Best Indicators of                    Clinical Development                                                                ...
About the Evolution Summit 2012  The      Pharma        Network          -  marcus evans Summits group                    ...
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Best Indicators of Clinical Development Success - Tom Macek, Takeda Global Research and Development


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Tom Macek, a speaker at the marcus evans Evolution Summit 2012, on successful clinical development.
Interview with: Tom Macek, PharmD, PhD, Director, Clinical Sciences, Takeda Global Research and Development

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Best Indicators of Clinical Development Success - Tom Macek, Takeda Global Research and Development

  1. 1. Best Indicators of Clinical Development SuccessInterview with: Tom Macek, It is not always apparent what a top treatments for diseases, ROI is dependentPharmD, PhD, Director, Clinical performing site is, as it may also be on developing efficiencies, from utilizingSciences, Takeda Global Research specific to the indication. It can be a site patients early in Phase I and having aand Development that recruits a large number of patients focused Phase II proof of concept and quickly or one that it is diligent in its adequate dose ranging, so we understand measures of symptoms. drugs before Phase III studies.In clinical development, speed is notalways the best indicator or predictor of A top performing site is most likely tosuccess; it can even be detrimental to be a marriage of the two: effectivethe quality of a program, says Tom recruitment of quality patients andMacek, PharmD, PhD, Director, Clinical effective methods for measuringSciences, Takeda Global Research andDevelopment. “We must do our utmost potential drug effects. We must be onto develop and plan programs asefficiently as possible and understand How can patient adherence to protocol guidelines be improved? the cutting-edgeour drugs as early in the developmentprocess as we can,” he adds. What role can social media or new technologies play in this space? of technologyA speaker at the marcus evans For quality data, it is essential that to understandEvolution Summit 2012, in Wheeling,Illinois, April 30 - May 2, Macek patients adhere to protocol guidelines and be compliant in how they take their how sciencediscusses how to improve clinical resultsby better patient recruitment, retention medication. Social media can be utilized to engage patients and ensure they can be utilizedand planning. follow instructions, but there are also a number of new technologies that for efficientFrom your perspective, what wouldimprove clinical development and monitor patient adherence, with electronic reminders for example. decision-makinghow? They may also incorporate sophisticatedThe unknowns of research are resulting biomarkers, to better understand howin patient populations that are not drugs are working and in which sub-setsmeeting the adequate entry criteria for of patients. We must be on the cutting- Any final words of wisdom?the study or are unknown to physicians. edge of technology to understand howTo improve clinical trials, we need a science can be utilized for efficient Speed and quality are not alwaysmore standardized approach to site decision-making. predictive of success, and may in factselection and patient recruitment, and be mutually exclusive. Clinicalwe must use indicators of quality How can the return on investment development teams are often rushed tothroughout the trial (particularly in (ROI) of clinical trials be meet corporate goals, so they struggleareas such as psychiatry that may use maximized? to meet expectations.more subjective methods of assessingefficacy). Maximizing ROI is about making truly We must do our utmost to develop and effective decisions on compounds early, plan programs as efficiently as possibleWhat is your definition of a top and having a well thought out and understand our drugs as early inperforming site? development plan. As we search for new the development process as we can.
  2. 2. About the Evolution Summit 2012 The Pharma Network - marcus evans Summits group This unique forum will take place at the Westin Chicago North Shore, Wheeling, delivers peer-to-peer information Illinois, April 30 - May 2, 2012. Offering much more than any conference, exhibition on strategic matters, professional or trade show, this exclusive meeting will bring together esteemed industry thought trends and breakthrough leaders and solution providers to a highly focused and interactive networking event. innovations. The Summit includes presentations on the future of drug development, developing a culture of safety and maximizing return on investment. Please note that the Summit is a Contact closed business event and the number of participants strictly Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits limited. Division Tel: + 357 22 849 313 Email: For more information please send an email to All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.comAbout marcus evans Summitsmarcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discussstrategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity toindividually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings.For more information, please visit: www.marcusevans.comUpcoming EventsDiscovery Summit (Europe) - www.discovery-summit.comDiscovery Summit (North America) - www.thediscoverysummit.comEvolution Summit (Europe) - www.evolution-summit.comTo view the web version of this interview please click here: