Quick Snapshot — who are you and what’s urgent right now?

• Please tell us your name, title, and the best contact for program-level decisions (email/phone)
• Which program / therapy are we discussing and what clinical stage is it in right now? Options: Discovery / Preclinical, IND-enabling, IND submitted, Phase 1, Phase 2, Commercial launch
• What is the single most important outcome you need from a CDMO relationship for this program? Options: On-time patient dosing, Predictable batch success rate, Regulatory-ready documentation, Smooth tech transfer, Scalable commercial capacity, Cost predictability, Other
• Who will be the primary day-to-day contact on your side for tech transfer and manufacturing coordination?
• How quickly do you need a manufacturing partner engaged to meet your next milestone? Options: Immediately (weeks), 1–3 months, 3–6 months, 6–12 months, 12+ months

Who's Actually Steering This Ship?

• If this program had to make a go/no‑go decision tomorrow, whose signature would be decisive and why?
• Which internal functions must explicitly approve vendor selection and contracts for this program? Options: VP Manufacturing, VP Process Development, Head of Quality/QA, Head of Regulatory, Program Director, Chief Legal/General Counsel, CFO/Finance, Other
• Describe the current RACI for manufacturing decisions—who owns strategy, execution, quality sign‑off, and budget?
• How aligned are your manufacturing, quality, and program leadership teams on outsourcing vs. building in‑house? Options: Fully aligned, Mostly aligned with minor gaps, Significant disagreement, No alignment / active conflict
• What internal political or resource constraints typically slow cross‑functional decisions in your organization?
• Who is responsible for communicating manufacturing decisions externally (investors, CROs, investigators)? Options: Program Director, Head of Communications, Clinical Lead, Regulatory Lead, Other

If This Slipped, Who Loses Sleep?

• What are the three highest-consequence outcomes if manufacturing timelines slip by 1–3 months? Options: Delayed patient dosing, Missed trial enrollment window, Regulatory filing delays, Investor/partner dissatisfaction, Increased costs, Competitive disadvantage, Other
• How many days/weeks of delay is considered tolerable before program leadership escalates to the board? Options: <7 days, 7–30 days, 1–3 months, 3–6 months, No tolerance / immediate escalation
• Tell us about a past manufacturing delay or batch failure that materially affected your program—what happened and who bore the consequences?
• Which stakeholders internally experience the most reputational risk if a batch failure occurs (select all that apply)? Options: Chief Technical Officer, VP Manufacturing, Head of Quality, Program Director, Clinical Operations, Regulatory Lead, Other
• Who in your organization would lead customer/patient communications if a dosing window was missed? Options: Program Director, Clinical Ops Lead, Regulatory Lead, Head of Communications, Other

What Does ‘Good’ Actually Look Like — In Numbers

• When a vendor says 'high yield and on‑time release,' what exact batch yield percentage would make you comfortable? Options: >95%, 90–95%, 80–90%, 70–80%, <70%
• What is your target window for release testing and batch release after an end‑of‑production run? Options: <48 hours, 48–72 hours, 3–7 days, >7 days
• Which measurable success signals would you require from an initial pilot run to proceed to engineering/GMP campaigns? Options: Yield target met, Critical quality attributes within spec, Assays qualified, Batch record completeness, No open CAPAs, Other
• What is the maximum acceptable initial batch failure rate (first N GMP batches) before you’d reconsider the relationship? Options: 0%, 1–5%, 6–10%, 10–20%, >20%
• Are there specific release assay turnaround times or analytical capabilities that are non‑negotiable for you? Please list.

The Hidden Failure Modes We're Not Talking About

• What single overlooked failure mode keeps you most worried when transferring your process to another facility?
• List the key process steps and the critical quality attributes (CQAs) you believe are most fragile during tech transfer.
• Which failure modes have you already observed (or had flagged in risk assessments) and how frequently have they occurred? Options: Never observed, Rare (<1%), Occasional (1–5%), Frequent (5–15%), Common (>15%)
• What mitigation strategies have you tried previously (e.g., tighter specs, operator training, in‑process controls) and which actually reduced failures?
• Who on your team is typically accountable for root‑cause investigations and corrective actions after a manufacturing deviation? Options: Head of Quality, VP Manufacturing, Process Development Lead, Program Director, Other
• Are there specific materials, consumables, or supplier dependencies that you consider single points of failure?

