Life Science Leader Magazine

JUL 2014

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contents Welcome to Life Science Leader @ RFWrightLSL linkedin.com/in/robertfwright pinterest.com/rfwrightlsl facebook.com/LifeScienceLeader W W W. LI FE S CI E N CE LE A D E R .CO M Columns: Insights: Reports: 6 8 J U LY 2 014 V O L . 6 N O. 7 LIFESCIENCELEADER.COM JULY 2014 4 LIFE SCIENCE LEADER (ISSN: 21610800) Vol. 6, No. 7 is published monthly by Jameson Publishing, Inc. at Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. Phone (814) 897-9000, Fax (814) 899-5580. Periodical postage paid at Erie, PA 16510 and additional mailing offices. Copyright 2014 by Peterson Partnership. All rights reserved. Printed in the USA. SUBSCRIPTION RATES for qualified readers in the U.S. $0. For nonqualified readers in the U.S. and all other countries $97 for one year. If your mailing address is outside the U.S. or Canada, you can receive the magazine digitally if you provide a valid email address. POSTMASTER: Send address corrections (Form 3579) to Life Science Leader, Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. PUBLICATIONS AGREEMENT No. 40722524 c/o AIM, 7289 Torbram Road, Mississauga, ON L4T 1G8 32 Industry Partnerships With Patient Foundations — The Best Practices Voices of BayBio's "Successful Public-Private Partnerships" Survey: Part Two 26 J&J;'s Approach To Capturing Disruptive Innovation In Clinical Trials An exclusive interview with Andreas Koester, M.D., Ph.D., VP of clinical trial innovation and external alliances Features: DRUG DISCOVERY By Seth Lederman, M.D. The Evolving Role Of Drug Mechanism Of Action In Drug Discovery And Development 40 Editor's Note Editorial Advisory Board / Ask The Board OUTSOURCING INSIGHTS | By Kate Hammeke Outsourcing Trends in Small Molecule API Manufacturing BIO INNOVATION NOTES | By Eric Langer Best Practices in Standardizing Single-Use Device Connectivity We have all the ingredients here to take Takeda Oncology to even broader and deeper places than it's ever been before. Michael Vasconcelles, M.D., global head, the Oncology Therapeutic Area at Millennium: The Takeda Oncology Company 20 Cover Story: 18 16 14 Companies To Watch 50 LEADERSHIP LESSONS By John Baldoni Defi ning Presence As A Leadership Behavior 46 CONTRACT SOURCING By Jim Zhang, Ph.D. Global Drug Discovery Outsourcing Market Gaining Momentum CLINICAL TRIALS By Jennifer Goldsmith & Lisa Mulcahy eTMFs: Moving From Electronic Filing Cabinet To Strategic Asset 42 PHARMA MANUFACTURING By Gail Dutton Merck's Continuous Process Improvement 38 48 INDUSTRY LEADER By Michael Fiske Best Practices For Designing Cell-Based cGMP Facilities MILLENNIUM REGULATORY COMPLIANCE By Suzanne Elvidge The Falsifi ed Medicines Directive — What Does It Really Mean? 36 10 Capitol Perspectives 0 7 1 4 _ T O C . i n d d 1 0714_TOC.indd 1 6 / 2 3 / 2 0 1 4 2 : 5 3 : 3 6 P M 6/23/2014 2:53:36 PM

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