Dr. Orell MielkeClinical Development · Neurology
Fractional & interim medical leadership

The expertise your programme needs most is the expertise you can least afford to keep on payroll.

I am a board-certified neurologist who spent twenty-two years turning clinical programmes into approvals — at a CRO, at a thirty-person biotech, and as head of the immunoglobulin section of a global pharma company. From 2027 I do that work for teams who need senior medical judgement at the decisive moments, not fifty-two weeks a year.

Available for engagements from January 2027 · Conversations and NDAs now

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Verifiable

  • CIDP approvals via FDA, EMA/CHMP, PMDA, Health Canada, Swissmedic, TGA, Medsafe and MHRA
  • US$6.0 bn franchise — the immunoglobulin portfolio whose clinical strategy I headed (CSL FY2025)
  • 7 years US orphan drug exclusivity secured
  • 30+ peer-reviewed papers, incl. the pivotal trial in The Lancet Neurology
  • 10+ concurrent programmes led, teams of 10–15 across six countries
  • Inspections and audits with FDA, MHRA, PMDA and national authorities
Where the industry stands

Fixed capacity is shrinking. Complexity is not.

Every clinical development team I speak to in 2026 is being asked the same thing: deliver the same rigour with fewer people, against a regulatory landscape that changed three times while you were recruiting.

−3.6 %
R&D spend across the top 16 pharma companies, 2025
BioSpace / Evaluate
39 %
of biotechs holding less than twelve months of cash
EY
~3,500
FDA positions cut — with documented delays to meetings and feedback
PharmaVoice / Pharma's Almanac
$2.67 bn
average cost to bring one asset to market — up from $2.23 bn
Deloitte

Three things landed at once

ICH E6(R3). Principles and Annex 1 have applied in the EU since July 2025; Annex 2 follows in January 2027. Risk-proportionate oversight replaces one-size-fits-all monitoring, and sponsor accountability for delegated work is now explicit.

An FDA under reconstruction. Roughly a fifth of the workforce gone, six changes at the top of CDER and CBER, meeting requests denied or slipping past their own targets. The preparation you used to do after the meeting request now has to be done before it.

Europe still losing ground. The EU's share of global trials fell from 22 % to 12 % in a decade. CTR and CTIS are now the only route, and the sponsors who struggle are the ones who treated the transition as a filing exercise.

What follows from it

None of this makes senior medical expertise less necessary. It makes it necessary in bursts — at the protocol, at the briefing package, at the data cut, at the inspection, at the report. Between those moments, a full-time chief medical officer is an expensive way to wait.

And the cost of getting those bursts wrong has gone up. A protocol that cannot answer the agency's first question costs a year. A study report that invites questions costs a review cycle. In a market where more than a third of biotechs have under twelve months of cash, a year is the whole company.

„That is the gap I work in: full seniority, partial time, complete accountability.“

What I do

Four decision points where senior judgement pays for itself — usually two to eight days a month.

At each of these, the medical call either saves you a year or costs you one. I take responsibility for the outcome, not for the slide deck.

01

Fractional & interim medical lead

The medical voice in your development team — permanently available, not permanently employed. I sit in your clinical development team, sign off on the medical questions, chair the medical monitor calls and represent the programme in front of your board, your investors or your partner.

  • Medical monitoring, safety review, protocol deviations
  • IDMC and steering committee set-up and chairing
  • Investigator and KOL relationships
  • Bridging a vacancy, a parental leave or a fundraise
Typical trigger: your medical director left, and the data cut is in eleven weeks.
02

Development plan & study design

The document that decides whether the next fifty million euros are well spent. I write clinical development plans and protocols that survive contact with an ethics committee, a sceptical investigator and a regulator on the same day — including the hard cases: small populations, subjective endpoints, placebo in a treated disease.

  • Clinical development plan, target product profile, evidence strategy
  • Endpoint selection, relapse definitions, PRO and MCID strategy
  • Designs for rare and small populations, open-label extensions, substudies
  • Second opinion on a design before you commit to it
Typical trigger: you have a molecule, a hypothesis and a board meeting in six weeks.
03

Study reports & regulatory documents

Most programmes do not fail at the data. They fail at the telling of it. I work hand in hand with medical writing, biostatistics and regulatory affairs to turn a locked database into documents that a reviewer can follow without asking — from topline shells to the clinical study report and the clinical modules of the dossier.

