What to expect when attending the FDA Narcolepsy Meeting in Person

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Arriving at FDA:
Arriving at FDA’s White Oak campus may be overwhelming the first time. Please leave lots of extra time to make the trip. Whether you are planning to drive or take public transportation, please factor in extra time for traffic, parking, shuttle buses and security check-in. If you’re flying into the Washington, D.C., metropolitan area, please see the end of this document for additional travel tips.

The meeting will take place at the FDA White Oak Campus at 10903 New Hampshire Ave., Building 31 Conference Center, Section A of the Great Room (Rm. 1503), Silver Spring, MD 20993.

All visitors should park in the SE Quadrant Surface Lot. Proceed to the first stop sign and turn right on Southwest Loop Road. Follow Southwest Loop Road all the way around, passing the SW Garage on your left. Continue driving, enter surface parking lot on your left. Once parked, walk or take the Campus Circulator Shuttle which will service the SE Quadrant Surface Lot and take visitors to Building 1. See map attached.

Public Transportation:
Silver Spring Metro Station, on the Red Line, is the closest metro stop. The Silver Spring Metro Station is approximately 4 miles, a 20 minute cab ride, from the White Oak Campus. Ride-On Bus route 22 operates between the Silver Spring Metro Station and White Oak Campus. Additionally, C8 Metro Bus operates between College Park and White Flint and makes a stop at the FDA White Oak Campus. For more information and bus schedules, visit: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241743.htm.

All participants must enter though Building 1 where they will go through the routine security check procedures for building entry. A visitor badge and escort will not be required to attend a public meeting in the Great Room. You will may have to go through a screening process similar to airport security. Please bring a photo ID for the security check-in.

Please feel free to bring coffee, drinks and snacks with you to the meeting. There is a refreshment stand near the meeting space with light refreshments and coffee for purchase. However, there is no other on-campus dining for visitors. Name Tags: There will be name tags outside the room, where you can list your full name, first name or initials (in case privacy issues are of concern). The panelists will use their full names and will be shown in the camera. Those in the audience will not be shown on camera or have their full names used.

Meeting Logistics/Accommodations:
Unite Narcolepsy has spoken with FDA about patients’ symptoms possibly happening during the meeting (like cataplexy or sleepiness). People with narcolepsy and loved ones will be seated together so you will be surrounded by peers who understand. There will also be a separate room nearby available to rest or nap. You are invited to take a break at any time, stand in the back of the room, visit the refreshments station or rest in the separate resting room.

Additionally, we’ve spoken with FDA about cataplexy possibly happening during patient speaking opportunities. We’ve suggested that folks may remain seated and that someone else can hold the microphone if cataplexy is a concern. If there are any other specific accommodation requests, please contact Pujita Vaidya at the FDA: Pujita.Vaidya@fda.hhs.gov.

Speaking Opportunities/Giving Input:
Ten people will be chosen by FDA to participate as panelists during the in-person FDA Meeting on Sept. 24. If you’d like to be considered for this speaking role, you must indicate so while registering. To be considered for a panelist position, you must answer the FDA’s Questions and return them to PatientFocused@fda.hhs.gov by September 13, 2013. Panelists will be notified of their selection around Sept. 17. Given the overwhelming interest in the panelist spots, you may not be selected, but there are other speaking opportunities for patient advocates at the meeting. The FDA will ask specific questions to the audience in a facilitated discussion. There will also be “open-mic” time allowing individuals an optional 3 minutes of remarks.

During the meeting FDA will also ask several polling questions. Patients and advocates attending in person will have “clicker” devices to register their answers. People watching by webcast will also be able to register their response to polling questions.

Anonymity/Not Speaking:
There is no requirement to speak at the meeting. If you’d like to attend and not speak, this is perfectly acceptable. Thank you!

FDA White Oak Campus Parking

DC Area Airports:
Washington area airports

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WEBINAR PROGRAM 2: Patients at the Center – The FDA’s Patient Focused Drug Development Initiative

unite narcolepsy webinar patients at the center FDA patient focused drug development initiativeDate Recorded: Thursday, Sept. 5 at 2 p.m. (Eastern)

Speakers: Monica Gow & Kim McCleary

Description: Did you know that 25 cents of every dollar consumers spend is regulated by the U.S. Food and Drug Administration? Did you know that “patient engagement” has been identified as the “blockbuster drug of decade”? Learn more about how drugs are developed and approved and why the FDA is highlighting narcolepsy as part of its Patient-Focused Drug Development Initiative. We’ll also remind you about ways you can help shape the future of treatment for narcolepsy.

Watch recording: http://youtu.be/DOF23NnPxoY

WEBINAR PROGRAM 1: Introducing the Unite Narcolepsy Initiative

Watch Now!Date Recorded: Thursday, Aug. 29 at 2 p.m. (Eastern)

Speakers: Julie FlygareMonica Gow, Kim McCleary

Description: Unite Narcolepsy is an education and empowerment initiative created to help inform people affected by narcolepsy about a unique opportunity to shape the future of narcolepsy treatment and to help them respond effectively. By encouraging and equipping broad participation, we aim to honor patients’ experiences and use the power of their testimony to ensure that patient needs are at the center of research efforts and regulatory decisions about narcolepsy treatment. Learn more about the Unite Narcolepsy initiative and all the ways that YOU can be part of this landmark opportunity!

Watch recording: http://www.youtube.com/watch?v=-7AExb4f9Xw

“Why does the FDA initiative matter?”

By Julie Flygare, J.D.

As a narcolepsy advocate, the FDA Patient Focused Drug Development Initiative (PFDDI) caught my attention right away.  It’s not everyday that patients and high-level decision makers get together to discuss what matters most for patients. Here are the top five reasons why the FDA initiative matters.

fda1. Educating FDA:

The FDA initiative allows people with narcolepsy and their loved ones to actively shape the future of narcolepsy treatment. As a direct result of the narcolepsy meeting, FDA will produce a meeting report, reflecting the input obtained from the narcolepsy community. The report will be posted on FDA’s website and circulated to the agency’s key decision makers. This information may also inspire the creation of new patient-focused outcome measures qualified for use in drug development, to better capture patient experience more systematically in clinical trials.

2. Re-gaining control:

As a person with narcolepsy, you may feel out of control at times – with your symptoms holding the reigns and making demands on your time and energy. While participating in the FDA initiative will

[Read more...]

Uniting for Patient-Centered Progress

The narcolepsy community unites!

FDA pageThis is an exciting time for the narcolepsy community! On September 24,2013, the U.S. Food Drug & Administration (FDA) will host a workshop on narcolepsy to collect information about narcolepsy from patients about the impact of narcolepsy on daily life. The FDA has selected narcolepsy to be the focus of a meeting under the Patient-Focused Drug Development Initiative (PFDDI), to better understand patients’ perspectives on the severity of the disease and the available therapies for the condition.

The upcoming PFDDI meeting on narcolepsy presents an unprecedented opportunity for the narcolepsy community to unite and create a brighter future for those living with the disease and their loved ones. [Read more...]