Life Sciences

flowchart TD
    A[Disease target identified from research] --> B[Compound library screened against target]
    B --> C[Hits validated in follow-up assays]
    C --> D[Lead compounds selected for optimization]

flowchart TD
    A[Lead compound enters preclinical testing] --> B[Toxicology studies conducted in animal models]
    B --> C[Data compiled and reviewed]
    C --> D{Safety profile acceptable?}
    D -->|Yes| E[IND application prepared]
    D -->|No| F[Compound deprioritized]

flowchart TD
    A[Trial protocol designed] --> B[Sites selected, patients recruited]
    B --> C[Data collected during trial visits]
    C --> D[Monitors verify data accuracy on-site]
    D --> E[Data locked and analyzed]

flowchart TD
    A[Clinical and manufacturing data compiled] --> B[Regulatory submission drafted]
    B --> C[Submitted to FDA]
    C --> D[FDA reviews, may request more information]
    D --> E{Approved?}
    E -->|Yes| F[Drug approved for market]
    E -->|No| G[Complete Response Letter, resubmission needed]

flowchart TD
    A[Production batch manufactured under GMP] --> B[Quality control tests run on batch]
    B --> C{Tests pass specification?}
    C -->|Yes| D[Batch released for distribution]
    C -->|No| E[Batch investigated, possibly rejected]

flowchart TD
    A[Drug approved] --> B[Pricing/reimbursement strategy set with payers]
    B --> C[Sales force trained and deployed]
    C --> D[HCP engagement begins]
    D --> E[Launch metrics tracked]

flowchart TD
    A[Target protein/gene identified] --> B[Cell line engineered to produce it]
    B --> C[Fermentation process optimized]
    C --> D[Product harvested and purified]

flowchart TD
    A[Delivery vector designed for target gene] --> B[Vector manufactured under GMP]
    B --> C[Patient cells collected if autologous]
    C --> D[Therapy manufactured per-patient or per-batch]
    D --> E[Therapy shipped to treatment site]

flowchart TD
    A[Sample collected from patient] --> B[Sequencing run performed]
    B --> C[Raw data processed through analysis pipeline]
    C --> D[Results interpreted by geneticist]

flowchart TD
    A[Raw biological data generated] --> B[Data cleaned and processed]
    B --> C[Computational analysis applied]
    C --> D[Results validated by scientist]

flowchart TD
    A[Patient samples analyzed for candidate markers] --> B[Statistical association with outcomes tested]
    B --> C[Candidate biomarkers validated in follow-up studies]

flowchart TD
    A[Patient's genetic profile obtained] --> B[Profile matched against treatment database]
    B --> C[Physician reviews match manually]
    C --> D[Treatment plan finalized]

flowchart TD
    A[Device concept designed] --> B[Prototype built]
    B --> C[Usability testing with target users]
    C --> D[Design iterated based on feedback]

flowchart TD
    A[Device testing data compiled] --> B[Submission prepared: 510k or PMA]
    B --> C[Submitted to FDA]
    C --> D{Cleared/approved?}
    D -->|Yes| E[Device can be marketed]
    D -->|No| F[Additional data requested]

flowchart TD
    A[Adverse event reported from field] --> B[Manufacturer investigates report]
    B --> C{Safety issue confirmed?}
    C -->|Yes| D[Recall or corrective action initiated]
    C -->|No| E[Report logged, no action]

flowchart TD
    A[Target analyte identified] --> B[Assay chemistry designed]
    B --> C[Validation studies run for accuracy/reliability]
    C --> D[Assay finalized for clinical use]

flowchart TD
    A[Patient sample received at lab] --> B[Sample processed on analyzer]
    B --> C[Technician reviews result for validity]
    C --> D[Result reported back to provider]

flowchart TD
    A[Patient tested for biomarker] --> B[Result determines therapy eligibility]
    B --> C[Result sent to prescribing physician]
    C --> D[Treatment decision made]

flowchart TD
    A[Candidate sites evaluated for trial fit] --> B[Sites selected and initiated]
    B --> C[Monitor conducts periodic on-site visits]
    C --> D[Site performance and compliance tracked]

flowchart TD
    A[Trial data collected from sites] --> B[Data cleaned for errors/inconsistencies]
    B --> C[Statistical analysis plan executed]
    C --> D[Results reviewed by biostatistician]

flowchart TD
    A[Investigational product manufactured] --> B[Packaged and labeled per protocol]
    B --> C[Shipped to trial sites]
    C --> D[Site inventory tracked manually against usage]

flowchart TD
    A[Product development plan reviewed] --> B[Regulatory strategy mapped per target market]
    B --> C[Filing sequence and timing planned]
    C --> D[Submissions coordinated across regions]

flowchart TD
    A[Master label content drafted] --> B[Localized for each region's requirements]
    B --> C[Regulatory review per region]
    C --> D[Approved labels sent to manufacturing]

flowchart TD
    A[Change proposed - e.g., manufacturing site] --> B[Impact assessment conducted]
    B --> C[Regulatory filing prepared per region]
    C --> D[Approval obtained before change implemented]

flowchart TD
    A[Deviation from SOP occurs] --> B[Deviation logged and investigated]
    B --> C[Root cause identified]
    C --> D[CAPA plan created and tracked to closure]

