David Lew, MS, BS, MBA

David is a strategic and collaborative leader with over 20 years of experience in global clinical research across CROs and site organizations, including Covance, Fred Hutch, PPD, IQVIA, and Velocity Clinical Research. He has held leadership roles ranging from Principal CRA to Executive Director in clinical operations and project management. With deep expertise in oncology and a track record of success across early to late-phase clinical trials, David combines high-level strategy with hands-on execution to drive project, program, and organizational excellence.

In addition to his industry leadership, David serves as an Adjunct Lecturer in the Master of Science in Regulatory and Clinical Research Management program at Regis College, where he develops and teaches courses. He also mentors graduate students at Johns Hopkins University, fostering the next generation of clinical research professionals.

David holds an M.S. in Biotechnology (Regulatory Affairs emphasis) from Johns Hopkins University, an M.B.A., B.S. in Biology (Physiology), B.S. in Biochemistry, and a Certificate in Biotechnology Project Management from the University of Washington. He maintains professional certifications, including ACRP’s CCRA and ACRP-PM and PMI’s PMP. In 2021, he was recognized with a bronze award in project management at the PharmaTimes Clinical Researcher of the Year competition. 

Rebecca Mains, BA, BS, MS

Rebecca is a regulatory consultant at Botanical Regulatory Consulting with over 10 years of experience in the pharmaceutical sector. Rebecca specializes in the development of botanical drugs, applying the scientific principles of herbal medicines to botanical drug regulations. She is highly experienced in the chemistry, manufacturing, and controls (CMC) of botanical drugs, working with sponsors in developing innovative botanical drug technologies for approval in the United States.

Rebecca is also an experienced medical writer, spending several years supporting pharmaceutical startups in developing novel treatments for various mental health conditions. In this role, she actively contributed to the approval of two first-in-class medications, Cobenfy™ for the treatment of schizophrenia and Zurzuvae™ for the treatment of postpartum depression.

Rebecca holds a degree in pharmacognosy and graduated from the UW School of Pharmacy’s BRAMS program. She also volunteers on the Bastyr University Institutional Review Board. Rebecca is passionate about using her regulatory knowledge to support innovation and novel treatments in the pharmaceutical sector. She is eager to serve and contribute her experience and passion to drive strategic decisions and support the organization’s mission."

Xiaoyu Qu, PhD, FACMG

Xiaoyu is the director of the Clinical Cancer Genomics Laboratory (CCG) at Fred Hutchinson Cancer Center. CCG provides cancer genetic tests for patients undergoing care for leukemia and lymphoma at Fred Hutch. CCG is also the centralized lab that provides a wide spectrum of cancer genetic tests for all patients enrolled in the NCI MyeloMatch clinical trial, redefining best genetic diagnostic practices to inform the most effective induction regimen for acute myeloid leukemia patients. Xiaoyu participates in workflow design, patient case review, and report sign-out for the trial. In addition, Xiaoyu volunteers on the annual meeting committee for the Cancer Genome Consortium, a professional organization committed to providing high quality education and promoting best laboratory practices in clinical cancer genomics.

Xiaoyu obtained her Ph.D. in Biology from Texas A&M University, post-doctoral training at Fred Hutch, and fellowship training at University of Washington. She is certified in Clinical Cytogenetics and Laboratory Genetics and Genomics by the American Boards of Medical Genetics and Genomics. Xiaoyu is an Executive MBA student at UW Foster School of Business Class of 2025.

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.

Monika Swietlicka, BA, BS, MBA

Monika has 18 years of experience in regulatory affairs and technical operations from various biotechnology settings, having specialized in discovery, pre-clinical, clinical, commercial, and translational research. She has a broad knowledge of product lifecycles from research and discovery through commercialization. During her career, Monika has collaborated extensively with the U.S. Food and Drug Administration and the European Medicines Agency. 

At Swietlicka and Associates, Monika serves as a strategic regulatory advisor for early to late-stage biotechnology companies. At Halloran, Monika serves as on demand executive, an interim Head of Regulatory or Regulatory Lead. Previously, Monika held various leadership roles. She spent 7 years as SVP/VP of Regulatory Affairs and Technical Operations at Immusoft, a cell and gene therapy company. In this role, Monika led the development and implementation of regulatory strategy and quality systems. She has authored content for FDA and EMA submissions, led Contract Manufacturing Organization tech transfer activities and compliance audits.

Monika holds an MBA in International Business and a BS in Biochemistry from Seattle Pacific University, a Certificate in Drug Development from Harvard University, and a BA from Cornish College of the Arts. This diverse skill set enables Monika to tackle challenges with a broad perspective, seamlessly integrating business strategy, scientific rigor, and creative thinking.

Yuki Wang, BS, MS 

Yuki has three years of experience in the medical device industry, with experience in clinical applications (Cardiac OR), laboratory quality control, manufacturing quality assurance, regulatory affairs, and FDA submissions. She holds a BS in Mechanical Engineering and an MS in Applied Bioengineering, and earned certifications in Biomedical Regulatory Affairs and Clinical Trials from the UW School of Pharmacy's BRAMS program. Yuki currently leads and facilitates the Quality and Regulatory operations at CHISON USA Inc. as a Quality and Regulatory Specialist in the ultrasound industry, based in Bellevue, and is pursuing her master's in Engineering Management at the same time.

Yuki is passionate about using her expertise in medical devices to bring responsible, high-quality medical care to the community. She is dedicated to making innovative technology accessible, enhancing healthcare for all. 

Eager to serve and contribute, Yuki aims to support a welcoming community that connects field experts for collaboration on improved healthcare outcomes and fosters continuous learning and development. Her goal is to enhance communication and promote the sharing of ideas and lessons learned, advancing public health and encouraging a responsible industry and nurturing academic environment.

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.