About Imara Strategic Advisors
Strategic Evidence for Smarter Decisions
Imara Strategic Advisors operates at the intersection of science, strategy, and policy—helping innovators, health systems, and public agencies turn complex data into clear, decision-grade strategies. We combine regulatory science & FDA consulting, real-world evidence (RWE) and clinical trial design, evidence & impact analytics, and acquisition & funding strategy into one integrated offering. The result: clients move seamlessly from concept to approval to measurable impact.
Our differentiator is the way we fuse regulatory foresight, clinical insight, and policy fluency into solutions that stand up to the scrutiny of regulators, payers, courts, and funders. For med-tech and digital health innovators, that means aligning design and human-factors realities with FDA expectations and post-market evidence requirements. For public-sector and mission-driven organizations, it means pairing rigorous evaluation with capture-ready narratives and coalitions that position programs for long-term success.
Team Overview
Imara’s leadership combines deep regulatory expertise with proven strategic execution. Dr. Mwanatumu Mbwana, a regulatory science leader and PhD-trained epidemiologist (RAC US/EU), has shaped RWE standards and device strategies across U.S. and global markets. Kassim Mbwana, a Shipley-trained strategist with $350M+ in direct wins, leads acquisition strategy and mixed-methods evaluation for complex initiatives. Consulting Partner, Dr. Juma S. Mbwana, a board-certified child neurologist and biomedical engineer, anchors our neuro and med-legal consulting—bringing rare insight into pediatric neuro devices and high-stakes medico-legal matters.
They are joined by Consulting Partners Dr. Oswaldo Urdapilleta (federal program evaluation and advanced analytics) and George C. Tagg, Jr. (public-sector capture, coalition building, and strategic positioning). Together, we transform strategic evidence into smarter decisions—bridging regulatory pathways, credible data, and successful market and policy outcomes.
Vision — To make rigorous, actionable evidence the fastest path to safe access, market adoption, and measurable impact.
Mission We guide clients through the evidence lifecycle—from study design to approval, implementation, and proof of impact—so they can meet regulatory standards, win critical resources, and achieve enduring results.
Meet our Team
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Co-Founder; Chief Regulatory & Evidence Officer
Dr. Mwanatumu Mbwana is a regulatory science leader and PhD-trained epidemiologist with more than 20 years of cross-sector experience spanning FDA regulatory affairs, cardiovascular and diabetes epidemiology, laboratory systems, global health, and program evaluation. She has supported health technology innovators, government agencies, and international health initiatives in navigating complex regulatory and evidence-generation challenges, translating scientific and operational complexity into practical strategies that strengthen decision making and improve health outcomes.
Her career includes leadership roles such as Associate Director of Evidence Generation at the Medical Device Innovation Consortium's National Evaluation System for Health Technology Coordinating Center (NESTcc), where she advanced national standards for real-world evidence (RWE) methodologies in collaboration with the FDA and industry partners. Earlier in her career, Dr. Mbwana served as a consultant on the PEPFAR Labs for Life program, where she mentored laboratory teams in resource-limited healthcare settings to implement quality management systems using the WHO AFRO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) framework and prepare for ISO 15189 accreditation. Working alongside a rural hospital laboratory in Kenya, she helped strengthen laboratory quality practices and build sustainable capacity for internationally recognized accreditation.
At Imara Strategic Advisors, Dr. Mbwana leads the firm's Regulatory Science & Evidence Strategy practice, helping clients align regulatory strategy, evidence generation, and evaluation with their broader development objectives. Her experience spans the design of real-world evidence studies, regulatory strategy for medical technologies, implementation of ISO-compliant laboratory quality systems, and evaluation of programs and health technologies across diverse healthcare settings.
Dr. Mbwana holds a PhD in Epidemiology from the University of Pittsburgh, an MS in Biotechnology from Johns Hopkins University, and a BS in Chemistry from the University of Maryland. She is Regulatory Affairs Certified (RAC) in both the United States and the European Union. Her interdisciplinary background enables her to integrate regulatory science, epidemiology, quality systems, and evaluation to help clients generate evidence that is scientifically rigorous, operationally feasible, and fit for purpose.
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Co-Founder; Chief Strategy & Evaluation Officer
Kassim is Co-Founder and Chief Strategy & Evaluation Officer at Imara Strategic Advisors, combining disciplined business development with deep program evaluation experience to help clients win and deliver high-impact work. A Shipley-trained capture and proposal leader, he has led end-to-end capture efforts and authored winning proposals and positioning clients on federal acquisition vehicles —work that has produced more than $50M in direct billable awards and helped clients compete on vehicles valued at hundreds of millions. Kassim’s recent BD leadership roles include guiding clients to over $300M in clean energy credits. He also successfully guided an academic-industry consortium through three proposal phases into the finalist round securing over $200M in partner commitments to augment potential federal funds of $160M if selected
At Imara Strategic Advisors, Kassim also leads all program evaluation activities, bringing more than 15 years of experience in mixed-methods evaluation for government, nonprofit, and mission-driven clients. He has served as Principal Investigator, Project Director, and Evaluation Manager on projects integrating quantitative and qualitative research design, advanced statistical analysis, and stakeholder engagement. His work includes designing evaluation frameworks, outcome monitoring systems, and performance measurement plans; conducting feasibility studies; and producing data-driven insights that inform funding, policy, and operational decisions. Kassim’s evaluation leadership has guided initiatives in health, housing, workforce, education, and nutrition programs—delivering credible, actionable findings that drive strategic improvements and demonstrate impact to funders, policymakers, and the public. He holds an M.P.P. in Social Policy & International Development from American University and a B.A. from Bowdoin College.