flowchart TD
    A[Batch completes manufacturing] --> B[Samples tested against specification]
    B --> C{Pass?}
    C -->|Yes| D[Batch released]
    C -->|No| E[Batch quarantined, investigated]

flowchart TD
    A[Supplier proposed for qualification] --> B[On-site audit conducted]
    B --> C[Findings documented]
    C --> D[Supplier approved or required to remediate]

flowchart TD
    A[Adverse event reported by patient/provider] --> B[Case processed and coded manually]
    B --> C[Causality assessed]
    C --> D[Reported to regulators per required timeline]

flowchart TD
    A[Adverse event database analyzed periodically] --> B[Statistical signal detection run]
    B --> C{Signal identified?}
    C -->|Yes| D[Safety team investigates further]
    C -->|No| E[Continue routine monitoring]

flowchart TD
    A[Known risk identified for product] --> B[Mitigation plan designed - e.g., education, restricted use]
    B --> C[Plan implemented and communicated]
    C --> D[Effectiveness monitored periodically]

flowchart TD
    A[Rep schedules visit with prescriber] --> B[Detailing conversation and materials shared]
    B --> C[Samples provided if applicable]
    C --> D[Visit logged in CRM]

flowchart TD
    A[Product priced for market] --> B[Payer negotiations conducted per contract]
    B --> C[Formulary placement decided]
    C --> D[Prior authorization criteria set]
    D --> E[Patients navigate PA process for access]

flowchart TD
    A[Marketing drafts promotional material] --> B[Submitted for MLR review]
    B --> C[Medical, legal, regulatory reviewers assess independently]
    C --> D{All approve?}
    D -->|Yes| E[Material approved for use]
    D -->|No| F[Revisions requested, resubmitted]

flowchart TD
    A[Sales and prescribing data collected] --> B[Analyst builds territory/targeting reports]
    B --> C[Reports reviewed with sales leadership]
    C --> D[Territory adjustments made periodically]

flowchart TD
    A[MSL identifies relevant KOL] --> B[Scientific meeting scheduled]
    B --> C[Peer-level discussion conducted]
    C --> D[Insights logged internally]

flowchart TD
    A[Study results available] --> B[Manuscript drafted with authors]
    B --> C[Internal review and approval]
    C --> D[Submitted to journal/conference]

flowchart TD
    A[HCP submits inquiry] --> B[Medical information specialist researches answer]
    B --> C[Response drafted from approved content]
    C --> D[Response sent to HCP]

flowchart TD
    A[Clinical and cost data gathered] --> B[Economic model built]
    B --> C[Cost-effectiveness ratio calculated]
    C --> D[Results submitted to payers/HTA bodies]

flowchart TD
    A[Real-world data sourced from health systems] --> B[Data cleaned and structured]
    B --> C[Outcomes analysis conducted]
    C --> D[Findings published or submitted to payers]

flowchart TD
    A[Patient enrolls in support program] --> B[Eligibility verified manually]
    B --> C[Copay assistance or education materials provided]
    C --> D[Adherence check-ins conducted periodically]

flowchart TD
    A[Patient's insurance coverage checked] --> B[Case manager identifies coverage gaps]
    B --> C[Manager assists with appeals/paperwork]
    C --> D[Coverage resolved or alternative funding found]

flowchart TD
    A[Production schedule created] --> B[Batch manufactured per SOP]
    B --> C[Batch record documented manually/electronically]
    C --> D[Record reviewed before batch release]

flowchart TD
    A[Sponsor selects CMO/CDMO partner] --> B[Technology transfer conducted]
    B --> C[CMO manufactures per agreed process]
    C --> D[Sponsor's quality team reviews batch records]

flowchart TD
    A[Product packed with temperature monitoring] --> B[Shipped through cold chain network]
    B --> C[Temperature logs checked on arrival]
    C --> D{Excursion detected?}
    D -->|Yes| E[Product investigated, possibly discarded]
    D -->|No| F[Product released for use]

flowchart TD
    A[Unique serial number applied to product] --> B[Serial number registered in tracking system]
    B --> C[Number verified at each supply chain handoff]
    C --> D[Product dispensed, final scan recorded]

flowchart TD
    A[Candidate asset identified for licensing] --> B[Due diligence conducted]
    B --> C[Deal terms negotiated]
    C --> D[Licensing agreement signed]

flowchart TD
    A[Partnership agreement established] --> B[Joint governance committee formed]
    B --> C[Progress reviewed at periodic meetings]
    C --> D[Decisions documented and tracked]

flowchart TD
    A[Target condition identified in animal species] --> B[Compound developed and tested]
    B --> C[Regulatory approval sought - typically faster pathway]
    C --> D[Product launched to veterinarians]

flowchart TD
    A[Herd health monitored by farm staff] --> B[Disease symptoms observed]
    B --> C[Veterinarian consulted, treatment prescribed]
    C --> D[Treatment administered and outcome tracked]

flowchart TD
    A[Product concept and formulation developed] --> B[Safety and efficacy testing conducted]
    B --> C[Regulatory pathway confirmed - lighter than Rx]
    C --> D[Product launched to retail]

flowchart TD
    A[Supplement formulated] --> B[Scientific literature gathered to substantiate claims]
    B --> C[Compliance review of labeling and claims]
    C --> D[Product launched]