FACT Seeks Candidates for Leadership Positions to Support New Growth Initiatives
A recent in-depth organizational assessment identified several new growth opportunities for FACT to help support the needs of the cell and gene therapy community. As the field continues to develop at a rapid pace, FACT is also anticipating growth and seeks candidates for several leadership positions. If you are interested or have a colleague that may be interested, please review the duties and qualifications of the following positions:
- Director of Development
- Business Development Director
- Deputy Medical Officer
- Chief Scientific Officer/Director of Education
A Word from FACT’s Chief Executive Officer
Welcome to 2022. The new year has ushered in many exciting changes for FACT and is certain to be a pivotal year in our organizational history. As we begin our new journey as an independent entity, I want to thank all of FACT’s volunteers, inspectors, committee members, board of directors, and staff for their unwavering dedication and outstanding contributions. FACT would certainly not be where it is today without all our supporting cast. Each person brings unique qualities and attributes that ensure a knowledgeable, diligent, and compassionate organization.
While we are likely to experience some challenges during this period of transition, it also provides an opportunity for everyone to take time for reflection, provide input, identify opportunities for improvement, and be purposeful in setting the new trajectory for FACT.
The leadership of FACT embarked upon a deep examination of current accreditation activities, exploration of new services and educational resources to offer our accredited and applicant programs, opportunities to attract additional talent, and strategies to support FACT’s growth. Commitment to the process was fueled by the goal of continuing to position FACT as the leader in the field of standards development and enable us to be even more responsive to the rapidly changing field of cellular therapy.
While change brings uncertainty, it also brings opportunities. Included with the transition to an autonomous organization, was the opportunity to refresh FACT’s visual identity and presence. We are putting the final touches on a new re-branded website and can’t wait to share it with you soon! Watch your inboxes for the new release.
Finally, my greatest hope for 2022 is the opportunity for everyone to see each other in person once again at the professional society meetings of ASTCT, ISCT, ASFA, CBA, and ASH. Looking forward to reconnecting with all of you!
With gratitude,
2021 Highlights: FACT Celebrates Anniversary, Announces Independence in Big Year for Organization
Last year was a big one for FACT. While celebrating our 25th anniversary, we committed to remaining a stalwart supporter of quality cellular therapy by adjusting our processes to overcome challenges caused by COVID-19 and announced our independence from the University of Nebraska Medical Center (UNMC) after a 25-year relationship. Read on for a review of a fantastic year!
FACT Began Virtual Inspections in Response to the COVID-19 Pandemic
Following a pause in on-site inspections due to the COVID-19 pandemic, FACT re-initiated accreditation renewal inspections virtually in 2021. By all accounts, the virtual inspections have been successful. The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. FACT greatly appreciates the hard work of the inspectors and applicants as we transitioned through this challenging time. FACT intends to return to on-site inspections when it is safe and possible to do so.
FACT Announced Plan for Embracing Continued Growth of Organization
In the midst of tremendous growth, FACT announced its plan to pursue independent operational status by the end of 2021. FACT has responded to progress and advancements in cellular therapy during its storied 25-year relationship with the University of Nebraska Medical Center, and future opportunities for the organization motivated the FACT Board of Directors to make this change. As an independent non-profit organization, FACT will have greater freedom to operate in a manner that allows it to rapidly and nimbly make changes as needed to pursue its mission to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.
FACT Celebrated its 25th Anniversary
In 2021, FACT celebrated 25 years of working with our colleagues in the field to improve cellular therapy, cord blood banking, and regenerative medicine. Congratulations to all of FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible. Although celebratory events were not possible due to the ongoing need for social distancing, the anniversary was celebrated via the virtual workshops, gifts of appreciation to FACT volunteers, and a 25th Anniversary Guest Book.
FACT and JACIE Published the Eighth Edition Hematopoietic Cellular Therapy Standards
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021. The Standards became effective on August 16, 2021.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and IEC requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards. Following months of initial reviews and revisions, the committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period.
Two Members Appointed to FACT Board of Directors
Two members representing one of FACT’s parent societies, the American Society for Transplantation and Cellular Therapy (ASTCT), joined the FACT Board of Directors for three-year terms (2021-2023). Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT benefits from his continued leadership in this new capacity. Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital. She also serves on FACT’s Clinical Outcomes Improvement Committee.
FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Drew Record Attendance
FACT held its second virtual Inspection & Accreditation Workshop on February 4, 2021 and first virtual FACT-ASTCT Quality Boot Camp on February 5, 2021. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp. We express our gratitude to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.
Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Began
The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.
FACT Joined International Organizations to Renew Support of ISBT 128 Coding and Labeling
In light of continuing adaptation to accommodate the rapidly expanding cellular therapy field, FACT joined 14 other organizations to issue a consensus statement reaffirming its support of ISBT 128 as the global standard for terminology, coding, and labeling of cellular therapy products. With a growing list of stakeholders and cellular therapy products, real-world experiences highlight the importance of standardized terminology, globally unique identifiers, and internationally readability to protect patient safety.
