20
FEATURE:
DEPARTMENTS
FDA
6
8
10
Janet Woodcock, director of the Center for Drug Evaluation
and Research (CDER) at the FDA, talks about new mandates, user fees, and uncertainties that will occupy the
FDA's drug center in 2014.
12
16
40
44
46
February 2014
CONTENTS
Welcome to
Life Science Leader
26
32
COMPANIES TO
WATCH: 2013 REVIEW
Capitol Perspectives
CMS Guts Patient Protections
Outsourcing Insights
The Rise Of Biologics Development
Bio Innovation Notes
Continuous Bioprocessing
Biopharm Dev. & Manufacturing
How MorphoSys Survived
R&D; and Clinical Trials
Risk-Based Monitoring
Pharma Business
Pharmacovigilance
Leadership Lessons
Leadership By Fear
HOW TO LAUNCH A
BIOTECH COMPANY
Find out what has happened to the
companies we featured in this section
in 2013
Editorial Board/Ask The Board
38
THE CLINICAL TRIAL
PARADOX
50
Editor's Note
A summary of key points to consider,
from the evolution of the idea for the
company through to your exit
An exclusive interview with Lilly's chief
medical officer and co-leader of the
company's Development Center of
Excellence, Timothy Garnett
@RFWrightLSL
linkedin.com/in/robertfwright
pinterest.com/rfwrightlsl
facebook.com/LifeScienceLeader
4
LifeScienceLeader.com
February 2014