By Courtney Andersen

In an age of increasing financial and logistical pressures facing biotech and pharmaceutical companies, optimizing R&D success is a critical task. But in a commentary published last year in Drug Discovery Today, Andrew Chadwick of Tessella and Matthew Segall of Optibrium argued that psychology could be hindering the productivity of drug discovery teams, even suggesting that the traditional approach to discovery is actually blocking progress…read more

Join Dr Andrew Chadwick, Principal Consultant at Tessella, as he discusses with Prof Orest Hurko, Senior Clinical Consultant, Biologics Consulting Group, Inc, how to get more value from decisions on predictive technology provision and planning.

Established in 2003, the award programme recognizes teams in industry and academia for their outstanding innovations and excellence in the enabling uses of technologies, practices, solutions, and novel business strategies that will advance drug discovery, development, biomedical research, and clinical research and trials.

To find out more about the awards ceremony visit http://www.bio-itworld.com/bp_awards.aspx

• Effective, ethical approaches to trial design that harness incompletely validated predictive and prognostic biomarkers
• Ways to improve the value of image information and other rich data
• The tradeoffs to expect in using biomarkers for early go/no-go decisions
• How graphical models of risk and uncertainty can help the business, portfolio and functional teams to jointly leverage these exciting TM opportunities

To listen to the podcast click here

The US Food and Drug Administration (FDA) end-of-Phase 2a (EOP2A) meeting guidance issued on the September 2009 emphasises the value of the greater use of trial simulation and alternative design strategies in the clinical trials design process. The FDA’s primary purpose of an EOP2A meeting is to select the dosing regime and design “informative dose-response trials”.

The guidance is to encourage sponsors to consider the design of their subsequent phases carefully.  Poor dose selection for Phase II and III trials is one area that can lead to the study failing and, given the rate of attrition through these stages, the industry is seeking to improve planning and design.  “Dose selection for phase 2 and phase 3 trials is a challenge in many drug development programs, and poor choice may lead to trial failure,” write the FDA. In fact, it is said that some very high profile failures in phase 3 and even post registration have been due to poor choice of dose during drug development.

In particular the FDA is encouraging the use of modelling and simulation in the planning for phase 2b and beyond: “the FDA recognizes trial planning may be improved by clinical trial simulations that employ quantitative models of drug exposure-response, effects in placebo group, and disease progression.”  Allowing the EOP2A to be focused on interpreting results and discussing dosage and trial design issues. Amongst the possible topics for the meeting they include: “Contrasting alternative trial design strategies (e.g., parallel, cross-over, adaptive, randomized withdrawal) and analyses (e.g., Bayesian)”.

There are broadly two different uses of modelling and simulation at this stage in drug development and both are important. One is to model and simulate the pharmacokinetics and the pharmacodynamics of the compound and study population, and the other is to simulate the trial design. The first allows decisions about the dosing, study population and patient follow-up timetable to be explored and the latter allows decisions about study size, recruitment rate, number of treatment arms, the nature of the statistical analysis and any pre-planned trial adaptations to be explored.

Simulation is often the only way to bring together and understand the many strands of pre-clinical information and allow informed trial design decisions to be made and tested before running the actual trial.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079690.pdf

Tom Parke

Tom Parke is head of clinical trial solutions at Tessella and has been working at Tessella for over ten years. For a large part of that time he has been working on Adaptive Clinical Trial projects particularly with Dr Mike Krams (first at Pfizer and now at Wyeth) and Don and Scott Berry at Berry Consultants.

Tom has helped implement numerous adaptive phase 2 dose finding trials that are now complete, for a range of pharmaceutical companies across a range of indications. For these trials, he managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algorithms with existing IVRS and EDC systems.

He is currently working on his 12^th adaptive dose finding trial, and consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities.

Before working at Tessella, Tom had worked at Praxis (part of Deloitte & Touche) most notably managing projects for part of the air traffic control system at Heathrow Airport, and control software for imaging systems for GE Medical Systems and Varian Oncology.

tom.parke@tessella.com

Tessella’s Tom Parke, head of clinical trial solutions and Dr Scott Berry, president and statistical scientist at Berry Consultants, will be speaking about innovative adaptive trials for oncology trials at the event.

To find out more about this event or to register online, please visit http://www.adaptcongress.com

A Tessella sponsored webinar featuring Mike Krams, vice president adaptive trials and applied programme strategies at Wyeth and Tom Parke, head of clinical technologies, Tessella, on adaptive clinical trials. Visit http://www.inetpresent.com/w/Tessella/107/reg/ to register.