Cryogenic Supply Chain Risk Management During Storage and Transportation of Reproductive Material

Life Sciences, Pharma Manufacturing and Supply Chain,
  • Thursday, July 19, 2018 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Earlier this year, two fertility clinics experienced liquid nitrogen tank failures and thousands of eggs and embryos were compromised. These two catastrophic incidents highlight the risks associated with the storage and transportation of human reproductive materials including sperm, eggs and embryos.

Cryoport has gathered reputable reproductive medicine industry experts to discuss risk management safeguards and regulatory concerns for the storage and transportation of human reproductive materials. The webinar will have a panel discussion format and will allow audience members to get their questions answered by the expert speakers. The virtual discussion provides these leading-industry experts with the opportunity to share their specific perspectives and ideas on these imperative issues.

This webinar will dive into regulatory risk concerns for the storage and transportation of frozen reproductive material, best practices for minimizing these risks and cutting-edge informatics to support risk migration.

Included in the discussion will be current equipment qualification, validation and monitoring techniques (human and informatic), equipment and systems redundancy, escalation processes related to deviation notifications, SOPs as well as legal safeguards, current and future regulatory considerations and insurance considerations.

Speakers

Erica J. Behnke, Ph.D., HCLD (ABB), Director of the Assisted Reproductive Technology Laboratories at the Institute for Reproductive Health

Erica J. Behnke, Ph.D., HCLD (ABB), is the director of the assisted reproductive technology laboratories at the Institute for Reproductive Health. She earned her Master of Science and Ph.D. degrees from the University of Minnesota in reproductive physiology, following a Bachelor of Science degree in animal husbandry from Michigan State University.

Behnke has directed reproductive laboratories in Cincinnati since 1987. She has also served as off-site director for several other laboratories located in Charleston, W.Va.; Jupiter, Fla.; Cincinnati and Cleveland.

Behnke is board-certified as a high-complexity clinical laboratory director by the American Board of Bioanalysis. Behnke has presented numerous roundtable sessions and postgraduate courses and currently serves on the SART Executive Council as liaison to the College of American Pathologists. Serving as a laboratory inspector since 1994, Behnke was appointed as commissioner for the Reproductive Laboratory Accreditation Program for CAP in 1999. She is also a member of the CAP Reproductive Medicine Resource Committee. Professional memberships include the American Society of Reproductive Medicine, the Society for Assisted Reproductive Technology and the American Association of Bioanalysts.

Message Presenter

Don Fish, Biorepository Operations Director, California Cryobank

Don Fish is the biorepository operations director at California Cryobank, responsible for the ongoing global program management of cold supply chain logistics of reproductive and stem cell tissue. Fish is experienced in overseeing operations to support organizational growth through strategic planning, metric analysis and process improvement based on Lean Six Sigma principles. His specialties include: program management, global operations management, logistics and supply chain management, process improvement, product development, cross-functional team leadership, strategic planning, metric analysis, P&L management, inventory management, manufacturing and regulatory requirement management.

Message Presenter

Kimball O. Pomeroy, Ph.D., HCLD, Scientific Director, The World Egg Bank

Kimball O. Pomeroy is a clinical embryologist who has directed several clinical laboratories throughout the United States. He has served as a member of the SART Executive Board, chair of the Reproductive Laboratory Technician’s Group and chair of the College of Reproductive Biology. He is a founding member of both the Regulatory Task Force and the Southwest Embryologist Summit. Pomeroy was a molecular biologist who collaborated with Dr. Glen Evans on the Human Genome Project (chromosome 11), working in transgenics. He has coauthored numerous papers, mostly dealing with the detection of embryo toxins and cryopreservation. Recently, he has coauthored several papers on the risks of cross-contamination of microbes during storage of tissue in liquid nitrogen. Pomeroy has worked as a consultant for several projects in Mexico, Nepal, China, Bolivia and the Bahamas.

Message Presenter

Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport

Mark W. Sawicki, Ph.D., is chief commercial officer of Cryoport, a provider of end-to-end cold chain logistics solutions to the life sciences industry. Sawicki, who has more than 15 years of experience in the pharmaceutical and biotechnology industries, holds a bachelor’s degree in biochemistry from the State University of New York at Buffalo and a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He also received graduate training at the Hauptman Woodard Medical Research Institute. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.

Message Presenter

Mitchel C. Schiewe, MS, Ph.D., HCLD, Lab Director, Ovation Fertility

Mitchel C. Schiewe, MS, Ph.D., HCLD, is a comparative reproductive physiologist with diverse laboratory, domestic and wildlife animal experiences. He has published articles on the topic of embryo and sperm cryopreservation since 1985 and was fortunate to be mentored by Bill Rall, Ph.D. Not only did he learn about vitrification during its early experimental phases, producing the first vitrified lambs in 1988 (Dissertation, 1989), he also gained knowledge about fundamental cryobiological principles and cryostorage practices. The goal in the 1980s was to develop practical cryopreservation methods that could be effectively applied under field conditions without electricity. Schiewe matriculated into human assisted reproductive technology (ART) in 1992, where he has been instrumental in developing and applying today’s ART. Schiewe was the founding chairman responsible for the formation of the Society for Reproductive Biologists and Technologists/American Society for Reproductive Medicine. He is devoted to professional service and teaching.

