Kaitlin is working on the NIBR CQA team to manage quality issues by supporting clinical operations teams with root cause analysis and CAPA management to ensure patient safety and data integrity. She is also, actively involved in cross-divisional quality improvement projects focused on informed consent, inspection readiness, and quality culture.

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017). Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California. Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Clinical trials:
Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
Training of clinical personal on use of medical devices (when applicable)
Quality control:
QC laboratory team leadership
Organization of QC laboratory according to GMP
Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
Auditing of QC laboratory methods and results
Preparation of regulatory required documents according to GMP (SOP, methods, reports...)

Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world's largest pharmaceutical blockchain consortium, LedgerDomain developed the world's first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.