SAVE THE DATE FOR OUR 2019 ANNUAL PUBLIC FORUM ON SEPTEMBER 5, 2019 IN WASHINGTON, DC!
To help direct your question to the right person, areas of focus for each staff member are provided here.
Tiffany Abushaikha joins MDIC as a Project Manager for the NEST Coordinating Center. With her, she brings years of professional and academic experience providing regulatory guidance, analytical, and strategic consultative support to clients in the healthcare and biotech sectors.
Prior to MDIC, Tiffany worked for Biotechnology Innovation Organization (BIO), the world’s largest biotech trade association, where she acted as a liaison between the public-private sectors to advance key science policy priorities as well as regulatory initiatives that reduce burdens for R&D advancements across industry and the total product life cycle. At BIO, she supported the Executive Vice President and section directors in composing industry data analysis reports, as well as the drafting of regulatory guidance documents and submissions. Prior to joining BIO, she acted as a research coordinator for NIH-funded studies at KAI where she helped lead disease-specific working groups for the Common Data Elements Project whose primary mission was to develop common data standards to encourage information sharing between investigators, improve patient outcome measures, and generate consistency in patient data collection. This initiative helped to increase the efficacy of clinical studies while also strengthening data quality.
Tiffany holds an MS in Bioinformatics and Computational Biology from the University of Maryland and an MS in Biotechnology and Regulatory Science from Johns Hopkins University. She is currently pursuing a Regulatory Affairs Certification (RAC).
Tom Anderson joins MDIC as Communications Manager for the NEST Coordinating Center. He previously worked in marketing and communications at the American Heart Association (AHA) on the development and expansion of the Resuscitation Quality Improvement (RQI) Program, a CPR training solution for healthcare providers. In a prior role at AHA, he directly supported the creation of the 2015 AHA Guidelines for CPR & ECC, which serve as the foundation for resuscitation science education in the United States.
Tom received a BA in Political Science from Elon University.
Tariq Bahich has over 8 years of experience in Accounting, Finance and Contract administration for International organizations including the Asian Development Bank, United States Institute of Peace and Lidl US. He has received his MBA from Indian Institute of Management in Bangalore India. He is currently pursuing his CPA.
Aurelia Brooks joins MDIC as an Executive Assistant for the NEST Coordinating Center. With her, she brings over 10 years of executive administrative experience supporting Directors, Vice Presidents, CFOs, and COOs for nonprofits, federal government, DC government, and various medical organizations.
Prior to MDIC, Aurelia worked as an Executive Assistant for several nonprofits such as The Aspen Institute, Save the Children, and Environmental Defense Fun
Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie joined MDIC in 2013 and manages MDIC’s patient centered benefit-risk assessment, patient engagement and quality initiatives. Prior to joining MDIC, Stephanie worked with an academic public health team working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012-13, Stephanie went on leave from her academic position to do a special assignment for the Food and Drug Administration Center for Devices and Radiological Health (CDRH), updating and training staff on a new risk communication process. Stephanie has also served as an adjunct instructor at Marquette University, teaching introductory communication courses.
Stephanie earned her Bachelor of Arts in Communication-Print Journalism from Pacific Lutheran University in Tacoma, Wash. and Master of Arts in Science, Health, and Environmental Communication from Marquette University in Milwaukee, Wis. Stephanie is also a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals and in 2018 was named a Fellow of the Association of Clinical Research Professionals (FACRP).
Lenwood has nearly two decades of experience in technology and intellectual property law. He manages the legal function of MDIC, serves as the liaison to the Board of Directors, addresses MDIC’s legal requirements, and primarily ensures compliance with the following areas: corporate governance, federal compliance, federal funding reporting requirements, and Board of Directors meetings.
Lenwood has significant experience in counseling individuals, as well as early-stage and large organizations, with various technology and intellectual property related legal issues, including procurement, license and service agreements, collaborative research agreements, corporate structure, finance, technology landscapes, and various regulatory issues. In private practice, he specialized in representing clients who dealt with various medical devices and methodologies, including hearing devices, biopsy devices, syringes, vascular implants, catheters, device and drug delivery systems, nuclear medicine, and medical imaging. He also previously served as a Patent Examiner in the surgical arts, and as a Nanotechnology Specialist, with the U.S. Patent and Trademark Office.
Lenwood received his BS in Mechanical Engineering from North Carolina A&T State University, his MS in Biomedical Engineering from The University of Virginia, and his JD from The George Washington University.
