Life Science Leader Magazine Supplements

CRO Supplement 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 8 ROUNDTABLE leaders edging the realities of enrollment timing. Recent data from the Tufts Center for the Study of Drug Development confirms that across diverse therapeutic areas patient enrollment is consistently much slower than planned. There are a number of potential take-home messages from that, but standard process improvement methodologies clearly indicate that you can't fix a problem if you're not willing to "take it offline" and address it. For many companies the current approach is to continue to plan based on market forces or other goals unrelated to enrollment drivers, and then when problems arise, deal with them in a reactive or crisis management fashion. CRO input is key to gathering up-to-date industry intelligence, both when using technology and improving planning processes. CRO personnel tend to have broader exposure across a num- ber of sponsors. While they can't share confidential information, they do bring a wealth of operational expertise. The big- gest challenge to getting the full benefit of that is within the CROs themselves as, from a sponsor perspective, they don't always seem to have robust mechanisms for sharing knowledge within the CRO. Collaboration between pharma companies and between pharma and CROs can enable innovation. Can you discuss when it is best to innovate together vs. when it is better to go it alone? GROTE: I'm willing to take the first stab at that one. From my perspective, the question is not WHEN to innovate versus go it alone, but how and what to innovate. Innovation can arise from unexpected sources, and sponsors are not always well- positioned to quickly take advantage of that because they tend to have more rigid SOPs than CROs. Their internal decision- making and approval processes can also be longer and more labor-intensive to What areas are "blind spots" in pharma clinical research (areas that may create big impact but are not currently being addressed or pursued in earnest), and how can sponsors and CROs work together to address them? LIPSET: That's an interesting question. While we may leverage novel channels in an attempt to reach patients with infor- mation about clinical trials, we have a blind spot as to what happens when those patients bring that information to their treating physicians. Data is revealing how many patients wish to learn about research studies, but how few healthcare providers discuss research participation. Anecdotes from patients complement this data, in some instances with stories of physicians actively discouraging partici- pation. Even the most effective message of a trial will be challenged if treating physicians fail to provide encouragement and support. Sponsors and CROs must develop strategies to better engage treat- ing physicians and help to shed light on this important blind spot. KASHER: We have seen slow uptake on developing multiple sponsor/molecule enduring protocols. Lung Map or iSPY are good examples of this approach. At the end of the day, the molecules which have the best risk to benefit ratio for a specific subpopulation of patients will be the winners. A protocol which can accom- modate multiple molecules on an ongoing basis eliminates the repetitive identifica- tion and contracting with sites, training is streamlined, and patients can have a better chance of getting an efficacious molecule. GROTE: Two significant "blind spots" immediately come to mind. One is that our industry continues to lag in maxi- mizing the use of technology. As Craig mentioned earlier, I expect to see that change over the coming years. The other is our fairly universal resistance to acknowl- industry has ever seen is the magnitude of and interest in collaboration that's arisen over the past few years. TransCelerate is an inspiring example of how we can create value without sacrificing competitive advantage. Recent inclusion of CROs in that collaboration via the ACRO forum points to how critical collabora- tion has become for continued success. We are rapidly approaching a time when the economics of developing drugs under our old competitive models will become prohibitive. But in an industry as large and diverse as ours, successful change fundamentally depends on having many parties buy into that change in a specific way that benefits all. That drive for col- laboration is also seen in individual spon- sor/CRO relationships. With the volume of jobs shifting from sponsors to CROs over the past several years, there's been a broad cross-fertilization of talent. Sponsors are rapidly discovering the benefits of relying on CROs for more strategic and value-add activities than in the past. LIPSET: In addition to that, I would just add that over the next five years I expect to see radical changes in how clinical trial data is captured (eSource, voice-of-the-patient, proliferation of wearable technologies), as well as where trials are conducted (following the evolving health delivery landscape). By E. Miseta INNOVATION IN CLINICAL TRIALS: WHAT CAN WE EXPECT IN 2015 AND BEYOND? Wearable devices and patient-friendly ePRO apps will have a great impact on trials and patient recruitment/retention. J E F F K A S H E R

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