Message Presenter

Shannon Curiel, Director of Sales, Reproductive Medicine, Cryoport (WEBINAR MODERATOR)

Shannon Curiel is director of sales, reproductive medicine (IVF), at Cryoport. Curiel launched her career in sales and logistics when she joined FedEx, starting a 20-year adventure in logistics management — one that included complex sales and the coordination of medical and nonmedical shipments worldwide. At Cryoport, Curiel identified the unique needs of fertility clinics and their patients for worldwide cryogenic shipping. For the past six years, she has worked with clinics and patients, focusing on building advanced cryogenic logistics solutions and specializing in cold chain management. She is deeply involved in the end-to-end logistics for shipping IVF domestically and internationally. Curiel holds a bachelor’s degree in marketing from Stephen F. Austin State University in Nacogdoches, Texas.

Message Presenter

Who Should Attend?

Industries: Reproductive Medicine, Cryogenic Storage, Egg Banks, Sperm Banks, Biorepository, IVF, Embryo Adoption, Cryopreservation

Job Areas: Management, Director, Operations, Logistics, Supply Chain, Clinical, Procurement and Purchasing, Quality Assurance, Research, Physician, Technician, Embryology, Regulatory Compliance

Job Functions: Logistics Manager, VP of Operations, Director of Clinical Operations, Laboratory Supervisor, Quality Assurance Manager, Lab Manager, Research and Development Manager, Research Scientist, Clinical Embryologist, Andrologist, Lab Technician, Clinic Tech, Clinical Laboratory Director, Research Director, Doctors, Biorepository Operations Director, Chief Medical Officer, CEO, Donor Program Coordinator, Vice President, COO, Lab Assistant, Managing Director, Supply Chain Manager, Embryologist, Laboratory Director, Quality and Regulatory Compliance Director

What You Will Learn

This webinar will dive into regulatory risk concerns for the storage and transportation of frozen reproductive material, best practices for minimizing these risks and cutting-edge informatics to support risk migration.

Topics will include:

  • Current equipment qualification, validation and monitoring techniques (human and informatic)
  • Equipment and systems redundancy
  • Escalation processes related to deviation notifications, SOPs as well as legal safeguards
  • Current and future regulatory considerations and insurance considerations

Xtalks Partners

Cryoport

Cryoport is the life sciences industry’s most trusted global provider of temperature-controlled logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells. Cryoport’s solutions are used by points-of-care, CROs, central laboratories, pharmaceutical companies, manufacturers, university researchers, et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport’s proprietary Cryoport Express® shippers, Cryoportal™ logistics management system, leading-edge SmartPak II™ condition monitoring system and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end temperature-controlled logistics partner that the industry trusts.

Institute for Reproductive Health

The Institute for Reproductive Health (IRH) is Greater Cincinnati’s largest and most comprehensive multidisciplinary group practice specializing in the complete care of the infertile patient. We provide diagnostic infertility work-ups as well as the full range of therapeutic options including In Vitro Fertilization (IVF), ICSI, Donor Egg, Egg Freezing, Tubal Reversal, Vasectomy Reversal, PGS/PGD and Sperm Banking. We offer three office locations to meet your infertility needs: Cincinnati, West Chester, Ohio, and Florence, KY. IRH physicians, Drs. Scheiber, Awadalla and Burwinkel, are consistently awarded top honors in the infertility field such as Best Doctors in America and Top Doctors.

California Cryobank

Founded in 1977, California Cryobank pioneered the frozen donor sperm industry in the 1980s and branched into cellular therapies with the launch of FamilyCord in 1997. After acquiring Donor Egg Bank USA in 2016, California Cryobank became the world’s largest and most experienced reproductive tissue bank, with the #1 brand in frozen donor sperm and frozen donor egg. California Cryobank is headquartered in Los Angeles, with laboratory/branch offices in Palo Alto, Calif., New York, Boston and Rockville, MD. California Cryobank distributes to all 50 states and over 30 countries, with international partnerships and/or joint ventures throughout Central America, South America and Europe.

The World Egg Bank

The World Egg Bank offers you more than just eggs – we pride ourselves on our relationships with our recipients, donors, and each clinic with which we work. Our staff utilizes sophisticated software to facilitate the process of selecting a donor, ordering eggs, securing financial arrangements, coordinating training and finalizing the shipping. Since we are the most experienced egg bank in the world, you can count on your cycle to proceed efficiently; we will keep you in the loop all along the way! With The World Egg Bank there are no complicated formulas, long term commitments, or false-hope guarantees – just plain science.

Ovation Fertility

Ovation Fertility is a national network of reproductive endocrinologists and scientific thought leaders focused on reducing the cost of live birth through more efficient and effective fertility care. Ovation Fertility’s IVF and genetics laboratories and affiliated practices work collaboratively to raise the bar with state-of-the-art, evidence-based fertility services that give hopeful parents the best chance of a successful pregnancy. Physicians partner with Ovation Fertility to offer their patients advanced preimplantation genetic testing for aneuploidy (PGT-A) and chromosomal structural rearrangements (PGT-SR). Ovation Fertility also provides donor eggs that come with the world’s first Euploid Embryo Guarantee™, as well as secure frozen egg, embryo and sperm storage; consultative services to help IVF laboratories improve quality and performance; and fertility preservation programs that enable more women to freeze their eggs and build future families. Learn more about Ovation Fertility’s vision of a world without infertility at www.OvationFertility.com.

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