Our Expertise
SMAC's core differentiation is precise, hands-on expertise across infectious disease, immunology, critical care, and rare and orphan disease, spanning drug, device, and diagnostic development. We understand the specific scientific and regulatory challenges these complex indications present, and we pair that understanding with a data-driven approach, so your program is supported by a team that has done this work before and knows what agency, payer, and peer review will ask.
Selected Experience
Across the team, SMAC brings deep disease-area expertise together with hands-on development, launch, and medical affairs experience. Our disease-area depth spans infectious disease, immunology, critical care, and rare and orphan disease, across small molecules, biologics, and in vitro diagnostics.
Development and regulatory track record of multiple FDA and EMA approvals and Phase 1 through Phase 3 programs, including NDA, BLA, MAA, and EUA submissions, FDA advisory committee preparation, and expedited and incentive pathways such as QIDP, Fast Track, Breakthrough Therapy, the Limited Population pathway (LPAD), and Orphan Drug designation.
Clinical development support across drug programs: trial and endpoint design, data analysis, regulatory planning, and publication planning and data dissemination, applied from numerous antibiotics to sepsis and other therapeutics
Microbiology, susceptibility testing, and breakpoints: from MIC and surveillance data through CLSI and EUCAST breakpoints to FDA-recognized interpretive criteria
Diagnostics: analytical and clinical validation and regulatory strategy (510(k), De Novo, and PMA) across molecular, susceptibility, and companion diagnostics
Medical affairs: strategy and execution across therapeutic areas, including standing up medical affairs functions from the ground up, MSL team buildout and training, advisory boards, scientific platforms, publication planning and launch readiness
Training and education: specialty scientific and commercial training for launch teams, adaptable across disease states through SMAC Academy
Business development support: scientific due diligence and asset evaluation to inform in-licensing and acquisition decisions
Case Studies
A few representative engagements:
Novel gram-negative antibiotic: from Phase 3 to submission
Challenge: a clinical-stage sponsor had to move from Phase 3 readout to NDA submission while simultaneously establishing susceptibility interpretive criteria, with no margin in the timeline.
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Approach: SMAC owned the microbiology and breakpoint strategy end to end, integrated PK/PD and biometrics into the dossier, and ran the CLSI and EUCAST submissions in parallel with the NDA.
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Outcome: NDA accepted, breakpoints established, and the antibiotic was approved with optimal universal breakpoints.
Launch-team readiness: medical and commercial training
Challenge: a sponsor approaching launch needed its MSL and commercial teams fluent in microbiology, PK/PD, susceptibility testing, and stewardship quickly.
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Approach: through SMAC Academy, we built separate medical and commercial learning pathways tailored to the molecule, its data, and its label, with certification and verifiable digital credentials.
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Outcome: field-ready teams at launch, speaking to the science accurately and compliantly from day one.
Scientific due diligence for a rare disease in-licensing decision
Challenge: a rare disease company evaluating in-licensing opportunities needed rigorous scientific due diligence across multiple candidate programs to inform an acquisition decision.
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Approach: SMAC conducted deep data dives across the candidate assets, assessed each program's scientific and clinical rationale, and built the scientific defense for the target acquisition.
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Outcome: a clear, evidence-based acquisition recommendation that the company's board used to reach its in-licensing decision.
Diagnostic development with for FDA submission and clearance
Challenge: a diagnostics company needed a rapid phenotypic AST device approved by the FDA for commercialization.
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Approach: SMAC helped design and oversee the execution of the clinical validation study.
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Outcome: 510(k) submission resulted in an FDA-cleared product.
Building a medical affairs function ahead of launch
Challenge: a sponsor with a late-stage asset had only the beginnings of a medical affairs strategy and needed to stand up the function before launch.
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Approach: SMAC provided functional medical affairs expertise, built the strategy and budget, supplied staffing support, built out the scientific platform, publication plan, KOL engagement strategy and medical information function.
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Outcome: over a nearly four-year partnership, the sponsor's medical affairs team and strategic approach matured into a launch-ready function that was seamlessly transitioned to an in-house team.
Sepsis diagnostic strategy: advisory boards on adoption and clinical use
Challenge: a sponsor bringing a new sepsis diagnostic to market needed to define where and how it would be used, including which hospital unit should adopt it, whether to position it as a rule-in or rule-out test, and what the operational and economic implications would be.
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Approach: SMAC designed and led multiple advisory boards to determine the optimal hospital unit for adoption, the rule-in versus rule-out positioning for sepsis detection, the implications for hospital workflow, and the potential hospital-level cost savings.
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Outcome: a launch-ready adoption and positioning strategy, including the target hospital unit, the rule-in versus rule-out intended use, and a hospital-level economic case the sponsor carried into launch planning.
Phase 2 program: trial closeout, biostatistics, and regulatory planning
Challenge: a sponsor running a Phase 2 drug program needed support to close out the trial and plan the regulatory path forward.
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Approach: SMAC supported the sponsor team through trial closeout, delivered the biostatistics, and led regulatory planning for the program's next phase.
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Outcome: a cleanly closed-out Phase 2 study, with the biostatistical read-out and the regulatory strategy the sponsor needed to plan its next phase with confidence.
Client Perspective
“You have a drug in late stage development and only a hint of a medical affairs strategy, what do you do? You panic, pray, or call SMAC. When called upon they provided functional expertise, staffing support and a networking strategy that helped relationship building. We’ve worked with SMAC for almost 4 years and our growing Medical Affairs team and strategic approach have benefited tremendously from this relationship.”
CMO, Pharmaceutical Company
“SMAC has been a valued partner to F2G across our olorofim program, contributing genuine depth in clinical microbiology and anti-infective development. Their team has strengthened both our clinical program and our NDA work, from scientific data review and interpretation through regulatory submission preparation. They are rigorous, responsive, and engage as true members of our team. I would gladly recommend them.”
John Rex, Chief Medical Officer, F2G