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Capabilities
SMAC provides integrated support across the capability areas below.
Microbiology and Diagnostics
Clinical Development and Regulatory Strategy
We carry infectious disease and immunology drug and diagnostic programs from MIC distributions and surveillance data through CLSI and EUCAST breakpoint setting to FDA-recognized interpretive criteria and device labeling—the full path that determines how a product is tested, dosed, and used in practice. • AST method development • Surveillance study design and management • CLSI and EUCAST breakpoint strategy and submission • IVD analytical and clinical validation studies • Regulatory strategy for IVD pathways, including 510(k), De Novo, and PMA • Companion and complementary diagnostic strategy • Device update strategy for newly recognized FDA susceptibility test interpretive criteria • Microbiology content for regulatory documents and product and device labeling • Positioning and differentiation in the context of antimicrobial resistance • Director-level oversight for laboratory compliance (e.g., CAP, CLIA)
We design and execute clinical development strategies that align scientific differentiation with regulatory requirements and real-world clinical impact. Our work spans protocol design, endpoint selection, and agency interactions across the entire development path. • Clinical trial design and execution • Endpoint selection and study population strategy • Target product profile and differentiation strategy to support label claims • Regulatory strategy and submission support across IND, NDA, BLA, MAA, and EUA pathways • Scientific engagement with external experts, breakpoint committees, and health agencies • Integration of PK/PD and dose justification into development plans • Phase 3 design, including non-inferiority margin justification, adaptive elements, and interim and DSMB planning • Expedited and incentive pathways, including QIDP, Fast Track, Breakthrough Therapy, and the Limited Population pathway (LPAD) • FDA advisory committee strategy and preparation • Critical care and acute-care program design, including sepsis and hemodynamic endpoints
Medical Affairs
Biometrics and Statistical Sciences
Whether you are standing up a medical affairs function for the first time or scaling one for launch, SMAC builds and operates it around your asset by translating clinical data into accurate, compliant scientific exchange. We flex to what you need, spanning strategy, field medical execution, and the operational infrastructure that keeps the function compliant across the product lifecycle. • Medical affairs strategy and annual planning • Scientific platform, lexicon, and core medical decks • Advisory board design and execution • Medical science liaison (MSL) team buildout and field medical training • KOL identification, mapping, and engagement planning • Insights synthesis and educational gap analysis • Medical affairs operations, including CRM build, investigator-initiated research (IIR) portal, medical information call center, SOPs and policies, and budget and vendor management
Our biometrics group provides statistical and data science support grounded in regulatory standards. We deliver analysis planning, programming, and interpretation built to withstand agency and peer review. • Statistical analysis plan (SAP) development • Sample size and statistical power calculations • Subgroup, PK/PD, and microbiological response analyses • Statistical programming and CDISC-aligned dataset preparation • Biostatistical input to protocols, clinical study reports, and publications • Interpretation and presentation of clinical trial and surveillance data • Trial designs for small and rare-disease populations, including adaptive, Bayesian, and external or natural-history control approaches • Model-informed drug development and population PK/PD modeling
Medical and Scientific Communication
Non-Dilutive Funding
We develop publication-quality scientific content for regulatory, congress, and peer-reviewed audiences. Every deliverable is evidence-based, accurate, and prepared to meet scientific and compliance review standards. • Publication planning and manuscript development • Congress strategy, including abstracts, posters, and symposia • Scientific narratives and data dissemination strategy • Slide decks, monographs, and scientific reference materials • Clear translation of complex data for clinical and scientific audiences
We help organizations identify and secure non-dilutive funding to advance clinical and diagnostic programs, providing landscape analysis, opportunity assessment, and scientific writing aligned to company priorities. • Non-dilutive funding landscape analysis and opportunity tracking • Grant and contract strategy for BARDA, DoD and CDMRP, CARB-X, and NIH and NIAID • Scientific writing and proposal development • Specific aims, objectives, and milestone framing • Budget and program narrative support • Women-owned (WBENC-certified) business eligible for federal and supplier-diversity opportunities
Rare and Orphan Disease
Rare and orphan programs share a hard reality: data are limited, patient populations are small, and endpoints are often novel. We help sponsors design and defend development and regulatory strategies suited to the disease state. • Orphan Drug, Rare Pediatric Disease, and priority review voucher strategy • Small-population and adaptive trial design, including external, historical, and natural-history controls • Novel endpoints and clinical outcome assessment (COA and PRO) development • Accelerated approval and surrogate endpoint strategy, with Breakthrough Therapy and Fast Track • Natural history studies, registries, and patient-focused drug development • Engagement with the FDA Office of Orphan Products and EMA orphan and COMP processes
Education and Training
SMAC Academy is our training and certification division, built for the medical and commercial teams that launch infectious disease, critical care, rare disease, and immunology drugs and diagnostic products. It applies the same scientific authority we bring to development programs to the work of building internal capability — in structured, repeatable form.
Specialty product launches depend on a narrow body of specialized knowledge including disease biology and mechanism of action, PK/PD and dosing, the relevant diagnostics and biomarkers, endpoint and outcome measures, and the treatment setting (from antimicrobial stewardship in infectious disease to the ICU in critical care). Topics that generalist training does not cover.
Medical and scientific pathway (medical affairs and MSL teams)
Commercial pathway (field and account teams)
Program-specific and enterprise delivery
• Disease biology, mechanism of action, and resistance mechanisms • PK/PD and dose optimization • Antimicrobial susceptibility testing (AST), breakpoints, and interpretive criteria • Specialty and companion diagnostics: interpreting and communicating results • Antimicrobial stewardship • Disease-state modules by indication, spanning infectious disease (sepsis and septic shock, complicated UTI and pyelonephritis, HABP/VABP, community-acquired bacterial pneumonia, complicated intra-abdominal infection, ABSSSI, and bloodstream infection), immunology and inflammation (such as atopic dermatitis, inflammatory bowel disease, and rheumatoid arthritis), rare and orphan disease (such as hereditary angioedema and complement-mediated disease), and critical care beyond sepsis (including ARDS)
• Disease-state and pathology essentials tailored for commercial teams • Resistance mechanisms and why they matter to prescribers • Competitive and market landscape positioning • Selling within an antimicrobial stewardship environment • Navigating the institutional sale — formulary, P&T review, and pharmacy access
• Bespoke modules built around your molecule, data, label, and competitive context • Enterprise team licensing across medical and commercial organizations • Annual content updates as breakpoints, approvals, and guidance evolve • Certification with verifiable digital credentials • Compliance and promotional review built into the development of all commercial content