No Prohibition On Disruptive Innovation And Opinions At DIA

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

By  Rob Wright

Chicago served as the site for this year’s 47th annual Drug Information Association’s (DIA) annual meeting, kicked off by Illinois Governor, Pat Quinn. With a focus on clinical trials, program chair Ken Getz reminded the audience of the pivotal role patients play in drug development. He went on to acknowledge how infrequently these brave individuals receive public recognition for the hope they provide others through participation in clinical trials. Dr. David Ho, M.D., Rockefeller University, conducted the keynote address, driving home Getz’s point on patient participation, citing the advances witnessed in HIV-AIDS research. Ho described HIV, which turns 30 this year, as being the worst global pandemic in history with 25 million dead, over 33 million presently infected, and 2.5 million new infections each year. The life sciences industry needs disruptive innovations and convergence between patients, providers, drug companies, regulatory agencies, and vendors in order to advance new treatments for the diseases which presently ravage the human race. Innovations we have, but true convergence and collaboration — not quite.

Disruptive Innovations
As I walked the show floor, I had the opportunity to speak with a variety of people in the life sciences industry. In my discussions, it became quickly apparent that the industry does not lack for data. What is lacking is the ease in which researchers can retrieve and organize the information. A variety of companies are working on solutions to this problem. For example, Paula Brown Stafford, president of clinical development at Quintiles, walked me through their new product, Infosario. Martin Young, VP of strategy at Oracle Health Sciences, explained their new offering, InForm. Brendan Buckley, Senior VP medical affairs, demonstrated Firecrest’s new Mobile Visit-byVisit Guide Application. The two most disruptive innovations I witnessed came from smaller players in the market,

ClearTrial and Explorys.
Kristin Lucas gave me a very thorough demo of ClearTrial 4.2 with a new web services application programming interface. The product is intuitive to use and makes clinical trial forecasting easy and more accurate than I thought possible. Forecasting is critical, given that in just eight years the average cost of bringing a drug to market has increased to well over $1 billion. Conducting clinical trials is one of the biggest expense categories for biopharmaceutical companies. Better forecasting leads to better asset management. I talked to some end users of ClearTrial’s products. The way they speak of the company reminded me of how Apple loyalists speak of their computers — a true love for a product relationship.

The other disruptive innovation — and I mean disruptive, as this presentation truly blew me away — was demonstrated to me by Charlie Lougheed with Explorys. Never heard of them? You will. Partnered with such renowned institutions as the Cleveland Clinic and St. Joseph Health System, Explorys has developed a product that I would describe as the “Google” of healthcare. A web-based offering, it provides data aggregation, providing clinicians with deep longitudinal insight into patients, treatments, and outcomes not previously available. Go to www.explorys.com to get more info. Yet, with all of these innovative products, the most critical components to drug innovation remain to be regulatory harmonization and people.

Thought Leader’ Opinion on Convergence
While at DIA, I had some rather lengthy discussions with several industry executives from the likes of Parexel, PRA, Theorem, and the FDA. All of them concur on the importance of collaboration and convergence among industry participants as being critical to drug innovation. Further, all agree that the present lack of harmonization between regulatory agencies is delaying innovation. Mitch Katz, executive director of medical research operations with Purdue, lamented that many companies are bragging about developing true collaborations. Yet, according to Katz, most of the contracts between vendors and sponsors remain transaction oriented. For true collaboration to occur, vendors need to get some “skin in the game.” Katz recommends vendors implement meet-or-beat metrics on delivery. By finishing a project early, the company is rewarded financially by the sponsor. But, finishing a project behind schedule should result in financial penalties. Katz believes this type of contracting represents a true collaboration, as both organizations are at equal risk. I liked his candor and insights so much I invited him to join Life Science Leader magazine’s editorial advisory board, which he graciously accepted.