Executive Summary
Dr. Andrea Pirzkall is an executive physician-scientist with nearly two decades of experience in clinical drug development across global pharmaceutical, biotechnology, and startup companies. Her expertise spans solid-tumor oncology, immuno-oncology, personalized medicine, biomarkers, imaging, medical devices, and AI-driven healthcare innovation, with a track record of evaluating and advancing cancer therapeutics through every stage of development while building and leading high-performing clinical teams.
As a Senior Partner at The Bracken Group, Andrea advises biotech, pharma, and startup clients on clinical development planning and execution — from IND filings and first-in-human studies through Phase III trials and NDA submissions in solid-tumor oncology — while assessing and building clinical development organizations and supporting technology evaluation across AI, imaging, biomarkers, and medical devices. As a serial Chief Medical Officer and Executive Director, she has stood up clinical development organizations at Asher Bio and Replimune — hiring and building in-house Medical & Clinical Science, Translational Medicine, Clinical Operations, Biometrics, Regulatory, and Medical Affairs functions, often within months and under demanding financing and enrollment timelines.
Across roles at Asher Bio, Replimune, BeiGene, and Genentech/Roche, Andrea has advanced first-in-human immunotherapies, led pivotal lung and head & neck programs that supported tislelizumab approvals, and played a critical role in the FDA ODAC review of the Avastin recurrent-glioblastoma filing. Before industry, she trained in radiation oncology at the University of Heidelberg and the German Cancer Research Center and held faculty appointments at UCSF in Radiation Oncology, Radiology, and Neurosurgery. Clients engage Andrea when an oncology or imaging-driven program needs a physician-executive who can connect first-in-human science to a credible path to approval — and build the team to get there.
Areas of Expertise
Oncology Drug Development
End-to-end development across solid tumors — clinical development planning, study design, and Phase 1–3 execution through IND, registrational trials, and NDA submission.
Immuno-Oncology
Cis-targeted immunotherapies, oncolytic immunotherapies, checkpoint and cytokine-fusion programs, and cancer immunotherapy combinations across multiple tumor types.
Clinical Development Strategy
Near- and long-term development roadmaps, endpoint and target product profile logic, and portfolio prioritization executed to support financing and program decisions.
Imaging & Biomarkers
PET and MR imaging endpoints, circulating tumor cells and tumor DNA, tumor biopsies, and biomarker-driven trial design linking patient selection to development intent.
First-in-Human & Early-Phase Trials
IND-enabling work, first-in-human study design, and proof-of-mechanism Phase 1 programs that generate informative early data to guide next development steps.
Building & Leading Clinical Organizations
Assessment, build-out, and leadership of clinical development functions — Medical Science, Translational Medicine, Clinical Operations, Biometrics, Regulatory, and Medical Affairs.
Regulatory & FDA Strategy
IND and NDA/BLA strategy, FDA interactions and advisory committee support, and global filing strategy — including data generated predominantly outside the US.
AI, Devices & Technology Assessment
Evaluation of AI-driven healthcare tools, imaging technologies, biomarkers, and medical devices as they pertain to clinical drug development and program strategy.