Essential Guide to Preparing for a Meeting at the FDA White Oak

Essential Guide to Preparing for a Meeting at the
FDA White Oak Campus
Are you preparing for an FDA Meeting at the
White Oak Campus?
Take some of the stress out of your stressful day – be sure to
have this guide to White Oak handy! For the days leading up to,
and the day of, you don’t need to worry about where to stay, eat,
park, or any surprises that might come with meetings held at this
unique facility. Be sure to review this guide before your meeting to
help your team finalize their logistical plan – and keep it for the day
of to make sure you’ve got everything covered.
What’s in this Guide?
FDA’s White Oak Campus FDA’s White Oak Campus
Address
10903 New Hampshire Avenue, Silver Spring, MD
20993
Directions from Union Station:
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Head west toward Columbus Circle Northeast
Turn right to stay on Columbus Circle
Northeast
Turn right onto Massachusetts Ave NE
Turn right onto North Capitol St NE
Slight right toward US-50 E/New York Ave NE
Turn right onto US-50 E/New York Ave NE
Take the Balt-Wash Pkwy ramp on the left to
Baltimore
Merge onto MD-295 N
Take the exit onto I-495 N/I-95 N toward
Baltimore/College Park
Continue onto I-495 W (signs for Interstate
495 W/Beltway/Silver Spring); follow
directions from Beltway below
This guide contains everything you need to know about attending
a meeting at the FDA White Oak Campus. Here’s what you’ll find
inside:
Page 1
 Guide Overview
 Directions to the White Oak Campus
Page 2
 Where to Stay and Where to Eat Near White Oak
 Transportation Options/Car Services
Page 3
 The Meeting Day at White Oak – Focus on FDA AdComms
o Room Layout
Page 4
 Parking and Security
 Meeting Checklist
Directions from the Capital Beltway
(I-495):
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Take the Capital Beltway in Maryland and
exit at the following interchange.
Exit 28A, New Hampshire Avenue, MD 650,
North, White Oak.
Travel approximately 2 miles on New
Hampshire Avenue, MD 650.
The White Oak site is on the right.
Turn right into the first entrance to the site at
the Mahan Road/Schindler Drive intersection
- there is a signal at this intersection.
67 Park Place East, 6th Floor
Morristown, NJ 07960
P 973-889-1600
F 973-889-1619
www.innovativescience.net
Accommodations near White Oak
Picking the Right Hotel
Staying at the right hotel may not seem
like an important decision when you’re
faced with an upcoming FDA meeting,
but it is! The right hotel sets the right
mood for productivity for the days
leading up to your meeting.
ISS recommends arriving with your
team to the DC area at least two days
before your meeting to make final
preparations and get in the meeting
mindset. The hotels on the right are ISS
favorites for an AdComm location, but
are also in close proximity to White Oak.
We pick hotels based on many factors
including, but not limited to accessibility,
meeting space, service, and just plain
comfort!
Picking the Right Restaurants
Eating at the right restaurants breaks up
the stress of preparing for an FDA
meeting.
We advise a low-key meal the night
before the actual meeting to let
everyone get the rest they need before
the big day, but a great meal out as a
team two nights before the meeting is a
fantastic way to celebrate how far
you’ve come and the good work that’s
been accomplished!
Check out our list on the right for some
perfect locations to host a night out for
your team. We always recommend a
private room when available and budgetfriendly – pair that with some great food
and drink and don’t forget a toast!
Transportation Services:
Barwood Taxi: (301) 984-1900
Capital Sedan and Limousine Service:
(877) 447-3326
America Bus and Limousine:
(866) 847-9655
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4 E
D
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Location Marked as “A” – FDA White Oak Campus
Starred Locations are ISS-preferred hotels, described in detail below; restaurants are numbered
Hotel Options:
A – FDA White Oak Campus
B – Bethesda North Marriott Hotel & Conference Center
Address: 5701 Marinelli Road Bethesda, MD 20852 Phone: (301) 822-9200
C – Bethesda Marriott
Address: 5151 Pooks Hill Rd Bethesda, MD 20814 Phone: (800) 228-9290
D – DoubleTree by Hilton Hotel Bethesda - Washington DC
Address: 8120 Wisconsin Avenue Bethesda, MD 20814 Phone: (301) 652-2000
E – DoubleTree by Hilton Hotel Washington DC - Silver Spring
Address: 8727 Colesville Road Silver Spring, MD 20910 Phone: (301) 589-5200
Great Restaurant Choices:
1. Mon Ami Gabi – a classic French bistro and steakhouse with some of the
best scallops we’ve ever had!
