SDRAN Address

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SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

 

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© 2016 SDRAN 

About

Our Mission

Dedicated to educational instruction and support to individuals for their professional development regarding the laws, regulations, and standards established by international, federal and state government regulatory agencies as they apply to the development, manufacture, distribution, and/or use of drugs, biologics, and medical devices.

Our Board of Directors

President - Christine Federovitch, PhD, RAC

Christine Federovitch, PhD, RAC, has over 10 years of Pharmaceutical and Medical Device experience with varied roles in Program and Clinical Trial Management, Alliance Management, Business Development and Operations. In her recent role with Navigate BioPharma Services Inc., a Novartis subsidiary, Christine leads the Operational Excellence program in addition to leading the Manufacturing and Laboratory Operations departments. She has contributed to several companion diagnostic partnerships focused on oncology biomarkers, in various pre-submission meetings with the FDA, preparation of manufacturing modules for PMA submission and CE marking, as well as PAIs. Christine received her Doctorate in Biology from University of California, San Diego and her Baccalaureate in Biochemistry from the University of Nevada, Reno. She also earned her US RAC credentials from RAPS in 2010.

 

Christine has previously served as the Secretary of SDRAN’s Board of Directors from 2011 through 2013, and also served on the Education Committee in 2010. She has taught the Introduction to the US RAC Session of the US RAC classes in 2013 and 2014, and has been a guest lecturer for the Scripps Research Institute and the University of California, San Diego undergraduate, graduate, and extension programs.

Christine’s vision for her term as the President-Elect of SDRAN is to support the Board of Directors to achieve their individual goals, support and expand the educational programs, and foster cooperation with local or neighboring organizations focused on fields related to SDRAN’s mission.

President Elect - Erica Livingston, RAC

Erica Livingston RAC, has been working in the local biotech industry for over 15 years including 8 years of Medical Device experience with varied roles in Product Development, Process Development, Commercialization, Operations and Quality. In her recent role with Qualomics, LLC, Erica serves as the Managing Director where she consults with a variety of clients on Quality and Regulatory matters. She specializes in Quality System development and optimization including production, corrective action and risk management. She is a Molecular Biologist who uses her bench experience to develop Quality, Manufacturing and Commercialization strategies for IVDs and LDTs. Her work includes design control, late stage development and transfer to manufacturing under ISO 13485 and 21 CFR part 820 for oncology biomarker products, lateral flow and other protein-based assays. Erica has managed GLP and CLIA/CAP Accredited laboratories. Erica has been a champion for Quality and Regulatory professionals by participating in workshops for local entrepreneurs and developers. Erica received her Bachelor’s of Science in Biology from University of California, San Diego. She holds certificates for auditing in ISO 13485 and MDSAP.

Erica earned her US RAC credentials from RAPS in 2017. She has experience with Medical Device submissions to Health Canada and the EU. Erica joined SDRAN’s Board of Directors in 2018. She taught the QSR lecture at the US RAC Session in 2018. 

Erica's vision for her term as the President-Elect of SDRAN is to support the Board of Directors as we continue to modernize our internal operations. As President-Elect, Erica will work to incorporate members feedback to expand our online education capabilities and other outreach efforts.

VP of Member Relations - Michelle Sands, MS

Michelle Sands, MS, has worked in the pharmaceutical industry for over twenty years. Her career started on the R&D side in drug metabolism as a bioanalytical chemist, and she transitioned into Regulatory Affairs over 8 years ago. Michelle is currently a Manager in Regulatory Affairs at Dart NeuroScience, LLC, where she is responsible for a wide variety of regulatory activities, encompassing multiple indications, and development stages. Michelle received Bachelor of Science degrees in Chemistry and Biology from the University of California, Irvine, a Master of Science degree in Analytical Chemistry from the University of Rhode Island, and in 2014 she received her Master of Science degree in Regulatory Affairs from San Diego State University.

