Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
Current ORCA Board of Directors Bios, by last name:
I have now been on the ORCA Board for two years and the President for the last year. The time has flown and the circumstances with which we connect are quite different. I admire ORCA's mission "to facilitate communication, networking and support in the professional and technical aspects.... " In a small organization such as ORCA, board governance ensures that membership thrives from meeting member needs in an accountable and proactive manner. While on the Board I have institued the shadowing program which has been of great interest to students. This year we hope to ramp an-online mentor time. I am keen on helping ORCA expand its support to new members or those in career transition who wish to tap into the excellent skills of existing members. I also believe that I can bring forward my previous governance skills to assist the board. As an inquiring mind, and a willing hand, I hope to dynamically serve the Board and ORCA membership. I would be pleased to have the trust of the membership in voting me to a next two year term.
Elizabeth Cross Nichol - https://www.linkedin.com/in/elizabeth-cross-nichol-35028a23/
Trish Kan Brown
Trish has over nine years of experience in the medical device industry, half of which was spent in regulatory affairs and the other half supporting quality system regulatory compliance activities. She is well-versed in national and international medical device regulations and standards to effectively guide regulatory and quality system strategies in support of innovative product development, and is highly experienced in domestic and international premarket submissions. Trish has been in a managerial role for the last six years, providing guidance and training to project team members and mentoring her direct reports.
Trish has recently left her current employment in pursuit of a happier and healthier next step in her career. During her downtime, she would like to better learn about the regulatory obstacles the industry is facing at the local, national and global level - keeping abreast of current issues can be a challenging task while working in a startup environment. As a member of the ORCA Board, Trish feels she would be a valuable contributor to new discussion topics and encourage members to continue talking about their experiences to help others in the community. Trish served as Secretary on the ORCA Board from 2016-2018, and she would appreciate the opportunity to run again for the upcoming term.
Mrs. Lyudmila Kipnis is a regulatory affairs consultant. She specializes in medical device regulations of the USA, EU, and Canada. Mrs. Kipnis holds a MSc degree in Biochemistry and a BSc in Biology from the Simferopol State University, Ukraine.
Prior to moving to Seattle, Mrs. Kipnis worked as a regulatory affairs consultant at ADRES Advanced Regulatory Services Ltd., Israel.
Elena Kuzmenko - I started my career in clinical research field as CRA working for European pharma company specializing in phase I-IV trials. Since then I have been also exposed to the device clinical research in academic and industry environment.
Regulatory affairs became my most recent passion with a great opportunity to learn and to build the network of like-minded community.
My LinkedIn account: https://www.linkedin.com/in/elena-kuzmenko-14662216/
Lynda Marie Emel - https://www.linkedin.com/in/lynda-marie-emel-37960830/
Lynda is a staff scientist at the Fred Hutchinson Cancer Research Center and the Associate Director of the HIV Prevention Trial Network's Statistical and Data Management Center. She has a PhD in Biological Anthropology from the University of Washington and her interests and expertise include clinical trial design and operations, research regulations, behavioral research methodology, and research ethics. She has over 30 years of experience in Cancer and HIV clinical trials data management and operations.
Albert came out to Seattle in 2002. He worked through a temp agency until he found a permanent position in 2003 with a biotech company making microarrays. As with many startups, the company closed down in 2010. Albert next worked for a company that made test kits for food safety testing. He quit his position in 2014 hoping for a career change. He worked as a part time contractor for awhile before joining a company started by his previous coworkers. They provide customized oligonucleotide pools for research and commercial applications.
Albert became interested in Regulatory Affairs and attended the certificated course at the U of WA in 2009. He was introduced to ORCA at that time and his participation grew over the years. He became a board member in 2015 and has served as its President for three years. This is his third and final nomination to the Board of Directors.
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.