PADAMOLOGY CONSULTING
Strategic medical affairs expertise for oncology drug development
Helping biotech and pharmaceutical companies navigate the scientific, operational, and medical complexity of oncology clinical development, from protocol design through study execution and regulatory milestones.
WHY PADAMOLOGY
Good science requires
strong medical leadership
Successful oncology drug development requires more than good science. It requires sound medical judgment, operational execution, and timely decision-making throughout the life of a study.
With more than 17 years in oncology clinical research and drug development, I partner with sponsors, CROs, and emerging biotech companies to solve complex clinical development challenges, strengthen medical oversight, and help studies execute more effectively.
My experience spans early- and late-phase oncology trials, including cell and gene therapies, immuno-oncology, antibody-drug conjugates, targeted therapies, and hematologic and solid tumor programs.
CONSULTING
Solutions are provided
MENTORSHIP
Experience is shared
COACHING
Clarity and decision-making are developed
WHO I WORK WITH
Strategic support for organizations advancing oncology
Venture-Backed
Oncology Startups
Pharmaceutical
Companies
Contract Research Organizations
Academic
Collaborations
Emerging Biotech
Companies
Investors Performing Scientific Due Diligence
CONSULTING SERVICES
How Padamology can support your work
01 MEDICAL MONITORING STRATEGY
Medical monitoring leadership, Medical review strategy, Eligibility review processes, Dose escalation support, Dose modification guidance, DLT adjudication, Safety signal assessment, Investigator medical support, Cross-functional medical leadership, Safety review meetings, Protocol interpretation, Medical monitoring plans, Escalation pathways
02 ONCOLOGY CLINICAL DEVELOPMENT CONSULTING
Development strategy, Early phase oncology planning, Study feasibility, Competitive landscape review, Standard-of-care assessment, Endpoint strategy, Biomarker strategy, Protocol review, Inclusion/exclusion optimization, Medical risk identification
03 CLINICAL TRIAL DESIGN REVIEW
Protocol review, Medical consistency review, Eligibility optimization, Safety assessments, Visit schedule review, Dose modification algorithms, Toxicity management plans, Operational feasibility, Medical review before submission
04 SAFETY & MEDICAL AFFAIRS CONSULTING
Safety review, Aggregate safety assessment, Signal detection, SAE adjudication, DSMB preparation, Safety committee participation, Risk mitigation planning, Medical governance
05 BUSINESS DEVELOPMENT & DUE DILIGENCE
RFP medical support, Bid defense preparation, Sponsor presentations, Scientific due diligence, Competitive intelligence, Development strategy discussions, Investor scientific review
06 CELL & GENE THERAPY CONSULTING
CAR-T development, Gene therapy, Cell therapy operational strategy, CRS/ICANS management, Manufacturing considerations, Long-term follow-up planning, Early phase safety oversight
07 PRECISION ONCOLOGY CONSULTING
Biomarker strategy, Molecular eligibility, Companion diagnostics, Precision medicine trial design, Tissue requirements, Central laboratory strategy
08 MEDICAL EDUCATION
Investigator meetings, Advisory boards, Medical monitor training, Clinical operations education, Oncology training, Executive education, Speaker engagements
09 STRATEGIC ADVISORY
EXECUTIVE ADVISORY: Supporting CEOs, CMOs, and clinical development leaders with strategic medical insight during key decision points.
Go/no-go decisions, Development planning, Portfolio prioritization, Medical risk assessment, Operational strategy, Clinical execution planning
10 SPEAKING & WORKSHOPS
The Future of Medical Monitoring, Early Phase Oncology, Precision Oncology, Medical Leadership, AI in Clinical Development, Clinical Trial Execution, Medical Decision Making
WHY CLIENTS WORK WITH ME
✔ Physician with 17+ years in oncology drug development
✔ Executive Medical Affairs leadership experience
✔ Experience across Phase I-IV oncology studies
✔ Expertise in solid tumors and hematologic malignancies
✔ Experience with ADCs, CAR-T, cell therapy, immunotherapy,
targeted therapies, and radiopharmaceuticals
✔ Deep understanding of CRO and sponsor perspectives
✔ Strategic, practical, and execution-focused approach
ENGAGEMENT MODELS
Hourly Consulting
Project-Based Consulting
Fractional Medical Affairs Leadership
Medical Advisor
Advisory Board Participation
Clinical Development Strategy Sessions
Protocol Reviews
Speaking Engagements
Executive Workshops
Retainers
INDUSTRIES SERVED
Biotechnology • Pharmaceutical • Clinical Research Organizations • Academic Research
Digital Health • Life Science Investors • Healthcare Innovation Companies