Michelle has been a member of SDRAN since 2011 and has been the current VP of Member Relations for the past two years, where she and her committee have organized the quarterly Speed Networking events, the annual Open House, and the annual Member Appreciation event. In addition to organizing events for SDRAN, Michelle also provides an analysis of the survey results to the Board Members each month, which helps the Board to determine how to better serve the members of SDRAN. In addition to being the VP of Member Relations, Michelle also volunteers on the Website Committee.

Michelle’s vision for her term as VP of Member Relations is to continue to support the quarterly Speed Networking events, streamline the survey process, and find new and innovative ways to increase membership.

VP of Programs - Sasi Mudumba, PhD

Sasi Mudumba, PhD, has over twenty years of experience in research, product development and commercialization in Life Sciences, Drug Discovery, and Medical Devices. She has been responsible for several FDA, EU and Health Canada submissions resulting in regulatory approvals for IVD products. She has also successfully developed and obtained regulatory approvals for multiplexed IVD assays on microarray technology. In her current role as the Vice President of Assay Development at Genalyte Inc, she is responsible for managing the research, development, validation, regulatory submission, and approval of diagnostic products. Sasi has a Master of Science in Biochemistry from the University of Hyderabad and a Ph.D. in Bio-Technology from the Jawaharlal Nehru Technological University, both located in Hyderabad, India.

Sasi has been a member of SDRAN since 2015 and an active volunteer of the Programs Committee helping in the organization of events.

Sasi’s vision for her term as VP of Programs is to continue to build a strong Program Committee, be receptive to membership feedback, and reach out to professionals who are willing to share their knowledge, experience and offer insight into current and future trends in devices, drugs, biologics, combination products, and regulatory affairs.

VP of Education - Thomas S. Crimmel, MD, MBA

Thomas S. Crimmel, MD, MBA, has over twenty years of educational experience in the Regulatory Affairs field. He started his teaching career at the Oklahoma Department of Health and Human Services, Tulsa Community College, and most recently at National University. During his tenure at National University, Tom has taught anatomy, physiology, microbiology, and biology in the undergraduate division of the College of Letters and Sciences and at the College of Health and Human Services, where he developed several courses for the Clinical Regulatory Affairs Master’s Program. He is now working with Phoenician Exports (a start-up food products company based in Spain) as the Vice President of International Regulatory Affairs. Tom has an M.D. from AUC School of Medicine and received both his M.B.A. and B.Sc. in Chemistry from Oral Roberts University. After developing an interest for teaching, he then sought out a Regulatory Affairs Program at UCSD and completed their extensive program in 2016.

Tom has been an active member of SDRAN since 2015 and has recently volunteered to support the Education Committee as the program leader for RAC CAN. During his time with the Education Committee, Tom has proactively supported the EU and US RAC programs. Before the conclusion of the RAC program, the Board of Directors collectively nominated Tom to serve as the VP of Education for the remainder of 2017.

Tom’s vision for his term as VP of Education is to expand the current program structure across the US and integrate the recently implemented WebEx setting throughout the entire RAC programs.

VP of Mentoring - Jenny Grodberg, PhD, RAC

Jennifer Grodberg, PhD, RAC (US) has over 24 years of experience in the pharmaceutical industry, spanning the pre-IND enabling phase through NDA submission, including FDA pre-approval inspections and Advisory Committee Meetings. Jenny currently serves as Sr. Vice President of Regulatory Affairs and Program Management at Forge Therapeutics, Inc. Prior to joining Forge, Jenny was Vice President of Regulatory Affairs at VenatoRx Pharmaceuticals, leading the successful IND filing and acquisition of both Qualified Infectious Disease Product and Fast Track designations for their lead β-lactam/β-lactamase antibiotic program VNRX-513.3. Before joining VenatoRx full time, Jenny had been a consultant providing regulatory strategy and content authoring for U.S., Canadian and European drug applications.  She previously served as Senior Director of Regulatory Affairs at Trius Therapeutics, Inc., participating in the development and ultimate FDA approval of the oxazolidinone antibiotic Sivextro.  Before entering the pharmaceutical industry, Jenny held a faculty appointment at Harvard Medical School in the Department of Medicine.  Jenny has a PhD in Microbiology and completed postdoctoral work at both the Weizmann Institute of Science in Rehovot, Israel, and Harvard Medical School. Jenny is past-president of the American Medical Writers Association Pacific Southwest Chapter and obtained her US RAC certification in 2007.

