs is also a very bold strategy. Previously, Pfizer actively utilized around 17 different CROs. What other strategies is Pfizer doing in an effort to achieve disruptive innovation?

Virtual Clinical Trial
In June, Pfizer announced it would pilot in the United States the first virtual clinical trial. The study is being conducted for a U.S. investigational new drug (IND) application whereby patients will be able to participate remotely without having to visit the trial sites. This new process is aimed at addressing rising R&D costs, which Hubbard estimates at being about $1.3 billion per drug. The process also has the potential to speed up clinical development, widen the available trial population, and improve compliance. The pilot is known as REMOTE, which stands for Research on Electronic Monitoring of OAB Treatment Experience. It uses mobile phone and Web-based technology to collect safety and efficacy data and is consistent with the FDA’s Clinical Trials Transformation Initiative (CITI) to improve the quality and efficiency of clinical studies. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, commended Pfizer on the program and encourages all manufacturers considering other novel ideas for advancing clinical trials to be proactive in discussions with the Agency as to trial design and oversight. On-site clinical trial monitoring accounts for approximately 30% of a study’s cost. Pfizer’s initiative just brought the cost of bringing a new drug to market back down to under billion dollars. Now that’s what I would call disruptive innovation!