CMC Operations
Adam Mazzo
Associate Director, Quality
Adam is a Quality Assurance and Compliance professional with over 20 years of experience in Biologics, Medical Device, and Cell and Gene Therapy. Adam brings to the team experience in building and scaling up GxP Quality Systems in support of the manufacture and control of Investigational and Commercial products. Adam also brings extensive auditing and inspection management experience.
Sein Pyo
Senior Manager, CMC Operations
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.
Chelsea McLauchlan
Senior Manager, CMC QC
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.
Casey Rich
QC Associate Scientist
Casey is a Quality Control professional with thirteen years of experience in CLIA and GMP environments. He has a background including method development, lab testing, validations, and instrumentation for both clinical diagnostics and drug product analysis.
Chloe Xie
Manager for Adjuvant, CMC Operations
Chloe is a CMC professional with six years of experience in small molecule drug substance and drug product process development and manufacturing. She is a life-long learner who is good at finding common ground with professionals from diverse cultural and technical backgrounds for pharmaceutical project management.
Eric Davidson
Quality Assurance Manager
Eric is a Quality Assurance professional with six years of experience in a cGMP environment. His background ranges from QA Operations to Quality Management Systems. Eric most recently specialized in deviations and CAPA management for a phase I-II clinical manufacturing site.
Clinical Operations
Tamra Madenwald
Associate Director, Clinical Operations
Tamra Madenwald, MA, MPH is Associate Director of Clinical Operations at Curevo Vaccine, joining Curevo in 2023. Tamra brings more than 20 years’ experience successfully implementing Phase I-IV vaccine clinical trials globally. Prior to joining Curevo, Tamra worked for Medicago Inc., overseeing their global pediatric SARS-CoV-2 vaccine clinical trial program. Prior to that role, Tamra worked for PATH’s Center for Vaccine Innovation and Access (CVIA), overseeing the planning and implementation of numerous global vaccine clinical development programs in Malaria, Pertussis, RSV, Polio, Pneumonia, and Influenza, many of which were successfully conducted in resource limited settings. Tamra came to PATH from the HIV Vaccine Trials Network (HVTN) at the Fred Hutchinson Cancer Research Center where she managed and oversaw numerous HIV vaccine trials globally. Tamra earlier served as Assistant Director of the Office of International Training at the Center for Interdisciplinary Research on AIDS (CIRA) at Yale University, as Project Coordinator of the Veterans Aging Cohort Study (VACS) at the University of Pittsburgh School of Medicine, and as a Field Coordinator for the International Rescue Committee (IRC) on humanitarian relief assignments in Kosovo, Croatia, and the former Soviet Republic of Georgia.
Tamra earned her B.A. from Bennington College, an M.A. from the University of Washington, and an M.P.H from the University of Pittsburgh.
Trina Slabiak
Associate Director, Medical Writing
Trina Slabiak, MS., brings over 20 years of experience in biomedical research with 12+ years of medical and regulatory writing experience. Trina’s medical writing and biomedical research background include oncology, HIV, metabolism, and gene therapy.
Prior to joining Curevo, Trina served as Principal Medical Writer at Corcept Therapeutics, where she managed their all their oncology medical writing projects. Prior to Corcept, Trina led the medical writing projects for a gene therapy IND submission at Adverum Biotechnologies. At Puma Biotechnology, she was a member of the NDA clinical and nonclinical teams for the neratinib (Nerlynx) submission. At Xoma, Trina worked on an IND submission for a triple IgG1 monoclonal antibody vaccine treatment for botulism neurotoxin serotypes A and E. Trina also has extensive experience working as a medical writing consultant.
Trina completed her undergraduate studies at Michigan State University in Biochemistry and her master’s studies at San Francisco State University in Cell and Molecular Biology. Trina has publications in oncology, HIV, metabolism, and regulatory affairs. She is RAC certified.
Megan Real-Hall
Clinical Trial Manager
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!
Courtney Rinehart
Sr. 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!
April Bradick
Statistical Programmer
April Bradick has been working with clinical research data since 2001 within academic organizations, non-profit institutes, and CROs. She has worked in multiple therapeutic areas of clinical research, including Cardiovascular, Neurology, Autoimmune, Respiratory, and Pediatrics. A life-long computer programmer, April has 17 years of experience with SAS and 4 years with Python. She holds a Master of Education in Community Counseling from Kent State University, and previously practiced as a Child and Family Therapist. Currently, she is pursuing a Master of Science degree in Applied Artificial Intelligence at the University of San Diego.
Operations
Jennifer Ortiz-Torres
Associate Director, Clinical Quality
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.
Anna Wrem
Associate Director, Program Management
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
Senior 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.
Nigel Gladhart
Program Manager
Nigel has a diverse background in clinical research as a Project/Program Manager spanning 15+ years. His experience comes from managing clinical trials within biotech/pharma, non-profit, and the U.S. Government. His focused therapeutic areas include oncology, infectious disease, mental health and sleep research.
Renae Koepke
Program Manager
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.
Jill McConnell
Office Manager
Jill has more than 30 years’ experience in operations, customer service, office, and facilities management in a variety of industries. She has participated in multiple mergers and acquisitions, the largest encompassing the consolidation of an eight-state operation into a single regional production center. Prior to joining Curevo, Jill oversaw facility services across 14 million square-feet for an industry-leading tech company. She then managed various teams responsible for developing training, CRM, quality assurance, and complaint resolution programs for a pet insurance company serving the United States and Canada. Jill specializes in communication, people leadership, team building, vendor relationships, and creating a positive workplace culture. Jill is a passionate follower of baseball and college basketball.
Regulatory
Sofia Stefanis
Associate Director, Regulatory Affairs
Sofia has 20+ years of regulatory experience and has a strong clinical regulatory background. Sofia has previously worked in drug development including pre-IND, IND, Phase 1, Phase 2, Phase 3, post-marketing, labeling, and international markets for small molecules and gene therapy. Her various roles have included project management across various departments, vendors, CROs, internal and external customers, and key project deliverables.
Sofia has a master’s in Regulatory and Clinical research and bachelor’s degree in Biology.
Nicole Hull
Associate Director, Regulatory Affairs
Nicole has 17+ years of regulatory experience working across a diverse range of health products (biologics, pharmaceuticals, radiopharmaceuticals and medical devices) and spanning the full range of product development from the preclinical stage, through to clinical development (Phase 1, 2 and 3 trials), marketing authorization, World Health Organization prequalification, and post-licensure life cycle management.
Nicole also brings expertise working across a broad range of regulatory jurisdictions including the US, Canada, South Africa, South Korea, India, Ghana and Kenya, as well as experience with the African Vaccine Regulatory Forum joint review platform.
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.