Life Science Leader Magazine Supplements

CRO Supplement 2015

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LIFESCIENCELEADER.COM 10 THE CRO LEADERSHIP AWARDS 2015 By E. Miseta INNOVATION IN CLINICAL TRIALS: WHAT CAN WE EXPECT IN 2015 AND BEYOND? appropriate, on clinical trials being con- ducted by the molecule development teams. There is risk of failure, as exists for the molecule itself, but this must be done in a smart manner that protects patient safety and data integrity. GROTE: Over the past few years our industry has seen a number of differ- ent models implemented that are geared to supporting innovation. What most of these seem to have in common is an underlying strategy of allowing a group of people to operate independently of the parent organization. Though differ- ent models vary on the level of support, number of personnel, strategic impera- tives, and "distance" from the parent organization, it's fascinating to me that all the models appear to have an under- lying premise that innovation will hap- pen better outside the sponsor's walls. Potentially that speaks to some opportu- nities for change within the walls as well. At Biogen we have created a few differ- ent approaches to working innovatively — disease-specific innovation units that conduct clinical trials, scientific collabo- rations to conduct research, and a group focused on a value-based approach to meeting unmet medical needs. While the people working in these areas are empowered to focus on novel opportuni- ties, these units remain an integral and fully integrated part of the larger devel- opment organization. LIPSET: There are many models for large organizations to adopt to support inno- vation. Some may ring-fence and protect their innovation activities, while others may embed their innovation efforts deep inside their operations. My approach has been the latter — I feel it is too easy to test most anything in a protected sandbox. It is harder to make it work from within the operations, where colleagues will chal- lenge new approaches at every step. But challenge makes the idea more robust and resilient, and ultimately more likely to succeed in the real world in bringing impact to the organization. Ultimately organizations should not become enamored with ideas. Innovation is about the implementation of appropri- ate ideas to drive value in the organization. Ideas are often commodities — we all have ideas. The hard work is curating those ideas, implementation, and ulti- mately scaling what works. But that is how we will return value and make an impact in developing new medicines. I also look for CRO partners to be aligned and transparent with regard to innovation. Where we can share priorities and goals, we can create oppor- tunities to co-invest that are mutually beneficial. The alternative leaves innova- tion as just another transaction. The most recent Pharmaceutical Outsourcing Monitor gave a tip of the hat to thought leaders like yourselves. But it also cautioned that we be careful to not overlook the innovative ideas that originate from the worker bees doing their jobs on a daily basis. How can a pharma company's culture help to support innovation, and are there ways to better align the culture of the sponsor and CRO to support innovation? LIPSET: That's interesting. I had actu- ally not seen that. I would say that I am very transparent about the source of good ideas – they don't come from me! I sit inside the operations area at Pfizer and surround myself with the smartest people I can find at all levels both inside and outside the company. My work is to help them bring their ideas to life, with robust business cases and plans to scale where they succeed. My goal in sharing examples of peers implementing disruptive new innovative approaches is not to champion one idea over another. I share these examples to inspire others and to show them how colleagues are driving to implementation and challenge us all to drive change. I saw this impact first-hand as we shared our journey with the REMOTE trial. While some of the components worked and others did not, perhaps the greatest legacy of that project is the impact on colleagues inside and outside of my organization in believing that they are not constrained by the way we see our world today. If we all choose to be fast followers, then it's a race to the back seat of the car with no one behind the wheel. KASHER: Well said, Craig. I completely agree with that. If anyone thinks the inno- vative ideas originate from the "thought leaders," they are sadly mistaken. The insight, ideas, and sanity checking large- ly come from people in the "trenches" at pharma, CROs, and research sites. To support innovation, a culture which fosters thinking differently must exist in the face of predominating pressure to go faster and deliver on "quarterly expecta- tions of the street." This is no different in pharma or CROs. Leadership which creates motivation and safety for folks to innovate is desperately needed across the industry. GROTE: Biogen and our clinical develop- ment CRO partner, Quintiles, are jointly focused on how to foster and get the full value of the innovations that arise from the people doing the work. We are collab- oratively sponsoring multiple programs to encourage individuals and teams to bring forward innovative ideas and have put a process in place that makes it easy and offers recognition for the "people on the ground" to bring forth suggestions and recommendations. While the formal program supporting this is relatively new, we're already seeing great enthusi- asm within both companies and a high level of responsiveness. L ROUNDTABLE leaders

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