FROM IDEA TO EXECUTION HOW TO START AN EGG BANK. RELEVANT DISCLOSURES Shareholder/Co-founder –...

F R O M I D E A T O E X E C U T I O N

HOW TO START AN EGG BANK

RELEVANT DISCLOSURES

Shareholder/Co-founder – Donor Egg Bank USA, LLC

OBJECTIVES

Understand the current cultural climate impacting women’s decisions to freeze

Provoke thought regarding variables to successful egg banking – autologous & donor

Identify different models for third party egg banking

Discuss methods of execution Review future trends and lessons learned

IDEA TO EXECUTION

Identify the market Manage quality nuances

Lab Clinical Set realistic expectations

Put operational logistics in place Consents & Legal documents

Determine the right model

It seemed so simple…

FROZEN EGG BASIC MODEL

Frozen eggs decouple the traditional process of stimulation followed by transfer.

Frozen Egg Cycle

Stimulation Cycle

Storage or Coordinati

on Fee

Transfer Cycle

THE FROZEN EGG MARKET

CULTURAL SHIFTS DRIVE FROZEN EGG BANKING

900% increase in women >35 having their first child since 1970

35% increase among women ages 40-44

Autologous: More women freezing eggs as “insurance against an uncertain future.”

Third Party: US Foreign Adoptions are at the lowest level since 1982 (6,441 adopted in 2014 vs. 23,000

in 2004) Source: US State Department Report to Congress, April 1, 2015

Source: May 2014; www.cdc.gov

REASONS FOR NOT HAVING CHILDREN EARLIER

Fertil Steril. 2013;100(5): 1343-49

Lack of Partner Professional Reasons

Financial Reasons Too Large of a Commitment

Other0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

88%

24%

15% 15%

8%

Survey of 500 women after completionof 1 egg freezing cycle

WHY DO WOMEN FREEZE THEIR EGGS?

Source: Fertil Steril. 2013;100(3): S24

Rank in order of importance:(some women ranked more than one option)

HOW WOMEN FIRST LEARNED ABOUT EGG FREEZING

Source: Fertil Steril. 2013;100(5): 1343-49

Friend

OB/GYN

TV/Magazine

Internet

Medical Doctor

Other

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

50.5%

25.3%

23.6%

18.7%

12.1%

10.4%

QUALITY

QUALITY FACTORS

1. Oocyte potential 2. Oocyte stimulation3. Freeze/Thaw Technician4. Lab environment5. Device Carrier6. Storage and handling7. Endometrial prep8. Sperm quality9. Media culture10.Transfer technique

QUALITY CONSISTENCY

Freeze Tech #Ongoing/ET

#Ongoing/ET

2013 2014

S-F 26 27% 6 60%

TB-S 26 39% 34 55%JL-S 113 51% 16 50%K-R 22 41% 2 50%JG-S 52 56% 53 49%K-S 28 61% 45 44%

PD-S 22 59% 42 43%T-C 7 57% 69 40%B-B 27 41% 9 38%B-F 18 22% 9 25%

FREEZE VS THAW SKILLSET

© 2014 Pro Baseball Insider, LLC (PBI)

FREEZE VS THAW DIFFERENTIALS

Tech #Freeze

#Thaw

On-going/ET Ongoing/ET

S-A 12 33% 8 75%

TO-C 62 40% 8 50%

R-F 9 22% 19 43%

S-F 5 60% 15 60%

M-R 43 63% 7 27%

C-R 0 n/a 21 45%

T-R 10 60% 14 50%

N-RS 10 70% 4 0%

J-S 53 49% 12 50%

L-S 22 50% 20 35%

HOW DO YOU KNOW?

High enough “N” to see trend Comparison data

Between embryologists Multiple cohort thaws

Track everything – device, # of eggs thawed, media, storage, etc. Mechanism to monitor/analyze

Clinical Impact

Creative Commons Licensing

OTHER LAB CONSIDERATIONS

Who on the embryology team? Vit: Best hands, best adherence to protocol Thaw: Highly skilled, best troubleshooter

Set-up for egg vit vs. thaw Lab environment and set up Thermometer Stop watch (count up function) Vit/thaw products/devices

Staffing on day of vit/thaw Practice & review of protocol Egg storage

DEVICE CARRIER

Open Systems Cryotop Cryolock Cryotec Etc.

Closed Systems CryoTip Rapid-I Etc.

OPERATIONAL LOGISTICS

Freezing –of eggs sets of 1, 2, 4 Thaw protocols

Thaw until… Set number of eggs – ie. 6

Guarantee Survival/Embryo/Blast $$ value on autologous

OPERATIONAL LOGISTICS

Consents specific to the process cryo-preserved eggs to freeze cryo-preserved eggs to thaw & make embryos

Disposition Autologous

Eggs not needed Premature death Donation Research

Third Party Look backs –eggs not usable Questionable quality – identifiable track record Unselectability Donor updates over time Abandoned eggs – returnable? Capital loss from poor quality or lookbacks (recalls)

REALISTIC EXPECTATIONS

ASRM Guidelines - “There are not sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women. “ ASRM/SART Practice Committees, Mature oocyte cryopreservation: a guideline, Fertil Steril. 2013;99:37-43

Egg freezing parties, Google/Facebook, newest “graduation gift”, 401K

How fear fuels the business of egg freezing, Danielle Paquette, Washington Post, March 6, 2015

Slogan “Lean in. But freeze first.”

EGG THAW OUTCOMES

IR= Implantation Rate

Courtesy of Shady Grove Fertility1.877.411.9292

THIRD PARTY MODELS

Independent egg bank Shared cycles Greater risk - $$ and unused inventory

Network – open/closed egg banking Limits risk Increases interdependency Minimizes unused inventory

Agency driven models Liability?

LESSONS LEARNED

More challenging than originally thought Lab environments and embryologists are not equally

skilled to freeze/thaw eggs Quality tracking is key – you can’t assume all is well. Logistics and infrastructure is essential Technology continues to evolve and best practices are

becoming known Economically beneficial and efficient use of egg

resources

Egg banking is the newest frontier in ART and much remains unexplored