Regulators, Inspections, and the Paper Trail

• If an FDA inspector reviewed your files tomorrow, where would you expect the most questions to land—and why?
• What regulatory milestone must manufacturing support next (select one)? Options: IND submission, End of Phase 1 report, Phase 2 readiness, BLA/MAA filing, Post‑market/commercial supply
• Which documents do you consider must‑have from a CDMO before a filing or inspection (select all that apply)? Options: Validated assays and SOPs, Complete batch records, Change control history, Stability data, Training records, Equipment qualification docs, Other
• Have you had regulatory findings or warning letters related to manufacturing in the last 5 years? If yes, what were the root causes? Options: No, Yes — documentation, Yes — process control, Yes — personnel/training, Yes — supplier management, Other
• What level of inspection access and transparency will you expect from a CDMO during audits (e.g., live tours, remote access to records, full audit report)? Options: Full onsite audit and tours, Remote access to records + selective onsite, Desk audit only, Custom arrangement (describe)
• Which regulatory partners or consultants (if any) will be involved in assessing the CDMO's readiness?

Capacity, Timing, and the Calendar Race

• If your critical path slipped by one month due to manufacturing capacity, what downstream program impact would you expect? Options: Minor internal replan, Delayed patient enrollment, Missed regulatory window, Budget overrun, Investor/partner escalation, Other
• What are your firm clinical or commercial dates that cannot move (e.g., first patient dosing, partner obligation)? Please list with deadlines.
• How flexible is your plan to shift manufacturing dates if supply or QC delays occur? Options: Highly flexible, Somewhat flexible, Minimally flexible, No flexibility — fixed dates
• Do you maintain backup manufacturing options or qualified secondary suppliers today? Options: Yes — fully qualified backup, Yes — informal backup, No, but exploring, No, single source
• What lead times do you require for critical materials and assays (e.g., cryoship, serums, custom reagents)?
• Which scheduling constraints from your side (clinic windows, patient availability, cohort timing) should we be aware of when proposing runs?

Money, IP, and Trust — The Unsaid Tradeoffs

• What parts of your process or analytics are IP-sensitive and require special handling or limited disclosure?
• Which contractual protections are non‑negotiable for you (select all that apply)? Options: Strong IP protections and data segregation, Indemnity for batch failures, Transparent pricing and change control, Inspection rights, Right to audit subcontractors, Other
• How comfortable are you sharing cell lines, SOPs, and raw data under a standard NDA? Options: Completely comfortable, Comfortable with redactions, Only under bespoke agreement, Not comfortable
• What would feel evidentially reassuring from a vendor to build trust quickly (e.g., site tour, operator credentials, historical batch metrics)?
• Are there specific insurance, liability, or indemnity levels you require from a CDMO? Options: Standard industry limits, Higher than standard, Specific policy clauses required, Unsure — need guidance
• What budget or commercial constraints (caps, milestone payments, milestone‑gated spend) will shape negotiation?

How We'll Know We're on the Same Team (Next 30–90 Days)

• What would you need to see in the first 30 days to feel confident we're aligned and capable? Options: Signed NDA + data transfer, Preliminary schedule and owners, Risk register and mitigation plan, Sample batch performance metrics, Site visit scheduled, Other
• What scope do you expect for a feasibility pilot (e.g., sample runs, analytics, documentation deliverables)? Options: Small feasibility runs only, Pilot + initial engineering run, Full engineering run with batch records, Custom—let's define together
• Which acceptance criteria should we include for a successful pilot-to‑GMP decision? Options: Yield threshold, CQA within spec, No unresolved deviations, Assay qualification, Complete traceable batch records, Other
• What cadence and format of progress reporting would make your team most comfortable (select all that apply)? Options: Weekly written updates, Weekly standup call, Biweekly steering committee, Shared project tracker, Real‑time QA dashboard access, Other
• What outstanding internal blockers must be cleared for us to begin (e.g., budget signoff, import permits, patient scheduling)? Please list with owners.
• Realistically, when could we start a scoped pilot if both parties agree today? Options: Immediately (within 2 weeks), 2–4 weeks, 1–2 months, 2–3 months, Longer — see notes

