logging in or signing up Solving the operational challenges of oncology clinical trials sbroady Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Copy Does not support media & animations WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 153 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: February 08, 2012 This Presentation is Public Favorites: 0 Presentation Description This Executive Briefing, entitled “Controlling the Known Variables” explores new strategies for solving your operational challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize your patient recruitment opportunities right here in North America. We have met with several biopharmaceutical companies, as well as leading investigative sites and oncology consortiums to uncover the secrets to maximizing the variables you can control. Contact Roberto Lara at (450 629-2200 ext 226 to discuss your next oncology study. Comments Posting comment... Premium member Presentation Transcript PowerPoint Presentation: CONTROLLING THE KNOWN VARIABLES Strategies for solving the operational challenges of oncology clinical trials EXECUTIVE BRIEFPowerPoint Presentation: The Promise of Personalized Medicine Reduce drug failure Reduce time/cost Enhance patient participation Increase number of approvals Reimbursement of effective drugs Tufts CSDDPowerPoint Presentation: At the 2011 ASCO Meeting we got a glimpse of what the future holds for patients and drug developers. A deeper understanding of the pathways governing cancer are showing significant results in deadly diseases that previously had limited options…PowerPoint Presentation: Glimpse Into The Future Vemurafenib – A BRAF Inhibitor (ASCO 2011) Targeted: A mutated form of a gene called BRAF found in more than half of patients with advanced melanoma Tailored : 63% less likely to die over a six-month period compared to those taking chemotherapyPowerPoint Presentation: Where Are We Today? Over 9,000 oncology drugs under evaluation ~16 targets actively studied Source: TCSDDPowerPoint Presentation: Where Are We Today?PowerPoint Presentation: Impact of Personalized Medicine on Clinical Trials 94% of companies investing in personalized medicine 50% of compounds in development qualify as personalized 75%* increase in funding for targeted therapies Tufts CSDD *Over the last 5 yearsPowerPoint Presentation: As an industry, we continue to focus on the traditional barriers to oncology clinical research here in North America…PowerPoint Presentation: Traditional barriers to oncology clinical research Applied Clinical Trials Live Webcast June 14, 2011PowerPoint Presentation: New issues as a result of personalized medicine Regulatory oversight (implications for R&D) Reimbursement (testing & costly treatment) Privacy, confidentiality and patient rightsPowerPoint Presentation: Most important issue is the impact Personalized Medicine will have on your clinical operations. The goal is to find new ways of reducing costs by finding the “Right Sites” more quickly.PowerPoint Presentation: Impact on Clinical Operations Cost Site/PI selection Administrative burden A Challenge Often OverlookedPowerPoint Presentation: Average cost of R&D is now $2.3 Billion USD R&D Spending On The RisePowerPoint Presentation: Low Approval Rate in OncologyPowerPoint Presentation: The declining number of North American investigators means that your ability to find the right sites that are motivated to work on your trials is more critical than ever.PowerPoint Presentation: Declining Number of Investigators Source: FDA’s Bioresearch Monitoring Information System File (BMIS)PowerPoint Presentation: Increased Administrative Burden Source: TCSDDPowerPoint Presentation: Source: Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal of Therapeutics. 2008 15(5); 450 - 457 Increased WorkloadsPowerPoint Presentation: Personalized medicine adds to the recruitment problem. Need for smaller patient populations means you need to screen more patients to find enough that are eligible for your trial.PowerPoint Presentation: POSSIBLE SOLUTIONS CONTROLLING THE KNOWN VARIABLESPowerPoint Presentation: Challenges Cost Site/PI Selection Administrative Burden Solutions Strategic Relationships Identifying Right Sites Optimizing Output Keys to SuccessPowerPoint Presentation: FDA & EMA have created programs to tackle questions surrounding biomarkers & defining endpoints Collaboration with Regulatory AgenciesPowerPoint Presentation: Networks to address “unmet clinical trial needs” Match investigators with trials of interest Reducing Costs by Enriching Site SelectionPowerPoint Presentation: Personalized Medicine Applied Clinical Trials Live Webcast June 14, 2011 Keys To SuccessPowerPoint Presentation: Scimega Research maintains an ongoing dialogue with a network of oncology investigators to identify their study needs. This allows us to match studies to sites that are motivated to recruit patients and get trials up and running.PowerPoint Presentation: SCIMEGA RESEARCH – REVERSE FEASIBILITY TM A new approach to site selection & patient recruitmentPowerPoint Presentation: Investigative Network Information Gathered Experience Interest Facilities Recruitment openings over next 6 months IRB requirements/schedule SOC – availability and reimbursement Catchment areaPowerPoint Presentation: The Value of Privileged RelationshipsBenefits To You: Benefits To You Accelerated communication with the right investigators Protocol synopsis, recruitment target and timelines & budget Access to pre-approved CDA templates = Immediate , accurate assessmentPowerPoint Presentation: CONCLUSION Are you controlling your known variables ? SPEAK TO US TODAY ABOUT YOUR SITUATION Contact Roberto Lara at (450) 629-2200 ext. 226 or email@example.comPowerPoint Presentation: About Scimega Research Scimega Research was founded as a specialty Oncology CRO in 1997 to meet the demand for superior clinical trial management services in the complex field of oncology clinical research. The company’s depth of oncology expertise and ability to offer full North American coverage brings tremendous value to its clients. But it’s our privileged relationships with North American investigative sites that allow us to fulfill our mission of accelerating strategic drug development decisions. To learn more visit us at www.scimega.com LinkedIn Group: Optimizing Oncology Clinical Research You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.