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  • Clinical Development in the Evolving Pharmaceutical Industry

     

    Colin Scott, a speaker at the marcus evans Evolution Summit 2013, on conducting clinical trials in a new pharma landscape.

    Interview with: Colin Scott, Senior director, Clinical Develop Respiratory, Forest Research Institute


    FOR IMMEDIATE RELEASE

    “The pharmaceutical industry is facing a major shift in clinical development strategy. Healthcare payers and providers are now demanding comparative efficacy to determine cost-effectiveness and running clinical studies in the US to generate these data is becoming increasing difficult. Adopting a patient-oriented development approach can overcome these problems. However, the industry is still faced with a non-personalized approach to registering drugs. This disconnect has to be addressed,” says Colin Scott, Senior Director, Clinical Development Respiratory, Forest Research Institute.

    Scott is a speaker at the upcoming marcus evans Evolution Summit 2013 in Palm Beach, Florida, May 8-10.

    What are your projections for the pharmaceutical industry?

    The clinical development paradigm which has served us so well for the past several decades is rapidly becoming obsolete. As Chief Medical Officers (CMOs) we are used to providing marketing with approved drugs based on numeric variables which are frequently irrelevant in terms of patient management. Times have changed. Doctors used to be the omniscient purveyors of solutions but after the explosion of information accessibility they are now providers of options; comparative data on individual patient relevant endpoints is essential to allow them to fill that role.

    The industry must start to identify subsets of patient populations which respond particularly well to the drugs in development. Umbrella diagnoses, much beloved by regulators, are no longer appropriate and block-buster drugs based on these misnomers will go the way of the dinosaur.

    To put this in perspective, in pulmonary medicine our first drugs were bronchodilators so we became used to using pulmonary function parameters as primary variables in all respiratory conditions. These show activity, not therapeutic utility. The disconnect is clear - patients with COPD will tell you they are breathless, not that their FEV1 is down 14 percent. In the future, development will focus on why they are breathless and what underlying pathophysiological mechanisms are involved in the specific type of breathlessness reported by individual patients. Only then can we know which drug class is most likely to provide benefit to which patient.

    Requirements for drug registration and how to achieve them are moving further and further away from clinical practice. This extends throughout the development process down to the management of trials. Conducting clinical trials is now a business which bears little relation to clinical practice. It is no wonder that fewer physicians are willing to participate. The time has come to rethink our strategy.

    How can this disconnect be bridged?

    There are many ways to bridge the gap between medical management and regulatory process. The first step in the process is accepting there is a problem. Encouraging signs are emerging that this is being recognized in both camps.

    What does this mean for CMOs?

    More attention must be paid in the early development process to fully characterize therapeutic activity. Drug-diagnostic combinations, a common phenomenon in oncologic research, will become much more widely used. In some conditions genomics will be the way of the future. In others surrogate end-point markers, currently used as end-points for drug evaluation, will be used to enrich patient populations to enhance the potential for patient-oriented efficacy.

    Without that focus, it is going to be extremely difficult to justify formulary adoption of new drugs and persuade clinicians to prescribe them. It will not be good enough to say that your drug works - you will have to show competitive advantage for it to be prescribed. The best way to optimizing prescription volume is not by hoping for the “block-buster” cure-all but by identifying which patients will get the most benefit from a drug.  

    The winning strategy will require merging full characterization of your drug with a personalized medicine approach and actively engaging in determining the drug’s competitive advantage. The time is fast approaching when we must return to the standards of Hippocratic medicine and treat patients, not diseases.


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

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


    About the Evolution Summit 2013

    This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May 8-10, 2013. 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 improving trial performance, establishing strategic alliances, site selection and e-recruitment.

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