CMC Operations
Paul FitzMorris
Senior CMC Operations Manager
Paul is a cGMP manufacturing specialist with experience in manufacturing investigational and commercial products. He has experience producing small molecules and biologics with particular experience in technical transfers and quality management.
Sein Pyo
CMC Operations Manager
Sein specializes in Process and Analytical Development, and cGMP. Sein has extensive experience in the management of projects and teams with a background in Bioinformatics and Biomedical Engineering.
Elizabeth Miao
CMC Quality Manager
Elizabeth brings experience in manufacturing quality assurance to the Curevo CMC team. Although most recently focused to support GMP and quality management system activities with respect to batch release, she also has supported several quality control and regulatory documentation reviews for ensuring manufacturing compliance and product quality and safety.
Chelsea McLauchlan
CMC QC Manager
Chelsea is a Quality Control professional with eight years of experience in the biologics, adjuvant, and nutraceutical sectors. She is well-versed in analytical instrumentation and has a background in the execution of QC testing for both contracts and privately manufactured products.
Clinical Operations
Renae Koepke
Clinical Trial Associate
Renae has an extensive background in medical research. Her experience includes over 10 years of laboratory management and project management in preclinical research pertaining to pharmaceuticals, ophthalmology, and neurobiology. More recently, she has been working in clinical research coordinating clinical trials for oncology and medical devices, and clinical trial design and study start-up processes.
Courtney Rinehart
Clinical Trial Associate
Courtney is originally from Iowa but studied Neuroscience and Pre-Medicine at Augustana College in Illinois. She explored clinical roles in mental health and senior care before entering the clinical research field as a CRC. Courtney earned an MS in Pharmacology through The Ohio State University, where her focus was on clinical pharmacology and clinical trial design. Prior to joining the Curevo team in October 2022, she was coordinating Phase II-IV drug and device trials for indications in CNS, Infectious Disease, Addiction, Cardiology, and Oncology.
Courtney, her husband, and their enormous dog enjoy hosting dinner and board game nights at their home for friends, out-of-town visitors, and Seattle-area newcomers. Her other hobbies include reading, music, kayaking, trying out new recipes, and following Kraken hockey!
Megan Real-Hall
CRA
Megan grew up in Utah and graduated from Westminster College in Salt Lake City, after which she started her career as a laboratory technologist in Virology at ARUP Laboratories. While there, she had an opportunity to work on a clinical trial which opened her eyes to the world of clinical research. This also motivated her to move to Seattle to pursue better job opportunities in the field. She has been in Seattle for almost 6 years and has worked in various research roles from the CRO, site, and sponsor levels, and has been with Curevo since March 2022. She lives in the Ballard neighborhood with her husband, two cats (Margot and Owen), and Corgi named Porkchop who is her whole world!
Rebecca Venetianer
Manager, Biometrics
Rebecca joined the Curevo team in September 2022 as Manager, Biometrics. Rebecca has a background in Epidemiology and Biostatistics, working most recently as a Biostatistician on Phases I through III clinical trials. She brings experience working on statistical planning and execution of clinical trials, management of programming teams, and collaboration with data management and clinical vendors along the study pipeline.
Scientific Affairs
Hyang Mi 'Amy' Moon
Associate Director, Product Development
HyangMi ‘Amy’ joined Curevo Team in May 2022. She plays the main role in the vaccine product development by facilitating Varicella program’s support and building external collaborations. Her work focuses on the strategic advancement of vaccine products in the early-to-late developmental stage. Amy is setting up objectives for the qualification of VZV-targeting vaccine products for commercial launch and she plans to lead the product lifecycle management.
Before joining Curevo, she worked as the Senior Program Manager in CANbridge Pharmaceuticals, driving external alliance management through collaborations with biotech and academic research institutions to lead AAV gene therapy programs to treat rare diseases. She previously served as a Business Development Manager in Yuhan-USA Corporation. She has participated in biopharma partnering and business discussions for oncology, autoimmune, metabolism and CNS disease-targeting drug assets. Her expertise is directed to human genetics, neuro-immune, and inflammatory or infectious diseases.
Amy graduated with B.S. and M.S. in Biological Sciences major from Seoul National University, Seoul, South Korea. She completed her Ph.D. in Biomedical Sciences from the University of California, San Francisco (UCSF) and she did postdoctoral training in Neurosurgery Department and the Institute for Stem Cell Biology and Regenerative Medicine (ISCBRM) at Stanford University.
Program Management
Anna Wrem
Senior Program Manager
Anna has extensive experience in laboratory operations, cradle-to-grave management of grants and contracts from various funding sources, budget projections, and analysis within the research and development setting.
M Aaron Shoemaker
Program Manager
Aaron’s previous training and experience are in managing data and development operations. His experience has led to developing and deploying data pipelines, operating and maintaining a high-performance computing system, and creating channels that reduce overlap in research.
Haley Nystrom
Program Manager
Haley has a diverse background in operations, people, and project management. Most recently, Haley worked as an Operations and People Manager for one of the world’s largest eye banks. In addition to helping fight corneal blindness, she managed a team that coordinated organ, tissue, and eye donation for transplantation within 8 different states. Haley also has experience as a project manager developing various cancer awareness campaigns for low-income families throughout northern India. She currently lives in WA with her cats Mosley and Edith and her dog Lola.
Shannan Moran
Office Manager
Shannan has over 30 years of experience in administrative, project, and event management. She has extensive experience in the healthcare and research industries. With a background in both, for-profit and non-profit organizations.
Regulatory
Sammy Eni Eni
Sr. Regulatory Affairs Specialist
Sammy has a PharmD and MS in analytical chemistry. He has 7 years of regulatory experience in regulatory CMC, submissions, and strategy.
Sammy’s last employer was at Beigene where he facilitated the submissions of BeiGene applications in ex-US regions. He is based in Winston Salem, North Carolina, and will be working remotely with periodic visits on-site.
Jennifer Ortiz-Torres
Clinical Quality Manager
Jennifer has over 15 years of experience in quality in the regulated industry, including GCP, GMP, GLP. She is a Certified Quality Auditor by the American Society for Quality since 2013 and has vast exposure and direct participation in regulatory audits. She is passionate about GCP auditing, process improvement and supporting the development of new technologies and alternatives for patients. Jennifer was born and raised in Puerto Rico and is based out of Omaha, NE, where she lives with her husband and two boys.
HR
Kathleen Calahan
HR Manager / Business Partner
With over 25 years of experience in a variety of industries, Kathleen’s background includes delivering essential HR solutions by fostering collaborative relationships that enrich the employee experience for success in the marketplace. Focus areas include: culture enhancement, coaching, change practices, retention strategies, performance, learning, and continuous improvement.
Accounting
Tricia Black
Staff Accountant
Tricia has extensive experience in the accounting and financial fields. Having worked in various industries ranging from entertainment to biotech, she has experience working in both private startups and large public organizations. Although most familiar with the day-to-day accounting functions, she has also helped companies implement new procedures, policies, and software to allow companies to scale as they grow.