Start by Painting the Product Picture

• What's the short name/identifier for this product or program (so we can refer to it consistently)?
• Which cell therapy modality best describes this product? Options: Autologous (patient-derived), Allogeneic (donor-derived), CAR-T, T‑cell receptor (TCR) therapy, NK cell product, MSC / stromal cell product, Other
• What is the intended indication and the current clinical/regulatory stage (e.g., pre‑IND, IND, Phase I/II, BLA planning)? Options: Pre‑IND / discovery, IND filing / IND‑enabling, Phase I, Phase II, Phase III / registrational, Commercial / post‑approval, Other
• Describe the core biological attributes we should know about (cell phenotype markers, transgene, vector type, potency concept)—briefly list the essentials.
• Are there any known regulatory constraints tied to the product (e.g., viral vector type, donor screening, controlled materials)? Options: Yes — viral vector considerations, Yes — donor screening / donor eligibility, Yes — controlled or hazardous materials, No known constraints, Unsure / needs review

If This Product Could Break the Process, Where Would It Hurt Most?

• Which single failure mode would cause the largest schedule slip or trial delay if it occurred during tech transfer or early GMP runs? Options: Low yield / insufficient cell dose, Loss of potency, Contamination or sterility failure, Critical reagent shortage, Incompatible process parameters post‑transfer, Analytical assay failure, Other
• List the top 3 critical quality attributes (CQAs) you monitor today (e.g., viability, potency, purity, identity, VCN) and the numeric acceptance ranges where they exist.
• How often do CQAs drift outside expected ranges today, and what typically explains those events? Options: Never, Rarely (1–5%), Occasionally (5–15%), Frequently (>15%), Unknown / not tracked
• Thinking about failure patterns, which of these best describes the root causes you've experienced? Options: Biological variability, Operator technique / training gaps, Consumable / reagent variability, Assay inconsistency, Equipment or facility limitations, Supply chain interruptions, Other
• Tell us about a recent failure that cost time or patients—what happened, what did you learn, and how did it change your approach?

Walk Me Through a Batch Like I’m on the Floor

• Start at collection: what are the end‑to‑end core process steps from receipt to final formulation for a typical batch?
• Which of these steps are currently manual vs automated in your process? Options: Collection/receipt, Cell isolation, Activation, Genetic modification (transduction/transfection), Expansion, Harvest/harvest hold, Formulation/fill, Cryopreservation/thaw, Release testing
• Where do you have defined in‑process hold points that have historically caused delays, and why (e.g., assay turnaround, scheduling, QC availability)?
• Do you require closed system single‑use technologies or open clean‑room steps for any portion of this workflow? Options: Fully closed, single‑use, Mostly closed with a few open steps, Open cleanroom process, Hybrid — depends on campaign, Unsure / under evaluation
• How many trained operators and what specialist skills (e.g., viral vector handling, aseptic fill, cryopreservation expertise) would need to be assigned on our side to run one campaign successfully?

What Keeps You Awake at Night When We Talk About Technology Transfer?

• If the transfer went poorly, which outcome would you fear most: altered product quality, delayed patient dosing, regulatory findings, or lost IP—rank the single biggest fear? Options: Altered product quality / potency, Patient dosing delays, Regulatory inspection findings, Intellectual property exposure, Cost over‑run / restart
• Have you previously attempted a facility-to-facility tech transfer? If yes, describe the largest mismatch (process, equipment, materials, documentation) that created problems. Options: Yes — equipment mismatch, Yes — materials / raw material differences, Yes — undocumented operator technique, Yes — assay transfer failures, No prior transfers, Prefer not to say
• Which process parameters do you consider non‑negotiable during transfer (i.e., must be preserved exactly)? Options: Cell density/inoculum, Culture time/temperature, MOI / vector dose, Harvest window, Cryopreservation recipe / CPA exposure, Other
• What level of protocol detail do you require for a handoff—complete step‑by‑step SOPs, critical control plan only, or something in between? Options: Full SOPs with acceptance criteria, Critical control plan + key SOPs, High‑level process map then iterative SOP build, Flexible — will negotiate
• How concerned are you about material single‑sourcing or vendor qualification causing schedule risk, and which reagents would be the most critical to qualify early? Options: Very concerned — multiple single‑source reagents, Somewhat concerned — 1–2 critical reagents, Not concerned — multi‑sourced, Unsure

