Jeffrey  Handen Author of Evaluating Organization Development
FEATURED AUTHOR

Jeffrey Handen

Vice-President, Professional Services
Medidata Solutions, Inc.

Dr. Handen brings over 20 years of experience in drug development, with a strong focus on clinical development, operations & risk management. At Medidata Solutions, Inc. Dr. Handen is responsible for designing & implementing clinical development solutions for global biopharmaceutical clients. Previously, Dr. Handen served as the Portfolio Director, Merck Research Labs & has held various research & management positions with IBM, the University of Pennsylvania & the National Institutes of Health.

Biography

Jeff Handen is Vice President of Professional Services with Medidata Solutions, Inc.   Before joining Medidata Solutions he was with Merck Research Laboratories for six years as Director of Portfolio and Project Management helping to plan, manage, and execute Merck’s clinical development portfolio.   Previous to Merck Dr. Handen held management and research positions of increasing responsibility with IBM, the University of Pennsylvania & the National Institutes of Health.

Dr. Handen has published in multiple peer-reviewed and business journals, presented at numerous industry conferences and scientific meetings as an invited speaker, served as past Editor-in-Chief of the “Industrialization of Drug Discovery” compendium and currently serves as the Editor-in-Chief of “Re-inventing Clinical Development”.

Dr. Handen has over twenty years’ experience in pharmaceutical and biotechnology R&D, process re-engineering, and systems & process and implementation.  As Vice President of Professional Services at Medidata Solutions, Inc., Dr. Handen is responsible for overseeing clinical development business process integration and solution architecting for optimizing clinical trials design and execution.

Areas of Research / Professional Expertise

    Clinical Development
    R&D
    Life Sciences
    Clinical Research
    Integration
    Project Planning
    Pharmaceutical Industry
    Cross-functional Team Leadership
    Healthcare
    Clinical Trials
    Management
    Project Management
    Portfolio Management
    CRO
    Pharmaceutics
    Biotechnology
    Change Management
    Risk Management

Books

Featured Title
 Featured Title - Re-inventing Drug Development - 1st Edition book cover

Articles

International Clinical Trials

Beyond the Borders; Global Country-Specific Differences in Clinical Trial Costs


Published: Aug 01, 2013 by International Clinical Trials
Authors: Jeffrey Handen, Ph.D., Irina Rafalovitch

Clinical trial grants represent the single biggest spend in a clinical trial, although this tends to only be about half of the total spend of any given study. Data management and monitoring, which are directly related to the quality of the data being captured and managed, account for 4 per cent and 30 per cent of the cost of a study, respectively. As a result, decisions on where to place a study should assess the total cost,.

Journal for Clinical Studies

Are Clinical Trials Agile Enough? What Pharma can Learn from Software Developmen


Published: Nov 30, 2012 by Journal for Clinical Studies
Authors: Jeffrey S. Handen, Ph.D.

With product development life-cycles often in excess of 10 years, drug developers must bring to market products that are not just competitively differentiated in the current landscape, but that will also be competitively differentiated and of value to the patient when compared against an unknown future standard of care. This paradigm creates inherent risks and necessitates surveying the environment constantly in order to rapidly adjust to new competitive threats and scientific opportunities

Applied Clinical Trials

SAE Rates in Clinical Trials


Published: May 30, 2012 by Applied Clinical Trials
Authors: Jeffrey S. Handen, Ph.D.

Capturing and managing serious adverse events (SAE) represents a significant compliance and complexity requirement to the management of clinical trials. However, a lack of transparency and benchmarks to expected rates and volumes of SAEs confounds the planning, resourcing, and development of safety case handling and reporting processes. An analysis of SAE rates from completed studies reported results over the past five years, 2007-2011, from Clinicaltrial.gov (n=4,221) was conducted.