FDAMA STAKEHOLDERS MEETING APRIL

1
FDAMA
STAKEHOLDERS
MEETING
APRIL 28, 1999
Boston,
Massachusetts
Talking
with
Stakeholders
About
FDA
Modernization
Boston University
Medical
Keefer Auditorium
715 Albany
Street
Massachusetts
Boston,
10:00 a.m. - 4:15 p.m.
LEE A. MARZILLI
REGISTERED
PROFESSIONAL
REPORTER
18 Boulder
Road
02420
Lexington,
MA
(781)862-4829
Schoo
2
INDEX
PAGE
OPENING
REMARKS
BY JOHN
REMARKS
BY DR.
REMARKS
BY MICHAEL
ARAM
PRESENTATION
BY JANICE
PRESENTATION
BY LISA
48
RAINES:
64
ANSWERS:
80
PRESENTATION
BY CAROLYN
FDAMA
16
BOURQUE:
BY LISA
AND
15
ELENGOLD:
PRESENTATION
QUESTIONS
8
DONOVAN:
BY MARK
AND
3
CHOBANIAN:
PRESENTATION
QUESTIONS
MARZILLI:
LOPEZ:
97
JONES:
108
ANSWERS:
STAKEHOLDERS
127
MEETING,
4/28/99
3
—
1
PRO
2
MS . FAIRFIELD:
get
started.
We’re
4
and
we’ll
started
5
track.
6
Food
7
to give
8
rooms
9
auditorium.
10
We’re
get
My name
and
Drug
you
are
and
is Paula
just
They
going
will
morning
12
and
break
will
be
13
which
is just
down
the
14
across
16
11:45,
17
here
18
signs
19
around
20
that’s
in the
and
up
22
New
23
thank
FDAMA
to be
center,
at
District
you,
Rest
our
third
Boardroom,
left.
the
It’s
wall.
vicinity
of
the
floor
14th
there
will
be
to elevators
and
introduce
at
our
FDA,
Marzilli,
John
Office.
Thank
everyone,
STAKEHOLDERS
going
Corporation,
on
you
the
right.
on
and
to
just
after
in the
floor.
with
the
Wilkins
clock
14th
like
to
on your
to the
MR . MARZILLI:
and
hall
directing
Director
England
in the
going
medical
door
Genzyme
to be
on
information.
a break
the
I’m
we
behind,
this
I’m
and
people
I would
District
from
keep
on your
from
is going
and
21
24
hall
be
to have
this
Lunch
and
don’t
bit
Fairfield.
the
speaker
the
try
housekeeping
outside
Why
a little
Administration,
some
s
morning.
running
11
the
I NG
Good
3
15
—
——
C E ED
you
for
MEETING,
this
time
from
John?
very
much,
getting
4/28/99
here
Paula,
this
the
4
—
—
1
morning.
2
Mass.
3
link
4
crawling
5
our
6
don’t
7
morning
8
it was
9
1’11
-- then
along
office
up
traffic
I won’t
have
12
driving
along
at
But
the
and
15
by bit
16
have
17
meeting,
18
the
19
industries
20
the
I can
you’ll
over
New
Food
and
Food
23
meeting
24
stakeholders
are
I travel
and
my
Pike
and
have
I’m
here
some
hair
to
and
Boston,
security
it shows
area
Drug
folks
so
sure
did
and
coffee
out
the
for
day
seats
people
as
so
I’m
coming
progresses,
fill
up
for
tremendous
from
a chance
bit
because
registered
of people
here,
we
this
interest
the
to meet
in
biotech
with
us
at
Administration.
is truly
22
people
me,
as the
these
in getting
This
and
you,
see
England
that
Pike.
a hundred
and
of
to thank
assure
toll
downtown
for
o’clock
Weston
of Mass.
into
to be pulling
I want
14
FDAMA
6:00
the
the
Normally
delight
director
in on
Massachusetts,
experience
the
11
here
here.
coming
a novel
as
you
in Stoneham,
the
came
in on
assure
to get
experience
do
of you
I came
I can
get
21
if any
-- and
Pike
10
13
_—
1 know
a historic
meeting
Drug
Administration.
We
are
today
as an outreach
with
our
across
STAKEHOL DERS
the
country.
MEETING,
The
4/28/99
for
the
having
meeting
this
5
.
_—_
1
kicks
2
with
the
3
held
across
4
with
the
5
District
6
Biologics.