 

Jenny has been a volunteer mentor for the SDRAN mentoring program since 2011, and Chair of the Mentoring Program Committee since 2013. She has been a lecturer for the SDRAN EU RAC Study Group since 2016.

Jenny’s vision for her term as VP of Mentoring is to further enhance the mentoring experience for both mentors and mentees by offering additional information and interaction opportunities and responding to participant recommendations.

VP of Website and Communications - Olivia Yu, PhD

Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to development and FDA approval. She has held various roles in preclinical research and development, Clinical Trial Management, Regulatory Affairs, and Project Management. She is currently an Associate Project Manager at Navigate BioPharma Services Inc., a Novartis subsidiary. Olivia received her Doctorate in Biomedical Sciences from the University of California, San Diego and her Bachelor's Degree in Biochemistry from the University of Santa Barbara, California.

Olivia’s vision for her term as the VP of Website and Communications of SDRAN is to continue to streamline processes for the organization's data management, registration, mailings and educational services. Olivia’s work is focused on continuous streamlining and improvement of communication methods to better serve SDRAN members.

Treasurer- Daniel Yeh, RAC

Daniel Yeh, RAC, has over ten years of experience in the Development, Manufacturing, and Commercialization of medical devices. In his current role as the Director of Regulatory and Quality at MedWaves Inc., Daniel is managing new product submissions as well as maintaining international registrations. His regulatory work includes 510(k) submissions, managing the quality system, and responding to annual FDA and ISO audits. Outside of quality, he also oversees product development and manages clinical activities including distributor sales, product training, and other medical affairs. Daniel is a graduate of UCSD where he majored in Biology. He obtained his US RAC certification in 2012. 

Daniel joined the Board of Directors in 2015 and is currently serving his second term as Treasurer. He has been a volunteer with SDRAN since 2010, has served on the Education Committee as EU Group Lead and technical support since 2014, and in 2017 he was the co-chair of the committee. In addition, Daniel supports the Member Relations Committee by planning and assisting at member events. During his term as the Treasurer of SDRAN’s Board of Directors, he has successfully transitioned financials records over to a software-based system and ensured compliance with local and federal financial requirements.

Daniel's vision for his term as Treasurer is to find innovative ways to give back to membership while maintaining a fiscally responsible budget.

Secretary - Mei-Fei Yueh, PhD, RAC

Mei-Fei Yueh, PhD, RAC, has extensive experience with writing and editing numerous manuscripts for biomedical journal submissions, subject narratives, grants, abstracts, posters, clinical study reports, and clinical protocols for pharmaceutical products. She is currently a Medical Writer at an IVD medical device company, Hologic. Prior to her role as a Medical Writer, she worked at UCSD as a Project Scientist and Scientific Writer and has published over 30 scientific manuscripts in the areas of drug metabolism and toxicology. She was also the Primary Investigator on various NIH funded grants. Mei-Fei earned her Bachelor degree in the Clinical Nutrition Department at Taipei Medical University in Taiwan, and her Ph.D. degree in the Molecular and Environmental Toxicology Department at Oregon State University. She earned her US RAC credentials in 2010 after she attended the RAC classes (US) offered by the SDRAN Education Committee.

Mei-Fei has been a member of SDRAN since 2009, and the current Secretary to the Board of Directors since 2016. She has also been serving on the Education Committee since 2011.

Mei-Fei’s vision for her term as Secretary is to ensure the Board adheres to the by-laws by creating new and revising existing policies, as deemed necessary; and maintain SDRAN’s Dropbox documentation archives which include, but not limited to, past program meeting information, BoD members information, BoD meeting agendas, BoD meeting minutes, SDRAN policies and amended by-laws, and monthly reports from each committee.

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