FACT Participated in Multistakeholder Efforts to Advance Cellular Therapies
FACT continues to participate in several multistakeholder groups to advance cellular therapies. FACT representatives are members of groups conducted by the Standards Coordinating Body (SCB), Parenteral Drug Association (PDA), and Deloitte NextGen Industry Working Group (IWG). FACT also participated in events such as the NMDP/Be the Match AcCELLerate Summit and the 80/20 Task Force Workshop of ASTCT. Planning also began for the third FACT Regenerative Medicine InterCHANGE, which took place in January 2022.
Global Affairs
Hospital Privado Universitario de Córdoba, Programa de Trasplante de Médula Ósea in Córdoba, Argentina was the first to earn a Certificate of Completion for Step One under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Stepwise Accreditation Program in May 2021. FACT and the Joint Accreditation Committee of ISCT-EBMT (JACIE) established the stepwise approach to globally improve hematopoietic cellular therapy and make transplantation accessible to patients. The FACT-JACIE Stepwise Accreditation Program aims to improve the quality and safety of bone marrow transplantation in lower-middle-income economies (LMIE) through compliance with established standards; creating a framework for quality management, education, and training; and providing a stepwise process towards full FACT-JACIE accreditation.
FACT Takes First Step in Transition with New Email Domain and Phone Numbers
FACT is pleased to announce the first step in efforts to transition to an enhanced website with the establishment of a new email domain and phone numbers. “With the objective of business development in a global market, FACT has registered the domain name factglobal.org. Effective immediately, all FACT communications will be issued using the new factglobal.org domain and phone numbers,” said Alisa Forsythe, FACT Information Technology Business Analyst.
To ensure a smooth transition, all emails addressed to the UNMC-based email addresses will receive an automatic reply announcing the domain name change, and those emails will be forwarded to the staff member’s new email address.
FACT Announces Plan for Embracing Continued Growth of Organization
In the midst of tremendous growth, FACT announced its plan to pursue independent operational status by the end of 2021. FACT has responded to progress and advancements in cellular therapy during its storied 25-year relationship with the University of Nebraska Medical Center, and future opportunities for the organization motivated the FACT Board of Directors to make this change. As an independent non-profit organization, FACT will have greater freedom to operate in a manner that allows it to rapidly and nimbly make changes as needed to pursue its mission to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.
In the official news release on April 5, 2021, leaders of FACT and UNMC expressed their excitement for the future of FACT:
“The relationship between UNMC and FACT is an incredible story of a mutually beneficial collaboration between the international field of cellular therapy and the University. Both UNMC and FACT can take pride in its success.” – Dr. Phyllis Warkentin, FACT Chief Medical Officer
“Twenty-five years ago, UNMC led efforts to form FACT to meet the need for professional standards across the field of hematopoietic cell transplantation. In that quarter-century, UNMC and FACT have enjoyed a long and successful partnership, and we are proud of FACT’s many successes and achievements in its respective fields of expertise. As FACT moves forward as an independent entity, UNMC wishes it nothing but the best, and we expect FACT will continue to grow and achieve greatness in the years to come.” – Doug Ewald, UNMC Vice Chancellor for Business, Finance and Business Development
“This transition represents an incredibly timely opportunity to allow FACT to expand our reach in the cellular therapy field nationally and internationally. As President, I am extremely excited to lead FACT at this transformational time.” – Dr. Catherine Bollard, FACT President
Read the full news release online
FACT International Headquarters New Staff
FACT’s training and development program’s purpose is to respond to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. Recognizing that education is as important as standards and accreditation within FACT’s mission to promote quality in cellular therapy, the office has welcomed Roxanne Alter, M.S., MLS (ASCP)cm as the Director of Education.
Roxanne received her Bachelor’s Degree from the University of Missouri at Kansas City and continued her education in the Medical Technologist Program at Research Medical Center in Kansas City. She worked as a medical technologist in Blood Bank and Hematology for several years. In 1985, she took a position at UNMC working for Dr. James Armitage in the Autologous Bone Marrow Transplantation designing a laboratory to evaluate products for transplant. She received her Masters of Science Degree under the direction of Dr. Dennis Wiesenberger publishing the thesis “In-Vitro Clonogenic Monitoring Peripheral Blood Stem Cell Collections following Interleukin-3 administration.” Ms. Alter was offered a faculty position as an Assistant Professor in the School of Allied health, designing curriculum and evaluating educational outcomes for Medical Laboratory Scientists and other health professionals. After twenty years in education, she became the Nebraska State Biosafety Officer and inspected clinical laboratories across the state. Roxanne Alter has a wealth of experience, which will serve her well in her new role as Director of Education.
FACT-accredited organizations continue to grow by number, geography, and complexity. To maintain and build upon the support provided by FACT since its inception 23 years ago, the office has welcomed three talented individuals to the accreditation office.
