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CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 14 leaders ROUNDTABLE Life Science Leader: How will future clinical trials (three to five years) in an outsourced model be different from today, and why? C. GALLEN, SK Biopharmaceuticals: Replacement of thoughtless, copy-the- last protocol, high-variance designs by expanded use of genomic, biomarker, and clinical enrichment designs (e.g. randomized withdrawal) will produce a more informed population selection. Sophisticated modeling combined with smarter Phase 2 programs will better define the dose, design, populations, and desirable outcome variables to reduce false negative trials. M. R. KELLER, formerly of Sangart: I don't see a radical change, but I antici- pate some evolution. CRO success is dem- onstrated in the metrics. CROs have the opportunity to influence study design and the elimination of excess secondary elements. Research from Tufts indicates sponsors are continuing to create com- plex protocols that are difficult to execute. CROs, as objective service providers, can help sponsors move toward more efficient and effective trial designs, and they will have the data to demonstrate the risks of poor trial design. J. ORLOFF, formerly of Novartis: There will be full operational as well as strategic integration of CRO resources with the sponsor's global program team that will make the relationship less trans- actional and more cohesive. This model also will move beyond the execution of clinical trials to trial design and strate- gic input into clinical development plans, and it will require different skillsets and expertise on both sides compared to what commonly exists today. What do you anticipate as being the biggest challenges in execut- ing future clinical trials in an out- sourced model, and why? Most trials and most CRO expertise is focused on the U.S. and Western Europe, while the vast majority of potential patients live outside that region. In the past, this made sense with the rationale of serving the big markets. But due to eco- Project leaders need to have a plan to provide exceptional training and over- sight to give monitors and managers the perspective required to achieve quality study execution. Sponsors must take staff "onboarding" seriously to ensure the CRO staff is well-versed in the goals of the proj- ect and endpoints of the studies. As we begin to more heavily rely on Big Data and remote monitoring, staff need to be able to critically review data for signals that impact the conduct and reporting for the study — again the ability to put everything into the perspective of the overall develop- ment process and plan. Fully integrated strategic partnerships between a CRO and a sponsor constructed to deliver on a program rather than á la carte transactional deliverables have the potential to reverse some of the existing incentives that undermine the goals of effi- ciency and simplicity. This could create a more cost-effective and flexible model that caters to the core skills of each partner. In the future, what internal/external roadblocks will prevent companies from successfully executing a clinical trial in an outsourced model? Weak signals come from narrow, super-selective, mechanistically targeted compounds whose effects are partially neutralized by compensatory processes in complex systems. Pharma companies will develop more robust multimechanis- tic compounds using pathophysiological screening to increase signal strength and trial power. CROs focused on time and cost but not quality generate high vari- ance results reducing power, requiring high intellectual expertise to use com- puter-assisted R&D to detect high vari- ance sites and measurements and to cor- rect errors and quality issues in real time before trials are compromised. Misaligned goals represent a real road- block seldom addressed by either spon- sors or CROs. Although both organiza- tions seek quality, sponsors are primar- ily concerned with time and CROs with cost, resulting in a difference in focus. "Us versus them" scenarios continue to be the norm. Communication between the internal/external parties is often limited to status reports to avoid difficult com- nomic and demographic changes, there will be a need to develop first-rate, cost- effective trial-conduct capabilities in the Asia-Pacific region and potentially North African regions. Colleagues who work within CROs are becoming increasingly disconnected from the discipline of drug development. Previously, it was common for many CRO employees to have sponsor experience, having joined a CRO when their sponsor company had downsized. Thus, they took their development experience into the new role. But now some CROs are staffing with individuals who have no pharma, biotech, or device experience. Inexperienced field staff may miss critical information due to their lack of knowledge regarding how medical practice differs from ideal drug development plans. The clinical trial enterprise is endan- gered because the model is antiquated and has not kept pace with advances in technology. Potential economic advan- tages of these improvements are absorbed by the legacy system. Incentives for an outsourced model must be reengineered to accommodate the need for more effi- cient practices in lower-cost settings, with rewards for efficiency and simplicity rath- er than volume and complexity. How do you anticipate overcoming these challenges? I think that basic economics will prevail. On the demand side, pharma companies are beginning to appreciate that for drugs entering development now, much of their future market will be in the Asia-Pacific region. Biotechs are lag- ging in this knowledge both for reasons of parochial orientation and resource limita- tions, and because the specialty markets they typically focus on are more developed in the West. In any case, demand will increase. Some global pharma companies are developing a presence in the region, albeit at prohibitive costs. Competition from emerging local providers will drive pricing, while more opportunity will drive local and medium-to-large CROs to seize first-mover advantage. In parallel, I think most regulatory authorities will move toward ICH (International Conference on Harmonization)-type standards. THE FUTURE OF CLINICAL TRIALS IN AN OUTSOURCED MODEL By R. Wright 0 3 1 4 _ C R O _ R o u n d t a b l e _ F u t u r e 3 C . i n d d 3 0314_CRO_Roundtable_Future3C.indd 3 2 / 1 9 / 2 0 1 4 1 : 4 4 : 1 9 P M 2/19/2014 1:44:19 PM

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