7
have
speakers
8
well,
folks
9
we’ve
had
here
morning
session
with
Office
The
12
the
13
opportunity.
day
will
that
New
agency,
and
Modernization
our
we work
18
to
19
get
a chance
20
see
where
21
where
with
interact
we
24
often
Act
to say,
there’s
an
work
and
“so
STAKEHOLDERS
a long
and
room
for
time
always
meet
with
that
FDA
the
and
that
are
together
are
how
as
for
the
from
basis,
we’ll
with
to
to get
for
us
and
of
the
dear
and
people
have
to paraphrase
that
a chance
Ed
we
Cox,
doing?”
improvement
hear
and
to
and
room
together.
important
something
where
forward
hear
maybe,
something
FDAMA
us
start
Center
and
aspect
for
will
the
forward
on a daily
and
can
It’s
agency,
important
be
from
District,
look
stakeholders,
17
23
we
will
addressing
to come
9:30
folks
relationships
foremost
an
that
progress
near
England
at
meeting
from
industry
we’re
and
It’s
22
folks
working
in the
from
and
from
morning
meetings
Our
first
I
of eight
country.
11
16
this
the
here
15
in Boston
first
10
14
———_
off
opportunity
that
we
that
don’t
this
MEETING,
for
get
us
an
to do very
Commissioner
4/28/99
as
has
6
1
highlighted
2
the
3
So
4
Henney’s,
5
as District
6
District,
7
opportunity
reins
the
8
_—_
as her
of
FDA
the
priority
agency
that
Modernization
Act
and
I can
assure
Director
and
As
first
it’s
she
with
there
you
all
conducted
across
10
we’ll
be
a stakeholders
11
Office
of Regulatory
12
meeting
in Chicago
13
will
14
veterinary
15
Affairs.
food
industry;
in the
medical
devices.
In San
16
meeting
with
17
in Philadelphia,
18
for
Drug
Paula,
meetings?
And
21
be meeting
with
23
our
24
be
Web
held.
FDAMA
with
will
the
also
industry.
with
Francisco
be
They
the
San
Diego
we’ll
industry
we’ 11 be meeting
20
And
meetings
area,
be
as well;
with
the
and
Center
Evaluation.
And,
22
this
In Atlanta
They
drug
biologics
take
meeting
City
the
to
other
in Kansas
19
be meeting
us
priority
England
country.
the
on board.
first
New
seven
the
over
of you.
being
with
my,
for
9
having
came
in the
are
taking
is Commissioner
important
to meet
I said,
here
in
I’m
site
And
have
if
I haven’t
the
sure
and
I covered
world.
all
seen
for
STAKEHOLDERS
of you
where
those
-- oh,
Thank
have
these
of you
MEETING,
all
the
in D.C.
we’ll
you.
clicked
meetings
that
4/28/99
have
onto
will
fellow
7
1
workers
that
2
meeting,
at
3
and
them
4
on www.fda.gov,
5
and
6
simultaneously
7
have
8
at
9
participants
tell
see
the
the
10
will
11
and
12
their
be
couldn’t
break
they
make
may
click
click
on our
.
can
Web
also
the
their
them
computers
FDAMA
be
will
Web
site
other
So we’ll
be
country
satellite
view
call
as well.
that
will
the
this
to
our
site
across
receiving
onto
to
broadcast
broadcast
There
it
want
onto
Commissioner’s
locations
people
you
can
and
a satellite
eight
received
with
locations
downlink
it on
FDA
their
that
as well,
Web
sites
in
offices.
13
This
14
and
15
this
16
get
17
from
18
really
19
together
20
maybe
it’s
is a first
an exciting
activity
to meet
the
as
folks
industry
with
And
that
forward
all
I would
part
in
the
country
and
New
England
area
here,
to
spending
the
and
I’m
day
of you.
like
to thank
for
22
today .
It was
encouraging
23
they
24
in putting
FDAMA
the
take
regulate
Campus
this
across
to
Director,
we
Medical
been
as District
from
21
have
me
opportunity
it goes
with
looking
for
the
hosting
STAKEHOLDERS
this
University
meeting
to work
greatest
together.
Boston
with
with
them,
of assistance
And
MEETING,
I’d
like
4/28/’99
us
and
to us
to
8
1
welcome
2
Boston
3
the
4
come
Aram
Chobanian,
University
School
up
Medical
here
and
I’d
welcome
us
It’s
a pleasure
7
back
with
8
years
9
the
Cardiorenal
Advisory
10
the
Orphan
Committee
11
feel
12
sponsoring
13
served
to have
FDA
for
particularly
much,
the
to the
John.
