Consulting

F4Bio Consulting bridges science and execution: we accelerate R&D with clarity and foresight, ensure quality data from the very first study, and apply targeted internal AI where it truly compresses time. Our consulting spans CMC strategy and analytics, program continuity and pragmatic leadership, enabling our clients to navigate complexity faster, safer and smarter.

How we accelerate - without cutting corners

R&D acceleration as the core driver

We align hypotheses, decision points and experiments to generate decision-grade evidence quickly, reducing rework and dead ends.

Internal AI, applied with intent

We deploy in-house AI assets (literature triage, assay mapping, dossier checklists, scenario scoring) where they shave days, not where they add noise.

Slow down to speed up

Short pause, sharp plan: clarify the question, select fit-for-purpose methods, and sequence work to avoid costly pivots later.

Regulatory by design

Anticipate moving goalposts: build auditable logic, capture assumptions, and prepare for novel approaches before guidance catches up.

Core of services

R&D Strategy & Design

From scientific intent to operational design: we structure R&D pipelines and link hypotheses, analytical readiness and decision governance into one actionable plan.

Deliverables

R&D master plan integrating hypotheses, milestones and decision matrices
Study architecture templates and translational validation routes
Risk register & governance toolkit (go/kill, RAID, escalation flow)
Analytical readiness map aligned with CMC and regulatory phases
Feasibility pathways for methods/technologies and analytical platforms
Competitive & technology watch reports (modalities, analytics, platforms)
Evidence summary packs for internal or partner decision boards

Client outcomes

Structured, traceable decision-making across R&D phases
Reduced rework and analytical bottlenecks
Clear prioritization and resource allocation
Faster transition from data to validated decisions
Alignment across scientific, technical and regulatory deliverables

Bioprocessing - DownStream

Optimize, scale and transfer downstream viral vector processes, from lab design to GMP readiness, ensuring robust, high-yield, and compliant purification workflows.

Deliverables

Process optimization and troubleshooting of viral vector DSP workflows (AAV, LV, ADV, VSV, HSV, RSV) to maximize yield, purity, and scalability.
Design and refinement of chromatographic, filtration, and analytical protocols ensuring reproducibility and GMP compliance.
Definition and optimization of CPPs and CQAs to achieve robust, phase-appropriate specifications.
Development of predictive scale-down models enabling efficient optimization and risk mitigation before scale-up.
Technology transfer leadership — generating protocols, training teams, and resolving scale-up issues.
Authoring and review of GMP documentation (MBR, BOM, Method of Production) for new DSP implementations.
Manufacturability assessments combining experimental validation and cost modeling to ensure process robustness and efficiency.
Design and qualification of new BSL-2 DSP laboratories, defining layout, utilities, and equipment for viral vector operations.
Technical leadership and mentoring of DSP teams, establishing KPIs and ensuring delivery of milestones on time and in quality.

Client outcomes

Efficient, high-yield purification processes reproducible from lab to GMP scale.
Reduced variability and faster troubleshooting through optimized CPP/CQA control.
Validated, transferable processes ready for clinical and commercial manufacturing.
Improved compliance and documentation traceability aligned with GMP expectations.
Enhanced DSP capabilities and team autonomy through structured training and lab readiness.
Stronger link between R&D and manufacturing performance for sustainable scalability.

CMC Strategy & Analytics

Make analytics a design lever: robust methods, trustworthy data, and CMC narratives that stand up to scrutiny.

Deliverables

Analytical development plan & method lifecycle roadmap (screening → validation)
Assay qualification packages and traceable data packages
Reference standards and bridging plans across platforms and sites
CMC analytical dossier sections ready for regulatory submissions
Gap analysis and remediation roadmap aligned with phase-appropriate expectations

Client outcomes

Predictable analytical timelines and reduced validation delays
Consistent data packages supporting IND/BLA or CTA filings
Enhanced traceability across development sites and partners
Clear alignment between analytics, manufacturing, and regulatory strategy

Leadership & Program Delivery

Leadership continuum that keeps momentum: operating model, governance rituals, team dynamics and stakeholder alignment.

Deliverables

Program operating model (roles, decision flow, KPIs, cadence)
Governance toolkit (review boards, RAID logs, milestone tracking templates)
Alignment dashboards connecting project, analytical and manufacturing data
Partner oversight frameworks (e.g. CDMO) — selection support, SOW design, performance reviews, escalation
Leadership coaching focused on scientific decision-making and stakeholder influence

Client outcomes

Smoother execution and reduced friction between teams and partners
Traceable progress monitoring with decision-ready insights
Increased accountability and ownership across scientific programs
Stronger leadership behaviours embedded in delivery culture

Training Design & Delivery

Applied training in scientific, technical and managerial/leadership domains — built for adoption and autonomy.

Deliverables

Training curricula and modular content tailored to scientific, analytical and leadership topics
Evaluation frameworks (pre/post assessment templates)
On-site and remote workshop kits with facilitator guides and case libraries
Change enablement playbooks supporting method adoption or new workflows

Client outcomes

Rapid upskilling on key scientific, technical and leadership skills
Homogeneous standards across multi-site or hybrid teams
Documented, repeatable learning assets that enable sustained autonomy
Improved retention and engagement of scientific personnel

Our collaborators

Roel Lievrouw

Fabien Baldacci

Expertise

Discover how our scientific and CMC expertise drives acceleration, data quality, and foresight across complex programs.

Explore our Expertise

Consulting

How we accelerate - without cutting corners

R&D acceleration as the core driver

Internal AI, applied with intent

Slow down to speed up

Regulatory by design

Core of services

R&D Strategy & Design

Bioprocessing - DownStream

CMC Strategy & Analytics

Leadership & Program Delivery

Training Design & Delivery

Our collaborators

Expertise

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