PARASOL
Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis
INTERIM MEETING JUNE 8-9, 2024
LOGISTICS
Locations
- Meeting Venue: Hannesarholt (Grundarstígur 10, 101 Reykjavík)
- Fosshotel Reykjavik: Þórunnartún 1, 105 Reykjavík
- Exeter Hotel: Tryggvagata 12, 101 Reykjavík
- Aurora Basecamp (Saturday offsite dinner): 417, 221 Hafnarfjörður
Q&A form to use during meeting: https://forms.gle/4WumV8iuX5NDAzjm7
QUESTIONS? PLEASE CONTACT:
Logistics:
- Glory Onwuka, ISGD Operations Project Manager gonwuka@is-gd.org
- Úlfhildur Bjarnason (Úlla), G-Events Meeting Planner ulla@g-events.is
Mobile: +354 6990441
Meeting Content:
- Laura Mariani, PARASOL PI lmariani@umich.edu
- Laurel Damashek, ISGD Executive Director ldamashek@is-gd.org
Mobile: +1 617 286 2388
Zoom Information
Please note the separate Zoom links/meeting ID and passcode for Saturday and Sunday.
AGENDA
Friday June 7, 2024
|
Time |
Activity |
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🍽️ 7:30 PM–9:30 PM |
Informal Dinner: Haust Restaurant at Fosshotel Please drop in for dinner anytime between 7:30 and 9, if your travel plans allow. Buffé menu: Soup of the day, Various types of salads, Turmeric rice , Shellfish, Salmon prepared in various ways, Smoked duck, Gambas with sweet chilli, Smoked ocean trout, Beef tataki, Shrimps. Vegan courses, Cold sauces, Main courses with fish, meat & vegan dishes. Assorted fruits, raw cakes, apple pie, ice cream bar and much more! |
Saturday June 8, 2024
|
Time |
Activity |
|
🍽️ |
Breakfast at hotels
(Coffee & tea will be available at meeting venue)
|
|
🚍 7:40 AM
|
Bus Pickup at Fosshotel
Dropoff 8:00 am at Lækjargata bus stop (5-7 min walk to Hannesarholt meeting venue)
|
|
8:15 AM
|
All participants arrive at Hannesarholt
|
|
8:30 AM
|
Meeting Opening/Welcome
Josh Tarnoff; Hrefna Gudmundsdottir; Matthias Kretzler
|
|
9:00 AM
|
FDA Perspective of Endpoint Model Development
Aliza Thompson
|
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9:30 AM
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PARASOL Status Overview
Tobias Huber
|
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10:00 AM
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Analytic Roadmap
Laura Mariani, Abigail Smith, Margaret Helmuth
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🥐 10:45 AM
|
BREAK
Morning refreshment: Homemade oatmeal cookies/vegan oatmeal cookies, sliced melons and grapes
|
|
11:00 AM
|
eGFR Data and Discussion
Presenters: Abigail Smith, Margaret Helmuth, Ulysses Diva
Moderator: Danny Gale
|
|
🍽️ 12:15 PM
|
LUNCH
Pan-fried cod with creamy barley, mushrooms, cauliflower, broccoli, arugula,
sun-dried tomatoes, salad and parmesan.
Vegan: Baked cauliflower with vegan creamy barley, mushrooms, broccoli, arugula,
sun-dried tomatoes, salad and parmesan.
|
|
1:30 PM
|
UPCR and eGFR (Accelerated Approval Pathway) Data and Discussion
Presenters: Alex Mercer, Margaret Helmuth Moderator: Alex Mercer
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|
🥐 2:15 PM
|
BREAK
Afternoon refreshment: Homemade marital bliss cake with whipped cream
(same in vegan option).
|
|
2:30 PM
|
UPCR and Kidney Failure (Traditional Approval Pathway) Data and Discussion
Presenter: Abigail Smith
Moderator: Keisha Gibson
|
|
3:15 PM
|
Patient Perspective
Kevin Fowler
|
|
3:30 PM
|
Transition to breakout groups
|
|
3:45 PM
|
Stress Testing the Model: What is needed to convince you?
