Experienced oncology development professionals, working as one boutique.

DrugDevX is a boutique oncology clinical-development consultancy. It brings together experienced professionals with significant prior pharmaceutical and biotech experience, and assembles the contributors each engagement needs.

We keep this site focused on the work rather than on individuals. Relevant experience, and the contributors proposed for an engagement, are discussed during scoping, once the question and any conflicts are clear.

Oncology only. The work runs from pre-IND strategy and first-in-human planning through Phase 1 to 3 conduct, regulatory interaction and post-approval evidence.

Disease areas include thoracic, gastrointestinal, head and neck, gynecologic and genitourinary oncology, and gliomas and glioblastomas.

Experience spans targeted therapies and tyrosine kinase inhibitors, immuno-oncology, hormone therapies, monoclonal and bispecific antibodies, T-cell engagers, antibody–drug conjugates and drug–device combinations. The approach is shaped by the asset, the disease setting and the evidence needed at each stage.

1. Frame the decision We clarify the program context, the intended outcome, the materials available and who is responsible for what.
2. Examine the evidence We connect clinical findings, design choices and execution assumptions, and make the limitations visible.
3. Set priorities Consequential risks are separated from secondary questions, with the trade-offs and what could change the answer made explicit.
4. Leave a next step A memorandum, issue register, roadmap or leadership discussion, matched to the mandate and written so your team can act on it.

• IndependenceRelevant conflicts and product-development interests, including DrugDevX’s own work on AI-assisted tools, are considered before an engagement is accepted and disclosed when they bear on the work.
• ConfidentialityFirst inquiries should be nonconfidential. Confidential materials are accepted only through an agreed process, and patient-level data are used only where the scope and information-handling arrangements allow.
• Specialist inputBiostatistics, regulatory affairs, CMC, nonclinical, safety, data management and legal questions are coordinated with the appropriate specialists, and responsibilities are written into the scope.
• Human reviewClinical judgment stays with qualified people. Any AI-assisted work is scoped to a defined use, with qualified clinical review of the output.

• Biotech companiesDevelopment strategy, fractional leadership and focused clinical support as programs advance.
• Large pharmaceutical teamsSpecialist input on defined clinical questions, priorities and scientific deliverables.
• Investors and analystsClinical assessment of assets, evidence, development plans and risk.
• CROs and technology teamsClinical expertise for trial design, oversight, data review and the design of tools.

Send a short, nonconfidential outline of the stage, the question and the timing. We will respond about fit, expertise, any conflicts and information requirements, and then agree the scope, deliverables and commercial terms before work begins.