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: 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): 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 B C 3 4 E D 12 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 Strategy Message Development and Management Slide Development and Management Briefing Book Mock and Internal Rehearsals 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? - Sodexo, privately catered or snack stand A/V Team plan in place - Large equipment brought in the day prior Transportation to and from facility secured Vendor selected to aid in meeting prep and organization
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