About

Our Mission

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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

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President -

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. She has successfully developed  novel Photonic Ring Immunoassays and obtained 510)k) clearance and EUA. 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 served the SDRAN and as  Board of Directors as VP of Programs (2018-2019), and as President-Elect in 2020 . Sasi has been a member of SDRAN since 2015 and served as an active volunteer of the Programs Committee in 2016 & 2017 helping in the organization of events. She was the instructor for the courses in Medical Devices for CAN RAC classes in 2018 - 2020.

Sasi’s vision for her term as President of SDRAN is to work with the Board of Directors in furthering the quality and variety of educational programs, networking, and learning opportunities to the members.

president@sdran.org

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President Elect - Michelle Sands, MS

Michelle Sands, MS has worked in the pharmaceutical industry for over 20 years. Her career started on the R&D side in drug metabolism as a bioanalytical chemist, and she transitioned into Regulatory Affairs over 10 years ago. Michelle is currently an Associate Director in Regulatory Affairs at Xencor, Inc., a biotherapeutics company, where she is responsible for a wide variety of regulatory activities for their oncology programs. 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 an SDRAN Board member since 2016. Michelle served as the VP of Member Relations for four years, and served as the VP of Education in 2020. As the VP of Member Relations, Michelle and her committee organized the quarterly Speed Networking events, the annual Open House and Members Appreciation events, and other member related activities for the Board. In her role as the VP of Education, Michelle and the Education committee revamped the SDRAN RAC programs to cover the new Pharmaceutical- and Medical Device-Focused RAC exam format. In addition to being the VP of Member Relations and VP of Education, Michelle also volunteered on the Education Committee and has volunteered as an SDRAN Mentor. 

 

Michelle’s vision for her term as President-Elect of SDRAN is to work with the Board of Directors in furthering the quality and variety of educational programs, networking, and learning opportunities for SDRAN’s members and non-members.  

presidentelect@sdran.org

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VP of Programs- Leah Shtilkind

Leah Shtilkind is a freelance data scientist with 4 years of experience working as a scientist in the biotech industry. Her experience spans quality assurance, assay development, lab management, and analytics. Her documentation, verification and validation testing, and experimental work at multiple companies successfully led to renewed investor funding.  She received her Bachelor of Science degree in biochemistry from the University of California San Diego and graduated at the top of her class from the University of West Georgia with a Master of Science degree in biology. Her interest in leveraging machine learning and compute power to gain deeper insights into the large datasets generated by modern medical devices led her to earn a certificate in Data Mining for Advanced Analytics from the University of California San Diego-Extension. She is now working on projects involving natural language processing and computer vision.

Leah has been an SDRAN member for 3 years and served as a volunteer on the web communications team for 2 years. She has supported SDRANs efforts to be a resource for regulatory professionals by maintaining job postings and sharing them with members. Her analytics efforts also helped inform decisions on future program topics and ways to continue to add value for members.

Leah’s vision for her term as the VP of Programs for SDRAN is to create a program that will increase members' breadth of knowledge in areas that influence the regulatory process and help members stay current on the latest FDA trends.

programs@sdran.org

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VP Member Relations - Ilham Naili,

PhD

Ilham Naili, Ph.D., has over 12 years of experience as a scientist, with multidisciplinary training in Microbiology, Immunology, Cell and Molecular Biology. She has worked in the academic, biotechnology, and more recently in the pharmaceutical sectors, and is looking to transition into Regulatory Affairs. Ilham received her Bachelor of Science in Physiology and Cell Biology from
Université Grenoble Alpes, France, her Master of Science in Microbiology from San Diego State University, and her European Doctorate in Health and Microbiology from Université Clermont Auvergne, France and Università Roma Tre, Italy. Ilham will complete her Regulatory Affairs
Essentials Certificate from UCSD Extension in March 2020.
 
Ilham has been a member of SDRAN since 2019 and an active volunteer with the Education Committee. In 2019, Ilham served as the Communication Manager for the RAC Canada Study Group.

