Go looking for the answer in FDA or EMA guidance and you will not find it. Surely, you assume, somewhere in the regulatory literature on evidence generation an agency has written down which function inside a sponsor company is supposed to hold the Integrated Evidence Plan, clinical development, regulatory affairs, medical affairs, someone. It would be reasonable admin, and regulators specify plenty else.
They have never specified this.
21 CFR 314.81 puts postmarketing reporting this way: "Each applicant shall make the reports for each of its approved applications." [1] 21 CFR 314.510, covering the postmarketing studies that ride on an accelerated approval, is no more specific: "The applicant shall carry out any such studies with due diligence." [2] The EMA's guidance on Post-Authorisation Safety Studies uses the same undifferentiated noun: "Marketing-authorisation holders (MAHs) are obliged to carry out imposed PASSs." [3] Applicant, sponsor, marketing-authorisation holder always the company, one legal throat to choke, never a department, never a job title.
Call this the sponsor fiction: the regulator's polite pretence that a company is one entity with one will, when inside the building it is, in the words of DiMasi and colleagues, "a fragmented collective of functional areas including research, clinical development, clinical operations, medical affairs, data management and health economics and outcomes." [4] The regulator has permanently delegated the accountability question to you, and it was never going to answer it. Every consultancy currently selling you a framework for the plan is quietly guessing at an answer the regulator refuses to give.
This post argues the plan needs exactly one named, accountable owner, distinct from its many legitimate contributors, and that neither the regulator nor the default committee model will ever hand you that name. We've written before about what a strong IEP does for your regulatory position; this one is about who inside the building actually has to hold the pen.
DiMasi's fragmentation finding [4] is a description of how the work is actually organised, not a complaint about any one function falling short. Every clause in that list names a real claim. Regulatory affairs has one on the submission strategy the plan exists to serve. So does biostatistics and RWE, on the methodology that has to survive an agency's statistical review, and medical affairs, on the post-approval evidence and the scientific narrative that outlives the trial. Clinical development's claim is the trial architecture the whole plan is built around. None of the four is wrong to want a say, and none should be silenced to tidy up the org chart.
Lee and colleagues reach a thinner but consistent verdict, independently, in a separate peer-reviewed piece: "organizational inertia and the need for cross-functional alignment remain" as named challenges, and "successful IEP implementation requires strong leadership, stakeholder buy-in, and optimized resource allocation." [5] Notice what that sentence does not do: it never says which function should lead, and nobody in the peer-reviewed literature does either.
A plan can have four legitimate functional contributors and zero accountable owners at the same time that's the actual problem. Contribution and accountability are not the same relationship to a document, and the moment you treat them as interchangeable is the moment this goes wrong.
Think of it as a relay, not a committee. Regulatory affairs runs its leg, biostatistics runs its leg, medical affairs and clinical development run theirs, and every leg is genuinely theirs to run. But a relay has exactly one pair of hands on the baton at any given moment. Slow runners cost you seconds; a missed handoff costs you the race, and handoffs only happen when someone was explicitly assigned to take them.
The Monday exercise: list everyone who currently writes into your IEP, then ask the harder question, who is accountable if it goes stale? If the two lists are identical, you have contributors, not an owner.
We have written elsewhere about what this same fragmented-collective reality looks like for a lean team short on runway, where there are simply fewer people to absorb it. That post assumed a working plan already existed; this one is about who signs for it.
Every team that skips naming an owner reaches for the same fallback, and it never feels like a mistake at the time: "leadership owns it collectively," or, more casually, "it's a living document, everyone updates it." This is the reasonable-sounding default any team under time pressure reaches for, not a failure of judgement, because naming one person feels like a political call nobody wants to make in month three.
It is also, reliably, how a plan goes stale.
