Accelerating Early-Phase Drug Development
Led by Dr. Cyrus Ghobadi, MD, PhD — bringing 18+ years of hands-on clinical development leadership to guide your immunology and inflammatory disease programs from IND through proof-of-concept and beyond.
End-to-End Early Development Expertise
From IND filing through proof-of-concept, I provide the strategic and operational expertise to advance your immunology programs with confidence.
First-in-Human Studies
Expert design and execution of FIH and Phase 1 studies with proven track record of reducing timelines by 25% while maintaining rigorous safety standards.
- FIH Protocol Design
- Dose Escalation Strategy
- Safety Monitoring
IND Strategy & Submission
Navigate the IND process with confidence. Direct experience preparing and submitting INDs with successful FDA interactions and regulatory outcomes.
- IND Package Development
- FDA Meeting Preparation
- Regulatory Correspondence
Clinical Pharmacology
Deep expertise in PK/PD analysis, dose selection, and translational biomarker strategies to optimize your clinical development program.
- PK/PD Analysis
- Dose Selection
- Biomarker Strategy
Global Regulatory Affairs
Strategic guidance for FDA and EMA interactions, with hands-on experience leading regulatory submissions across US and EU markets.
- FDA/EMA Interactions
- Global Registration
- Regulatory Strategy
Proof-of-Concept Design
Design Phase 1b/2a studies that generate compelling efficacy signals and robust data packages to inform go/no-go decisions.
- PoC Study Design
- Endpoint Selection
- Phase 2 Planning
Medical Monitoring
Experienced Principal Investigator and Medical Monitor providing direct oversight of safety assessments and clinical operations.
- Safety Oversight
- CRO Management
- Site Selection
Physician-Scientist with Hands-On Leadership
I'm a Strategic Clinical Development Executive with 18+ years leading early-stage immunology programs from IND through Phase 2 across autoimmune and inflammatory diseases in US, EU, and global markets. My career spans executive roles at AbbVie, Eli Lilly, and AstraZeneca, where I've built a track record of advancing novel therapeutics from First-in-Human through proof-of-concept.
What sets me apart is my dual perspective as both a physician-scientist and industry executive. I've served as Principal Investigator on numerous early-phase studies, giving me hands-on understanding of clinical trial execution that informs my strategic recommendations. At AbbVie, I led a Clinical Pharmacology unit supporting 15+ early-phase immunology programs while managing an $8M+ clinical operations budget.
My expertise spans rheumatology, respiratory, dermatology, gastroenterology, and immuno-oncology. I've successfully reduced First-in-Human study timelines by 25% through cross-functional process optimization—and I bring this same efficiency-focused approach to every consulting engagement.
Therapeutic Expertise
Extensive hands-on experience across multiple therapeutic areas, with particular depth in immunology and inflammatory disease programs.
Executive Medical Director, Head of Clinical Pharmacology – AbbVie
Senior Medical Director, Immunology – Eli Lilly
Medical Director, Translational Medicine – AstraZeneca
Principal Investigator – hVIVO / Clinical Research Units
PhD in Clinical Pharmacology – University of Sheffield
Peer-Reviewed Publications
Contributing to the scientific literature in clinical pharmacology, drug development, and translational medicine.
Advancing the utilization of real-world data and real-world evidence in clinical pharmacology and translational research
Liu J, Rowland-Yeo K, Winterstein A, Dagenais S, Liu Q, Barrett JS, Zhu R, Ghobadi C, et al.
Cytokines and epidermal lipid abnormalities in atopic dermatitis: A systematic review
Upadhyay PR, Vidal LS, Abe B, Ghobadi C, Sims JT
Clinical pharmacology applications of real-world data and real-world evidence in drug development and approval - An industry perspective
Zhu R, Vora B, Menon S, Younis I, Dwivedi G, Meng Z, ..., Ghobadi C, et al.
Prediction of CYP2D6 phenotype from genotype across world populations
Gaedigk A, Simon SD, Pearce RE, Bradford LD, Kennedy MJ, Leeder JS, Ghobadi C, et al.
A systems pharmacology approach to predict drug-drug interactions
Ghobadi C, et al.
Evaluation of the relationship between plasma concentrations of en- and zuclomiphene and induction of ovulation
Ghobadi C, et al.
Drug-drug interactions and CYP2D6 polymorphism
Ghobadi C, et al.
Pharmacokinetic and pharmacodynamic modeling
Ghobadi C, et al.
Population pharmacokinetics in drug development
Ghobadi C, et al.
Simulating pharmacokinetics using physiologically-based models
Ghobadi C, et al.
CYP2D6 genotype and drug metabolism
Ghobadi C, et al.
Individualized dosing strategies in clinical practice
Ghobadi C, et al.
Trusted by Industry Leaders
What colleagues and collaborators say about working with Dr. Ghobadi
I had the pleasure of working with Cyrus at AbbVie in the Clinical Pharmacology Department, where he led AbbVie Clinical Pharmacology Research Unit organization and oversaw Phase 1 healthy volunteer trials with exceptional scientific rigor and operational excellence. His MD/PhD training and deep expertise in clinical pharmacology and translational science consistently strengthened our programs. He is a rare combination of strategic thinker, supportive mentor, and results-driven clinician-scientist.
Let's Discuss Your Program
Ready to accelerate your early-phase development? Schedule a confidential consultation to explore how I can help advance your immunology program.