Show Me the Numbers—Yield, Purity, and the Stories Behind Them

• What is your target finished product dose and the average yield per batch you currently achieve (or expect) — provide units or ranges.
• What acceptance criteria do you use for release related to yield, viability, potency, and purity?
• How many lots/batches are in your internal dataset and how variable are key metrics (CV% or range) across them? Options: <5 lots, 5–15 lots, 16–50 lots, >50 lots, No organized dataset
• What are the most common reasons you've had to reject or scrap a batch historically? Options: Low cell count / dose shortfall, Failed sterility / contamination, Out‑of‑spec potency, Documentation errors / missing data, Raw material failure, Other
• When yield or purity falls short, what mitigation steps do you prefer (rework, additional expansion, patient reschedule, regulatory notification)? Options: Rework / salvage processing, Extend expansion time, Use backup product or donor, Reschedule patient, Regulatory engagement, Other

Testing, Assays, and the Confidence They Buy (or Don't)

• Which release and stability assays are mature and fully qualified today versus which are still exploratory or development stage? Options: Identity, Viability, Potency, Purity (residuals/impurities), Vector copy number, Sterility / endotoxin, Other
• Which assays do you expect us to run in‑house versus transfer back to your lab or a CRO? Options: All assays run by us, Core release assays in‑house, specialized assays by Sponsor, Most assays by Sponsor / CRO, Undecided — open to discussion
• What is the current turnaround time for your critical assays (from sample in to result), and which are schedule bottlenecks? Options: <24 hours, 24–72 hours, 3–7 days, >7 days, Variable / unknown
• How confident are you in the robustness and reproducibility of your potency assay today, and what would convince you it’s production‑ready? Options: Very confident, Somewhat confident, Not confident — needs development, Unknown
• Are there stability or hold‑time constraints for intermediate or finished product that we must design around? Please specify the longest acceptable holds.

If We Partner, What Would Success Look and Feel Like?

• Imagine the first GMP campaign with us is complete—what one measurable outcome would make you say we delivered? Options: On‑time patient dosing, Achieved target yield/potency consistently, No major quality deviations, Smooth regulatory interactions, Cost within forecast, Other
• Which KPIs should we report back to you weekly so you feel in control (e.g., yield vs target, assay pass rate, deviations, material availability)? Options: Yield vs target, Potency pass rate, Sterility / contamination events, Deviation count open/closed, Material on‑time delivery, Cycle time per batch, Other
• What communication cadence and escalation protocol would keep you comfortable during transfer and early GMP runs? Options: Daily operations call + immediate escalation, 3× weekly updates, Weekly summary + urgent alerts, Biweekly check‑ins, Asynchronous updates only
• What are the non‑negotiable regulatory milestones or filing dates we must align with (e.g., IND submission, first patient dosed by X date)?
• If a trade‑off became necessary (speed vs documented robustness), which direction would you prefer we bias toward in early campaigns? Options: Prioritize speed to patient, Prioritize robustness/documentation for filing, Balance equally, Decision depends on program stage

Practical Constraints & Unknowns — Dependencies That Make or Break Schedules

• Which external dependencies are most likely to derail your timelines (rank one): vendor material lead times, patient scheduling, regulatory review, or internal decision delays? Options: Vendor material lead times, Patient scheduling / clinical site availability, Regulatory review timelines, Internal governance / approval delays, Other
• List any single‑source suppliers or custom reagents you rely on and the typical lead time for each.
• Do you have master files, CMC packages, or device registrations that we can reference during transfer, or will that documentation need to be generated from scratch? Options: Complete CMC / master files available, Partial documentation available, Documentation needs to be generated, Unsure / will need to confirm
• Are there clinical or site constraints we should know about (e.g., single patient per dosing window, cryo‑chain limitations, narrow shelf‑life)?
• What unknowns would you most like us to help reduce during feasibility (e.g., hold‑time validation, assay qualification, alternative suppliers)? Options: Hold‑time validation, Assay qualification, Alternative raw material sourcing, Process robustness characterization, Regulatory strategy alignment, Other

Start Here — Quick snapshot of your program

• What is your role and the one sentence summary of your responsibility for this program? Options: VP of Manufacturing, Head of Process Development, Program Director, Chief Technical Officer, Other
• What modality and product type are we talking about? Options: Autologous CAR‑T, Allogeneic CAR‑T, TCR‑T, NK cell therapy, Mesenchymal stem cells (MSC), Other
• Where are you in the development timeline right now? Options: Pre‑IND / IND enabling, IND filed / Phase 1, Phase 2 / Dose expansion, Pivotal / Phase 3, Commercial launch planning
• Roughly how many patient doses or batches do you expect per month at initial GMP scale?
• Do you have internal GMP capacity today or are you fully outsourcing? Options: Fully internal, Hybrid (some internal, some CDMO), Fully outsourcing, Evaluating options
• What is your target window for first commercial GMP campaign or pivotal batch release (quarter/year)? Options: Next 3 months, 3–6 months, 6–12 months, 12+ months, Not sure

If this program slips, where does it hurt the most?