Rachael L. Fleurence, PhD is the inaugural Executive Director of the newly formed National Evaluation System for health Technology (NEST) Coordinating Center. As an initiative of MDIC’s public-private partnership, NESTcc’s mission is to establish clear pathways within the medical device ecosystem to support the timely, reliable, and cost-effective development of evidence using Real-World Data sources for key stakeholders, including the medical device industry, regulators, payers, patients, clinicians, and health systems. Dr. Fleurence joins NEST from the Patient-Centered Outcomes Research Institute (PCORI) where she was the Program Director for PCORI’s initiative to build the National Patient-Centered Clinical Research Network, or PCORnet, sine 2012. PCORnet has been a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United-States. Dr. Fleurence was also the inaugural director for the PCORI Methods Program in 2012. Dr. Fleurence has served on a number of Boards and Steering Committees, including most recently the National Medical Device Evaluation System Planning (NEST) Planning Board, the Medical Device Innovation Consortium (MDIC) Board and the SMART IRB Steering Committee, an effort to streamline IRB reviews across academic research institutions. She chaired the PCORnet Executive Committee from 2015-2017, and served as the vice-chair of the PCORnet Council.
A health economist and health services researcher by training, Dr. Fleurence received a BA from Cambridge University (United-Kingdom), a MA in business management from ESSEC-Paris (France), and a MSc and PhD in health economics from the University of York (United-Kingdom).
Jessica Gasvoda joins MDIC as a Project Manager for the NEST Coordinating Center. She previously worked at the Patient-Centered Outcomes Research Institute (PCORI). At PCORI she supported the management of PCORnet, the National Patient Centered Clinical Research Network, an initiative designed to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United States. As a Program Associate she focused on governance, communications, and meeting planning to advance the mission of PCORnet.
Jessica received her BS in Community Health from George Mason University and is currently pursuing a MPH from South University.
Pamela Goldberg joined MDIC in March of 2018 and is an internationally recognized leader in healthcare technology innovation and entrepreneurship. Her leadership, technology focus and finance background make her a sought after speaker on the international circuit.
Goldberg was previously CEO of the Massachusetts Technology Collaborative and the first woman to lead the organization in its 30-year history. Goldberg worked closely with industry, academic and government leaders to advance technology-based solutions that improved the health care system, expanded high-speed Internet access and strengthened the growth and development of the state’s technology sector with specific focus on digital health, data analytics, robotics, and cybersecurity.
Passionate about innovation and entrepreneurship, Goldberg served as the Director of The Center for Entrepreneurial Leadership at Tufts University, a program she launched to drive innovation for the university. Through Goldberg’s leadership, the program grew to over 500 students per year, and supported the start of over 50 businesses in Massachusetts. Goldberg received the Acton Foundation’s National Teaching Award for Entrepreneurship and established the school’s nationally recognized business plan competition.
Goldberg is advisor and board member to several technology startups and earlier in her career launched three start-up ventures: a music production company, a women’s history organization and a hospice. At the start of her career, she was an investment banker at Citibank and then launched the investment banking division of State Street Bank.
Goldberg received her BA from Tufts University and MBA from Stanford University.
Sharon L. Graves, is the Sub-Award Manager for the NEST Coordinating Center. Sharon brings several years of federal contract administration experience to the NEST Team. She joins MDIC from Leidos Biomedical Research Inc., the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, where she was responsible for lifecycle contract administration of federally funded contracts and grants.
Sharon received her MBA with focuses in Finance and Project Management from Devry University.
Carolyn Hiller joined MDIC as Program Manager to launch their Clinical Diagnostics initiative. She brings diverse experiences in the healthcare sector; in addition to nearly a decade working in the medical device industry, she brings over a decade of executive leadership experience in the non-profit sector including national organizations representing patients, researchers, physicians, and clinical facilities.
Drawing on over 20 years of experience, she uses logic and intuition to achieve success at leading teams, often comprised of members from competing organizations. She has developed programs from conception through phase-out. Her organizational development experience includes facilitating relationships between organizations, increasing volunteer engagement, creating collaborative partnerships, establishing strategies for resource allocation, providing organization-wide strategic direction, and managing risk. She has a particularly strong track record for successfully identifying and launching new programs in emerging markets.
She has worked with physicians to develop and launch profitable educational product lines. She facilitated a summit of 12 national sleep-related organizations for coalition building, and followed up with successfully advocating for a patient-led lobbying coalition that led to establishing the National Center for Sleep Disorders Research within the federal National Institutes of Health NHLBI. She also guided the American Academy of Sleep Medicine’s successful application and acceptance into American Medical Association’s House of Delegates, the principal policy-making body of the AMA.