Social psychology settled this territory decades before anyone was writing evidence-generation plans, and it is only fair to flag up front that what follows is a laboratory finding about people, applied here by analogy, not a management study of biotechs. Darley and Latané, in 1968, found that the presence of others who nominally share responsibility for responding to an emergency reduces the odds that any one individual acts, and slows the ones who eventually do. [7] Wallach, Kogan and Bem, working independently in 1964, found that groups collectively land on riskier, more neglectful courses of action than the same individuals would choose alone, because felt accountability dilutes the moment it is shared. [8] Neither team ever studied a biotech, but the mechanism they found, accountability evaporating the instant it is distributed, is exactly what "everyone owns it" produces on a leadership team.
That is what diffusion does to an IEP left to "everyone": not a moral failing in any one function, just what happens, reliably, when no single person owns the consequence if it goes stale.
And it bites at the worst possible moment: a pivotal readout, a pre-BLA meeting, or the middle of an investor's diligence process, exactly when someone across the table asks to see the plan and what gets opened is eight months out of date. A quiet month would have cost nothing. This is never a quiet month.
I watched something close to this happen once, at a company I will not name for the obvious reason. The IEP had been "everyone's" for the best part of a year, every function with a folder and an opinion, and updating it was, by informal agreement, whoever noticed it needed doing. Nobody noticed for two straight quarters, until a diligence team asked to see the plan three weeks before a financing round was due to close, and what came off the shared drive was accurate as of the previous autumn and silent on everything since. Nobody on that team was careless. The plan simply didn't have a name attached to it, so no one felt it was specifically theirs to keep current.
If your IEP's update cadence depends on someone volunteering, that's hope, not ownership.
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Get the template pack →These next cases prove something narrower than "poor ownership causes failed trials," worth saying before naming them. ClinicalTrials.gov records protocols and timelines, not internal org charts, and a registry search for a phrase like "cross-functional steering committee" returns nothing, because that is simply not what registries are for. What these three programmes show is the scale of the cost when a multi-year evidence commitment outlives whoever happened to be managing it, not the specific internal mechanism that let it drift.
Makena, approved under the accelerated pathway on the strength of a single trial, carried a confirmatory obligation that ran roughly nine years, from a 2009 start to a 2018 primary completion (NCT01004029) a trial whose sponsor of record changed hands twice while it was still running, from the drug's original owner to Lumara Health and then, in 2014, to AMAG Pharmaceuticals, before the trial reported no benefit in 2019 and the drug was withdrawn from the market in 2023. [9]
Eteplirsen's confirmatory obligation, tied to its 2016 accelerated approval, was re-papered across three separate registered protocols in succession: NCT02255552, completed in 2019; NCT03985878, terminated after enrolling only 15 patients; and NCT03992430, still active, with a primary completion date now listed as October 2026. [10] A full decade later, the obligation still is not closed out.
One live case shows the same mechanism from the other side of the table, and it deserves the caveat up front: this is the agency's accountability breaking down, not a sponsor's. Replimune's BLA for its oncolytic therapy RP1 has drawn two Complete Response Letters, in July 2025 and again in April 2026; the company has disclosed that a different FDA review team, replacing the one that had overseen the application for years, was assigned specifically "to maintain objectivity and account for potential bias," and reportedly would not meet with Replimune despite the company's request. STAT News, citing FDA officials, attributed part of the outcome to "leadership changes, staff upheaval, and internal dysfunction" at the agency. [12] Discontinuous accountability produces the same visible stall whichever side of the table it happens on.
An IEP's commitments are routinely multi-year obligations that will outlive whoever manages them today. Attach accountability to a person's attention span or a committee's mood, and the years compound the risk quietly, right up until the moment they stop being quiet.
Only one source in the research base draws this line as a structural claim, not an appeal to collaborate more. ZS describes "an assigned, accountable project owner who can make swift decisions and present strategic options to leadership", typically "the medical affairs product lead or their collaborator in real-world evidence (RWE) or health economics outcomes research (HEOR)," a different job from "an operations lead," typically a project manager or Strategy & Operations person assigned per study, who "actively coordinate with relevant cross-functional teams." [6] Neither is the same as the contributors who feed the plan its content.