• What single manufacturing problem would force you to delay patient dosing or a filing? Options: Low yield causing insufficient doses, Impurity or potency failure, Failed comparability after transfer, QC release delays, Regulatory inspection finding
• Tell us about a recent manufacturing incident (if any): what happened, and what was the downstream impact?
• How often are such failures or near‑misses occurring in your program today? Options: Monthly, Quarterly, Rarely — once a year or less, Never experienced yet
• When a failure happens, how long can your program realistically absorb the delay before major consequences (e.g., missed trial enrollment, FDA milestone impact)? Options: < 1 month, 1–3 months, 3–6 months, > 6 months, Unsure
• How does the team feel when a run is at risk — frustrated, resigned, scrambling? Describe the emotional and operational response.

Who truly holds the keys — decision dynamics and escalation

• If something critical goes wrong on a GMP run, who will ultimately make the go/no‑go call? Options: VP Manufacturing, Head of Quality, Program Director, Chief Medical Officer, Cross‑functional committee
• Who are the three stakeholders you must convince before signing a multi‑batch contract, and what does each care most about?
• Where do stakeholder priorities conflict today (e.g., speed vs. comparability vs. cost)? Give concrete examples.
• What’s the escalation path for a QA/quality event — who is notified, and how fast do decisions happen? Options: Immediate executive escalation, QA + Program lead first, execs if unresolved, Escalate only for regulatory impact, Unsure / undocumented
• Which stakeholder’s approval is most likely to slow a decision, and why?

Are we changing the product when we change the process?

• Which critical quality attributes (CQAs) absolutely must remain stable during transfer and scale‑up? Options: Viability, Potency, Purity/impurity profile, Transduction/expresssion level, Identity markers, Other
• Which process parameters do you consider most sensitive — the ones small shifts break CQAs? Options: Culture duration, Cell concentration at inoculation, Transduction MOI, Wash and formulation steps, Cryopreservation conditions, Other
• Which release assays are qualified today and which still need development or bridging? Options: Viability, Potency, Sterility/mycoplasma, Endotoxin, Identity by flow, Genetic assays, None / all need qualification
• Have you previously seen a tech transfer change that altered clinical performance or comparability? Tell us what changed and the impact.
• How much comparability data will regulators expect for your IND/BLA — head‑to‑head, statistical, or totality of evidence? Options: Head‑to‑head comparability, Bridging data + analytical comparability, Regulatory guidance not yet defined for product, Unsure

What minimum evidence lets you say yes?

• What are the non‑negotiable quantitative targets for initial GMP runs (e.g., minimum yield, potency range, acceptable impurity levels)?
• Which of these outcomes would you accept as proof of feasibility from a pilot run? Options: Consistent yield across 3 runs, Potency within predefined range, Stable identity markers, Complete batch documentation and traceability, QC assays passing predefined criteria
• How much variability in key metrics is tolerable during engineering runs before you require process rework? Options: < 5% CV, 5–15% CV, 15–30% CV, > 30% CV / not tolerable
• What regulatory filings or filing language must be in place prior to commercial campaigns (e.g., IND amendments, CMC language, comparability protocols)?
• What documentation or audit evidence will make your QA comfortable with releasing pivotal/commercial batches? Options: Complete batch records, Validated assays and certificates, Operator training records, Vendor qualification and material certificates, All of the above

Where will the schedule break — supply chain, people, or lab?

• If we book your first GMP slots, which single constraint is most likely to cause a missed ship or delayed release? Options: Qualified assay delays, Material/component shortages, Staffing or training gaps, QC turnaround time, Logistics/cold chain
• Do you have critical vendors or single‑source components that would halt a run if unavailable? Please list and indicate lead times.
• How much cross‑training exists for operators and QC staff — could another site or team step in quickly? Options: Fully cross‑trained, Partially cross‑trained, Single team / not cross‑trained, Unsure
• What is your current QC turnaround time for release assays and what would be an acceptable target? Options: < 48 hours, 48–72 hours, 3–7 days, > 7 days
• Have you had reagent or raw material lot changes cause release failures before? How long did resolution take?