I go
twenty-two
FDA,
and
quite
to
today.
for
Committee,
close
University
14
University
15
constituents
16
four
17
hospital.
18
Medicine,
the
19
of
Public
Health.
20
who
are
21
hospital
that
22
together
Boston
23
Hospital;
and
24
we
have
Medical
chaired
was
on
a while,
group
here.
The
living
Medical
Center
At
institutions,
FDAMA
today,
time,
for
of
site
here
to
Dean
that
so
we
I
are
today.
Boston
really
a long
the
the
him
very
all
of
to ask
the
you
you
and
like
as a consultant
Drug
Provost
to
Thank
6
the
the
Campus
of Medicine.
DR . CHOBANIAN:
5
.
——
Dr.
three
School
is made
the
three
School
medical
schools
schools
are
in the
Boston
is a merged
City
Hospital
the
School
and
the
those
know,
that
our
gone
very
has
now
a very
unified
of
School
of you
we
have
a
University
medical
4/28/99
have
brought
with
merger
we
a merged
area
that
MEETING,
of different
and
as
entity
Boston
campus
of Dentistry,
In addition,
STAKEHOLDERS
up
and
well,
and
9
—
—
1
campus .
2
—
There
of research
3
the
4
activity,
if you
include
5
hospital,
exceeds
$150
6
it’s
7
which
8
We
9
molecular
genetics,
10
medicine,
to studying
11
facility,
and
12
instrumentation
campus.
The
a broad
are
total
range
working
range
13
—
is a lot
from
There
the
are
your
very
fundamental
by
16
included
17
specialized
center
18
in coronary
heart
19
and
20
pulmonary
21
competed
22
Center,
23
in academia
24
industry.
some
a wide
by
way
devices
and
some
of
actually.
work,
to
translational
in the
animal
care
clinical
nationally
most
other
range
disease,
and
collaborates
the
those
We
now
country
MEETING,
a
National
with
where
Mass
people
as well
4/28/99
disease
in chronic
spectroscopy,
the
have
in hypertension,
in asthma,
for
funded
in Parkinson’s
in mass
successfully
STAKEHOLDERS
agencies,
are
of activities.
disease,
around
designated
of which
of research
disease,
which
year;
companies,
the
thirteen
15
Alzheimer’s
the
projects,
with
all
and
this
research
on
program
school
million
of Excellence,
NIH,
the
here
as well.
Centers
FDAMA
sponsored
to evaluating
14
the
of
activity
we
Spec
both
as with
10
.
We
1
2
that’s
3
the
4
in that
5
Excellence
been
a Navel
very
individuals
kind
7
now
8
activities
9
some
that
relates
nine-acre
11
plan
12
buildings.
13
second
14
Building,
15
January;
16
is for
17
research
18
third
19
approved
by
20
is going
to be
21
is currently
22
preliminary
23
that .
that’s
The
of the
two,
will
and
first
and
the
be
about
forty
fourth
the
being
planned,
STAKEHOLDERS
our
see,
or
that
building
biomedical
And
we
that
Group.
summer,
and
the
Research
of
building
in the
discussions
six
in December
percent
middle
a master
you
Medical
Planning
started
In addition,
FDAMA
includes
companies.
Master
right
which
in the
buildings
research
of
of your
that
for
Vail.eri
doing
we have
purposes,
biotech
we’re
and
Evans
c)f
so forth.
really
completed
commercial
for
two
Bob
enterprise,
parked
approved
some
a Center
to some
complex,
been
with
have
of what
Laboratory
I know
and
BioSquare
probably
of
We
Health
I think
is the
and
worked
setting.
part
10
24
that
have
exciting
of you
Research
successful,
here
of
Blood
in Women’s
The
6
.
have
there
have
has
a
been
A garage
and
a hotel
are
some
with
companies
regarding
hospital
here
a very
MEETING,
4/28/99
has
1
active
2
City
3
a new
ambulatory
4
style
of the
5
will
6
fall.
7
here
8
the
9
which
is including
10
stone
conversions
11
believe
12
now
13
value
14
were
15
now
plan.
Many
Hospital,
be
will
So
care
other
whole
going
and
are
about
So
thank
you
appreciate
18
you
have
the
all
20
pronounce
21
often
22
want
23
for
24
logistics
your
the
FDAMA
thank
Dr.
name
area,
of brownAnd
came
$5,000
and
I can’t
are
coming.
here,
they
and
dollars.
