Founder's Experience as a Consulting Biostatistician for 36 Adaptive Trial Designs, Experience from 150+ Clinical Trials, & Details on Qualifications

Adaptive Trial Design Experience | Qualifications & Overall Experience

(A) Founder's Adaptive Clinical Trial Design related Experience:

• 36 Adaptive Trial Designs or Group-Sequential Designs to date: Development or Biostatistical Consulting

  • 24 Adaptive Trial Designs to date: Development and/or Biostatistical Consulting, including components such as

    • Sample Size Re-Estimation allowing for Interim Effect Size and other Adaptive Re-Sizing of Trial

    • Seamless Phase IIB/III Design approach that Selects "Best" Dosage Regimen at end of Stage 1

    • Selection of "Best" Patient Population Adaptively

  • 12 additional Group-Sequential Designs to date: Development and/or Consulting

  • Multiple Indications within Oncology, Cardiovascular, CNS, & Endocrinology covered by these 36 Adaptive Designs or Group-Sequential Designs

  • In Phase III or Phase II/III Trials Founder has already obtained Major Gains in terms of Reduced Cost, Decreased Time, or Increased Chance of the Clinical Trial being Positive for several Sponsors with these approaches

  • Majority of these 36 Designs have been for Confirmatory Clinical Trials, but consulting has also been provided for an increasing number of Adaptive Clinical Trial Designs in Phase I & Phase II

• Development of a new Adaptive Trial Design methodology (MULTOB) , which was included in a 2008-2010 PhRMA study of New Methods for Phase II Dose-Ranging Studies

  • Co-author of 2 PhRMA Working Group White Papers on Adaptive Trial Designs for Dose-Ranging Studies

  • MULTOB's simpler Non-Adaptive Version also shown to perform well for Selecting "Best" Dose(s) to take into Phase III Clinical Trials

• Frequent Presenter on Innovative Approaches to Clinical Trial Design at the DIA Annual Meeting, and at other key conferences

  • Two of these DIA presentations on Adaptive Clinical Trial Design had Regulatory discussants

Adaptive Trial Design Experience | Qualifications & Overall Experience

(B) Founder's Qualifications and Additional Experience

• Ph.D. 1988 in Design of Experiments, University of Reading, U.K.

• 28 Years Total Experience as a Biostatistician

• 21 Years Experience in the Pharmaceutical Industry

• Worked as a Consulting Biostatistician or Team Biostatistician on 150+ Studies in Numerous Indications

• Vice-President & World-Wide Head of Quintiles' Strategic Biostatistics Unit until 2007 where also provided Statistical Consulting on Adaptive Trial Design and other cutting edge clinical trial design or analysis methods

• Fellow of the Royal Statistical Society (Chartered Statistician), Member of the American Statistical Association, Member of the Drug Information Association, Member of the Biometric Society, Member of the Society for Clinical Trials

• Frequent Representation of Clients in Meetings with Regulators

• Predictive Biomarkers: Presenter & Session Chair at DIA 2011 Annual meeting

  • New approaches to Identify Predictive Biomarkers, particularly for Oncology, currently under active development by Founder

• Currently Serving on multiple Data Monitoring Committees

• Due Diligence assessments for potential investors: Provided biostatistical component of these assessments on approximately 15 occasions

Adaptive Trial Design Experience | Qualifications & Overall Experience