Year-End 2016 Report from the CBA President:
Advocacy, Education and International Expansion
At a CBA Board of Directors meeting in January, President Joanne Kurtzberg provided an update on the association’s past year of accomplishments.
Among the highlights were an expanded global presence, steps toward a publishing agreement for scientific research, new U.S. legislation benefiting cord blood therapies around the world, and participation in medical meetings targeting health professionals in related cell therapy fields.
The meeting in January was the first for an expanded 17-member Board of Directors that affords greater international representation. “I am excited about the energy and ideas that our new directors are bringing to the table,” Dr. Kurtzberg said.
Presented below is her summary of CBA accomplishments during the past year.
ADVOCACY – an effective voice for the cord blood industry in public policy, legislation, regulation and delivery systems
- The CBA Board of Directors approved a series of 32 policy statements that have put the association on the record in important areas of quality and safety, research and development, legislation and regulation, market expansion, and public education. The statements will provide a framework for future policy positons.
- Our Government and Global Affairs Committee, with representatives from 13 countries, is developing guidelines for harmonizing government regulation of cord blood banking around the world.
- CBA, together with the National Marrow Donor Program, led a coalition that successfully achieved reauthorization of the Stem Cell Act in the United States, providing funding for the C.W. Bill Young Program and the National Cord Blood Inventory for another five years.
- The association’s representatives met with numerous U.S. senators and representatives and testified in Congress for the re-authorization and funding of the National Cord Blood Inventory.
- CBA leaders helped craft and support the 21st Century Cures Act that has become U.S. law. The Act requires a review and optimization of regulations for cord blood and cord tissue products, and it provides for a streamlined pathway for approval of these products.
- CBA and industry leaders met several times with the FDA about improving the process of cord blood bank licensure and optimizing cord blood bank regulations.
- The association retained one of the most prestigious government relations firms for representation in legislative and regulatory initiatives critical to banking of cord blood and birthing tissues.
- Our website is well on its way to becoming one of the most useful and authoritative sources of cord blood information on the internet. In addition to educational information for expectant parents, the site now includes an archive of dozens of webinars for cord blood bank administrators and technicians, a summary of the uses of cord blood and related birthing tissues in current therapies and in clinical studies, a compendium of diseases for which cord blood therapies are currently used and those in which cord blood is being studied, and abstracts of therapeutic uses of cord blood recently reported in the medical literature and at scientific meetings.
- The association co-produced or collaborated in nine major conferences for health care professionals, presenting research advances in banking and cellular therapies. These included full-day sessions at annual meetings of the International Society for Cellular Therapy and the Phacilitate Gene & Cell Therapy World, as well as co-sponsorship of sessions at the World Stem Cell Summit and the Perinatal Stem Cell Society annual conference.
- The association’s Board of Directors was expanded from 13 to 17 members to enable a larger number of countries to be represented among the directors.
MARKET EXPANSION – broadened consumer access to banking services and cellular therapies
- The CBA Market Expansion Committee is identifying opportunities for cord blood banking representatives to present lectures, submit abstracts, staff exhibits and otherwise participate in meetings and conferences of allied health care professional organizations.
- The committee has gathered information on expectant parent and patient advocacy organizations for interaction and to provide information about the value of cord blood.
- Several webinars addressing future therapeutic indications for cord blood have been co-produced with FACT. The webinars are archived and can be access on the CBA website. The registration fee was waived for CBA members.
- A leadership summit with commercial industry partners was held last fall to explore collaborations that expand uses of and demand for cord blood and related tissues.
QUALITY – accreditation for banks and standards for products and services
- CBA provided input for the 6th edition of NetCord-FACT Cord Blood Standards that took effect last fall, and the association now has representatives on the standards and accreditation committees for both AABB and FACT.
- The CBA Quality Standards Committee is developing policy on minimum standards for cord blood processing and testing.
- The committee also has begun a study that compares and evaluates the current systems of standard-setting and accreditation for cord blood banks.
- Association leaders collaborated with other cell therapy and health care organizations through the Bipartisan Policy Commission to seek expedited regulatory approval of novel therapies without sacrificing quality.
- CBA has testified at FDA hearings to clarify 361 versus 351 guidelines that pertain to cord blood.
- CBA leaders have had multiple meetings with the U.S. Food and Drug Administration staff to advocate for licensure regulations that don’t create obstacles that stifle innovation or that make access to cord blood units more difficult and costly for patients.
EDUCATION – aware, informed and empowered parents, donors, health care providers and general public
- Authoritative and balanced information for expectant parents was developed and published on the CBA website, making it a primary place on the internet for information about all banking options – public, family, and directed donation.
- The CBA Public Education Committee created protocol for managing consumer media inquiries about cord blood.
- State-level health agencies were informed about the cord blood education information posted on the CBA website.
RESEARCH AND DEVELOPMENT – advancement and rapid adoption of novel technologies and therapies
- CBA leaders worked closely with members of the U.S. Congress and others to develop provisions of the 21th Century Cures Act. The new law requires a review and optimization of regulations that govern cord blood and cord tissue products, and it provides for a streamlined pathway for approval of these products.
- An agreement is being developed with the journal Stem Cells Translational Medicine, published by AlphaMed Press, for a regular series of publications about cord blood, cord tissues, birthing tissues and regenerative medicine.
- The CBA Scientific Affairs Committee is evaluating the feasibility of tracking clinical studies that use cord blood and birthing tissues in regenerative medicine and other cellular therapies.
- CBA has collaborated with AABB on co-sponsoring the International Cord Blood Symposium, and has had a major presence at other important scientific conferences, as noted above.
THE YEAR AHEAD – over the coming year, the CBA is committed to:
- recruit new members
- harmonize cord blood laws and regulations throughout the world
- guide and facilitate the rollout of the 21st Century Cures legislation in the U.S. and additional legislative actions
- work with the FDA and global equivalents to clarify 361 and 351 product guidelines
- finalize a partnership with Stem Cells Translational Medicine for a section on advances in cord blood banking, technologies and therapies
- educate expectant parents and health care professionals about delayed umbilical cord clamping
- understand and guide MSC manufacturing
- make hematopoietic cell therapy patients and their health care providers aware that no one should ever be told that they don’t have a donor
The best way to influence the future is to create it. The Cord Blood Association is all about creating the future for cord blood.
Joanne Kurtzberg, MD