HOW TO START AN EGG BANK FROM IDEA TO EXECUTION 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 Coordination 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 100% 90% 88% 80% Survey of 500 women after completion of 1 egg freezing cycle 70% 60% 50% 40% 30% 24% 20% 15% 15% 8% 10% 0% Lack of Partner Professional Reasons Financial Reasons Too Large of a Commitment Other Fertil Steril. 2013;100(5): 1343-49 WHY DO WOMEN FREEZE THEIR EGGS? Rank in order of importance: (some women ranked more than one option) Source: Fertil Steril. 2013;100(3): S24 HOW WOMEN FIRST LEARNED ABOUT EGG FREEZING Other 10.4% Medical Doctor 12.1% Internet 18.7% TV/Magazine 23.6% OB/GYN 25.3% Friend 50.5% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% Source: Fertil Steril. 2013;100(5): 1343-49 QUALITY QUALITY FACTORS 1. Oocyte potential 2. Oocyte stimulation 3. Freeze/Thaw Technician 4. Lab environment 5. Device Carrier 6. Storage and handling 7. Endometrial prep 8. Sperm quality 9. Media culture 10. Transfer technique QUALITY CONSISTENCY Freeze Tech # S-F TB-S JL-S K-R JG-S K-S PD-S T-C B-B B-F 26 26 113 22 52 28 22 7 27 18 Ongoing/ET 2013 27% 39% 51% 41% 56% 61% 59% 57% 41% 22% # 6 34 16 2 53 45 42 69 9 9 Ongoing/ET 2014 60% 55% 50% 50% 49% 44% 43% 40% 38% 25% FREEZE VS THAW SKILLSET © 2014 Pro Baseball Insider, LLC (PBI) FREEZE VS THAW DIFFERENTIALS Tech # Freeze # On-going/ET Thaw 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 $$ value on autologous OPERATIONAL LOGISTICS Consents specific to the process cryo-preserved eggs to freeze cryo-preserved eggs to thaw & make embryos Disposition Autologous Eggs not needed Premature death Donation Research Look backs –eggs not usable Questionable quality – identifiable track record Unselectability Donor updates over time Abandoned eggs – returnable? Capital loss from poor quality or lookbacks (recalls) Third Party REALISTIC EXPECTATIONS ASRM Guidelines - “There are not sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women. “ ASRM/SART Practice Committees, Mature oocyte cryopreservation: a guideline, Fertil Steril. 2013;99:37-43 Egg freezing parties, Google/Facebook, newest “graduation gift”, 401K How fear fuels the business of egg freezing, Danielle Paquette, Washington Post, March 6, 2015 Slogan “Lean in. But freeze first.” EGG THAW OUTCOMES 1.877.411.9292 IR= Implantation Rate Courtesy of Shady Grove Fertility THIRD PARTY MODELS Independent egg bank Shared cycles Greater risk - $$ 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