Address: Bethesda Row; 7239 Woodmont Avenue, Bethesda, MD 20814
2. Food Wine & Co – don’t let the simple name fool you; this American bistro
offers a great mix of food items and has the perfect private room for
entertaining.
Address: 7272 Wisconsin Avenue, Bethesda, MD 20814
3. Mrs K's Toll House – this historical venue offers more than great food, be
sure to take a tour of the grounds of this unique house.
Address: 9201 Colesville Road, Silver Spring, MD 20910
4. Cubano’s – for something a little more out of the ordinary – give Cubano’s a
try – certainly one of the best Cuban restaurants in the DC area!
Address: 1201 Fidler Ln. Silver Spring, MD 20910
Your Meeting Day
Focus On: FDA Advisory Committee Meetings
Meeting Room Layout
FDA Advisory Committee Meetings are held in the Great Room (Room
1503), in Building 31 on the White Oak Campus. FDA offers sponsors
the opportunity to tour the room prior to their meeting and sponsors
should contact their meeting's Designated Federal Official (DFO) to
schedule a walk-through.
The Great Room is set up with a traditional U-shape for the committee.
The audience faces the U and a large projection screen. When facing
the U, the FDA and their technicians sit on the right hand side. The
sponsor and their equipment table are on the left hand side.
Meeting Room inside the FDA White Oak Campus
The figure below provides a schematic for the Great Room set-up.
Working Spaces and
Lunch
Two rooms are available for
sponsor use in Building 31
and are located adjacent to
the great room. The diagram
to the right has these rooms
highlighted in green.
Sponsors will have access to
Building 31 and their rooms
at 6:15am the day of their
meeting.
Important Note about Audio/Visual!
The DFO will work hand in hand with your A/V team
– having an A/V team with experience at White Oak
is a PLUS! Any equipment that does not fit through
the metal detectors will need to be brought to the
loading dock in Building 51, typically by 2:30pm the
day prior to your meeting.
Lunch can be catered
through Sodexo and should
be coordinated with the
DFO – outside food is
allowed but must go through
security.
The building also has a small
snack stand which offers
sandwiches and beverages;
however quantities are
limited and the stand is cash
only.
Innovative Science Solutions
AdComm Preparation Services
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Strategy
Message Development and Management
Slide Development and Management
Briefing Book
Mock and Internal Rehearsals
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Meeting Logistics
Speaker and Presentation Training
Audio/Visual Management
Q&A Preparation
Open Public Hearing Management
Parking, Security, and White Oak Checklist
Parking
On the day of the meeting you will enter the FDA campus
through Building 1 (Building at the head of the circle driveway
when you pull into campus). If you are utilizing shuttles for the
day of your meeting, your team should be dropped off and
picked up here.
If team members are driving – parking is located in the
Southeast Surface Lot (upper right hand side of the map on
the right.) A shuttle is available to transport individuals from
the parking area to Building 1.
Security
All attendees will need to enter the campus through security
at Building 1. There are metal detectors and any bags,
purses, etc., will need to go through security scanners. For
advisory committee meetings, you are not required to wear
visitor badges while on the campus; however, a government
issue ID is required to enter the building for other meetings
held on campus – a victory badge will then be issued to you.
If you plan on bringing internal security team members, be
sure to let the DFO know so the building’s security team is
alerted to their presence.
FDA Meeting Preparation Checklist
Team accommodations secured for
days leading up to meeting
ABOUT INNOVATIVE SCIENCE
SOLUTIONS
Innovative Science Solutions (ISS) is a leading scientific
consulting firm serving the worldwide pharmaceutical,
biotechnology, and medical device industries. We are a
team of scientists, regulatory strategists, and consultants
providing a wide range of fully-integrated services to
industry and counsel.
ISS has over a decade of experience in developing
regulatory strategies including support for FDA Advisory
Committee meetings. We are involved in more FDA
AdComms per year than even the largest pharmaceutical
companies. For more information on how ISS can help
you prepare for your next meeting, contact:
[email protected].
Reach out to the DFO to confirm
walkthrough prior to meeting (if
needed) – confirm presence of
internal security team
Lunch plans made for team?
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Sodexo, privately catered or
snack stand
A/V Team plan in place
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Large equipment brought in the
day prior
Transportation to and from facility
secured
Vendor selected to aid in meeting
prep and organization