ROUNDTABLE
leaders
LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015
8
Choose the wrong CMO and your project could
easily be derailed, costing your company
billions. But how do you avoid making such
a mistake? To help answer that question,
Life Science Leader brought together a panel
of outsourcing experts at the inaugural
Outsourced Pharma West conference and
exhibition in San Francisco last November. Our
panelists share some personal experiences
and lessons learned on the topic.
The panel participants included:
1
WHAT ARE SOME CHALLENGES TO
FINDING A PARTNER THAT ALIGNS
WITH YOUR NEEDS?
Terry Novak, Pernix Therapeutics: When
you ask that question, you will always
hear people saying the same thingsā¦
capabilities, quality, and regulatory. And
all of those factors are important. But
I believe sponsors need to take a very
detailed approach to these partnerships,
much like performing due diligence when
acquiring a new product. I like to look at
quality, regulatory, and delivery history,
but I ask a lot of other questions as well.
What is their turnover rate? How long has
the management team been in place? Are
they able to scale up? If they can't, am I
going to have to pay for the capital? These
are all questions that should be addressed
up front. I was always big on case studies
and whether they had worked on a project
like mine and were able to deliver. Be
as detailed as you possibly can be and
HOW
TO
QUALIFY
A
CMO'S
CAPABILITIES
AND
BENCHMARK
ITS
PERFORMANCE
By
E.
Miseta
FIRELLI ALONSO-CAPLEN
Senior director of biotherapeutics & vaccines, Pfizer
JOE GUILES
Director of process chemistry, Medivation
HEIDI HOFFMANN
Senior director of manufacturing, Sutro Biopharma
JUNNING LEE
SVP technical operations, Theravance Biopharma
TERRY NOVAK
COO, Pernix Therapeutics