Let's be blunt about what "the sponsor is accountable" actually means: nothing, until you decide who inside your building that is. So decide, and treat it as three separate jobs, named plainly:
Where does that first job most defensibly sit early on? A senior clinical development or regulatory strategy lead, reporting to the CMO or CSO, reasoned from where the plan's centre of gravity sits before a first approval: the regulatory interactions it exists to prepare for. That is this post's own recommendation, not a placement any source documents as an industry standard, because none does, and it is not fixed for the company's life. ZS notes that governance meetings recur "two to eight times per year based on where the product is in its life cycle" [6]: cadence tracking the stage, a smaller claim than a documented handoff of the role itself. What is directionally true, covered at the length it deserves in our post on the shift from clinical development to medical affairs, is that the owner's functional home plausibly moves toward medical affairs and RWE/HEOR as launch approaches; this post gestures at that shift rather than re-deriving it.
For a refresher on what the document itself is for before you decide who owns it, that groundwork is already covered; this post cares only about the name on the file.
Write down one name, one title, this quarter. Then write your operations lead's name next to it, even if today it is the same person. The distinction matters most exactly when the team grows and the two jobs need to split, which is precisely the moment nobody remembers to do it.
Here is the strongest objection to all of this, and it deserves a fair hearing rather than a strawman's dismissal: at a twelve-person biotech, doesn't everyone already know who owns everything, because there is nobody else to hand it to? Isn't naming a formal "accountable owner" solving a problem your headcount has not created yet?
It's a good question, and the honest answer is no, for a reason that has nothing to do with headcount. The fragmentation DiMasi describes is functional, not a function of team size. [4] At twelve people, one person routinely wears three of the functional hats named above already: clinical development, regulatory strategy, half of medical affairs. Unless one of those hats is explicitly labelled "I hold the plan," the same diffusion happens inside one overloaded person's week that happens across a twenty-person committee, because the mechanism never depended on headcount, only on how many nominal claims sit on the same responsibility. Naming the owner costs nothing; it makes explicit what was already implicit, and implicit is exactly what goes missing under deadline pressure.
There is a genuine gap worth stating rather than papering over: no credible published benchmark exists for biotech clinical, regulatory and medical-affairs headcount ratios by company stage. [13] That said, do not wait for the "right" team size to make this call. It is a decision, not a hire, and you can make it this afternoon regardless of how many names are on the payroll.
Give the accountable owner one concrete job beyond holding the title: convening the cross-functional review at named triggers, not a standing meeting everyone silently tolerates and nobody prepares for. Name the triggers: pre-IND, End-of-Phase-II, pre-BLA, every fundraising round. Each is a moment someone outside your building will ask to see the plan, and each is exactly when a stale plan costs the most.
The regulator will only ever hold the sponsor fiction accountable, one undifferentiated legal entity with no department and no name attached. Who that actually is inside your walls has always been your decision to make, not theirs to hand you, and a relay only drops when nobody was assigned to take the handoff.
Which title? Not "leadership."
This is the kind of ownership-and-cadence work we help teams settle when they are standing up an IEP for the first time, whatever size they currently are. But the decision itself doesn't require us, or anyone else. It requires a name on a document, by Friday.