  • CSR strategy, shells, medical narrative, author of record
  • Modules 2.5, 2.7.3 and 2.7.4; briefing books; responses to information requests
  • Agency-ready across FDA, EMA/CHMP, PMDA, Health Canada, MHRA, Swissmedic and TGA
  • Label negotiation — down to the wording of a single sentence
  • Publication strategy, manuscripts, congress abstracts, lay summaries
Typical trigger: database lock is done and nobody owns the story.
04

New indications in neurology & neuroimmunology

Opening an indication is a different craft from running a trial in one. It means finding the patients who can be measured, the endpoint the agency will accept, the investigators who will fight for it — and knowing when the honest answer is that the indication is not there. I have opened several, and stopped one.

  • Indication scouting, feasibility, patient pool and business case
  • Orphan designation and exclusivity strategy
  • Advisory boards and expert meetings that produce a decision, not a summary
  • Life-cycle strategy for an approved product in a new population
Typical trigger: your product works in one disease and someone asked „why not this one too?“
Therapeutic focus

Neurology and neuroimmunology — peripheral and central.

I am a trained neurologist. That is not a line in a biography; it is the reason an investigator will take my call and a reviewer will accept my reasoning about an endpoint. These are the diseases I have designed studies in, argued about with agencies, or published on.

Peripheral nervous system & neuromuscular

Where most of the last fifteen years were spent.
CIDP MMN Guillain-Barré syndrome Dermatomyositis & IIM Myasthenia gravis Paraproteinaemic neuropathy Small fibre neuropathy Paediatric CIDP

Endpoint fluency matters here: INCAT, I-RODS, MRC and Rasch-built measures, grip strength, electrophysiology as an endpoint rather than a footnote.

Central nervous system & neuroinflammation

Where the newer work sits — including imaging biomarkers after ischaemic stroke.
Acute ischaemic stroke Neuroinflammation Autoimmune encephalitis NMOSD / MOGAD Multiple sclerosis Post-COVID syndrome & dysautonomia Neurodegeneration & immune mechanisms

Adjacent and well-travelled: primary and secondary immunodeficiency, transplantation, haemolysis and transfusion safety — the immunology that sits under all of the above.

Perspective

I have sat on every side of this table.

Most senior people in clinical development have spent their career in one kind of organisation, and it shows in what they assume. I have worked in four — which is why I can tell within an hour whether your problem is a science problem, a process problem or a resourcing problem.

Dr. Orell Mielke
Dr. Orell Mielke, MD — board-certified neurologist, twenty-two years in clinical development.
Global pharma

Head of an immunoglobulin portfolio

Fifteen years at CSL Behring, latterly leading clinical global programmes and heading the immunoglobulin section within the immunology therapeutic area. Ten or more programmes at once, teams of ten to fifteen across Germany, the US, Switzerland, the UK, Japan and Belgium, and the main negotiator with FDA, EMA, PMDA and Health Canada. The portfolio accounted for roughly 39 % of group revenue in FY2025. Health authority work spanned FDA, EMA with CHMP and PRAC, PMDA, Health Canada, MHRA, Swissmedic, TGA, Medsafe, ANSM in France and the Paul-Ehrlich-Institut. This is where I learned what a submission really costs.

Mid-cap

Director, plasma proteins

Three years at Biotest with eight direct reports, running immunoglobulin development across hepatitis B and C, CMV, immunodeficiency, sepsis, severe pneumonia and transplantation. The first subcutaneous hepatitis B immunoglobulin for transplant patients was approved in the EU during that time. Mid-cap means owning both the strategy and the execution, with nobody to hand the difficult half to.

Biotech

VP Clinical R&D — building the function from zero

Two years at a thirty-person CNS biotech, reporting to the CEO, the board and the investors. Clinical development, drug safety, regulatory and quality — all of it, built from nothing. We secured EU orphan drug designation for an intravenous cannabinoid receptor agonist in severe traumatic brain injury, and the Phase IIa in ninety-seven comatose patients showed a significant thirty-day survival benefit. I know exactly how it feels when the runway is the constraint on the science.