§ Group 1: Clinicians (Moderators: Kirk Campbell, Bill Smoyer)
§ Group 2: Statisticians (Moderator: Cathie Spino)
§ Group 3: Industry representatives (Moderator: Uptal Patel)
§ Group 4: Virtual (Stéphan Troyanov, Kerry Willis)
|
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4:45 PM
|
Transition to large group
|
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5:00 PM
|
Report Outs
Moderator: Barbara Gillespie
|
|
5:45 PM
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Adjourn
Laurel Damashek
|
|
🚍 6:00 PM
|
Bus to Fosshotel
Bus will depart from Lækjargata bus stop promptly at 6:00
|
|
🚍 7:00 PM
|
Buses depart from Fosshotel and Exeter Hotel to Aurora Basecamp
(Separate buses, 1 per hotel)
Note: Our dinner location is not reachable by public transit; please be on time for the bus
|
|
🍽️ 7:30 PM
|
Offsite Dinner
Aurora Basecamp, (417, 221 Hafnarfjörður, about 30 minutes from Reykjavik)
Tapas and live cutting station menu:
Parma ham and mushroom sandwich with rocket salad and parmesan
Grilled vegetable taco with spinach and chili date dressing
Black garlic marinated chicken tender spears with mango ginger dressing
Duck confit gyoza with miso glaze, Coconut shrimp with chili mayo
Langoustine burger with garlic sauce, green apples, and dill
Cauliflower nuggets with hot sauce
Wild mushroom-marinated beef tenderloin
Sides: Chimichurri potatoes Broccoli, and Jerusalem artichoke salad, Chili-truffle bearnaise
Dessert:Chocolate mousse with caramel brownie and fresh berries
Vegetarian options on the Buffé:
Avocado burger with herb dressing and pickled vegetables.
Mushroom tarte with pickled pearl onions.
Vegetable gyoza with sesame dressing
Falafel with couscous, pomegranate, and tahini dressing
Carrot and lentil pattie with tomato salsa and garlic dressing.
Chocolate mousse with strawberries.
|
|
🚍10:00 PM
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Return buses depart Aurora Basecamp for Fosshotel and Exeter Hotel
(Separate buses, 1 per hotel)
|
Sunday June 9, 2024
|
Time |
Activity |
|
🍽️ |
Breakfast at hotels (Coffee & tea will be available at meeting venue) |
|
🚍 7:20 AM |
Bus Pickup at Fosshotel Dropoff 7:30 am at bus stop at Lækjargata bus stop (5-7 min walk to Hannesarholt meeting venue) |
|
7:45 AM |
All participants arrive at Hannesarholt |
|
8:00 AM |
Meeting Opening/Welcome Josh Tarnoff |
|
8:05 AM |
Goalpost for October & Proposed Analyses Panel: Aliza Thompson, Laura Mariani, Abigail Smith, Barbara Gillespie, Melissa West |
|
8:45 AM |
Transition to breakout groups |
|
9:00 AM |
Breakout groups § Group 1: Pediatrics (Moderator: Rasheed Gbadegesin) § Group 2: Medications (Moderator: Vimal Derebail) § Group 3: Subgroups (Moderator: Alessia Fornoni) § Group 4: Trial design impact (Moderator: Hiddo Heerspink) |
|
9:45 AM |
Transition to large group |
|
10:00 AM |
Report Outs Moderator: Barbara Gillespie |
|
🥐 10:30 AM |
Break Morning refreshment: Bread bun, cheese/vegan cheese and jam, sliced melons and grapes. |
|
10:45 AM |
Future of PARASOL Brad Rovin, Matthias Kretzler |
|
11:45 AM |
Wrap Up Tobias Huber |
|
🍽️ 12:00 PM |
Adjourn; Lunch Pan fried Langa with coconut lemongrass vegetable sauce (onions, peppers, green beans, cauliflower baby corn) rice and salad. Vegan: homemade falafel buns with coconut lemongrass vegetable sauce (onions, peppers, green beans, cauliflower baby corn), rice and salad. |
|
🚍 12:45 PM |
Bus returns to Fosshotel Bus will depart from Lækjargata bus stop promptly at 12:45 |
WEATHER AND TRAVEL PLANNING
🚍 Reykjavik airport is about an hour from downtown and taxi fare can run to hundreds of dollars/euro/pounds. The best airport transfer option is the Flybus coach. Buses meet all arriving flights at the airport and can be booked in advance here. Tickets are also available in the arrivals hall.
-
For Fosshotel: get off at Bus Stop 12, Þórunnartún
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For Exeter Hotel: get off at
Bus stop #4 Miðbakki
☀️ Reykjavik forecast
🌤️ The average low temperature in June is 48° Fahrenheit (9° Celsius), and the average high temperature is 59° Fahrenheit (15° Celsius). We recommend packing layers and a raincoat as well as waterproof shoes.
😎 Our meeting is less than 2 weeks before the summer solstice and Reykjavik will have 20 hours of sunlight a day! The sun will rise around 3 am and set near midnight. Please be sure to bring sunscreen, sunglasses, and a sleep mask.
👕 Meeting attire: Business casual
MEETING WIFI INFORMATION
Hljóðberg, main meeting room:
Wifiname: hljodberg
password: jonjon2017
1st and 2nd floor:
Wifiname: Hannesarholt
password: steinn2017