Evolution Summit Fall 2017

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  • Best Indicators of Clinical Development Success

    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


    In clinical development, speed is not always the best indicator or predictor of success; it can even be detrimental to the quality of a program, says Tom Macek, PharmD, PhD, Director, Clinical Sciences, Takeda Global Research and Development. “We must do our utmost to develop and plan programs as efficiently as possible and understand our drugs as early in the development process as we can,” he adds. 

    A speaker at the marcus evans Evolution Summit 2012, in Wheeling, Illinois, April 30 - May 2, Macek discusses how to improve clinical results by better patient recruitment, retention and planning.

    From your perspective, what would improve clinical development and how?

    The unknowns of research are resulting in patient populations that are not meeting the adequate entry criteria for the study or are unknown to physicians. To improve clinical trials, we need a more standardized approach to site selection and patient recruitment, and we must use indicators of quality throughout the trial (particularly in areas such as psychiatry that may use more subjective methods of assessing efficacy).

    What is your definition of a top performing site?

    It is not always apparent what a top performing site is, as it may also be specific to the indication. It can be a site that recruits a large number of patients quickly or one that it is diligent in its measures of symptoms. A top performing site is most likely to be a marriage of the two: effective recruitment of quality patients and effective methods for measuring potential drug effects.

    How can patient adherence to protocol guidelines be improved? What role can social media or new technologies play in this space?

    For quality data, it is essential that patients adhere to protocol guidelines and be compliant in how they take their medication. Social media can be utilized to engage patients and ensure they follow instructions, but there are also a number of new technologies that monitor patient adherence, with electronic reminders for example. They may also incorporate sophisticated biomarkers, to better understand how drugs are working and in which sub-sets of patients. We must be on the cutting-edge of technology to understand how science can be utilized for efficient decision-making.

    How can the return on investment (ROI) of clinical trials be maximized?

    Maximizing ROI is about making truly effective decisions on compounds early, and having a well thought out development plan. As we search for new treatments for diseases, ROI is dependent on developing efficiencies, from utilizing patients early in Phase I and having a focused Phase II proof of concept and adequate dose ranging, so we understand drugs before Phase III studies.

    Any final words of wisdom?

    Speed and quality are not always predictive of success, and may in fact be mutually exclusive. Clinical development teams are often rushed to meet corporate goals, so they struggle to meet expectations. We must do our utmost to develop and plan programs as efficiently as possible and understand our drugs as early in the development process as we can.

    Contact: Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division

    Tel: + 357 22 849 313
    Email: press@marcusevanscy.com

    About the Evolution Summit 2012

    This unique forum will take place at the Westin Chicago North Shore, Wheeling, Illinois, April 30 - May 2, 2012. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on the future of drug development, developing a culture of safety and maximizing return on investment.

    For more information please send an email to info@marcusevanscy.com or visit the event website

    marcus evans group – life sciences / pharma sector portal

    The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations.


    Please note that the Summit is a closed business event and the number of participants strictly limited.

    About marcus evans Summits

    marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com 

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