CRO

Medical monitor and bid defender

Two years at Parexel as medical advisor and assistant medical director, monitoring trials across multiple sclerosis, epilepsy, brain injury, infectious encephalitis, vascular dementia, bipolar disorder, cerebral malignancies, pain, renal failure and HIV — and winning competitive bid defences in pain indications with a combined project value in the tens of millions of dollars. I know how your CRO builds a proposal, because I used to build them.

Before industry: board certification in neurology at Mannheim University Hospital, where I led one of the first German stroke units, and a research period at the Cochrane Stroke Centre in Edinburgh on early CT signs of infarction — work that still gets cited today.

Track record

Four programmes that explain how I work.

Not a list of everything I have touched. Four situations that come back in every company I work with.

Opening an indication

A therapy everyone used, and nobody had proven.

Immunoglobulins had been given in CIDP for years, but subcutaneous maintenance therapy had no approval anywhere — and no obvious way to get one. You cannot ethically randomise stable patients to placebo in a disease that relapses. The answer was a design with a restabilisation phase before randomisation: patients were withdrawn, allowed to deteriorate under observation, restabilised, and only then randomised. It was defensible to ethics committees, credible to investigators and interpretable to three regulators.

Result: approval by the FDA in 2017 and 2018, by Japan's MHLW in 2019, seven years of US orphan exclusivity, and the pivotal trial published in The Lancet Neurology.

What travels: how to build a design that satisfies an ethics committee and a regulator with the same argument — instead of a compromise that convinces neither.
Turning a safety signal into an asset

The finding that could have closed a product line.

Reports of haemolysis after immunoglobulin infusion were accumulating with no agreed case definition, no mechanism and no way to tell a real signal from noise. Rather than manage it defensively, we built a programme: a case definition agreed with the FDA, an aggregate analysis with the plasma protein association and the NIH, a scientific workshop, a post-marketing study, a risk-factor analysis.

Result: a first-author paper in Transfusion identifying anti-blood-group antibodies and individual susceptibility as the mechanism. The signal stopped being a liability and became the company's scientific position.

What travels: a safety signal you understand is an advantage. One you only report is a countdown.
Moving fast without cutting corners

A paediatric programme, concept to protocol, in under six months.

An FDA post-marketing requirement in paediatric CIDP: a population that is small, dispersed and easy to postpone. Instead of the usual eighteen-month cycle, we went from concept to a finished protocol with confirmed feasibility in under six months — by making the design decisions in the right order and testing feasibility while the protocol was still being written, rather than after. Separately, a post-marketing commitment study was closed early with the agency's agreement, releasing budget and people a full cycle sooner.

What travels: speed in development is almost never about working faster. It is about not doing things in the wrong sequence.
Ending a programme well

The phase 3 that missed its primary endpoint.

A global phase 3 in a rare autoimmune muscle disease, 134 patients, recruited to completion in a population most sponsors consider unrecruitable. Then the topline arrived and the responder rates were 64 % against 62 % on placebo. There was no result to spin.

What followed is the part that matters: an orderly database lock, a clean study report, an honest publication and a clear recommendation to stop. Sites were told properly. Patients were told properly. The learning stayed inside the organisation instead of leaving with the programme.

What travels: anyone can steer a programme that is working. Ask a candidate what they did with one that was not — the answer tells you everything.
How we work

Three ways in. All of them reversible.

No retainer you cannot exit, no minimum term that outlives the problem. If the programme changes shape, the engagement changes with it.

Sprint

Two to ten days, fixed scope
  • Second opinion on a protocol or development plan
  • Preparation for a regulatory meeting
  • Due diligence on an asset or a programme
  • Written recommendation, not a workshop

Fractional

Two to eight days a month, rolling
  • Standing medical seat in your development team
  • Named in your organisation chart and to your partners
  • Reachable between the days when it matters
  • Reviewed every quarter, adjustable both ways

Interim

Three to twelve months, near full time
  • Covering a vacancy in medical or clinical leadership
  • Carrying a submission or a study close-out to the end
  • Building the function and handing it over
  • Onboarding and training your permanent hire

All three are available from January 2027. Scoping conversations, NDAs and programme reviews are possible now, so that January starts with the work rather than with the orientation.