Imagine success — six months after your first GMP campaign

• What three measurable signals will prove the partnership worked (e.g., on‑time dosing, percent of batches released, regulatory inspection outcome)? Options: On‑time patient dosing, Batch release rate (%), Regulatory inspection with no major findings, Stable product CQAs over time, Commercial launch readiness
• How will internal stakeholders know they can relax — what reporting cadence and KPIs do you want? Options: Weekly executive summary, Daily run dashboards during campaigns, Post‑run technical reports, Monthly program review
• What ongoing improvements would you expect from a CDMO partner after the initial campaigns (e.g., reduced variability, faster release, cost optimization)?
• If a deviation occurs post‑release, how would you like communications and root cause engagement to be handled? Options: Immediate notification + remediation plan, Notify after initial assessment, Only if patient or regulatory impact, Other
• Would you want a shared channel for near‑real‑time issues and continuous improvements (e.g., Slack, secure portal)? Options: Yes — real‑time channel, Monthly consolidated reports, Only formal documentation, Unsure

Contracts, IP, and the things that make a team say yes (or walk away)

• What contracting model would make you most comfortable to commit (pick all that apply)? Options: Per‑batch pricing, Capacity reservation / guaranteed slots, Milestone‑based payments, Hybrid retainer + per batch, Other
• What IP or confidentiality concerns keep you up at night when sharing process details with a CDMO? Options: Freedom to operate / licensing, Process know‑how leakage, Use of cell lines or constructs, Data ownership and access, None
• Who must be named or present in the contract for inspections, audits, or regulatory interactions?
• What go/no‑go criteria post‑pilot would you require before signing for multi‑batch commercial production? Options: Predefined yield/potency met, Three consecutive passing runs, Regulatory filing updated, Mutual operational readiness checklist
• What are your biggest negotiation levers (price, slot priority, liability limits, inspection responsibilities) and which are non‑negotiable?

Getting Comfortable — Tell Us About Your Program

• What is your role and primary responsibility for this program? Options: VP, Process Development, Head of Manufacturing, Program Director, Chief Technical Officer, QC/QA Lead, Other
• What stage is the program currently at and what milestone are you racing toward right now? Options: Pre-IND / IND-enabling, Phase 1 clinical, Phase 2/3 clinical, Preparing for commercial launch, Other
• Which cell therapy modality and product format are we talking about? Options: Autologous CAR-T, Allogeneic CAR-T, T-cell therapy (non-CAR), NK cell therapy, MSCs / stromal cell product, Gene-modified cell therapy, Other
• What single outcome would make you consider this engagement an unequivocal success?
• What is your target go-live date for first GMP patient/lot (month/year)? Options: Within 3 months, 3-6 months, 6-12 months, 12-18 months, 18+ months, Unsure

Why Now Feels Risky — The Consequences You Can’t Ignore

• If the next six months went badly, what single consequence would hurt the program the most?
• Which of these risks keeps you up at night right now? Options: Batch failure causing dosing delays, Technology transfer changing product profile, Capacity contention with other sponsors, Regulatory findings during inspection, Supply chain for critical reagents, Assay failures/unreliable CQAs, Other
• Have you experienced any of these risks before? Tell us one concrete example and its impact.
• When these risks manifest, how do they typically show up operationally? Options: Patient dosing delayed, Increased number of engineering runs, Regulatory hold or request for more data, Cost overruns, Rework and additional testing, Other
• Roughly, what is the schedule or cost impact if one critical batch fails (days and/or dollars)?

Who Holds the Keys? — Decision Roles and Pressure Points

• Who will ultimately sign off on selecting a contract manufacturer, and what will they require to sleep at night?
• Which stakeholders must be engaged in the decision (select all that apply)? Options: VP Manufacturing, Head of Process Development, Program Director, Chief Medical Officer, Head of Quality/QA, Head of Regulatory, Procurement/Legal
• What is the decision timeline and the key gating milestones for contracting? Options: Decision within 30 days, 30-60 days, 60-90 days, 90+ days, Tied to specific regulatory filing
• What types of evidence or deliverables will the decision-makers expect to see before committing? Options: Pilot batch data, On-site audit report, SOPs and quality agreements, Draft contract and SLAs, Regulatory inspection readiness documentation, References from similar programs
• Who will be the day-to-day operational contact from your side and what decision authority will they have?

