Endpoint Overview    Consulting Services    GI Experience    CNS Experience    Other Experience    Client List    Publications    Curriculum Vitae    Contact Endpoint    Return Home Consulting Services Strategic Drug Development evaluate the medical and commercial potential of compounds in preclinical or early clinical development formulate comprehensive clinical development plans to the highest medical, scientific, and ethical standards position products for optimal marketing through a carefully integrated Phase I through IV clinical trials program optimize go/no-go decision points during drug development help emerging companies articulate a comprehensive approach to drug development customized to their compound, planned indication, and specific corporate needs interact with regulatory agencies to gain endorsement of the clinical trial program and planned regulatory submission assist with strategic planning of FDA advisory committee presentations Clinical Trial Design and Implementation design state-of-the-art clinical trials to optimally achieve key goals at each stage of a compound's development provide strategic review of draft protocols assure that clinical studies will meet the requirements of regulatory agencies and institutional review boards ("ethics committees") worldwide act as the medical monitor for emerging companies: supervise CRAs and provide help with the evaluation and processing of adverse events Product and Data Evaluation review and interpret complex pre-clinical and clinical data recommend future directions for projects and compounds evaluate opportunities and perform due diligence for potential investors in early-stage products or companies write interpretive critiques of publicly-available key reports, documents, manuscripts and competitor data Partnering and Strategic Alliances suggest partnering strategies for emerging companies evaluate and help negotiate in- and out-licensing opportunities coordinate activities between companies co-developing a compound coordinate activities between a sponsoring company and its CRO Educational and Academic produce authoritative overviews of medical conditions and their current pharmacotherapy in areas relevant to a company's portfolio identify and help select opinion leaders in North America and Europe interpret and put into perspective the views of academic experts and opinion leaders assemble and/or chair expert advisory panels educate company staff in various aspects of strategic drug development. Return to Top Copyright © 2001-2008 Kenneth Klein, MD All Rights Reserved