David Hammond LinkedIn

David is an Associate Teaching Professor and Associate Director in the BRAMS Biomedical Regulatory Affairs program through the School of Pharmacy at the University of Washington and also the Chair of the IRB at Bastyr University. When he is not working with the universities, he is a private consultant to medical device and biologics companies

Dave has worked in clinical research and regulatory affairs for more than 25 years. He holds a CCRP from SOCRA and a CIP from PRIM&R. He earned his BS in Zoology from the University of Idaho and my MS in Biomedical Regulatory Affairs from the University of Washington.

Victoria (Vicky) Hunsicker Sanko LinkedIn

Vicky is a life sciences industry executive based in Redmond, Washington. She has an MBA from Cornell University’s Johnson School and degrees in chemical engineering and biochemistry from The Pennsylvania State University and University of Colorado, respectively. Victoria is certified in Biomedical

Regulatory Affairs by the University of Washington.

For nearly 30 years, Victoria has worked with client companies primarily in the biomedical industry – medical devices, biotech and pharmaceuticals – the medical information and IT systems sector as well as the tech sector, having evolved from technical business and engineering positions in the industrial gases and chemicals industry.

Vicky’s unique, entrepreneurial expertise with business startups, medical information, competitor intelligence, clinical literature research, biomedical technology and business assessment led her to found The Next Phase®, Inc. The Next Phase has been a member of the Seattle business community since 1995. The company’s client reach is global – primarily the UK, EU, Canada and Australia as well as the U.S. Clients receive customized problem solutions to optimize business growth.

Kauser Hussain LinkedIn

Kauser currently leads and oversees the Quality Control Microbiology operations at Bristol Myers Squibb’s Cell Therapy manufacturing facility in Bothell, Washington. Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Environmental monitoring of cleanrooms where patient material is handled and manufactured; finished product testing for safety before the drug product is shipped out to be infused into the patient; ensuring contamination control of the manufacturing facility are some of the critical functions that Kauser’s organization

performs. She is also the site sponsor for Diversity and Inclusion, supporting various People & Business Resource Groups’ initiatives at Bristol Myers Squibb.

Kauser has over 20 years of experience in Microbiology. She earned her PhD in Microbiology from Auburn University, Auburn, Alabama, where she studied Campylobacter epidemiology. After her PhD she pursued a postdoc at the University of Arkansas for Medical Sciences, Little Rock, Arkansas, where she studied cell signaling mechanisms of Coxiella burnetii infected human lung macrophages. She recently earned an executive MBA from Foster School of Business at the University of Washington.

In her spare time Kauser enjoys traveling with her husband and her 7-year-old, pottery, and photography.

Tim Rapuano LinkedIn

Tim is a Clinical Trials Project Manager at the University of Washington Laboratory Medicine & Pathology, Molecular Virology Laboratory. He has had a long career in QA at Pfizer but has always been interested in clinical trial management. In 2012 he earned his Master of Science in Quality Assurance and Regulatory Affairs from Temple University, Philadelphia PA. After a bold move in early 2022 to relocate from New York City to Seattle during the pandemic, Tim began his transition into clinical research by stockpiling certifications in clinical research operations and project management.

In addition to his educational background, Tim has served in many volunteer and leadership roles supporting the sport of croquet at both the local and national levels. From 2015 to 2022, Tim served as the MidAtlantic Regional Vice President of the United States Croquet Association. In this role Tim managed communications from 5 U.S. states plus Bermuda, and managed a 3-4 day tournament at a different location each year. As the Vice President of the New York Croquet Club from 2016 to 2021, Tim was the director of education, recruitment, website, equipment, and tournament programming.

Tim hopes to serve ORCA in the coming years with whatever is needed, including membership recruitment, project management or event programming.

Elena Rechkina LinkedIn

Elena is currently a Laboratory Operations Manager at the International Clinical Research Center (ICRC), Department of Global Health, University of Washington. ICRC provides the essential framework, implementation and coordination of multi-center international and local infectious disease prevention trials, clinical studies for new treatment options and medical devices. The ICRC facilitates collaborations, improves observational cohort studies and clinical trial operations; provides repositories of biologic specimens and reagents for future scientific investigations for pathogenesis and prevention research related to HIV, Tuberculosis, COVID-19 and other infectious diseases. In her current role, Elena works with Principal Investigators of the various clinical study projects helping them operationalize clinical trials protocols, streamline clinical specimen collection, processing, testing and archiving.

Prior to ICRC, Elena worked for 6.5 years at the Seattle based startup IDGenomics SPC as a Director of Lab and Operations. IDGenomics mission is to guide antibiotic prescription choices correctly the first time by matching the infecting bug with the correct drug. Company combines molecular diagnostics with epidemiological surveillance and big-data tools to guide antibiotic choices within 45 minutes, or before the patient leaves the doctor's office or clinic. IDGenomics products are designed to personalize the treatment of infectious diseases, and improve the lives of patients. In her role at IDGenomics, Elena participated as a scientist and operations manager in the development of in-vitro diagnostics, particularly Point-Of-Care rapid diagnostic tests (medical devices) from feasibility, design, preclinical trials, validation studies to the pre-submission to the FDA.

Elena's extensive 17+ years' experience in the development of medical devices and clinical studies fits perfectly to the scope of Organization of Regulatory and Clinical Associates (ORCA) community. Her experience in operations at the biotech company including project management, sales and marketing, customer service, social media creation and maintenance might benefit ORCA. Extensive experience volunteering as a mentor for group of life science professionals will help direct educational and mentorship components of ORCA.

Elena has a Ph.D. in Virology and Molecular Biology from the D.I. Ivanovsky Virology Institute Moscow, Russia; MS in Biology, MS in Civil Law from Lobachevsky State University, Nizhny Novgorod, Russia; experience working in academic and biotech settings internationally (Russia and US), Certificate in Biotechnology Project Management from UW.

Jessica Rowden LinkedIn

Jessica is currently a Senior Regulatory Coordinator at Fred Hutchinson Cancer Center on the Global Oncology team, providing regulatory support for clinical trials based out of Seattle and Uganda. Prior to working at Fred Hutch, Jessica provided regulatory and compliance expertise at MultiCare Health System and provided laboratory support for the HIV Trials Network at Fred Hutch. She gained her Bachelor’s degree from the University of Washington in American Ethnic Studies and furthered her education by completing a Biomedical Regulatory Affairs certificate through the BRAMS program at UW. She currently serves on the MultiCare Health System Institutional Review Board reviewing studies to ensure that trials are appropriately executed in an ethical and safe manner.

Jessica is certified in Health Care Compliance through the HCCA and has over 15 years of experience in the healthcare industry. In her spare time, she enjoys spending time with her family – her husband and two young sons.

Reitha Weeks LinkedIn

Reitha received her BS from Oregon State University and her PhD in Genetics from the UW in 1987. She worked for 13 years in the biotech industry at multiple companies in Seattle, progressing from bench scientist to company director. Reitha was Program Manager for Science Outreach at Northwest Association for Biomedical Research from 2004-2013. She was responsible for curriculum development, workshops for teachers, educational conferences for researchers, and a variety of science outreach programs and collaborations. Currently, she is Program Coordinator for Shoreline Community College’s biotech summer camps for high school students. She is active in Seattle AWIS (Association for Women in Science) as a member since 1987. Reitha has been on the ORCA board since 2021, currently serving as co-chair of the dinner social. She is also on the boards of Seattle AAUW and UW WiSE Professional Advisory Board, as well as several Biotech Advisory Boards for high schools. She also teaches a few classes each year at Edmonds Community College’s Creative Retirement Institute.