Hidden Assumptions — What We Might Be Taking for Granted

• What assumption about your process or controls are you most willing to bet the timeline on — and why might that assumption be wrong?
• Which product attributes are absolute non-negotiables for you? Options: Target cell identity/phenotype, Transduction efficiency, Potency assay result, Viability threshold, Impurity limits, Closed system workflow, Other
• Which process steps are least characterized or most dependent on tacit operator skill?
• How confident are you in your current analytical methods (CQAs and release assays) for showing comparability? Options: High confidence, Moderate confidence, Low confidence, No validated assays yet
• When was the last time you ran a comparability, bridging, or stability study that would support transfer? Options: Within 3 months, 3-12 months, 12-24 months, More than 24 months ago, Not yet performed

If FDA Inspected Tomorrow — The Evidence You’d Lean On

• If FDA walked through and asked why batches are acceptable, what single piece of evidence would you want to point to first?
• Which measurable success signals must we demonstrate together? Options: Batch yield / cell dose achieved, Viability, Potency measurements, Transduction efficiency, Impurity/sterility results, Time to release
• What numeric targets or acceptable ranges do you require for those signals?
• Which regulatory submissions or documents are on your roadmap and which must be supported by our work? Options: IND, BLA, IMPD, DMF, Comparability package, Stability data for CMC
• How will you define clinical readiness versus commercial readiness for this product?

The Pilot Run That Proves It — Expectations and Acceptance

• What would a failed pilot run reveal that would force you to change program strategy?
• What are the must-pass objectives for pilot and engineering runs? Options: Yield and dose consistency, Purity/impurity limits, Process robustness across operators, Complete batch records, Analytical method performance, Stability indicators
• How many pilot/engineering batches would you consider sufficient to make a go/no-go decision? Options: 1, 2, 3, 3-5, More than 5, Undecided
• What acceptance criteria and decision gates would you use to move from pilot to commercial GMP?
• Who will be on the review board for pilot data and how will a go/no-go vote be documented? Options: Internal steering committee, Head of Quality/QA, External scientific advisor, Executive sponsor

Risk Sharing, Commercial Lines, and What We Put on the Table

• What portion of program risk are you unwilling to absorb, and where would you expect the manufacturer to shoulder accountability?
• Which commercial and contractual terms matter most to you? Options: Service level agreements (SLAs), Financial penalties for missed timelines, Milestone-based payments, IP protections and use restrictions, Inspection and liability clauses, Other
• What level of audit/access and inspection transparency will you require? Options: Routine audits and reports, Live remote access, On-site inspections only on request, Full audit trail and documentation access
• What are your top confidentiality or IP concerns when sharing process details with an external partner?
• Which proof points would make you confident in our accountability (select all that apply)? Options: Historical success rate for similar modalities, Recent audit reports and inspection history, Client references and case studies, On-site tour and operator interviews, Shared SOPs and joint training plans

Logistics, Materials, and Practical Readiness

• What single logistical constraint would most likely derail your planned campaign?
• Who is responsible for supplying critical starting materials and how reliable are those sources? Options: Sponsor supplies all critical materials, Manufacturer supplies some materials, Third-party suppliers, Mixed model
• Are there single-source reagents, cell banks, or assays that require special handling or lead time? Please list them.
• What cold chain or shipping requirements are mandatory for your product? Options: Cryopreserved in LN2, Dry ice frozen shipments, Refrigerated 2-8C, Ambient stable, Other
• Do you have validated release assays today or will you need assay development/validation support? Options: Fully validated and transferable, Partially validated, Not validated — need support, Unsure
• What training, staffing, or resource constraints on your side would impact campaign launch?

Next Steps — What Would Make You Say Yes (and Fast)

• What is the minimal evidence package that would enable you to commit within 30 days?
• Which items would you want included in a formal discovery deliverable? Options: Executive summary + risks, Pilot plan and acceptance criteria, Draft QA/QC and batch record templates, Commercial terms outline, Regulatory readiness checklist, Full data appendix
• What is your preferred timeline for contracting and running the first GMP batch? Options: Start contracting immediately, batch within 30 days, Contract in 30-60 days, batch in 60-90 days, Contract in 60-90 days, batch >90 days, Unsure
• Who must be at the next meeting to make progress (names and roles)?
• How would you like us to present the findings from this discovery so they are most useful to your decision-makers? Options: Short executive summary, Full technical report and appendices, Workshop with stakeholders, Live data review session
• Are there any constraints, sensitivities, or political factors inside your organization we haven't touched on that would affect selection or timelines?