Our Consulting Partners
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Consulting Partner, Neurological & Med-Legal Services
Dr. Juma Mbwana is a board‑certified child neurologist with a BS in Biomedical Engineering from Yale, Dr. Juma Mbwana blends clinical leadership with engineering fluency to solve complex pediatric neurology problems. At Children’s National Hospital he serves as Medical Director for the Neuroscience Inpatient Unit, the Neurology/Specialty Infusion Center, and the Annapolis & Howard County regional clinics, and leads the Stronger Infusions Initiative to standardize high‑reliability ambulatory infusion care. He is an Associate Professor of Neurology, Rehabilitation Medicine, and Pediatrics at the George Washington University School of Medicine & Health Sciences, where he teaches and mentors across inpatient, outpatient, and neuro‑critical settings..
At Imara Strategic Advisors, Dr. Mbwana brings rare end‑to‑end perspective to medical device consultations in pediatric neurology—bridging device design and human‑factors realities with clinical workflow, safety, and evidentiary needs. As founder of JSM Neurology Consulting LLC, he provides record reviews, independent medical examinations (IMEs), and expert witness testimony in high‑stakes injury, malpractice, and disability matters, translating complex data into clear, defensible insights. His scholarly work spans informatics and neuroimaging—including multi‑center EHR initiatives to advance epilepsy care and novel fMRI metrics for language mapping—giving clients a rigorous, data‑driven lens for validation studies, protocol design, and real‑world evidence generation for neuro sensors, wearables, and therapeutic technologies.
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Consulting Partner, Evidence & Impact Analytics
Dr. Oswaldo Urdapilleta is a senior evaluation leader with more than 20 years of experience designing and directing high-profile studies across U.S. federal health, labor, and social policy portfolios. He currently serves as a Principal Research Associate at Optimal Solutions Group, where he leads complex, mixed-methods evaluations for clients including the U.S. Small Business Administration (SBA) and the U.S. Department of Labor (DOL). His projects include the SBA Evaluation of Microloan Program Outcomes, and the T.H.R.I.V.E. Emerging Leaders Reimagined program evaluation—each integrating rigorous quantitative analysis, qualitative inquiry, and OMB-cleared data collection to inform national policy and operational improvements.
Dr. Urdapilleta has also served as Director of Health & Employment at Summit Consulting, where he led award-winning research partnerships with the Social Security Administration and DOL, and as a senior leader at IMPAQ International (now part of AIR), directing major Centers for Medicare & Medicaid Services (CMS) demonstrations and evaluations. His body of work includes rigorous program and policy evaluations for agencies such as CMS, DOL, USDA Food and Nutrition Service, and the Administration for Children and Families, combining advanced statistical modeling, administrative data analysis, and qualitative inquiry to produce findings that inform national policy and program design.
At Imara Strategic Advisors, Dr. Urdapilleta serves as an advisor strategically extending the firm’s capabilities and expertise for the Evidence & Impact Analytics practice. He has authored peer-reviewed journal articles, federal evaluation reports, and conference presentations, and is a highly cited contributor in health services research and policy evaluation. Dr. Urdapilleta earned his PhD in Public Policy from the University of Maryland, College Park, and his BA in Economics from the Instituto Tecnológico Autónomo de México (ITAM), grounding his evaluation practice in both economic rigor and real-world policy application.
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Consulting Partner, Acquisition & Funding Strategy
George C. Tagg, Jr. is a nationally recognized business development strategist and government affairs expert who partners with Imara Strategic Advisors to help clients navigate complex acquisition, grants, and procurement environments. As Founder and CEO of GTC 360° Advisors, he has led competitive capture and advocacy campaigns that have secured over $800 million in contracts and grants for government agencies, nonprofits, and mission-driven companies. His approach—shaped by senior roles in both the public and private sectors—combines capture strategy, stakeholder engagement, and high-impact messaging to position clients for long-term success.
George’s public service career includes work as NATO Policy Advisor at the U.S. Department of State, where he helped shape strategic planning for the 2018 NATO Summit, and as Senior Advisor for Russia in the Office of the Secretary of Defense, where he contributed to high-level negotiations, ceasefire agreements, and military deconfliction operations. In the private sector, he served as Global Head of the Government + Public Sector practice at Hill + Knowlton Strategies, advising city, state, and national governments on economic development and competitive positioning. A licensed attorney, George holds a JD and MA in International Affairs from American University and a BA in Political Science, summa cum laude, from the University of Tennessee.