Clinical strategy
Target product profile, clinical development plan, indication sequencing, and the clinical evidence your next raise will need.
Independent clinical development consultancy
Senior clinical development support for biotech and pharma
I support biotech and pharma sponsors at any stage, from start-ups taking a first programme into the clinic to established teams that need experienced help on a study. Nineteen years in pharma and biotech R&D, thirteen at GSK, most recently leading an engineered CAR-Treg therapy from target product profile to first patient.
| Experience | 19 years in pharma and biotech R&D, 13 at GSK including 2 at GSK R&D China |
|---|---|
| Phases | First-in-human to Phase 3 |
| Focus | Autoimmune, transplant, rare and acute disease |
| Modalities | Engineered cell therapy, antibodies, enzymes, small molecules |
| Publications | 4 peer-reviewed, in first-in-human safety and dose selection |
| Location | Southampton, UK · working with UK, EU and US sponsors |
Services
How I can help
Senior clinical input at the point where it shapes the programme most: before the protocol is locked and before the first regulatory submission.
First-in-human and Phase 1/2 design
Protocol, investigator's brochure and informed consent. Cohorts, escalation and stopping rules, and incorporating early patient exploration.
Regulatory
Clinical sections of CTAs and INDs, scientific advice briefing packages, and representing the sponsor at agency meetings.
Safety governance
SRC and DMC charters, in-stream review of safety and biomarker data, and benefit-risk for dose escalation.
Interim and fractional clinical lead
Embedded clinical leadership, from one day a week to full-time: CRO and vendor oversight, cross-functional leadership, KOL and advisory board set-up and input.
Ways to engage
Ad hoc advice, a monthly retainer, a fixed-scope deliverable, or dedicated time up to one full-time equivalent. Contracted through Prometheus Clinical Ltd.
Selected work
Programmes I've helped move forward
Cell therapy · Autoimmune · Quell Therapeutics
CD19 CAR-Treg, from TPP to first patient
Drove the target product profile and clinical development plan and led trial design from concept to first patient. The CHILL Phase 1/2 study in systemic sclerosis and difficult-to-treat rheumatoid arthritis opened in April 2026 at ten centres in the UK, Germany and Spain. Led regulatory submissions and scientific advice, and set up independent safety governance.
NCT07473154Cell therapy · Transplant · Sangamo, Quell
CAR-Treg in kidney and liver transplant
Clinical science support on TX200-TR101, a Phase 1/2a kidney transplant study at five centres, and on Quell's LIBERATE Phase 1/2 study in liver transplant.
Rare and acute disease · Current
Acute autoimmune neuropathy, Phase 2 and 3
Protocol authorship for Phase 2 and Phase 3 studies in a disease with no approved therapy, and contribution to a planned US IND submission.
First-in-human safety · GSK
Finding the cause of infusion reactions
Traced cytokine-release reactions in a domain-antibody first-in-human study to pre-existing anti-VH autoantibodies, then supported re-engineering and Phase 1 re-evaluation of the molecule.
Clin Exp Immunol 2015About
John Tonkyn
I've spent my career in early clinical development, first in large pharma and then in clinical-stage biotech. At GSK I worked across four grades over thirteen years, including two years in Shanghai setting up early-phase clinical operations for GSK R&D China.
Since then I've worked at Roche, ONO, Sangamo, Almirall and Quell Therapeutics, most recently as Director of Clinical Development, where I led a CAR-Treg programme from concept to its first patients. In 2026 I set up Prometheus Clinical to offer that experience to biotech and pharma sponsors flexibly, from ad hoc advice to a full-time interim role.
Therapeutic areas
- Systemic sclerosis
- Rheumatoid arthritis
- Psoriatic arthritis
- Psoriasis
- Hidradenitis suppurativa
- Atopic dermatitis
- Kidney and liver transplant
- Guillain-Barré syndrome
- Neurology
- Asthma
- Obesity
- Infectious disease
- Phase 1 oncology
Education
MSc Pharmacometrics and Model-Based Drug Development, University of Manchester (2019)
BSc (Hons) Physiology and Biochemistry, University of Southampton (2007)
Career
- 2026 –Prometheus ClinicalFounder and Principal Consultant
- 2024 – 2025Quell TherapeuticsDirector, Clinical Development
- 2023 – 2024AlmirallTranslational Medicine and Clinical Science Consultant
- 2022 – 2023Sangamo TherapeuticsAssociate Director, Clinical Science
- 2021 – 2022ONO Pharmaceutical UKSenior Clinical Operations Manager
- 2020 – 2021RocheClinical Research Study Leader
- 2007 – 2020GlaxoSmithKlineScientist to Global Clinical Development Manager
Publications
- Specificity of human anti-VH autoantibodies and impact on the design and clinical testing of a VH domain antibody antagonist of TNFR1. Clin Exp Immunol 2015. doi
- First-time-in-human study and prediction of early bactericidal activity for GSK3036656 in tuberculosis. Antimicrob Agents Chemother 2019. doi
- Quantification of human brain PDE4 occupancy by GSK356278: a [11C](R)-rolipram PET study. J Cereb Blood Flow Metab 2018. doi
- Randomized placebo-controlled trial evaluating the ophthalmic safety of single-dose tafenoquine in healthy volunteers. Drug Saf 2019. doi
Need senior clinical development support?
Tell me where your programme is and what's next. A 20-minute call is usually enough to see whether I can help, and how.
EmailEmail[email protected]
Based inSouthampton, United Kingdom