She holds an MBA from the University of St. Thomas, as well as a BA in Marketing from Metropolitan State University, and an AAS in Animal Health Technology from the University of Minnesota.
Dure Kim, PharmD joins MDIC as a Project Manager for the NEST Coordinating Center. Dure brings experiences in research project management, health services research, and real-world evidence. Prior to MDIC, he was a Postdoctoral Fellow in Comparative Effectiveness Research and Patient Centered Outcomes Research at the University of Maryland, Baltimore. In his fellowship training, he was responsible for managing the Comparative Effectiveness Research Certificate Program and was engaged in a variety of research projects using secondary data sources. Dure received a Doctor of Pharmacy from Mercer University.
Leah McConnell is an award-winning communications and marketing director with an extensive background in the biomedical and health sciences field. Leah joined MDIC in 2018 to bring the organization’s work to life through dynamic and compelling stories that engage the med tech industry and the wider community more deeply with MDIC’s mission. As MDIC’s first Director of Marketing and Communications, Leah provides vision, leadership, and implementation of strategic communications, sustainability branding, and media relations across multichannel platforms. She is also responsible for developing relationships with key external partners and manages the organization’s membership of diverse industry stakeholders. Prior to joining MDIC, Leah has supported a portfolio of companies and organizations to include projects with U.S. Air Force, Independence Blue Cross, FDA, Naval Medical Research Center, and more.
Leah earned her B.S. in Communications Media from Indiana University of Pennsylvania and her M.S. in Public Relations and Marketing from the University of Denver. She is a recipient of two Gold AVA Digital Awards for her work with content design and development as well as building successful social campaigns. She is also a recipient of The Power 30 Under 30TM Awards for professional and community excellence.
Brandon Miller joined MDIC in 2019 as an operations assistant. In this role, he ensures the smooth running of MDIC’s day-to-day office functions, provides front-office support, and assists with IT logistics. Prior to joining MDIC, Brandon served in operations for the nonprofit and for-profit sectors for more than 10 years. His background includes serving in operations for several cable networks, including BBC America, TV One and Discovery Communications. In his free time, Brandon enjoys getting creative in a variety of ways, from photography to writing and podcasting. Brandon is a proud native of the District of Columbia.
Rachel R. Rath, MPH is the Chief of Staff for MDIC’s NEST Coordinating Center. She joins MDIC from the Patient-Centered Outcomes Research Institute (PCORI). Since joining PCORI in 2014, she helped build and manage the development of the PCORnet, the National Patient-Centered Clinical Research Network, a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United States. Most recently she focused her on governance, sustainability, and communications efforts to advance the mission of PCORnet. PCORI’s investment in PCORnet has exceeded $400 million from a combination of infrastructure and research investments. In March 2017, the PCORnet partners successfully launched an independent non-profit entity to advance the long-term sustainability of PCORnet. Prior to joining PCORI, she worked with disease-specific organizations including the National Multiple Sclerosis Society and the COPD Foundation and served as an Applied Behavioral Analysis (ABA) Therapist for children with Autism Spectrum Disorders.
Rachel received her MPH in global health policy from The George Washington University and is currently pursuing an MBA from Georgetown University.
Dr. Rincon-Gonzalez leads the Early Feasibility Study initiatives to drive overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients. Prior to joining MDIC, Liliana worked as a Research Assistant Professor and as a Clinical Research Coordinator in the Department of Biomedical Engineering at Florida International University (FIU). Here she provided scientific and regulatory support to Investigators and staff on clinical and research projects. During her tenure at FIU, she was both a scientist and the clinical research coordinator for an investigator-initiated First-in-Human Early Feasibility Study for a Class III medical device funded by the National Institutes of Health and the Department of Defense. Liliana coordinated scientists, engineers, clinicians, prosthetists and staff to successfully implant and to test the first fully implantable and wireless neurostimulator designed to provide the sense of touch and hand opening to an upper limb amputee fitted with a sensorized prosthetic hand.
In addition, Liliana has over 10 years’ experience designing, managing and running biomedical and neuroscience research with human participants as well as experience with human subject protections and IRB submissions. She has published numerous peer-reviewed journal articles related to understanding how individuals process body-posture and tactile signals with the purpose of designing neurostimulators to provide sensory feedback to patients.
Liliana earned her BA in Psychology, BSE in Bioengineering, MS in Biomedical Engineering and PhD in Biomedical Engineering from Arizona State University in Tempe, AZ. She then completed a postdoctoral fellowship in the Donders Institute for Brain, Cognition and Behaviour at Radboud University in Nijmegen, The Netherlands. She is currently a primary IRB Member at the Health Sciences Panel at Florida International University.