Nicole Gallardo joins FACT as an Administrative Associate. Originally from Germany, Nicole completed Vocational Training in Wholesale and Foreign Trade in Bremerhaven, Germany in 1992. Shortly after, Nicole moved to the United States and worked at the Richdale Property Management Group as an auditor. In 2007, Nicole accepted a position at UNMC’s College of Pharmacy as an Office Associate where she worked until joining the FACT team in the summer of 2018. In 2015, Nicole graduated from the University of Nebraska – Omaha (UNO) with a certificate in Public Management, and in May 2019, Nicole will graduate from UNO with a Bachelor’s Degree in Multidisciplinary Studies with a concentration in General Administration, a milestone accomplishment.
Sue Peters joins FACT as an Accreditation Coordinator. Sue is an ASCP certified Medical Laboratory Scientist, with extensive experience at the clinical microbiology laboratory at Nebraska Medicine, where cultures from cellular therapy products are performed, as well as cultures from transplant patients. She has also worked in the Microbiology/Molecular Department at the Nebraska Public Health Laboratory, where she gained experience in identifying strains of influenza, foodborne pathogens, and bioterrorism organisms. There, she also had the unique experience of working in the Biocontainment Unit with Ebola patients. Sue then transitioned to the role as an Infection Preventionist at Nebraska Medicine, and from there as a microbiology supervisor at a biotechnology company before joining the FACT team in October 2018.
Elda Nazario joins FACT as an Accreditation Coordinator. Originally from Sabana Grande, Puerto Rico, Elda attended college at the Interamerican University in Puerto Rico, and graduated with a bachelor’s degree in Biology in 2002. In 2007, Elda graduated from Medical Technology School and worked as a Medical Laboratory Scientist in Puerto Rico for approximately ten years. In 2016, Elda moved to Omaha, Nebraska and worked as a Medical Laboratory Scientist at the Nebraska Medicine Laboratory at the Oakview Medical Building, and in October 2018, Elda accepted a position at FACT. As a fluent Spanish-speaking Accreditation Coordinator, Elda will be integral to FACT’s initiatives in Latin America.
FACT International Headquarters Grows Along with its Accredited Organizations
A testament of FACT leadership’s dedication to its accredited organizations and volunteer inspectors is the strong infrastructure provided at the FACT accreditation office in Omaha, Nebraska. FACT staff members provide executive guidance, implementation strategies, committee support, and, most importantly, guidance to organizations and inspectors. All of these activities are directed by and accomplished for volunteer committees of experts, who are deserving of support that matches their contributions.
FACT-accredited organizations continue to grow by number, geography, and complexity. To maintain and build upon the support provided by FACT since its inception 20 years ago, the office has welcomed four talented individuals to the accreditation office.
Suzanne Clabaugh joins FACT as an Accreditation Coordinator. In her previous employment, she managed an academic research laboratory for UNMC and Wright State University focused on T-Cell homeostasis and Interleukin 2. Suzanne has proven to be quite productive, and is responsive to her organizations’ and inspectors’ needs, “I enjoy my work as a coordinator because it gives me the opportunity to interact with many different people in locations around the world, and it challenges me.” She encourages organizations to make good use of their coordinators’ services. “We are here to help in any way we can, and everything runs more smoothly when we have an open and easy, interactive relationship.”
Cassie Kennedy, a recent graduate from the University of Iowa, is a FACT Accreditation Coordinator. While enrolled in the Biomedical Engineering program, she worked with pulmonary clinical research studies. She is helpful by nature, and enjoys guiding the applicant through the accreditation process. “I learn something new and interesting every day,” says Cassie. Her advice to applicants is to use the field on the Compliance Application that is available for entering applicable document names and page numbers as evidence of compliance. “This field is optional, but including relevant SOPs and page numbers is helpful to both the applicant and the inspector.”
Another new FACT Accreditation Coordinator, Dina Becirovic, previously worked at Creighton University’s Department of Preventive Medicine – Hereditary Cancer Research Center and was responsible for maintaining the integrity and viability of over 50,000 biological specimens. Dina is a forward-thinking individual, and what she likes about her current role, and FACT in general, is the interdisciplinary collaborative effort and process improvement to promote patient safety and provide quality patient care. “Additionally, I appreciate the knowledge and fairness of current leadership and the futuristic outlook on reaching more organizations to ensure patient safety.” She suggests applicants and inspectors build and capitalize on working relationships with their FACT Accreditation Coordinators.
Mikaela VanMoorleghem, FACT’s Education and Training Coordinator, is responsible for developing and administering the growing educational program for FACT inspectors and applicants. Her entire career has been dedicated to education, formerly in the secondary and collegiate environments. “The medical education field has proven to be a very welcome challenge for me. I am learning so much and I find that each day is completely different.” Mikaela has risen to the challenge, increasing FACT’s offerings for training and expanding collaborations with other societies. “I also enjoy traveling for FACT and meeting so many talented people throughout the world. I encourage inspectors to take advantage of opportunities to perform inspections and learn from each other, understand different perspectives, and enjoy different cultures around the world.”
A common thread throughout the perspectives of all of FACT’s new employees is the enjoyment they get from working with the FACT community – at applicant programs and with the inspectorate. FACT staff admires everyone who has contributed to the mission of quality cellular therapy and is proud to work with you.