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[1] FDA. 21 CFR 314.81 (Other postmarketing reports). Verbatim: "Each applicant shall make the reports for each of its approved applications." Read via the Cornell Legal Information Institute. https://www.law.cornell.edu/cfr/text/21/314.81
[2] FDA. 21 CFR 314.510 (Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity — the accelerated-approval provision under Subpart H). Verbatim: "The applicant shall carry out any such studies with due diligence." Read via the Cornell Legal Information Institute. https://www.law.cornell.edu/cfr/text/21/314.510
[3] EMA. "Post-Authorisation Safety Studies (PASS)." Verbatim: "Marketing-authorisation holders (MAHs) are obliged to carry out imposed PASSs." https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass
[4] DiMasi JA, Olson MS, Smith Z, Getz KA, Capkun G. (2025). "Assessing the Value of Integrated Evidence Approaches in Drug Development." Therapeutic Innovation & Regulatory Science;59(4):808–816. PMID: 40266444. DOI: 10.1007/s43441-025-00778-y. https://pmc.ncbi.nlm.nih.gov/articles/PMC12181097/
[5] Lee WC, Blanchette C, Pokras S, Shaikh J, Miller J. (2025). "The evolution and future of integrated evidence planning." Expert Review of Pharmacoeconomics & Outcomes Research;25(6). PMID: 40266581. DOI: 10.1080/14737167.2025.2497876. https://pubmed.ncbi.nlm.nih.gov/40266581/
[6] ZS. "Best practices for executing an integrated evidence plan." https://www.zs.com/insights/best-practices-integrated-evidence-planning-and-generation
[7] Darley JM, Latané B. (1968). "Bystander intervention in emergencies: diffusion of responsibility." Journal of Personality and Social Psychology;8(4):377–383. PMID: 5645600. DOI: 10.1037/h0025589. https://pubmed.ncbi.nlm.nih.gov/5645600/
[8] Wallach MA, Kogan N, Bem DJ. (1964). "Diffusion of responsibility and level of risk taking in groups." Journal of Abnormal Psychology;68:263–274. PMID: 14126840. DOI: 10.1037/h0042190. https://pubmed.ncbi.nlm.nih.gov/14126840/
[9] AMAG Pharmaceuticals, Inc. "Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth" ("PROLONG"). ClinicalTrials.gov: NCT01004029. Start 2009-10; primary completion 2018-10. https://clinicaltrials.gov/study/NCT01004029 — Trial sponsor history (originally Hologic and KV Pharmaceutical, then Lumara Health, then AMAG Pharmaceuticals following AMAG's 2014 acquisition) and primary result ("17-OHPC did not decrease recurrent PTB") per Blackwell SC, et al. "17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial." American Journal of Perinatology. 2020;37(2):127–136. PMID: 31652479. DOI: 10.1055/s-0039-3400227. AMAG's 2014 acquisition of Lumara Health and Covis Group's 2020 acquisition of AMAG per Fierce Pharma, "Troubled AMAG snaps up fresh-from-bankruptcy Lumara in $1.25B deal," https://www.fiercepharma.com/m-a/troubled-amag-snaps-up-fresh-from-bankruptcy-lumara-1-25b-deal, and BioSpace, "Covis Group to Acquire AMAG Pharmaceuticals in $647 Million Deal" (2 Oct 2020), https://www.biospace.com/covis-buys-amag-pharma-for-647-million. Market withdrawal per FDA, "FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena," https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.
[10] Sarepta Therapeutics. Eteplirsen confirmatory/follow-on protocols. ClinicalTrials.gov: NCT02255552 (completed 2019); NCT03985878 (terminated, enrolled 15); NCT03992430 "MIS51ON" (active, primary completion listed 2026-10-31). https://clinicaltrials.gov/study/NCT02255552 , https://clinicaltrials.gov/study/NCT03985878 , https://clinicaltrials.gov/study/NCT03992430
[11] Biogen. "ENVISION" — A Study to Verify the Clinical Benefit of Aducanumab in Participants With Alzheimer's Disease. ClinicalTrials.gov: NCT05310071. Started 2022-06; listed completion 2024-08; terminated; 1,027 participants, 265 sites. https://clinicaltrials.gov/study/NCT05310071
[12] Replimune Group. RP1 (vusolimogene oderparepvec) BLA disclosures, corroborated across BioSpace, Dermatology Times, CancerNetwork, PharmExec and BioPharma Dive (Jacob Bell, 29 May 2026); STAT News (Adam Feuerstein, 4 August 2025), cited via FDA officials. First CRL July 2025; second resubmission October 2025; second CRL April 2026; third resubmission announced 29 May 2026.
[13] No published benchmark for biotech clinical, regulatory and medical-affairs headcount ratios by company stage could be located in the course of researching this piece; stated here as a confirmed gap rather than filled with an unverifiable figure.