We
to host
the
$10,000,
a million
Chobanian,
correctly,
really
this
you
this
STAKEHOLDERS
and
I want
job
they
Dr.
to
have
meeting.
MEETING,
I’d
having
pronounced.
wonderful
for
this
and
hope
day.
incorrectly
to
with
increased
I first
for
also
condominiums
have
a half
MR . MARZILLI:
19
of
condominiums.
opportunity
a good
going
the
here
change
number
between
are
a major
a large
When
into
this
now
could
and
beginning
it’s
these
year,
that
part
that
Boston
fits
residential
You
they
17
buildings
area,
to
for
this
that
seeing
fifty-fold.
selling
facility
we’re
prices
for.
buildings,
probably
in the
the
old
demolished
older
I think
changes
the
be
constructed,
in the
16
of
my
to
name
Chobanian,
thank
done
It’s
like
your
for
just
4/28/99
I
staff
all
been
so
the
12
—
1
really
great.
2
extend
our
3
Administration
4
given
really
thanks
us.
And
5
We
now
Fairfield,
our
7
Paula
tell
8
this
all
you
I’d
6
will
on behalf
for
Thank
want
like
Public
us
of
the
very
to
thank
the
Food
assistance
and
and
Drug
you’ve
much.
to
introduce
Affairs
a bit
you
Paula
Specialist,
about
the
and
logistics
for
morning.
MS . FAIRFIELD:
9
10
going
to have
11
Director
12
and
13
left
14
Office
for
the
Center
Mark
is Steve
Masielo,
I’d
16
they’d
17
to have
18
Executive
19
James
20
and
21
Senior
like
come
up
Strategic
Vice
After
of
Vice
Policy
their
short
break.
24
presentations.
Seated
who
is the
the
first
stage,
Director
of
the
speakers
please.
We’re
by Janice
Bourque,
the
Biotech
Mass.
from
and
Genzyme
Raines,
Corporation.
with
Taunton-Rigby,
MEETING,
going
Affairs
Lisa
we’ll
continue
if
Council,
Government
at Biopure,
we’ll
Alison
STAKEHOLDERS
Evaluation
to Mark’s
three
presentations,
Then
Deputy
Biologics
President,
President
23
FDAMA
to the
presentations
Weston,
for
the
We’ re
at CEBER.
to ask
Director
John.
from
Elengold.
of Compliance
15
you,
presentations
Research,
22
Thank
4/28/99
have
a
three
more
President
13
1
and
2
Lopez,
3
Counsel
4
Jones
CEO
the
Aquila
Corporate
6
have
7
we’ll
8
the
9
downlink
the
have
14th
the
12
form,
13
that
At
look
out
them
from
16
you
Before
the
17
complete
la
teleconference
19
people
out
20
21
22
23
24
the
On
Mark
at
that
and
Carolyn
fax
day
and
the
note,
will
the
packets,
the
them
up
on
notice
is a
If you’d
you’d
people
like
that
fill
faxed
will
take
directly.
is over,
for
I’d
the
that
registration
1’11
then
satellite
agenda
that
have
leave
be
you’ll
Meeting.
evaluation
and
begin.
questions
and
we’ll
answers,
which
behind
we’ll
the
General
finished,
o’clock
Stakeholders
with
and
will
side
to headquarters,
15
1:00
in your
left-hand
FDAMA
are
break,
presentation
If you
on
lunch
floor.
, Lisa
HIMA.
of questions
our
and
Corporation,
presentations
a period
11
President
of Haemonetics
When
10
Biopharmaceuticals
Vice
representing
5
__—-_
of
turn
like
FDA
with
you
to
video
one
of
our
desk.
the
meeting
over
to
Elengold.
MR . MARZILLI:
couple
I just
had
to make
of announcements.
MS . FAIRFIELD:
FDAMA
Mark,
STAKEHOLDERS
What
did
MEETING,
I forget?
4/28/99
a
14
1
MR . MARZILLI:
2
to err
3
right?
4
the
6
to
7
chance
8
to
9
putting
.
earlier,
come
down
all
And,
the
12
them.
13
day
14
to get
15
our
16
Compliance
17
on
18
commissioned
19
in our
20
you
21
to one
22
get
two
24
you
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FDAMA
STAKEHOLDERS
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4/28/99
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product
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FDAMA
people,
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MEETING,
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4/28/99
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FDAMA
STAKEHOLDERS
MEETING,
4/28/99
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