Ilham’s vision for her term as the VP of Member Relations is to continue building a strong networking environment through SDRAN, ensuring member support and satisfaction, and finding new ways to increase membership enrollments.

membership@sdran.org

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VP of Education Kevin Daly,

RAC

Kevin E. Daly, RAC, has over 30 years’ experience leading Regulatory Affairs, Clinical Affairs, and Quality System Management programs, primarily for FDA class II and III medical device manufacturers.  Kevin has served in executive management positions for both start-ups and for global medical device manufacturers, including C. R. Bard, Inc., Medtronic, Inc., MicroTherapeutics, Inc. (d.b.a. ev3 Neurovascular), and MicroVention, Inc., a division of Terumo Medical, Japan.  

 

His experience includes service as an Expert in Residence at the University of California - Irvine Institute for Innovation, as an Advisory Board member for the University of California - San Diego Extension Programs for development of training course curricula on medical device regulatory affairs programs, and as an Advisory Committee member for EvoNexus, a startup company incubator in Southern California.  Kevin also participates as a volunteer mentor for the SDRAN mentoring program.

 

He holds a B.S. in Biology from Fairleigh Dickinson University, N.J., has completed post-graduate business courses at Stevens Institute of Technology, Hoboken, N.J., and Rivier College, Nashua, N.H., and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society.

 

Kevin’s vision for his term as VP of Education will be to support the SDRAN RAC exam preparatory program to help foster SDRAN member career growth.

education@sdran.org

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VP of Mentoring - Jenny Grodberg,

PhD, RAC

Jennifer Grodberg, PhD, RAC (US) has over 27 years of experience in the pharmaceutical industry, 17 years of it in Regulatory Affairs. Currently serving as a regulatory affairs consultant, Jenny provides strategic and hands-on regulatory support for programs spanning the pre-IND enabling phase through NDA/BLA submissions. Her past positions include  that of  Sr. Vice President of Regulatory Affairs and Program Management at Forge Therapeutics, Inc., Vice President of Regulatory Affairs at VenatoRx Pharmaceuticals, and positions of increasing responsibility during her tenure at Trius Therapeutics, Inc., where she participated 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 in response to participant recommendations, build upon the success of an inaugural group mini-mentoring forum to offer this program annually, and to identify additional mentoring outreach opportunities.

mentoring@sdran.org

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VP of Website and Communications -

Olivia Yu,

PhD

Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to clinical development and FDA approval. She has held various roles in preclinical research, Clinical Trial Management, Regulatory Affairs, and Project Management. She is currently a 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/Molecular Biology from the University of California, Santa Barbara.

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. Additionally, she hopes to better integrate the offerings of SDRAN to the community in a more digital fashion. Olivia’s work is focused on continuous streamlining and improvement of communication methods to better serve SDRAN members.

webcommunications@sdran.org

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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 third 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 financial 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.

treasurer@sdran.org

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Secretary- Jaimie Brugnano,

PhD

Jamie Brugnano, PhD, RAC (US) has over five years’ experience in regulatory affairs in pharmaceuticals and biologics. She is currently a Senior Manger of RA Bachem Americas where she leads a team in CMC strategy and documentation, including writing drug master files and technical packages and addressing questions from regulatory authorities globally. Jamie started her career as a research and development scientist at the intersection of bioprinting and tissue engineering and then made a successful transition into regulatory affairs. Jamie earned her doctorate in Biomedical Engineering from Purdue University and her Bachelor of Science in Biology from Harvey Mudd College.

Jamie has been a member of SDRAN since 2016 and has taken advantage of the different programs that SDRAN has to offer including RAC classes (US and EU) and the mentoring program (as a mentee). Jamie has given back to SDRAN by serving as a volunteer on the Programs Committee for 2 years. She is excited to now serve on the SDRAN Board of Directors as Secretary.

Jamie’s vision for her term as secretary is to support the Board of Directors by keeping accurate and informative meeting minutes and keeping the Bylaws and Articles of Incorporation up to date. In addition, Jamie will work with the Board of Directors to ensure that SDRAN continues to achieve their mission to provide educational instruction and support for professional development. 

secretary@sdran.org