Remote by default, on site when the moment deserves it — an investigator meeting, an inspection, a regulatory meeting, a board day. Based in Germany, working across CET, US Eastern and Japan time.

The weekly brief

I read this field every week. You are welcome to read what I make of it.

Every Thursday, one issue on clinical development — weighted towards neurology, neuroimmunology and the regulatory decisions coming out of Europe and the United States. What moved, which trials read out, and for each item what I would do about it if it were my programme. Written for the person who has to make the decision, not for the person who has to write the summary.

I am available for engagements from January 2027. Reading along costs you nothing — and by the time we speak, you will already know how I think.

  • Regulatory FDA and EMA first — approvals, complete response letters, guidances, procedural and capacity change
  • Clinical development Trial results and terminations, endpoint and design decisions, decentralised elements, AI in development
  • Safety Signals, label changes, PRAC recommendations, recalls, Dear-HCP letters
  • Programme risk Manufacturing, supply, sites and vendors — where a clinical programme is genuinely at stake
Latest issue · Issue 1 · 13 August 2026

The week your contract manufacturer became the critical path

A court told the Pentagon to back off China's biggest CRO. Four days earlier, a clean clinical dossier was rejected because of somebody else's factory. Plus GDUFA IV, the first orexin agonist, and a surrogate endpoint that cost 92 % of a share price.

Read this issue All issues

Published Thursdays. English only. No sign-up.

Before you ask

The questions that come up first.

Why not simply hire a CRO or a consultancy?

Because you will get a team, a process and a deliverable — and the medical judgement will still be missing. A CRO executes the plan you give it. A consultancy documents your options. Neither will tell you, in one sentence, that your primary endpoint will not survive the first FDA question. I have sat on the sponsor side of that conversation for twenty-two years, including as the person who had to answer for it.

Is part-time enough for something this important?

For the medical role, usually yes — because the work is not evenly distributed. A protocol takes concentrated weeks; the months after it take judgement calls and availability. What matters is that the same person makes all of those calls, remembers why the last one was made, and is accountable for the outcome. That is what a fractional arrangement buys you. What it does not replace is a clinical operations team.

My molecule is not an immunoglobulin. Does your experience transfer?

The molecule is rarely the hard part. What transfers is everything around it: how to choose an endpoint a regulator will accept, how to design for a population too small for conventional statistics, how to run a data monitoring committee, how to answer an information request without opening three new ones. Across four organisations I have worked on plasma-derived proteins, recombinant Fc multimers, monoclonal antibodies and a small molecule in traumatic brain injury — and monitored trials in multiple sclerosis, epilepsy, encephalitis, vascular dementia, oncology, renal failure and HIV. If a programme genuinely sits outside what I can judge, I will say so in the first conversation.

How do you handle confidentiality and conflicts of interest?

NDA before the first substantive conversation, always. I do not take two mandates that compete in the same indication at the same time, and I will tell you which therapeutic areas are currently blocked before you share anything. Years inside plasma protein companies mean some doors are closed to me — I would rather name them early than explain them late.

When are you available?

For engagements, from January 2027 — all three models. What is possible now: a scoping conversation, an NDA, and a view of your programme, so that January starts with the work rather than with three months of orientation. The programmes worth doing need that lead time anyway, which is why the useful conversation is the one you have a quarter early.

Contact

Where does your programme stand — and where would senior support move it forward?

Leave a number and a time that suits you, and I will call back within 24 hours. I answer personally, and I will tell you in that first conversation whether I am the right person — including when the answer is no.

Fifteen minutes for a first call, no preparation required, no obligation on either side. I work across CET, US Eastern and Japan time, so an early or a late slot is usually workable.

An NDA can be in place before anything substantive, always. If you would rather look at the detail first, the curriculum vitae covers the programmes, the regulatory interactions and the publication list.

Download CV (PDF)

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