BIOTECH SUPPLY
CHAIN ACADEMY
October 8-9, 2012
Crowne Plaza, Foster City, CA
"Building the Biotech Supply
Chain: Adolescence to
Maturity: What Does it Take?"
Susanne Somerville
Vice President, Supply Chain, North
America
Genentech
© 2012, Genentech
How can I give you something in 30
minutes that you will take and use?
•I wanted to give a talk about our industry, and what is
holding us back from “maturity”, when I got an
interesting answer from colleagues:
“We are mature. Our processes are mostly industrialized.”
“We have dialed it in. We are on the top of the curve.”
•My answer:
“It doesn’t feel mature to me”
“We don’t know what we haven’t achieved – so how can
we be “mature” yet? Ever?”
© 2012, Genentech
Maybe my definition of “mature”
wasn’t the same…
“grow up”?
•
•
•
Adolescence
Immature
Make it up as you go
Ad hoc
reactive
•
•
•
Establish processes
Platform development
(copy instead of
reinvent)
Continuous
Improvement (part 1)
Mature
•
•
•
•
Continuous Improvement
(Part 2)
Breakthrough changes
Innovation
Step function improvement
as a regular practice…
… and maybe it has to do with the problem you are trying to solve…
Last Decade
Problem
•
Statement •
•
3/17/2016
COGS reduction
Capacity Limits
Plant Flexibility /
Design
Next Decade
•
•
•
•
•
•
Cost / Speed of Development
Biosimilar Impact
Flexible Cost Structure
Health Care Reform
Emerging Markets
Personalized Medicine
3
© 2012, Genentech
Adolescence to Mature
Conclusion: To get to Mature, it is
all about what you believe can
happen:
1. Guides what you will actually
accomplish
2. Guides what you will prepare
3/17/2016
for
4
© 2012, Genentech
The quest for 1 gram/liter
How many people
here thought 1 g/L
was Commercially
possible?
Did people change their
mind when they started
hearing people did it at
small scale…
3/17/2016
5
© 2012, Genentech
Belief then drives innovation in other
areas…
• Less need for capacity, smaller fermentation
vessels
– New problems: risk management, purification
bottlenecks
• Less resources / time / changes needed for
Phase II / III / commercial process design
– New problem: stop developing!
You have to believe the changes can happen to see
the next few chess moves ahead – and that is
where you will really deliver value to the company
(but are the bets too scary to make…)
3/17/2016
6
© 2012, Genentech
Clinical Supplies
Industry Practice
•
Vision
• Can we eliminate
patient stockouts
•
AND deliver a
stable packaging
•
plan?
• Genentech’s Journey to implement Class A
Each trial is a new project –
coordinated, not planned
Constant packaging plan
changes
Patient supply misses
• Started in 2006
• Implemented measurement in 2008: Production Plan Performance (did I
make and release the item # and quantity (+/- 10%) at the end of the
month I said I would make at the beginning of the month)
• 2009 ISPE presentation: Clinical Pack PPP ~80% (and people did not
believe me)
3/17/2016
7
• 2010: multiple sequential months at 100%, 1 stockout
© 2012, Genentech
Belief then drives innovation in other
areas…
• Stable Pack operations
– New problem: how do we change our identity
from being the best fire fighters? How do we take
advantage of predictable performance?
• No patients missed
– New opportunity: Different relationship with
study doctors?
• Improved ability to execute studies as
planned
– New opportunity: Can we spend the money we
save on other programs?
3/17/2016
8
© 2012, Genentech
So what “beliefs” should we have? Who
is ready to make “bets”?
• Shorter Development Time
– Transcelerate:
http://www.distilnfo.com/pharma/2012/09/22/tenpharmaceutical-companies-unite-to-accelerate-development-ofnew-medicines/
– More Phase II results straight to market
– Higher success rates in clinical programs
• More use of CMOs
– Larger companies have more fixed cost pressure
– More unique business areas not previously outsourced
• Shift in markets we serve
– US / Western Europe continued price pressure (and it might
go much further than we think)
– Critical mass is starting to make a difference in emerging
markets
• Changes in IT development cycles
– How can your company take advantage of this industry shift?
3/17/2016 What will happen if you don’t?
• Faster technical
development –
no
development?
• More money
available to fund
• those
Betternext
/ more
molecules?
flexible contract
•
•
•
•
terms?
More “virtual”
More local Mfg?
companies?
Volatility in
Forecasting?
How to manage
transportation?
9
© 2012, Genentech
Final Thoughts
• How can you break current beliefs? What
stands in the way to get to “mature”?
– Can you give opportunities to improve for people
in areas they know nothing about?
• Think three chess moves ahead
– What bets would you be willing to make?
• Follow the pack with caution…
– Contrarian theory can put you ahead
3/17/2016
10
© 2012, Genentech
Acknowledgements
Brian Kelley
Dana Andersen
Matt Croughan
Tim Moore
Randy Schwemmin
Charlie Cammarata
Gwin Gamboa
3/17/2016
11
© 2012, Genentech