Biorbis

Understanding the Effective Design and Execution of Oncology Clinical Trials

Confirmed Speakers
Dr Judith Cooper Vice President, Clinical Oncology Biostatistics Johnson & Johnson Pharmaceutical R&D	Dr Nicholas Sarlis Senior Medical Director, Oncology Portfolio Sanofi-Aventis U.S.	Zhenming Shun, Ph.D. US Head of Oncology, Biostatistics Sanofi-Aventis
Dr Stephanie Green Senior Director, Biostatistics Pfizer	Dr Cong Chen Director Late-Stage Statistics Merck	Dr Zheng Su Senior Statistician Genentech
Dr J. Kyle Wathen Research Statistician M.D. Anderson Cancer Centre	Dr Li Yan Managing Director US Chinese Anti-Cancer Association	Dr Antonio Gualberto Senior Director Pfizer Oncology
Elizabeth Anderson, MPH BSN, Associate Director, Clinical Research Genzyme	Jeffrey S. Litwin, M.D. F.A.C.C., Executive Vice President and Chief Medical Officer ERT	Robin McCabe, MMH Senior Clinical Manager Novartis
Dr Giacomo Mordenti, Senior Expert Biostatistician and Team Leader, EMD Serono Dr Jeff Jackson, Group Leader Oncology Biomarkers, Bristol-Myers Squibb Dr Ionel Mitrica, Director, Clinical Development, GlaxoSmithKline Dr Qing Liu, Senior Research Fellow, Statistical Science, Johnson & Johnson Pharmaceutical R&D Dr Samuel DePrimo, Associate Director, Exelixis Dr Robert Morgan, Senior Vice President, Regulatory Affairs, Quality and Clinical Development, Ziopharm Oncology

As I'm sure you're aware, the progression of drug candidates through the clinic is a double-edged sword. Get it right and your hardwork pays off, get it wrong in confirmatory studies and the financial implications can be enormous. Understanding optimal trial design strategies and the regulatory requirements is critical to clinical success.

Drawing on the experiences of the world's leading anticancer drug developers (including Novartis, Genentech, Johnson & Johnson, GlaxoSmithKline, Merck, Pfizer, EMD Serono, Bristol-Myers Squibb and many other pioneering biotechs) we developed an agenda that delivers practical value and clear coverage of the central topics right now.

What's being covered on the Agenda?

Key areas being focussed on include;

• Reducing attrition rates in oncology drugs in the clinic through better trial design
• Incorporating adaptive trial design into oncology trials
• Benefits of randomised controlled Phase II trials vs single-arm uncontrolled trials
• Importance of the Independent Review
• Understanding what constitutes a ‘result’ in patient response
• Assessment of clinical endpoints in oncology
  • How to implement the latest FDA guidelines on Progression-Free Survival (PFS) endpoints
• Effective Strategies to develop successful companion diagnostics
  • Translating preclinical biomarkers into the clinical setting
  • Trial design strategies to identify biomarker subpopulations during ongoing clinical trials
• Challenges and opportunities for global oncology operations
• Streamlining operational protocols to identify and remove process bottlenecks
  • Maximising patient recruitment and retention through international collaborative groups
  • Building effective partnerships with CROs and clinical research groups
• Improving communication in comparative effectiveness research in clinical trial design
  • Understanding decision critical data for reimbursement appraisals
  • Integration of requirements into effective trial design

Why Attend?

• Understand the latest research efforts in oncology clinical trial design to streamline drug approval success
• You will leave the meeting with a variety of new ideas and contacts to take back to your research organisation
• The Biorbis Advancing Clinical Trials in Oncology conference focuses on delivering practical value, accelerating progress of drug candidates through the clinic and maximising the speed to market for your cancer therapy

Background

As oncology clinical trials become increasingly more complex and the industry moves to develop more targeted therapies, a revaluation of traditional trial designs is already underway. With academic and industry pioneers leading the field, the time is now to capitalise on this progress and make the most of the wealth of experience already available. You'll know, as well as I do, that 60% of cancer drugs fail in Phase III of their development resulting in an approximate loss of $100 million to the company or investor involved each time.

Appropriate clinical trial design, endpoint selection and incorporation of diagnostics development are critical to success.