dry eye assessment and management penny asbell, md, mba brendan barry, ba seth epstein, md yi wei,...

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Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

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Page 1: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Dry Eye Assessment and Management Penny Asbell, MD, MBA

Brendan Barry, BASeth Epstein, MD

Yi Wei, PhD

Page 2: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

May provide key information to differentiate DED subjects

Expand our knowledge of the mechanism of action leading to DED

Lead to new targets for treatment of DED

Page 3: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Personnel: sites are responsible to train IATA-

certified personnel before shipping;

Frequency: shipping at least twice /year,

Service type: overnight delivery by FedEx with dry

ice;

Shipper kit: delivered to sites, two weeks before

expected shipping date set by

Biomarker Lab

Dry ice: Ordered by sites, one week before

expected shipping date from local dealer.

Page 4: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Only personnel with IATA certification

can ship

Must have submitted DREAM

certification forms

Page 5: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

1. Copies of each sample’s Tear Sample Registration Form

2. Shipping Log3. Shipper Declaration Form

Page 6: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD
Page 7: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD
Page 8: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

INFECON-5000 Shipper kitStandard-grade packing tapeScotch tapeParafilmDry Ice, 5 lb/bag

Page 9: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

1. A liquid-tight 0.5L polyethylene pressure vessel , withstand 95 kPa pressure;

2. 5.6 lb of dry ice, last for 60 hours;3. All required labels and markings

included;4. Compact size and shipping weight;5. INF-9875 Return Label;6. Packing instructions printed on shipper

box flap;7. Inside dimensions: 7.5 x 4.25 x 8.5 in.

(0.5L vessel);8. Outside dimensions: 11 x 8 x 12.25 in.9. Additional parts are available upon

request.

Complies with U.N. regulations, ICAO/IATA Packing Instruction 602 and 904 and applicable DOT regulations

Page 10: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

7.5

Yi Wei/Seth Epstein/Ines Lashley Department of Ophthalmology, Box 1183Annenberg Building, Rm 22-11Icahn School of Medicine at Mount Sinai1 Gustave L Levy Place, New York, NY 10029Tel: (212) -824-7644(Off); (212) 241-6795(Lab);Fax: (212) 241-4550Email: [email protected]

Page 11: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Yi Wei/Seth Epstein/Ines Lashley Department of Ophthalmology, Box 1183Annenberg Building, Rm 22-11Icahn School of Medicine at Mount Sinai1 Gustave L Levy Place, New York, NY 10029Tel: (212) -824-7644(Off); (212) 241-6795(Lab);Fax: (212) 241-4550Email: [email protected]

Attn: Meng C. Lin, OD, PhD

University of California, Berkeley School of Optometry Clinical Research Center381 Minor HallBerkeley, CA 94720-2020Phone: (510) 643-9252; FAX: (510) 643-4202

Page 12: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Sites should maintain their own Temperature Freezer Log

Temperature should be checked daily

Use gloves when removing tear sample storage box

Page 13: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Sites are responsible for ordering from local dealer

Must order one week before expected shipping date

Avoid direct skin contact when handling dry ice – always wear gloves

Place vessel on dry ice during shipment preparation

Page 14: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Immediately place tubes on dry ice when removed from Ultra-cold freezer or liquid nitrogen.

― Samples will melt Examine the collecting tubes to ensure

they are:― Tightly closed and sealed with

Parafilm (re-seal if needed)― Labels are legible and match Tear

Registration Form

Page 15: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Insert 1 sample tube into each cell of the bubble bag (1/cell)―6/bubble bag; 30/shipper kit

If placing more than 1 tube per cell, ensure there is no contact between tubes (use cotton, tape, etc)

Seal and wrap the bubble bag and insert into vessel

Page 16: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Properly seat “O” ring into the lid Slide pieces of dry ice in the bottom chamber Place the properly closed vessel back into the

Shipper kit, making certain it is seated in the die-cut foam insert

Page 17: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Fill Shipper with 5 lb of dry ice around vessel Cover the chamber with blue foam Insert all 3 forms in the space between the two

boxes Seal the box with provided packing tape

Page 18: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

Secure to the box:― shipping labels― hazardous materials labels

Call FedExfor pick up or send to a nearby FedEx store for overnight delivery

Page 19: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

X

FedEx Label with “Dry Ice” Checked

Page 20: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

INFECON 5000 Shipper kit will be sent two weeks before your expected shipping date

You will be expected to order dry ice from a local provider one week prior to expected shipping date

Shipping date should always be arranged on Monday or Tuesday; avoid any holidays or long weekends.

Must e-mail Biomarker Lab with each shipment to alert

them the # of samples and the date of shipment

Page 21: Dry Eye Assessment and Management Penny Asbell, MD, MBA Brendan Barry, BA Seth Epstein, MD Yi Wei, PhD

[email protected]

(212)-241-6795