United States
Physician scientist = both MD and PhD in clinically and TA focus relevant translational research. Clinical drug development leader and translational medicine expert. Special expertise in deep integration of unmet clinical needs, disease landscape, immunology, rare disease, oncology and CNS, target product profile differentiation, biology, regulatory, operations, toxicology, ADME/DMPK, collaborating to optimize clinical development across key milestones. Global pharmaceutical companies and biopharma, led 20+ clinical drug development programs: First-In-Human Phase 1 studies, global Phase 2 and global Phase 3 registration clinical trials, label negotiations, regulatory submissions and interactions across critical milestones in USA and Europe. Executed, expert review and sign off >100 clinical trial protocols, including as scientific review committee Chairman. Expertise and experience spans 25+ years in clinical and biomedical sciences, multiple top 10 world-class institutions. 15+ years clinical experience as MD leading teams, treating patients in clinics or acute emergencies (London, Cambridge, Oxford), 14+ years translational medicine, c.10 years pharmaceutical industry drug development, extensive experience leading design & execution of clinical trials & program level strategy. Therapy area: -Immunology: dermatology (psoriasis, atopic dermatitis, HS etc.), gastro (UC, Crohn's disease), rheumatology (lupus/SLE), allergy and rare disease (CSU, HAE) -Neuroscience: multiple sclerosis, Parkinson’s disease, dementias -Oncology: solid tumors (GI, breast, prostate, urothelial, lung), CLL/MCL -Clinical pharmacology: RBA/BE, DDI, 14C, organ impaired, FE, QTc/TQT, pediatric, Japan/China bridging -CVD, hematology: FXI inhibition, coagulation, ITP, PVD Modality: -Small molecules: orthosteric, allosteric, covalent, reversible, prodrug -Biologics: Monoclonal antibodies, peptides, ADC -xRNA: siRNA -Radioligands Graduated First Class (Summa Cum Laude): Cambridge University, College Valedictorian. Board-certified Dr. Published academic papers in top-tier peer-reviewed international journals, world class teams. Proven track record of excellence in academic & clinical drug development. Successful submissions (IND, NDA, CTA/IMPD, MAA etc.), including first-in-class molecules, global marketing approvals of medicines. Led clinical stage business development activities, e.g., Due Diligence, building teams. Promotion discussions as part of leadership team. Well networked.
Global clinical development leader accountable for the strategy, design, and execution of global Phase 2b and Phase 3 registration/pivotal trials in Immunology. Approximately >75,000 employees. Work cross-functionally to support registration, market access, and lifecycle management. Engage with regulators, external experts, and internal stakeholders on clinical development strategy. Advise also on early clinical development strategy and study design as needed
Lead the design and execution of early clinical development programs. Medical lead and monitor for first-in human studies and will play a critical role in shaping our development plans. Previously undruggable SH2 domain targeting proprietary small molecule platform. Lead and sole compound in clinic REX8756 in partnership with Sanofi is oral STAT6 orthosteric inhibitor (non-degrader, no known CRBN liability). Approximately 60 employees.
RNA platform technology in tissue specific siRNA and RNA editing. Clinical Lead on: -Immunology -Neuroscience -Cardiovascular Medicine -Rare Disease Multiple programs in the clinic (clinical trials in Phase 1, 2 and global Phase 3 siRNAs) and preclinical. Approximately 70 employees. 14th C1-inhibitor Deficiency & Angioedema Workshop, Budapest (Hungary), 29 May - 1 June, 2025: Abstract of Clinical Phase 2 study - ADX324, A Q6-Month SC Investigational siRNA Targeting Prekallikrein for HAE Attack Prevention. Gourab Datta et al. May2025: Collaboration and license option agreement with AbbVie to develop siRNA therapies in multiple disease areas, including immunology, neuroscience, and oncology.
Approximately 45,000 employees. Number 1 pharmaceutical company in the world by market cap. Early phase immunology (e.g., psoriasis, atopic dermatitis, lupus/SLE): preclinical, Phase 1 and Phase 2. Late phase oncology (CLL, MCL, breast cancer, prostate cancer): NDA and label negotiations, clinical pharmacology package. Clinical drug development and translational medicine, including regulatory submissions (IND, NDA, FDA meeting requests and other communications), and multiple strategic activities (external Due Diligence pre-in licensing and/or M&A, working group, authoring white paper and other internal drug development guidance documents, present to board of directors etc.).
Exploratory Medicine and Pharmacology (EMP)
Approximately 200 employees. Execution on over 50 Phase 1, first-in-human, clinical pharmacology and Phase 2 clinical trials of investigational drugs (biologics and small molecules) covering multiple TAs across immunology and allergy, oncology, neurology/neuropsychiatry, respiratory and cardiovascular: pharmacovigilance, protocol and IB reviews, staff oversight, clinical trial compliance, safety reporting and regulatory interactions, dose decisions and dose escalation meetings, Sponsor partnerships (global pharmaceutical companies and biotechs).