Dan brings award-winning knowledge and experiences spanning twelve years implementing strategic healthcare solutions addressing care delivery, research, therapy adherence, process improvements, and business development.
In that time, Dan has led Health Information Technology (HIT) teams in identifying and implementing best practices for clinical research, care communication, therapy adherence and outcomes. He has won multiple awards implementing Electronic Health Records (EHR/EMR)s, Electronic Data Capture (EDC) tools, and developing a HIT solution automating clinical trial subject adverse event (AE) notifications and therapy adherence. He has assembled and optimized cross-functional medical product (IDE, IND and BLA) clinical research teams to (a) identify stakeholders and track milestones, (b) measure and manage project risks, and (c) achieve project deliverables. Dan established and led the North American Clinical Development Unit (CDU) for a large European medical product sponsor. He managed an integrated health economic outcomes research (HEOR) joint venture between the University of Minnesota, a community hospital, and a private practice. Dan previously held voting member roles on (1) a State-wide commission for anatomical tissue donation, and (2) a community hospital’s Institutional Review Board (IRB).
Dan is pursuing a Master of Science in Health Economics at Johns Hopkins University and earned a Bachelor of Science in Genetics and Cell Development from the University of Minnesota and a Bachelor of Arts in Political Science from Saint John’s University. He spent one year interning as a research assistant in the University of Minnesota’s Stem Cell Institute. In addition, Dan holds certifications as a Six Sigma Green Belt through the Project Management Institute (PMI), and as a Certified Scrum Product Owner (CSPO) through the Scrum Alliance.
Liz Spurgin is a healthcare business and policy executive who joined MDIC in July 2018 and leads membership initiatives to promote enhanced speed and predictability of coverage and payment for innovative new medical technology.
Her sector-wide experience includes roles in industry, provider, payer and consulting with a focus on market access, evidence development, policy and payment. Her work at MedStar Health, Deltex Medical and two Washington DC advisory firms centered on removing economic and clinical barriers to advances in patient care. She is a strong advocate for technologies, services and practices that improve population health.
Liz received her BA from the University of Illinois and her MBA from the University of Connecticut.
Dr. Jithesh Veetil, PhD joined MDIC as a Program Director to lead Data Science and Technology initiatives. His prime focus at MDIC is to aid in the development of regulatory grade tools based on computational modeling & simulation science relevant to clinical applications, This program builds upon the success MDIC has had with the Virtual Patient model that resulted in mock submission for clinical trials augmented with virtual patient data. These exciting programs in the pre-competitive MedTech sector will be carried out in collaboration with MDIC members and their engineers, statisticians, regulatory professionals, and medical doctors. The goal is to utilize the External Evidence Methods (historical, prospective and concurrent data- including but not limited to – Digital Evidence, Clinical Trial Data, Real World Evidence-RWE, Electronic Health Records-EHR, and Patient reported Outcomes-PRO) to better understand safety, efficacy and performance of medical devices. Dr. Veetil also leads the cybersecurity projects at MDIC
Dr. Veetil has extensive experience in designing and development of programs towards modernizing scientific workforce and practices by building academic-industrial-nonprofit collaboration through his work at National Institutes of Health (NIH) campus as the Lead Scientist and Program Manager for the Foundation for Advanced Education in the Sciences (FAES). Previously, Jithesh worked with Global Biological Standards Institute (GBSI), a Washington DC based non-profit as its Scientific Program Manager, leading the development and implementation of multiple programs on science policy, communications, and advocacy, including those related to cell line authentication, antibody validation, and reproducibility in biomedical research and development. Dr. Veetil also served as the Operations Manager for Preludesys Inc., working with international clientele from medical, IT, insurance and paralegal organizations on medical/healthcare data management.
Dr. Veetil completed his PhD in Biomedical Engineering at University of Arkansas, Fayetteville, AR, followed by postdoctoral fellowship at NIH. He has published numerous peer-reviewed manuscripts, reviews and book chapters. He also holds Masters in Biotechnology and Bachelors in Food Technology.
Robbert Zusterzeel, MD, PhD, MPH is the Data Network Director for MDIC’s NEST Coordinating Center. He joins MDIC from the U.S. Food and Drug Administration (FDA) where he led multiple groups conducting translational regulatory research. Dr. Zusterzeel earned his M.D. and Ph.D. from Maastricht University, The Netherlands as well as a Master of Public Health (MPH) in epidemiology from Harvard University. He has published numerous peer-reviewed journal articles related to the safety and effectiveness of medical devices and drugs and predicting individualized response to therapies using and creating study data across the full product lifecycle.