Clinical Development in the   Evolving Pharmaceutical Industry                                            The industry mus...
The Pharma Network – marcus                  About the Evolution Summit 2013  evans Summits group delivers  peer-to-peer  ...
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Clinical Development in the Evolving Pharmaceutical Industry: Interview with: Colin Scott, Senior director, Clinical Develop Respiratory, Forest Research Institute

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Clinical Development in the Evolving Pharmaceutical Industry: Interview with: Colin Scott, Senior director, Clinical Develop Respiratory, Forest Research Institute, a speaker at the marcus evans Evolution Summit 2013, on conducting clinical trials in a new pharma landscape.

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Clinical Development in the Evolving Pharmaceutical Industry: Interview with: Colin Scott, Senior director, Clinical Develop Respiratory, Forest Research Institute

  1. 1. Clinical Development in the Evolving Pharmaceutical Industry The industry must start to identify way of the future. In others surrogate subsets of patient populations which end-point markers, currently used as respond particularly well to the drugs in end-points for drug evaluation, will be development. Umbrella diagnoses, used to enrich patient populations to much beloved by regulators, are no enhance the potential for patient- longer appropriate and block-buster oriented efficacy. drugs based on these misnomers will go the way of the dinosaur. Without that focus, it is going to be extremely difficult to justify formulary To put this in perspective, in pulmonary adoption of new drugs and persuade medicine our first drugs were clinicians to prescribe them. It will not bronchodilators so we became used to be good enough to say that your drug using pulmonary function parameters as works - you will have to showInterview with: Colin Scott, Senior primary variables in all respiratory competitive advantage for it to bedirector, Clinical Develop conditions. These show activity, not prescribed. The best way to optimizingRespiratory, Forest Research therapeutic utility. The disconnect is prescription volume is not by hoping forInstitute clear - patients with COPD will tell you the “block-buster” cure-all but by they are breathless, not that their FEV1 identifying which patients will get the is down 14 percent. In the future, most benefit from a drug.“The pharmaceutical industry is facing a development will focus on why they aremajor shift in clinical development breathless and what underlying The winning strategy will requirestrategy. Healthcare payers and pathophysiological mechanisms are merging full characterization of yourproviders are now demanding involved in the specific type of drug with a personalized medicinecomparative efficacy to determine cost- breathlessness reported by individual approach and actively engaging ineffectiveness and running clinical patients. Only then can we know which determining the drug’s competitivestudies in the US to generate these data drug class is most likely to provide advantage. The time is fast approachingis becoming increasing difficult. benefit to which patient. when we must return to the standardsAdopting a patient-oriented develop- of Hippocratic medicine and treatment approach can overcome these Requirements for drug registration and patients, not diseases.problems. However, the industry is still how to achieve them are moving furtherfaced with a non-personalized approach and further away from clinical practice.to registering drugs. This disconnect has This extends throughout theto be addressed,” says Colin Scott, development process down to theSenior Director, Clinical DevelopmentRespiratory, Forest Research Institute. management of trials. Conducting clinical trials is now a business which Conducting clinical trials bears little relation to clinical practice. ItScott is a speaker at the upcoming is no wonder that fewer physicians aremarcus evans Evolution Summit willing to participate. The time has come2013 in Palm Beach, Florida, May 8-10.What are your projections for the to rethink our strategy. How can this disconnect be is now apharmaceutical industry? bridged? businessThe clinical development paradigm There are many ways to bridge the gapwhich has served us so well for the pastseveral decades is rapidly becoming between medical management and regulatory process. The first step in the which bears little relationobsolete. As Chief Medical Officers process is accepting there is a problem.(CMOs) we are used to providing Encouraging signs are emerging thatmarketing with approved drugs based this is being recognized in both camps.on numeric variables which arefrequently irrelevant in terms of patientmanagement. Times have changed. What does this mean for CMOs? to clinicalDoctors used to be the omniscientpurveyors of solutions but after the More attention must be paid in the early development process to fully practiceexplosion of information accessibility characterize therapeutic activity. Drug-they are now providers of options; diagnostic combinations, a commoncomparative data on individual patient phenomenon in oncologic research, willrelevant endpoints is essential to allow become much more widely used. Inthem to fill that role. some conditions genomics will be the
  2. 2. The Pharma Network – marcus About the Evolution Summit 2013 evans Summits group delivers peer-to-peer information on This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May strategic matters, professional 8-10, 2013. Offering much more than any conference, exhibition or trade show, this trends and breakthrough exclusive meeting will bring together esteemed industry thought leaders and innovations. 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. www.evolutionsummit.com Please note that the Summit is a closed business event and the Contact number of participants strictly limited. Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com 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.comEvolution Summit (Europe) - www.evolution-summit.comTo view the web version of this interview, please click here: www.evolutionsummit.com/ColinScott

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